chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: HPI  Swelling The problem is  new. The current episode started 3 days (Noticed a little swelling Sunday night, slowly increased over Monday and Today (11/13/2018). Since onset, the problem has been  gradually worsening. Affected locations include  left arm. Symptom characteristics include redness, swelling, warmth and pain (Painful when touched). Exposed to: Had flu shot on 11/11/2018 in left upper arm and PREVNAR 13 in right upper arm at this Clinic. Associated symptoms include pain (when touched). Negative for cough, facial edema, fatigue, fever, joint pain, myalgias, shortness of breath, stiff neck, swollen glands and non-blanching rash. Treatments tried: rubbing alcohol. Treatments provided  no relief. PMH includes Negative for diabetes, immunocompromised, MRSA and allergies.
Age: 78.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Peripheral swelling
Clinical narrative: HPI  Swelling The problem is  new. The current episode started 3 days (Noticed a little swelling Sunday night, slowly increased over Monday and Today (11/13/2018). Since onset, the problem has been  gradually worsening. Affected locations include  left arm. Symptom characteristics include redness, swelling, warmth and pain (Painful when touched). Exposed to: Had flu shot on 11/11/2018 in left upper arm and PREVNAR 13 in right upper arm at this Clinic. Associated symptoms include pain (when touched). Negative for cough, facial edema, fatigue, fever, joint pain, myalgias, shortness of breath, stiff neck, swollen glands and non-blanching rash. Treatments tried: rubbing alcohol. Treatments provided  no relief. PMH includes Negative for diabetes, immunocompromised, MRSA and allergies.
Age: 0.92
Sex: M
Vaccine: MMRV
Symptoms: Atonic seizures, Autism spectrum disorder, Crying, Generalised tonic-clonic seizure, Infantile spasms
Clinical narrative: Fever over 105 for days, non-stop crying, vomiting, rash. He developed seizures and Lennox Gestaut Sydrome. He is 4 right now but has daily seizures. Seizures varies between 20-100 per day, including drop, infantile spasms, tonic clonic. He also has autism.
Age: 0.92
Sex: M
Vaccine: MMRV
Symptoms: Lennox-Gastaut syndrome, Pyrexia, Rash, Seizure, Vomiting
Clinical narrative: Fever over 105 for days, non-stop crying, vomiting, rash. He developed seizures and Lennox Gestaut Sydrome. He is 4 right now but has daily seizures. Seizures varies between 20-100 per day, including drop, infantile spasms, tonic clonic. He also has autism.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site infection
Clinical narrative: Infection at site.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pain in extremity, Skin warm, Tenderness
Clinical narrative: 5 or 6 hours after receiving shot I started having intense pain when I moved my arm. Very intense pain with movement or touch continued for about 18 hours. Most of my upper arm was one big irregular red welt, hot to the touch. It is now 47 hours since I received it, it is still red, hot & very tender to the touch, though it doesn't hurt so much to move my arm anymore. I got a flu shot in my left arm at the same time, that arm is ok.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: 5 or 6 hours after receiving shot I started having intense pain when I moved my arm. Very intense pain with movement or touch continued for about 18 hours. Most of my upper arm was one big irregular red welt, hot to the touch. It is now 47 hours since I received it, it is still red, hot & very tender to the touch, though it doesn't hurt so much to move my arm anymore. I got a flu shot in my left arm at the same time, that arm is ok.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging abnormal, Pain, Product administered at inappropriate site
Clinical narrative: Flu vaccine given too high within hour unable to move shoulder and extreme pain. Went to on 10/17/18 and approximately 2 weeks later then had MRI last Monday which showed partial thickness bursar surface supraspinatus tendon tear with associated rotator cuff tendinitis still have pain and decreased range of motion due to increase pain with movement.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Rotator cuff syndrome
Clinical narrative: Flu vaccine given too high within hour unable to move shoulder and extreme pain. Went to on 10/17/18 and approximately 2 weeks later then had MRI last Monday which showed partial thickness bursar surface supraspinatus tendon tear with associated rotator cuff tendinitis still have pain and decreased range of motion due to increase pain with movement.
Age: 64.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Broke out with shingles next day.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Rash papular, Rash pruritic, Viral test negative
Clinical narrative: Developed red papules on lower extremities, some with white center within a few hours of injection, they were itchy, and not blanchable. Rash nearly resolved by 11/6/18.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Eye discharge, Oral discomfort, Vaccination complication, Vomiting
Clinical narrative: Patient received the dose around 2pm - went home and took a nap. Woke up around 5:30pm with his mouth and salivary glands on fire, chills, vomiting, and then yellow matter coming out of his eyes.  Wife called 911. EMTs took him to the ER. He was administered Benadryl and a nausea medication and discharged. The ER MD determined it was a reaction from the vaccine.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Musculoskeletal pain, X-ray
Clinical narrative: Pain at site of injection and continuous shoulder pain for over one year. Has had X-ray on 11/12/17 for shoulder pain. Went to Doctor 11-16-18 will start Physical Therapy.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm, Urticaria
Clinical narrative: Day after injection noticed redness and swelling (arm). Arm was hot and some hives were apparent. Itching was terrible. Went to an internal medicine Dr. on 10/31/2018 and got a steroid shot. Also used cortisone cream. Symptoms lasted exactly 2 weeks. Although they did get less over time.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Body temperature increased, Erythema, Pain, Swelling
Clinical narrative: Developed soreness and temp to 99.9 the night of the vaccination, woke up the next morning with an area of erythema and worsening soreness. She was seen the next day, had 4 cm x 3 cm area of erythema, mild swelling but no distinct lump.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Pruritus, Vaccination site swelling
Clinical narrative: Redness and swelling affecting the area of the L arm just distal to the location of the 2 vaccines.  Also, she c/o itchy skin.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Fontanelle bulging
Clinical narrative: Bulging fontanel.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Feeling abnormal, Headache, Influenza like illness, Malaise
Clinical narrative: The evening after the vaccine was given, the patient became sick with a fever (101), body aches, headache, and nausea. For the next two days she felt awful, as if she had the flu. She also had a chicken egg sized knot on her arm with redness and itching. Most of the swelling went down 4 days later, but it still itches and she is uing Benadryl to help it. This is the first time this has happened to her with the flu shot.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Nodule, Pain, Peripheral swelling, Pruritus
Clinical narrative: The evening after the vaccine was given, the patient became sick with a fever (101), body aches, headache, and nausea. For the next two days she felt awful, as if she had the flu. She also had a chicken egg sized knot on her arm with redness and itching. Most of the swelling went down 4 days later, but it still itches and she is uing Benadryl to help it. This is the first time this has happened to her with the flu shot.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: The evening after the vaccine was given, the patient became sick with a fever (101), body aches, headache, and nausea. For the next two days she felt awful, as if she had the flu. She also had a chicken egg sized knot on her arm with redness and itching. Most of the swelling went down 4 days later, but it still itches and she is uing Benadryl to help it. This is the first time this has happened to her with the flu shot.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: Uticaria and swelling on left arm at injection site.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Aphasia, Decreased eye contact, Disability, Regressive behaviour
Clinical narrative: After receiving the shot my son stopped waving, talking and keeping eye contact. My son has been labeled as medially disabled now.
Age: 84.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Abdominal discomfort, Chills, Erythema, Nausea, Pain in extremity
Clinical narrative: Patient described swelling of her arm and pain to the upper part of her arm, stomach upset and nausea, chills throughout the night, and continued redness and swelling to the left arm.
Age: 84.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling
Clinical narrative: Patient described swelling of her arm and pain to the upper part of her arm, stomach upset and nausea, chills throughout the night, and continued redness and swelling to the left arm.
Age: 22.0
Sex: F
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms 2 days now 5 days later, feel that again.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Sudden onset of calls and fever. Abated over a course of 4-5 hours.
Age: 7.0
Sex: F
Vaccine: DTAP, FLU4, IPV, MMR, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Child should have received Tdap - IIS was run before child turned 7 - did not catch difference until after vaccine given.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Patient received her flu vaccine on 11/5/18 in her left arm. Per mom, within a few hours the area of her injection became red, swollen, itchy, hot to the touch and a hard lump/mass was felt by mom. Mom states that she took the patient to the iwalk in clinic on 11/7/2018 and they gave the patient penicillin thinking it might have been an infection. After taking the penicillin for a few days she started noticing a rash that formed on her arms and legs and a few spots on her lower abdomen, no rash present on her chest, back, face , neck, hands or feet. Patient then came in to be evaluated by us on 11/15/18. Mom states the patient has had her flu vaccine every year and has never had a reaction before. Asked mom what size needle was used. Mom confirmed a 1 inch needle was used, due to patient's arm size she requires a 1 1/2 to 2 inch needle. Her brother has a true egg allergy but gets his vaccine on a regular basis with no problems.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Rash, Wrong technique in product usage process
Clinical narrative: Patient received her flu vaccine on 11/5/18 in her left arm. Per mom, within a few hours the area of her injection became red, swollen, itchy, hot to the touch and a hard lump/mass was felt by mom. Mom states that she took the patient to the iwalk in clinic on 11/7/2018 and they gave the patient penicillin thinking it might have been an infection. After taking the penicillin for a few days she started noticing a rash that formed on her arms and legs and a few spots on her lower abdomen, no rash present on her chest, back, face , neck, hands or feet. Patient then came in to be evaluated by us on 11/15/18. Mom states the patient has had her flu vaccine every year and has never had a reaction before. Asked mom what size needle was used. Mom confirmed a 1 inch needle was used, due to patient's arm size she requires a 1 1/2 to 2 inch needle. Her brother has a true egg allergy but gets his vaccine on a regular basis with no problems.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Aphthous ulcer, Asthenia, Fatigue, Injection site pain, Pain
Clinical narrative: Pain at injection site in the evening after injection -pain at injection site lasted 1 week. Evening of injection day - general body aches and pain which lasted 2 days. General weakness and very tired - lasted 2 days after injection. Aphthous ulcer on right side of tongue - appeared 2 days after injection - ulceration and pain still present 9 days later (but condition improving).
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Viral test
Clinical narrative: Pain at injection site in the evening after injection -pain at injection site lasted 1 week. Evening of injection day - general body aches and pain which lasted 2 days. General weakness and very tired - lasted 2 days after injection. Aphthous ulcer on right side of tongue - appeared 2 days after injection - ulceration and pain still present 9 days later (but condition improving).
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Influenza like illness, Nausea, Pain
Clinical narrative: Abdominal flu-like symptoms, including nausea to the point of being able to keep down only four bites of food that day, exhaustion, body aches.
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not provided. On 02-NOV-2018, the patient was vaccinated with PNEUMOVAX 23, with the valid lot # N004564 and an expiry date of 22-OCT-2018 (strength, dose, route, and frequency were not provided) for prophylaxis. So, the reporter stated that the patient received a properly stored, but expired vaccine dose of PNEUMOVAX 23. No adverse effects were present. No additional information was provided.
Sex: F
Vaccine: HPV4
Symptoms: Precancerous skin lesion
Clinical narrative: This spontaneous report was received from a pharmacist via field employee refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. Approximately on an unknown date in 2008 (also reported as over 10 years ago), the patient had received complete HPV vaccination series with GARDASIL (dose, units and frequency unknown) (lot# and expiration date not reported) for unknown indication. On an unknown date, the patient presented with precancerous legions (Precancerous skin lesion). The outcome of precancerous skin lesion was reported as not recovered. The causality of the event precancerous skin lesion  was not reported. There was no product quality compliant reported. Upon internal review, the event Precancerous skin lesion was considered to be medically significant.
Sex: U
Vaccine: DTAPIPVHIB, HEP, MMRV, PNC13
Symptoms: Product preparation error
Clinical narrative: Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 months old patient who received only HIB portion of PENTACEL.with sterile water, The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. As concomitant medication: patient received PREVNAR, Hepatitis B, PROQUAD on an unknown date. On 12-Sep-2018, the patient received a 0.5 ml single dose of suspect PENTACEL lot C5451AC via intramuscular route in the left thigh. It was a case of actual medication error due to Inappropriate reconstitution technique. It was unknown whether adverse event occurred or not. 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 and Module VI of the 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.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves 15 patients (age and gender not reported) who were vaccinated with unstable product reached 34f-64f dose of FLUZONE QUADRIVALENT (Batch number: UT6259KA/ UT6259LA, expiration date: 30 Jun 2019, dose, route and site of administration was not reported) on an unspecified date from 16 Oct 2018 till 23 Oct 2018. It was an actual medication error due to product storage error. It was unknown if patients had adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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: 1.42
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA314176 and 2018SA314360 (same reporter). This case involves an 17-months old male patient who received an expired once dose of 0.25ml of vaccine FLUZONE QUADRIVALENT (batch number: UT5897MA, expiry date: 30-Jun-2018) via intramuscular route in the left thigh on 06-Nov-2018. 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. It was reported the patient received an expired dose of FLUZONE QUADRIVALENT. It was not reported that if any adverse reaction was experienced or not. 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.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 09-Nov-2018 regarding an unsolicited valid non-serious case received from a other health care professional. This case involves a two years old patient who received a 0.5 ml dose of vaccine FLUZONE QUADRIVALENT (Batch number: UJ045AA, expiration date: 30-Jun-2019, route: intramuscular and site of administration: left deltoid) on 08-Nov-2018. The patient's medical history was not reported. The subject did not receive any other vaccine. It was an actual medication error due to overdose (0.5 ml dose was given to a child who is two years old). It was unknown whether the patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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: 0.33
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 09-Nov-2018 regarding an unsolicited valid non-serious case received from a health professional. Additional information received on 12-Nov-2018 from a health professional. This case is linked to cases 2018SA314537 and 2018SA314539 (same reporter). This case involves a 5 months old patient who was administered just the Dtap and polio portion of PENTACEL (batch number, EXP date, route and site of administration were not reported) on 08-Nov-2018. 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 inappropriate reconstitution technique. It was reported that patient received only liquid portion of PENTACEL. It was not reported if the patient experienced any adverse event or not. 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: 0.58
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 7 months old male patient who was inadvertently vaccinated with an dose of PENTACEL (lot number not reported via unknown route in unknown administration site) in which the nurse not use the liquid IPV/DTA portion to mix with the ACTHIB portion on an unknown date. It was reported that the pharmacist (reporter) was uncertain if it was mixed with sterile water or sodium chloride. 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 inappropriate reconstitution technique. It was not reported if patients had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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: 17.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 17 years old male patient who received 0.5 ml third dose of vaccine MENACTRA (lot U6204AA) via intramuscular route in the left deltoid instead of vaccine TRUMENBA on 12-Nov-2018. It was reported that, on the same day, the patient also received a 0.5 ml dose of vaccine FLUZONE. 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 wrong vaccine administered and extra dose administered. It was not reported if patients had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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: 0.33
Sex: U
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 09-Nov-2018 regarding an unsolicited valid non-serious case received from non-other health professional. This case involves four months old patient (gender not reported) who was vaccinated with 0.25ml FLUZONE QUADRIVALENT (batch number, expiration date, dose, route and site of administration was not reported) on 09-Nov-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration. It was unknown whether the patient had any adverse event. 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: 0.92
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA311665 and 2018SA314360 (same reporter). This case involves an 11 months old female patient who received an expired dose of 0.25ml of vaccine FLUZONE QUADRIVALENT (batch number: UT5897MA, expiry date: 30-Jun-2018) (dose in series not reported) via intramuscular route in the left thigh on 11-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. It was a case of actual medication error due to expired vaccine used. It was not reported that if any adverse reaction was experienced or not. 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 and Module VI of the 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: TDAP
Symptoms: Back pain, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 45 years old female patient who experienced pain that radiated to left side of her back and then developed spine pain and local injection site redness, swelling and, pain, while she received vaccine ADACEL. The patient's no prior back pain history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Drug hypersensitivity (allergies are to NSAIDs and acetaminophen). The patient had no concomitant medication. On 17-Sep-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5850AA expiry date: 17-Jan-2020 via intramuscular route in the left deltoid. On an unknown date, patient developed a non-serious pain that radiated to left side of her back and then developed spine pain Unknown latency following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date, patient developed a non-serious local injection site redness, swelling and, pain Unknown latency following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Lab data was not reported. Final diagnosis was local injection site redness, swelling and, pain and pain that radiated to left side of her back and then developed spine pain. It was not reported if the patient received a corrective treatment. The outcome of event of local injection site redness, swelling and, pain was unknown at the time of reporting but the arm pain had left and event of pain that radiated to left side of her back and then developed spine pain was Not Recovered/Not Resolved at the time of reporting (however duration was reported as 01 month). Documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Spinal pain
Clinical narrative: Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 45 years old female patient who experienced pain that radiated to left side of her back and then developed spine pain and local injection site redness, swelling and, pain, while she received vaccine ADACEL. The patient's no prior back pain history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Drug hypersensitivity (allergies are to NSAIDs and acetaminophen). The patient had no concomitant medication. On 17-Sep-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5850AA expiry date: 17-Jan-2020 via intramuscular route in the left deltoid. On an unknown date, patient developed a non-serious pain that radiated to left side of her back and then developed spine pain Unknown latency following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date, patient developed a non-serious local injection site redness, swelling and, pain Unknown latency following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Lab data was not reported. Final diagnosis was local injection site redness, swelling and, pain and pain that radiated to left side of her back and then developed spine pain. It was not reported if the patient received a corrective treatment. The outcome of event of local injection site redness, swelling and, pain was unknown at the time of reporting but the arm pain had left and event of pain that radiated to left side of her back and then developed spine pain was Not Recovered/Not Resolved at the time of reporting (however duration was reported as 01 month). Documents held by sender: none.
Sex: M
Vaccine: FLUR4
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from Consumer. This case involves a 72 years old male patient who received FLUBLOK QIV but told him it was FLUZONE HIGH DOSE (batch number, expiry date were not reported for both vaccine) on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administration as 72 year old and when he went to the doctor's office thinking he was getting the FLUZONE HIGH DOSE they gave him the FLUBLOK QUADRIVALENT but told him it was FLUZONE HIGH DOSE. It was unknown if the patient had any adverse event. 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: M
Vaccine: FLU3
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 81 years old male patient who inadvertently received second dose of FLUZONE HIGH DOSE (Batch number: UJ043AA, expiration date: 22-May-2019, site of administration: left deltoid and route was not reported) on 23-Oct-2018 and again same vaccine on 07-Nov-2018 (Batch number: UJ043AA, expiration date: 22-May-2019, site of administration: left deltoid and route was not reported) instead of PNEUMOCOCCAL VACCINE (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to extra dose administered and wrong vaccine administered (pneumococcal vaccine was ordered and nurse inadvertently gave a second FLUZONE HIGH DOSE). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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: 60.0
Sex: U
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 60 years old patient of unknown gender who received vaccine FLUZONE HIGH DOSE, lot number not reported via unknown route in unknown administration site accidentally. The patient's past medical history and concomitant medication were not provided. It was a case of actual medication error due to accidental overdose and inappropriate age at vaccine administration. It was unknown whether patient experienced any adverse event or not. 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.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via call. This case involves a 78 years old female patient who developed inflamed arm/red patch about two inches in size, but it's below the site of the injection, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Notes: No other vaccines were administered. On 06-Nov-2018, the patient received a 0.5 ml single dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ052AA; expiry date: 09-Jun-2019 in the left arm. On an unknown date, the patient developed a non-serious inflamed arm/red patch about two inches in size, but it's below the site of the injection, following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. No lab data reported. Final diagnosis was inflamed arm/red patch about two inches in size, but it's below the site of the injection. It was not reported if the patient received a corrective treatment. The patient didn't go to ER department also. The patient outcome is reported as unknown for inflamed arm/red patch about two inches in size, but it's below the site of the injection. List of documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case involves a 68 years old female patient who was vaccinated with a 0.5 ml dose of expired vaccine TENIVAC](lot U5411CA and Exp. Date 30 Jun 2018) via intramuscular route in the left deltoid on 12 November 2018. It was reported that, no other vaccines were given on 12 November 2018 (today). The patients past medication history, concomitant medication was not reported. It was an actual medication error case due to Expired product administered. It was reported that, there were no side effects. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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: 0.42
Sex: U
Vaccine: DTAPHEPBIP, IPV, PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional (Office Staff) . This case involves a 6 months old patient of unknown gender who received PEDIARIX and IPOL along with PEDIARIX. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR for Immunisation on an unknown date. On 08-Nov-2018, the patient received a 0.5 ml third single dose of suspect IPOL Suspension for injection lot N1K931M via unknown route in the left thigh along with a non-company suspect, PEDIARIX on same date. It was a case of actual medication error due to extra dose administered. It was reported that patient had no adverse event. 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 and Module VI of the Good 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: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Blood test, Body temperature increased, Respiratory syncytial virus test, Seizure, Streptococcus test
Clinical narrative: Mom checked temperature on 11-14-18 and it was 99.2 she said then 5 min. later he had a seizure and checked temp. again it was 102.4.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Urine analysis
Clinical narrative: Mom checked temperature on 11-14-18 and it was 99.2 she said then 5 min. later he had a seizure and checked temp. again it was 102.4.
Age: 27.0
Sex: M
Vaccine: HEP, TD
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Hepatitis B vaccine was given instead of Hepatitis A vaccine. No adverse symptoms reported at this time.
Age: 10.0
Sex: M
Vaccine: FLU4, VARCEL
Symptoms: No adverse event, Product administration error
Clinical narrative: Patient was given Influenza vaccine that was not requested. Patient reported no adverse reaction after 15-20  minutes under observation. This was not the first time patient has received the flu vaccine.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Contusion, Erythema
Clinical narrative: A few days after I had a burn on my left pointer finger which felt like I touched a hot pan. It lasted a while then bruised over. I thought nothing of it until maybe 6 days later I had a burning sensation around my left elbow which also felt like I touched a hot pan. That also left a red round mark and then bruised over and within a few days was gone. Never happened before and because it was the same arm as the shot I associated it with getting the shot.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Headache, muscle aches, tiredness.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Feeling cold, Feeling hot, Headache
Clinical narrative: Patient experienced hot sensation all over body and then felt freezing. Her bones ached all over and she experienced a headache. Symptoms started 2 to 3 hours after shot. She felt completely better 48 hours after vaccination.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site mass, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Upper left arm area. Within an hour, sore, achy, warm-area grew to approx. 3" round circle at injection site. By 2 days, upper part still sore, then a band across the lower part of bicep, the width of two fingers, and thickness swelled-and a rash. Down near the elbow crease, below the rash band and swelling a lump and rash in a rough circle. All dissipated withing 2 days of rash. NOT a shingles rash. October 13 - my right arm had broken out in shingles on lower inside of arm, in two places.  Got medicine immediately within 2 hours of the rash coming out. Completely cleared by Oct 23.   Flu shot given Oct 31st.
Age: 55.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Immunisation, Underdose
Clinical narrative: At Hepatitis A outreach, box of Hepatitis A vaccine in cooler, was pediatric instead of adult. Used vial of pediatric instead of adult. Revaccination with Adult Hepatitis A Vaqta R018775 in Left Deltoid. Exp 2019Aug09
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise, Myalgia
Clinical narrative: Malaise, myalgia, flu-like symptoms with out GI distress, shaking chills.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Pt received vaccine at outside pharmacy so I do not have lot numbers etc. With dose #1, he had no issues. After dose #2, he developed erythema at the injection site, now progressed over several days to much of his upper R arm. I am electing to treat him for cellulitis.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site pustule, Injection site swelling
Clinical narrative: High dose flu shot received at Employee Health at hospital October 18, 2018. Area of injection developed what appeared to be a pustule at injection site within 2 days of injection. Returned to Employee Health November 1, 2018, to have area on right upper arm evaluated. Area of injection site did not heal and continued to get bigger, raised, reddened, painful, and itchy. Three weeks after injection have raised reddened area with pain and itching area of approximately 1 cm by 1 centimeter.  Saw Primary care physician for evaluation. Determined possible cellulitis vs keloid formation at injection site. Prescribed a course of antibiotics then to follow up with Dermatologist at later date for course of treatment.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Vaccination site swelling
Clinical narrative: C/O HALF DOLLAR SIZED AREA OF SWELLING AT VACCINE SITE. NO FEVER, SORENESS OR FEVER.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2012, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. On or about 2016, the patient was treated by a physician at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider (physician) recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 18-OCT-2012, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. On or about 07-OCT-2016, the patient was treated by a physician at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages as a result of shingles and other zoster-related injuries. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.