chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: FLUX, FLUX(H1N1), FLUX, FLUX(H1N1)
Symptoms: Ocular hyperaemia, Palpitations, Pharyngeal oedema, Rash generalised
Clinical narrative: This medically confirmed literature case (initial receipt 16-Dec-2015) concerns a 27 year old female patient. The author identified confirmed cases of anaphylaxis from the Vaccine Safety Datalink from vaccination records from January 2009 through December 2011. The patient had no history of atopy. On an unspecified date between 01-Jan-2009 through 31-Dec-2011, the patient received Influenza virus vaccine (manufacturer and batch number not reported) and H1N1 (manufacturer and batch number not reported). On an unspecified date, 2 hours after vaccination, the patient experienced anaphylaxis. The symptoms included generalized erythema and rash, red itchy eyes, increased heart rate, palpitations, swelling (throat) and chest heaviness. The case met Brighton Collaboration case definition of anaphylaxis criteria level 1. She received treatment with oral antihistamines and acetaminophen. The outcome was recovered. The patient was referred to PCP (primary care physician). Linked case: 2015057134 (same patient). Reporter's comments: The attributed trigger was vaccine.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Cough, Diarrhoea, Dysphonia, Dyspnoea
Clinical narrative: This medically confirmed literature case (initial receipt 16-Dec-2015) concerns a 44-year old female patient. The author identified confirmed cases of anaphylaxis from the Vaccine Safety Datalink from vaccination records from January 2009 through December 2011. The patient had medical history of atopy: anaphylaxis, asthma, allergic rhinitis and 'other (ASA)'. On an unspecified date between 01-Jan-2009 through 31-Dec-2011, the patient received influenza virus vaccine (manufacturer and batch number not reported). Less than 30 minutes after vaccination, the patient experienced anaphylaxis. The symptoms included generalized pruritus and rash, wheeze, shortness of breath, throat tightening, hoarse voice, cough, vomited and diarrhoea. The case met Brighton Collaboration case definition of anaphylaxis criteria level 2. She received treatment with parenteral antihistamines, oral steroids, oxygen and bronchodilators. The outcome was recovered. Reporter's comments: The attributed trigger was vaccine.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus generalised, Rash generalised, Throat tightness, Vomiting, Wheezing
Clinical narrative: This medically confirmed literature case (initial receipt 16-Dec-2015) concerns a 44-year old female patient. The author identified confirmed cases of anaphylaxis from the Vaccine Safety Datalink from vaccination records from January 2009 through December 2011. The patient had medical history of atopy: anaphylaxis, asthma, allergic rhinitis and 'other (ASA)'. On an unspecified date between 01-Jan-2009 through 31-Dec-2011, the patient received influenza virus vaccine (manufacturer and batch number not reported). Less than 30 minutes after vaccination, the patient experienced anaphylaxis. The symptoms included generalized pruritus and rash, wheeze, shortness of breath, throat tightening, hoarse voice, cough, vomited and diarrhoea. The case met Brighton Collaboration case definition of anaphylaxis criteria level 2. She received treatment with parenteral antihistamines, oral steroids, oxygen and bronchodilators. The outcome was recovered. Reporter's comments: The attributed trigger was vaccine.
Age: 9.0
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Angioedema, Cough
Clinical narrative: This medically confirmed literature case (initial receipt 16-Dec-2015) concerns a 9 year old female patient. The author identified confirmed cases of anaphylaxis from the Vaccine Safety Datalink from vaccination records from January 2009 through December 2011. The patient had no history of atopy. On an unspecified date between 01-Jan-2009 through 31-Dec-2011, the patient received Influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, less than 30 minutes after vaccination, the patient experienced anaphylaxis. The symptoms included angioedema and cough. The case met Brighton Collaboration case definition of anaphylaxis criteria level 2. She received treatment with epinephrine, oral antihistamines, oral steroids, bronchodilators and ice pack. The outcome was recovered and the patient was referred to a pediatrician. Reporter's comments: The attributed trigger was vaccine.
Sex: U
Vaccine: FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: This medically confirmed spontaneous report (initial receipt 07-Mar-2016) concerns an unknown demographics patient. On an unspecified date, the patient received influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date, the patient experienced an anaphylactic reaction. The outcome was not reported.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Angioedema, Cough, Dyspnoea, Enlarged uvula
Clinical narrative: This medically confirmed literature case (initial receipt 16-Dec-2015) concerns a 29 year old female patient. The author identified confirmed cases of anaphylaxis from the Vaccine Safety Datalink from vaccination records from January 2009 through December 2011. The patient had no history of atopy. On an unspecified date between 01-Jan-2009 through 31-Dec-2011, the patient received influenza virus vaccine (manufacturer and batch number not reported), which was administered one day before the reaction. On an unspecified date, 8 hours after vaccination, the patient experienced anaphylaxis. The symptoms included angioedema, swelling on lips, uvula and mouth, generalised urticarial, pruritus, rash, shortness of breath and cough. The case met Brighton Collaboration case definition of anaphylaxis criteria level 1. She received treatment with oral antihistamines and oral H2 blockers and oral steroids. The outcome was recovered and the patient was referred to PCP (primary care physician). Reporter's comments: The attributed trigger was vaccine.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Lip swelling, Mouth swelling, Pruritus, Rash, Urticaria
Clinical narrative: This medically confirmed literature case (initial receipt 16-Dec-2015) concerns a 29 year old female patient. The author identified confirmed cases of anaphylaxis from the Vaccine Safety Datalink from vaccination records from January 2009 through December 2011. The patient had no history of atopy. On an unspecified date between 01-Jan-2009 through 31-Dec-2011, the patient received influenza virus vaccine (manufacturer and batch number not reported), which was administered one day before the reaction. On an unspecified date, 8 hours after vaccination, the patient experienced anaphylaxis. The symptoms included angioedema, swelling on lips, uvula and mouth, generalised urticarial, pruritus, rash, shortness of breath and cough. The case met Brighton Collaboration case definition of anaphylaxis criteria level 1. She received treatment with oral antihistamines and oral H2 blockers and oral steroids. The outcome was recovered and the patient was referred to PCP (primary care physician). Reporter's comments: The attributed trigger was vaccine.
Age: 14.0
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Vomiting, Wheezing
Clinical narrative: This medically confirmed literature case (initial receipt 16-Dec-2015) concerns a 14 year old female patient. The author identified confirmed cases of anaphylaxis from the Vaccine Safety Datalink from vaccination records from January 2009 through December 2011. The patient had a history of atopy: asthma, allergic conjunctivitis and rhinitis. On an unspecified date between 01-Jan-2009 through 31-Dec-2011, the patient received influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, 2 hours after vaccination, the patient experienced anaphylaxis. The symptoms included wheeze and vomiting. The case met Brighton Collaboration case definition of anaphylaxis criteria level 2. She received treatment with oral antihistamine and bronchodilators. The outcome was recovered. Reporter's comments: The attributed trigger was vaccine.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt: On 14-Oct-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5mL for prevention of influenza. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 26-FEB-2016) concerns a 23 year-old female patient. On 12-OCT-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-JUN-2016 yet reported as 12-JUN-2016). The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. the outcome was not reported.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This is medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 47-year-old female patient. On 14-Oct-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5mL for the prevention of influenza. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion as 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 30 year-old male patient. On 09-Oct-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5mL for the prevention of influenza. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 30 year-old male patient. On 09-Oct-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5 mL. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 23 year-old female patient. On 09-Oct-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5mL. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 36 year-old female patient. On 08-Oct-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5mL for the prevention of influenza. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion as 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 59 year-old female patient. On 24-Sep-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5mL via the intramuscular route. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 Fahrenheit) for no more than 24 hours. The outcome was not reported.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 34 year-old male patient. On 22-Sep-2015, the patient received AFLURIA (batch number U55406: expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5 mL via the intramuscular route. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 49 year-old male patient. On 08-Oct-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5mL via the intramuscular route. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 59 year-old female patient. On 07-Oct-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5 mL via the intramuscular route. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 57 year-old female patient. On 07-Oct-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5mL via the intramuscular route. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 35 year-old female patient. On 07-Oct-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5mL via the intramuscular route. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 70 year-old male patient. On 06-Oct-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5mL via the intramuscular route. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 30 year-old female patient. On 02-Oct-2015, the patient received AFLURIA (batch number: U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5ml via the intramuscular route. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 51 year-old male patient. On 29-Sep-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported on 12-Jun-2016) 0.5mL via the intramuscular route. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34d degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 75 year-old male patient. On 29-Sep-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5 mL via the intramuscular route. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was reported.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 61 year-old male patient. On 26-Sep-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5mL via the intramuscular route. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 28 year-old female patient. On 25-Sep-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun 2016 yet reported as 12-Jun-2016) 0.5mL via the intramuscular route. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 38 year-old male patient. On 26-Sep-2015, the patient received AFLURIA (batch number: U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5mL via the intramuscular route. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect product storage, Medication error
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 28 year-old female patient. On 22-Sep-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016). The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 49 year-old female patient. On 22-Sep-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016). The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 39 year-old female patient. On 21-Sep-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2106). The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 61 year-old female patient. On 18-Sep-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016). The AFLURIA vaccine was stored at 0.6 to 1.1 degree Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 46 year-old male patient. On 09-Sep-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016). The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 36 year-old female patient. On 21-Sep-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5 ml via the intramuscular route. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 61 year-old male patient. On 10-Sep-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5 ml via the intramuscular route. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 31 year-old female patient. On 09-Sep-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5 ml via the intramuscular route. The AFLURIA vaccine was store at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site pain, Injection site ulcer
Clinical narrative: 6/1/16 - pt came to store w/open sore on left upper arm (not deltoid). Pt said she's had sore/open sore for several months. Patient told doctor - the problem was on going since the fall. Told Rx - since January 2016. Pt states Dr. lanced wound and cleared out. It was getter better 2 weeks ago and then sore returned. Current Dr. gave her steroid pack and will see next week.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Full blood count normal, Pyrexia
Clinical narrative: Fever up to 103 degrees F lasting 5 days. Fever began a few hours after vaccine and has continued off and on 102-103 x 6 days.
Age: 1.53
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Erythema, Injection site inflammation, Pruritus, Scab, Skin discolouration
Clinical narrative: Mom noted a flesh colored spot on 5/27/16. (+) pruritic (+) scabbed and more inflamed over next few days Left thigh at injection site. No fever (+) 3 mm with mild erythema. BACTROBAN OT BID prn.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Rash vesicular
Clinical narrative: Local swelling/redness and vesicular lesion noted at site of MMR. This began 2 days after vaccine given.
Age: 11.0
Sex: M
Vaccine: HEP, MNQ, TDAP, VARCEL
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Had Hep B / Tdap in (L) arm and Varicella and MCV (R) arm. (R) arm with sl. erythema afternoon of vaccines and left arm similar and since then worsened to swelling, pain and redness of (L) arm. No fever.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 26-Feb 2016) concerns a 47 year-old female patient. On 09-Sep-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5 mL via the intramuscular route. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 02-SEP-2015, the patient was vaccinated with ZOSTAVAX (0.65 ml, Lot #L016284, expiration date: 07-AUG-2016), which was improperly stored for 20 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to 2 patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 18-SEP-2015, the patients were vaccinated with ZOSTAVAX (0.65 ml, Lot #L024997, expiration date: 06-OCT-2016), which were improperly stored for 4 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 25-SEP-2015, the patient was vaccinated with ZOSTAVAX (0.65 ml, Lot #L024997, expiration date: 06-OCT-2016), which was improperly stored for 11 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to 2 patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 01-SEP-2015, the patients were vaccinated with ZOSTAVAX (0.65 ml, Lot #L016284, expiration date: 07-AUG-2016), which were improperly stored for 19 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 21-AUG-2015, the patient was vaccinated with ZOSTAVAX (0.65 ml, Lot#L016284, expiration date: 07-AUG-2016), which was improperly stored for 8 days (incorrect product storage). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to 2 patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 19-AUG-2015, the patients were vaccinated with ZOSTAVAX (0.65 ml, Lot #L016284, expiration date: 07-AUG-2016), which were improperly stored for 6 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 18-AUG-2015, the patient was vaccinated with ZOSTAVAX (0.65 ml, Lot#L011529, expiration date: 03-JUL-2016), which was improperly stored for 15 days (Incorrect product storage). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 20-AUG-2015, the patient was vaccinated with ZOSTAVAX (0.65 ml, Lot# L016284, expiration date: 07-AUG-2016), which was improperly stored for 8 days (incorrect product storage). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 24-AUG-2015, the patient was vaccinated with ZOSTAVAX (0.65 ml, Lot#L016284, expiration date: 07-AUG-2016), which was improperly stored for 11 days (Incorrect product storage). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician assistant concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On an unknown date in 2015, the patient was vaccinated with the first dose of GARDASIL (lot # and expiration date unspecified). On 24-MAR-2016, the patient received the second dose of GARDISIL (lot # and expiration date unspecified) and then received the third dose of GARDASIL (lot # and expiration date unspecified) on 18-MAY-2016 (Inappropriate schedule of vaccine administered). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with ROTATEQ (lot # L008054, expiration date: 30-NOV-2016, orally, dose was not reported). Concomitant drug was not reported. The vaccines were at 29 F for 648 minutes and 55 F for 360 minutes because of data logger issue. There was no previous temperature excursion. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with M-M-R II (lot # K006396, expiration date: 04-MAY-2016, route and dose were not reported). Concomitant drug was not reported. The vaccines were at 29 F for 648 minutes and 55 F for 360 minutes because of data logger issue. There was no previous temperature excursion. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with GARDASIL (lot # K006191, expiration date: 02-FEB-2017, route and dose were not reported). Concomitant drug was not reported. The vaccines were at 29 F for 648 minutes and 55 F for 360 minutes because of date logger issue. There was no previous temperature excursion. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 13-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L025737, expiration date 28-JUL-2017 (dose and route of administration were not reported). The administered dose of vaccine underwent a temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no data logger involved. There were no previous excursions reported. There was no adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 06-MAY-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L025737, expiration date 28-JUL-2017 (dose and route of administration were not reported). The administered dose of vaccine underwent a temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no data logger involved. There were no previous excursions reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: The spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 05-MAY-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9) lot #L025737, expiration date 28-JUL-2017 (dose and route of administration were not reported). The administered dose of vaccine underwent a temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no data logger involved. There were no previous excursions reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 09-MAY-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot #L025737, expiration date 28-JUL-2017 (dose and route of administration were not reported). The administered dose of vaccine underwent a temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no data logger involved. There were no previous excursions reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 02-MAY-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L025737, expiration date 28-JUL-2017 (dose and route of administration were not reported). The administered dose of vaccine underwent a temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no data logger involved. There were no previous excursions reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 26-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L025737, expiration date 28-JUL-2017 (dose and route of administration were not reported). The administered dose of vaccine underwent a temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no data logger involved. There were no previous excursions reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 20-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L025737, expiration date 28-JUL-2017 (dose and route of administration were not reported). The administered dose of vaccine underwent a temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no data logger involved. There were no previous excursions reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 29-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot #L025737, expiration date 28-JUL-2017 (dose and route of administration were not reported). The administered dose of vaccine underwent a temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no date logger involved. There were no previous excursions reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with RECOMBIVAX HB (lot # L016427, expiration date: 13-APR-2017, route and dose were not reported). Concomitant drug was not reported. The vaccines were at 29 F for 648 minutes and 55 F for 360 minutes because of data logger issue. There was no previous temperature excursion. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with VARIVAX (lot # K018960, expiration date: 15-OCT-2016, route and dose were not reported). Concomitant drug was not reported. The vaccines were at 6 F for 16 hours because of data logger issue. There was no previous temperature excursion. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates since 11-FEB-2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L033343, expiration date: 13-SEP-2017; dose and route were not provided). The vaccine underwent a temperature excursion in range between 30 degrees Fahrenheit and 53.2 degrees Fahrenheit for undetermined amount of time, which was detected by a data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates since 11-FEB-2016, the patients were vaccinated with improperly stored doses of M-M-R II (lot # L009545, expiration date: 19-MAR-2017, lot # L024268, expiration date: 01-JUL-2018 and lot # L027591, expiration date: 23-JUL-2017; dose and route were not provided) reconstituted with sterile diluent (lot # reported as L051109, expiration date: 25-MAY-2018 and lot # reported as L044086, expiration date: 02-JUN-2018). The vaccine and the diluent underwent a temperature excursion in range between 30 degrees Fahrenheit and 53.2 degrees Fahrenheit for undetermined amount of time, which was detected by a data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates since 11-FEB-2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L043213, expiration date: 28-AUG-2017, and lot # L048459, expiration date: 22-FEB-2018; dose and route were not provided). The vaccine underwent a temperature excursion in range between 30 degrees Fahrenheit and 53.2 degrees Fahrenheit for an undetermined amount of time, which was detected by a data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates since 11-FEB-2016, the patients were vaccinated orally with improperly stored doses of ROTATEQ (lot # L002042, expiration date: 28-JUL-2016, lot # L008578, expiration date: 14-DEC-2016 and lot # reported as M014318, expiration date: 30-SEP-2017; dose was not provided). The vaccine underwent a temperature excursion in range between 30 degrees Fahrenheit and 53.2 degrees Fahrenheit for undetermined amount of time, which was detected by a data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Off label use, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse referring to a 12 month old female patient. This patient has no relevant medical history, concomitant medications, or drug history. On 25-MAY-2016, the patient was accidentally given GARDASIL 9 (lot # L024993, expiration date 17-OCT-2017, 0.5 ml, intramuscular) instead of the LIQUID PEDVAXHIB. This was also off label administration because of the patient's age. No adverse events had been reported to the facility thus far. This patient had not relevant laboratory data. As of 25-MAY-2016, the reporter stated that they would not be administering GARDASIL 9 to the patient again, and the outcome of the of off label administration as well as accidental administration was unknown, however nothing had been reported yet. Additional information has been requested.