chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Vaccination complication
Clinical narrative: The patient came to the pharmacy on 5/8/19 to receive his first dose of the SHINGRIX vaccine. On 7/15/19 the patient contacted the pharmacy and spoke with the pharmacist intern about experiencing an adverse reaction to the vaccine 4 days after it was administered. The patient said that he had extreme difficulty with breathing and decided to seek treatment at the emergency room.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia, Influenza virus test negative, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: My 12 year old daughter received her second Gardasil shot on Saturday morning. She had localized pain in her arm at the injection site but no other issues. On Sunday, her entire arm was in pain with areas of numbness. On Monday, the fever started. Typical temperature when not being brought down by ibuprofen is 102.6 degrees F- 103 degrees F. It is now Monday morning, she has maintained a fever that spikes whenever the ibuprofen isn't at peak effectiveness, and her toe, leg, and injection-site arm are all throbbing in pain. I took her back to the pediatrician yesterday (same practice that administered the vaccine) and was told that a side effect from GARDASIL would not include such a high fever and that she probably just has a coincidentally-timed virus. Strep and flu tests came back negative.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Streptococcus test negative
Clinical narrative: My 12 year old daughter received her second Gardasil shot on Saturday morning. She had localized pain in her arm at the injection site but no other issues. On Sunday, her entire arm was in pain with areas of numbness. On Monday, the fever started. Typical temperature when not being brought down by ibuprofen is 102.6 degrees F- 103 degrees F. It is now Monday morning, she has maintained a fever that spikes whenever the ibuprofen isn't at peak effectiveness, and her toe, leg, and injection-site arm are all throbbing in pain. I took her back to the pediatrician yesterday (same practice that administered the vaccine) and was told that a side effect from GARDASIL would not include such a high fever and that she probably just has a coincidentally-timed virus. Strep and flu tests came back negative.
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash
Clinical narrative: Patient received measles-mumps-rubella vaccine 0.5 mL SQ, after 10 minutes passes started complaining of itching on arms and chest area with some rashes noted
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site reaction, Pyrexia
Clinical narrative: Chills, fever (100.7), fatigue, local injection site reaction that lasted about 3 days
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Ear congestion, Ear pain, Fatigue, Herpes zoster, Hyperaesthesia
Clinical narrative: On Tuesday, 6/18/2019 began to feel soreness and stiffness in right shoulder and neck area. I felt like it was flu symptoms. On Wednesday 6/19/2019 feeling tired, sore , began to research symptoms for Lyme's disease, inasmuch as ticks are often pulled from my body. On Friday, 6/21/2019 feeling very tired and sore, I then had a very painful earache and the feeling as if it was full of water, as a swimmers ear symptom, and within 3 hours had a migraine, something  I have had but a few in my lifetime.  Friday evening, I noticed a rash on my right shoulder and neck area, yet no itch or inflammation as I normally experience with the urticaria experienced with allergies.  Saturday 6/22/2019 and Sunday 6/23/2019, the rash began to spread down my spinal column on neck and right ear , scapular, entire right shoulder and right pectoral , and becoming very sensitive to touch and painful .My right scalp felt as if it was sunburned and sporadically a severe pain would penetrate deep inside my right ear and temporal area. A very painful area developed along the right side of my neck at the hairline, yet not the same time as ear or temporal pains.   Monday, 6/24/2019 I called my family practice and was seen by Dr. and she determined it to be shingles.  She prescribed medications and the symptoms continue.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Influenza like illness, Migraine, Musculoskeletal pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: On Tuesday, 6/18/2019 began to feel soreness and stiffness in right shoulder and neck area. I felt like it was flu symptoms. On Wednesday 6/19/2019 feeling tired, sore , began to research symptoms for Lyme's disease, inasmuch as ticks are often pulled from my body. On Friday, 6/21/2019 feeling very tired and sore, I then had a very painful earache and the feeling as if it was full of water, as a swimmers ear symptom, and within 3 hours had a migraine, something  I have had but a few in my lifetime.  Friday evening, I noticed a rash on my right shoulder and neck area, yet no itch or inflammation as I normally experience with the urticaria experienced with allergies.  Saturday 6/22/2019 and Sunday 6/23/2019, the rash began to spread down my spinal column on neck and right ear , scapular, entire right shoulder and right pectoral , and becoming very sensitive to touch and painful .My right scalp felt as if it was sunburned and sporadically a severe pain would penetrate deep inside my right ear and temporal area. A very painful area developed along the right side of my neck at the hairline, yet not the same time as ear or temporal pains.   Monday, 6/24/2019 I called my family practice and was seen by Dr. and she determined it to be shingles.  She prescribed medications and the symptoms continue.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Otitis externa, Pain, Rash
Clinical narrative: On Tuesday, 6/18/2019 began to feel soreness and stiffness in right shoulder and neck area. I felt like it was flu symptoms. On Wednesday 6/19/2019 feeling tired, sore , began to research symptoms for Lyme's disease, inasmuch as ticks are often pulled from my body. On Friday, 6/21/2019 feeling very tired and sore, I then had a very painful earache and the feeling as if it was full of water, as a swimmers ear symptom, and within 3 hours had a migraine, something  I have had but a few in my lifetime.  Friday evening, I noticed a rash on my right shoulder and neck area, yet no itch or inflammation as I normally experience with the urticaria experienced with allergies.  Saturday 6/22/2019 and Sunday 6/23/2019, the rash began to spread down my spinal column on neck and right ear , scapular, entire right shoulder and right pectoral , and becoming very sensitive to touch and painful .My right scalp felt as if it was sunburned and sporadically a severe pain would penetrate deep inside my right ear and temporal area. A very painful area developed along the right side of my neck at the hairline, yet not the same time as ear or temporal pains.   Monday, 6/24/2019 I called my family practice and was seen by Dr. and she determined it to be shingles.  She prescribed medications and the symptoms continue.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dysarthria, Feeling abnormal, Hypoaesthesia, Mydriasis, Pallor
Clinical narrative: 9:45am following TST and Menactra administration pt became pale and pupils dilated.  I had pt talk to me while coworker brought a bottle of water.  Pt's words were slow and slurred.  She took about 2 sips of water and fainted.  I used ammonia inhalant to wake her up.  Once she came to she could tell me her name, dob, where she was, and what she was doing here.  I provided peanut butter crackers and water.  She declined juice.  Pt stated she had not eaten breakfast that morning and feels she got herself worked up prior to coming in for vaccines.  We contacted her mother on the phone, who came over to the office.  I informed mother of the incident and our documenting procedures.  Mother took the child home with her.  I received a call at 11:15am from mother, who stated that approx 10:55am as she was driving patient home, she closed her eyes, and mom thought she may have fainted again.  When patient "woke up" her speech was slurred and she complained of numbness/tingling in her Left hand, and "didn't feel right".  During the phone call, patient stated she was feeling better and denied any more numbness or tingling in the L hand.  I advised mom that if these symptoms continue, to take the child to see her doctor or to the ED.  Patient's mother called clinic on 7/17/19 to inform RN that patient vomited a couple of times in the afternoon, but as of the morning of 7/17/19 she was feeling much better with no further symptoms.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Paraesthesia, Slow speech, Syncope, Vomiting
Clinical narrative: 9:45am following TST and Menactra administration pt became pale and pupils dilated.  I had pt talk to me while coworker brought a bottle of water.  Pt's words were slow and slurred.  She took about 2 sips of water and fainted.  I used ammonia inhalant to wake her up.  Once she came to she could tell me her name, dob, where she was, and what she was doing here.  I provided peanut butter crackers and water.  She declined juice.  Pt stated she had not eaten breakfast that morning and feels she got herself worked up prior to coming in for vaccines.  We contacted her mother on the phone, who came over to the office.  I informed mother of the incident and our documenting procedures.  Mother took the child home with her.  I received a call at 11:15am from mother, who stated that approx 10:55am as she was driving patient home, she closed her eyes, and mom thought she may have fainted again.  When patient "woke up" her speech was slurred and she complained of numbness/tingling in her Left hand, and "didn't feel right".  During the phone call, patient stated she was feeling better and denied any more numbness or tingling in the L hand.  I advised mom that if these symptoms continue, to take the child to see her doctor or to the ED.  Patient's mother called clinic on 7/17/19 to inform RN that patient vomited a couple of times in the afternoon, but as of the morning of 7/17/19 she was feeling much better with no further symptoms.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Pt had high fever and muscle aches 48 hours
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Severe itching on hands and arms up to elbow started about 6:00 and then began spreading farther up arms.  Took two OTC Benadryl and went to ER.  Received an injection of Solu-Medrol (IVP) IVP 125 mg and was told since I had already taken the Benadryl they were concerned if they gave me more, I would start shaking.  About an hour the itching has lessened substantially but did not go away.  Prescribed 2 Benadryl 25mg each every 6 hours for 3 days and 2 Prednisone 20mg eachfor 3 days.  Continue to have moderate to mild itching today.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: PATIENT REPORTS THAT HER ARM BECAME SWOLLEN AND PAINFUL THE EVENING AFTER HER VACCINE AND DID NOT SUBSIDE FOR 1 WEEK. THE SWELLING AND PAIN WENT FROM THE TOP OF HER ARM TO HER ELBOW. MOVEMENT AND SHOULDER WAS UNAFFECTED. SHE ALSO REPORTS THAT SHE HAD A FEVER THROUGHOUT THE SAME WEEK. SHE DID NOT TAKE MEDICATIONS OR DO ANYTHING TO RELIEVE THE SYMPTOMS. AFTER 1 WEEK SHE SAYS THAT IT RESOLVED AND THERE ARE NO MORE SYMPTOMS.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Abdominal pain, Blood creatinine increased, Blood glucose normal, Cough, Dehydration
Clinical narrative: Per patient's mother, symptoms started 3 days after vaccine administration. They included high fever, up to 104.8 degrees fahrenheit, and severe muscle aches. He ended up being taken to the emergency room on the 4th day following vaccine administration (6/28/19). He presented with a high fever, sore throat, abdominal pain and non productive cough. He was tachycardic on arrival. He was given IV fluids and had several lab tests. Heart rate normalized after IV fluids. Patient was discharged with a diagnosis of fever of unknown origin, dehydration, leukocytosis.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Haematocrit increased, Haemoglobin increased, Immature granulocyte percentage increased, Leukocytosis, Lipase decreased
Clinical narrative: Per patient's mother, symptoms started 3 days after vaccine administration. They included high fever, up to 104.8 degrees fahrenheit, and severe muscle aches. He ended up being taken to the emergency room on the 4th day following vaccine administration (6/28/19). He presented with a high fever, sore throat, abdominal pain and non productive cough. He was tachycardic on arrival. He was given IV fluids and had several lab tests. Heart rate normalized after IV fluids. Patient was discharged with a diagnosis of fever of unknown origin, dehydration, leukocytosis.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Monocyte count increased, Myalgia, Neutrophil count increased, Oropharyngeal pain, Protein total normal
Clinical narrative: Per patient's mother, symptoms started 3 days after vaccine administration. They included high fever, up to 104.8 degrees fahrenheit, and severe muscle aches. He ended up being taken to the emergency room on the 4th day following vaccine administration (6/28/19). He presented with a high fever, sore throat, abdominal pain and non productive cough. He was tachycardic on arrival. He was given IV fluids and had several lab tests. Heart rate normalized after IV fluids. Patient was discharged with a diagnosis of fever of unknown origin, dehydration, leukocytosis.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia, Red blood cell count increased, Streptococcus test negative, Tachycardia, Urine analysis normal
Clinical narrative: Per patient's mother, symptoms started 3 days after vaccine administration. They included high fever, up to 104.8 degrees fahrenheit, and severe muscle aches. He ended up being taken to the emergency room on the 4th day following vaccine administration (6/28/19). He presented with a high fever, sore throat, abdominal pain and non productive cough. He was tachycardic on arrival. He was given IV fluids and had several lab tests. Heart rate normalized after IV fluids. Patient was discharged with a diagnosis of fever of unknown origin, dehydration, leukocytosis.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: White blood cell count increased
Clinical narrative: Per patient's mother, symptoms started 3 days after vaccine administration. They included high fever, up to 104.8 degrees fahrenheit, and severe muscle aches. He ended up being taken to the emergency room on the 4th day following vaccine administration (6/28/19). He presented with a high fever, sore throat, abdominal pain and non productive cough. He was tachycardic on arrival. He was given IV fluids and had several lab tests. Heart rate normalized after IV fluids. Patient was discharged with a diagnosis of fever of unknown origin, dehydration, leukocytosis.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Computerised tomogram head normal, Full blood count normal, Headache, Metabolic function test normal
Clinical narrative: Headache within 20 minutes of vaccine, pallor appearance to her skin, vomiting, syncope x 1 and weakness.  Patient sent to ER where she was admitted for observation. Patient afebrile.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Pallor, Syncope, Urine analysis normal, Vomiting
Clinical narrative: Headache within 20 minutes of vaccine, pallor appearance to her skin, vomiting, syncope x 1 and weakness.  Patient sent to ER where she was admitted for observation. Patient afebrile.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Tremor
Clinical narrative: pain in the injection site, myalgia, tremor for 24 hours
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Back pain, Headache, Injection site pain, Injection site swelling, Neck pain
Clinical narrative: Swelling and pain at site ongoing headaches back pain sore neck
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Left arm redness, itching, pain ~13cm x7cm near site of injection
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Wrong product administered
Clinical narrative: Patient given Pediarix instead of Pentacel. Patient was due for DTap, Hib, Polio(pentacel), Hep B, Rota and PCV13.  She was given DTap, Hep B, Polio(pediarix), hep b, rota and PCV13.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt was given two doses of Hep. B vaccine  on 7/18/2019 Pt has had NO immediate adverse reaction/event.
Age: 28.0
Sex: F
Vaccine: TYP
Symptoms: Cough, Influenza like illness, Oropharyngeal pain, Productive cough
Clinical narrative: Stated that she awoke with a sore throat, cough and phlegm on 7/17/19.  Today, sore throat/cough continue, with flu-like symptoms.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: headache, body aches, sore arm, diarrhea, tired
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Influenza like illness, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Patient called stating she is having flu like symptoms, nausea and fatigue after receiving the immunization. Slightly red at sight, minimal swelling
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion
Clinical narrative: Bruising on left forearm morning after injection, no pain.
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis, Herpes zoster
Clinical narrative: shingles; Bell's palsy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On approximately 11-NOV-2008, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not provided) for the prevention of shingles. On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine the patient developed Bell's palsy and shingles. As a direct and proximate result of Company's wrongdoings, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered and would continue to suffer significant medical expenses, pain and suffering, and other damages. As a direct and proximate result of Company's defective zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations not presented prior to using Company's product. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of Bell's palsy and shingles was reported as not recovered/not resolved. The reporter considered the events to be related to Zoster Vaccine Live(ZOSTAVAX).  Bell's palsy and shingles were considered to be disabling. Upon internal review, the event of Bell's palsy was considered to be medically significant
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: doses were very painful; This case was reported by a consumer via patient support programs and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's husband via voicemail. The age at vaccination was not reported. It was reported that the Shngrix was very painful. The patient received Shingrix and experienced very painful. The patient's husband was told that it was normal, but was calling to find out why it was so painful. For the tolerance of 2nd dose, refere case US2019AMR122634.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 4 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was inquiring on the call if it was possible that the patient developed shingles after vaccination with Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2019, the patient received the 1st dose of Shingrix. In June 2019, less than a year after receiving Shingrix, the patient experienced shingles. 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.  Additional details were provided as follows: This case was reported by the patient for self. The age at vaccination was not reported. The patient received the Shingrix in mid March 2019 and had mild shingles 4 weeks ago, from the reporting date. The patient was treated by the physician and everything cleared up. The patient was inquiring if 2nd dose could be received, as the patient was okay to get 2nd dose.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Insomnia, Myalgia, Nausea
Clinical narrative: headache; nauseous; muscle aches; he did not sleep; This case was reported by a consumer and described the occurrence of headache in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2019, the patient received the 1st dose of Shingrix. On 8th July 2019, less than a day after receiving Shingrix, the patient experienced headache, nausea, muscle pain and insomnia. On an unknown date, the outcome of the headache, nausea, muscle pain and insomnia were unknown.   It was unknown if the reporter considered the headache, nausea, muscle pain and insomnia to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and he did not sleep, was nauseous, muscle aches, and a headache. These are all side effects listed.
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations, Pyrexia
Clinical narrative: high fever; heart racing; This case was reported by a nurse via sales rep and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and heart racing. On an unknown date, the outcome of the fever and heart racing were unknown.   The reporter considered the fever and heart racing to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received shingrix and complained of a high fever of 103 degree Fahrenheit, heart racing went to emergency room concerned.  The reported believed they were related. Adverse event lasted 2 days.  The patient did indicate that she would be getting 2nd dose.      Lab Comments: lab test performed on unknown date
Sex: U
Vaccine: VARZOS
Symptoms: Body temperature increased
Clinical narrative: temperature; This case was reported by a nurse via call center representative and described the occurrence of body temperature increased in a 75-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 12 hrs after receiving Shingrix, the patient experienced body temperature increased. On an unknown date, the outcome of the body temperature increased was unknown.   It was unknown if the reporter considered the body temperature increased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's body temperature was 100.8 degree Fahrenheit, 12 hours after receiving Shingrix. The reporter asked was this an expected side effect.      Lab Comments: Lab test performed on unknown date
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected  vaccination failure; Shingles; This case was reported by a pharmacist via sales rep and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Rerun- Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication.  The sales representative reported that, the pharmacist told her today approximately 20 minutes prior to reporting that he has having issues with completion rates of Shingrix due to his customers hearing of shingles outbreaks from the Shingrix vaccine. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for infection were not provided. The sales representative reported that, the pharmacist told him these comments were coming from multiple patients who were hearing these Rumors or claims from other people. This was 1 of the 2 cases reported by same reporter.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: heretic rash on left outer thigh and back; This case was reported by a nurse via sales rep and described the occurrence of rash herpetiform in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included zostavax.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced rash herpetiform. On an unknown date, the outcome of the rash herpetiform was recovered/resolved.   It was unknown if the reporter considered the rash herpetiform to be related to Shingrix.  Additional details were provided as follows: The patient presented to the physician's office at the time of reporting with a heretic rash on his left outer thigh and back. The rash has been present for a week.  The reporter stated that they have not done testing to confirm herpes zoster, but it has a dermatology distribution from the lumbar. The patient received Shingrix on unknown date. However, the prescription to receive at the pharmacy was written on 19th March 2019. The reporter stated that the rash was not blistered and she attributed this mild presentation to the fact that the patient had received Shingrix.  The patient received Zostavax. The patient was otherwise healthy with no immunocompromising medication and condition. The reporter agreed to follow up from GlaxoSmithKline.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Malaise, Pain in extremity, Tenderness
Clinical narrative: redness on her arm; tenderness in her arm; didn't feel well; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number HY4GT, expiry date 21st September 2021) for prophylaxis.   On 5th July 2019, the patient received Shingrix (intramuscular). On 5th July 2019, less than a day after receiving Shingrix, the patient experienced pain in arm and feeling unwell. On 7th July 2019, the patient experienced erythema of extremities. On an unknown date, the outcome of the pain in arm and erythema of extremities were recovering/resolving and the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the pain in arm, feeling unwell and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient received the Shingrix vaccine on Friday and later that day, her arm was tender and she did not feel well. 2 days after vaccination, the patient noticed the redness on her arm, but it was not at the injection site. Instead the redness was several inches away, almost on the opposite side of her arm. The patient was feeling better but there was still some tenderness and the redness was lighter at the day of reporting. The reporter did not consent to follow-up.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Miliaria, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Itchy rash; Bumps/rash popular/raised rash; skin lesions; hot rash; Red rash; flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On 25th March 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms. In April 2019, the patient experienced itchy rash, raised rash, skin lesion, heat rash and red rash. On an unknown date, the outcome of the influenza-like symptoms and skin lesion were recovered/resolved and the outcome of the itchy rash, heat rash and red rash were unknown and the outcome of the raised rash was not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, itchy rash, raised rash, skin lesion, heat rash and red rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix at his physician's office, on his right arm, deltoid muscle, intramuscularly. The batch number was not reported. He did experience flu-like symptoms the same day which resolved by the next day of vaccination. The patient states after about a week later, he started to experience lesions red, raised, hot, itchy on his right upper torso, shoulder, and back which went away and came back later.  At the time of reporting he has bumps on his left shoulder and left scapula area. He reports also having these skin lesions, which look like insect bites on his right knee which has resolved. Patient has been referred to infectious disease for follow up. The reporter consented to follow up.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: Itchy rash; Bumps/rash popular/raised rash; skin lesions; hot rash; Red rash; flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On 25th March 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms. In April 2019, the patient experienced itchy rash, raised rash, skin lesion, heat rash and red rash. On an unknown date, the outcome of the influenza-like symptoms and skin lesion were recovered/resolved and the outcome of the itchy rash, heat rash and red rash were unknown and the outcome of the raised rash was not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, itchy rash, raised rash, skin lesion, heat rash and red rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix at his physician's office, on his right arm, deltoid muscle, intramuscularly. The batch number was not reported. He did experience flu-like symptoms the same day which resolved by the next day of vaccination. The patient states after about a week later, he started to experience lesions red, raised, hot, itchy on his right upper torso, shoulder, and back which went away and came back later.  At the time of reporting he has bumps on his left shoulder and left scapula area. He reports also having these skin lesions, which look like insect bites on his right knee which has resolved. Patient has been referred to infectious disease for follow up. The reporter consented to follow up.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: some soreness in his arm; myalgia; fatigue; fever; shivering; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (Injection site pain after receiving 1st dose on February 2019, see case US2019AMR123448).   On 7th July 2019, the patient received the 2nd dose of Shingrix (intramuscular) 50 µg. On 8th July 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, myalgia, fatigue, fever and shivering. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the myalgia, fatigue, fever and shivering were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, myalgia, fatigue, fever and shivering to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose in left deltoid.  The patient had some soreness in his arm when he went to bed last night.  This morning he woke up with myalgia throughout his whole body, fatigue, fever and shivering.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: some soreness in his arm; myalgia; fatigue; fever; shivering; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (Injection site pain after receiving 1st dose on February 2019, see case US2019AMR123448).   On 7th July 2019, the patient received the 2nd dose of Shingrix (intramuscular) 50 µg. On 8th July 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, myalgia, fatigue, fever and shivering. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the myalgia, fatigue, fever and shivering were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, myalgia, fatigue, fever and shivering to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose in left deltoid.  The patient had some soreness in his arm when he went to bed last night.  This morning he woke up with myalgia throughout his whole body, fatigue, fever and shivering.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Influenza
Clinical narrative: common flu symptoms; shivering; This case was reported by a pharmacist via call center representative and described the occurrence of flu symptoms in an unspecified number of the patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced flu symptoms and shivering. On an unknown date, the outcome of the flu symptoms and shivering were unknown.   It was unknown if the reporter considered the flu symptoms and shivering to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The pharmacist reported that the many patients in her practice experience common flu symptoms, such as shivering, after getting the Shingrix vaccine. The reporter was unable to provide specific information related to specific patients and vaccine.
Age: 11.0
Sex: F
Vaccine: HPVX, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: patient has redness & swelling on both shoulders, painful & hot to touch. a day after vaccines administer
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Spoke to pt mom, no adverse reaction to Adult vaccine.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Peripheral swelling, Skin warm
Clinical narrative: Injection site 4" x 2" oblong reddened area. Swollen hand and warm to touch. -7/18/19 Area was the size of a quarter on 7/17/19, much worse on 7/18/19 Applying ice, Ibuprofen et Benadryl every 6'
Age: 1.83
Sex: M
Vaccine: DTAP, IPV
Symptoms: Local reaction, Pyrexia, Rash
Clinical narrative: Patient presented to clinic with rash and fever starting one day before. Rash was getting worse. Area approximately 3x5cm. Doctor believes it is an exaggerated local reaction plus vaccine related fever also a possibility. Patient was prescribed clindamycin. Date of visit was 7/12/19.
Age: 89.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Blood test normal, Hypersensitivity, Pruritus
Clinical narrative: extreme allergic reaction starting on upperback, then lower, then thighs, legs given given a low dose steroid pills very itchy
Age: 89.0
Sex: F
Vaccine: TYP, TYP
Symptoms: Drug eruption, Neck pain, Rash, Rash erythematous
Clinical narrative: extreme allergic reaction starting on upperback, then lower, then thighs, legs given given a low dose steroid pills very itchy
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 8.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: significant upper arm swelling, redness and itching still red after almost 1 month
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site reaction, Muscle rigidity, Vaccination site hypersensitivity, Vaccination site warmth
Clinical narrative: Reports after a vaccine was given to Pt, the next morning she noticed increased sensitivity to her left arm where vaccine was given. Later that day it became hot and rigid. This lasted Sunday and Monday and was still a little red Tuesday but getting better.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: Client received vaccines on 7/15/19 at around 200 pm pt showed no s/s of an allergic reactions. stated feels fine. per mom pt complained of slight HA on 7/15/19, continued with HA on 7/16/19. On 7/17/19 at about 1130 am pt c/o tingling/numbness to (R) Foot radiating to (R) extremity, then LLE. and continued to upper body and upper (B) extremities. Episode happened for 5 minutes x 1. pt states feels fine today.
Age: 91.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood culture negative, Blood pressure decreased, Blood test normal, Chest X-ray, Laboratory test
Clinical narrative: FEVER OF 102 EVENING AFTER VACCINATION, HAD A BLOOD PRESSURE DROP WHILE INPATIENT.BLOODWORK/CULTURES HAVE COME BACK NEGATIVE, TYLENOL BROUGHT FEVER DOWN EASILY, WAS GIVEN OXYGEN WHILE INPATIENT.
Age: 91.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Urine analysis
Clinical narrative: FEVER OF 102 EVENING AFTER VACCINATION, HAD A BLOOD PRESSURE DROP WHILE INPATIENT.BLOODWORK/CULTURES HAVE COME BACK NEGATIVE, TYLENOL BROUGHT FEVER DOWN EASILY, WAS GIVEN OXYGEN WHILE INPATIENT.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Asthenia, Immediate post-injection reaction, Loss of consciousness, Nausea, Pallor
Clinical narrative: Patient was in a seated position when HPV9 was administered; Immediately after vaccine administration, patient had a syncopal episode and his body jumped three times resembling a seizure.  He came to in about 2-5 seconds complaining of nausea, weakness and his face was pale.  Patient was then carefully transferred to laying position on the exam table until the episode passed.  He was then transferred to emergency department in a wheelchair for evaluation.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Seizure like phenomena, Syncope
Clinical narrative: Patient was in a seated position when HPV9 was administered; Immediately after vaccine administration, patient had a syncopal episode and his body jumped three times resembling a seizure.  He came to in about 2-5 seconds complaining of nausea, weakness and his face was pale.  Patient was then carefully transferred to laying position on the exam table until the episode passed.  He was then transferred to emergency department in a wheelchair for evaluation.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Limb mass, Peripheral swelling
Clinical narrative: PATIENT STARTED TO EXPERIENCE A SWELLING IN THE ARM WHICH HASN'T GONE AWAY, THE LUMP IS STILL PRESENT AFTER 2 WEEKS,
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Limb mass, Swelling
Clinical narrative: PATIENT STARTED TO EXPERIENCE A SWELLING IN THE ARM WHICH HASN'T GONE AWAY, THE LUMP IS STILL PRESENT AFTER 2 WEEKS,
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Influenza like illness, Nausea, Rash
Clinical narrative: flu like symptoms, lightheadedness, headache, nausea, rash on back
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Barium double contrast abnormal, Blood glucose, Diet refusal, Enema administration, Intussusception
Clinical narrative: Patient woke vomiting and refusing formula on 7/14/19. Mom took to ER and they done abdominal ultrasound. Findings of ileocolic intussusception were found. Patient was admitted for observation for 2 days after a reduction of intussusception.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Patient woke vomiting and refusing formula on 7/14/19. Mom took to ER and they done abdominal ultrasound. Findings of ileocolic intussusception were found. Patient was admitted for observation for 2 days after a reduction of intussusception.
Age: 16.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient received vaccination today. Is accompanied by Father . VIS explained and given.  Advised patient wait in clinic for 15 minutes to observe for any possible adverse or allergic reaction. Patient fainted about 1 minute after receiving last vaccine. Lost consciousness for approximately 10 seconds. Dr. was called into the exam room to assess patient. Pulse, oxygen and blood pressure taken about 2 minutes after incident. All within normal range - documented under vitals. Patient layed on exam table for ~ 10 minutes with legs elevated. Took blood pressure again- normal range. On Dr.'s direction patient sat on exam table for 10 minutes, retook vitals - normal limits. Had patient stand up for a few minutes, retook vitals - normal limits. Dr. reassessed patient and okayed to leave.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site warmth, Injection site erythema, Injection site inflammation, Injection site pruritus
Clinical narrative: Inflamed administration site, red, hot, and itchy. Counseled patient to take some diphenhydramine according to OTC box directions and apply a towel cooled by water. Follow-up with us or primary care provider if inflammation does not reduce in 8 hours.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: Patient was given 2nd dose Shingrix vaccine on 07/06/2019. The patient went his PCP with a full body rash.  He developed a rash 4 to 5 days after the vaccine. He came into the pharmacy on 07/16/2019 to pick up the prednisone and triamcinolone cream.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Arrhythmia, Headache, Injection site pain, Pain, Pain in extremity
Clinical narrative: Headache, severe injection site pain, body aches, racing heart, "arrhythmia".  mom says child had similar symptoms after receiving first in series but never notified parent.   symptoms continued until today.  still with some minor arm pain but other symptoms seemed to have resolved.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Palpitations
Clinical narrative: Headache, severe injection site pain, body aches, racing heart, "arrhythmia".  mom says child had similar symptoms after receiving first in series but never notified parent.   symptoms continued until today.  still with some minor arm pain but other symptoms seemed to have resolved.
Age: 22.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Syncopal episode within 20 minutes of vaccine administration.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: reports a fever that evening up to 101.7. No rash, no trouble breathing, no skin irritation
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Diarrhoea, Pain in extremity, Vomiting
Clinical narrative: sore arm, chills, weakness, vomiting, loose stool,
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Myalgia, Pain in extremity
Clinical narrative: massive arm pain, massive shivering, massive muscle aches and weakness. took acetaminophen and ibuprofin. on 3rd day, still weak and aching  but far less severe than previous days.
Age: 0.42
Sex: M
Vaccine: IPV
Symptoms: Skin warm
Clinical narrative: mom states baby felt warm, but had not checked the babies temp, after checking Mom reported it being 99.9
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Myalgia, Pain in extremity
Clinical narrative: ARM VERY SORE BY EVENING AND NEXT EVENING. MUSCLE ACHES LIKE THE FLU. THE MUSCLE ACHES GO WORSE EACH DAY AND THEN 2 NITHTS I WOKE UP SHIVERING BADLY. NEVER HAVE HAD A REACTION LIKE THIS.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Fatigue, Hypoaesthesia, Loss of consciousness
Clinical narrative: Patient passed out hours later after Getting shots and her Blood Drawn.   Then Patient Came back into the Clinic with Numbness of fingers and toes. Fatigue and Chills.  We Sent the Patient to the ER.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient states that arm has gotten swollen and red since vaccination. Patient was informed to contact their primary care dr to discuss reaction and decide if care is required
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: PATIENT REPORTED PERFUSE SWEATING APPROXIMATELY 1 DAY AFTER VACCINATION WITH LOW GRADE FEVER AND NAUSEA. THIS LASTED 2 DAYS.
Age: 62.0
Sex: M
Vaccine: HEPAB, VARZOS
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Patient stated he experienced soreness in his arm the next day and for many days.  Since then he has experienced and continues to experience muscle weakness in the arm the shingrix was given.