chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: C-reactive protein normal, Computerised tomogram head normal, Electroencephalogram normal, Full blood count normal, Generalised tonic-clonic seizure
Clinical narrative: On 7/17/2017, patient had an unresponsive episode followed by a tonic-clonic seizure at home and another upon arrival to the ER.  She had a thorough work up including labs, spinal tap, brain CT and  MRI, EEG. Stayed overnight in PICU. Treated with SOLUMEDROL and acyclovir empirically. Labs were all essentially normal including the EEG. She was sent home on no regular meds (just DIASTAT prn recurrent seizures) to follow up with Neurology. On 9/12/2017, patient had another unresponsive episode followed by a tonic-clonic seizure at home. Brought to ER. Given a dose of ATIVAN and started on Valproic Acid and admitted overnight again. EEG was again normal. She was discharged home on KEPPRA and follow up with Neurology arranged.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Intensive care, Lumbar puncture normal, Metabolic function test normal, Nuclear magnetic resonance imaging brain normal, Red blood cell sedimentation rate normal
Clinical narrative: On 7/17/2017, patient had an unresponsive episode followed by a tonic-clonic seizure at home and another upon arrival to the ER.  She had a thorough work up including labs, spinal tap, brain CT and  MRI, EEG. Stayed overnight in PICU. Treated with SOLUMEDROL and acyclovir empirically. Labs were all essentially normal including the EEG. She was sent home on no regular meds (just DIASTAT prn recurrent seizures) to follow up with Neurology. On 9/12/2017, patient had another unresponsive episode followed by a tonic-clonic seizure at home. Brought to ER. Given a dose of ATIVAN and started on Valproic Acid and admitted overnight again. EEG was again normal. She was discharged home on KEPPRA and follow up with Neurology arranged.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Unresponsive to stimuli, Urine analysis normal
Clinical narrative: On 7/17/2017, patient had an unresponsive episode followed by a tonic-clonic seizure at home and another upon arrival to the ER.  She had a thorough work up including labs, spinal tap, brain CT and  MRI, EEG. Stayed overnight in PICU. Treated with SOLUMEDROL and acyclovir empirically. Labs were all essentially normal including the EEG. She was sent home on no regular meds (just DIASTAT prn recurrent seizures) to follow up with Neurology. On 9/12/2017, patient had another unresponsive episode followed by a tonic-clonic seizure at home. Brought to ER. Given a dose of ATIVAN and started on Valproic Acid and admitted overnight again. EEG was again normal. She was discharged home on KEPPRA and follow up with Neurology arranged.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient received her first dose of SHINGRIX on 3/27/18. Pharmacist went through normal immunization process of cleaning hands, gathering supplies, donning gloves, discussing potential side effects including pain and redness at injection site, cleansing vaccination location, and administering the vaccine. Patient called the pharmacy 3/31/18 with concerns of the injection site being painful, red, and warm. The pharmacist on duty recommended for the patient to monitor the site, use ice to help reduce redness and warmth, and if things got worse or she developed a temperature that she should seek medical attention. Pharmacist called patient on 5/31/18 to notify her that she's due for second dose and patient shared concerns of continued discomfort -- she's been experiencing a dull aching pain at the injection site since receiving the shot 2 months ago. Pharmacist contacted GSK to inquire (longest duration of pain reported in clinical study of 41 days) and passed this information along to the patient. Patient will consider this information and decide whether or not she receives the second dose. Pharmacist did mention that the CDC recommends completing the series even if side effects occurred (other than allergic reaction).
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Cold sweat, Influenza like illness, Injection site irritation, Injection site pain
Clinical narrative: Patient called 6/1 to report that he had arm pain and irritation at the injection site around 8pm on 5/29. He reportts waking the next morning at 6am with clammy feeling and flu-like symptoms that persisted through the day on Thursday (5/31).
Age: 25.0
Sex: F
Vaccine: FLUX, TTOX, FLUX, TTOX
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Extreme pain in both arms for 1-2 weeks after shots administered, lasting pain in right shoulder up to June 1, 4 months after shot.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, Pyrexia, Vaccination site discolouration
Clinical narrative: Child received KINRIX IM, Left Deltoid, on 5/30/18 (5th Dtap, 5th Polio dose). (without noted incident). 05/31/18 am, mom reported child had fever to 101.2, redness, swelling and discomfort to arm. Today, 6/1/18; symptoms continued with increased redness, swelling to left arm. Per MD note "approx. 4 by 2.5cm raised, eryth edematous region left post arm at vaccination site.  Irregular border and irreg. coloration (vesicular) within area.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Vaccination site oedema, Vaccination site vesicles
Clinical narrative: Child received KINRIX IM, Left Deltoid, on 5/30/18 (5th Dtap, 5th Polio dose). (without noted incident). 05/31/18 am, mom reported child had fever to 101.2, redness, swelling and discomfort to arm. Today, 6/1/18; symptoms continued with increased redness, swelling to left arm. Per MD note "approx. 4 by 2.5cm raised, eryth edematous region left post arm at vaccination site.  Irregular border and irreg. coloration (vesicular) within area.
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of local reaction in a female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced local reaction. On an unknown date, the outcome of the local reaction was unknown. It was unknown if the reporter considered the local reaction to be related SHINGRIX. Additional details were provided as follows: This case was received via click to chat forum. The age at vaccination was not reported. The healthcare professional reported that she had the patient who received their dose of SHINGRIX and had a local reaction. No further information was reported.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash, Swelling
Clinical narrative: Localized redness, little bumpy, redness to touch presentation day after vaccine was administered. Area is swollen and this has gone down a little bit after 2 days. Area is also a little itchy. Area 2x4 Recommended treatment-cold compress to area, Antihistamine such as BENADRYL and topical Hydrocortisone if needed for itching. Recommended to follow up with MD early next if no improvement.
Age: 0.25
Sex: M
Vaccine: HIBV
Symptoms: Death
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of death NOS in a 3-month-old male patient who received HIBERIX (batch number 73T35, expiry date 9th June 2019). The patient's past medical history included prematurity. On 17th May 2018, the patient received the 1st dose of HIBERIX (intramuscular) .5 ml. On 19th May 2018, 2 days after receiving HIBERIX, the patient experienced death NOS (serious criteria death and GSK medically significant). On 19th May 2018, the outcome of the death NOS was fatal. The reported cause of death was death. It was unknown if the reporter considered the death NOS to be related to HIBERIX. Additional details were provided as follows: The patient was born prematurely. The estimated delivery due date was 8th April 2018 and his birth weight was 1.440 kg. At 12:00 the patient received HIBERIX in the right thigh. There was no cause of death known. The patient was taken to the emergency room where he was pronounced dead.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms and feels awful. The patient was treated with ADVIL. On an unknown date the outcome of the influenza-like symptoms and feels awful were unknown. It was unknown if the reporter considered the influenza-like symptoms and feels awful to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional heard report from another provider who was asking about trends in adverse events reported with SHINGRIX doses. The health care professional stated that the patient she heard about experienced flu like symptoms and felt terrible after receiving SHINGRIX. The patient took ADVIL, took a nap, and felt fine after. The health care professional stated this was not her patient and didn't want to report adverse events. The reporter did not agree to follow up from GlaxoSmithKline. This case has been linked with US2018GSK095204, reported by the same reporter for the same patient and US2018GSK092161, reported by the same reporter.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Pancreatitis acute
Clinical narrative: This case was reported by a other health professional and described the occurrence of acute pancreatitis in a adult patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 14 days after receiving SHINGRIX, the patient experienced acute pancreatitis (serious criteria GSK medically significant). On an unknown date, the outcome of the acute pancreatitis was unknown. It was unknown if the reporter considered the acute pancreatitis to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient developed acute pancreatitis 14 days after administration of SHINGRIX. The reporter was asking if there had been any reports of acute pancreatitis after SHINGRIX injection.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Abdominal pain upper, Chills, Dyspnoea, Feeling cold
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old male patient who received SHINGRIX. On 18th May 2018 15:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm. On 18th May 2018, the patient experienced shivering, feeling cold, headache, nausea, stomach pain, cold and sweating. On 21st May 2018, the patient experienced difficulty breathing. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the shivering, feeling cold, headache, nausea, stomach pain, cold and sweating were recovered/resolved and the outcome of the difficulty breathing was unknown. The reporter considered the pain in arm, shivering, feeling cold, headache, nausea, stomach pain, cold and sweating to be related to SHINGRIX. It was unknown if the reporter considered the difficulty breathing to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. At around 6:00pm or 7:00pm on the night of less than a day after receiving the vaccination, the patient started feeling cold, shivering, and freezing and at night the patient woke up soaking wet and reported that he had to change his t-shirt three times during the night. Then he began to feel nauseous, stomach pain, and developed a violent headache which would not go away. On 21st May 2018, 3 days after vaccination the patient could not take a deep breath last night, because he would get stabbing pain in his abdomen. The patient still had these symptoms this morning but had resolved by the time of the call, around 2:00pm. The patient still had these symptoms this morning but had resolved by the time of the call, around 2:00pm. The patient also reported having a sore arm from the vaccination which still had not resolved. It felts like someone had punched him in the arm. The patient gave consent to contact the physician and provided contact details for the same.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Hyperhidrosis, Nasopharyngitis, Nausea, Night sweats
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old male patient who received SHINGRIX. On 18th May 2018 15:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm. On 18th May 2018, the patient experienced shivering, feeling cold, headache, nausea, stomach pain, cold and sweating. On 21st May 2018, the patient experienced difficulty breathing. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the shivering, feeling cold, headache, nausea, stomach pain, cold and sweating were recovered/resolved and the outcome of the difficulty breathing was unknown. The reporter considered the pain in arm, shivering, feeling cold, headache, nausea, stomach pain, cold and sweating to be related to SHINGRIX. It was unknown if the reporter considered the difficulty breathing to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. At around 6:00pm or 7:00pm on the night of less than a day after receiving the vaccination, the patient started feeling cold, shivering, and freezing and at night the patient woke up soaking wet and reported that he had to change his t-shirt three times during the night. Then he began to feel nauseous, stomach pain, and developed a violent headache which would not go away. On 21st May 2018, 3 days after vaccination the patient could not take a deep breath last night, because he would get stabbing pain in his abdomen. The patient still had these symptoms this morning but had resolved by the time of the call, around 2:00pm. The patient still had these symptoms this morning but had resolved by the time of the call, around 2:00pm. The patient also reported having a sore arm from the vaccination which still had not resolved. It felts like someone had punched him in the arm. The patient gave consent to contact the physician and provided contact details for the same.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old male patient who received SHINGRIX. On 18th May 2018 15:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm. On 18th May 2018, the patient experienced shivering, feeling cold, headache, nausea, stomach pain, cold and sweating. On 21st May 2018, the patient experienced difficulty breathing. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the shivering, feeling cold, headache, nausea, stomach pain, cold and sweating were recovered/resolved and the outcome of the difficulty breathing was unknown. The reporter considered the pain in arm, shivering, feeling cold, headache, nausea, stomach pain, cold and sweating to be related to SHINGRIX. It was unknown if the reporter considered the difficulty breathing to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. At around 6:00pm or 7:00pm on the night of less than a day after receiving the vaccination, the patient started feeling cold, shivering, and freezing and at night the patient woke up soaking wet and reported that he had to change his t-shirt three times during the night. Then he began to feel nauseous, stomach pain, and developed a violent headache which would not go away. On 21st May 2018, 3 days after vaccination the patient could not take a deep breath last night, because he would get stabbing pain in his abdomen. The patient still had these symptoms this morning but had resolved by the time of the call, around 2:00pm. The patient still had these symptoms this morning but had resolved by the time of the call, around 2:00pm. The patient also reported having a sore arm from the vaccination which still had not resolved. It felts like someone had punched him in the arm. The patient gave consent to contact the physician and provided contact details for the same.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Bursitis, Inflammation, Joint range of motion decreased, Tendonitis
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in joint involving shoulder region in a 71-year-old female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced pain in joint involving shoulder region, joint range of motion decreased, bursitis, tendonitis and inflammatory reaction. On an unknown date, the outcome of the pain in joint involving shoulder region, joint range of motion decreased, bursitis, tendonitis and inflammatory reaction were not recovered/not resolved. The reporter considered the pain in joint involving shoulder region and joint range of motion decreased to be possibly related to SHINGRIX. It was unknown if the reporter considered the bursitis, tendonitis and inflammatory reaction to be related SHINGRIX. Additional details were provided as follows: The reporter, her advocate, stated that the patient had received the injection of the vaccine at her primary physician's office. The reporter believed that the adverse reactions started the next day for the patient. The patient experienced severe pain and limited range of motion in her left shoulder joint. The patient experienced severe pain and limited range of motion in her left shoulder joint. The patient waited a few weeks after the injection hoping the side effects would get better before reporting her experience. The patient went to a physical therapist about the side effects, but there was no improvement with the range of motion and pain experienced from it. The reporter had not spoke to the patient in a week, but knows that the patient went to see an orthopedic surgeon. The surgeon did determine and there were no problems with her rotator cuff. Less than a year, after vaccination (surgeon could not rule out) the patient had bursitis, tendinitis or some other inflammatory reaction. The patient's condition had not gotten any better. There had been several treatment options discussed, but the vaccine itself could not be ruled out as the cause of the side effects. Going forward, the patient would be asked if the symptoms had been resolved, if not, other options might be looked at for the patient. This information was all that the reporter felt comfortable in share without the consent of the patient. The reporter had no objections of being contacted about the report for additional information about the patient and her experienced.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Hypotension, Myalgia, Nausea
Clinical narrative: Nausea, diarrhea, muscle aches, fever, headache, fainting, low blood pressure.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Syncope
Clinical narrative: Nausea, diarrhea, muscle aches, fever, headache, fainting, low blood pressure.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Headache, Loss of consciousness, Slow response to stimuli
Clinical narrative: Patient came in for MCV4 and documented on questionnaire of past vasovagal syncope. She was placed in supine position for vaccine but lost consciousness for about 5 - 10 seconds and slow to respond; denied breathing difficulties. Vitals: BP 102/60 Pulse: 88. She was kept in supine position for 15 minutes. During this time, she complained of dizziness and headache; her mother gave her ADVIL at this point. She then sat up and was in seated position for 15 minutes. While sitting, she stated her head still but dizziness was decreasing. She was then escorted to the waiting area for another 30 minutes. When patient was discharged from clinic, she stated her head continued to bother her. She was instructed to hydrate well and not exercise for the remainder of the day.  Patient verbalized understanding.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Peripheral swelling, Tenderness
Clinical narrative: Large bump, nerve tenderness in arm at injection site and down arm.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Pt developed fever 9 days post-vaccine administration, without other focal signs of infection. Tx. Acetaminophen every 4hrs. as need for fever and return in case of deterioration.
Age: 15.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, IPV, MMRV, MNQ, TDAP, VARCEL
Symptoms: Diarrhoea, Pallor, Posture abnormal, Pyrexia, Skin warm
Clinical narrative: Tdap, HPV and polio given in left arm when patient became pale and began to slouch over. This was approximately 0945. He was lowered to a laying position on the exam table. He was tense and warm and not initially responding to his name. Assistance called for another nurse. No difficulty breathing noted. Within 30 seconds, patient was alert and responding. Cool towel applied to forehead, ice pack to neck. Blood pressure checked and found to be 108/70. Patient reports feeling better and denies any difficulty breathing. Patient reports he has not had any food or drink yet today so he is given water and a snack. Mother wishes to proceed with the immunizations that are left. At 1015, when patient reported he was feeling well, 2 nurses finished giving vaccinations. No further loss of consciousness and patient reports feeling well. Patient remained in office for approximately 30 more minutes after final vaccination. Prior to going home, BP 118/78. He is in good spirits and laughing. 3 day follow up call, Mom notes day after vaccination patient had vomiting/diarrhea/fever. States he felt better by day 2 and now on day 3 is well and back to school and eating.
Age: 15.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, IPV, MMRV, MNQ, TDAP, VARCEL
Symptoms: Tension, Unresponsive to stimuli, Vomiting
Clinical narrative: Tdap, HPV and polio given in left arm when patient became pale and began to slouch over. This was approximately 0945. He was lowered to a laying position on the exam table. He was tense and warm and not initially responding to his name. Assistance called for another nurse. No difficulty breathing noted. Within 30 seconds, patient was alert and responding. Cool towel applied to forehead, ice pack to neck. Blood pressure checked and found to be 108/70. Patient reports feeling better and denies any difficulty breathing. Patient reports he has not had any food or drink yet today so he is given water and a snack. Mother wishes to proceed with the immunizations that are left. At 1015, when patient reported he was feeling well, 2 nurses finished giving vaccinations. No further loss of consciousness and patient reports feeling well. Patient remained in office for approximately 30 more minutes after final vaccination. Prior to going home, BP 118/78. He is in good spirits and laughing. 3 day follow up call, Mom notes day after vaccination patient had vomiting/diarrhea/fever. States he felt better by day 2 and now on day 3 is well and back to school and eating.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 68-year-old male patient who received SHINGRIX (batch number T5242, expiry date March 2020). On 9th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 1 day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. The reporter considered the pain in arm to be possibly related to SHINGRIX. Additional details were provided as follows: The patient experienced pain in the right arm, especially while sleeping. The health care professional believed the symptoms started the day after. On 21st May 2018, the patient stopped in the pharmacy while picking up his wife's prescription and mentioned that the pain had not gone away.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient developed right arm swelling 1 day post-vaccines administration with associated erythema warm, tenderness and fever (suggestive of cellulitis). Right deltoid area extending 10 cm vertically(from acromium to humerus measuring 21.5 cm in circumference compare with 8.75 cm in left arm). Tx: Cephalexin 300mg PO every 12 hrs. x 5 days, cold compresses and acetaminophen when needed for fever.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Patient developed right arm swelling 1 day post-vaccines administration with associated erythema warm, tenderness and fever (suggestive of cellulitis). Right deltoid area extending 10 cm vertically(from acromium to humerus measuring 21.5 cm in circumference compare with 8.75 cm in left arm). Tx: Cephalexin 300mg PO every 12 hrs. x 5 days, cold compresses and acetaminophen when needed for fever.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 64-year-old male patient who received SHINGRIX. In April 2018, the patient received the 1st dose of SHINGRIX. On 5th May 2018, several days after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling and injection site erythema were recovered/resolved. The reporter considered the injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The concomitant drug included prostate medication. The patient received SHINGRIX on left arm. The patient's wife reported that the patient experienced a red arm and swelling at the injection site after receiving the SHINGRIX vaccine. The patient had denied permission to contact their physician.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Extra dose administered
Clinical narrative: Pt received PROQUAD injection and additional varicella injection. 6-1-18 manufacturer called. Parent notified.
Age: 36.0
Sex: M
Vaccine: MENB
Symptoms: Injection site discomfort, Injection site pain, Myalgia, Pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site burning in a 36-year-old male patient who received BEXSERO (batch number 169701, expiry date January 2019). On 19th April 2018, the patient received the 1st dose of BEXSERO (intramuscular). On 19th April 2018, immediately after receiving BEXSERO, the patient experienced injection site burning and injection site discomfort. On 20th April 2018, the patient experienced muscle soreness. On an unknown date, the outcome of the injection site burning, injection site discomfort and muscle soreness were recovered/resolved. The reporter considered the injection site burning, injection site discomfort and muscle soreness to be related to BEXSERO. Additional details were provided as follows: The patient received SHINGRIX vaccine on right deltoid. The physician (MD) called and stated that, the patient received first dose of BEXSERO (unsure of time) and complained of burning, pain and discomfort on entry during administration of BEXSERO. The patient also experienced general soreness on the next day of vaccination. The physician put physician assistant on the phone to provide additional details. Everything resolved but unsure when it resolved. The physician and physician assistant were unsure if patient took anything for symptoms.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Chills, Mobility decreased, Myalgia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 64-year-old female patient who received SHINGRIX. Concurrent medical conditions included hypertension. Concomitant products included metoprolol. On 10th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 10th March 2018, 6 hrs after receiving SHINGRIX, the patient experienced fever, pain in arm, bone pain, chills, muscle pain and mobility pain and mobility decreased. The patient was treated with ibuprofen. On 11th March 2018, the outcome of the fever and chills were recovered/resolved. On an unknown date, the outcome of the pain in arm, bone pain, muscle pain and mobility decreased were recovered/resolved. The reporter considered the fever, pain in arm, bone pain, chills, muscle pain and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient reported that within an hour after receiving SHINGRIX experienced soreness in her left arm, which lasted for 4 to 5 days. The patient reported that approximately 6 hours after receiving a does of SHINGRIX experienced bone and muscle pain, that was very painful and the patient could barely move, which lasted for 6 to 8 hours. The patient had taken ibuprofen and it got better. The patient stated that by the next day the pain was much better. The patient also reported that approximately 6 hours after receiving SHINGRIX, she experienced chills and fever and by the next day of vaccination, she was fine. The patient had denied the permission to contact with her physician.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: 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 64-year-old female patient who received SHINGRIX. Concurrent medical conditions included hypertension. Concomitant products included metoprolol. On 10th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 10th March 2018, 6 hrs after receiving SHINGRIX, the patient experienced fever, pain in arm, bone pain, chills, muscle pain and mobility pain and mobility decreased. The patient was treated with ibuprofen. On 11th March 2018, the outcome of the fever and chills were recovered/resolved. On an unknown date, the outcome of the pain in arm, bone pain, muscle pain and mobility decreased were recovered/resolved. The reporter considered the fever, pain in arm, bone pain, chills, muscle pain and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient reported that within an hour after receiving SHINGRIX experienced soreness in her left arm, which lasted for 4 to 5 days. The patient reported that approximately 6 hours after receiving a does of SHINGRIX experienced bone and muscle pain, that was very painful and the patient could barely move, which lasted for 6 to 8 hours. The patient had taken ibuprofen and it got better. The patient stated that by the next day the pain was much better. The patient also reported that approximately 6 hours after receiving SHINGRIX, she experienced chills and fever and by the next day of vaccination, she was fine. The patient had denied the permission to contact with her physician.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Pain in extremity
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm, injection site erythema and injection site lump. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the injection site erythema and injection site lump were recovered/resolved. The reporter considered the pain in arm, injection site erythema and injection site lump to be related to SHINGRIX. Additional details were reported as follows: The age vaccination was not reported. The patient stated that his arm hurt and he experienced redness around injection site and had a lump around injection site. The patient reported that it did not need for medical intervention and no need for hospitalization. The patient believed it related to vaccination with SHINGRIX. All injection site reactions were resolved within few days.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a nurse regarding a currently 1 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 23-APR-2018, the patient was vaccinated with a dose of the following vaccine that was improperly stored: VARIVAX lot # N027000 and expiration date 28-SEP-2019, per unknown route (frequency and anatomical location were not reported) for prophylaxis. The dose of VARIVAX vaccine was exposed to a temperature excursion at or above 6° Fahrenheit (°F) up to 14 ° Fahrenheit (°F) with a time frame of 15 hours. There was a previous temperature excursion of the same temperatures for 48 hours. A digital data logger was involved. Furthermore, no product quality complaint (PQC) was involved.
Sex: M
Vaccine: MENB
Symptoms: Headache
Clinical narrative: This is a spontaneous report from a contactable physician through a Pfizer sales representative. The physician reported for two patients. This is the second of two reports. A male patient of an unspecified age received TRUMENBA on an unknown date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced headache. Clinical outcome of the event was unknown at time of this report. The information on the batch number has been requested. Sender's Comments: Linked Report(s) : US-PFIZERINC-2018225112 Different patients, same reporter, drug, event.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in a adult patient who received SHINGRIX. Previously administered products included SHINGRIX (1st dose received and experienced events (refer case US2018GSK093084)). On an unknown date, the patient received the 2nd dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional heard report from another provider who was asking about trends in adverse reported with SHINGRIX doses. With this dose of SHINGRIX, the patient was worried about flu like symptoms again but had reported pain only. The health professional stated this was not her patient and did not want to report adverse events. This case was linked with US2018GSK093084, reported by the same reporter for the same patient and US2018GSK092161, reported by the same reported.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Bedridden, Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain in a 63-year-old male patient who received SHINGRIX. Previously administered products included Shingles Vaccine with an associated reaction of no adverse event (some years ago). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site discoloration, injection site warmth and bedridden. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site discoloration, injection site warmth and bedridden were unknown. It was unknown if the reporter considered the injection site pain, injection site pain, injection site erythema, injection site discoloration, injection site warmth and bedridden to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient. The patient received SHINGRIX vaccine on right arm. The patient wanted to report the worst reaction he had ever experienced, after receiving a SHINGRIX vaccine (reported as Shingret vaccine). Neither his physician nor his pharmacist warned him of the possible adverse reaction to the vaccine. The patient was given the SHINGRIX vaccine on a Friday afternoon, and he found himself confined to bed for 3 full days and 2 partial days. The patient reported that, to the touch on the place on his right arm where the vaccine was given, within 1 hour the patient noticed a red or black mark on his arm the size of a softball. It started to elevate his skin and was warm to the touch. No matter how he tried to position himself, it ached constantly. Again, he wanted to state that this injection was the worst he had ever experienced. If he had known that he would have been in pain for the amount of time described, he would not have taken the vaccine. The patient's conclusion was that it was not tested enough and that the FDA and GSK rushed it to market. The patient was requesting the information that he should have been given with large warning labels describing the side effects. And the worst part was that he had to go back and get a second injection of SHINGRIX. The patient wanted to know the research on the reaction to the second injection.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain in a 63-year-old male patient who received SHINGRIX. Previously administered products included Shingles Vaccine with an associated reaction of no adverse event (some years ago). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site discoloration, injection site warmth and bedridden. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site discoloration, injection site warmth and bedridden were unknown. It was unknown if the reporter considered the injection site pain, injection site pain, injection site erythema, injection site discoloration, injection site warmth and bedridden to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient. The patient received SHINGRIX vaccine on right arm. The patient wanted to report the worst reaction he had ever experienced, after receiving a SHINGRIX vaccine (reported as Shingret vaccine). Neither his physician nor his pharmacist warned him of the possible adverse reaction to the vaccine. The patient was given the SHINGRIX vaccine on a Friday afternoon, and he found himself confined to bed for 3 full days and 2 partial days. The patient reported that, to the touch on the place on his right arm where the vaccine was given, within 1 hour the patient noticed a red or black mark on his arm the size of a softball. It started to elevate his skin and was warm to the touch. No matter how he tried to position himself, it ached constantly. Again, he wanted to state that this injection was the worst he had ever experienced. If he had known that he would have been in pain for the amount of time described, he would not have taken the vaccine. The patient's conclusion was that it was not tested enough and that the FDA and GSK rushed it to market. The patient was requesting the information that he should have been given with large warning labels describing the side effects. And the worst part was that he had to go back and get a second injection of SHINGRIX. The patient wanted to know the research on the reaction to the second injection.
Sex: M
Vaccine: MENB
Symptoms: Dermatitis contact, Folliculitis, Rash
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of contact dermatitis in a 17-year-old male patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, several days after receiving BEXSERO, the patient experienced contact dermatitis, folliculitis and rash. On an unknown date, the outcome of the contact dermatitis, folliculitis and rash were unknown. It was unknown if the reporter considered the contact dermatitis, folliculitis and rash to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient's parent reported that the patient had rash on his legs few days after vaccination with BEXSERO. There was no rash near the injection site and no fever as well. The physician felt it was folliculitis or contact dermatitis. The patient's parents were concerned it was related to BEXSERO.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Chest X-ray, Chest pain, Chills, Computerised tomogram
Clinical narrative: None stated.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Concussion, Electrocardiogram, Feeling abnormal, Feeling of body temperature change, Influenza like illness
Clinical narrative: None stated.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Middle insomnia, Neck pain, Pain, Pruritus generalised
Clinical narrative: None stated.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Suture insertion, Troponin, Urine analysis
Clinical narrative: None stated.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 78-year-old female patient who received SHINGRIX. Concurrent medical conditions included drug allergy (The patient had IMURAN and TYLENOL allergy, where IMURAN caused temperature increase to 103). On 18th April 2018 14:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 19th April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema, injection site discoloration and injection site warmth. The patient was treated with antibiotics nos. On an unknown date, the outcome of the injection site swelling and injection site erythema were not recovered/not resolved and the outcome of the injection site discoloration and injection site warmth were unknown. The reporter considered the injection site swelling and injection site erythema to be probably related to SHINGRIX. It was unknown if the reporter considered the injection site discoloration and injection site warmth to be related to SHINGRIX. Additional information was reported as follows: The patient took other unknown medications as concomitant medication. The patient after vaccination with SHINGRIX developed a pink, swollen, hot area at the injection site that was red at the time of reporting and swollen. The area was black and blue at the center that looks like a bug bite. The patient had been prescribed with antibiotics and an ointment, but they do not appear to be helping.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in an unspecified number of adult patients who received SHINGRIX. 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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not applicable for this report. The healthcare professional did not have patient's specific information. The healthcare professional reported that for every 5 patients she vaccinates with SHINGRIX, about 2 of them or roughly half, complained of a sore arm after the fact. The reporter did counsel them ahead of time that this would occur but they state it was more sore than they expect it to be. It lasted about 1 or 2 days and then resolved. The reporter just stated this as a general statement.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a female patient who received SHINGRIX. 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 general body pain and fever. On an unknown date, the outcome of the general body pain and fever were recovered/resolved. It was unknown if the reporter considered the general body pain and fever to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The pharmacist stated that the patient picked up a prescription for SHINGRIX and went to the physician's office to had SHINGRIX administered. The pharmacist stated the patient said that body aches and fever lasted about 2 days and resolved on the 3rd day. The healthcare professional did not have any additional details.