chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash macular
Clinical narrative: blotchy red patches and itchiness in the RIGHT arm even though vaccination side was LEFT deltoid. She was advised to take benadryl and consult MD for 2nd dose. Reports no Shortness of Breath or any other symptoms.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Asthenia, Dehydration, Feeling hot, Pallor, White blood cell count increased
Clinical narrative: approx 1hr after vaccine - became hot. weak & mother states "gray" face - called ambulance - was see in ER. - dehydration received IVF & WBC count was elevated
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: GUARDIAN REPORTS CHILD'S RGIHT UPPER ARM RED, WARM, AND PAINFUL. REPORTS EXTENDS FROM ABOVE THE INJECTION SITE TO A COUPLE OF INCHES ABOVE THE ELBOW.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Bacterial infection, Computerised tomogram
Clinical narrative: Patient's mom stated that her daughter got infected with bacteria now on antibiotic after getting boostrix at pharmacy. Also per patient, she told us she went to ER and ER Dept md put her on antibiotic drips Vancomycin, did CT scan same day with oRal antibiotic Bactrim DS on 8/20/19, we spoke to the patient to follow up to make sure she is doing fine. Per patient, she confirmed she is doing fine.
Age: 21.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Pain in extremity
Clinical narrative: Achey arm for 2 days started to improve on 3rd day.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Nuclear magnetic resonance imaging, Pain in extremity, X-ray
Clinical narrative: Within 12 hours of the injection I developed severe, deep pain in my left arm but not at the site of the injection.  The pain was in front toward my armpit.  I also had limited range of motion.   Over the course of these last 9 months, I have seen four doctor and have received 3 cortisone shots (two blind and one guided).  I have also had physical therapy.   My pain level is still high and I have limited use of my arm.   I am now going to have  an ultrasound and possible EMG.  I am still trying to find out the source of the pain.  I have no doubt it was from the flu shot I have last November 25.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Injected limb mobility decreased, Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: felt "crappy"; "hurt going in/was a painful injection; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd April 2019, the patient received the 1st dose of Shingrix. On 2nd April 2019, less than a day after receiving Shingrix, the patient experienced feeling unwell and injection site pain. The patient was treated with paracetamol (Tylenol). On 5th April 2019, the outcome of the feeling unwell and injection site pain were recovered/resolved.   It was unknown if the reporter considered the feeling unwell and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient was hurt and the injection site was painful.  The patient felt crappy for the first 2 days but still went to work. This case was linked with case US2019093267 (wife's case) reported by the same reporter.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Pyrexia
Clinical narrative: felt "crappy"; "hurt going in/was a painful injection; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd April 2019, the patient received the 1st dose of Shingrix. On 2nd April 2019, less than a day after receiving Shingrix, the patient experienced feeling unwell and injection site pain. The patient was treated with paracetamol (Tylenol). On 5th April 2019, the outcome of the feeling unwell and injection site pain were recovered/resolved.   It was unknown if the reporter considered the feeling unwell and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient was hurt and the injection site was painful.  The patient felt crappy for the first 2 days but still went to work. This case was linked with case US2019093267 (wife's case) reported by the same reporter.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Malaise
Clinical narrative: felt "crappy"; "hurt going in/was a painful injection; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd April 2019, the patient received the 1st dose of Shingrix. On 2nd April 2019, less than a day after receiving Shingrix, the patient experienced feeling unwell and injection site pain. The patient was treated with paracetamol (Tylenol). On 5th April 2019, the outcome of the feeling unwell and injection site pain were recovered/resolved.   It was unknown if the reporter considered the feeling unwell and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient was hurt and the injection site was painful.  The patient felt crappy for the first 2 days but still went to work. This case was linked with case US2019093267 (wife's case) reported by the same reporter.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abdominal discomfort, Decreased appetite, Dehydration, Diarrhoea, Headache
Clinical narrative: Flu Like Symptoms; Physical collapse/Low energy; Fever; Diarrhea; Dehydration; Sore arm; Lack of appetite; Upset stomach; could barely move; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms, feeling of total lack of energy, fever, diarrhea, dehydration, pain in arm, appetite absent, upset stomach and mobility decreased. On an unknown date, the outcome of the influenza-like symptoms, feeling of total lack of energy, fever, diarrhea, dehydration, pain in arm, appetite absent, upset stomach and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, feeling of total lack of energy, fever, diarrhea, dehydration, pain in arm, appetite absent, upset stomach and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated after receiving Shingrix vaccine, he experienced flu like symptoms, physical collapse where he could barely move for about 36 hours, fever, upset stomach with diarrhea, dehydration, soreness in arm, lack of appetite and low energy. All the effects lasted for about 3 to 4 days. The patient gave consent to follow up. No further details were provided. This case has been linked to the case US2019142318, reported by the same reporter.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Hypersomnia, Mobility decreased
Clinical narrative: Flu Like Symptoms; Physical collapse/Low energy; Fever; Diarrhea; Dehydration; Sore arm; Lack of appetite; Upset stomach; could barely move; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms, feeling of total lack of energy, fever, diarrhea, dehydration, pain in arm, appetite absent, upset stomach and mobility decreased. On an unknown date, the outcome of the influenza-like symptoms, feeling of total lack of energy, fever, diarrhea, dehydration, pain in arm, appetite absent, upset stomach and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, feeling of total lack of energy, fever, diarrhea, dehydration, pain in arm, appetite absent, upset stomach and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated after receiving Shingrix vaccine, he experienced flu like symptoms, physical collapse where he could barely move for about 36 hours, fever, upset stomach with diarrhea, dehydration, soreness in arm, lack of appetite and low energy. All the effects lasted for about 3 to 4 days. The patient gave consent to follow up. No further details were provided. This case has been linked to the case US2019142318, reported by the same reporter.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abdominal discomfort, Asthenia, Decreased appetite, Dehydration, Diarrhoea
Clinical narrative: Flu Like Symptoms; Physical collapse/Low energy; Fever; Diarrhea; Dehydration; Sore arm; Lack of appetite; Upset stomach; could barely move; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms, feeling of total lack of energy, fever, diarrhea, dehydration, pain in arm, appetite absent, upset stomach and mobility decreased. On an unknown date, the outcome of the influenza-like symptoms, feeling of total lack of energy, fever, diarrhea, dehydration, pain in arm, appetite absent, upset stomach and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, feeling of total lack of energy, fever, diarrhea, dehydration, pain in arm, appetite absent, upset stomach and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated after receiving Shingrix vaccine, he experienced flu like symptoms, physical collapse where he could barely move for about 36 hours, fever, upset stomach with diarrhea, dehydration, soreness in arm, lack of appetite and low energy. All the effects lasted for about 3 to 4 days. The patient gave consent to follow up. No further details were provided. This case has been linked to the case US2019142318, reported by the same reporter.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Influenza like illness, Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: Flu Like Symptoms; Physical collapse/Low energy; Fever; Diarrhea; Dehydration; Sore arm; Lack of appetite; Upset stomach; could barely move; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms, feeling of total lack of energy, fever, diarrhea, dehydration, pain in arm, appetite absent, upset stomach and mobility decreased. On an unknown date, the outcome of the influenza-like symptoms, feeling of total lack of energy, fever, diarrhea, dehydration, pain in arm, appetite absent, upset stomach and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, feeling of total lack of energy, fever, diarrhea, dehydration, pain in arm, appetite absent, upset stomach and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated after receiving Shingrix vaccine, he experienced flu like symptoms, physical collapse where he could barely move for about 36 hours, fever, upset stomach with diarrhea, dehydration, soreness in arm, lack of appetite and low energy. All the effects lasted for about 3 to 4 days. The patient gave consent to follow up. No further details were provided. This case has been linked to the case US2019142318, reported by the same reporter.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: Flu Like Symptoms; Physical collapse/Low energy; Fever; Diarrhea; Dehydration; Sore arm; Lack of appetite; Upset stomach; could barely move; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms, feeling of total lack of energy, fever, diarrhea, dehydration, pain in arm, appetite absent, upset stomach and mobility decreased. On an unknown date, the outcome of the influenza-like symptoms, feeling of total lack of energy, fever, diarrhea, dehydration, pain in arm, appetite absent, upset stomach and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, feeling of total lack of energy, fever, diarrhea, dehydration, pain in arm, appetite absent, upset stomach and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated after receiving Shingrix vaccine, he experienced flu like symptoms, physical collapse where he could barely move for about 36 hours, fever, upset stomach with diarrhea, dehydration, soreness in arm, lack of appetite and low energy. All the effects lasted for about 3 to 4 days. The patient gave consent to follow up. No further details were provided. This case has been linked to the case US2019142318, reported by the same reporter.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Influenza like illness, Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: Flu Like Symptoms; Physical collapse/Low energy; Fever; Diarrhea; Dehydration; Sore arm; Lack of appetite; Upset stomach; could barely move; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms, feeling of total lack of energy, fever, diarrhea, dehydration, pain in arm, appetite absent, upset stomach and mobility decreased. On an unknown date, the outcome of the influenza-like symptoms, feeling of total lack of energy, fever, diarrhea, dehydration, pain in arm, appetite absent, upset stomach and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, feeling of total lack of energy, fever, diarrhea, dehydration, pain in arm, appetite absent, upset stomach and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated after receiving Shingrix vaccine, he experienced flu like symptoms, physical collapse where he could barely move for about 36 hours, fever, upset stomach with diarrhea, dehydration, soreness in arm, lack of appetite and low energy. All the effects lasted for about 3 to 4 days. The patient gave consent to follow up. No further details were provided. This case has been linked to the case US2019142318, reported by the same reporter.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS, FLUC4, VARZOS
Symptoms: Chills, Erythema, Headache, Injection site erythema, Lymphadenopathy
Clinical narrative: Pt reported tingling up arm to neck day vaccine was given, later that evening had swelling and pain as well. Next day said she had bruising under the arm and the right breast area and side. Pt reported events 8/21/19 and still showed bruising and said some pain.  No bruising, swelling or pain at injection site- all seemed localized to the breast and right side and underside of the arm.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS, FLUC4, VARZOS
Symptoms: Nausea, Neck pain, Pain in extremity, Pain in jaw, Paraesthesia
Clinical narrative: Pt reported tingling up arm to neck day vaccine was given, later that evening had swelling and pain as well. Next day said she had bruising under the arm and the right breast area and side. Pt reported events 8/21/19 and still showed bruising and said some pain.  No bruising, swelling or pain at injection site- all seemed localized to the breast and right side and underside of the arm.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS, FLUC4, VARZOS
Symptoms: Vomiting
Clinical narrative: Pt reported tingling up arm to neck day vaccine was given, later that evening had swelling and pain as well. Next day said she had bruising under the arm and the right breast area and side. Pt reported events 8/21/19 and still showed bruising and said some pain.  No bruising, swelling or pain at injection site- all seemed localized to the breast and right side and underside of the arm.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS, FLUC4, VARZOS
Symptoms: Axillary pain, Breast pain, Contusion, Pain, Paraesthesia
Clinical narrative: Pt reported tingling up arm to neck day vaccine was given, later that evening had swelling and pain as well. Next day said she had bruising under the arm and the right breast area and side. Pt reported events 8/21/19 and still showed bruising and said some pain.  No bruising, swelling or pain at injection site- all seemed localized to the breast and right side and underside of the arm.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS, FLUC4, VARZOS
Symptoms: Swelling
Clinical narrative: Pt reported tingling up arm to neck day vaccine was given, later that evening had swelling and pain as well. Next day said she had bruising under the arm and the right breast area and side. Pt reported events 8/21/19 and still showed bruising and said some pain.  No bruising, swelling or pain at injection site- all seemed localized to the breast and right side and underside of the arm.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Blood blister, Ear infection, Eczema, Food allergy, Food aversion
Clinical narrative: Patient's symptoms that family reported back included the development of the following over the next few weeks/months after vaccination: GI issues/GERD, upper respiratory issues, asthma-type symptoms/wheezing, eczema, food allergies (IgG allergy to peanuts), ear infections, speech delays, sensory food aversions (all vegetables and all but 2 fruits unless pureed), pooping blood and open bloody blisters up to his mid-back, potentially RSV and/or pneumonia.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Gastrointestinal disorder, Gastrooesophageal reflux disease, Haematochezia, Respiratory disorder, Speech disorder developmental
Clinical narrative: Patient's symptoms that family reported back included the development of the following over the next few weeks/months after vaccination: GI issues/GERD, upper respiratory issues, asthma-type symptoms/wheezing, eczema, food allergies (IgG allergy to peanuts), ear infections, speech delays, sensory food aversions (all vegetables and all but 2 fruits unless pureed), pooping blood and open bloody blisters up to his mid-back, potentially RSV and/or pneumonia.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Wheezing
Clinical narrative: Patient's symptoms that family reported back included the development of the following over the next few weeks/months after vaccination: GI issues/GERD, upper respiratory issues, asthma-type symptoms/wheezing, eczema, food allergies (IgG allergy to peanuts), ear infections, speech delays, sensory food aversions (all vegetables and all but 2 fruits unless pureed), pooping blood and open bloody blisters up to his mid-back, potentially RSV and/or pneumonia.
Age: 18.0
Sex: F
Vaccine: FLU4, MMR, MNQ, TDAP
Symptoms: Dizziness, Dyspnoea, Loss of consciousness
Clinical narrative: patient recieved 4 vaccines as part of preparation for missionary service. Flu, mmr, tdap, menactra.  within 5 minutes patient began to feel faint and light headed then mentioned difficulty breathing and was advised to sit down. patient fainted shortly after and was unconscious. pharmacist administered one dose of epinephrine and patient was lain down on floor with feet elevated. Technician called 911 and paramedics arrived shortly thereafter.  Patient was conscious and resting when paramedics arrived.  Parents were called and arrived shortly after paramedics.  patient was well and left with parents. no other interventions given.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: 100.5 degree fever day after vaccination; sore arm
Sex: F
Vaccine: VARCEL
Symptoms: Eyelid margin crusting, Swelling of eyelid
Clinical narrative: swollen crusty eyelids; swollen crusty eyelids; This spontaneous report as received from a pharmacist refers to a 43-year-old female patient. The patient's pertinent medical history included multiple sclerosis. The patient's concurrent conditions included allergy to morphine, prednisone, metoclopramide (REGLAN) and sumatriptan (IMITREX). The patient's concomitant medications were not reported.  On 27-JUN-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # R011809, expiration date 23-APR-2020, subcutaneously for routine vaccination (dose and frequency were not reported). On 28-JUN-2019, the patient experienced swollen crusty eyelids. The events recovered on an unknown date in July 2019 (reported as maybe 3 or 4 days after starting).  The relatedness between the events and the suspect vaccine was not reported.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Seizure
Clinical narrative: The next morning he had a full seizure and was hospitalized at an unspecified hospital; This spontaneous report was received from an unspecified reporter via a company representative, and refers to a 16 year old male patient. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided.      On an unknown date, 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), for prophylaxis (strength, dose, frequency, route, lot number and expiration date were not provided).         On an unknown date (reported as "the next morning"), the patient had a full seizure and was hospitalized at an unspecified hospital.      At the time of reporting, the outcome of seizure was unknown.  The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the reported seizure was not provided.  Upon internal review, the event seizure was determined to be medically significant.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Gaze palsy, Pyrexia, Seizure like phenomena
Clinical narrative: the patient "experienced seizure like activity for five minutes and her eyes rolled up in her head".; the patient "experienced seizure like activity for five minutes and her eyes rolled up in her head".; fever of 101.3F; This spontaneous report has been received from a nurse referring to an 18-month-old female patient who had no concurrent conditions, medical history, concomitant therapies or drug allergy or reactions.          On 12-AUG-2019, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) (lot # R030115, expiration date reported as 29-DEC-2019; strength: vial 25/0.5 (unit not provided); dose was not reported) intramuscularly for prophylaxis (also reported as scheduled vaccine).         On 13-AUG-2019, the patient experienced seizure like activity for five minutes and her eyes rolled up in her head. The patient also had a fever of 101.3 Fahrenheit (F). The patient was taken by emergency medical services to an unspecified hospital on the same date. The patient received rectal acetaminophen (TYLENOL). On that date, the patient went home. It was unknown if there were diagnostics or studies performed. The patient sought medical attention. The outcome of the events was unknown. The causality between the events and hepatitis a vaccine, inactivated (VAQTA) was not reported.  The reporter considered all the events to be medical significant (reported as need intervention to prevent serious criteria).
Age: 17.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse effects were reported; the 17 year old patient was inadvertently administered an adult dose of VAQTA; This spontaneous report was received from a registered nurse referring to a 17 year old patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      On 14-AUG-2019, also reported as "yesterday", the patient was inadvertently administered an adult dose of hepatitis a vaccine, inactivated (VAQTA) lot # S007265 (verified to be a valid lot number), expiration date reported as 20-JUL-2020, but upon internal validation established as 07-JUL-2020, for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; improperly stored MMR II was administered on 8/15/2019; This spontaneous report was received from a pharmacy technician and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 15-AUG-2019, the patient was vaccinated with an improperly stored dose of mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, subcutaneously (lot # R027063, expiry date 20-SEP-2020, albumin status rHa; exact dose and injection site were not provided) for prophylaxis. The vaccine was exposed to a temperature of 70 Fahrenheit degrees (F) for 4 days. There were no previous temperature excursions. Digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: on unspecified dates, unspecified patients received improperly stored GARDASIL 9; No adverse effects reported; This spontaneous report was received from a pharmacy tech referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported.  On unspecified dates, the patients were vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R024271 and expiration date 08-MAY-2021 (dose, frequency and route were not provided) for prophylaxis. The administered doses of the vaccines were stored with the temperature of 31.29 degrees Fahrenheit for 10 minutes. There was a digital data logger involved, but there was no previous temperature excursion.
Age: 72.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; One female Patient was administered improperly stored M-M-R II; This spontaneous report was received from The Office Manager referring to a 72 year old  female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 15-JUL-2019, the patient was administered an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA recombinant Human albumin (rHA) (M-M-R II) (Strength, route, dose, frequency, and anatomical location were unknown) with lot # R031628 and expiration date 01-NOV-2020.   The administered dose of the vaccine experienced a total time and highest temperature above 47°F (51.1 F, multiple) degrees Fahrenheit for 29 hours. There was a digital data logger invloved, but there was no previous temperature excursion. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Injection site soreness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The reporter indicated that almos every patient she had vaccinated with Shingirx, expereicned soreness at injection site. The reporter was unable to provide any additional information because the consumer was not in the pharmacy at the time of call.  The reporter consented to follow up.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Abnormal Pap test due to HPV; Abnormal Pap test due to HPV; This spontaneous report was received from an office manager via a company representative and refers to 23-year-old female patient. Information on patient's pertinent medical history, concurrent condition, concomitant medication and drug allergies/reaction were not reported.   On 27-DEC-2007, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot# 0524U (not valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), the lot is valid for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine), second dose on 17-MAR-2008, lot# 0930U (not valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), the lot is valid for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine) and third dose on 22-JUL-2008 lot# 1446U (not valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), the lot is valid for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine) (dose, route and expiration date were not reported) for prophylaxis.   On an unknown date in July 2019, the patient had an abnormal Pap test due to human papillomavirus (HPV) (human papilloma virus test positive and smear cervix abnormal). The patient was being treated through an unspecified obstetrician-gynecologist (OB/GYN). The outcome of human papilloma virus test positive and smear cervix abnormal was unknown. Causality assessment for the events human papilloma virus test positive and smear cervix abnormal was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Constipation, Flatulence, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: redness; swelling; itching; red bull's eye appearance and hot to touch; spot removed of head; constipation; gas; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 24th June 2019, less than a day after receiving Shingrix, the patient experienced constipation, gas and skin discoloration. On 25th June 2019, the patient experienced injection site erythema, swelling, injection site itching and injection site warmth. The patient was treated with ibuprofen (Advil) and non-drug therapy, non-drug therapy (Ice Pack (No Medication)). On 28th June 2019, the outcome of the injection site erythema and swelling were recovered/resolved. On an unknown date, the outcome of the injection site itching, constipation, gas, injection site warmth and skin discoloration were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, swelling, injection site itching, constipation, gas, injection site warmth and skin discoloration to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix on left arm. The patient received Shingrix and after 1 day had a red bull's eye appearance at the site with hot to touch. The patient saw her doctor for those and itching at the site that she described as itching on the inside of her skin. The redness had resolved along with the swelling today. The patient had the itching. The patient used ice packs and Advil as advised by her physician. It was just a bad day all together on day of vaccination. The patient saw her Dermatologist that day, had a spot removed on her head. The patient had a couple of stitches placed and noted she had overdone it on fiber, and had to go to her local Emergency room with constipation and gas. She noted all of that has resolved also. The reporter give consent to follow up. Emergency room visit required. The reporter reported Advil taken and itching had stopped.
Sex: F
Vaccine: VARZOS
Symptoms: Skin discolouration, Skin lesion removal, Suture insertion, Swelling
Clinical narrative: redness; swelling; itching; red bull's eye appearance and hot to touch; spot removed of head; constipation; gas; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 24th June 2019, less than a day after receiving Shingrix, the patient experienced constipation, gas and skin discoloration. On 25th June 2019, the patient experienced injection site erythema, swelling, injection site itching and injection site warmth. The patient was treated with ibuprofen (Advil) and non-drug therapy, non-drug therapy (Ice Pack (No Medication)). On 28th June 2019, the outcome of the injection site erythema and swelling were recovered/resolved. On an unknown date, the outcome of the injection site itching, constipation, gas, injection site warmth and skin discoloration were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, swelling, injection site itching, constipation, gas, injection site warmth and skin discoloration to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix on left arm. The patient received Shingrix and after 1 day had a red bull's eye appearance at the site with hot to touch. The patient saw her doctor for those and itching at the site that she described as itching on the inside of her skin. The redness had resolved along with the swelling today. The patient had the itching. The patient used ice packs and Advil as advised by her physician. It was just a bad day all together on day of vaccination. The patient saw her Dermatologist that day, had a spot removed on her head. The patient had a couple of stitches placed and noted she had overdone it on fiber, and had to go to her local Emergency room with constipation and gas. She noted all of that has resolved also. The reporter give consent to follow up. Emergency room visit required. The reporter reported Advil taken and itching had stopped.
Age: 18.0
Sex: M
Vaccine: HPVX, MENB
Symptoms: Pyrexia
Clinical narrative: not feel well; pain; fatigue; chills; fever; sweaty; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included HPV 16-18 (HPV vaccine) for prophylaxis.   Previously administered products included HPV vaccine (received 2 doses without any problem) and Menveo.   On 24th July 2019 11:30, the patient received the 1st dose of Bexsero and the 3rd dose of HPV vaccine. On 24th July 2019, 1 days after receiving Bexsero and HPV vaccine, the patient experienced fever and sweating. On 24th July 2019 23:30, the patient experienced fatigue and chills. On 25th July 2019, the patient experienced pain. On 26th July 2019, the patient experienced feeling unwell. The patient was treated with ibuprofen (Motrin), paracetamol (Tylenol) and non-drug therapy, non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the fatigue, chills, fever, pain and sweating were recovered/resolved and the outcome of the feeling unwell was not recovered/not resolved.   The reporter considered the fatigue, chills, fever, pain, sweating and feeling unwell to be related to Bexsero. It was unknown if the reporter considered the fatigue, chills, fever, pain, sweating and feeling unwell to be related to HPV vaccine.  Additional details were reported as follows: The patient's mother reported for the patient. The patient received the first Bexsero vaccine as part of his routine vaccination because he was attending college. The reporter clarified that he did receive the third part of HPV series at the same time and on the same arm where he got Bexsero vaccine. However, he did not have any reaction to the other two HPV vaccine that he received in the past; so at this point, they were only suspecting that the events are due to the Bexsero vaccine.  Later on the same day of receiving Bexsero vaccine, on that evening, the patient complained about unusual fatigue and around 11:30 PM at night he had the chills.  The patient had a fever of 101.6 degrees F at 3:30 AM. The reporter gave him Motrin 1,000 mg and called her health plan that has someone working 24/7 for advice. They told her to take him to emergency room if the temperature goes over 104 degrees F. The patient's temperatures escalated to 102 and again, it was 103 within 40 minutes after calling the health plan. The patient seemed to be in pain. The reporter got some compressed ice and took his temperature again. Within 15 or 20 minutes of making that phone call, his temperature were over 104 degrees. She took her son to the emergency room (ER). At the ER, her son had his temperature taken rectally and they were 102.8 degrees. He was given fluids and stayed for an hour at the ER. They discharged him on both Motrin and Tylenol staggered every 3 hours (alternating both medications every 3 hours). The patient was sweaty and had fever (of 99.8 degrees F) the entire day. The physician reported this event to the CDC.  The reporter consented for follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Tenderness
Clinical narrative: Itching on arm; Redness on arm; Tenderness on arm; Swelling on arm; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number 95XF7, expiry date 29th October 2021) for prophylaxis.   On 8th August 2019, the patient received the 1st dose of Shingrix. On 12th August 2019, 4 days after receiving Shingrix, the patient experienced itchy upper limbs. In August 2019, the patient experienced erythema of extremities, pain in arm and swelling arm. On an unknown date, the outcome of the erythema of extremities, pain in arm, swelling arm and itchy upper limbs were not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities, pain in arm, swelling arm and itchy upper limbs to be related to Shingrix.  Additional information received were as follows: The pharmacist reported that the patient experienced redness, tenderness, swelling, and itching on left arm. The healthcare professional confirmed redness, swelling, tenderness had began to improve. The redness was described as a faint red.  The healthcare professional noted that the itching began on the reporting date The reporter consented to follow up.
Age: 73.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Blister, Blister rupture, Pruritus
Clinical narrative: open Blisters; Itchy blisters; This case was reported by a pharmacist via call center representative and described the occurrence of blister in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number 5TH3L, expiry date 31st July 2020) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMOVAX 23) for prophylaxis.   On 1st August 2019, the patient received the 1st dose of Shingrix and PNEUMOVAX 23. On an unknown date, several days after receiving Shingrix, the patient experienced blister and pruritus. On an unknown date, the outcome of the blister and pruritus were unknown.   It was unknown if the reporter considered the blister and pruritus to be related to Shingrix.  Additional information received were as follows: On 12th August 2019, in the morning, the patient presented in the pharmacy. Few days after receiving Shingrix, the patient experienced a severe reaction of open blisters on bilateral arms, knees, legs, and ankles. The patient could not provide pharmacist an exact date when blisters first occurred. The patient stated the blisters were itchy and they opened after he scratched them.  The patient denied nerve pain, pain, fever, and rash. The pharmacist stated that the patient was seen by his primary care provider, who referred him to the pharmacy for further discussion regarding his symptoms and recommendations. The pharmacist consented to follow up. The pharmacist stated that they had been having a system issue where the system automatically populates the expiration date for the product as such, she was not sure whether the expiration date provided for the Shingrix dose was accurate.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu-like symptoms: lack of energy, high temperature, aching body, headache.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Breath holding, Crying, Dizziness, Emotional distress, Hypotonia
Clinical narrative: mmunization record reviewed, HPV, menactra and Tdap immunizations recommended.   Screening reviewed - no contraindications/precautions.     Consent obtained and VIS provided - client's questions answered.  Immunizations administered under Standing Orders as in Orders.   Client observed for adverse reactions -  adverse reaction response:  Patient entered the exam room and went to sit on the exam table.  Writer showed patient's mother the vaccine and verified that the HPV, Menactra and Tdap were in the syrnges and ready for administration.  Patient was nervous and reluctant to take off jacket.  With encouragement from her mother and writer, patient removed her jacket.  Both arms were tense and she was holding on to the left side of the exam table.  With encouragment from writer and patient's mother patient let go of table and attempted to relax. She recieved the menactra vaccine to her left arm IM and giggled saying it didn't hurt that bad.  Writer administered the Tdap in the Left Deltoid at which time, patient said, 'oh that hurt." She then puffed out her cheeks which looked like she was holding her breath, she stiffened and then she became flaccid with eyes open and was laid on her back on the exam table by her mother and this writer.  She turned slightly to her right, facing her mother, tonic clonic movement was noted in both arms and legs as well as her head.  Patient's eyes were open. This lasted 40 seconds.  She was breathing and her mucus membrane color remained pink. after 20 seconds patient raised her head and said what happened.  She was distressed and started crying.  She said her face felt like it was buzzing.  Writer called for assistance and offered patient support and a popcycle which she ate slowly.  She took drank some water as well. She did not become naseaus nor was she incontent of urine or stool.  Mother declined to have the HPV vaccine given.  At 0945, Writer notified Dr. via telephone, Dr. wanted patient observed for 20 minutes and if there was a concern by writer or patient mother, Dr. recommended patient go to urgent care.   BP was 104/60 pulse 62 and  Respirations 18.  Patient repoted that she felt dizzy after the second shot and it was reported that patient had not eaten today.   Patient and mother were given verbal support and reasurrance by writer.  Patient's mother reported that patient's grandmother had a seizure diagnosis, took medications which controled the seizures.   Patient got down from table, walking around in the exam room, she denied visual changes or feeling dizzy, she denied light, sound or color changes before the episode.  She stated she felt okay.  Mother stated she wanted to take her daughter to the ED for evaluation.   Writer informed the mother and patient that due to this episode the PHO would not be able to give her anymore vaccines, but that she could recieve any additional vaccines at a providers office if approved by the provider.  Both mother and daughter left the clinic without further incident.