chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020). Concomitant products included Pravastatin, PEPCID and TOPROL. On 11th May 2018 12:00, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, 1 day 1 hr after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, injection site swelling and injection site itching. The patient was treated with Anti-Itch Cream. In May 2018, the outcome of the injection site pain, injection site swelling and injection site itching were recovered/resolved. On an unknown date, the outcome of the injection site erythema was recovering/resolving. The reporter considered the injection site erythema, injection site pain, injection site swelling and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. On 12th May 2018, 25 hours after receiving SHINGRIX, the patient experienced redness, swelling, itching, stinging and soreness at the injection site. After several days, the patient visited her healthcare professional's office and saw not her regular doctor, but his partner. The partner advised her to put warm compresses on the site and prescribed an anti-itch cream, which did alleviate the itching and stinging. He advised the patient that her regular physician should call in a prescription of cortisone to take before receiving the 2nd dose. The day before reporting, the patient saw her regular physician for a routine follow-up appointment. While there the patient discussed the reaction with him. The swelling, itching, stinging and soreness had resolved after about 1 week, but the redness, while fading, was still very noticeable. The physician advised that the patient should not get the 2nd dose because cortisone might interfere with the effectiveness of the vaccine, and she might have a more severe reaction with the 2nd dose.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Lip swelling
Clinical narrative: Pt developed left leg redness and swelling one day after receiving vaccines. Lip swelling also noted.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Injection site hypoaesthesia, Injection site movement impairment
Clinical narrative: Patient was given the shot in the (L) deltoid. He immediately felt numb and weak on the entire (L) arm. He regained over 30min strength in the (L) hand but was only able to flex the elbow to 100 degrees. He felt less sensation in the upper arm on the left side.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of shingles in a 63-year-old female patient who received SHINGRIX. Previously administered products included ZOSTAVAX (received one year before the reporting date). On 18th May 2018, the patient received the 1st dose of SHINGRIX. On 22nd May 2018, 4 days after receiving SHINGRIX, the patient experience shingles and rash. The patient was treated with VALTREX. On an unknown date, the outcome of the shingles and rash were unknown. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were provided as follows: The patient began to develop a rash on her neck. On 25th May 2018, the patient was seen by her primary care provider at which time it was confirmed that the patient had Shingles. As treatment, the patient was prescribed VALTREX. No hospitalization or emergency room visit was required. Vaccine was not administered by the reporter but was administered at a pharmacy.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in an unspecified number of adult patients who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a physician assistant. The age at vaccination was not applicable for this report.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Delayed 2 two days post vaccination -upper left arm-at site of injection. Became red, warm, swollen and very tender and painful-2 weeks later-still pink and slightly swollen.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Dermal erythema and swelling around vax site R thigh.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Overweight, Pain, Pyrexia
Clinical narrative: Overnight b/w 5/26/18 and 5/27/18 pt. experienced chills, aches, and a fever of 101. Didn't experience w/1st dose.
Age: 56.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Patient became very ill with flu-like symptoms and developed a fever.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Extra dose administered
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of dizziness in a 18-year-old female patient who received BEXSERO (batch number 16B501, expiry date 28th February 2019). Previously administered products included BEXSERO (1st dose received on 20th July 2017, batch number 158501C, expiry date 31st March 2018) and BEXSERO (2nd dose received on 22nd August 2017, batch number 16B701, expiry date 27 February 2019). On 24th May 2018, the patient received the 3rd dose of BEXSERO. On 24th May 2018, unknown after receiving BEXSERO, the patient experienced extra dose administered. On 25th May 2018, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was not recovered/not resolved and the outcome of the extra dose administered was unknown. It was unknown if the reporter considered the dizziness to be related to BEXSERO. Additional details were provided as follows: At the time of reporting the patient was 19 years old. The patient was inadvertently vaccinated with a third dose of BEXSERO, which led to extra dose administered. One day after vaccination, the patient began to experience dizziness. No emergency room (ER), doctor visit, hospitalization or intervention was required. The dizziness was not considered life threatening or disabling. The healthcare provider was unsure if lot was 15B501C or 158501C, however as per sale data review corrected to 158501C.
Age: 71.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Influenza like illness
Clinical narrative: Patient became ill with flu-like symptoms.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Influenza like illness, Myalgia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a 4 to 5 adult patients who received SHINGRIX. On an unknown date, the patients received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced influenza-like symptoms, myalgia, arthralgia and headache. On an unknown date, the outcome of the influenza-like symptoms, myalgia, arthralgia and headache were unknown. It was unknown if the reporter considered the influenza-like symptoms, myalgia, arthralgia and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The healthcare professional (HCP) reported that his office had probably vaccinated around 60 patients with a dose of SHINGRIX vaccine and at least 4 to 5 of them had felt like they were hit by a truck, when asked to clarify, the reporter stated that, more like flu-like symptoms, myalgia, arthralgia and headache. The HCP did not have any additional information. This case has been linked with case US2018GSK095445, reported by the same reporter.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Dermal erythema and swelling around vax site R thigh.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Eyelid oedema, Fatigue, Headache, Influenza like illness
Clinical narrative: This case was reported by a pharmacist via out of hour services and described the occurrence of eye swelling in a 72-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020). Concomitant products included omeprazole, Aspirin (Baby), ALLEGRA D, clonazepam and EFFEXOR ER. On 26th May 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 26th May 2018, 3 hrs after receiving SHINGRIX, the patient experienced eye swelling, head discomfort and impending doom. On an unknown date, the outcome of the eye swelling, general body pain, head discomfort, erythema, knee pain and impending doom were recovered/resolved. The reporter considered the eye swelling, general body pain, head discomfort and erythema to be related to SHINGRIX. It was unknown if the reporter considered the knee pain and impending doom to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The registered pharmacist reported that the patient reported that she might be having reactions from the vaccine the following day. The patient presented on Sunday with puffiness under her eyes and there were two points where it was really bad. Her body was aching all over and her knees and joints were aching. The patient's head felt like it was a balloon and she felt like death according to the pharmacist. The registered pharmacist reported that the patient was healthy as a horse. She spoke with the patient on Sunday morning and told her how to treat her side effects. Her all side effects were resolved and she was fine. This information had already been reported to VAERS.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Ocular hyperaemia, Pyrexia
Clinical narrative: This case was reported by a pharmacist via out of hour services and described the occurrence of eye swelling in a 72-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020). Concomitant products included omeprazole, Aspirin (Baby), ALLEGRA D, clonazepam and EFFEXOR ER. On 26th May 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 26th May 2018, 3 hrs after receiving SHINGRIX, the patient experienced eye swelling, head discomfort and impending doom. On an unknown date, the outcome of the eye swelling, general body pain, head discomfort, erythema, knee pain and impending doom were recovered/resolved. The reporter considered the eye swelling, general body pain, head discomfort and erythema to be related to SHINGRIX. It was unknown if the reporter considered the knee pain and impending doom to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The registered pharmacist reported that the patient reported that she might be having reactions from the vaccine the following day. The patient presented on Sunday with puffiness under her eyes and there were two points where it was really bad. Her body was aching all over and her knees and joints were aching. The patient's head felt like it was a balloon and she felt like death according to the pharmacist. The registered pharmacist reported that the patient was healthy as a horse. She spoke with the patient on Sunday morning and told her how to treat her side effects. Her all side effects were resolved and she was fine. This information had already been reported to VAERS.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anxiety, Arthralgia, Erythema, Eye swelling, Head discomfort
Clinical narrative: This case was reported by a pharmacist via out of hour services and described the occurrence of eye swelling in a 72-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020). Concomitant products included omeprazole, Aspirin (Baby), ALLEGRA D, clonazepam and EFFEXOR ER. On 26th May 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 26th May 2018, 3 hrs after receiving SHINGRIX, the patient experienced eye swelling, head discomfort and impending doom. On an unknown date, the outcome of the eye swelling, general body pain, head discomfort, erythema, knee pain and impending doom were recovered/resolved. The reporter considered the eye swelling, general body pain, head discomfort and erythema to be related to SHINGRIX. It was unknown if the reporter considered the knee pain and impending doom to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The registered pharmacist reported that the patient reported that she might be having reactions from the vaccine the following day. The patient presented on Sunday with puffiness under her eyes and there were two points where it was really bad. Her body was aching all over and her knees and joints were aching. The patient's head felt like it was a balloon and she felt like death according to the pharmacist. The registered pharmacist reported that the patient was healthy as a horse. She spoke with the patient on Sunday morning and told her how to treat her side effects. Her all side effects were resolved and she was fine. This information had already been reported to VAERS.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a pharmacist via out of hour services and described the occurrence of eye swelling in a 72-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020). Concomitant products included omeprazole, Aspirin (Baby), ALLEGRA D, clonazepam and EFFEXOR ER. On 26th May 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 26th May 2018, 3 hrs after receiving SHINGRIX, the patient experienced eye swelling, head discomfort and impending doom. On an unknown date, the outcome of the eye swelling, general body pain, head discomfort, erythema, knee pain and impending doom were recovered/resolved. The reporter considered the eye swelling, general body pain, head discomfort and erythema to be related to SHINGRIX. It was unknown if the reporter considered the knee pain and impending doom to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The registered pharmacist reported that the patient reported that she might be having reactions from the vaccine the following day. The patient presented on Sunday with puffiness under her eyes and there were two points where it was really bad. Her body was aching all over and her knees and joints were aching. The patient's head felt like it was a balloon and she felt like death according to the pharmacist. The registered pharmacist reported that the patient was healthy as a horse. She spoke with the patient on Sunday morning and told her how to treat her side effects. Her all side effects were resolved and she was fine. This information had already been reported to VAERS.
Age: 3.0
Sex: M
Vaccine: HEP, HIBV
Symptoms: Injection site pain, Pyrexia, Skin warm, Vaccination site pain
Clinical narrative: Mom felt the child was warm on Friday night, June 1st but never measured temperature until Sunday evening, June 3rd when the temp was up to 103 F, pain on R leg and tenderness at vaccine site. The duty nurse recommended Tylenol and fever came down. Temperature 103 F at noon on Monday June 4th and given Tylenol then came to clinic for a follow up. Patient active and in good spirit.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Coordination abnormal, Discomfort, Gait disturbance, Influenza like illness
Clinical narrative: Around 2:00-2:15 that afternoon I began feeling flu like symptoms which became progressively worse over the next several hours. When I left work around 5:00 PM I experienced severe muscle aches, had trouble walking, difficulty walking down stairs, severe difficulty moving in general. When I arrived home, lacking energy and needed to lay down as I felt very heavy and had trouble moving, walking, felt uncoordinated. I am 5-10, 212 lbs. By 7:30 PM it was much worse, I took 2 ADVIL Liquid capsules and went to bed and slept until 6 AM the next day. By the end of the day on Wednesday the flu like symptoms were better and mobility was much improved.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Around 2:00-2:15 that afternoon I began feeling flu like symptoms which became progressively worse over the next several hours. When I left work around 5:00 PM I experienced severe muscle aches, had trouble walking, difficulty walking down stairs, severe difficulty moving in general. When I arrived home, lacking energy and needed to lay down as I felt very heavy and had trouble moving, walking, felt uncoordinated. I am 5-10, 212 lbs. By 7:30 PM it was much worse, I took 2 ADVIL Liquid capsules and went to bed and slept until 6 AM the next day. By the end of the day on Wednesday the flu like symptoms were better and mobility was much improved.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Fatigue, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient reports swelling at injection site (up to tennis ball size), sensitive and warm to touch; fatigue, aching, joints and muscle pain. Swelling worsened on 6/2/18, patient visited physician and received Prednisone to treat (30 mg for 5 days).
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Myalgia
Clinical narrative: Patient reports swelling at injection site (up to tennis ball size), sensitive and warm to touch; fatigue, aching, joints and muscle pain. Swelling worsened on 6/2/18, patient visited physician and received Prednisone to treat (30 mg for 5 days).
Sex: F
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a consumer via a company representative and refers to a female non-pregnant patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date in May 2018, reported as "last week", the patient was vaccinated with GARDASIL 9, injection, as prevention of human papilloma virus (HPV) (dose, frequency, route of administration, lot # and expiration date were not reported). On an unknown date in May 2018, reported as "now", the patient had "a rash on her stomach and legs". The outcome of rash was reported as not recovered/not resolved. No causality assessment was provided.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 1 year old female patient. The patient's pertinent medical history included asthma. There was no concomitant therapy, or drug reactions/allergies. On 12-MAY-2018, the patient was vaccinated with VARIVAX, (lot # N029628, expiration date 23-OCT-2019) subcutaneous in the left thigh  as part of a routine vaccination (strength, dose and frequency were not provided). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT), (lot # N030572, expiry date 20-APR-2020). On an unspecified date in May 2018,  the patient developed redness and tenderness at the injection site. The patient was seen in the emergency department on 23-MAY-2018 and was prescribed an unspecified dose of cephalexin upon discharge from the emergency department. The outcome of injection site erythema and injection site pain was reported as not recovered. The causal assessment between the redness and tenderness at the injection site and the suspect therapies  was not reported. This is 1 of 2 reports from the same reporter, concerning patients who experienced a reaction to this lot number of VARIVAX, a lot check was requested.; Sender's Comments: US-009507513-1805USA012458:
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Myalgia, fever (T max 101.0 F), chills. Myalgia started 1400 hrs, fever 23:30 hours, peaked 0600 on 6/5.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Myalgia, fever (T max 101.0 F), chills. Myalgia started 1400 hrs, fever 23:30 hours, peaked 0600 on 6/5.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Facial pain, Fatigue, Impaired work ability, Lymphadenopathy, Swelling face
Clinical narrative: 5/18/18 Patient noted swollen glands at base of skull, collar bone, under jaw, side of neck but stated improving 5/21/18 and feeling "normal". 6/4/18 Developed "chipmunk cheek" on right side with achiness in cheek and feeling tired. Seen in clinic and recommended to stay out of work for 3 additional days and avoid young children/elderly and discussed ways to prevent transmission to roommate.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Pain
Clinical narrative: The morning following immunization, the patient reported to our Triage Phone Line the following sx:  Body aches, chills, pain at injection site, severe headache at base of skull, took temp and was afebrile.  Sx worsened by that evening, gradually lessened over next two days, and were completely resolved by 6/5/18.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: Patient called about 4 hours after receiving the vaccine and reported, arm pain, redness, warmth at the site, and stated she could not move her arm. She used tylenol and ice, the next morning, she called and said she had pain in her shoulder and along with the pain in her arm being worse.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Myalgia, Neuralgia
Clinical narrative: Patient is having muscular and nerve pain and never had this before the shot and continue to have it. Also had significant cellulitis and went to see her PCP. He advised her to get the 2nd dose.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pruritus, Injection site scab, Oedema
Clinical narrative: MOP reports 4 yo son received routine vaccines on 5/29/2018. KINRIX IM to left thigh and MMRV (PROQUAD) to right thigh. That evening his left thigh began to turn red about vaccine site and increased to quarter size. By Wednesday (5/30) it site had a 1-2 inch red circle, Thursday 5/31 there was about a 4 inch circle about vaccine site. She contacted Immunization Clinic who recommended she take her son to ER where HCP dx cellulitis vs normal site reaction. As a precaution, they began Keflex x 10 days. Mom follow up with HCP on 6/1/2018 and reports marked improvement of site reaction. Mom advised today 6/4 the redness has resolved with a red spot at vaccine site that appears to be scabbing over (child scratching site). She states he did not have any fever or any other systemic reactions and had full use of both legs. No site reaction reported to right thigh MMRV vaccine site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Rash
Clinical narrative: MOP reports 4 yo son received routine vaccines on 5/29/2018. KINRIX IM to left thigh and MMRV (PROQUAD) to right thigh. That evening his left thigh began to turn red about vaccine site and increased to quarter size. By Wednesday (5/30) it site had a 1-2 inch red circle, Thursday 5/31 there was about a 4 inch circle about vaccine site. She contacted Immunization Clinic who recommended she take her son to ER where HCP dx cellulitis vs normal site reaction. As a precaution, they began Keflex x 10 days. Mom follow up with HCP on 6/1/2018 and reports marked improvement of site reaction. Mom advised today 6/4 the redness has resolved with a red spot at vaccine site that appears to be scabbing over (child scratching site). She states he did not have any fever or any other systemic reactions and had full use of both legs. No site reaction reported to right thigh MMRV vaccine site.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Malaise, Pain in extremity, Swelling
Clinical narrative: MOTHER STATES PT HAD SIGNIFICANT GENERAL MALAISE AND JOINT PAIN STARTING HOURS AFTER ADMINISTRATION. THE NEXT DAY SHE HAD LOCALIZED SWELLING AND SIGNIFICANT SORENESS TO LT ARM.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong patient received medication
Clinical narrative: Vaccine Given to wrong pt. Brother was suppose to receive vaccine not patient. Mother was counseled by M.D. and was instructed that pt. should be okay.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity
Clinical narrative: Patient complained that by the evening after receiving the Tdap he was unable to move his left arm due to pain. He described the pain as throbbing that radiated to fingertips. The patient was seen in the office 5/9/18 by his provider, he was given a MEDROL dose pack and advised to ice for the next few days. On 6/4/18, pt still was complaining of pain in left shoulder. At times the pain level being an 8. At this time, pt was referred to ortho for further evaluation.
Age: 47.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Vaccine given outside of indicated range (patient is only 47 years old).
Age: 17.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Nausea
Clinical narrative: MOTHER CALLED THE NEXT MORNING AND STATED PT WOKE UP VERY NAUSEATED, LASTED FOR SEVERAL HOURS.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Cold sweat, Fatigue, Nausea, Syncope
Clinical narrative: Patient was Ok right after immunization, upon scheduling f.u vaccine patient had a syncopal episode. Patient was nauseous, calmmy, fatigued for about 20 minutes.
Age: 67.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Body temperature increased, Diarrhoea, Nausea
Clinical narrative: In bed all day, after each dose, with: stomach pain, diarrhea, nausea and low grade temp elevation. Symptoms slightly less by 4th dose.
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Oropharyngeal pain, Urticaria, Vomiting
Clinical narrative: Parent reported on 5/22/2018, hives, vomiting, sore throat occurred two days after child was vaccinated.
Age: 66.0
Sex: M
Vaccine: TYP
Symptoms: Anticoagulant therapy, Arrhythmia, Asthenia, Atrial fibrillation, Atrial flutter
Clinical narrative: My husband had some loose stools after one or two doses, however, a few hours after the fourth dose, at 11PM June 1st, he had a health crisis. His reaction started at night and we did not react initially, assuming he was in bed with the same problems I suffered. However, in the morning, when he had debilitating balance issues, and could not even crawl to the bathroom, it became clear that this problem required medical attention. We went to the doctor and they discovered an arrhythmia and sent us to the emergency room where he was diagnosed with atrial fibrillation and atrial flutter and admitted to the hospital. After 2 days in the hospital and a battery of tests he was diagnosed with a cerebellar stroke. My husband is now home, with a walker and Meclizine and a medication to thin his blood, and has started on his journey toward recovery that will include trips to his doctor, a cardiologist, a neurologist and physical therapy. I am sure that you can see why I thought this was worth reporting. We are praying for his health and strength to return to normal.
Age: 66.0
Sex: M
Vaccine: TYP
Symptoms: Balance disorder, Blood test, Cerebellar stroke, Chest X-ray, Computerised tomogram head
Clinical narrative: My husband had some loose stools after one or two doses, however, a few hours after the fourth dose, at 11PM June 1st, he had a health crisis. His reaction started at night and we did not react initially, assuming he was in bed with the same problems I suffered. However, in the morning, when he had debilitating balance issues, and could not even crawl to the bathroom, it became clear that this problem required medical attention. We went to the doctor and they discovered an arrhythmia and sent us to the emergency room where he was diagnosed with atrial fibrillation and atrial flutter and admitted to the hospital. After 2 days in the hospital and a battery of tests he was diagnosed with a cerebellar stroke. My husband is now home, with a walker and Meclizine and a medication to thin his blood, and has started on his journey toward recovery that will include trips to his doctor, a cardiologist, a neurologist and physical therapy. I am sure that you can see why I thought this was worth reporting. We are praying for his health and strength to return to normal.
Age: 66.0
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea, Electrocardiogram, Inability to crawl, Nuclear magnetic resonance imaging brain abnormal, Urine analysis
Clinical narrative: My husband had some loose stools after one or two doses, however, a few hours after the fourth dose, at 11PM June 1st, he had a health crisis. His reaction started at night and we did not react initially, assuming he was in bed with the same problems I suffered. However, in the morning, when he had debilitating balance issues, and could not even crawl to the bathroom, it became clear that this problem required medical attention. We went to the doctor and they discovered an arrhythmia and sent us to the emergency room where he was diagnosed with atrial fibrillation and atrial flutter and admitted to the hospital. After 2 days in the hospital and a battery of tests he was diagnosed with a cerebellar stroke. My husband is now home, with a walker and Meclizine and a medication to thin his blood, and has started on his journey toward recovery that will include trips to his doctor, a cardiologist, a neurologist and physical therapy. I am sure that you can see why I thought this was worth reporting. We are praying for his health and strength to return to normal.
Age: 66.0
Sex: M
Vaccine: TYP
Symptoms: Walking aid user
Clinical narrative: My husband had some loose stools after one or two doses, however, a few hours after the fourth dose, at 11PM June 1st, he had a health crisis. His reaction started at night and we did not react initially, assuming he was in bed with the same problems I suffered. However, in the morning, when he had debilitating balance issues, and could not even crawl to the bathroom, it became clear that this problem required medical attention. We went to the doctor and they discovered an arrhythmia and sent us to the emergency room where he was diagnosed with atrial fibrillation and atrial flutter and admitted to the hospital. After 2 days in the hospital and a battery of tests he was diagnosed with a cerebellar stroke. My husband is now home, with a walker and Meclizine and a medication to thin his blood, and has started on his journey toward recovery that will include trips to his doctor, a cardiologist, a neurologist and physical therapy. I am sure that you can see why I thought this was worth reporting. We are praying for his health and strength to return to normal.
Age: 71.0
Sex: M
Vaccine: TDAP
Symptoms: Altered state of consciousness, Anaphylactic reaction, Aortic valve replacement, Atrial fibrillation, Blood glucose normal
Clinical narrative: Pt came in today for apt for annual. While pt was checking out he complained to employee that he felt dizzy and he felt like he was going to pass out. I asked pt to have a seat and relax. BP was: 57/43, manually-50/40. Again, pt stated that he was going to pass out! Employee gave pt a bottle of water and we escorted him to exam room 2 and laid pt flat on the exam table. Pt's lips started to turn purple. I rechecked his BP manually and it was 55/40. Employee came into the exam room and checked blood sugar. BS level was: 104 Pt started to complain of chest tightness and his eyes started to roll back. Dr gave pt aspirin 81 mg x 1, 50MG BENADRYL and injected an .3 EPI-PEN into right thigh. Employees gave pt O2 via nasal cannula (2 LITERS). He was seen by all three providers: 2 Dr 2s and FNP-C. DR. stated pt may have had a possible reaction to the TDAP shot he was given. One of the employees called EMS and they arrived five minutes later and took to ER.
Age: 71.0
Sex: M
Vaccine: TDAP
Symptoms: Chest discomfort, Cyanosis, Dizziness, Eye movement disorder
Clinical narrative: Pt came in today for apt for annual. While pt was checking out he complained to employee that he felt dizzy and he felt like he was going to pass out. I asked pt to have a seat and relax. BP was: 57/43, manually-50/40. Again, pt stated that he was going to pass out! Employee gave pt a bottle of water and we escorted him to exam room 2 and laid pt flat on the exam table. Pt's lips started to turn purple. I rechecked his BP manually and it was 55/40. Employee came into the exam room and checked blood sugar. BS level was: 104 Pt started to complain of chest tightness and his eyes started to roll back. Dr gave pt aspirin 81 mg x 1, 50MG BENADRYL and injected an .3 EPI-PEN into right thigh. Employees gave pt O2 via nasal cannula (2 LITERS). He was seen by all three providers: 2 Dr 2s and FNP-C. DR. stated pt may have had a possible reaction to the TDAP shot he was given. One of the employees called EMS and they arrived five minutes later and took to ER.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Administration site nodule
Clinical narrative: Nodule at site of administration, abscess? 5-7-18, AUGMENTIN 500 mg/125 mg, BID x 10 days 6-4-18 Sent to Dr, infectious disease who thought possibly reaction to aluminum adjuvant.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC13
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: No adverse outcomes noted. Patient had no prior vaccinations before today's visit.
Sex: F
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: The initial case was missing the following minimum criteria: Unspecified number of patients. Upon receipt of follow-up information on 31May2018, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for 3 patients. This is third of three reports. A female patient of an unspecified age (more than 65 years old) received PREVNAR 13, via an unspecified route of administration from an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced oval shaped red patch with red dot under injection site on an unspecified date after pneumococcal 13-val conj vac (dipht crm197 protein) received. The outcome of event was unknown. The information on the lot number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018225880 same reporter and suspect drug, similar event in different patients;US-PFIZER INC-2018225881 same reporter and suspect drug, similar event in different patients.
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: This is a spontaneous report from a contactable physician. This report was received via a Pfizer sales representative. This Physician reported similar event for 3 patients. This is first of three reports. A male patient of an unspecified age received PREVNAR 13, (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced oval shaped red patch with red dot under injection site on an unspecified date. The outcome of the event of oval shaped red patch with red dot under injection site was unknown. The information on the lot number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018223259 same reporter and suspect drug, similar event in different patients;US-PFIZER INC-2018225881 same reporter and suspect drug, similar event in different patients.
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: This is a spontaneous report from a contactable physician received via a Pfizer sales representative. This physician reported similar events for 3 patients. This is the second of three reports. A male patient of an unspecified age (reported as above 65, unit unknown) received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced oval shaped red patch with red dot under injection site. The outcome of events was unknown. Information regarding the batch number has been requested. Sender's Comments: Linked Report(s) : US-PFIZER INC-2018223259 same reporter, suspect drug and event/ different patient;US-PFIZER INC-2018225880 same reporter, suspect drug and event/ different patient.
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Pain
Clinical narrative: This is a spontaneous report from a contactable consumer. This report was received via a Pfizer sales representative. A female patient of an unspecified age (reported as at least 65) received PREVNAR 13 (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization and SHINGRIX, via an unspecified route of administration on an unspecified date at an unspecified dose for immunization. The patient's medical history and concomitant medications were not reported. The patient received both the pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) and varicella zoster vaccine rge (cho) vaccine together and said it hurt, was sore on an unspecified date. The outcome of the event was unknown. No follow-up attempts are possible; information about batch number cannot be obtained.
Sex: U
Vaccine: PNC13
Symptoms: Headache, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer-sales representative. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced fever and headache after receiving the suspected vaccine on an unspecified date. Outcome of the events, fever and headache was unknown. Information on batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Feeling drunk
Clinical narrative: This is a spontaneous report from a contactable pharmacist through a Pfizer sales representative. A female patient of an unspecified age received PREVNAR 13 on an unknown date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient felt like she was drunk. Clinical outcome was unknown at time of this report. The information on the lot number has been requested.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: Initial unsolicited pregnancy report received from a nurse on 06-Feb-2018. This case involves a 17-year-old female patient who was vaccinated with a 0.5 ml dose of DAPTACEL (frequency: once, batch number, expiration date, dose in series and site of administration were not reported) via intramuscular route instead of ADACEL (batch number, expiration date was not reported) on 31-Jan-2018. She was 33.5 weeks pregnant at the time and the error was discovered today. Pregnancy information (LMP, estimated delivery date were not reported. The patient's medical history and concomitant medication were not reported. It was a case of actual medication error due to wrong vaccine administered. No adverse event reported at this time. Patient's pregnancy outcome was not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Follow-up information was received from a nurse on 18-May-2018. As per follow up information received on 18-May-2018, it was confirmed by the reporter that the correct vaccine ADACEL (correct vaccine) has been administered and hence DAPTACEL (wrong suspect vaccine, reported in the initial version) has been deleted. Patient had a medical history of epilepsy on an unknown date. Patient's last menstrual period date was 08-Jun-2017, estimated delivery date was 18-Mar-2018 and patient was in her 40 weeks of gestation. It was reported that patient's Apgar score was 6 and 8. Pregnancy information including patient's birth type was reported as live birth not otherwise specified and born by cesarean type. Lab data included patient was performed HIV test, hepatitis, immune to rubella antibody and Hepatitis B non-reactive (result: negative) on an unknown date. Patient was received MECLOZINE HYDROCHLORIDE, PYRIDOXINE HYDROCHLORIDE (PNV) for pregnancy, and IRON for anemia, ZANTAC for heartburn and ZOLOFT for depression daily via oral route on 22-Aug-2017. List of documents held by sender: none.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Diarrhoea, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Initial unsolicited report received from nurse on 25-Apr-2018. This case involves four months old male patient who was vaccinated with 0.5 ml dose of QUADRACEL (batch number, expiry date was not reported) once, intramuscularly in left thigh on 20 Apr 2018. The patient's medical history and concomitant medication were not reported. On an unspecified date, following the vaccination, patient had hives, diarrhea, vomiting, fever and a red swollen warm area on the left thigh. On 21 Apr 2018, patient was taken to emergency room. Laboratory investigation and corrective treatment were not reported. Patient was not recovered from events. Follow up information was received from nurse on 22-May-2018. The batch number for the suspect vaccine QUADRACEL was updated as C5222AA. It was reported that patient had no pre-existing-diagnosed allergies, birth defects and medical conditions and also no illness at time of vaccination. Concomitant medications included patient was vaccinated with PNEUMOCOCCAL VACCINE 13V, HIB VACCINE CONJ (HAEMOPHILUS INFLUENZAE TYPE B VACCINE CONJUGATED) and ROTAVIRUS VACCINE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. On an unknown date, patient was recovered/resolved from all the events. On an unknown date, patient was performed KUB (kidney-urinary-bludder) Radiography (result: not reported). Patient was received BACITRACIN/ NEOMYCIN/ POLYMYXIN B for as a corrective treatment for vaccination site inflammation on an unknown date. List of documents held by sender: none.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Urinary system X-ray, Urticaria, Vaccination site inflammation, Vomiting
Clinical narrative: Initial unsolicited report received from nurse on 25-Apr-2018. This case involves four months old male patient who was vaccinated with 0.5 ml dose of QUADRACEL (batch number, expiry date was not reported) once, intramuscularly in left thigh on 20 Apr 2018. The patient's medical history and concomitant medication were not reported. On an unspecified date, following the vaccination, patient had hives, diarrhea, vomiting, fever and a red swollen warm area on the left thigh. On 21 Apr 2018, patient was taken to emergency room. Laboratory investigation and corrective treatment were not reported. Patient was not recovered from events. Follow up information was received from nurse on 22-May-2018. The batch number for the suspect vaccine QUADRACEL was updated as C5222AA. It was reported that patient had no pre-existing-diagnosed allergies, birth defects and medical conditions and also no illness at time of vaccination. Concomitant medications included patient was vaccinated with PNEUMOCOCCAL VACCINE 13V, HIB VACCINE CONJ (HAEMOPHILUS INFLUENZAE TYPE B VACCINE CONJUGATED) and ROTAVIRUS VACCINE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. On an unknown date, patient was recovered/resolved from all the events. On an unknown date, patient was performed KUB (kidney-urinary-bludder) Radiography (result: not reported). Patient was received BACITRACIN/ NEOMYCIN/ POLYMYXIN B for as a corrective treatment for vaccination site inflammation on an unknown date. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial information received on 14-May-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case involves a patient (Age and gender was not reported) who was vaccinated with dose of PENTACEL (batch number, expiry date, route and site of administration were not reported) on an unspecified date. It was actual medication error due to inappropriate reconstitution technique. As the sterile diluent was used to mix the ACTHIB and the components were administered separately. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Eye pruritus, Eyelid oedema, Injection site erythema, Ocular hyperaemia, Pyrexia
Clinical narrative: Pt. had fever up to 102 degree last night. Woke up with red, puffy, itchy eyes. Has a red/pink circle around injection site.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypersensitivity, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Patient states developed local swelling around injection site after vaccination. The next day, he had a rash all down his left arm and in his groin area. It was extremely itchy. It continued to spread to his forehead. He came to the pharmacy Monday and explained what happened. It was reported to Glaxo. Patient was also advised to seek medical attention. He went to a walk in clinic this morning  and was told he had an allergic reaction down his arm and that he had shingles in his groin area. He was given steroids and anti viral medications
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Patient states developed local swelling around injection site after vaccination. The next day, he had a rash all down his left arm and in his groin area. It was extremely itchy. It continued to spread to his forehead. He came to the pharmacy Monday and explained what happened. It was reported to Glaxo. Patient was also advised to seek medical attention. He went to a walk in clinic this morning  and was told he had an allergic reaction down his arm and that he had shingles in his groin area. He was given steroids and anti viral medications