chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site rash, Injection site swelling, Pain, Rash
Clinical narrative: rash; swelling upper left arm; hardness upper left arm; headache; chills; body aches; felt hot; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of headache in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had 6 years ago). Previously administered products included Zostavax (received a few years ago).   On 13th September 2019, the patient received the 1st dose of Shingrix. On 14th September 2019, 1 days after receiving Shingrix, the patient experienced chills, general body pain, feeling hot and influenza-like symptoms. On 15th September 2019, the patient experienced headache. On an unknown date, the patient experienced rash, injection site swelling and injection site induration. On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the chills, general body pain, feeling hot, influenza-like symptoms, rash, injection site swelling and injection site induration were recovered/resolved.   It was unknown if the reporter considered the headache, chills, general body pain, feeling hot, influenza-like symptoms, rash, injection site swelling and injection site induration to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The patient stated that, after vaccination with dose of Shingrix, had rash near injection site. The patient reported that upper left arm was swollen and hard. After vaccination with Shingrix, the patient had headache that came and gone. The patient did not received medication like Tylenol or Advil that seems to help with headache. No any additional information was provided. The patient consented to follow up.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Yesterday between 16:00 - 17:00 started having pain and swelling, left bicep to shoulder. Redness noted at top of shoulder, no redness at injection site. Bicep area quite swollen. Denies fevers.
Age: 41.0
Sex: M
Vaccine: UNK, FLU4
Symptoms: Bursitis, Injection site pain
Clinical narrative: presented with left shoulder pain- diagnosed with bursitis- given NSAIDS and exercises to do at home.
Age: 41.0
Sex: M
Vaccine: UNK, FLU4
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: presented with left shoulder pain- diagnosed with bursitis- given NSAIDS and exercises to do at home.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Injection site pain, Injection site swelling, Pain
Clinical narrative: Swelling and aching at injection site.  Onset of Fever, chills, aches, vomiting  on Saturday night.  Vomiting ended on Sunday.  Fever broke on Monday morning.  General fatigue lasting through Monday night.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: Swelling and aching at injection site.  Onset of Fever, chills, aches, vomiting  on Saturday night.  Vomiting ended on Sunday.  Fever broke on Monday morning.  General fatigue lasting through Monday night.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pallor, Pruritus, Rash macular, Urticaria
Clinical narrative: Patient presented to office 10/3 complaining of itchiness with redness on bilateral legs, neck, and chest that started 10/2/19 at night. Mom states she had flu shot on Tuesday (Oct. 1) and a child she sits for has impetigo.  Physician notes include: A blanching macular rash throughout the body in small areas- a few appear more urticarial. Suspect reaction to the flu vaccine.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination complication
Clinical narrative: Patient presented to office 10/3 complaining of itchiness with redness on bilateral legs, neck, and chest that started 10/2/19 at night. Mom states she had flu shot on Tuesday (Oct. 1) and a child she sits for has impetigo.  Physician notes include: A blanching macular rash throughout the body in small areas- a few appear more urticarial. Suspect reaction to the flu vaccine.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Muscular weakness, Nausea, Pyrexia, Vomiting
Clinical narrative: pt stated had nausea, vomiting , high fever, chills, weak in legs on 10/2 -- she stated she feels better today other than be a little weak and is contacting her doctor just to let him know of reaction and if she needs to do anything else
Age: 40.0
Sex: F
Vaccine: FLU4, HEPA, TDAP
Symptoms: Bone scan normal, Bursitis, Contusion, Immediate post-injection reaction, Magnetic resonance imaging abnormal
Clinical narrative: Started having pain in my right arm immediatley after the shots, Went to the doctor a few weeks later once the pain did not go away. He ordered xrays , then on next appt. he sent me to an orthopedic specialist.  that doctor ordered MRI of the arm, it shows a contusion, but he disagrees that a contusion can be there that length of time. He tehn ordered a bone scan wich was normal. I am now being referred to a shoulder specialist, My orthopedic doctor had diagnosed me with either busitis or tendonitis , he is not sure , he also wanted to do exploratory surgery which I denied at this time. I was given cortizone shot to try to relieve the pain with no avail, in 9/2019.
Age: 40.0
Sex: F
Vaccine: FLU4, HEPA, TDAP
Symptoms: Pain in extremity, Tendonitis, X-ray
Clinical narrative: Started having pain in my right arm immediatley after the shots, Went to the doctor a few weeks later once the pain did not go away. He ordered xrays , then on next appt. he sent me to an orthopedic specialist.  that doctor ordered MRI of the arm, it shows a contusion, but he disagrees that a contusion can be there that length of time. He tehn ordered a bone scan wich was normal. I am now being referred to a shoulder specialist, My orthopedic doctor had diagnosed me with either busitis or tendonitis , he is not sure , he also wanted to do exploratory surgery which I denied at this time. I was given cortizone shot to try to relieve the pain with no avail, in 9/2019.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient developed pain, redness, swelling, warmth around the injection site (left deltoid), patient came to urgent care for evaluation on 10/03/19- was prescribed keflex for cellulitis
Age: 21.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Pain
Clinical narrative: I have had a sharp pain in my left arm that stems from the injection site with any movement of my left arm. This has been going on for exactly one month now. Since the vaccine
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dyspnoea, Headache, Lethargy, Pain
Clinical narrative: Profound swelling, pain, headache, lethargy, shortness of breath. Unable to move arm without pain. Debilitating pain
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Profound swelling, pain, headache, lethargy, shortness of breath. Unable to move arm without pain. Debilitating pain
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Get aches, pain, but resolved within 24 hours
Age: 52.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site warmth
Clinical narrative: Redness around injection sites of both arms. Slide warm to the site. Flu like symptoms. No streaking of redness for local sites.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration, Skin warm, Tenderness
Clinical narrative: 70mm x 35mm reddened area that is wam, tender and  hard to touch.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Influenza like illness
Clinical narrative: Chills, body aches, tiredness, congestion, flu-like symptoms, lack of hunger, mild headache
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Respiratory tract congestion
Clinical narrative: Chills, body aches, tiredness, congestion, flu-like symptoms, lack of hunger, mild headache
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Acute disseminated encephalomyelitis, Computerised tomogram, Lumbar puncture, Magnetic resonance imaging, Paralysis
Clinical narrative: ADEM/with paralysis
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Plasmapheresis
Clinical narrative: ADEM/with paralysis
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Escherichia infection, Escherichia test positive, Psoriasis, Rash
Clinical narrative: On June 24,2019. Husband and I was gave the shingles shot, My husband went first, and then I went. Three weeks later I develop a rash on my left breast . I called my primary doctor, he treated me for a yest infection. Four week later the symptoms was not gone. So my primary doctor refer me to a dermatology, the dermatology took a swap culture, and a biopsy from my left breast. In a week the reult came back I have psoriasis, which I have on my belly line, my hair, and feet, genital area. two week later the swap culture came back I hae e-coli and staph infection. it only effect me and not my husband,
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin culture positive, Staphylococcal infection, Staphylococcus test positive
Clinical narrative: On June 24,2019. Husband and I was gave the shingles shot, My husband went first, and then I went. Three weeks later I develop a rash on my left breast . I called my primary doctor, he treated me for a yest infection. Four week later the symptoms was not gone. So my primary doctor refer me to a dermatology, the dermatology took a swap culture, and a biopsy from my left breast. In a week the reult came back I have psoriasis, which I have on my belly line, my hair, and feet, genital area. two week later the swap culture came back I hae e-coli and staph infection. it only effect me and not my husband,
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Incorrect route of product administration, Swelling, Wrong product administered
Clinical narrative: 6cm  oval mild swelling  and redness , injected  .1cc flu vaccine intradermally instead of PPD for tuberculin skin screening
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Pain, Product administered at inappropriate site
Clinical narrative: Gave a subcutaneous injection in the muscle.  Patient complained of soreness
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Rash, Swelling
Clinical narrative: Patient initially asked for flu vaccine at drop off and requested regular dose.  Insurance rejected the claim but the High Dose vaccine was covered due to he age.  Patient agreed to try the high dose was fine but swelling and rash occurred late that evening.  She started to experience stiffness in her neck which alarmed her to see Urgent Care.  Patient came by next day to pick up prednisone and informed me at counseling that ER gave her a dose of prednisone and she feels much better. She has a bit of swelling but rash has subsided.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Facial paralysis
Clinical narrative: FACIAL PARALYSIS, FACIAL DROOP
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Abortion spontaneous, Affective disorder, Alopecia, Anxiety, Arthralgia
Clinical narrative: Initial symptoms were sensativity to light, headaches, extreme fatigue;  Initial symptoms were followed by cognative issues, joint pain including costochondritis (swollen, painful, inflammed sternum, shoulder, elbow, ribs); moody and inability to do physical activity due to joint pain and fatigue;  Irritability and light-headedness; mouth sores; developed sensativity to dairy; hair loss; miscarriage; anxiety; flushing; allergies; and a myriad of other random complaints.  Over a number of years I visited an eye doctor, general physicians, two chiropractors, urgent care, a naturopath, an allergy Md, an endocrinologist, a rheumatologist, etc.   I've had numerous diagnostic tests while dealing with these issues.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Cognitive disorder, Costochondritis, Dairy intolerance, Decreased activity, Diagnostic procedure
Clinical narrative: Initial symptoms were sensativity to light, headaches, extreme fatigue;  Initial symptoms were followed by cognative issues, joint pain including costochondritis (swollen, painful, inflammed sternum, shoulder, elbow, ribs); moody and inability to do physical activity due to joint pain and fatigue;  Irritability and light-headedness; mouth sores; developed sensativity to dairy; hair loss; miscarriage; anxiety; flushing; allergies; and a myriad of other random complaints.  Over a number of years I visited an eye doctor, general physicians, two chiropractors, urgent care, a naturopath, an allergy Md, an endocrinologist, a rheumatologist, etc.   I've had numerous diagnostic tests while dealing with these issues.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Fatigue, Flushing, Headache, Hypersensitivity
Clinical narrative: Initial symptoms were sensativity to light, headaches, extreme fatigue;  Initial symptoms were followed by cognative issues, joint pain including costochondritis (swollen, painful, inflammed sternum, shoulder, elbow, ribs); moody and inability to do physical activity due to joint pain and fatigue;  Irritability and light-headedness; mouth sores; developed sensativity to dairy; hair loss; miscarriage; anxiety; flushing; allergies; and a myriad of other random complaints.  Over a number of years I visited an eye doctor, general physicians, two chiropractors, urgent care, a naturopath, an allergy Md, an endocrinologist, a rheumatologist, etc.   I've had numerous diagnostic tests while dealing with these issues.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Inflammation, Irritability, Joint swelling, Musculoskeletal chest pain, Musculoskeletal pain
Clinical narrative: Initial symptoms were sensativity to light, headaches, extreme fatigue;  Initial symptoms were followed by cognative issues, joint pain including costochondritis (swollen, painful, inflammed sternum, shoulder, elbow, ribs); moody and inability to do physical activity due to joint pain and fatigue;  Irritability and light-headedness; mouth sores; developed sensativity to dairy; hair loss; miscarriage; anxiety; flushing; allergies; and a myriad of other random complaints.  Over a number of years I visited an eye doctor, general physicians, two chiropractors, urgent care, a naturopath, an allergy Md, an endocrinologist, a rheumatologist, etc.   I've had numerous diagnostic tests while dealing with these issues.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Photophobia, Stomatitis, Swelling
Clinical narrative: Initial symptoms were sensativity to light, headaches, extreme fatigue;  Initial symptoms were followed by cognative issues, joint pain including costochondritis (swollen, painful, inflammed sternum, shoulder, elbow, ribs); moody and inability to do physical activity due to joint pain and fatigue;  Irritability and light-headedness; mouth sores; developed sensativity to dairy; hair loss; miscarriage; anxiety; flushing; allergies; and a myriad of other random complaints.  Over a number of years I visited an eye doctor, general physicians, two chiropractors, urgent care, a naturopath, an allergy Md, an endocrinologist, a rheumatologist, etc.   I've had numerous diagnostic tests while dealing with these issues.
Age: 16.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Wrong product administered
Clinical narrative: Pediarix was given in lieu of the Flu vaccine that was ordered.   They are very similar in appearance,
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pyrexia, Rash
Clinical narrative: patient received first dose. Woke up with fever, rash and headache.
Age: 2.0
Sex: M
Vaccine: UNK
Symptoms: Dysphemia, Speech disorder
Clinical narrative: My son is 2 years old an can talk full sentences clear as day. Very smart. He is out of the blue stuttering BAD for the first time an can barley talk an say a sentence. It?s very very bad. I?m  very concerned and want to know what to do.  He has never had a problem with speech before. He was fine before the shots
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Headache, Malaise, Pain, Pyrexia
Clinical narrative: Fever, chills, aches and pains, general malaise, headache Starting day after second dose of Shingrix
Age: 15.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine given - No adverse reaction.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Patient told me on 10/2/19, that she went to the hospital the evening of the vaccination because she had fever & chills. She stated they sent her home. She stated she felt her fever & chills were related to the vaccination, but they couldn't be sure. I told her I thought we needed to report this to VAERS, but she did not want to, stating they couldn't be sure so she didn't want to report it. I left a message for her family Dr & called VAERS for guidance.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse affects; first dose was given on 8/5/2019, and second was given on 9/18/2019; This spontaneous report was received from a nurse prescriber via company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported.  On 05-AUG-2019, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis. On 18-SEP-2019, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis. The nurse prescriber reported that the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was given sooner than it should be. No adverse effects reported.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were provided as follows: The patient's sister reported the case. The age of vaccination was not reported. The patient experienced sore arm after receiving Shingrix. No further details were available. The reporter did not consent to follow up. This case has been linked to US2019175459, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain
Clinical narrative: A lot of pain; Cannot move arm very well; This case was reported by a consumer via call center representative and described the occurrence of pain in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced pain and mobility decreased. On an unknown date, the outcome of the pain and mobility decreased were unknown.   It was unknown if the reporter considered the pain and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however the patient could be elderly. After receiving 1st dose of Shingrix, the patient did not experienced any event but after 2nd shot experienced lot of pain and could not move arm. The reporter consented for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling abnormal, Immediate post-injection reaction, Influenza like illness
Clinical narrative: Pain at Injection; Lousy/ feeling terrible; Flu-like Symptoms; Chills; Feeling tired; Hurting; not feel good/ felt like crap; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th September 2019, the patient received the 1st dose of Shingrix. On 19th September 2019, immediately after receiving Shingrix, the patient experienced injection site pain, feeling bad, influenza-like symptoms, chills, tiredness, pain and feeling unwell. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the injection site pain, feeling bad, influenza-like symptoms, chills, tiredness, pain and feeling unwell were unknown.   It was unknown if the reporter considered the injection site pain, feeling bad, influenza-like symptoms, chills, tiredness, pain and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The patient stated that it hurt when needle was injected into her arm. The patient approximately 4 hours after vaccination felt lousy. The patent approximately 6 hours after vaccination was  in bed with flu like symptoms. The flu like symptoms described as chills, feeling tired, hurting, and not feel good. The patient took 2 extra strength Tylenol before going to bed early at 7:30 PM which helped a little. The patient took Tylenol the next morning after waking up because she felt like crap. The patient did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Pain
Clinical narrative: Pain at Injection; Lousy/ feeling terrible; Flu-like Symptoms; Chills; Feeling tired; Hurting; not feel good/ felt like crap; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th September 2019, the patient received the 1st dose of Shingrix. On 19th September 2019, immediately after receiving Shingrix, the patient experienced injection site pain, feeling bad, influenza-like symptoms, chills, tiredness, pain and feeling unwell. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the injection site pain, feeling bad, influenza-like symptoms, chills, tiredness, pain and feeling unwell were unknown.   It was unknown if the reporter considered the injection site pain, feeling bad, influenza-like symptoms, chills, tiredness, pain and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The patient stated that it hurt when needle was injected into her arm. The patient approximately 4 hours after vaccination felt lousy. The patent approximately 6 hours after vaccination was  in bed with flu like symptoms. The flu like symptoms described as chills, feeling tired, hurting, and not feel good. The patient took 2 extra strength Tylenol before going to bed early at 7:30 PM which helped a little. The patient took Tylenol the next morning after waking up because she felt like crap. The patient did not consent to follow up.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: Can not administer the whole product into the skin, completely depress the plunger; it stops with either 0.2ml or 0.3ml remaining, no AE; Can not administer the whole product into the skin, completely depress the plunger; feel pressure when they press down, no AE; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 17 years old patient who was vaccinated with a dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] lot number lot UJ237AB via unknown route in an unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to vaccine underdose. It was reported that when they drew up the 0.5ml dose and the assistant practice manager attempted to inject into a staff member and the plunger stopped with 0.2 ml remaining in the syringe. It is also a case of syringe issue as it was reported that the nurse is not able to completely depress the plunger; it stops with either 0.2ml or 0.3ml remaining. Can not administer the whole product into the skin,  feel pressure when they press down.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Fluzone HD administered to the patient, no AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA268361, 2019SA268355, 2019SA268356, 2019SA268357, 2019SA268358, 2019SA268359, 2019SA268360 and 2019SA268362 (same reporter).  This case involves a 84 years old female patient who received 0.5 ml dose of expired vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UI994AA, Exp. Date 09-Apr-2019) via intramuscular route in the left deltoid, on 13-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Fluzone HD administered to the patient, no AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA268361, 2019SA268346, 2019SA268356, 2019SA268357, 2019SA268358, 2019SA268359, 2019SA268360 and 2019SA268362 (same reporter).  This case involves a 90 years old female patient who received 0.5 ml dose of expired vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UI994AA, Exp. Date 09-Apr-2019) via intramuscular route in the right deltoid, on 13-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Fluzone HD administered to the patient, no AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA268361, 2019SA268355, 2019SA268346, 2019SA268357, 2019SA268358, 2019SA268359, 2019SA268360 and 2019SA268362 (same reporter).  This case involves a 87 years old female patient who received 0.5 ml dose of expired vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UI994AA, Exp. Date 09-Apr-2019) via intramuscular route in the right deltoid, on 13-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Fluzone HD administered to the patient, no AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA268361, 2019SA268355, 2019SA268356, 2019SA268346, 2019SA268358, 2019SA268359, 2019SA268360 and 2019SA268362 (same reporter).  This case involves a 86 years old female patient who received 0.5 ml dose of expired vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UI994AA, Exp. Date 09-Apr-2019) via intramuscular route in the left deltoid, on 13-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Fluzone HD administered to the patient, no AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA268361, 2019SA268355, 2019SA268356, 2019SA268357, 2019SA268346, 2019SA268359, 2019SA268360 and 2019SA268362 (same reporter).  This case involves a 65 years old female patient who received 0.5 ml dose of expired vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UI994AA, Exp. Date 09-Apr-2019) via intramuscular route in the left deltoid, on 13-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose Fluzone HD administered, no AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA268346, 2019SA268355, 2019SA268356, 2019SA268357 and 2019SA268358 (same reporter).  This case involves a 87 years old male patient who received 0.5 ml dose of expired vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UI994AA, Exp. Date 09-Apr-2019) via intramuscular route in the right deltoid, on 13-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Fluzone HD administered to the patient, no AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA268361, 2019SA268362, 2019SA268346, 2019SA268355, 2019SA268356, 2019SA268357, 2019SA268358 and 2019SA268359 (same reporter).  This case involves a 84 years old female patient who received 0.5 ml dose of expired vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UI994AA, Exp. Date 09-Apr-2019) via intramuscular route in the left deltoid, on 13-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Fluzone HD administered to the patient, no AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA268346, 2019SA268355, 2019SA268356, 2019SA268357, 2019SA268358, 2019SA268359, 2019SA268360 and 2019SA268362 (same reporter).  This case involves a 81 years old female patient who received 0.5 ml dose of expired vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UI994AA, Exp. Date 09-Apr-2019) via intramuscular route in the right deltoid on 13-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose Fluzone HD administered, no AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA268361, 2019SA268346, 2019SA268355, 2019SA268356, 2019SA268357, 2019SA268358, 2019SA268359 and 2019SA268360 (same reporter).  This case involves a 74 years old male patient who received 0.5 ml dose of expired vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UI994AA, Exp. Date 09-Apr-2019) via intramuscular route in the left deltoid, on 13-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Daptacel was given to patient on 24SEP2019/no AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 years old female patient who received expired 0.5 mL dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5254AA, expiry date-18-09-2019 Frequency = once via unknown route in the right thigh on 24-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation; INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT) for Immunisation; and POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE) for Immunisation.  It was a case of actual medication error due to Expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received expired dose of vaccine Pentacel/ No AE; Initial information received on 25-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 months old female patient who received expired dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot C55428A/ C55428AA, expiry date- 08-Sep-2019 via unknown route in the left vastus lateralis On 25-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  It was a case of actual medication error due to Expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Wrong product administered
Clinical narrative: patient was given Fluzone Quadrivalent this morning instead of Fluzone HD/NO AE; Initial information received on 25-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 74 years old female patient who received vaccinesand INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE]   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Sep-2019, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6645MA via intramuscular route in the right deltoid instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported.  It was a case of actual medication error due to wrong vaccine administered.  It was unknown if any adverse event occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 10.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: patient was administered Daptacel that expired on Sep 18, 2019, no AE; 10 years old patient received Daptacel, no AE; Initial information received on 25-Sep-2019 regarding an unsolicited valid non-serious case received from a health care professional (X-Ray Technician).  This case involves 10 year old male patient who was vaccinated with expired 0.5 ml dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE (POLIO) for Immunisation; and HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.  On 25-Sep-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE Lot C5254AA, expiration date: Sep 18, 2019 via unknown route in the left upper arm.  It was a case of actual medication error due to expired vaccine used and inappropriate age at vaccine administration.  At the time of the report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error  List of documents held by the sender: none
Age: 16.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok Quadrivalent was administered to a 16 year old, NO AE; Initial information received on 25-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (Office Staff).  This case is linked to case 2019SA269553 (same reporter).  This case involves a 16 years old female patient who was vaccinated with Flublok quadrivalent (INFLUENZA QUADRIVALENT RECOMBINANT VACCINE) [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Sep-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1913, Exp 6/29/2020 via intramuscular route in the right deltoid.  It was a case of actual medication error due to Inappropriate age at vaccine administration.  At the time of the report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error  List of documents held by the sender: none