chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Malaise, Myalgia, Nausea, Vision blurred
Clinical narrative: When I woke up on 11/14/24 I felt dizzy and nauseous. I had to stop brushing my teeth to sit down. Then my vision when completely dark for about 30 seconds, but I did not lose consciousness. My vision returned but was blurry and that lasted about 5 more minutes. I was able to start drinking some water/electrolytes and began to feel better. After this episode, I check my blood pressure at home and it was 86/42. I continue to rest and hydrate and my blood pressure rose to 90-100/~60. I felt sick for about another 24 hours - headache, malaise, myalgias, brain fog. I did not do anything else unusual the day before and never have had anything like this before nor any syncopal or pre-syncopal episodes.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event reported by facility.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt scheduled himself to have a flu shot. His doctor was out of the office so I offered to give his shot to him. I was unaware that pt had a flu shot in October. I spoke to the physician that I work for and pt should not have any adverse effects from the second flu shot.
Age: 50.0
Sex: F
Vaccine: PNC21, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Two days after vaccine administration, the vaccination site where Capvaxive and Shingrix were given became swollen, itchy, hot to the touch and a red circle formed. The redness started out small and has expanded out to about the size of a hand. The size of the redness has not gotten smaller and the itching and heat have not gotten better and it has been 5 days since vaccination. As of today 11/25/24, she had not tried any OTC treatment. I recommended an antihistamine and a cold pack on the site to see if any relief was found. I also recommended she put a call in to her doctor to give them a heads up in case they wanted see her since it is a holiday week. She said the reaction is localized to that arm and experienced no swelling elsewhere.
Age: 59.0
Sex: F
Vaccine: FLU3, PNC21
Symptoms: Chest pain, Dyspnoea, Erythema, Flank pain, Pain in extremity
Clinical narrative: patient received capvaxive and flublok vaccines on 11/18/24. patient noticed pain and swelling in right arm (both injections given in right arm). by tuesday evening 11/19/24, patient states that redness and more swelling became more prevalent. she then proceeded to treat symptoms with ice pack on arm and tylenol by mouth. patient was due at facility for checkup on 11/20/24 and provider at hospital noticed more reaction symptoms present on the back of patient's right arm and moving down to the lower part of arm. patient was instructed to follow up with pcp asap for concerns of infection from vaccines (cellulitis). patient was seen at pcp on 11/21/24 at pcp and was given rocephin antibiotic shot. patient states hours later than she then began having symptoms of sharp flank and chest pains and what she perceived to be a panic attack (shortness of breath). patient was told by ER nurse that "it is known that pneumonia vaccines and flu vaccines are not to be given at the same especially in the same arm and that they have always done them separated at the hospital." patient presented at 3495 to report adverse reactions that she believes were caused from the capvaxive vaccine (she has tolerated flublock in the past).
Age: 59.0
Sex: F
Vaccine: FLU3, PNC21
Symptoms: Panic attack, Peripheral swelling
Clinical narrative: patient received capvaxive and flublok vaccines on 11/18/24. patient noticed pain and swelling in right arm (both injections given in right arm). by tuesday evening 11/19/24, patient states that redness and more swelling became more prevalent. she then proceeded to treat symptoms with ice pack on arm and tylenol by mouth. patient was due at facility for checkup on 11/20/24 and provider at hospital noticed more reaction symptoms present on the back of patient's right arm and moving down to the lower part of arm. patient was instructed to follow up with pcp asap for concerns of infection from vaccines (cellulitis). patient was seen at pcp on 11/21/24 at pcp and was given rocephin antibiotic shot. patient states hours later than she then began having symptoms of sharp flank and chest pains and what she perceived to be a panic attack (shortness of breath). patient was told by ER nurse that "it is known that pneumonia vaccines and flu vaccines are not to be given at the same especially in the same arm and that they have always done them separated at the hospital." patient presented at 3495 to report adverse reactions that she believes were caused from the capvaxive vaccine (she has tolerated flublock in the past).
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tinnitus, Vertigo
Clinical narrative: MODERNA #1 1/14/2021 MODERNA #2 2/11/2021 MODERNA #3 1/11/2022 PATIENT DEVELOPED WORSENED TINNITUS AN DEVELOPMENT OF NEW VERTIGO.  TREATED WITH ANTIVERT AND POTOCOL BASE SPIKE DETOXIFICATION.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No Adverse event has been reported by facility
Age: 70.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Mobility decreased, Pain, X-ray limb
Clinical narrative: 2 days following administration soreness and decreased range of motion, persistent pain. Ibuprofen and heat to alleviate pain.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event
Clinical narrative: No adverse event has been reported by Assisted Living Facility.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event has been reported by the assisted living facility.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Migraine, Nausea
Clinical narrative: Extremely severe migraine, Nausea, chills.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Headache, Night sweats, Vomiting
Clinical narrative: headache, night sweats, vomiting, problem focusing
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event
Clinical narrative: No adverse event has been reported by assisted living facility.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye pruritus, Feeling hot, Injection site rash, Ocular hyperaemia
Clinical narrative: 24 hours after shot had extreme rash/welts on both arms from elbows on up to shoulders.  Red purple, itchy hot.  Also felt within eyes, ears, mouth.  Day later had some on right foot.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Oral discomfort, Oral mucosal erythema, Oral pruritus, Rash, Rash erythematous
Clinical narrative: 24 hours after shot had extreme rash/welts on both arms from elbows on up to shoulders.  Red purple, itchy hot.  Also felt within eyes, ears, mouth.  Day later had some on right foot.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Skin warm, Urticaria
Clinical narrative: 24 hours after shot had extreme rash/welts on both arms from elbows on up to shoulders.  Red purple, itchy hot.  Also felt within eyes, ears, mouth.  Day later had some on right foot.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Heart rate increased, Laboratory test, Palpitations
Clinical narrative: I initially was very short of breath, especially when walking in the neighborhood or walking upstairs. This progressed to palpitations, very rapid heart rate, dizziness, etc. I didn't initially recognize this as possibly being from the vaccine. I thought I was out of shape, having stopped going to the gym when Covid began. That's why I didn't report it on the Vsafe questionnaire. I am not sure of the exact date when symptoms began, but it was right after getting the first vaccine. I was diagnosed as having Postural Orthostatic Tachycardia  Syndrome and neurocardiogenic syncope  in 2022. After seeing reports that some cases of POTS have been associated with the Covid vaccine, I asked my doctor if that was a possibility in my case. I was told it was probable, but there was no way to confirm.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Postural orthostatic tachycardia syndrome, Syncope, Tilt table test positive
Clinical narrative: I initially was very short of breath, especially when walking in the neighborhood or walking upstairs. This progressed to palpitations, very rapid heart rate, dizziness, etc. I didn't initially recognize this as possibly being from the vaccine. I thought I was out of shape, having stopped going to the gym when Covid began. That's why I didn't report it on the Vsafe questionnaire. I am not sure of the exact date when symptoms began, but it was right after getting the first vaccine. I was diagnosed as having Postural Orthostatic Tachycardia  Syndrome and neurocardiogenic syncope  in 2022. After seeing reports that some cases of POTS have been associated with the Covid vaccine, I asked my doctor if that was a possibility in my case. I was told it was probable, but there was no way to confirm.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Brain fog, Headache, Influenza like illness
Clinical narrative: patient said next evening started with normal flu-like symptoms but then developed pain in all joints, head pounding, brain fog, pain that starts in back of head that wraps around and down left side
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Headache, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient received vaccines mid day on 11/21/2024. By 7 pm that same evening patient complained of a "bump" on left deltoid. It was large and red mother reported. On 11/22/2024 patient woke up with a headache and mild fever. Mother took patient to ER. Tylenol and Ibuprofen was given to patient by Mother and it relieved the headache. But Mother still took patient to ER to get arm looked at, as she stated the site was swollen as big as a tennis ball. ER treated for possible infection and one dose of Keflex was given. Patient was seen back in our office today and Provider diagnosed patient with local reaction to Meningococcal vaccine, which is improving. Advised to use ice and Benadryl cream to site. Site reaction today is about 8cm.
Age: 1.17
Sex: M
Vaccine: FLUN3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: I was asked by our preceptor if I had experience with the FluMist administration and when I replied "yes", she handed me a the mist and asked me to administer it to the patient. Following administration, she re-reviewed the age of the patient and realized the patient was too young to have received the live vaccine. I should have looked at the patients paperwork and double-checked that the patient was of age to receive the mist instead of relying solely on our preceptor's review of it.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Angiogram normal, Head discomfort, Headache, Hypoaesthesia
Clinical narrative: On day 3 I woke up with some mild loss of memory (family members names) I looked at my phones contact list to see if I could pick out the names of family members who were in the room with me at that time. I couldn't not recall the names of my husband and my daughter.  This lasted about 15 minutes.  My memory came back and then my left hand went numb and that lasted about 10 minutes. I ended up with a massive headache which I thought was because of a sinus infection so I treated with Sudafed and tylenol.  Nothing helped.  The next day it happened again so I had taken some Afrin to relieve the pressure and the pain again it didn't help. I called my doctor's office and they wanted to see me right away. She ordered testing.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging normal, Migraine with aura, Ultrasound Doppler
Clinical narrative: On day 3 I woke up with some mild loss of memory (family members names) I looked at my phones contact list to see if I could pick out the names of family members who were in the room with me at that time. I couldn't not recall the names of my husband and my daughter.  This lasted about 15 minutes.  My memory came back and then my left hand went numb and that lasted about 10 minutes. I ended up with a massive headache which I thought was because of a sinus infection so I treated with Sudafed and tylenol.  Nothing helped.  The next day it happened again so I had taken some Afrin to relieve the pressure and the pain again it didn't help. I called my doctor's office and they wanted to see me right away. She ordered testing.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Laboratory test, Palpitations, Small fibre neuropathy
Clinical narrative: PFIZER #1 4/7/2021 PFIZER #2 4/28/2021 DEVELOPED SMALL FIBER SENSORY NEUROPATHY OF LOWER EXTREMITY AND PALPITATIONS.  TREATED WITH NICOTINE PATCH OTC AND PROTOCOL BASE SPIKE DETOXIFICATION
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis ulcerative, Colonoscopy abnormal, Gastrointestinal haemorrhage
Clinical narrative: New onset GI bleeding 2 weeks after 1st Pfizer injection.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Feeling cold, Head injury, Loss of consciousness, Seizure
Clinical narrative: After injection of the vaccine, patient lost consciousness and fell out of the mobility scooter he was seated in. Fell onto floor and hit his head. Had brief seizure activity/convulsions. Came to quickly and was alert. Patient was cold and perpetrating upon returning to consciousness. Emergency services were called and took over care from that point.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received a third dose of the shingrix vaccine
Age: 1.92
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Mood altered
Clinical narrative: pediatric pt was given adult dose of comirnaty. Talked to mom on the phone today, states daughter was "bummed out" (moody) the day after vaccines but is back to her normal self today.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: GAVE VACCINE THAT WAS PAST THE BEYOND USE DATE
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient had received a DTAP in May of 2024 and it wasn't uploaded to database and he received another dose on 9/11/24. Mother of child denies any side effects from the extra dose.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Gait disturbance, Joint swelling, Pain in extremity, Pyrexia
Clinical narrative: High temperature, bad cough, pain in legs, rash on lower legs, intense pain in middle of each calf, swollen ankles, vertigo, problems walking
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Vertigo
Clinical narrative: High temperature, bad cough, pain in legs, rash on lower legs, intense pain in middle of each calf, swollen ankles, vertigo, problems walking
Age: 24.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Inappropriate schedule of product administration
Clinical narrative: A third dose of the MMR vaccine was administered to the patient prior to the patient being due for the vaccine.
Age: 24.0
Sex: F
Vaccine: MMR, MMR
Symptoms: No adverse event, Wrong product administered
Clinical narrative: A third dose of the MMR vaccine was administered to the patient prior to the patient being due for the vaccine.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional AE; HCP called to report an inadvertent administration of an adult dose of VAQTA to a 10 yr old patient on 10/18/2024.; This spontaneous report has been received from a nurse, regarding to a 10-year-old. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 18-OCT-2024, the patient was vaccinated with an inadvertent adult dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, at a dose of 5 milliliters (ml), administered as prophylaxis (route of administration, anatomical site of injection, lot number, and expiration date, were not provided) (Incorrect dose administered).  No additional adverse event was reported (No adverse event).
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Therapeutic response unexpected
Clinical narrative: boy with aggressive RRP did not need further surgeries in the 10 months following vaccination; This spontaneous report came from  a chapter of the book concerning a 2-year-old male patient. The editors of the book were captured as reporters.   The patient's medical history and concomitant medications were not provided. The patients'  current conditions included Recurrent Respiratory Papillomatosis (RRP).   On an unknown date, the patient was vaccinated neither with  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); or neither with  quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).   In the book it was reported that the patient with RRP did not need further surgeries in the 10 months following vaccination, which was an unexpected response for the vaccine (Therapeutic response unexpected).   The causal relationship between the suspect vaccines and Therapeutic response unexpected was captured as related.
Sex: U
Vaccine: COVID19, RVX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain barre syndrome; This serious case was reported by a consumer via other manufacturer and described the occurrence of guillain barre syndrome in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included Tozinameran (Pfizer BioNTech COVID-19 vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine and Pfizer BioNTech COVID-19 vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced guillain barre syndrome (Verbatim: Guillain barre syndrome) (serious criteria GSK medically significant and other: Serious as per reporter). The outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to RSV vaccine.     The company considered the guillain barre syndrome to be unrelated to RSV vaccine.   Additional Information: GSK Receipt Date: 18-NOV-2024  The reporter reported that for RSV vaccine and reporting increased cases of Guillain-Barre syndrome for people using Pfizer vaccine GlaxoSmithKline vaccine.  The reporter reported moderna had shown no cases for it.  The reporter read it online last May 2024. It was unknown if the reporter considered the guillain barre syndrome to be related to Pfizer BioNTech COVID-19 vaccine.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK RSV vaccine.
Sex: U
Vaccine: TDAP
Symptoms: Pertussis, Vaccination failure
Clinical narrative: Suspected vaccination failure; Mild Pertussis; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, 2 months after receiving Boostrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and pertussis (Verbatim: Mild Pertussis) (serious criteria GSK medically significant). The outcome of the vaccination failure was not reported and the outcome of the pertussis was resolved.   It was unknown if the reporter considered the vaccination failure and pertussis to be related to Boostrix.     The company considered the vaccination failure and pertussis to be unrelated to Boostrix.   Additional Information: GSK Receipt Date: 13-NOV-2024 Nurse stated that the patient was fully vaccinated with Boostrix, and developed a mild case of Pertussis 2 months post vaccination.  HCP was suspicious that there was a new strain of pertussis and wonders if there were studies ongoing evaluating this concern. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding pertussis were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about details regarding  completion of primary vaccination schedule and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Boostrix.  Pertussis is an unlisted event which is considered unrelated to GSK vaccine Boostrix.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-NOV-2024 The reporter reported that she was looking to report to someone who did research on the vaccine that after taking the vaccine , she had shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: got random hives; This spontaneous case was reported by a patient family member or friend and describes the occurrence of URTICARIA (got random hives) in a 7-year-old male patient who received mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Nov-2023, the patient received dose of mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (unknown route) 1 dosage form. On 22-Nov-2023,  after starting mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024), the patient experienced URTICARIA (got random hives). The patient was treated with Diphenhydramine hydrochloride (Benadryl) in November 2023 for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (got random hives) outcome was unknown.        For mRNA-1273.815 (MODERNA COVID-19 VACCINE 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Patient got random hives on 22 Nov 2023, but that was only a few hours controlled by Benadryl. They attributed it to strep he got 2 days later at the time. Patient had two Moderna before that in the year it became available.   This case was linked to US-MODERNATX, INC.-MOD-2024-777324 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2024: Live significant follow-up received- treatment drug added.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia areata, Asthenia, Autoimmune thyroiditis, Brain fog, Chronic fatigue syndrome
Clinical narrative: Depression; diagnosed in the same year with Hashimotos Thyroiditis; brain fog; Hypersomnia which interfered with daily life sleeping 14-16 hours per day; memory problems; ME/CFS/Severe unrelenting fatigue/post exertional malaise; postural orthostatic tachycardia syndrome; appetite loss; alopecia areata/hair loss; weakness; This spontaneous case was reported by a patient and describes the occurrence of AUTOIMMUNE THYROIDITIS (diagnosed in the same year with Hashimotos Thyroiditis) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011L20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 09-Feb-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. In 2021, the patient experienced AUTOIMMUNE THYROIDITIS (diagnosed in the same year with Hashimotos Thyroiditis) (seriousness criterion medically significant), BRAIN FOG (brain fog), HYPERSOMNIA (Hypersomnia which interfered with daily life sleeping 14-16 hours per day), MEMORY IMPAIRMENT (memory problems), CHRONIC FATIGUE SYNDROME (ME/CFS/Severe unrelenting fatigue/post exertional malaise), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (postural orthostatic tachycardia syndrome), DECREASED APPETITE (appetite loss), ALOPECIA AREATA (alopecia areata/hair loss) and ASTHENIA (weakness). On an unknown date, the patient experienced DEPRESSION (Depression). At the time of the report, AUTOIMMUNE THYROIDITIS (diagnosed in the same year with Hashimotos Thyroiditis), BRAIN FOG (brain fog), HYPERSOMNIA (Hypersomnia which interfered with daily life sleeping 14-16 hours per day), MEMORY IMPAIRMENT (memory problems), CHRONIC FATIGUE SYNDROME (ME/CFS/Severe unrelenting fatigue/post exertional malaise), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (postural orthostatic tachycardia syndrome), DECREASED APPETITE (appetite loss), ALOPECIA AREATA (alopecia areata/hair loss), ASTHENIA (weakness) and DEPRESSION (Depression) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that symptoms were continued and worsened over the next 3 and a half years.  Patient had to decrease the work level which led to financial problems. Patient was bedridden and weak from debilitating fatigue, needed 6 months of physical therapy to somewhat gain strength yet still unable to do enough due to post exertional malaise. It was reported that ability to keep up with work was interfered.  It was unknown if the patient experienced any additional symptoms/events.  Treatment information was not reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Depression, Hypersomnia, Memory impairment, Postural orthostatic tachycardia syndrome
Clinical narrative: Depression; diagnosed in the same year with Hashimotos Thyroiditis; brain fog; Hypersomnia which interfered with daily life sleeping 14-16 hours per day; memory problems; ME/CFS/Severe unrelenting fatigue/post exertional malaise; postural orthostatic tachycardia syndrome; appetite loss; alopecia areata/hair loss; weakness; This spontaneous case was reported by a patient and describes the occurrence of AUTOIMMUNE THYROIDITIS (diagnosed in the same year with Hashimotos Thyroiditis) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011L20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 09-Feb-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. In 2021, the patient experienced AUTOIMMUNE THYROIDITIS (diagnosed in the same year with Hashimotos Thyroiditis) (seriousness criterion medically significant), BRAIN FOG (brain fog), HYPERSOMNIA (Hypersomnia which interfered with daily life sleeping 14-16 hours per day), MEMORY IMPAIRMENT (memory problems), CHRONIC FATIGUE SYNDROME (ME/CFS/Severe unrelenting fatigue/post exertional malaise), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (postural orthostatic tachycardia syndrome), DECREASED APPETITE (appetite loss), ALOPECIA AREATA (alopecia areata/hair loss) and ASTHENIA (weakness). On an unknown date, the patient experienced DEPRESSION (Depression). At the time of the report, AUTOIMMUNE THYROIDITIS (diagnosed in the same year with Hashimotos Thyroiditis), BRAIN FOG (brain fog), HYPERSOMNIA (Hypersomnia which interfered with daily life sleeping 14-16 hours per day), MEMORY IMPAIRMENT (memory problems), CHRONIC FATIGUE SYNDROME (ME/CFS/Severe unrelenting fatigue/post exertional malaise), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (postural orthostatic tachycardia syndrome), DECREASED APPETITE (appetite loss), ALOPECIA AREATA (alopecia areata/hair loss), ASTHENIA (weakness) and DEPRESSION (Depression) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that symptoms were continued and worsened over the next 3 and a half years.  Patient had to decrease the work level which led to financial problems. Patient was bedridden and weak from debilitating fatigue, needed 6 months of physical therapy to somewhat gain strength yet still unable to do enough due to post exertional malaise. It was reported that ability to keep up with work was interfered.  It was unknown if the patient experienced any additional symptoms/events.  Treatment information was not reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash macular, Vaccination site rash
Clinical narrative: ever since I got the injection. It's been itchy; It's a larger blotchy area around the injection site on my shoulder about 3 inches by 3 inches in an irregular pattern; It's a larger blotchy area around the injection site on my shoulder about 3 inches by 3 inches in an irregular pattern; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (ever since I got the injection. It's been itchy), RASH MACULAR (It's a larger blotchy area around the injection site on my shoulder about 3 inches by 3 inches in an irregular pattern) and VACCINATION SITE RASH (It's a larger blotchy area around the injection site on my shoulder about 3 inches by 3 inches in an irregular pattern) in a patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (Dose 1), Moderna COVID-19 vaccine (Dose 2) and Moderna COVID-19 vaccine (Dose 3); for Product used for unknown indication: FLU (never had an issue with any injection of any even flu shots of any type). Past adverse reactions to the above products included No adverse effect with FLU, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine and Moderna COVID-19 vaccine.    On 16-Nov-2024, the patient received fourth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 16-Nov-2024, the patient experienced PRURITUS (ever since I got the injection. It's been itchy), RASH MACULAR (It's a larger blotchy area around the injection site on my shoulder about 3 inches by 3 inches in an irregular pattern) and VACCINATION SITE RASH (It's a larger blotchy area around the injection site on my shoulder about 3 inches by 3 inches in an irregular pattern). At the time of the report, PRURITUS (ever since I got the injection. It's been itchy), RASH MACULAR (It's a larger blotchy area around the injection site on my shoulder about 3 inches by 3 inches in an irregular pattern) and VACCINATION SITE RASH (It's a larger blotchy area around the injection site on my shoulder about 3 inches by 3 inches in an irregular pattern) had not resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that patient was in good health. Patient never had an issue with any injection of any even flu shots of any type.  No treatment information was provided.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Piloerection, Pyrexia
Clinical narrative: covid vaccine gave her a "goose egg" on her right arm; fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PILOERECTION (covid vaccine gave her a "goose egg" on her right arm) and PYREXIA (fever) in a 69-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043835) for COVID-19 prophylaxis.    Co-suspect product included non-company product Influenza vaccine for an unknown indication.    Concurrent medical conditions included Endometrial cancer. Concomitant products included Lenvatinib mesilate (Lenvima) for Endometrial cancer.   On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On an unknown date, the patient experienced PILOERECTION (covid vaccine gave her a "goose egg" on her right arm) and PYREXIA (fever). At the time of the report, PILOERECTION (covid vaccine gave her a "goose egg" on her right arm) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   It was reported that concomitant drug Lenvima first dispense was on 08-Aug-2024. After Lenvima patient previously reported diarrhea, tiredness, fatigue, fever, less of an appetite, lost a little weight, and blood pressure has been high a few times. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had Covid once; had Covid once; This is a spontaneous report received from a Consumer or other non HCP.  A 59-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, in Oct2023 as dose number unknown, single. Vaccination history included: Bnt162b2 (Dose: 1, Anatomical locations: Arm), for Covid-19 Immunization; Bnt162b2 (Dose: 2, Anatomical locations: Arm), for Covid-19 Immunization; Bnt162b2 (Dose: 3, Anatomical locations: Arm), for Covid-19 Immunization; Bnt162b2 (Dose: 4, Anatomical locations: Arm), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2024, outcome "unknown" and all described as "had Covid once". The patient got the Pfizer Covid shot probably in the fall, Sep or Oct timeframe, got flu and covid vaccines around the same time, like Oct2023 and then got Covid in Apr2024.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400306501 same patient, different dose and event;
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clot; This is a spontaneous report received from a Consumer or other non HCP.  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 and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "Blood clot". The event "blood clot" required physician office visit. Clinical course: Reporter stated that their Primary care doctor, told them it was very suspicious. He also had five of the patients that came down with blood clots after they took the Pfizer vaccine the first one. Reporter further stated it was just too coincidental like they said that five other people in their primary care doctor's office also got blood clots after they received the first, the second injection, he didn't know which one it was, that caused it but there was definitely a connection to that.  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-202400308254 same reporter/product, different patient/event;
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clot; This is a spontaneous report received from a Consumer or other non HCP.  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 and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "Blood clot". The event "blood clot" required physician office visit.  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-202400308254 Same reporter/drug, different patient/event.;
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Psoriasis
Clinical narrative: eczema; psoriasis; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient (unknown if pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: ECZEMA (non-serious), outcome "unknown"; PSORIASIS (non-serious), outcome "unknown". Batch/lot number is not provided, and it cannot be obtained.  Additional information: Caller came from a dermatologist and was planning to get the Pfizer booster and mentioned that her doctor cautioned her about the increase in eczema and was diagnosed with psoriasis if she will get the Pfizer covid vaccine. Caller added that she already gotten the few other ones 7 months ago and can't imagine doing anything to make it worse. Caller would like to know if what information Pfizer has about these two problems.
Sex: M
Vaccine: FLUX
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling, Type III immune complex mediated reaction
Clinical narrative: Large swelling at his influenza vaccine injection site (3rd injection); Large swelling at his influenza vaccine injection site (1st injection); Large swelling at his influenza vaccine injection site (2nd injection); Painful, indurated, and pruritic swellings at each location; Painful, indurated, and pruritic swellings at each location; The literature (initial receipt: 05-NOV-2024) concerns a child male patient with Arthus reaction, a type III hypersensitivity reaction, triggered by interaction between vaccine antigens and pre-existing IgG antibodies.  The patient experienced large swelling at his influenza vaccine (trade name, manufacturer and lot number not reported  to be requested upon follow up) injection site on two separate occasions, 13 months apart. His third dose was divided between two injection sites, yet he developed painful, indurated, and pruritic swellings at each location within four hours, resolving after three days.  Authors' comment: This case series emphasizes the need for providers to recognize Arthus reactions with vaccines beyond tetanus toxoid. Strategies like dose splitting may not prevent reactions.; Reporter's Comments: The events were considered as related.
Sex: F
Vaccine: FLUX
Symptoms: Skin lesion, Swelling
Clinical narrative: Large, localized swelling; Lesions; The literature (initial receipt: 05-NOV-2024) concerns a child male patient Arthus reaction, a type III hypersensitivity reaction, triggered by interaction between vaccine antigens and pre-existing IgG antibodies.   The patient developed large, localized swelling within hours of her annual influenza vaccine (trade name, manufacturer and lot number not reported - to be requested upon follow up) since infancy. Lesions resolved after two weeks.   Authors' comment: This case series emphasizes the need for providers to recognize Arthus reactions with vaccines beyond tetanus toxoid. Strategies like dose splitting may not prevent reactions.; Reporter's Comments: Event localized swelling and Lesions considered as related
Age: 11.0
Sex: M
Vaccine: FLU3, HPV9, MNQ, TDAP
Symptoms: Expired product administered
Clinical narrative: HPV vaccine given after expiration date of 11-9-24.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (R) deltoid became swollen raised warm & tender now 1. 5 inches x 3 - 4 days then decrease swelling   2 wks later still 1 cm diameter lump under skin tender but without redness
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Limb mass, Pain in extremity, Skin warm
Clinical narrative: Redness, very hot, enlarged lump size of egg on arm; painful
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal distension, Abdominal pain, Polymenorrhoea
Clinical narrative: Unexpected period started on Saturday, after the vaccine, bringing my period 14 days early. I due-diligently track my cycle and this unexpected period accompanied with sever abdominal pain and bloating (also unusual symptoms for me) caused me some concern. The only thing that changed in my lifestyle is that I received a mandatory Seasonal Flu vaccine on Friday, Nov 22. This vaccine has caused hormonal changes inside my body resulting in an extra period.
Age: 67.0
Sex: M
Vaccine: UNK
Symptoms: Cognitive disorder, Hypoaesthesia, Memory impairment, Muscular weakness, Pyrexia
Clinical narrative: Numbness and weakness in the arms and  legs on my way back from the provider who gave vaccination.  Tunnel vision. Low grade fever. Severe problems with memory and cognition. I am still feeling the effects to this day that is why I am reporting this.
Age: 67.0
Sex: M
Vaccine: UNK
Symptoms: Tunnel vision
Clinical narrative: Numbness and weakness in the arms and  legs on my way back from the provider who gave vaccination.  Tunnel vision. Low grade fever. Severe problems with memory and cognition. I am still feeling the effects to this day that is why I am reporting this.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pruritus, Skin warm
Clinical narrative: REDNESS SORENESS WARM TO TOUCH  ITCHY
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: A family of 3 came to the pharmacy to get flu shots (two adults and a 17 year old). Employee prepped the vaccinations ahead of time by grabbing 1 Fluzone (for ages 6 months and older) and 2 Flublock (for 18 years and older). Employee administered the first flu shot to the mother with the correct vaccination, then he proceeded to vaccinate the 17 year old. He had the handheld with him in the booth and got the DOB and scanned the correct vaccine, but then grabbed the incorrect prepped vaccine and failed to verify which one he was going to give to the 17 year old before administering it. Which then he gave the 17 year old the flublock instead of the fluzone. After administering his shot, he proceeded to vaccinate the father. When he was about to vaccinate the father, he scanned the correct box and grabbed the vaccine but this time he did accurately check the prepped vaccine and realized his mistake. He gave the father the correct vaccine and talked to the parents about what happened. They were not upset as "he is almost 18 years old" anyways. We told them we will call them in a day or two to see how he is doing after the vaccination.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: AREA NEAR VACCINATION SITE IS TENDER AND SLIGHTLY SWOLLEN. THERE IS A SIGNIFICANT PATCH OF REDNESS AT LEAST 1.5 INCHES IN DIAMETER NEAR THE VACCINATION SITE.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Loss of consciousness, Nausea
Clinical narrative: Patient was walking around shopping and passed out. She was caught by her mother and did not hit anything on the way down. Patient reported vision disturbances before passing out after she came to. She left shortly after walking out of the store. I called to check on patient 30 mins and 2 hours later and she still reported a headache and nausea. Mom was monitoring.  At this time I do not know the result of the adverse event as symptoms were still ongoing.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong product administered
Clinical narrative: Patient came to pharmacy to receive a Covid-19 vaccine (Moderna brand requested).  Patient received a Flu shot (FLUAD for 65 and older) instead.  Patient was every upset because she wanted the Covid-19 vaccine today and Flu shot in December instead.  We offered to come to her house to give her the Covid-19 vaccine because it is not easy for her to go to a pharmacy.   Patient called back a few hours later and did not want us to come to her house to give her the Covid-19 vaccine.  She made an appointment with another pharmacy for Covid-19 vaccine.
Age: 1.67
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was due for DTaP and was given Tdap instead.