chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Food allergy, Fungal infection, Injection site erythema, Injection site rash, Insomnia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of seizure in a 6-month-old female patient who received PEDIARIX (batch number FF723, expiry date unknown). On 21st November 2013, the patient received the 1st dose of PEDIARIX (intramuscular) .5 ml. On 21st November 2013, less than a day after receiving PEDIARIX, the patient experienced injection site rash and injection site erythema. On 22nd November 2013, the patient experienced crying, fontanel bulging and fever. On 23rd November 2013, the patient experienced weakness, behavior abnormal, communication disorder, difficulty sleeping and yeast infection. On 28th November, the patient experienced diaper rash and eating disorder. On 29th November 2013, the patient experienced seizure (serious criteria GSK medically significant), ear infection, sore throat and diarrhea. On 18th December 2013, the patient experienced restlessness, acne and skin eruption. On 1st March 2016, the patient experienced eczema and food allergy. PEDIARIX was discontinued (Dechallenge was unknown). Rechallange with PEDIARIX was unknown. In November 2014, the outcome of the injection site rash and injection site erythema were recovered/resolved. On an unknown date, the outcome of the seizure, crying, fontanel bulging, weakness, behavior abnormal, communication disorder, difficulty sleeping, yeast infection, diaper rash, eating disorder, ear infection, sore throat, diarrhea, restlessness, acne, skin eruption, eczema, food allergy and fever were unknown. It was unknown if the reporter considered the seizure, injection site rash, injection site erythema, crying, fontanel bulging, weakness, behavior abnormal, communication disorder, difficulty sleeping, yeast infection, diaper rash, eating disorder, ear infection, sore throat, diarrhea, restlessness, acne, skin eruption, eczema, food allergy and fever to be related to PEDIARIX. Additional details were provided as follows: The patient was administered PEDIARIX in the left thigh. On 22nd November 2013, 1 day after receiving vaccination, the patient experienced crying, fontanel bulging and fever and body temperature was recorded as 103 degree. On 23rd November 2013, 2 days after receiving vaccination, the patient experienced weakness, behavior abnormal, communication disorder, difficulty sleeping and yeast infection. On 28th November 2013, 7 days after receiving vaccination, the patient experienced diaper rash and eating disorder. On 29th November 2013, 8 days after receiving vaccination, the patient experienced seizure (serious criteria GSK medically significant), ear infection, sore throat and diarrhea. On 18th December 2013, 27 days after receiving vaccination, the patient experienced restlessness, acne and skin eruption. On 1st March 2016, 831 days after receiving vaccination, the patient experienced eczema and food allergy.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Oropharyngeal pain, Pyrexia, Rash, Restlessness, Seizure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of seizure in a 6-month-old female patient who received PEDIARIX (batch number FF723, expiry date unknown). On 21st November 2013, the patient received the 1st dose of PEDIARIX (intramuscular) .5 ml. On 21st November 2013, less than a day after receiving PEDIARIX, the patient experienced injection site rash and injection site erythema. On 22nd November 2013, the patient experienced crying, fontanel bulging and fever. On 23rd November 2013, the patient experienced weakness, behavior abnormal, communication disorder, difficulty sleeping and yeast infection. On 28th November, the patient experienced diaper rash and eating disorder. On 29th November 2013, the patient experienced seizure (serious criteria GSK medically significant), ear infection, sore throat and diarrhea. On 18th December 2013, the patient experienced restlessness, acne and skin eruption. On 1st March 2016, the patient experienced eczema and food allergy. PEDIARIX was discontinued (Dechallenge was unknown). Rechallange with PEDIARIX was unknown. In November 2014, the outcome of the injection site rash and injection site erythema were recovered/resolved. On an unknown date, the outcome of the seizure, crying, fontanel bulging, weakness, behavior abnormal, communication disorder, difficulty sleeping, yeast infection, diaper rash, eating disorder, ear infection, sore throat, diarrhea, restlessness, acne, skin eruption, eczema, food allergy and fever were unknown. It was unknown if the reporter considered the seizure, injection site rash, injection site erythema, crying, fontanel bulging, weakness, behavior abnormal, communication disorder, difficulty sleeping, yeast infection, diaper rash, eating disorder, ear infection, sore throat, diarrhea, restlessness, acne, skin eruption, eczema, food allergy and fever to be related to PEDIARIX. Additional details were provided as follows: The patient was administered PEDIARIX in the left thigh. On 22nd November 2013, 1 day after receiving vaccination, the patient experienced crying, fontanel bulging and fever and body temperature was recorded as 103 degree. On 23rd November 2013, 2 days after receiving vaccination, the patient experienced weakness, behavior abnormal, communication disorder, difficulty sleeping and yeast infection. On 28th November 2013, 7 days after receiving vaccination, the patient experienced diaper rash and eating disorder. On 29th November 2013, 8 days after receiving vaccination, the patient experienced seizure (serious criteria GSK medically significant), ear infection, sore throat and diarrhea. On 18th December 2013, 27 days after receiving vaccination, the patient experienced restlessness, acne and skin eruption. On 1st March 2016, 831 days after receiving vaccination, the patient experienced eczema and food allergy.
Sex: F
Vaccine: HEP
Symptoms: Culture negative, Laboratory test normal, Myocarditis
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of acute myocarditis in a 8-day-old female patient who received ENGERIX B (batch number 52X7T, expiry date 7th September 2020). In March 2018, the patient received the 1st dose of ENGERIX B. In April 2018, 4 days after receiving ENGERIX B, the patient experienced acute myocarditis (serious criteria hospitalization, GSK medically significant, life threatening and other: as per reporter). The patient was treated with milrinone. On an unknown date, the outcome of the acute myocarditis was recovering/resolving. It was unknown if the reporter considered the acute myocarditis to be related to ENGERIX B. Additional details were provided as follows: The patient received ENGERIX-B on her 4th day of life (March 2018). On 8th day of life (April 2018), the patient was admitted into the hospital for acute myocarditis. The patient required treatment with Milrinone and was admitted into the intensive care unit for 4 days before being discharged. The patient had since recovered and was almost back to 100 percent normal, per the physician. All lab reports, cultures, and testing came back normal, so there was no obvious cause. The reporter was unsure if this was related to the vaccine.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Increased insulin requirement
Clinical narrative: Patient received SHINGRIX vaccine, came in 3 days later, said he felt fine but his insulin requirement had doubled.
Sex: U
Vaccine: FLU4
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by physician via call center representative and described the occurrence of allergic reaction in a patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. The health care professional mentioned that the patient had an allergic reaction to a previous flu vaccine. The health care professional did not provided information about the brand of flu vaccine or any patient information.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX. Concomitant products included Atorvastatin and Paroxetine. On 27th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving. The reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The case was reported by the patient's husband. The patient received the SHINGRIX vaccine last Friday in the left deltoid and experienced pain in her left arm within a few hours after receiving the vaccine. The patient had denied permission to contact their physician.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Shot was extremely painful going in. By that night I had a raging headache. By the next morning my headache was worse. My arm where the shot was administered was extremely painful, very red, swollen and painful to the touch. I was nauseated, had diarrhea, and very fatigued. All these symptoms continued to get worse over the course of 4 days. By the 5th day after the shot, I finally started getting some relief. EXTREMELY concerned about going back in for the follow up injection!!
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Nausea
Clinical narrative: Shot was extremely painful going in. By that night I had a raging headache. By the next morning my headache was worse. My arm where the shot was administered was extremely painful, very red, swollen and painful to the touch. I was nauseated, had diarrhea, and very fatigued. All these symptoms continued to get worse over the course of 4 days. By the 5th day after the shot, I finally started getting some relief. EXTREMELY concerned about going back in for the follow up injection!!
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Swelling, tenderness, blotchy redness at site of Hep B vaccination. Patient complained of a severe headache and malaise. Vaccine was given on Monday, headache symptom lasted through Thursday night. As of Friday morning, swelling and tenderness was starting to subside and redness started to disappear by Thursday morning.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Malaise, Rash macular
Clinical narrative: Swelling, tenderness, blotchy redness at site of Hep B vaccination. Patient complained of a severe headache and malaise. Vaccine was given on Monday, headache symptom lasted through Thursday night. As of Friday morning, swelling and tenderness was starting to subside and redness started to disappear by Thursday morning.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Myalgia, Nausea
Clinical narrative: Severe pain at site of injection, muscle aches, fever, chills, nausea and fatigue.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Severe pain at site of injection, muscle aches, fever, chills, nausea and fatigue.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Slight swelling, reddened area approximately tennis ball sized, tactile warmth, pain. Mom advised to apply cool compress & inform us if it worsenes.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site haemorrhage, Pain, Pyrexia
Clinical narrative: Bleeding at injection, then extensive bruising (contusion) still continuing 11 days since the vaccine was administered. (Reaction to vaccine itself was a bit of aches, pains, slight fever, gone after 24 hours).
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Cough, Headache, Lacrimation increased, Nasal congestion, Nasopharyngitis
Clinical narrative: After an hour of the shot got itchy sore throat. After 8=10 hours "cold" symptoms started. Runny nose, watery eyes, progressed to stuffy nose, light headache, coughing . Symptoms worse at night.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Oropharyngeal pain, Rhinorrhoea, Throat irritation
Clinical narrative: After an hour of the shot got itchy sore throat. After 8=10 hours "cold" symptoms started. Runny nose, watery eyes, progressed to stuffy nose, light headache, coughing . Symptoms worse at night.
Age: 0.33
Sex: F
Vaccine: DTAP, IPV, PPV
Symptoms: Blood test, Haematemesis, Haematochezia, Pyrexia, Red blood cell count
Clinical narrative: Child ran fever day of shots. Two days after shots she vomited blood. I took her to the ER and the said she blood in stool as well. We transferred her to another clinic.
Age: 0.33
Sex: F
Vaccine: DTAP, IPV, PPV
Symptoms: White blood cell count
Clinical narrative: Child ran fever day of shots. Two days after shots she vomited blood. I took her to the ER and the said she blood in stool as well. We transferred her to another clinic.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Extreme nausea.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 19-APR-2018, the patient was inadvertently vaccinated with an expired dose of VAQTA injection (strength, dose and frequency were not reported) (lot # N012324, expiration date: 05-APR-2018) for prophylaxis (expired product administered). No adverse effects were reported. No further information was provided. There was no product quality complaint (PQC) reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1804USA010908:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 19-APR-2018, the patient was inadvertently vaccinated with an expired dose of VAQTA injection (strength, dose and frequency were not reported) (lot # N012324, expiration date: 05-APR-2018) for prophylaxis (expired product administered). No adverse effects were reported. No further information was provided. There was no product quality complaint (PQC) reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1804USA010813:
Sex: U
Vaccine: HEP
Symptoms: Seroconversion test negative, Therapy non-responder
Clinical narrative: This literature report has been received from authors of a published article. This article was performed as urrently, Hepatitis B (HepB) was preventable through vaccination. However the  immunity to HepB among lung transplant candidates at time of evaluation was only 23%, although vaccine response rates among young, healthy individuals are approach 90%. Therefore, the  rapid vaccine series over 21 days was  an attractive alternative to the standard 6 month schedule. Because many lung transplant candidates are immunocompromised, combining the high dose vaccine option (for the immunocompromised) with the rapid schedule was a logical strategy to achieve HepB immunity prior to transplantation. This report refers to 13 patient's of unknown age and gender candidates to lung transplant. No pertinent medical history, drug reactions, allergies or concomitant therapies were provided. Referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, known allergies and concomitant medications was not provided. The purpose of this study was that there is growing use of increased risk donor organs that convey a higher risk of donor transmission of Hepatitis B, Hepatitis C, and HIV. Unknown dates, the patients were vaccinated on days 0, 7 and 21 with hepatitis b vaccine (manufacturer unknown) with a dose of 40 mcg (20mcg/1mL in each deltoid) for prophylaxis ( route, lot number and expiration date were not reported). Then, serologic testing to check immunity was performed at least 6 weeks after completion of the series. If patients did not develop immunity to HepB, the rapid/high dose series was administered a second time. This 13 patients failed to seroconvert after the second series and were considered non-responder and no further action was taken, the vaccine was safe and well tolerated. This non-responder patients tended to be older, male and on immunosuppresive medication. At the time of the report, the outcome of the adverse event was unknown. The reporter considered therapy non-responder to be related to Hepatitis B Vaccine (Recombinant) (manufacturer unknown).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant (also reported as nurse prescriber) referring to a currently 4 year old patient of unknown gender. The patient's medical history, concurrent conditions or concomitant medication were not informed. On an unknown date, the patient was vaccinated with a dose of PROQUAD lot # N025929, expiration date 18-MAR-2019, subcutaneously, for prophylaxis (dosage information was not informed), following a temperature excursion. No adverse effects were reported. It was also informed that the temperature was -10.97C, time frame 35 minutes, There was no previous temperature excursion. A "data logger" was involved. This one of two cases from the same reporter.; Sender's Comments:  US-009507513-1805USA001822:
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from an office manager referring to a 13 month old male patient. The patient's medical history or concurrent conditions were not reported. On 02-MAY-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot number N021720, expiration date 10-AUG-2019, for prophylaxis) (dosage information, route and site of administration were not informed). Concomitant therapies included Merck sterile diluent. It was also reported that the temperature/time frame was: 14 degrees C to -10 degrees C ( -12 degrees C ) for 45 minutes. Temperature/Time frame : -9 degrees C to 8 degrees C ( - 6 degrees C ) for 1 hour. There was no previous temperature excursion. A "data logger" was involved.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant (also reported as nurse prescriber) referring to a currently 4 year old patient of unknown gender. The patient's medical history, concurrent conditions or concomitant medication were not informed. On an unknown date, the patient was vaccinated with a dose of PROQUAD (lot # N025929, expiration date 18-MAR-2019, subcutaneously), for prophylaxis (dosage information was not informed), following a temperature excursion. No adverse effects were reported. It was also informed that the temperature was -10.97C, time frame 35 minutes, There was no previous temperature excursion. A "data logger" was involved. This one of two cases from the same reporter. Sender's Comments: US-009507513-1805USA001406.
Age: 28.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Initial unsolicited report received from pharmacist on 26-Apr-2018. This case involves 28 years old female patient who was vaccinated with 0.5 ml one dosage form of ADACEL (batch number, expiry date was not reported) intramuscularly in right deltoid on 25 Apr 2018. The patient's medical history and concomitant medication were not reported. On 25 Apr 2018, by the evening time; same day following the vaccination, the patient had a hard bump the size of a half dollar at the injection site. The area was itchy, red, warm, and tender to touch. The pt was C/O a sore arm. Laboratory investigation and corrective treatment were not reported. Patient was not recovered from event. List of documents held by sender: none. Sender's Comments: This case concerns an adult patient who developed paresthesia of limbs, fatigue and throat irritation after vaccination with FLUQUADRI. The time to onset is compatible with the role of vaccine. However, there is no information provided regarding patient's past history, medical condition at the time of vaccination and lab tests ruling out alternate etiologies, particularly infectious. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 28.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Injection site warmth, Pain in extremity
Clinical narrative: Initial unsolicited report received from pharmacist on 26-Apr-2018. This case involves 28 years old female patient who was vaccinated with 0.5 ml one dosage form of ADACEL (batch number, expiry date was not reported) intramuscularly in right deltoid on 25 Apr 2018. The patient's medical history and concomitant medication were not reported. On 25 Apr 2018, by the evening time; same day following the vaccination, the patient had a hard bump the size of a half dollar at the injection site. The area was itchy, red, warm, and tender to touch. The pt was C/O a sore arm. Laboratory investigation and corrective treatment were not reported. Patient was not recovered from event. List of documents held by sender: none. Sender's Comments: This case concerns an adult patient who developed paresthesia of limbs, fatigue and throat irritation after vaccination with FLUQUADRI. The time to onset is compatible with the role of vaccine. However, there is no information provided regarding patient's past history, medical condition at the time of vaccination and lab tests ruling out alternate etiologies, particularly infectious. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 23.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Feeling abnormal, Product quality issue, Vertigo
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of dizziness in a 23-year-old female patient who received HAVRIX (batch number TB995, expiry date 25th October 2020). On 20th April 2018 09:30, the patient received HAVRIX 1 ml. On 20th April 2018, less than a day after receiving HAVRIX, the patient experienced dizziness and feeling abnormal. On an unknown date, the patient experienced pharmaceutical product complaint. In April 2018, the outcome of the dizziness and feeling abnormal were recovered/resolved. On an unknown date, the outcome of the pharmaceutical product complaint was unknown. The reporter considered the dizziness and feeling abnormal to be related to HAVRIX. Additional details were provided as follows: Concomitant medications included birth control pill. After receiving the vaccine, the patient became dizzy but did not pass out. The patient also experienced a significant head rush. The reporter insisted that the adverse event experienced was related to the lot of the HAVRIX product and insisted that a quality assurance (QA) report be filed. The reporter related QA reported to quality.
Age: 94.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of extensive swelling of vaccinated limb in a elderly female patient who received SHINGRIX. On 13th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, erythema and pruritus. On an unknown date, the outcome of the extensive swelling of vaccinated limb, erythema and pruritus were not recovered/not resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, erythema and pruritus to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced raised redness, swelling around the entire arm located 1 inch below the injection site and itching. These symptoms persisted at the time of reporting. The reporter agreed to be followed up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Fatigue, Headache, Induration
Clinical narrative: This case was reported by a physician via out of hour services and described the occurrence of pain in a 56-year-old female patient who received SHINGIRX. Concurrent medical conditions included connective tissue disorder. On 30th March 2018, the patient received the 1st dose of SHINGRIX. In March 2018, 1 day after receiving SHINGRIX, the patient experienced tenderness. On 31st March 2018, the patient experienced pain, erythema of extremities, joint pain and induration. On an unknown date, the patient experienced swelling, fatigue and headache. The patient was treated with prednisone (oral). On an unknown date, the outcome of the pain, swelling, fatigue, headache and tenderness were recovered/resolved and the outcome of the erythema of extremities, joint pain and induration were unknown. It was unknown if the reporter considered the pain, swelling, fatigue, erythema of extremities, headache, joint pain, induration and tenderness to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient and also a medical doctor. The age at vaccination was not reported. The patient received SHINGRIX on left arm. The patient woke up with severe joint pain and redness on her arm. Also, there was hard spot 6cm in diameter on her arm that was tender and there was redness around it but it was not fluctuant. The redness was not tender. Less than a month after receiving SHINGRIX, the patient also experienced headache and fatigue. The patient had a history of mixed connective tissue disease and the reaction felt like a major flare of this. Less than a month after receiving SHINGRIX, the patient's reaction looked like a local inflammatory response on her arm, but there were a lot of aches and pains elsewhere. The patient started taking Prednisone 10 mg per day and then began to wean it. It took a week for the redness and swelling to go away. She called back GlaxoSmithKline after receiving a voice mail with request to please callback from GlaxoSmithKline. She could not remember the exact day or time she left her original voicemail with GlaxoSmithKline. She was not watchin but thinks the product was administered intramuscularly into her left upper arm at the pharmacy. She was calling back GlaxoSmithKline to inquire whether or not she should continue with the vaccine series. She was transferred to medical information team regarding her current inquiry. Clarification has been raised for the confirmation of event local inflammatory response whether it was experienced by the patient after vaccination or not.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Swelling, Tenderness
Clinical narrative: This case was reported by a physician via out of hour services and described the occurrence of pain in a 56-year-old female patient who received SHINGIRX. Concurrent medical conditions included connective tissue disorder. On 30th March 2018, the patient received the 1st dose of SHINGRIX. In March 2018, 1 day after receiving SHINGRIX, the patient experienced tenderness. On 31st March 2018, the patient experienced pain, erythema of extremities, joint pain and induration. On an unknown date, the patient experienced swelling, fatigue and headache. The patient was treated with prednisone (oral). On an unknown date, the outcome of the pain, swelling, fatigue, headache and tenderness were recovered/resolved and the outcome of the erythema of extremities, joint pain and induration were unknown. It was unknown if the reporter considered the pain, swelling, fatigue, erythema of extremities, headache, joint pain, induration and tenderness to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient and also a medical doctor. The age at vaccination was not reported. The patient received SHINGRIX on left arm. The patient woke up with severe joint pain and redness on her arm. Also, there was hard spot 6cm in diameter on her arm that was tender and there was redness around it but it was not fluctuant. The redness was not tender. Less than a month after receiving SHINGRIX, the patient also experienced headache and fatigue. The patient had a history of mixed connective tissue disease and the reaction felt like a major flare of this. Less than a month after receiving SHINGRIX, the patient's reaction looked like a local inflammatory response on her arm, but there were a lot of aches and pains elsewhere. The patient started taking Prednisone 10 mg per day and then began to wean it. It took a week for the redness and swelling to go away. She called back GlaxoSmithKline after receiving a voice mail with request to please callback from GlaxoSmithKline. She could not remember the exact day or time she left her original voicemail with GlaxoSmithKline. She was not watchin but thinks the product was administered intramuscularly into her left upper arm at the pharmacy. She was calling back GlaxoSmithKline to inquire whether or not she should continue with the vaccine series. She was transferred to medical information team regarding her current inquiry. Clarification has been raised for the confirmation of event local inflammatory response whether it was experienced by the patient after vaccination or not.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Injected limb mobility decreased, Injection site inflammation, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 64-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020). On 12th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced shingles, pruritus, skin scaly, injection limb mobility decreased, red face, pain and injection site inflammation. The patient was treated with VALTREX. In April 2018, the outcome of the injected limb mobility decreased and injection site inflammation were recovered/resolved. On an unknown date, the outcome of the shingles, pruritus, skin scaly, red face and pain were unknown. The reporter considered the shingles, pruritus, skin scaly, injected limb mobility decreased, red face, pain and injection site inflammation to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. At 15:40, the patient received SHINGRIX vaccine on left arm. The patient experienced shingles on the left side of her face, mostly on the left side of her forehead. On 26th April 2018, the patient went into the pharmacy and stated that it was improving. The reporter described the patient's face looked scaly and red. The patient experienced pain and itching that was so bad that she wanted to scratch her whole face off. Less than a month after receiving SHINGRIX, the patient experienced inflammation at the injection site and she was unable to move her arm for two to three days. The patient went to her physician and was prescribed VALTREX.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin exfoliation
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 64-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020). On 12th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced shingles, pruritus, skin scaly, injection limb mobility decreased, red face, pain and injection site inflammation. The patient was treated with VALTREX. In April 2018, the outcome of the injected limb mobility decreased and injection site inflammation were recovered/resolved. On an unknown date, the outcome of the shingles, pruritus, skin scaly, red face and pain were unknown. The reporter considered the shingles, pruritus, skin scaly, injected limb mobility decreased, red face, pain and injection site inflammation to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. At 15:40, the patient received SHINGRIX vaccine on left arm. The patient experienced shingles on the left side of her face, mostly on the left side of her forehead. On 26th April 2018, the patient went into the pharmacy and stated that it was improving. The reporter described the patient's face looked scaly and red. The patient experienced pain and itching that was so bad that she wanted to scratch her whole face off. Less than a month after receiving SHINGRIX, the patient experienced inflammation at the injection site and she was unable to move her arm for two to three days. The patient went to her physician and was prescribed VALTREX.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 65-year-old male patient who received SHINGRIX (batch number 49ST9, expiry date 4th July 2020). On 22nd April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. The patient was treated with medication unknown (Ice Pack (NOS)). On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown. The reporter considered the injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: At 15:28, the patient received SHIGNRIX in left deltoid. The following morning the patient woke up with redness, swelling, and an red patch at the injection site. The healthcare professional instructed the patient to apply ice and call her if events had not improved. The healthcare professional had not heard back from the patient since.
Sex: U
Vaccine: HEPA, HPV2, MENB
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site swelling in a patient who received BEXSERO. Concomitant products included HPV vaccine and Hepatitis A vaccine. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was unknown. It was unknown if the reporter considered the injection site swelling to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The shot was done concomitantly with HPV and Hepatitis A vaccines at the same day. A patient had swelling in the site of administration.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Cough, Influenza virus test negative, Musculoskeletal chest pain, Productive cough, Pyrexia
Clinical narrative: Started with a cough on April 22nd, increasingly got worse. By April 25th high fever of 101.5 went to Urgent Care received an antibiotic Levofloxacin 500mg and Mucinex Expectorant. Ran a low grade fever for 4 days, cough increased, ribs hurt, wheezing with each inhale and exhale. I am not the type of person who thinks you get sick from shots. I get the flu shot every year. However I do think it is strange that I have never had an upper respiratory illness before in my life. Today is May 4th, no longer have fever, still coughing and bringing up mucus but feel better.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Wheezing
Clinical narrative: Started with a cough on April 22nd, increasingly got worse. By April 25th high fever of 101.5 went to Urgent Care received an antibiotic Levofloxacin 500mg and Mucinex Expectorant. Ran a low grade fever for 4 days, cough increased, ribs hurt, wheezing with each inhale and exhale. I am not the type of person who thinks you get sick from shots. I get the flu shot every year. However I do think it is strange that I have never had an upper respiratory illness before in my life. Today is May 4th, no longer have fever, still coughing and bringing up mucus but feel better.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Hyperaesthesia, Nausea, Pain
Clinical narrative: Fever, chills, headache, body aches, skin very sensitive, nausea. Naturally my digital thermometer battery had died.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, chills, headache, body aches, skin very sensitive, nausea. Naturally my digital thermometer battery had died.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This 12 mo old patient received an adult dose of HAVRIX on Tuesday, May 1st.  No reaction noted or stated.  I called mom on May 4th to follow-up, and she said there were no issues (mom was informed same day the Hep A was given about this dose).
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Feeling of body temperature change, Headache, Injection site pain
Clinical narrative: Patient claims she had nausea, headache, dizziness, almost fainted, was hot and cold, tiredness, and soreness at site of injection
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Presyncope
Clinical narrative: Patient claims she had nausea, headache, dizziness, almost fainted, was hot and cold, tiredness, and soreness at site of injection
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Pyrexia, Rash erythematous
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020). Concurrent medical conditions included blood pressure abnormal, blood cholesterol abnormal and diabetes. Concomitant products included Water Pill. On 12th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 12th April 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. In April 2018, the patient experienced fever, erythematous rash and injection site erythema. In April 2018, the outcome of the injection site pain and fever were recovered/resolved and the outcome of the erythematous rash and injection site erythema were not recovered/not resolved. The reporter considered the injection site pain, fever, erythematous rash and injection site erythema to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient was taking concomitant medication for blood pressure, cholesterol and diabetes. The pharmacist who administered the injection called and reported the patient experienced pain and soreness immediately after the injection in the right upper arm. In April 2018, less than a month after vaccination, the patient experienced a red rash that travelled up the arm to the shoulder and a mild fever after the injection. The pharmacist stated that, at the time of reporting, all symptoms had resolved except there was still slight redness at the injection site. No additional information was available at the time of the call. The reporter gave permission to contact her and would like to receive follow-up in related to this adverse event. This case was linked to case US2018071879, as reported by same reporter.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of swelling arm in a 19-year-old female patient who received BEXSERO (batch number 166201, expiry date October 2018). On 29th March 2018, the patient received the 1st dose of BEXSERO. On 29th March 2018, unknown after receiving BEXSERO, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. Additional details were provided as follows: The age at vaccination was not reported. The patient received BEXSERO subcutaneously instead of intramuscular route, which led to inappropriate route of vaccine administration. No side effects were reported. Follow up information received from other health professional via call center representative on 25th April 2018: The patients demographic details were updated. The patient received BEXSERO on an unknown arm. On an unknown date, in less than a month after receiving BEXSERO, the patient experienced injection site swelling and injection site redness. On an unknown date, the outcome of the injection site swelling and injection site redness were unknown. It was unknown if the reporter considered the injection site swelling and injection site redness to be related to BEXSERO. This was the medication error associated with harm. The VAERS details were updated.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Dyspepsia, Myalgia, Paraesthesia
Clinical narrative: Fever, chills, myalgia, heart burn, emesis, dizziness, rash on arms, prickly feeling on palms and soles of feet.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Fever, chills, myalgia, heart burn, emesis, dizziness, rash on arms, prickly feeling on palms and soles of feet.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Condition aggravated, Electrocardiogram ambulatory abnormal, Ventricular extrasystoles
Clinical narrative: One episode of AFib in May 2016, followed by another episode in May 2017. The SHINGRIX vaccine may have caused a flare up of AFib and PVC. Patient was hospitalized for AFib on April 27th 2018 and had another severe AFib on April 30th 2018 and was transported by ambulance and hospitalized at another hospital. She has had almost continual PVC since April 27th and physician doesn't know how to stop the PVC. She is wearing a Holter monitor and the cardiac nurse reports that she is having continual, small AFibs.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Full blood count normal, Induration, Pain in extremity
Clinical narrative: Patient is presenting a cellulitis in the left arm. The arm is red, hot and  has a type of encapsulation (hard part). The same day she received the vaccine presented fever and pain in the arm. She used acetaminophen and started tacking Augmentin 875 mg every 12 hours.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Skin warm, White blood cell count normal
Clinical narrative: Patient is presenting a cellulitis in the left arm. The arm is red, hot and  has a type of encapsulation (hard part). The same day she received the vaccine presented fever and pain in the arm. She used acetaminophen and started tacking Augmentin 875 mg every 12 hours.
Age: 66.0
Sex: F
Vaccine: TD
Symptoms: Injection site induration, Injection site pain, Lymphadenopathy
Clinical narrative: Swollen right supraclavicular lymph nodes, pain at injection site, 30mm induration, no erythema.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary mass, Chills, Erythema, Fatigue, Headache
Clinical narrative: Shivering and sweaty all night the first night. Headache for 3 days, muscle aches 3 days, nausea, and fatigue for 2 days, muscle/nerve prickles and twitches 1 day, lump on arm that was very tender, red, and hot to the touch for 5 days. Swelling in armpit with a large lump in the armpit began on day 3 and is subsiding on day 5.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Limb mass, Muscle twitching, Myalgia, Nausea
Clinical narrative: Shivering and sweaty all night the first night. Headache for 3 days, muscle aches 3 days, nausea, and fatigue for 2 days, muscle/nerve prickles and twitches 1 day, lump on arm that was very tender, red, and hot to the touch for 5 days. Swelling in armpit with a large lump in the armpit began on day 3 and is subsiding on day 5.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Skin warm, Tenderness
Clinical narrative: Shivering and sweaty all night the first night. Headache for 3 days, muscle aches 3 days, nausea, and fatigue for 2 days, muscle/nerve prickles and twitches 1 day, lump on arm that was very tender, red, and hot to the touch for 5 days. Swelling in armpit with a large lump in the armpit began on day 3 and is subsiding on day 5.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Oedema peripheral, Pain, Pyrexia, Rash
Clinical narrative: Patient reported to our clinic after receiving the SHINGRIX vaccine at an alternate site. On 2nd day after SHINGRIX vaccine, patient reported rash/swelling, fever and body aches. Rash/swelling continued for two weeks with rash growing to entire vaccinated arm between the elbow and axilla.  Entire axillary are was swollen. Initial symptoms passed after about 2+ weeks, but still has swelling to the posterior axillary which is troublesome.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling
Clinical narrative: Patient reported to our clinic after receiving the SHINGRIX vaccine at an alternate site. On 2nd day after SHINGRIX vaccine, patient reported rash/swelling, fever and body aches. Rash/swelling continued for two weeks with rash growing to entire vaccinated arm between the elbow and axilla.  Entire axillary are was swollen. Initial symptoms passed after about 2+ weeks, but still has swelling to the posterior axillary which is troublesome.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site warmth, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Patient reported to our clinic after receiving the SHINGRIX vaccine at an alternate site. On 2nd day after SHINGRIX vaccine, patient reported rash/swelling, fever and body aches. Rash/swelling continued for two weeks with rash growing to entire vaccinated arm between the elbow and axilla.  Entire axillary are was swollen. Initial symptoms passed after about 2+ weeks, but still has swelling to the posterior axillary which is troublesome.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Swelling
Clinical narrative: Patient reported to our clinic after receiving the SHINGRIX vaccine at an alternate site. On 2nd day after SHINGRIX vaccine, patient reported rash/swelling, fever and body aches. Rash/swelling continued for two weeks with rash growing to entire vaccinated arm between the elbow and axilla.  Entire axillary are was swollen. Initial symptoms passed after about 2+ weeks, but still has swelling to the posterior axillary which is troublesome.