chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: White blood cell count decreased
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of lethargy in a 63-year-old male patient who received Flu Seasonal TIV Dresden (Flu trivalent vaccine) for prophylaxis. The patient's past medical history included allergic to dogs. Previously administered products included Flu vaccine with an associated reaction of adverse reaction (received In 1971, and had a reaction to an unknown influenza vaccine which required hospitalization for two days). Additional patient notes included none. On 10th August 2010, the patient received Flu trivalent vaccine. On 10th August 2010, less than a day after receiving Flu trivalent vaccine, the patient experienced lethargy, weakness, decreased white cell count and liver function test abnormal. Flu trivalent vaccine was discontinued. On an unknown date, the outcome of the lethargy, weakness, decreased white cell count and liver function test abnormal were recovered/resolved. It was unknown if the reporter considered the lethargy, weakness, decreased white cell count and liver function test abnormal to be related to Flu trivalent vaccine. Additional details were reported as follows: This case was reported by the patient who himself was a physician. The age at vaccination was not reported, however it could be 62 or 63. On 10th August 2010, the patient experienced lethargy and weakness. The patient had blood work two days after the Flu trivalent vaccine, and his AST (aspartate aminotransferase) levels were 38 and his ALT (alanine aminotransferase) was at 72. The patient's WBC (white blood cells) was down to 2.3. The patient had recovered and did not have a flu shot since.
Age: 63.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Hepatic enzyme increased, White blood cell count decreased
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of lethargy in a 63-year-old male patient who received Flu Seasonal TIV Dresden (Flu trivalent vaccine) for prophylaxis. The patient's past medical history included allergic to dogs. Previously administered products included Flu vaccine with an associated reaction of adverse reaction (received In 1971, and had a reaction to an unknown influenza vaccine which required hospitalization for two days). Additional patient notes included none. On 10th August 2010, the patient received Flu trivalent vaccine. On 10th August 2010, less than a day after receiving Flu trivalent vaccine, the patient experienced lethargy, weakness, decreased white cell count and liver function test abnormal. Flu trivalent vaccine was discontinued. On an unknown date, the outcome of the lethargy, weakness, decreased white cell count and liver function test abnormal were recovered/resolved. It was unknown if the reporter considered the lethargy, weakness, decreased white cell count and liver function test abnormal to be related to Flu trivalent vaccine. Additional details were reported as follows: This case was reported by the patient who himself was a physician. The age at vaccination was not reported, however it could be 62 or 63. On 10th August 2010, the patient experienced lethargy and weakness. The patient had blood work two days after the Flu trivalent vaccine, and his AST (aspartate aminotransferase) levels were 38 and his ALT (alanine aminotransferase) was at 72. The patient's WBC (white blood cells) was down to 2.3. The patient had recovered and did not have a flu shot since.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Headache, Impaired work ability, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received on 30th June 2018, refer linked case US2018GSK209685). On 7th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 8th November 2018, 1 days after receiving SHINGRIX, the patient experienced inability to work. In November 2018, the patient experienced injection site pain, headache, fever, shivering, sleeplessness and nasopharyngitis. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the headache, fever, shivering, sleeplessness, nasopharyngitis and inability to work were recovered/resolved. It was unknown if the reporter considered the injection site pain, headache, fever, shivering, sleeplessness, nasopharyngitis and inability to work to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right arm. The patient experienced soreness at the injection site, headache, fever, and shivered all night. The patient said that she slept very little because she was cold and could not get warm. After receiving SHINGRIX, the patient missed work the next day. The patient's arm was still slightly sore however, all other symptoms resolved within 24 hours. The reporter gave permission for her physician to be contacted. The reporter was unable to provide additional information.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Nasopharyngitis, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received on 30th June 2018, refer linked case US2018GSK209685). On 7th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 8th November 2018, 1 days after receiving SHINGRIX, the patient experienced inability to work. In November 2018, the patient experienced injection site pain, headache, fever, shivering, sleeplessness and nasopharyngitis. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the headache, fever, shivering, sleeplessness, nasopharyngitis and inability to work were recovered/resolved. It was unknown if the reporter considered the injection site pain, headache, fever, shivering, sleeplessness, nasopharyngitis and inability to work to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right arm. The patient experienced soreness at the injection site, headache, fever, and shivered all night. The patient said that she slept very little because she was cold and could not get warm. After receiving SHINGRIX, the patient missed work the next day. The patient's arm was still slightly sore however, all other symptoms resolved within 24 hours. The reporter gave permission for her physician to be contacted. The reporter was unable to provide additional information.
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fatigue in a female patient who received BEXSERO (batch number ABX682AA, expiry date unknown) for prophylaxis. On 31st October 2018, the patient received BEXSERO. On an unknown date, less than a month after receiving BEXSERO, the patient experienced fatigue, headache, muscle pain, joint pain and nausea. On an unknown date, the outcome of the fatigue, headache, muscle pain, joint pain and nausea were not recovered/not resolved. It was unknown if the reporter considered the fatigue, headache, muscle pain, joint pain and nausea to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The patient was given Men B vaccine at their college. Still at the time of reporting, the patient has fatigue, headache, muscle pain, joint pain, and nausea. The healthcare professional (HCP) did not want to provide any additional information since their facility did not give the vaccine to this patient. The HCP gave consent to follow up.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Neuralgia, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 82-year-old male patient who received SHINGRIX for prophylaxis. On 11th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In September 2018, less than a month after receiving SHINGRIX, the patient experienced injection site pain, fever and neuropathic pain. In September 2018, the outcome of the injection site pain and fever were recovered/resolved. On an unknown date, the outcome of the neuropathic pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain, fever and neuropathic pain to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the physician for himself. After the dose of SHINGRIX the patient had some minimal soreness at the injection site and might be a mild fever. About 2 weeks after the injection he developed neuropathic pain in his mid abdomen that did not cross the midline and went around towards his back. It hurted when pressed, but otherwise did not bother him. The patient had not experienced any rash, but the pain was similar to shingles. The patient had consented to follow up.
Sex: F
Vaccine: FLUX
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in a female patient who received Flu vaccine for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Flu vaccine. Additional information was reported as follows: The age at vaccination was not reported. The patient had an adverse reaction (unspecified) to a unspecified flu vaccine in the past. The reporter did not know which flu vaccine it was. No further information was obtained from the healthcare professional.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received SHINGRIX (batch number L9CS4, expiry date 22nd February 2021) for prophylaxis. On 12th November 2018, the patient received the 2nd dose of SHINGRIX (subcutaneous). On 12th November 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. In November 2018, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site erythema and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient was given the 2nd dose of the SHINGRIX series subcutaneously, which led to inappropriate route of vaccination. The patient experienced soreness at the injection site, pain, and redness. The reporter gave consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Hepatic enzyme increased
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of elevated liver enzymes in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 7 days after receiving SHINGRIX, the patient experienced elevated liver enzymes. On an unknown date, the outcome of the elevated liver enzymes was recovering/resolving. It was unknown if the reporter considered the elevated liver enzymes to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The batch number and expiry date was not unknown. The patient had elevated liver enzymes approximately 1 week after dose 1 of SHINGRIX. Repeat test was ordered since that time. Enzymes had come down, but unsure if back to normal. The reporter gave consent to follow up. Lab Comments: Lab test was done on an unknown date.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 48-year-old male patient who received FLULAVAL QUADRIVALENT 2018-2019 season) (batch number H79Z3, expiry date 12th June 2019) for prophylaxis. Concurrent medical conditions included glenoid labral tear. On 5th November 2018, the patient received the 1st dose of FLULAVAL QUADRIVALENT 2018-2019 season (intramuscular). On 6th November 2018, 1 days after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional information received as follows: The physician reported the case for himself. The patient received FLULAVAL QUADRIVALENT 2018-2019 season on the left deltoid. The patient experienced difficulty in raising arm. The batch number reported for FLULAVAL QUADRIVALENT 2018-2019 season (H7923), did not exist and was updated to H79Z3, as per sales database. The reporter gave consent to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex, Rash
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of herpes simplex in a 63-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. On 28th September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced herpes simplex and rash. On an unknown date, the outcome of the herpes simplex and rash were unknown. It was unknown if the reporter considered the herpes simplex and rash to be related to SHINGRIX. Additional details were reported as follows: The healthcare professional stated that their patient developed a rash after SHINGRIX. They confirmed shingles at an urgent care facility, however when the patient went to saw their primary care doctor they stated that it was not Shingles. The healthcare professional stated it was an HSV1 rash.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Chills, Erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (received on unknown date (refer case: US2018208921). On 6th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 6th November 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, general body pain, fever, stomach pain, weakness, joint pain and chills. In November 2018, the patient experienced injection site erythema, injection site pain and rash. On 15th November 2018, the patient experienced feeling of warmth facial and red face. In November 2018, the outcome of the injection site erythema and injection site pain were recovered/resolved. On 16th November 2018, the outcome of the feeling of warmth facial and red face were recovered/resolved. On an unknown date, the outcome of the influenza-like symptoms, general body pain, fever, stomach pain, weakness, joint pain and chills were recovered/resolved and the outcome of the rash was unknown. It was unknown if the reporter considered the injection site erythema, injection site pain, influenza-like symptoms, general body pain, fever, stomach pain, weakness, joint pain, chills, feeling of warmth facial, red face and rash to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX in right deltoid. The patient woke up that night with chills which again turned into flu-like symptoms that included body aches, fever, stomach ache, weakness and all joints hurting. These events resolved within 1.5 days. The patient was presented with injection site pain, redness and soreness that lasted approximately three days. The day before reporting, the patient woke up with her face very hot and red. She stated that her face looked like it was sunburned. The patient did not consent to follow up. The reporter did not want her physician to be contacted and indicated that she herself was a pharmacist. The patient had the SHINGRIX vaccine a week ago and had adverse effects for 2 days. At the time of reporting, the patient had rash on face. This case was linked with case US2018208921, reported by the same reporter for the same patient.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Influenza like illness, Injection site erythema, Injection site pain, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (received on unknown date (refer case: US2018208921). On 6th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 6th November 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, general body pain, fever, stomach pain, weakness, joint pain and chills. In November 2018, the patient experienced injection site erythema, injection site pain and rash. On 15th November 2018, the patient experienced feeling of warmth facial and red face. In November 2018, the outcome of the injection site erythema and injection site pain were recovered/resolved. On 16th November 2018, the outcome of the feeling of warmth facial and red face were recovered/resolved. On an unknown date, the outcome of the influenza-like symptoms, general body pain, fever, stomach pain, weakness, joint pain and chills were recovered/resolved and the outcome of the rash was unknown. It was unknown if the reporter considered the injection site erythema, injection site pain, influenza-like symptoms, general body pain, fever, stomach pain, weakness, joint pain, chills, feeling of warmth facial, red face and rash to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX in right deltoid. The patient woke up that night with chills which again turned into flu-like symptoms that included body aches, fever, stomach ache, weakness and all joints hurting. These events resolved within 1.5 days. The patient was presented with injection site pain, redness and soreness that lasted approximately three days. The day before reporting, the patient woke up with her face very hot and red. She stated that her face looked like it was sunburned. The patient did not consent to follow up. The reporter did not want her physician to be contacted and indicated that she herself was a pharmacist. The patient had the SHINGRIX vaccine a week ago and had adverse effects for 2 days. At the time of reporting, the patient had rash on face. This case was linked with case US2018208921, reported by the same reporter for the same patient.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (received on unknown date (refer case: US2018208921). On 6th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 6th November 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, general body pain, fever, stomach pain, weakness, joint pain and chills. In November 2018, the patient experienced injection site erythema, injection site pain and rash. On 15th November 2018, the patient experienced feeling of warmth facial and red face. In November 2018, the outcome of the injection site erythema and injection site pain were recovered/resolved. On 16th November 2018, the outcome of the feeling of warmth facial and red face were recovered/resolved. On an unknown date, the outcome of the influenza-like symptoms, general body pain, fever, stomach pain, weakness, joint pain and chills were recovered/resolved and the outcome of the rash was unknown. It was unknown if the reporter considered the injection site erythema, injection site pain, influenza-like symptoms, general body pain, fever, stomach pain, weakness, joint pain, chills, feeling of warmth facial, red face and rash to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX in right deltoid. The patient woke up that night with chills which again turned into flu-like symptoms that included body aches, fever, stomach ache, weakness and all joints hurting. These events resolved within 1.5 days. The patient was presented with injection site pain, redness and soreness that lasted approximately three days. The day before reporting, the patient woke up with her face very hot and red. She stated that her face looked like it was sunburned. The patient did not consent to follow up. The reporter did not want her physician to be contacted and indicated that she herself was a pharmacist. The patient had the SHINGRIX vaccine a week ago and had adverse effects for 2 days. At the time of reporting, the patient had rash on face. This case was linked with case US2018208921, reported by the same reporter for the same patient.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 50-year-old female patient who received SHINGRIX (batch number D294J, expiry date 22nd March 2021) for prophylaxis. On 14th November 2018, the patient received SHINGRIX. On 15th November 2018, 1 days after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were not recovered/not resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX vaccine on left deltoid and experienced redness and swelling at the injection site the next day. On the day of reporting, the area of the redness and swelling is about 4 inches in diameter.
Sex: F
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shingles in a adult female patient who received SHINGRIX for prophylaxis. Co-suspect products included dTpa vaccine for prophylaxis and PREVENAR for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX, dTpa vaccine and PREVENAR. On an unknown date, 2 days after receiving SHINGRIX and dTpa vaccine, the patient experienced shingles. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX and dTpa vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX, along with PREVNAR, and a TdaP vaccine. The patient broke out in shingles. The patient was given Acyclovir and symptoms resolved within 72 hours. The patient then had recurrent shingles and given acyclovir once more and again resolved within 72 hours. The vaccines were administered at a pharmacy, so healthcare professional had no information on the vaccines.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site nodule, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 72-year-old male patient who received SHINGRIX for prophylaxis. On 19th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In November 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm and injection site lump. On 19th November 2018, the patient experienced fever. On 20th November 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the pain in arm and injection site lump were unknown. It was unknown if the reporter considered the fever, pain in arm and injection site lump to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left arm. The reporter was a patient who received SHINGRIX and experienced low grade fever of 100.5 degrees F that resolved within 24 hours. The patient was experiencing sore arm and small knot at the injection site.
Sex: U
Vaccine: MENB, MNQ
Symptoms: Meningitis meningococcal, Vaccination failure
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a patient who received BEXSERO for prophylaxis. Co-suspect products included BEXSERO for prophylaxis, MENVEO for prophylaxis and MENVEO for prophylaxis. On 6th July 2016, the patient received the 1st dose of BEXSERO. On 6th September 2016, the patient received the 2nd dose of BEXSERO. On an unknown date, the patient received the 1st dose of MENVEO. On 6th July 2016, the patient received the 2nd dose of MENVEO. On 19th November 2018, 2 years and 136 days after receiving BEXSERO and MENVEO, 2 years and 74 days after receiving BEXSERO and unknown after receiving MENVEO, the patient experienced vaccination failure (serious criteria GSK medically significant) and meningococcal meningitis (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the vaccination failure and meningococcal meningitis were unknown. It was unknown if the reporter considered the vaccination failure and meningococcal meningitis to be related to BEXSERO, BEXSERO, MENVEO and MENVEO. Additional details were received as follows: The age at vaccination was not reported. On 19 November 2018, the patient was hospitalized for bacterial meningococcal meningitis. At the time of reporting patient was in the hospitalized. The reporter did not consent to follow up. No further details were provided. Field representative would follow up with the primary reporter. This case was advised by medical affairs lead to report this event.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Lower respiratory tract infection, Pneumonia, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pneumonia in a 63-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Concurrent medical conditions included back disorder and bladder cancer. On 17th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pneumonia (serious criteria GSK medically significant), chest infection (serious criteria GSK medically significant) and product supply issue. On an unknown date, the outcome of the pneumonia was recovered/resolved and the outcome of the chest infection was not recovered/not resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the pneumonia and chest infection to be related to SHINGRIX. Additional information received as follows: Three months before reporting date, the patient experienced pneumonia for which he was treated and has resolved. Approximately one month before reporting date, he was diagnosed with a chest infection outside of his lungs for which he was currently being treated and it had not resolved. The patient had been unable to find second dose of SHINGRIX and was now outside of 6 month window for second dose. The reporter gave consent to follow up. The contact details of the physician were provided.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Day after injection area became hot and red - moving down arm.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Axillary pain, Chills, Erythema, Headache, Mobility decreased
Clinical narrative: 11/18: pt complained of swelling, redness, pain, inability to move arm, fever, chills, HA, armpits sore. Began within 12 hours. 11/19: condition worsens. 11/20: pt. received Rx for KEFLEX 500mg.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: 11/18: pt complained of swelling, redness, pain, inability to move arm, fever, chills, HA, armpits sore. Began within 12 hours. 11/19: condition worsens. 11/20: pt. received Rx for KEFLEX 500mg.
Age: 52.0
Sex: F
Vaccine: FLU4, PNC13, TDAP
Symptoms: Erythema, Headache, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling
Clinical narrative: (R) arm very swollen, red, painful, itchy and warm. Stiffness in neck muscle on right side and headache.
Age: 52.0
Sex: F
Vaccine: FLU4, PNC13, TDAP
Symptoms: Pruritus, Skin warm
Clinical narrative: (R) arm very swollen, red, painful, itchy and warm. Stiffness in neck muscle on right side and headache.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose normal, Chills, Electrocardiogram normal, Head discomfort, Nausea
Clinical narrative: Patient received SHINGRIX vaccine on 11/15/2018. The next morning she awoke with chills and nausea and feeling her her head was heavy. She then had a syncopal episode. No cardiac or neurologic symptoms, no other new meds. Pt was found by housekeeper and EMS was called. They evaluated her and told her glucose and EKG was fine-they fine- they advised ER visit which she declined. I evaluated her in office but by this time was completely asymptomatic. She had has never had a prior syncopal episode.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: Patient received SHINGRIX vaccine on 11/15/2018. The next morning she awoke with chills and nausea and feeling her her head was heavy. She then had a syncopal episode. No cardiac or neurologic symptoms, no other new meds. Pt was found by housekeeper and EMS was called. They evaluated her and told her glucose and EKG was fine-they fine- they advised ER visit which she declined. I evaluated her in office but by this time was completely asymptomatic. She had has never had a prior syncopal episode.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Amylase increased, Cholelithiasis, Lipase increased, Ultrasound biliary tract
Clinical narrative: Patient developed abdominal pain approximately 4 days prior to hospital admission and approximately 1 day after receiving the vaccination for herpes zoster (SHINGRIX). The pain was not relieved by lying down or worsened by eating. Ultrasound showed some sludge in the gallbladder but no evidence of stones or inflammation. Pancreatic enzymes were elevated. Patient has improved with IV fluids and supportive care.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Ultrasound scan abnormal
Clinical narrative: Patient developed abdominal pain approximately 4 days prior to hospital admission and approximately 1 day after receiving the vaccination for herpes zoster (SHINGRIX). The pain was not relieved by lying down or worsened by eating. Ultrasound showed some sludge in the gallbladder but no evidence of stones or inflammation. Pancreatic enzymes were elevated. Patient has improved with IV fluids and supportive care.
Age: 0.0
Sex: M
Vaccine: FLU4, HEP
Symptoms: Vaccination error
Clinical narrative: Influenza vaccine administered to patient in error.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Contusion, Headache, Influenza like illness
Clinical narrative: Administration of SHINGRIX vaccine led to substantial bruising and soreness at injection site. Within 12 hours, significant flu-like symptoms, including severe body aches, headache, convulsion-like chills, and gastrointestinal upset. Occurred with both initial dose and follow-up dose. Reporter is 50-year old male, good health. Symptoms prevented normal activities and were significant.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Loss of personal independence in daily activities, Pain, Vaccine positive rechallenge
Clinical narrative: Administration of SHINGRIX vaccine led to substantial bruising and soreness at injection site. Within 12 hours, significant flu-like symptoms, including severe body aches, headache, convulsion-like chills, and gastrointestinal upset. Occurred with both initial dose and follow-up dose. Reporter is 50-year old male, good health. Symptoms prevented normal activities and were significant.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Drooling, Glassy eyes, Musculoskeletal stiffness, Unresponsive to stimuli
Clinical narrative: Had his 4 year check up with MMRV and DTap/IPV given yesterday afternoon. This morning Mom reported he had a glassy eyed look, but she did not take temp. They were running errands in the car when he became unresponsive, stiff and started drooling. He remained unresponsive, so she called 911 and was taken to the ED for further evaluation. Currently there.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site warmth, Myalgia
Clinical narrative: Head ache, muscle/joint aches, f/c, warm/redness around injection site. Patient was prescribed Benadryl 25mg,, Ibuprofen 600 mg and Prednisone 20mg. Symptoms resolved.
Age: 65.0
Sex: F
Vaccine: UNK, PPV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 65.0
Sex: F
Vaccine: UNK, PPV
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Hepatic cyst, Insomnia
Clinical narrative: None stated.
Age: 65.0
Sex: F
Vaccine: UNK, PPV
Symptoms: Malaise, Metabolic function test abnormal, Nausea, Nuclear magnetic resonance imaging liver abnormal, Pain
Clinical narrative: None stated.
Age: 65.0
Sex: F
Vaccine: UNK, PPV
Symptoms: Paraesthesia, Pyrexia, Ultrasound abdomen abnormal
Clinical narrative: None stated.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Redness, swelling, pain, warm to touch, developed within 24 hours of receiving vaccine.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: I developed severe arm soreness in my left arm only a couple of hrs. after this shot was administered. When it was administered it seemed to have been injected too high on my arm compared to what I am used to, but I figured the person who administered it knew what she was doing. I have sharp pains in my left shoulder joint which feels like it is centered in my rotator cuff. The pain goes up my neck and down my left shoulder blade. My arm feels useless-like a rag. Certain movements are extremely painful, including reaching behind me, pulling my sheets over me at night and I need to use my good arm to lift my bad arm now. My arm was perfectly healthy prior to the injection. I have visited the Public Health Nurse twice and my individual doctor once. The shot was administered through a Immunization Clinic, and the nurse noted above was an administrator for the event. She didn't have much advice for me, but the doctor advised that I take two ALEVE tabs twice a day and ice the site, which I have been doing for days but to no avail. It has been 17 days since the shot was administered. I am very worried that my arm has suffered long-term damage. The adverse reaction was not my fault and I do not think I should have to pay for medical bills related to this. I do not know where to turn. Can you please advise with how to alleviate pain as well as financial options?
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Paraesthesia, Peripheral swelling, Pruritus
Clinical narrative: Patient noticed legs itching the evening after receiving vaccination, at night she felt a burning/tingling sensation and looked to see swelling and redness on back of calf on both legs. Patient presented to pharmacy on the following day; the rash that developed has a similar appearance of a shingles rash.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Patient noticed legs itching the evening after receiving vaccination, at night she felt a burning/tingling sensation and looked to see swelling and redness on back of calf on both legs. Patient presented to pharmacy on the following day; the rash that developed has a similar appearance of a shingles rash.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, RV5
Symptoms: Abdominal rigidity, Crying, Diarrhoea haemorrhagic, Electrocardiogram, Enema administration
Clinical narrative: Multiple episodes of vomiting with a shrill cry, bloody diarrhea, pale, and lethargic. Firmness felt on right abdomen. Suspected intussusception. Transferred to hospital from E.R. given IV fluids. Abdomen ultrasound confirmed DX. Procedure: Air enema fluoro intussusception reduction.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, RV5
Symptoms: Intussusception, Laboratory test, Lethargy, Pallor, Ultrasound abdomen abnormal
Clinical narrative: Multiple episodes of vomiting with a shrill cry, bloody diarrhea, pale, and lethargic. Firmness felt on right abdomen. Suspected intussusception. Transferred to hospital from E.R. given IV fluids. Abdomen ultrasound confirmed DX. Procedure: Air enema fluoro intussusception reduction.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, RV5
Symptoms: Urinary system X-ray, Vomiting
Clinical narrative: Multiple episodes of vomiting with a shrill cry, bloody diarrhea, pale, and lethargic. Firmness felt on right abdomen. Suspected intussusception. Transferred to hospital from E.R. given IV fluids. Abdomen ultrasound confirmed DX. Procedure: Air enema fluoro intussusception reduction.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Hyperhidrosis, Influenza, Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: Within 14 hours of receiving the second injection, I was awakened feeling ill and sweating with flu symptoms and a fever. Within 24 hours, the area around the injection became very red, hot and swollen and it was difficult to move and lift the arm. Glands under the arm became tender and swollen. I had trouble sleeping due to the fever and body aches, despite taking long-acting paracetamol twice daily. These symptoms persisted for 3-4 days.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site warmth, Lymphadenopathy, Malaise, Pain, Pyrexia
Clinical narrative: Within 14 hours of receiving the second injection, I was awakened feeling ill and sweating with flu symptoms and a fever. Within 24 hours, the area around the injection became very red, hot and swollen and it was difficult to move and lift the arm. Glands under the arm became tender and swollen. I had trouble sleeping due to the fever and body aches, despite taking long-acting paracetamol twice daily. These symptoms persisted for 3-4 days.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Sleep disorder
Clinical narrative: Within 14 hours of receiving the second injection, I was awakened feeling ill and sweating with flu symptoms and a fever. Within 24 hours, the area around the injection became very red, hot and swollen and it was difficult to move and lift the arm. Glands under the arm became tender and swollen. I had trouble sleeping due to the fever and body aches, despite taking long-acting paracetamol twice daily. These symptoms persisted for 3-4 days.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Local erythema and pain at injection site and fatigue for three days. Used TYLENOL for relief. Not clear duration since still having symptoms today.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site swelling, Skin discolouration, Skin exfoliation, Skin lesion
Clinical narrative: Pt. received HPV vaccine in the morning. That evening noticed large red, swollen area on deltoid area anterior to injection site. After 5 days pt. came to Health Services was 9x4 cm area of irreg shaped lesion, red/brown in color with no swelling. Returned for recheck 11/27/18- darkened area with slight swelling noted on (L) upper arm. Small area of flaking at edges noted. We will continue to monitor the patient.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Hypersensitivity, Injection site erythema
Clinical narrative: Received 2nd shot of Zoster vaccine on 11/16/18 and had an allergic reaction to it. Very swollen, red the size of a saucer at the injection site, fever and shivering for 2 1/2 days, tired and weak. No reaction to the first shot received on 6/18/18. Got the shot at my local pharmacy. SHINGRIX 50 mg.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Received 2nd shot of Zoster vaccine on 11/16/18 and had an allergic reaction to it. Very swollen, red the size of a saucer at the injection site, fever and shivering for 2 1/2 days, tired and weak. No reaction to the first shot received on 6/18/18. Got the shot at my local pharmacy. SHINGRIX 50 mg.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 15 months old patient who received expired FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U5912CA via intramuscular route in the left thigh. It was a case of actual medication error due to expired vaccine used. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.33
Sex: F
Vaccine: DTAP, FLU4, HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from other health professional (office staff). This case involves a 16 months old female patient who was vaccinated with a dose of 0.25 ml dose of DAPTACEL lot C5065AA; expiry date: 08-Oct-2018 via intramuscular route in the right thigh. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included 0.5 ml dose of ACT-HIB for Immunisation; and 0.25 ml dose of FLUARIX for Immunisation. It was a case of actual medication error due to expired vaccine used. No adverse events have been reported after observation for 10 minutes. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Contraindication to vaccination
Clinical narrative: Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves Adult patient (age and gender not reported) who experienced an egg allergy, while he/she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unknown date, the patient received a dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine lot number not reported. It was a case of contraindication to vaccination. It was also reported that the reporter not know if the patient could eat eggs and tolerate to some extent or if she had an anaphylactic reaction. No Lab data was reported. Final diagnosis was egg allergy (Contraindication to vaccination). It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for gave a patient FLUZONE HIGH DOSE who has an egg allergy. Documents held by the sender: none.