chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, PPV, VARZOS
Symptoms: Blood pressure increased, Drug interaction, Feeling abnormal, Loss of consciousness, Malaise
Clinical narrative: After the Covid-19 Vaccines she was horribly tired; had brain fog; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 29Oct2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Macular degeneration" (unspecified if ongoing), notes: She has macular degeneration and gets a shot for that once a month. It goes into her right eye.; "Blood pressure high" (unspecified if ongoing), notes: Started around age 65; "Osteoporosis postmenopausal" (unspecified if ongoing), notes: Osteoporosis postmenopausal. Concomitant medication(s) included: LISINOPRIL oral taken for hypertension; PROLIA taken for osteoporosis postmenopausal as dose number unknown, single; VITAMIN C [ASCORBIC ACID]. Vaccination history included: BNT162b2 (Dose 1: , Date: 08Feb2021, Lot: EL9266, Location: Left arm), administration date: 08Feb2021, when the patient was 79-year-old, for COVID-19 immunization; BNT162b2 (Dose 2:, Date: 01Mar2021, Lot: EN6203, Location: Left arm), administration date: 01Mar2021, when the patient was 79-year-old, for COVID-19 immunization; Flu shot (With the flu shot, about every other year she would feel lousy.), reaction(s): "feel lousy"; Pneumococcal (With the third Pneumococcal shot, she did have trouble with it. Her arm swelled up, and she felt lousy.), administration date: 2020, reaction(s): "felt lousy", "Her arm swelled up"; Shingles (The second Shingles shot that they gave her, the one that is 60-70 days apart was God-awful), reaction(s): "she didn't feel good", "arm was sore". The following information was reported: FATIGUE (non-serious) with onset 29Oct2021, outcome "recovering", described as "After the Covid-19 Vaccines she was horribly tired"; FEELING ABNORMAL (non-serious) with onset 29Oct2021, outcome "recovering", described as "had brain fog". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, PPV, VARZOS
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: After the Covid-19 Vaccines she was horribly tired; had brain fog; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 29Oct2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Macular degeneration" (unspecified if ongoing), notes: She has macular degeneration and gets a shot for that once a month. It goes into her right eye.; "Blood pressure high" (unspecified if ongoing), notes: Started around age 65; "Osteoporosis postmenopausal" (unspecified if ongoing), notes: Osteoporosis postmenopausal. Concomitant medication(s) included: LISINOPRIL oral taken for hypertension; PROLIA taken for osteoporosis postmenopausal as dose number unknown, single; VITAMIN C [ASCORBIC ACID]. Vaccination history included: BNT162b2 (Dose 1: , Date: 08Feb2021, Lot: EL9266, Location: Left arm), administration date: 08Feb2021, when the patient was 79-year-old, for COVID-19 immunization; BNT162b2 (Dose 2:, Date: 01Mar2021, Lot: EN6203, Location: Left arm), administration date: 01Mar2021, when the patient was 79-year-old, for COVID-19 immunization; Flu shot (With the flu shot, about every other year she would feel lousy.), reaction(s): "feel lousy"; Pneumococcal (With the third Pneumococcal shot, she did have trouble with it. Her arm swelled up, and she felt lousy.), administration date: 2020, reaction(s): "felt lousy", "Her arm swelled up"; Shingles (The second Shingles shot that they gave her, the one that is 60-70 days apart was God-awful), reaction(s): "she didn't feel good", "arm was sore". The following information was reported: FATIGUE (non-serious) with onset 29Oct2021, outcome "recovering", described as "After the Covid-19 Vaccines she was horribly tired"; FEELING ABNORMAL (non-serious) with onset 29Oct2021, outcome "recovering", described as "had brain fog". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired Moderna booster vaccine.  Patient exhibits not adverse signs or symptoms.   Patient evaluated and instructed to report any issues.  He verbalized his understanding.  No treatment given.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired Moderna booster vaccine.  Patient exhibits not adverse signs or symptoms.   Patient evaluated and instructed to report any issues.  He verbalized his understanding.  No treatment given.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired Moderna booster vaccine.  Patient exhibits not adverse signs or symptoms.   Patient evaluated and instructed to report any issues.  He verbalized his understanding.  No treatment given.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired Moderna booster vaccine.  Patient exhibits not adverse signs or symptoms.   Patient evaluated and instructed to report any issues.  He verbalized his understanding.  No treatment given.
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired Moderna booster vaccine.  Patient exhibits not adverse signs or symptoms.   Patient evaluated and instructed to report any issues.  He verbalized his understanding.  No treatment given.
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired Moderna booster vaccine.  Patient exhibits not adverse signs or symptoms.   Patient evaluated and instructed to report any issues.  He verbalized his understanding.  No treatment given.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired Moderna booster vaccine.  Patient exhibits not adverse signs or symptoms.   Patient evaluated and instructed to report any issues.  He verbalized his understanding.  No treatment given.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired Moderna booster vaccine.  Patient exhibits not adverse signs or symptoms.   Patient evaluated and instructed to report any issues.  He verbalized his understanding.  No treatment given.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired Moderna booster vaccine.  Patient exhibits not adverse signs or symptoms.   Patient evaluated and instructed to report any issues.  He verbalized his understanding.  No treatment given.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired Moderna booster vaccine.  Patient exhibits not adverse signs or symptoms.   Patient evaluated and instructed to report any issues.  He verbalized his understanding.  No treatment given.
Age: 87.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired Moderna booster vaccine.  Patient exhibits not adverse signs or symptoms.   Patient evaluated and instructed to report any issues.  He verbalized his understanding.  No treatment given.
Age: 87.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired Moderna booster vaccine.  Patient exhibits not adverse signs or symptoms.   Patient evaluated and instructed to report any issues.  He verbalized his understanding.  No treatment given.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired Moderna booster vaccine.  Patient exhibits not adverse signs or symptoms.   Patient evaluated and instructed to report any issues.  He verbalized his understanding.  No treatment given.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired Moderna booster vaccine.  Patient exhibits not adverse signs or symptoms.   Patient evaluated and instructed to report any issues.  He verbalized his understanding.  No treatment given.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired Moderna booster vaccine.  Patient exhibits not adverse signs or symptoms.   Patient evaluated and instructed to report any issues.  He verbalized his understanding.  No treatment given.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired Moderna booster vaccine.  Patient exhibits not adverse signs or symptoms.   Patient evaluated and instructed to report any issues.  He verbalized his understanding.  No treatment given.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired Moderna booster vaccine.  Patient exhibits not adverse signs or symptoms.   Patient evaluated and instructed to report any issues.  He verbalized his understanding.  No treatment given.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired Moderna booster vaccine.  Patient exhibits not adverse signs or symptoms.   Patient evaluated and instructed to report any issues.  He verbalized his understanding.  No treatment given.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired Moderna booster vaccine.  Patient exhibits not adverse signs or symptoms.   Patient evaluated and instructed to report any issues.  He verbalized his understanding.  No treatment given.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired Moderna booster vaccine.  Patient exhibits not adverse signs or symptoms.   Patient evaluated and instructed to report any issues.  He verbalized his understanding.  No treatment given.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired Moderna booster vaccine.  Patient exhibits not adverse signs or symptoms.   Patient evaluated and instructed to report any issues.  He verbalized his understanding.  No treatment given.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired Moderna booster vaccine.  Patient exhibits not adverse signs or symptoms.   Patient evaluated and instructed to report any issues.  He verbalized his understanding.  No treatment given.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired Moderna booster vaccine.  Patient exhibits not adverse signs or symptoms.   Patient evaluated and instructed to report any issues.  He verbalized his understanding.  No treatment given.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired Moderna booster vaccine.  Patient exhibits not adverse signs or symptoms.   Patient evaluated and instructed to report any issues.  He verbalized his understanding.  No treatment given.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure increased, Dizziness, Feeling abnormal
Clinical narrative: I reported before that I had an elevated blood pressure of 140/125 which I never had before in my life after feeling a bit dizzy or weird which led me to take blood pressure. I am writing too because I also joint pain in my whole body beginning a few days after. Since then I have continued to have high blood pressure with high as much of 150 but mostly in the 130?s  for systolic and as high of 99, normally in the nineties for diastolic. Even when my systolic is 133, not hugely elevated my diastolic pressure usually is between 94 and 97.  I never had high blood pressure before this vaccine.  But since then my blood is rarely normal.   Additionally, I have continue to suffer from joint pain but not as badly as the first 6 months after it. I?ve two booster shots. The first one, surprisingly affected me positively, my joint pain going away completely for the first few days, after which unfortunately, it came back.  Second one I changed and got Moderna. I was hoping to get the same relief I felt from my Pfizer booster hoping that it could be permanent, but not such luck. I didn?t improve my joint pain even for a few days.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Pyrexia
Clinical narrative: Injection site pain, fatigue, fever, chills
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: Significant increase of tinnitus that I didn't realize was perhaps caused by the vaccine.  This past year the ringing in my ears has been "different" than it was & constant.  Tinnitus runs in my family & I've had it for a number of years, but it has certainly increased.  I don't know for sure if it's related to the vaccine, but I haven't done/had anything  to cause it to increase as it has.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Decreased appetite, Diarrhoea, Dysgraphia
Clinical narrative: Whole-body hives began approximately one week after receiving the Modern COVID-19 booster vaccine. Hives began suddenly around 7 PM, and frequently moved locations. Accompanying the hives was severe itching, swelling of the hands, loss of appetite, headache, muscle stiffness and aches, heartburn, chest pain, discomfort swallowing, shortness of breath, diarrhea, and tiredness. Visited the doctor after three days when it became impossible to sleep or type/write. Prescribed four Zyrtec and two Pepcid daily, have been taking this dose for four weeks now. Currently, the only symptoms present are hives and itchiness when medication is stopped, heartburn, some chest discomfort, short daily periods of shortness of breath (30 min max), and muscle soreness.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspepsia, Dysphagia, Dyspnoea, Fatigue, Headache
Clinical narrative: Whole-body hives began approximately one week after receiving the Modern COVID-19 booster vaccine. Hives began suddenly around 7 PM, and frequently moved locations. Accompanying the hives was severe itching, swelling of the hands, loss of appetite, headache, muscle stiffness and aches, heartburn, chest pain, discomfort swallowing, shortness of breath, diarrhea, and tiredness. Visited the doctor after three days when it became impossible to sleep or type/write. Prescribed four Zyrtec and two Pepcid daily, have been taking this dose for four weeks now. Currently, the only symptoms present are hives and itchiness when medication is stopped, heartburn, some chest discomfort, short daily periods of shortness of breath (30 min max), and muscle soreness.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Musculoskeletal stiffness, Myalgia, Peripheral swelling, Pruritus
Clinical narrative: Whole-body hives began approximately one week after receiving the Modern COVID-19 booster vaccine. Hives began suddenly around 7 PM, and frequently moved locations. Accompanying the hives was severe itching, swelling of the hands, loss of appetite, headache, muscle stiffness and aches, heartburn, chest pain, discomfort swallowing, shortness of breath, diarrhea, and tiredness. Visited the doctor after three days when it became impossible to sleep or type/write. Prescribed four Zyrtec and two Pepcid daily, have been taking this dose for four weeks now. Currently, the only symptoms present are hives and itchiness when medication is stopped, heartburn, some chest discomfort, short daily periods of shortness of breath (30 min max), and muscle soreness.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Whole-body hives began approximately one week after receiving the Modern COVID-19 booster vaccine. Hives began suddenly around 7 PM, and frequently moved locations. Accompanying the hives was severe itching, swelling of the hands, loss of appetite, headache, muscle stiffness and aches, heartburn, chest pain, discomfort swallowing, shortness of breath, diarrhea, and tiredness. Visited the doctor after three days when it became impossible to sleep or type/write. Prescribed four Zyrtec and two Pepcid daily, have been taking this dose for four weeks now. Currently, the only symptoms present are hives and itchiness when medication is stopped, heartburn, some chest discomfort, short daily periods of shortness of breath (30 min max), and muscle soreness.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, Upper-airway cough syndrome, Wheezing
Clinical narrative: This was my 4th dose, I started feeling the same effects I had with my 3rd dose. I started wheezing at night with nasal congestion and a postnasal drip because of the wheezing. My PCP gave me Steroids, Z-pak, an Albuterol Inhaler and Tessalon Perles for my cough.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Rash
Clinical narrative: Extreme eczematous rash on neck, chest, breasts, back of shoulders, back of arms, inner forearms, abdomen, waist, thighs front and back, behind knees, sides of knees, inner and outer elbows, buttocks, and tops of hands. Treatment has included a six-day course of Methylprednisolone (21 pills at 4mg each), twice daily application of triamcinolone acetonide ointment 0.1%, Claritin once daily, 50 mg Benadryl daily, three times daily application of itch relief spraydiphenhydramine hydrochloride 2% with zinc acetate0.1%, colloidal oatmeal baths daily. OTC Topical treatments have been ongoing since April 3. Prednisone and Triamcinolone treatment started on April 11. As of today, April 21, symptoms have not changed.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Angina pectoris, Asthenia, Brain oedema, Confusional state
Clinical narrative: Severe headaches - 4 months - gotten better over time Light headed, weak, tired, light fevers, confusion in thoughts, forgetful, short term memory loss, blurry vision, red painful eyes, high blood pressure, heart pains, brain feels swollen or some sort of pressure, all around unwell feeling, irritable - ongoing
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Eye pain, Fatigue, Head discomfort, Headache
Clinical narrative: Severe headaches - 4 months - gotten better over time Light headed, weak, tired, light fevers, confusion in thoughts, forgetful, short term memory loss, blurry vision, red painful eyes, high blood pressure, heart pains, brain feels swollen or some sort of pressure, all around unwell feeling, irritable - ongoing
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Irritability, Malaise, Memory impairment, Ocular hyperaemia
Clinical narrative: Severe headaches - 4 months - gotten better over time Light headed, weak, tired, light fevers, confusion in thoughts, forgetful, short term memory loss, blurry vision, red painful eyes, high blood pressure, heart pains, brain feels swollen or some sort of pressure, all around unwell feeling, irritable - ongoing
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Thinking abnormal, Vision blurred
Clinical narrative: Severe headaches - 4 months - gotten better over time Light headed, weak, tired, light fevers, confusion in thoughts, forgetful, short term memory loss, blurry vision, red painful eyes, high blood pressure, heart pains, brain feels swollen or some sort of pressure, all around unwell feeling, irritable - ongoing
Age: 29.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: None stated.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Balance disorder, Coordination abnormal, Fatigue
Clinical narrative: DAYS AND WEEKS AFTER GETTING THE SHOT, I HAD INCREASING WEAKNESS AND FATIGUE.  MY FEET WERE FEELING AS IF MY ARCHES WERE FALLING.  MY ANKLE AND HIPS WERE WEAK AND UNCOORDINATED.  BACK PAIN AND PELVIC FLOOR PAIN. THIS CONTINUED DAILY FOR WEEKS.  I HAD SIGNIFICANT BALANCE ISSUES. THE WEEK BEFORE I WAS ADMITTED TO THE HOSPITAL IT WAS HARD FOR ME TO WALK AND LEGS WERE FEELING HEAVY.   WOKE UP ON OCTOBER 11, 2021 UNABLE TO WALK.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Foot deformity, Gait disturbance, Gait inability, Limb discomfort, Magnetic resonance imaging
Clinical narrative: DAYS AND WEEKS AFTER GETTING THE SHOT, I HAD INCREASING WEAKNESS AND FATIGUE.  MY FEET WERE FEELING AS IF MY ARCHES WERE FALLING.  MY ANKLE AND HIPS WERE WEAK AND UNCOORDINATED.  BACK PAIN AND PELVIC FLOOR PAIN. THIS CONTINUED DAILY FOR WEEKS.  I HAD SIGNIFICANT BALANCE ISSUES. THE WEEK BEFORE I WAS ADMITTED TO THE HOSPITAL IT WAS HARD FOR ME TO WALK AND LEGS WERE FEELING HEAVY.   WOKE UP ON OCTOBER 11, 2021 UNABLE TO WALK.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pelvic pain, X-ray
Clinical narrative: DAYS AND WEEKS AFTER GETTING THE SHOT, I HAD INCREASING WEAKNESS AND FATIGUE.  MY FEET WERE FEELING AS IF MY ARCHES WERE FALLING.  MY ANKLE AND HIPS WERE WEAK AND UNCOORDINATED.  BACK PAIN AND PELVIC FLOOR PAIN. THIS CONTINUED DAILY FOR WEEKS.  I HAD SIGNIFICANT BALANCE ISSUES. THE WEEK BEFORE I WAS ADMITTED TO THE HOSPITAL IT WAS HARD FOR ME TO WALK AND LEGS WERE FEELING HEAVY.   WOKE UP ON OCTOBER 11, 2021 UNABLE TO WALK.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Client presented at the vaccination site on 11.11.21. Client reported she received 1st dose Moderna COVID vaccine on 04.14.21 and 2nd dose Moderna COVID vaccine on 05.12.21, both are from vaccination site without any symptoms for both doses. Client is requesting to receive her Moderna COVID booster vaccine today one day earlier than she is qualifies for the Moderna COVID booster vaccine. Client reported she doesn?t have any known allergies or have any chronic illnesses. Client told she is not taking any medications. PHN submitted a medical consult via text message to clinical project coordinator, requesting to proceed with the Moderna COVID booster vaccine. Per the doctor, approval to proceed with Moderna COVID booster vaccine was obtained from medical consult team via text message from clinical project coordinator. Client received Moderna COVID booster vaccine, LOT #: 066F21A on 11.11.21 at 1511 by RN. The client did not report any symptoms during the 30-minute observation period. PHN educated client on possible adverse reactions and when to seek EMS. Client verbalized understanding. Client left vaccination site at 1541 unassisted and with a steady gait.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Contusion, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Chills ~ 4 hrs after injection persisting for 12 hrs Body/Muscle Aches ~ 4 hrs after injection persisting for ~ 2-3 days Redness, Swelling and Pain at injection site ~ 4 hrs after injection persisting for ~ 2-3 days Syncope ~ 20 hrs after injection (single event leading to minor contusions)
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pain, Syncope
Clinical narrative: Chills ~ 4 hrs after injection persisting for 12 hrs Body/Muscle Aches ~ 4 hrs after injection persisting for ~ 2-3 days Redness, Swelling and Pain at injection site ~ 4 hrs after injection persisting for ~ 2-3 days Syncope ~ 20 hrs after injection (single event leading to minor contusions)
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inflammation, Syncope
Clinical narrative: Chills ~ 4 hrs after injection persisting for 12 hrs Body/Muscle Aches ~ 4 hrs after injection persisting for ~ 2-3 days Redness, Swelling and Pain at injection site ~ 4 hrs after injection persisting for ~ 2-3 days Syncope ~ 20 hrs after injection (single event leading to minor contusions)
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Mechanical urticaria, Rash, Scratch, Tinnitus
Clinical narrative: Full body rash started about 24 December 2021. Red skin and hives when scratching. Been taking Cetirizine about once a day to control symptoms for the last 4 months. Rash was aggressive at the start and has been gradually getting better as time progresses but is still present at 21 April 2022 and I am still taking Cetirizine. Dermatographia (Skin writing) is also present and last about 30 minutes after I scratch. Also tinnitus (ringing in the ears) is very noticeable since the rash outbreak in December 2021.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Full body rash started about 24 December 2021. Red skin and hives when scratching. Been taking Cetirizine about once a day to control symptoms for the last 4 months. Rash was aggressive at the start and has been gradually getting better as time progresses but is still present at 21 April 2022 and I am still taking Cetirizine. Dermatographia (Skin writing) is also present and last about 30 minutes after I scratch. Also tinnitus (ringing in the ears) is very noticeable since the rash outbreak in December 2021.
Sex: M
Vaccine: COVID19, MMR
Symptoms: Tic
Clinical narrative: Neurological tics; This spontaneous report has been received from a pharmacist via Pfizer and refers to a 16-year-old male patient. The patient's current conditions included an autoimmune disease (unspecified). His medical history included coronavirus disease-2019 (COVID-19). Concomitant medications were not provided.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (manufacturer unknown) as prophylaxis (dose, route of administration, anatomical location of vaccination, lot number and expiration date were not provided); and with COVID-19 vaccine (dose, route of administration, anatomical location of vaccination, indication, lot number and expiration date were not provided).  On an unknown date, the patient experienced neurological tics (tic).  The outcome of the event was not provided.  The reporter considered tic to be not related to measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (manufacturer unknown), but to be related to an autoimmune disease. The causality assessment between the event and COVID-19 vaccine was not provided.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE; Customer called to report an AE with PROQUAD. The caller said a patient received an expire dose; This spontaneous report has been received from a medical assistant, concerning a patient of unknown gender and age. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies was unknown.  On 21-MAR-2022, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) as prophylaxis (lot number T032150 has been verified to be a valid lot, expiration date reported and stablished as 20-MAR-2022) (formulation, strength, exact dose, vaccination scheme, route of administration and anatomical location, lot number and expiration date were not provided) (expired product administered). The vaccine did not experienced any temperature excursion. No adverse events (AE) reported (no adverse event).
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient got her first dose of GARDASIL 9 on 08-JUN-2021 and got her second dose of GARDASIL 9 on 22-MAR-2022.; No additional AEs reported.; This spontaneous report has been received from a registered nurse and refers to a female patient of unknown age. The patient's current conditions, pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  On 08-JUN-2021, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter, as prophylaxis (lot number T024831 has been verified to be valid, expiration date 18-NOV-2022); and on 22-MAR-2022, she received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter, as prophylaxis (lot number U008897 has been verified to be valid, expiration date 16-MAY-2023) (routes of administrations and anatomical locations of vaccinations were not provided) (inappropriate schedule of product administration). No additional adverse events were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse events reported; seven doses of improperly stored GARDASIL 9 were administered to 7 different patients; This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 08-MAR-2022, the patient was administered improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 1 dose, lot number: U008899, expiration date: 12-AUG-2023 (strength, dose, formulation, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The vaccine was improperly stored at 33.4 degrees Fahrenheit for 2595 hours. There were no previous temperature excursions reported. No other adverse events reported (no adverse event).  This is one of seven reports received from the same reporter. ; Sender's Comments:  US-009507513-2203USA007997:02134086 US-009507513-2203USA007825:02134097 US-009507513-2203USA007812:02134094 US-009507513-2203USA007915:02134094 US-009507513-2203USA008053:02134093 US-009507513-2203USA008097:02134087
Age: 12.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Medical Assistant reporting the administration of PEDVAX HIB to a 12 year old Patient.; No additional adverse events reported.; This spontaneous report was received from a medical assistant concerning a 12-year-old patient of unknown gender. Information regarding the patient's concomitant therapies, current conditions, medical history and historical drug was not provided.   On 31-MAR-2022, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) 0.5 milliliters, lot number U024489 expiration date 02-NOV-2023 (route of administration were not provided) administered as prophylaxis (Product administered to patient of inappropriate age.)  No adverse symptoms were reported.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; received improperly stored vaccines; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 03-MAR-2022, the patient was vaccinated with an improperly stored of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis (lot # u026664 and 1741817 has been verified to be a valid lot number rotavirus vaccine, live, oral, pentavalent, expiration date reported and establish as 24-FEB-2023, and 30-JUL-2022 respectively) (strength, dose, route of administration and anatomical location were not provided) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) for prophylaxis (lot # u026217 has been verified to be a valid lot number haemophilus b conjugate vaccine (meningococcal protein conjugate), expiration date reported and establish as 02-NOV-2023).  The temperature of storage and time frame of the excursion were 34.3° Fahrenheit (F) for 55 minutes respectively.  If a digital data logger was involved was not reported.  The vaccines did not experience a previous temperature excursion.  No adverse event reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Caller reports an expired dose of VAQTA was administered. No temperature excursion on the vaccine. No additional information. No PQC reported.; This spontaneous report was received from a nurse prescriber refers to a patient of unknown age and gender.There was no information about the patient's medical history, concurrent conditions or concomitant medication.   On 08-APR-2022, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA), prefilled syringe,dose: 0.5 milliliter, lot # T023913, expiration date: 31-MAR-2022 for prophylaxis (route, and dose number were not reported) (expired product administered). No temperature excursion on the vaccine. No additional information. No product quality comaplint reported.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: The patient developed redness, pain, and itching at the injection site; The patient developed redness, pain, and itching at the injection site; The patient developed redness, pain, and itching at the injection site; This spontaneous report was received from a medical assistant referring to a 4-year-old female patient. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.   On 07-APR-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 ml, lot #U039254, expiration date: 09-JUN-2023, subcutaneously for prophylaxis (strength was not provided).  On 09-APR-2022, the patient developed redness, pain, and itching at the injection site (vaccination site erythema, vaccination site pain and vaccination site pruritus). On 10-APR-2022, the family was advised to draw a circle around the redness. When the patient came into the office on 11-APR-2022 (reported as today), the redness was past the circle. The patient received treatment with acrivastine (BENADRYL) cream every 4-6 hours. At the time of reporting, the patient had not recovered from the events. No cancer or overdose.  The causal relationship between the events and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was not reported.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA004476:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE or PQC reported; Caller explained the PROQUAD was administered after a temperature excursion; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The pertinent medical history, concomitant therapies and drug allergy or reactions were not provided.   On 05-APR-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter, (lot #U024508, expiration date: 02-FEB-2023, therapy type: rHA) for prophylaxis (strength, route of administration were not provided) for prophylaxis after a temperature excursion: 12.95 F for 21 hours 15 minutes 0 seconds (product storage error). There was no previous temperature excursion. There was no additional adverse event (AE) or product quality compliant (PQC) reported (no adverse event).
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Expired dose of PROQUAD was administered to a 4 year old on 4/11/2022; This spontaneous report was received from a nurse and refers to a 4-years-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 11-APR-2022, the patient received measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, lot # T034613, expiration date: 10-APR-2022, administered for prophylaxis (strength, dose number, dose, and route of administration were not provided) (expired product administered).   There were no other issues or concerns noted (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; PROQUAD was administered after a temperature excursion.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 11-APR-2022, the patient was vaccinated with an improperly stored of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)for prophylaxis (lot # U039254 has been verified to be a valid lot number measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported and establish as 09-JUN-2023) (strength, dose, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were 12.95° Fahrenheit (F) for 21 hours and 15 minutes respectively.  If a digital data logger was involved was not reported.  The vaccine did not experience a previous temperature excursion.  No adverse event reported.
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder, Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: herpes zoster; postherpetic neuralgia; balance issues; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On an unspecified date, the patient was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) (strength, dose, route of administration, lot # and expiration date were not reported) for the prevention of shingles (herpes zoster). On an unspecified date, after receiving Defendants' zoster vaccine live(ZOSTAVAX) vaccine, Plaintiff  suffered multiple outbreaks of a painful rash, herpes zoster, postherpetic neuralgia and balance issues. As a result of these symptoms, Plaintiff was seen and treated by medical providers in Oregon and is still under their care. As a direct and proximate result of defective zoster vaccine live(ZOSTAVAX)vaccine, Plaintiff's symptoms have resulted in physical limitations not present prior to using the product. Plaintiff also experience mental and emotional distress due to resulting physical imitations and seriousness of Plaintiff' condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live(ZOSTAVAX), Plaintiff sustained severe and permanent personal injuries. Further, as a tragic consequence of wrongful conduct, Plaintiff suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Defendants' conduct, Plaintiff have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The outcome of the events was reported as not recovered. The lawyer considered the reported events to be related to zoster vaccine live(ZOSTAVAX).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller is HCP who reports administered dose of PROQUAD that experienced temperature excursion. No additional details available. No further adverse events. No product quality complaints.; Caller is HCP who reports administered dose of PROQUAD that experienced temperature excursion. No additional details available. No further adverse events. No product quality complaints.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 12-APR-2022, the patient was vaccinated with an improperly stored of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (lot # T035410 has been verified to be a valid lot number measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported and establish as 14-APR-2022) (strength, dose, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were not provided. If a digital data logger was involved was not reported.  The vaccine did not experience a previous temperature excursion.  No adverse event reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Caller reported PROQUAD administered after temperature excursion.   PROQUAD Lot # U029325  3/19/2023 experienced 2 excursions during a 24 hour period.  One dose was administered after first excursion but before the second excursion occurred therefore; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 11-APR-2022, the patient was vaccinated with an improperly stored of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter, subcutaneously, for prophylaxis (lot # U029325 has been verified to be a valid lot number measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported and establish as 19-MAR-2023) (strength and anatomical location were not provided).  The temperature of storage and time frame of the excursion were -13.3° Celsius (C) for 1 hour and 19 minutes respectively.  If a digital data logger was involved was not reported. If a digital data logger was involved was not reported.  The vaccine did not experience a previous temperature excursion.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP reported an adverse event for PROQUAD. Caller explained the PROQUAD was administered after a temperature excursion. No additional AE or PQC reported. No additional information provided.  ?    Names of vaccines involved (including lot/exp): PROQ; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 06-APR-2022, the patient was vaccinated with an improperly stored of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter, for prophylaxis (lot # U039254 has been verified to be a valid lot number measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported and establish as 09-JUN-2023) (strength, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were 12.95° Fahrenheit (F) for 21 hour and 15 minutes respectively.  If a digital data logger was involved was not reported.  The vaccine did not experience a previous temperature excursion.  No adverse event reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's; improperly stored PROQUAD vaccine was administered; Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.     On 29-APR-2021, an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T031603, expiration date on 15-MAR-2022) (strength, dose, route of administration, dose were not reported) for prophylaxis. No additional adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: No other issues or concerns noted.  NO PQC.; Customer called to report that a patient received MMRII Intramuscular instead of Subcutaneous.  It was administered on April 15, 2022.  No other issues or concerns noted.  NO PQC.; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 15-APR-2022, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) via intramuscular instead of subcutaneous, for prophylaxis (strength, dose, frequency, lot# and expiration date were not reported) (incorrect route of product administration). No other issues or concerns noted, no PQC.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever; nausea; vomiting; diarrhea; This case was reported by a consumer via call center representative and described the occurrence of fever in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (received 1st dose of Shingrix on 18th August 2021 (refer case US2022063383)). Concurrent medical conditions included diarrhea (sensitivity reaction (diarrhea, nausea and vomiting) from eating red meats), nausea (sensitivity reaction (diarrhea, nausea and vomiting) from eating red meats) and vomiting (sensitivity reaction (diarrhea, nausea and vomiting) from eating red meats).   On 20th October 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced fever, nausea aggravated, vomiting aggravated and diarrhea aggravated. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, nausea aggravated, vomiting aggravated and diarrhea aggravated were recovered/resolved.   It was unknown if the reporter considered the fever, nausea aggravated, vomiting aggravated and diarrhea aggravated to be related to Shingrix.     Linked case(s) involving the same patient: US2022063383   Additional Information: GSK Receipt Date: 11-APR-2022 Reporter's comment: The reporter was the patient, who called in regarding adverse reactions she had to Shingrix. The patient reported she received second dose of Shingrix and after taking vaccine she developed a similar reaction, citing nausea, vomiting and fever which lasted few days after and had since resolved.  The patient also mentioned that since receiving Shingrix, she had an increased sensitivity reaction (diarrhea, nausea and vomiting) from eating red meats.  The patient reported that this had been an issue for her since before taking the vaccine but had become markedly worse since Shingrix. She had been evaluated for a possible alpha gal allergy and did not have a diagnosis as of the reporting time.  The reporter consented to follow up. The reporter was provided information on side effects per package insert and content. Provided medical advise disclaimer.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022063383:Same patient/reporter