chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Third trimester pregnancy
Clinical narrative: SINGLE SUBSEGMENTAL PULMONARY EMBOLISM WITHOUT ACUTE COR PULMONALE 5/2/2023 PREECLAMPSIA, THIRD TRIMESTER ACUTE PULMONARY EMBOLISM 5/2/2023 PREECLAMPSIA, THIRD TRIMESTER SINGLE SUBSEGMENTAL PULMONARY EMBOLISM WITHOUT ACUTE COR PULMONALE 5/2/2023 MATERNAL DELIVERY OUTCOME, SINGLETON BIRTH, LIVEBORN ACUTE PULMONARY EMBOLISM 5/2/2023 MATERNAL DELIVERY OUTCOME, SINGLETON BIRTH, LIVEBORN
Age: 0.58
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Moderna covid vaccine given on 4/24/23 was a 0.2ml dose with the wrong vial (pink top Bivalent) but should have been 0.25ml with blue top. This change was implemented on 4/20/23 and we were unaware of the vial and dose change. Patient needs one more dose as she is currently now considered undervaccinated.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome, Uterine leiomyoma
Clinical narrative: OBSTRUCTIVE SLEEP APNEA 4/18/2023 UTERINE FIBROIDS
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Angina unstable
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE UNSTABLE ANGINA ANGINA, UNSPECIFIED
Age: 30.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Acupuncture, Circumstance or information capable of leading to medication error, Conversion disorder, Dyskinesia, Magnetic resonance imaging
Clinical narrative: Uncontrollable movements began with foot moving and full body shakes 3 hours after the shot was given. Shakes progressively moved throuhgout body to every part, including face and throat movement. Went to ER a total of 4 times, no answers for the condition were given any visit. Primary care doctor prescibed muscle relaxers and benzos while I waited for a Neurologoist. Also tried acupuncture, to help during this time. Had a huge welt on my arm for a month. Was diagnosed with Functional Neurological Disorder December 9, 2022. Still going to acupuncture, functional medicine doctors to help symptoms. Still dealing with ongoing symptoms as of June 2023. (pharmacy report states both the flu and COVID shot were adminstered in left arm, but they were not. One was in left and one was in right. COVID was left and flu was right.)
Age: 30.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Tremor, Urticaria
Clinical narrative: Uncontrollable movements began with foot moving and full body shakes 3 hours after the shot was given. Shakes progressively moved throuhgout body to every part, including face and throat movement. Went to ER a total of 4 times, no answers for the condition were given any visit. Primary care doctor prescibed muscle relaxers and benzos while I waited for a Neurologoist. Also tried acupuncture, to help during this time. Had a huge welt on my arm for a month. Was diagnosed with Functional Neurological Disorder December 9, 2022. Still going to acupuncture, functional medicine doctors to help symptoms. Still dealing with ongoing symptoms as of June 2023. (pharmacy report states both the flu and COVID shot were adminstered in left arm, but they were not. One was in left and one was in right. COVID was left and flu was right.)
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Discontinued product administered, Nasopharyngitis, Pyrexia
Clinical narrative: Patient was administered a dose of the monovalent COVID-19 vaccines after they were no longer authorized. Patients' parents were notified and they did state she had some cold symptoms. She came into our clinic 05/17/2023 and was given ibuprofen 100 mg/5 mL oral suspension for her acute upper respiratory infection.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Upper respiratory tract infection, Vomiting
Clinical narrative: Patient was administered a dose of the monovalent COVID-19 vaccines after they were no longer authorized. Patients' parents were notified and they did state she had some cold symptoms. She came into our clinic 05/17/2023 and was given ibuprofen 100 mg/5 mL oral suspension for her acute upper respiratory infection.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure
Clinical narrative: J96.00 ACUTE RESPIRATORY FAILURE 4/11/2023 ACUTE RESPIRATORY FAILURE
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Pulmonary embolism
Clinical narrative: HYPOTENSION ACUTE PULMONARY EMBOLISM
Age: 0.58
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Moderna covid vaccine given on 5/15/23 was a 0.2ml dose with the wrong vial (pink top Bivalent) but should have been 0.25ml with blue top. This change was implemented by CDC on 4/20/23 and we were unaware of the vial and dose change. Patient needs one more dose as she is currently now considered undervaccinated.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Hypersensitivity
Clinical narrative: ANAPHYLAXIS, INIT ALLERGIC REACTION, INIT ALLERGIC REACTION, SUBSEQ
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Obstructive sleep apnoea syndrome, Septic shock
Clinical narrative: G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, MODERATE 4/27/2023 ARTHRITIS OF LEFT GLENOHUMERAL JOINT G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, MODERATE 4/27/2023 SEPTIC SHOCK
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pancytopenia, Pulmonary embolism, Rectal haemorrhage
Clinical narrative: ACUTE PULMONARY EMBOLISM 4/9/2023 PANCYTOPENIA ACUTE PULMONARY EMBOLISM 4/9/2023 RECTAL BLEEDING
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE LEFT BELLS PALSY
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Immunisation reaction, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: About an hour and a half after the innoculation, the deltoid muscle area of my arm started to ache and felt hot.  This lasted about a week. The other events included itching in the area of the injection. A redness of the skin started at the location of the injection and over the next few hours, spread to about an 8 inch diameter area.  This continued for about a week. I sent a photo to my doctor and described the reaction I was having that seemed to not be getting better. She told me that it was an adverse reaction and take ibuprofin for any pain. And let her know if it didn't go away.  A few days later the redness and heat subsided .
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Hypersensitivity
Clinical narrative: ANGIOEDEMA, INIT ALLERGIC REACTION, INIT
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: No adverse symptoms
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic respiratory failure, Deep vein thrombosis, Hypoxia, Respiratory failure
Clinical narrative: ACUTE DVT OF RIGHT TIBIAL VEIN ACUTE DVT OF LEFT TIBIAL VEIN CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXIA
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Acute coronary syndrome, Acute myocardial infarction
Clinical narrative: ACUTE NON ST ELEVATION MI ACUTE CORONARY SYNDROME, UNSPECIFIED
Age: 79.0
Sex: M
Vaccine: UNK
Symptoms: Computerised tomogram, Computerised tomogram thorax abnormal, Pulmonary thrombosis
Clinical narrative: BLOOD CLOT IN LUNGS
Age: 1.5
Sex: F
Vaccine: UNK
Symptoms: Wrong product administered
Clinical narrative: Tdap= given wrong vaccine on 6/13/23 from MA, was supposed to be Dtap.Pt mom informed and office informed.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia
Clinical narrative: She called and states she has had left shoulder pain for past 6 months and that's the only that it could be, and states her family member has had similar symptoms.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Was given a 3rd shot of Shingrix. First 2 completed 2018. 3rd one was not needed, No adverse event reported from extra dose
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Neuropathy peripheral
Clinical narrative: PERIPHERAL NEUROPATHY ACUTE HYPOXEMIC RESPIRATORY FAILURE
Age: 44.0
Sex: M
Vaccine: COVID19-2
Symptoms: Angina pectoris
Clinical narrative: ANGINA, UNSPECIFIED
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Breath sounds abnormal, Death, Headache, Increased bronchial secretion, Livedo reticularis
Clinical narrative: June 11, 2023 midnight: Headache and not feeling well.  Requested a cool washcloth for her head. Had a small liquid emesis. Prn emetrol offered but declined. Requested to go to restroom and had a large bowel movement. She stated she felt better.   Assisted back to bed.  She was monitored often. 2 tylenol 325mg given for temp. Around 3am, she was found unresponsive with secretions, rattles in lungs.  Mottling started from hip to feet.  Family called.  She was monitored often. Family arrived to be with her.  She passed around 5am.
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Malaise, Unresponsive to stimuli, Vomiting
Clinical narrative: June 11, 2023 midnight: Headache and not feeling well.  Requested a cool washcloth for her head. Had a small liquid emesis. Prn emetrol offered but declined. Requested to go to restroom and had a large bowel movement. She stated she felt better.   Assisted back to bed.  She was monitored often. 2 tylenol 325mg given for temp. Around 3am, she was found unresponsive with secretions, rattles in lungs.  Mottling started from hip to feet.  Family called.  She was monitored often. Family arrived to be with her.  She passed around 5am.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Hypotension
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE CHRONIC HYPOTENSION ACUTE HYPOXEMIC RESPIRATORY FAILURE
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: ADULT OBSTRUCTIVE SLEEP APNEA, MODERATE
Age: 57.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Nerve injury
Clinical narrative: Patient mom came in to report a nerve injury from the injections. She said the pharmacist hit a nerve.
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Hypoxia
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXEMIA
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Resident rec'd Pfizer Biontech bivalent on 6/8/23 on 6/11/23 resident developed moderate amount swelling at inject site with some warmth, denies pain, resident had no c/o until 6/11 and reported to this nurse today that this happens with every vaccine I have rec'd all the way back to being a child. I reminded her that she told me prior to vaccination that she has "no problems" and she said she guess she forgot to mention that. She reports none of the previous episodes were treated with abx and they just resolve. Swelling is better today she reports and denies pain, slight warmth, resolving, seen by PCP and will continue to monitor
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Anxiety, Depressed mood, Emotional distress, Incorrect dose administered, Injection site pain
Clinical narrative: The guard at the base of the Heplisav B vaccine was not removed by an immunizing tech and the vaccine not primed before the needle was introduced into the patient's deltoid muscle. The patient therefore was poked by the needle but did not receive the vaccine since the vaccine was still in the lock position. I was immediately informed by the tech afterwards, but the patient was extremely upset and did not want to receive the vaccine from me.  Patient reports today that she is experiencing soreness at the injection site and said she is very sad and anxious.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Product preparation error, Product preparation issue
Clinical narrative: The guard at the base of the Heplisav B vaccine was not removed by an immunizing tech and the vaccine not primed before the needle was introduced into the patient's deltoid muscle. The patient therefore was poked by the needle but did not receive the vaccine since the vaccine was still in the lock position. I was immediately informed by the tech afterwards, but the patient was extremely upset and did not want to receive the vaccine from me.  Patient reports today that she is experiencing soreness at the injection site and said she is very sad and anxious.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Acute respiratory failure, Symptom recurrence
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE ST ELEVATION MI, ANTEROLATERAL WALL ACUTE ST ELEVATION MI, INFEROLATERAL WALL ACUTE ST ELEVATION MI, POSTEROBASAL WALL ACUTE ST ELEVATION MI, UNSPECIFIED ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/4/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient received 1st dose of PCV20 vaccine at our center on 05/15/2023. Patient roomate called in on 5/19/2023 to report patient had pain, redness and swelling to  left arm under the site of injection after vaccine.  patient denies hives, rash, other redness/sweeling.  patient state symptoms improved but continues to be erythematous and swelling.  Advised patient use tylenol, Icing. call back to center if condition not improved.
Age: 0.5
Sex: M
Vaccine: COVID19-2
Symptoms: Infant irritability, Poor quality sleep, Product storage error
Clinical narrative: Summary of the event: Vaccine was administered after storage at room temperature for greater than 24 hours and greater than 12 hours after first puncture.   Summary of details: Date vaccine moved to refrigeration:01Jun2023 Date/time vaccine was moved to room temp: 08June2023 12:25pm Date/time of first vial puncture: 08Jun2023 at 1:44 PM Date of administration: 09Jun2023 3:48PM Total time at room temperature: 27 hours and 57 minutes Total time past first puncture: 26 hrs and 4 minutes Lot: AS7185B  Fussy and did not sleep well the first night after vaccine, but otherwise doing well.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Bradycardia, Hypotension, Presyncope
Clinical narrative: Patient experienced near syncope 10 minutes after administration of vaccine. Patient transported back to exam room where attended by physician. Vitals were monitored. Pt was initially bradycardic with low blood pressure. Pt monitor closely for 30 minutes. Alert and oriented throughout. Mother present throughout. Vitals stable. Patient eating and drinking refreshments in office provided by staff. Walked out of clinic without any issues.
Age: 0.17
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Vaccine given on 6/12/23 with an expiration date of 4/24/23.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy bone marrow, Blood test, Chest X-ray, Computerised tomogram thorax, Dyspnoea
Clinical narrative: Extreme fatigue, difficulty breathing increased in severity from approximately 10 days after immunization until hospitalized
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Extreme fatigue, difficulty breathing increased in severity from approximately 10 days after immunization until hospitalized
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Member received Tdap in Left deltoid on 5/31/2023. Complained of arm pain june 2nd, 2023. Member also received Rocephin injection in the same route.
Age: 0.5
Sex: M
Vaccine: COVID19-2
Symptoms: Contusion, Infant irritability, Injection site bruising, Injection site pain, Pain
Clinical narrative: Summary of the event: Vaccine was administered after storage at room temperature for greater than 24 hours.   Summary of details: Date vaccine moved to refrigeration:01Jun2023 Date/Time vaccine was moved to room temp: 08Jun2023 12:25pm Date/time of first vial puncture: 08Jun2023 at 1:44 PM Date of administration: 09Jun2023 at 3:22 PM  Total time at room temperature: 26 hours and 57 minutes Total time since first puncture: 25 hrs 38 minutes Lot: AS7185B Next morning patient was doing well. a bit sore/fussy and some mild bruising/tenderness on the thighs
Age: 0.5
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error, Tenderness
Clinical narrative: Summary of the event: Vaccine was administered after storage at room temperature for greater than 24 hours.   Summary of details: Date vaccine moved to refrigeration:01Jun2023 Date/Time vaccine was moved to room temp: 08Jun2023 12:25pm Date/time of first vial puncture: 08Jun2023 at 1:44 PM Date of administration: 09Jun2023 at 3:22 PM  Total time at room temperature: 26 hours and 57 minutes Total time since first puncture: 25 hrs 38 minutes Lot: AS7185B Next morning patient was doing well. a bit sore/fussy and some mild bruising/tenderness on the thighs
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Pustule, Swelling
Clinical narrative: After pt's Kinrix and MMRV vaccine he had localized redness and swelling and a little pustule that developed.  He was treated with clindamycin with resolution of symptoms.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Audiogram abnormal, Blood test normal, Electroencephalogram normal, Laboratory test normal, Magnetic resonance imaging normal
Clinical narrative: Bilateral tinnitus of 8000 Hz at 20db of spontaneous onset two weeks after application of the first dose of the vaccine against COVID 19 on 03/26/2021  Treatment Methylprednisolone 4mg administered twice, in 2022 and in 2023 Emgality 120mg administered by 18 months, currently in treatment.   Result: NO resolution of tinnitus
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Bilateral tinnitus of 8000 Hz at 20db of spontaneous onset two weeks after application of the first dose of the vaccine against COVID 19 on 03/26/2021  Treatment Methylprednisolone 4mg administered twice, in 2022 and in 2023 Emgality 120mg administered by 18 months, currently in treatment.   Result: NO resolution of tinnitus
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Headache, Injected limb mobility decreased, Pyrexia
Clinical narrative: Patient presented to pharmacy yesterday for a second dose of a shingrix. I noticed he qualified for Pneumovax23 so I recommended it and he agreed to get both vaccines on the same day. He received Pneomovax23 in his right arm and felt good when he left the pharmacy yesterday post administration. Today he came in to let me know that he had to go to the ER overnight due adverse reactions he felt including : fever,chills,headache and and inability to raise his right arm. He stated he was starting to feel better today but his arm still has limited mobility. He was NOT upset but thought I should be made aware of the reactions.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Hyperhidrosis, Lyme disease
Clinical narrative: I experienced generalized achiness, malaise, sweats and total lack of energy.  This began within 24 hours of booster.  Within a week I had joint pain in ankles, knees and wrists.  I continued to be very tired.  I got an NSAID and advised to hydrate well.  This lasted about 3 three weeks.  I had already diagnosed previously with lime disease but this seemed to be a flare up.  This past weekend I another flare up.  I also have a cold at this time.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nasopharyngitis, Pain
Clinical narrative: I experienced generalized achiness, malaise, sweats and total lack of energy.  This began within 24 hours of booster.  Within a week I had joint pain in ankles, knees and wrists.  I continued to be very tired.  I got an NSAID and advised to hydrate well.  This lasted about 3 three weeks.  I had already diagnosed previously with lime disease but this seemed to be a flare up.  This past weekend I another flare up.  I also have a cold at this time.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: The provider sent in a prescription to Pharmacy on 6/13/2023 for a Shingrix series.  The dose was administered with no issues.  Upon entering the vaccination details into vaccination database, I discovered that the patient has already received a complete series (1st dose 10/13/2020 & 2nd dose 01/07/2021) making this dose her 3rd.   Generally, we double check the database before administration, but this was missed since provider sent in the request.
Age: 27.0
Sex: M
Vaccine: TDAP
Symptoms: Heart rate decreased, Loss of consciousness, Pallor
Clinical narrative: Patient became pale and lost consciousness. It took the ambulance about 3 minutes to arrive and he lost consciousness at least 2 confirmable times. We moved him onto the floor and gave him an ice pack for his back/neck. Paramedics stated that he had a very low heart rate and advised patient to go to hospital for further testing.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, HIBV
Symptoms: Extra dose administered
Clinical narrative: Extra dose of HIB was administered by medical assistant. Patient was contacted by Provider. No symptoms
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered, Expired product administered
Clinical narrative: Expired monovalent vaccine given, no treatment required, no harm to patient
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired monovalent given, no treatment required, no harm to patient
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired monovalent given, no treatment required, no harm to patient
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired monovalent given, no treatment required, no harm to patient
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: According to phone call received vaccine expired 5/11/2023 and was administered on 5/12/2023.  No email received with update regarding expiration of this vaccination. Vaccination was ordered for administration starting in September 2022 which is less than 1 year.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired monovalent given, no treatment required, no harm to patient
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction. Received phone call stating vaccine expired week prior to administration. No email received noting that vaccine would be expiring.
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE; a patient received an expired dose of MMR-II; This spontaneous report was received from Other Health Professional and refers to a 4-year-old male.  The patient's medical history included  respiratory failure, tracheostomy, and ill-defined disorder. The patient's concurrent conditions included  digeorge's syndrome, and tetralogy of fallot. Concomitant therapies were not reported.  On 27-APR-2023, the patient started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, unk, lot #U011995, expiration date: 15-APR-2023, administered for prophylaxis (strength, and route of administration were not provided).  On 27-APR-2023, the patient received an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). No additional adverse event (AE) (no adverse event). At the time of reporting, the outcome of the event a patient received an expired dose of MMR-II was not known. The action taken with M-M-R II regarding a patient received an expired dose of MMR-II was reported as Not Applicable.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: VARIVAX was administered to patient while it had a temperature excursion; No additional AE; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) dose 1, lot number W025274, expiration date 10-AUG-2024 (route of administration not reported) for prophylaxis (product storage error). No adverse event was reported.  The vaccines underwent a temperature excursion of 24.4 degrees Fahrenheit for 5 hours and 51 minutes. No previous excursions were detected.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: had redness, swelling and itching for approximately three weeks after receiving what she understood was a shingles vaccine; had redness, swelling and itching for approximately three weeks after receiving what she understood was a shingles vaccine; had redness, swelling and itching for approximately three weeks after receiving what she understood was a shingles vaccine; This spontaneous report was received from a lawyer and the patient, and refers to a female adult  patient (57 or 58 years-old). The patient's concurrent history included abstains from alcohol and non-tobacco user. The patient's medical history included road traffic accident, injury, knee Operations (three) and historic vaccinations included flu (unspecified). No information was provided regarding the patient's previous drug reactions, allergies and concomitant medications.  In approximately 2015, the patient was vaccinated with what she understood was a shingles vaccine (manufacturer unknown) from the pharmacist at her workplace (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis.  In approximately 2015, the patient experienced redness (erythema), swelling and itching (pruritus) for approximately three weeks after receiving the vaccine. The outcome of pruritus, swelling and erythema was reported as recovered.        The reporter did not provide the causality assessment between the events and therapy with shingles vaccine (manufacturer unknown).  On 15-FEB-2019, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) and experienced adverse events, under litigation (Captured in: 2202USA003923).; Sender's Comments:  US-009507513-2202USA003923:
Sex: F
Vaccine: HPV9
Symptoms: Blood glucose normal, Blood test normal, Clonus, Face injury, Fall
Clinical narrative: Employee states that a 20 year old patient received her firstdose of GARDASIL-9 and immediately after while walking through the waiting to leave, patient experienced a syncope episode which caused her to fall face forward onto the ground; Inbound call from Merck employee reporting AE for GARDASIL-9 on behalf of nurse prescriber.  Confirmed that employee was informed of AE on 6-JUN-2023 and reported it morning of 7-JUN-2023.  Employee states that a 20 year old patient received her firs; In the emergency room, patient had her blood drawn and was found to have a blood sugar of 42.; Clonic movement; This spontaneous report was received from Consumer and refers to a 20-year-old female.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, lot #, expiry date, route of administration, and indication were not provided).  On an unknown date, there was an inbound call from Merck employee reporting AE for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on behalf of nurse prescriber. Confirmed that employee was informed of AE on 6-JUN-2023 and reported it morning of 7-JUN-2023. Employee states that a 20 year old patient received her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and immediately after while walking through the waiting to leave, patient experienced a syncope episode which caused her to fall face forward onto the ground. A witness in the waiting room told the HCP that the patient appeared to have a clonic-like movement. As a result of the fall, patient experienced a facial injury that required her to go to the emergency room. In the emergency room, patient had her blood drawn and was found to have a blood sugar of 42. Any treatment received in the emergency room was unknown by reporter. Per reporter, patient is now recovered but unknown date of recovery. Exact date of AE is unknown however it was within the last month. No additional AE/PQC reported. On an unknown date, the patient was admitted to the hospital due to Face injury. On an unknown date, patient recovered from face injury, syncope, blood glucose abnormal and clonus. The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding events was reported as Not Applicable.  The causal relationship between events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown. Upon internal review, the event face injury and syncope was determined to be medically significant.
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Employee states that a 20 year old patient received her firstdose of GARDASIL-9 and immediately after while walking through the waiting to leave, patient experienced a syncope episode which caused her to fall face forward onto the ground; Inbound call from Merck employee reporting AE for GARDASIL-9 on behalf of nurse prescriber.  Confirmed that employee was informed of AE on 6-JUN-2023 and reported it morning of 7-JUN-2023.  Employee states that a 20 year old patient received her firs; In the emergency room, patient had her blood drawn and was found to have a blood sugar of 42.; Clonic movement; This spontaneous report was received from Consumer and refers to a 20-year-old female.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, lot #, expiry date, route of administration, and indication were not provided).  On an unknown date, there was an inbound call from Merck employee reporting AE for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on behalf of nurse prescriber. Confirmed that employee was informed of AE on 6-JUN-2023 and reported it morning of 7-JUN-2023. Employee states that a 20 year old patient received her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and immediately after while walking through the waiting to leave, patient experienced a syncope episode which caused her to fall face forward onto the ground. A witness in the waiting room told the HCP that the patient appeared to have a clonic-like movement. As a result of the fall, patient experienced a facial injury that required her to go to the emergency room. In the emergency room, patient had her blood drawn and was found to have a blood sugar of 42. Any treatment received in the emergency room was unknown by reporter. Per reporter, patient is now recovered but unknown date of recovery. Exact date of AE is unknown however it was within the last month. No additional AE/PQC reported. On an unknown date, the patient was admitted to the hospital due to Face injury. On an unknown date, patient recovered from face injury, syncope, blood glucose abnormal and clonus. The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding events was reported as Not Applicable.  The causal relationship between events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown. Upon internal review, the event face injury and syncope was determined to be medically significant.
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no aditional AE; freezer underwent an excursion and they did not realize the excursion until later/temperature excursion for VARIVAX and PROQUAD/ VARIVAX and PROQUAD may have been administered to multiple patients; This spontaneous report has been received from a nurse, concerning female patient of unreported age. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not provided.  On 15-MAY-2023, the reporter's freezer underwent a temperature excursion; in which varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) were stored. On that same day, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # W017567 and expiration date 06-MAY-2024, 0.5 milliliter for prophylaxis (dose number and route of administration were not provided).  Other suspect therapies included varicella virus vaccine live (oka/merck) (VARIVAX) lot # U039723 and W031812 with following expirations dates 15-DEC-2023 and 05-OCT-2024, 0.5 milliliter for prophylaxis (dose number and route of administration were not provided) (product storage error and no adverse event).; Sender's Comments:  US-009507513-2306USA004089: US-009507513-2306USA004090: US-009507513-2306USA004084: US-009507513-2306USA004087: US-009507513-2306USA004085: US-009507513-2305USA007959: US-009507513-2306USA004083: US-009507513-2306USA004086:
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no aditional AE; freezer underwent an excursion and they did not realize the excursion until later/temperature excursion for VARIVAX and PROQUAD/ VARIVAX and PROQUAD may have been administered to multiple patients; This spontaneous report has been received from a nurse, concerning a 12-month-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not provided.  On 15-MAY-2023, the reporter's freezer underwent a temperature excursion; in which varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) were stored. On that same day, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # W035466 and W017567 with following expiration dates 06-MAY-2024 and 29-NOV-2023, 0.5 milliliter for prophylaxis (dose number and route of administration were not provided).  Other suspect therapies included varicella virus vaccine live (oka/merck) (VARIVAX) lot # U039723 and W031812   with following expirations dates 15-DEC-2023 and 05-OCT-2024, 0.5 milliliter for prophylaxis (dose number and route of administration were not provided) (product storage error and no adverse event).; Sender's Comments:  US-009507513-2306USA004090: US-009507513-2306USA004089: US-009507513-2306USA004087: US-009507513-2306USA004082: US-009507513-2306USA004088: US-009507513-2305USA007959: US-009507513-2306USA004085: US-009507513-2306USA004083: US-009507513-2306USA004084:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no aditional AE; freezer underwent an excursion and they did not realize the excursion until later/temperature excursion for VARIVAX and PROQUAD/ VARIVAX and PROQUAD may have been administered to multiple patients; This spontaneous report has been received from a nurse, concerning a 11-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not provided.  On 15-MAY-2023, the reporter's freezer underwent a temperature excursion; in which varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) were stored. On that same day, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # W035466 and W017567 with following expiration dates 06-MAY-2024 and 29-NOV-2023, 0.5 milliliter for prophylaxis (dose number and route of administration were not provided).  Other suspect therapies included varicella virus vaccine live (oka/merck) (VARIVAX) lot # U039723 and W031812   with following expirations dates 15-DEC-2023 and 05-OCT-2024, 0.5 milliliter for prophylaxis (dose number and route of administration were not provided) (product storage error and no adverse event).; Sender's Comments:  US-009507513-2306USA004089: US-009507513-2306USA004090: US-009507513-2306USA004082: US-009507513-2306USA004088: US-009507513-2306USA004086: US-009507513-2305USA007959: US-009507513-2306USA004085: US-009507513-2306USA004083: US-009507513-2306USA004084:
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no aditional AE; freezer underwent an excursion and they did not realize the excursion until later/temperature excursion for VARIVAX and PROQUAD/ VARIVAX and PROQUAD may have been administered to multiple patients; This spontaneous report has been received from a nurse, concerning a 12-month-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not provided.  On 15-MAY-2023, the reporter's freezer underwent a temperature excursion; in which varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) were stored. On that same day, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # W035466 and W017567 with following expiration dates 06-MAY-2024 and 29-NOV-2023, 0.5 milliliter for prophylaxis (dose number and route of administration were not provided).  Other suspect therapies included varicella virus vaccine live (oka/merck) (VARIVAX) lot # U039723 and W031812   with following expirations dates 15-DEC-2023 and 05-OCT-2024, 0.5 milliliter for prophylaxis (dose number and route of administration were not provided) (product storage error and no adverse event).; Sender's Comments:  US-009507513-2306USA004090: US-009507513-2306USA004089: US-009507513-2306USA004086: US-009507513-2306USA004087: US-009507513-2305USA007959: US-009507513-2306USA004085: US-009507513-2306USA004083: US-009507513-2306USA004082: US-009507513-2306USA004084:
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no aditional AE; freezer underwent an excursion and they did not realize the excursion until later/temperature excursion for VARIVAX and PROQUAD/ VARIVAX and PROQUAD may have been administered to multiple patients; This spontaneous report has been received from a nurse, concerning a 3-year-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not provided.  On 15-MAY-2023, the reporter's freezer underwent a temperature excursion; in which varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) were stored. On that same day, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # W035466 and W017567 with following expiration dates 06-MAY-2024 and 29-NOV-2023, 0.5 milliliter for prophylaxis (dose number and route of administration were not provided).  Other suspect therapies included varicella virus vaccine live (oka/merck) (VARIVAX) lot # U039723 and W031812   with following expirations dates 15-DEC-2023 and 05-OCT-2024, 0.5 milliliter for prophylaxis (dose number and route of administration were not provided) (product storage error and no adverse event).; Sender's Comments:  US-009507513-2306USA004082: US-009507513-2306USA004090: US-009507513-2306USA004086: US-009507513-2306USA004087: US-009507513-2306USA004088: US-009507513-2305USA007959: US-009507513-2306USA004085: US-009507513-2306USA004084: US-009507513-2306USA004083:
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no aditional AE; freezer underwent an excursion and they did not realize the excursion until later/temperature excursion for VARIVAX and PROQUAD/ VARIVAX and PROQUAD may have been administered to multiple patients; This spontaneous report has been received from a nurse, concerning a 4-year-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not provided.  On 15-MAY-2023, the reporter's freezer underwent a temperature excursion; in which varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) were stored. On that same day, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # W035466 and W017567 with following expiration dates 06-MAY-2024 and 29-NOV-2023, 0.5 milliliter for prophylaxis (dose number and route of administration were not provided).  Other suspect therapies included varicella virus vaccine live (oka/merck) (VARIVAX) lot # U039723 and W031812   with following expirations dates 15-DEC-2023 and 05-OCT-2024, 0.5 milliliter for prophylaxis (dose number and route of administration were not provided) (product storage error and no adverse event).; Sender's Comments:  US-009507513-2306USA004082: US-009507513-2306USA004086: US-009507513-2306USA004087: US-009507513-2306USA004088: US-009507513-2306USA004089: US-009507513-2306USA004085: US-009507513-2305USA007959: US-009507513-2306USA004084: US-009507513-2306USA004083:
Age: 17.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: missed dose; product origin unknown; No additional AE; This spontaneous report was received from a physician referring to a currently 27-year-old female patient. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions and concomitant drugs were not reported.   According to the patient, on unknown dates, the patient received two doses of "HPV vaccine (manufacturer unknown)" (strength, dose, route of administration, anatomical location, lot#, and expiration date were not reported) for prophylaxis (product origin unknown). However, the state records only showed one dose administered to the patient on 26-FEB-2013 (product dose omission issue). No additional adverse events (AE) were reported (no adverse event).
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: Diagnosed with shingles on 6/04/23/Suspected Vaccination failure; Shingles; rash on on right cheek to jaw line; This serious case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 26-OCT-2022, the patient received the 2nd dose of Shingrix. On 22-JUL-2022, the patient received the 1st dose of Shingrix. On 03-JUN-2023, 220 days after receiving Shingrix and 316 days after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Diagnosed with shingles on 6/04/23/Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and exanthema facial (Verbatim: rash on on right cheek to jaw line). The outcome of the vaccination failure was unknown and the outcome of the shingles and exanthema facial were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and exanthema facial to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles and exanthema facial to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 07-JUN-2023 The patient was diagnosed with shingles on 4th June 2023. The symptoms began with rash on right cheek to jaw line. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting. The reporter agreed to follow up from GlaxoSmithKline.
Sex: M
Vaccine: VARZOS
Symptoms: Blindness unilateral, Herpes zoster, Vaccination failure
Clinical narrative: got shingles the worst case ever / Suspected vaccination failure; blind in the left eye; got shingles the worst case ever; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got shingles the worst case ever / Suspected vaccination failure) (serious criteria GSK medically significant), blind left eye (Verbatim: blind in the left eye) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles the worst case ever). The outcome of the vaccination failure was unknown and the outcome of the blind left eye and shingles were not reported.   It was unknown if the reporter considered the vaccination failure, blind left eye and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, blind left eye and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-JUN-2023 This case was reported by a patient's child via interactive digital media. The patient received the Shingles shot then got shingles the worst case ever. The patient went blind in the left eye. The reporter mentioned that there was a medication that lessens symptoms if anyone got Shingles. The reporter suggested that it was needed to look up safety and effectiveness of this shot and all vaccines. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: After taking it got shingles twice/ Suspected vaccination failure; Got shingles twice; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: After taking it got shingles twice/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got shingles twice). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-JUN-2023 This case was reported by a patient via interactive digital media. The reporter reported that he or she sat at the table at the wedding as three peoples shared as they all received Shingles vaccine. The reporter stated that after received Shingles vaccine the two of the three patients experienced Shingles twice. Follow-up would not possible as no contact details were available.