chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: FLUX, PPV, TTOX, FLUX, PPV, TTOX
Symptoms: Demyelination, Electromyogram abnormal, Gait inability, Guillain-Barre syndrome, Lumbar puncture abnormal
Clinical narrative: Patient was vaccinated prior to trip. Approx 3-4 weeks later, upon return from trip developed pins/needle sensation which progressed to thighs; weakness of legs; unable to ambulate and presented to our facility.
Age: 1.5
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Abnormal behaviour, Anger, Aphasia, Decreased appetite, Emotional distress
Clinical narrative: Fever 103.8; decreased appetite x 10 days; rash on trunk that spread to face and hands over 2 week period; strong personality changes- woke up mad every morning, inconsolable, appeared to be in pain, stopped speaking (only has a few words to begin with but definitely stopped communicating). Still, as of 8/21/18 (today) his personality is off- he's just not himself. The rash is almost completely gone; no fevers; appetite is back; still irritable which is not his normal personality.
Age: 1.5
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Irritability, Pain, Personality change, Pyrexia, Rash
Clinical narrative: Fever 103.8; decreased appetite x 10 days; rash on trunk that spread to face and hands over 2 week period; strong personality changes- woke up mad every morning, inconsolable, appeared to be in pain, stopped speaking (only has a few words to begin with but definitely stopped communicating). Still, as of 8/21/18 (today) his personality is off- he's just not himself. The rash is almost completely gone; no fevers; appetite is back; still irritable which is not his normal personality.
Age: 10.0
Sex: M
Vaccine: FLUR4, FLUR4
Symptoms: Wrong drug administered
Clinical narrative: FLUBLOK QUAD given instead of FLUZONE QUAD.
Age: 10.0
Sex: M
Vaccine: FLUR4, FLUR4
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: FLUBLOK QUAD given instead of FLUZONE QUAD.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong patient received product
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided. On 06-AUG-2018, the patient received a dose of PROQUAD (lot # N010246), expiration date 25-SEP-2018, for prophylaxis (exact dose and route of administration was not provided) and sterile diluent (lot # N030173, expiration date 02-JUL-2020). The dose of PROQUAD was intended for the patient's brother. No adverse effects reported. The outcome of the event was unknown.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Helicobacter infection, Immediate post-injection reaction, Rash generalised
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of helicobacter pylori infection in a 67-year-old male patient who received SHINGRIX (batch number G933B, expiry date 22nd November 2020) for prophylaxis. On 6th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 6th August 2018, immediately after receiving SHINGRIX, the patient experienced generalized rash. In August 2018, the patient experienced helicobacter pylori infection (serious criteria GSK medically significant). The patient was treated with Amoxicillin and Clarithromycin ER. On an unknown date, the outcome of the helicobacter pylori infection was unknown and the outcome of the generalized rash was not recovered/not resolved. It was unknown if the reporter considered the helicobacter pylori infection and generalized rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right arm. The pharmacist reported daughter of the patient called and reported he had his injection of SHINGRIX and right away experienced an all over body rash. The rash had not resolved. The patient also mentioned he was placed on an antibiotic for Helicobacter pylori infection and the onset date of this was unknown. The pharmacist stated she noted to the daughter this rash was frequent with antibiotics but the daughter noted it was before starting the antibiotic. The patient was placed on Amoxicillin 500mg and Clarithromycin ER 500mg for the Helicobacter pylori infection. This case has been linked with US2018147981, reported by the same reporter.
Age: 34.0
Sex: F
Vaccine: ANTH
Symptoms: C-reactive protein normal, Chills, Computerised tomogram head normal, Full blood count normal, Influenza like illness
Clinical narrative: Patient had flu like symptoms including nausea, vomiting and rigors. Patient then developed episodes of altered mental status
Age: 34.0
Sex: F
Vaccine: ANTH
Symptoms: Mental status changes, Metabolic function test normal, Nausea, Red blood cell sedimentation rate normal, Vomiting
Clinical narrative: Patient had flu like symptoms including nausea, vomiting and rigors. Patient then developed episodes of altered mental status
Age: 68.0
Sex: F
Vaccine: PNC13, TYP
Symptoms: Back pain, Contusion, Mobility decreased, Pain, Skin discolouration
Clinical narrative: Patient claims had massive swelling and bruising, turning black and blue. Pain radiates from the vaccine site down past the scapula on her right side of her back. She has been unable to lift her arm high since the vaccines were administered. Patient says it has been like this for 5 months. She went to an ER and they prescribed her 3 medications. Swelling and color has subsided however she still has the pain.
Age: 68.0
Sex: F
Vaccine: PNC13, TYP
Symptoms: Swelling, Vaccination site pain
Clinical narrative: Patient claims had massive swelling and bruising, turning black and blue. Pain radiates from the vaccine site down past the scapula on her right side of her back. She has been unable to lift her arm high since the vaccines were administered. Patient says it has been like this for 5 months. She went to an ER and they prescribed her 3 medications. Swelling and color has subsided however she still has the pain.
Age: 65.0
Sex: F
Vaccine: HEPA, PNC13, VARZOS
Symptoms: Fatigue, Herpes zoster, Neuralgia, Pain, Pyrexia
Clinical narrative: 3 days fever, aches and fatigue starting day after shots. Then a little over 2 months later, I got shingles, with rash on left rib and nerve pain left shoulder blade and down left arm.
Age: 65.0
Sex: F
Vaccine: HEPA, PNC13, VARZOS
Symptoms: Rash
Clinical narrative: 3 days fever, aches and fatigue starting day after shots. Then a little over 2 months later, I got shingles, with rash on left rib and nerve pain left shoulder blade and down left arm.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Eye swelling, Lip swelling
Clinical narrative: Swelling underneath left eye and swelling of top lip two days after vaccine administration.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Malaise, Rash pruritic
Clinical narrative: Patient c/o head ache, malaise, flu-like symptoms starting the morning after having received the vaccination and lasting for approximately 24 hours. Patient states that one week later she developed a raised, extremely itchy rash on her torso that lasted for three weeks.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Emotional distress, Fear, Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Within less than 5 min of DTaP administration I was called back into the room by reporter and observed pt's R shoulder where she had received IM DTaP dose to be pink, swollen, and covered in hives. No swelling of the face or hives anywhere besides the affected shoulder. No wheezing or difficulty breathing. Weight-based dose of both Benadryl and ibuprofen given by mouth. No vomiting. Pt alert and appears to be upset/scared by situation and sitting on mom's lap. Confirmed with mom and in pt's chart that she has not had a reaction like this with any DTaP doses previously. Within 15-20min of Benadryl and Motrin doses hives are visibly lessening (still present but less swollen) and pt is playing and running around. Discharged in good condition. Advised mom may repeat Benadryl and Motrin dose in 6 hrs if necessary if symptoms flare back up.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives on lower extremities bilateral, upper extremities bilateral, severe itching - BENADRYL (50 mg PO given and epinephrine 0.5 mg SQ given at clinic then sent to ER.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Pain, Paraesthesia, Rash papular
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of shingles in a 63-year-old male patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. The patient's past medical history included shingles (experienced in 2014). Concomitant products included SHINGRIX. On 20th July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, 3 days after receiving SHINGRIX, the patient experienced shingles, tingling, pain burning, back pain and erythropapular rash. The patient was treated with antivirals for systemic use (Antiviral). On an unknown date, the outcome of the shingles, pain burning, back pain and erythropapular rash were unknown and the outcome of the tingling was not recovered/not resolved. It was unknown if the reporter considered the shingles, tingling, pain burning, back pain and erythropapular rash to be related to SHINGRIX. Additional details reported as follows: The healthcare professional reported that the patient developed burning pain and tingles on his left trunk and back 3 days after receiving his second dose of SHINGRIX. The patient had Shingles in 2014 in the same area and stated that this felt the same. On 30th July 2018, the was seen in the office where less than a month after vaccination a mild erythematous rash with a few papules was noted on the involved area. Antivirals were prescribed. The patient was contacted by phone on 1st August 2018, and stated that the rash was no worse. On 3rd August 2018, he reported that the rash was larger.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discomfort
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site discomfort in a elderly male patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a year after receiving SHINGRIX, the patient experienced injection site discomfort. On an unknown date, the outcome of the injection site discomfort was recovered/resolved. It was unknown if the reporter considered the injection site discomfort to be related to SHINGRIX. Additional details reported as follows: The caller was GlaxoSmithKline employee from R and D that was made aware of two individuals who received SHINGRIX. The employee reported he first heard of these events this week. Employee would reach out for additional info and encourage consumer to call. This case has been linked with US2018144842 and US2018144839, reported by same reporter and linked with case US2018GSK151216 (reported for same patient for 2nd dose).
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, fatigue, headache and myalgia. On an unknown date, the outcome of the injection site pain, fatigue, headache and myalgia were recovered/resolved. It was unknown if the reporter considered the injection site pain, fatigue, headache and myalgia to be related to SHINGRIX. Additional details reported as follows: The caller was GlaxoSmithKline employee from R and D that was made aware of two individuals who received SHINGRIX. The events began the evening of the injections. This case has been linked with US2018144841 and US2018144839, reported by same reporter and linked with case  US2018GSK150475 (reported for same patient for 2nd dose).
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of chills in a adult patient who received SHINGRIX for prophylaxis. On 8th August 2018, the patient received the 2nd dose of SHINGRIX. On 8th August 2018, less than a day after receiving SHINGRIX, the patient experienced chills, headache, general body pain and fever. On 10th August 2018, the outcome of the chills, headache, general body pain and fever were recovered/resolved. It was unknown if the reporter considered the chills, headache, general body pain and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. In the evening of the date of vaccination, the patient experienced chills, headache, fever and achiness as being all over her body.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Influenza like illness, Loss of personal independence in daily activities, Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 9th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, joint pain, general body pain, activities of daily living impaired and myalgia. The patient was treated with CELEBREX. On an unknown date, the outcome of the influenza-like symptoms and general body pain were recovered/resolved and the outcome of the joint pain was not recovered/not resolved and the outcome of the activities of daily living impaired and myalgia were unknown. It was unknown if the reporter considered the influenza-like symptoms, joint pain, general body pain, activities of daily living impaired and myalgia to be related to SHINGRIX. Additional details reported as follows: The caller was a pharmacist reporting an adverse event on behalf of himself. The patient received SHINGRIX on left arm. The patient experienced flu like symptoms and body aches that lasted approximately 2 days. The caller stated that he had been experiencing pain in his joints (knee, back and hip) that had been going on for approximately 20 days. The caller stated that the joint pain was affecting his everyday life and that he was taking CELEBREX for the joint pain. The healthcare professional stated the joint pain he was experiencing could be myalgia.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 9th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, joint pain, general body pain, activities of daily living impaired and myalgia. The patient was treated with CELEBREX. On an unknown date, the outcome of the influenza-like symptoms and general body pain were recovered/resolved and the outcome of the joint pain was not recovered/not resolved and the outcome of the activities of daily living impaired and myalgia were unknown. It was unknown if the reporter considered the influenza-like symptoms, joint pain, general body pain, activities of daily living impaired and myalgia to be related to SHINGRIX. Additional details reported as follows: The caller was a pharmacist reporting an adverse event on behalf of himself. The patient received SHINGRIX on left arm. The patient experienced flu like symptoms and body aches that lasted approximately 2 days. The caller stated that he had been experiencing pain in his joints (knee, back and hip) that had been going on for approximately 20 days. The caller stated that the joint pain was affecting his everyday life and that he was taking CELEBREX for the joint pain. The healthcare professional stated the joint pain he was experiencing could be myalgia.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional details were provided as follows: The healthcare professional stated that SHINGRIX was inadvertently stored in the freezer, which led to incorrect storage of vaccine.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 60-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included low blood pressure. On 24th July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, 14 hrs after receiving SHINGRIX, the patient experienced dizziness, pain in arm, fever and diarrhea. On an unknown date, the outcome of the dizziness was not recovered/not resolved and the outcome of the pain in arm, fever and diarrhea were recovered/resolved. It was unknown if the reporter considered the dizziness, pain in arm, fever and diarrhea to be related to SHINGRIX. Additional details were provided as follows: This case was not reported to anyone previously. The patient received SHINGRIX into left arm. The patient stated that, 14 hours after receiving the vaccine, he noticed that his left arm was sore. The patient stated that approximately 14 hours after receiving the vaccine; he also experienced dizziness, diarrhea and fever. The patient stated that the soreness in his arm lasted for 5 days before resolving. The patient stated that the diarrhea and fever resolved, however, the dizziness had not gone away.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Injection site swelling, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, headache, stiff neck, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site pain, headache, stiff neck, injection site swelling and injection site warmth were recovered/resolved. It was unknown if the reporter considered the injection site pain, headache, stiff neck, injection site swelling and injection site warmth to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported, but it could be 74 or 75 years old. The patient received the SHINGRIX vaccine on left arm. The patient stated the area of injection site was hot. She also experienced stiff neck on the left side. She stated all her symptoms lasted for total of 3 days and then she recovered. The patient had denied permission to contact their physician. No further details were provided.
Sex: F
Vaccine: MEN
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of adverse reaction in a female patient who received Meningococcal B vaccine for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Meningococcal B vaccine. Additional details were reported as follows: This case was reported by the patient's mother. The reporter thought that she was dying and the side effects (unspecified) were terrible.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Back pain, Chills, Dizziness, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On 10th August 2018, the patient received SHINGRIX. On 10th August 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain and injected limb mobility decreased. On 11th August 2018, the patient experienced fever, back pain and stomach pain. In August 2018, the patient experienced dizziness, tongue disorder, chills, feeling unwell and headache. The patient was treated with TYLENOL and BENADRYL. On an unknown date, the outcome of the injection site pain, injected limb mobility decreased, dizziness, tongue disorder, chills, feeling unwell, fever, back pain, stomach pain and headache were unknown. It was unknown if the reporter considered the injection site pain, injected limb mobility decreased, dizziness, tongue disorder, chills, feeling unwell, fever, back pain, stomach pain and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On the day before reporting, at morning, the patient received the SHINGRIX in the upper arm and believed that she having some adverse reactions. When the shot was administered the patient had immediate pain in upper arm, to the point that she could not even move arm without pain. The night before reporting, 12 hours after receiving SHINGRIX, the patient experienced dizziness, tongue felt funny, chills, just a general feeling of being out of sorts. The patient took TYLENOL and 2 BENADRYL, which helped the tongue issue. The patient also had chills and 1 day after receiving SHINGRIX, at the morning of date of reporting the patient experienced low grade temperature of 99.9 degree F. One day after receiving SHINGRIX, the patient felt like she had been run over by a truck, stomach felt like someone has punched and back hurts. Also, less than a week after receiving SHINGRIX, the patient experienced headache. The patient still has a headache. The patient was asking that these were common side effects or not and would be honest she was a bit concerned about getting the 2nd dose.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Malaise, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On 10th August 2018, the patient received SHINGRIX. On 10th August 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain and injected limb mobility decreased. On 11th August 2018, the patient experienced fever, back pain and stomach pain. In August 2018, the patient experienced dizziness, tongue disorder, chills, feeling unwell and headache. The patient was treated with TYLENOL and BENADRYL. On an unknown date, the outcome of the injection site pain, injected limb mobility decreased, dizziness, tongue disorder, chills, feeling unwell, fever, back pain, stomach pain and headache were unknown. It was unknown if the reporter considered the injection site pain, injected limb mobility decreased, dizziness, tongue disorder, chills, feeling unwell, fever, back pain, stomach pain and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On the day before reporting, at morning, the patient received the SHINGRIX in the upper arm and believed that she having some adverse reactions. When the shot was administered the patient had immediate pain in upper arm, to the point that she could not even move arm without pain. The night before reporting, 12 hours after receiving SHINGRIX, the patient experienced dizziness, tongue felt funny, chills, just a general feeling of being out of sorts. The patient took TYLENOL and 2 BENADRYL, which helped the tongue issue. The patient also had chills and 1 day after receiving SHINGRIX, at the morning of date of reporting the patient experienced low grade temperature of 99.9 degree F. One day after receiving SHINGRIX, the patient felt like she had been run over by a truck, stomach felt like someone has punched and back hurts. Also, less than a week after receiving SHINGRIX, the patient experienced headache. The patient still has a headache. The patient was asking that these were common side effects or not and would be honest she was a bit concerned about getting the 2nd dose.
Sex: F
Vaccine: VARZOS
Symptoms: Tongue disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On 10th August 2018, the patient received SHINGRIX. On 10th August 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain and injected limb mobility decreased. On 11th August 2018, the patient experienced fever, back pain and stomach pain. In August 2018, the patient experienced dizziness, tongue disorder, chills, feeling unwell and headache. The patient was treated with TYLENOL and BENADRYL. On an unknown date, the outcome of the injection site pain, injected limb mobility decreased, dizziness, tongue disorder, chills, feeling unwell, fever, back pain, stomach pain and headache were unknown. It was unknown if the reporter considered the injection site pain, injected limb mobility decreased, dizziness, tongue disorder, chills, feeling unwell, fever, back pain, stomach pain and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On the day before reporting, at morning, the patient received the SHINGRIX in the upper arm and believed that she having some adverse reactions. When the shot was administered the patient had immediate pain in upper arm, to the point that she could not even move arm without pain. The night before reporting, 12 hours after receiving SHINGRIX, the patient experienced dizziness, tongue felt funny, chills, just a general feeling of being out of sorts. The patient took TYLENOL and 2 BENADRYL, which helped the tongue issue. The patient also had chills and 1 day after receiving SHINGRIX, at the morning of date of reporting the patient experienced low grade temperature of 99.9 degree F. One day after receiving SHINGRIX, the patient felt like she had been run over by a truck, stomach felt like someone has punched and back hurts. Also, less than a week after receiving SHINGRIX, the patient experienced headache. The patient still has a headache. The patient was asking that these were common side effects or not and would be honest she was a bit concerned about getting the 2nd dose.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of the adult patients who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter stated that to them the wolf represents the big government. The reporter also stated that there were too many kids with too many problems that took all the vaccines. The reporter stated, do not forget the vaccine given to new borns for Hepatitis C. The reporter stated that many people received shingles vaccine and experienced shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for SHINGRIX and time to onset for event were not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pruritus
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of chills in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills, influenza-like symptoms and pruritus. On an unknown date, the outcome of the chills, influenza-like symptoms and pruritus were unknown. It was unknown if the reporter considered the chills, influenza-like symptoms and pruritus to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of SHINGRIX and reported chills, flu like symptoms, and itching around his waist.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a elderly female patient who received SHINGRIX for prophylaxis. On 3rd August 2018, the patient received the 2nd dose of SHINGRIX. On 3rd August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, fatigue, headache and myalgia. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, fatigue, headache and myalgia were recovered/resolved. It was unknown if the reporter considered the injection site pain, fatigue, headache and myalgia to be related to SHINGRIX. Additional details reported as follows: The caller was GlaxoSmithKline employee from R and D that was made aware of two individuals who received SHINGRIX. The event began the evening of the injections. This case has been linked with US2018144841 and US2018144839, reported by same reporter and linked with case US2018144842 reported for same patient for 1st dose).
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discomfort
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site discomfort in a elderly male patient who received SHINGRIX for prophylaxis. On 3rd August 2018, the patient received the 2nd dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site discomfort. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site discomfort was recovered/resolved. It was unknown if the reporter considered the injection site discomfort to be related to SHINGRIX. Additional details reported as follows: The caller was GlaxoSmithKline employee from R and D that was made aware of two individuals who received SHINGRIX. The consumer here reported injection site discomfort with both doses. First dose received two months ago and his last shot on 3rd August 2018. The employee reported he first heard of these events this week. Employee would reach out for additional info and encourage consumer to call. This case has been linked with US2018144842 and US2018144839, reported by same reporter and linked with case US2018144841 (reported for same patient for 1st dose).
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Initial information received on 10-Aug-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves two patients (age and gender not reported) who was vaccinated with dose of ADACEL which was associated with exceeded shipping storage limits (batch number, expiration date, dose, route and site of administration was not reported for both vaccines) on an unspecified date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to exceeded shipping storage limits. It was reported that ADACEL was delivered late to facility. 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 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: 0.58
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RVX
Symptoms: Expired product administered
Clinical narrative: Initial information received on 10-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 7 months (7 months 26 days) old male patient who was vaccinated with 0.5 ml expired second dose of PENTACEL (PENTACEL Lot: of dry C50378A expiry: 12/07/2018 PENTACEL Liquid Lot: C50208A expiry: 06/30/2018) in the right thigh (route not reported) on 06-Aug-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE in right thigh for Immunisation; PREVENAR in left thigh for Immunisation; and ROTAVIRUS VACCINE for Immunisation on an unknown date. It was a case of actual medication error due to expired vaccine used. It was unknown if any adverse event was occurred or not following the 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 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 the sender: None.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from non-healthcare professional. This case was linked with 2018SA226678, 2018SA226687 and 2018SA226689. This case involves a 17 years old female patient who administered MENACTRA for which shipment was received at 3 days instead of 2 days and administered, while she received vaccine MENACTRA and TRUMENBA in the same visit. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 10-Aug-2018, the patient received 0.5 ml second dose of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine (lot U6016AA, expiry date- 09 Oct 2019) in the right deltoid. It was a case of actual medication error due to incorrect product storage and extra dose administered. 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.
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age female patient who experienced vomit, while she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in Nov 2017, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via intramuscular route in the thigh nos. On an unknown date in Nov 2017, the patient developed a non-serious vomit, (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was reported that, the patient covered in vomit from head to toe. (Other relevant tests included no lab data.) Final diagnosis was vomit. It was not reported if the patient received a corrective treatment. The patient outcome is reported as unknown for vomit.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Crying, Dizziness, Dyspnoea, Respiratory rate increased, Wheezing
Clinical narrative: Child reported SOB and dizziness after receiving vaccines. Advised to relax against the wall, cool compresses applied to neck and forehead moved fan to blow on pt. Respiration rate 20 with pulse of 96. Pt reported was okay and felt same every 2 minutes up until 0900 at which point she reported increased difficulty breathing. Child advised to move to more of a high Fowlers against wall with feet on bench. Request help from another nurse. Bilateral inspiratory wheezes with ausculataion of lung sounds. 1 dose of Epi prepped in room, administrator called 911 to request transport to ER. Vitals P 120 R. 22 B/P 122/64 At 0910 child reported feeling better, inspiratory wheezes still present but greatly reduced. Child was able to converse throughout entire reaction 0915 child reports feeling better wheezes had resolved, child was advised ambulance was coming to pick her up to take to ER for further evaluation. Child started to cry and increased respirations( 24) at which point ambulance arrived and was taken to EMS.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Diarrhoea, Hypotension, Pyrexia, Retching, Tachycardia
Clinical narrative: Per mom, one to two hours after receiving vaccines the patient developed tachycardia, hypotension and non-bloody vomiting and diarrhea. Mom was notified that his vitals were abnormal when he presented for his specialist appointment one to two hours after being vaccinated. Mom took him home after that appointment and gave him some Benadryl. PCP was not notified until the following morning when he presented for parental concerns for a possible vaccine reaction. At that time, he had a fever of 100.6 associated with tachycardia. Blood pressure and remaining vitals were normal. No further vomiting or diarrhea, but still gagging intermittently per mom. Patient was given some ibuprofen for the fever and Zofran. He was monitored for 1-2 hours. He remained stable so he was discharged home.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Vital functions abnormal, Vomiting
Clinical narrative: Per mom, one to two hours after receiving vaccines the patient developed tachycardia, hypotension and non-bloody vomiting and diarrhea. Mom was notified that his vitals were abnormal when he presented for his specialist appointment one to two hours after being vaccinated. Mom took him home after that appointment and gave him some Benadryl. PCP was not notified until the following morning when he presented for parental concerns for a possible vaccine reaction. At that time, he had a fever of 100.6 associated with tachycardia. Blood pressure and remaining vitals were normal. No further vomiting or diarrhea, but still gagging intermittently per mom. Patient was given some ibuprofen for the fever and Zofran. He was monitored for 1-2 hours. He remained stable so he was discharged home.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Flu like symptoms. Including fever, chills, myalgia, injection site pain.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Hypersensitivity, Injection site pain
Clinical narrative: Patient-reported an allergic reaction to the vaccine on 8/8/2018 - stating pain and tenderness at the injection site. Patient came in for physician evaluation with Dr. PHYSICIAN ASSESSMENT:   Allergic reaction to chickenpox injection Suspect secondary infection. PLAN OF CARE: Findings explained to the patient, injection was given in the lower one third of the arm lateral aspect Report to the nurse clinic has been done. The patient is to take a loratadine 10 mg daily Empirically given a prescription for Bactrim DS 1 tablet 2 times a day for 7 days. She will follow-up in MD office if any worsening of symptoms or not clinically better.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Photopsia, Visual impairment
Clinical narrative: Patient reported vision changes with flashing lights, squiggly lines, and black spots the evening after receiving the vaccination. This last for approximately 7 minutes. The next day patient reported redness and warm to touch at injection site.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Cellulitis, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Soreness in left deltoid 12 hrs after vaccination; redness, warmth, swelling, soreness from injection site down into left upper arm and lack of energy and tiredness 24 hrs after vaccination and for past 3 days.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Soreness in left deltoid 12 hrs after vaccination; redness, warmth, swelling, soreness from injection site down into left upper arm and lack of energy and tiredness 24 hrs after vaccination and for past 3 days.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cold sweat, Dizziness, Hyperhidrosis, Hypotension, Nausea
Clinical narrative: 10 minutes after receiving the above vaccines, patient complained of nausea, lightheadedness and feeling lie had trouble with vision. PT was noted to be pale, clammy and diaphoretic. Pt was answering question but very slow to respond. Denied pain anywhere. PT initial BP before vaccines 102/60 HR 67. After vaccines when ill. Pt had BP 78/56, HR 84. Initial pulse ox 95% on RA.Pt was slow to recover and continued to have low BP and appear pale. Pt BGT 95. PT given  Few small sips of water. EMS called to transport to hospital for further evaluation. Dad agreed to plan. Dad reports he has not had previous vaccine reactions. Pt hx unremarkable. Biological father does report he himself had episodes of passing out as a child.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pallor, Slow response to stimuli, Visual impairment
Clinical narrative: 10 minutes after receiving the above vaccines, patient complained of nausea, lightheadedness and feeling lie had trouble with vision. PT was noted to be pale, clammy and diaphoretic. Pt was answering question but very slow to respond. Denied pain anywhere. PT initial BP before vaccines 102/60 HR 67. After vaccines when ill. Pt had BP 78/56, HR 84. Initial pulse ox 95% on RA.Pt was slow to recover and continued to have low BP and appear pale. Pt BGT 95. PT given  Few small sips of water. EMS called to transport to hospital for further evaluation. Dad agreed to plan. Dad reports he has not had previous vaccine reactions. Pt hx unremarkable. Biological father does report he himself had episodes of passing out as a child.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling, redness, pain worsening for 1 week - (6 days). Pt. prescribed antibiotic as treatment. Suspect also due to very poorly controlled diabetes.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Discomfort, Dizziness, Feeling abnormal
Clinical narrative: (1st) shot - began to get rash next day (have had this with reactions to molds, smoke, preservatives in flu shot several yrs ago); rash tends to be all over body milder on face and hands and feet; stomach felt "off"; sickish no energy for 3-5 days - felt as if "lost" 5 days or could do little. (2nd) shot took BENADRYL as per PCP - rash developed later but extremely dizzy and lightheaded 1st AM (took no more BENADRYL!); (better after 6) - began sore throat (extreme) within hrs; cold began - still have remnants. Assume cold was due to shot "sapping" immune system making me vulnerable - rash lasted 3 days or so in this time have on legs and thighs and overall - generally during after experience with the rash - it is more spotty - i.e. where I am warmest, etc. Again very uncomfortable feel off - stomach off - no energy; again rash is not unfamiliar but was significantly worse with these 2 shots. Am wondering what, if any, ingredients is similar in the flu shot preservatives of 45 yrs ago and this shingles shot - (I have been getting preservative free flu shots).
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Oropharyngeal pain, Rash generalised
Clinical narrative: (1st) shot - began to get rash next day (have had this with reactions to molds, smoke, preservatives in flu shot several yrs ago); rash tends to be all over body milder on face and hands and feet; stomach felt "off"; sickish no energy for 3-5 days - felt as if "lost" 5 days or could do little. (2nd) shot took BENADRYL as per PCP - rash developed later but extremely dizzy and lightheaded 1st AM (took no more BENADRYL!); (better after 6) - began sore throat (extreme) within hrs; cold began - still have remnants. Assume cold was due to shot "sapping" immune system making me vulnerable - rash lasted 3 days or so in this time have on legs and thighs and overall - generally during after experience with the rash - it is more spotty - i.e. where I am warmest, etc. Again very uncomfortable feel off - stomach off - no energy; again rash is not unfamiliar but was significantly worse with these 2 shots. Am wondering what, if any, ingredients is similar in the flu shot preservatives of 45 yrs ago and this shingles shot - (I have been getting preservative free flu shots).
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Headache, Influenza virus test negative, Myalgia, Pyrexia
Clinical narrative: Patient received her GARDASIL vaccine on 7/31/18 afternoon. Monitored for 15 mins. No reaction. The next day, she developed fever, headache, chills and myalgias. ER physician attributed this for a reaction to HPV.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Streptococcus test negative, Urine analysis normal, Vaccination complication
Clinical narrative: Patient received her GARDASIL vaccine on 7/31/18 afternoon. Monitored for 15 mins. No reaction. The next day, she developed fever, headache, chills and myalgias. ER physician attributed this for a reaction to HPV.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Nausea, Pallor, Syncope
Clinical narrative: Syncopal event about 10-15 minutes after shots given. Does have known diagnosis of vasovagal syncope. Monitored her for about 2.5 hr. since she was dizzy, pale, nauseated. She finally slept for approximately 30 min. and felt better.
Age: 60.0
Sex: U
Vaccine: FLU4, VARZOS
Symptoms: Adverse reaction
Clinical narrative: Patient states went to ER due to "bad reaction". No specifics given. Attempted to contact patient to no avail. Was in pharmacy less than 24 hr after incident.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site urticaria, Injection site warmth
Clinical narrative: Post varicella vaccine administration developed hive and warmth to touch at injection site. Took BENADRYL. Reaction resolved. No fever.