chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Lung infection, Pericarditis
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pericarditis in a 60-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 10 days after receiving SHINGRIX, the patient experienced pericarditis (serious criteria GSK medically significant) and lung infection (serious criteria GSK medically significant). On an unknown date, the outcome of the pericarditis and lung infection were unknown. It was unknown if the reporter considered the pericarditis and lung infection to be related to SHINGRIX. Additional details were reported as follow: The patient was from other physician's patient. The age at vaccination was not reported. At the time of reporting, the patient was 60 years old. The patient was in excellent physical condition with regular workout regimens and very healthy diets. The patient's wife was a clinical psychologist at hospital. In between June to August 2018, the patient received SHINGRIX. The patient reported that, after initial infection of the pericardium the patient's lungs were also involved. The patient was not hostile to vaccines and the patient's friend spent several years advocating for evidence-based medicine. The patient considered the coincidence, had just learned of the reporter's expertise and interest in this particular area of vaccine research, the patient thought the reporter might be interested in pursuing this further. The patient was happy to grant the access to his chart and the patient's friend had similarly willing to share his information. The patient had given the consent to contact him either by email or by the phone call. The patient's friend also experienced similar events (refer case US2018GSK215671). Follow up information received on 30th November 2018: The physician granted the access by the pericarditis patients to their files.
Sex: M
Vaccine: VARZOS
Symptoms: Lung infection, Pericarditis
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pericarditis in a 60-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 10 days after receiving SHINGRIX, the patient experienced pericarditis (serious criteria GSK medically significant) and lung infection (serious criteria GSK medically significant). On an unknown date, the outcome of the pericarditis and lung infection were unknown. It was unknown if the reporter considered the pericarditis and lung infection to be related to SHINGRIX. Additional details were reported as follow: The case was reported by the patient's friend. The age at vaccination was not reported. At the time of reporting, the patient was 60 years old. The patient was in excellent physical condition with regular workout regimens and very healthy diets. The patient received SHINGRIX several months before the time of reporting. It was reported that, after initial infection of the pericardium the patient's lungs were also involved. The event was treated at hospital. The patient's friend was not hostile to vaccines and the patient spent several years advocating for evidence-based medicine. The patient's friend considered the coincidence, had just learned of the reporter's expertise and interest in this particular area of vaccine research, his thought the reporter might be interested in pursuing this further. The patient's friend was happy to grant the access to his chart and the patient's friend had similarly willing to share his information. The patient's friend had given the consent to contact him either by email or by the phone call. The patient's friend also experienced similar events (refer case US2018GSK215669). Follow up information received on 30th November 2018: The physician granted the access by the pericarditis patients to their files.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On 28th November 2018, the patient received SHINGRIX. In November 2018, less than a week 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. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received shingles shot a day before reporting and experienced sore arm. The patient wanted to know how long her arm would be sore. The patient did not have time for providing additional details. This case has been linked to the case US2018GSK216567 (husband's case), reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, 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 male patient who received SHINGRIX for prophylaxis. On 28th November 2018, the patient received SHINGRIX. In November 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm and influenza-like symptoms. On an unknown date, the outcome of the pain in arm and influenza-like symptoms were not recovered/not resolved. It was unknown if the reporter considered the pain in arm and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient received shingles shot a day before reporting and experienced sore arm and he felt like he had flu like symptoms. The reporter wanted to know how long patient's arm would be sore and also about the flu like symptoms. The patient did not have time for providing additional details. This case has been linked to the case US2018GSK216566, reported by the same reporter.
Sex: U
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional details were received as follows: The age at vaccination was not reported. The patient presented with injection site pain which lasted for 10 days. The reporter did not agree to receive follow up from GlaxoSmithKline.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of fever in a 60-year-old male patient who received SHINGRIX for prophylaxis. On 5th July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and vomiting. On an unknown date, the outcome of the fever and vomiting were recovered/resolved. It was unknown if the reporter considered the fever and vomiting to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the office manager/ vaccine coordinator. The age at vaccination was not reported, however it could be 59 or 60 years. The patient received a dose of SHINGRIX in the office. The patient experienced a temperature of 105 degrees and vomiting. The patient went to emergency room. The symptoms were acute and lasted for 1 to 2 days. The reporter did not agree to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of ophthalmic herpes zoster in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 122 days after receiving SHINGRIX, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the ophthalmic herpes zoster was unknown. It was unknown if the reporter considered the ophthalmic herpes zoster to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported having shingles approximately 4 months from receiving a dose of SHINGRIX. It occurred around his eye previously and he reported did have in eye. The patient did eventually completed the series with 2nd dose of SHINGRIX on an unknown date. The patient agreed to be contacted for follow up.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Accidental underdose, Exposure via skin contact, Fatigue, Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 80-year-old female patient who received SHINGRIX for prophylaxis.  Co-suspect products included SHINGRIX for prophylaxis. On 16th July 2018, the patient received the 1st dose of SHINGRIX. On 27th October 2018, the patient received the 2nd dose of SHINGRIX. On 16th July 2018, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. On 28th October 2018, the patient experienced injection site erythema and injection site swelling. On 29th October 2018, the patient experienced injection site itching, general body pain and tiredness. In November 2018, the outcome of the injection site erythema and injection site itching were recovered/resolved. On an unknown date, the outcome of the injection site swelling, general body pain and tiredness were recovered/resolved and the outcome of the accidental underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site itching, general body pain and tiredness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported The patient reported that while administering 1st dose, vaccine ran down her arm when injected, when led to accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. The patient did not know how much of the vaccine if any she received. The patient did not experience any injection site reactions from that dose. The following day after 2nd dose, the injection area was red and swollen. The area of redness measured 2.5 inches in diameter.  The following day after vaccination she also felt achy all over and tired and the injection site became itchy. The swelling lasted 3 to 4 days. The redness and itchiness lasted a total of 7 days.  The achy and tiredness lasted 2 days. The patient had consented to follow up and provided contact details of the physician.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 80-year-old female patient who received SHINGRIX for prophylaxis.  Co-suspect products included SHINGRIX for prophylaxis. On 16th July 2018, the patient received the 1st dose of SHINGRIX. On 27th October 2018, the patient received the 2nd dose of SHINGRIX. On 16th July 2018, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. On 28th October 2018, the patient experienced injection site erythema and injection site swelling. On 29th October 2018, the patient experienced injection site itching, general body pain and tiredness. In November 2018, the outcome of the injection site erythema and injection site itching were recovered/resolved. On an unknown date, the outcome of the injection site swelling, general body pain and tiredness were recovered/resolved and the outcome of the accidental underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site itching, general body pain and tiredness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported The patient reported that while administering 1st dose, vaccine ran down her arm when injected, when led to accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. The patient did not know how much of the vaccine if any she received. The patient did not experience any injection site reactions from that dose. The following day after 2nd dose, the injection area was red and swollen. The area of redness measured 2.5 inches in diameter.  The following day after vaccination she also felt achy all over and tired and the injection site became itchy. The swelling lasted 3 to 4 days. The redness and itchiness lasted a total of 7 days.  The achy and tiredness lasted 2 days. The patient had consented to follow up and provided contact details of the physician.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. The reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had a sore arm at the injection site after receiving his dose of SHINGRIX vaccine. The call center representative was unable to obtain the physician's name and phone number secondary to call flow.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 14th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 14th June 2018, less than a day 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 details were provided as follows: The patient received SHINGRIX in the right arm. After receiving SHINGRIX, she experienced arm soreness for one week and her right arm was very painful. The pain and soreness resolved after one week. Consent to follow up was given.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 23rd May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. In July 2018, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported an adverse event via click to chat. The age at vaccination was not reported. The age at vaccination was not applicable for 2nd dose report. The healthcare professional reported, the patient that received SHINGRIX vaccine then contracted shingles at the end of July. The patient was now due for her 2nd dose of SHINGRIX. Till the date of this report, the patient had not received the 2nd dose of SHINGRIX, which led to incomplete course of vaccination. The reporter wanted to know whether the 2nd dose was advisable to be given when the patient had shingles 4 months ago. Later, chat disconnected. It was unable to clarify if healthcare professional would like follow up.  When asked for patient and product identifiers, the healthcare professional stated, that he was not working on the day of reporting. Would be working on following day and could furnish that information. The patient wanted to know if she could receive her 2nd vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Influenza like illness, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of discomfort in a female patient who received SHINGRIX for prophylaxis. On 23rd July 2018, the patient received SHINGRIX. On 23rd July 2018, 16 hrs after receiving SHINGRIX, the patient experienced discomfort, fever and influenza-like symptoms. On an unknown date, the outcome of the discomfort, fever and influenza-like symptoms were unknown. It was unknown if the reporter considered the discomfort, fever and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that, 16 hours after she had the vaccine administered in her left arm she felt very uncomfortable and had a low grade fever. The patient stated she felt like she had the flu. The reporter did not give consent to follow up with a pharmacy.
Age: 9.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of localized itching in a 9-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season (batch number YA95S, expiry date 30th June 2019) for prophylaxis. On 23rd November 2018, the patient received the 1st dose of FLUARIX QUADRIVALENT 2018-2019 season (intramuscular). On 23rd November 2018, 30 min after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced localized itching, rash and hives. The patient was treated with BENADRYL. On an unknown date, the outcome of the localized itching, rash and hives were unknown. It was unknown if the reporter considered the localized itching, rash and hives to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: This case was reported by a physician assistant. The patient received FLUARIX QUADRIVALENT 2018-2019 season on the left arm. The patient experienced itching on her feet, and rash and hives on her arms, back, and legs. Reporter's Comments: The Physician's Assistant (PA) reported that the patient experienced itching on her feet, and rash and hives on her arms, back, and legs thirty minutes after the injection. The PA reported that the patient was treated with BENADRYL.
Age: 9.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of localized itching in a 9-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season (batch number YA95S, expiry date 30th June 2019) for prophylaxis. On 23rd November 2018, the patient received the 1st dose of FLUARIX QUADRIVALENT 2018-2019 season (intramuscular). On 23rd November 2018, 30 min after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced localized itching, rash and hives. The patient was treated with BENADRYL. On an unknown date, the outcome of the localized itching, rash and hives were unknown. It was unknown if the reporter considered the localized itching, rash and hives to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: This case was reported by a physician assistant. The patient received FLUARIX QUADRIVALENT 2018-2019 season on the left arm. The patient experienced itching on her feet, and rash and hives on her arms, back, and legs. Reporter's Comments: The Physician's Assistant (PA) reported that the patient experienced itching on her feet, and rash and hives on her arms, back, and legs thirty minutes after the injection. The PA reported that the patient was treated with BENADRYL.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Cardiac operation, Mitral valve prolapse, Transfusion, Vascular graft
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of mitral valve prolapse in a 67-year-old male patient who received SHINGRIX for prophylaxis. On 21st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 12th September 2018, less than a year after receiving SHINGRIX, the patient experienced mitral valve prolapse (serious criteria hospitalization). The patient was treated with blood transfusion, auxiliary products (Blood Transfusion) and non-drug therapy (Surgery). On an unknown date, the outcome of the mitral valve prolapse was recovering/resolving. It was unknown if the reporter considered the mitral valve prolapse to be related to SHINGRIX. Additional information was reported as follows: After vaccination with the first dose of SHINGRIX on right arm, the patient underwent a open heart surgery to fix mitral valve prolapse and carried out two bypass surgeries. The patient received blood transfusions during and after the surgery. The patient was hospitalised for a total period of 7 days. At the time of reporting, the patient was recovering. The patient enquired if he should receive the SHINGRIX vaccine considering that he had received a blood transfusion. The patient was referred to his health care provider. The reporter provided information as per content. The reporter gave consent to follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 67-year-old male patient who received SHINGRIX for prophylaxis.  On 3rd October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site muscle pain and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site muscle pain and injection site itching were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site muscle pain and injection site itching to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in the left deltoid. The pharmacist reported that the issues the patient experienced resolved in one week.
Age: 25.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, Psychiatric symptom
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of psychiatric symptom in a 25-year-old male patient who received Flu Seasonal QIV Dresden for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden for prophylaxis. Concurrent medical conditions included autistic disorder and mutism. On 2nd November 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On 29th November 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On 19th November 2018, 17 days after receiving Influenza vaccine Quadrivalent 2018-2019 season and not applicable after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced psychiatric symptom (serious criteria hospitalization). On 29th November 2018, the patient experienced extra dose administered. On an unknown date, the outcome of the psychiatric symptom and extra dose administered were unknown. It was unknown if the reporter considered the psychiatric symptom to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: This case was reported by the patient's mother. On 2nd November 2018, the patient went to a physician visit with primary care on received first flu vaccine. The reporter reported that the patient had annual flu vaccinations, and it so happened that the patient was hospitalized for psychiatric reasons on 19th November 2018 and was discharged on 29th November 2018.  The patient's mother was upset because on his discharge papers, it indicated that they had given him a second flu vaccine without her knowledge or consent, which led to extra dose administered.  The patient received second flu vaccinations prior to discharge from a psychiatric hospital on 29th November 2018. The patient's mother was concerned about possible side effects. The patient's mother also mentioned the patient was given a pneumococcal vaccine unauthorized by her. The reporter gave consent to follow up.
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 28-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 21 years old male patient received vaccine MENACTRA twice on 22-Oct-2018 (lot number, expiry date, dose in series and route were not reported) and on 27-Nov-2018 (lot number: U5984AC, expiry date, dose in series and route was not reported) in the right arm. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. It was a case of actual medication error due to extra dose administered. No adverse reactions reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Insomnia, Tremor
Clinical narrative: For about 24 hours, I had very sore joints and shakes in bed, not exactly feverish, but chilled as though I were feverish. I couldn't sleep all night and these effects were felt until after 4-5:00 in the afternoon - about 24 hours after receiving the second SHINGRIX shot.
Age: 0.17
Sex: M
Vaccine: DTAP
Symptoms: Crying, Diet refusal, Irritability
Clinical narrative: Mother called the office the morning after the immunization to report the infant had cried inconsolably for 3-4 hours. She reports that nothing worked to soother him, she tried breastfeeding, rocking, swaddling, Infant Tylenol 1.25 ml by mouth, swinging, walking the floors while holding him and warm bath without relief. After he stopped the continuous crying he remained irritable and wouldn't eat the rest of the night and the next morning, crying off and on. Mother reports the afternoon of 12/6/18 he finally breastfed and was back to his normal.
Age: 64.0
Sex: F
Vaccine: HEPA
Symptoms: Arthralgia, Grip strength decreased, Injected limb mobility decreased, Injection site nerve damage, Injection site pain
Clinical narrative: States around 5:00 PM she noted her arm was sore at the injection site and her arm was hurting below the elbow. The pain worsened and spread to the palm of her hand and wrist. Around 3:00 AM, Friday morning, the pain became worse, waking her up. Pain continued from the elbow down into the hand, wrist area, was unable to bend her arm, no strength or grip in the hand. If she placed her hand flat on a table, she experienced excruciating pain in the palm of her hand and fingers. Following this, she experienced tingling between her fingers. Friday morning she contacted her family physician, described her symptoms and he stated he stated he believed a nerve had been hit during the injection process, instructed her to go to an urgent care for an X-ray to rule out a fracture. Client went to urgent care. X-ray was performed, negative for fracture. Physician provided same diagnosis as family physician, Radical Nerve (unsure of last word). Prescribed Prednisone and Neurontin. Was instructed to stop Prednisone when symptoms improved. Client state she took Prednisone Friday - Sunday, and stopped on Monday, December 3. Continues Neurontin, takes AM and PM. Pain is greatly improved, continues to have sore palm of wrist. Recovering but not fully recovered.
Age: 64.0
Sex: F
Vaccine: HEPA
Symptoms: Pain in extremity, Paraesthesia, Sleep disorder, X-ray normal
Clinical narrative: States around 5:00 PM she noted her arm was sore at the injection site and her arm was hurting below the elbow. The pain worsened and spread to the palm of her hand and wrist. Around 3:00 AM, Friday morning, the pain became worse, waking her up. Pain continued from the elbow down into the hand, wrist area, was unable to bend her arm, no strength or grip in the hand. If she placed her hand flat on a table, she experienced excruciating pain in the palm of her hand and fingers. Following this, she experienced tingling between her fingers. Friday morning she contacted her family physician, described her symptoms and he stated he stated he believed a nerve had been hit during the injection process, instructed her to go to an urgent care for an X-ray to rule out a fracture. Client went to urgent care. X-ray was performed, negative for fracture. Physician provided same diagnosis as family physician, Radical Nerve (unsure of last word). Prescribed Prednisone and Neurontin. Was instructed to stop Prednisone when symptoms improved. Client state she took Prednisone Friday - Sunday, and stopped on Monday, December 3. Continues Neurontin, takes AM and PM. Pain is greatly improved, continues to have sore palm of wrist. Recovering but not fully recovered.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Blood immunoglobulin A decreased, Blood immunoglobulin E normal, Blood thyroid stimulating hormone normal, Full blood count normal, Injection site urticaria
Clinical narrative: The patient developed hives at the site of injection the following day. The hives spread to his face within 2-3 days. He continued to have intermittent hives over the course of the next month. He was evaluated by allergy who thought the hives were likely due to the vaccine.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: The patient developed hives at the site of injection the following day. The hives spread to his face within 2-3 days. He continued to have intermittent hives over the course of the next month. He was evaluated by allergy who thought the hives were likely due to the vaccine.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site injury, Injection site pain
Clinical narrative: Left shoulder injury, pain, difficulty with ROM at 4 weeks post immunization injection.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Allergy test positive, Arthralgia, Blood test normal, Borrelia test negative, Dust allergy
Clinical narrative: 10/14/18 GOT THE FLU SHOT 10/24/18 - WAS SEEN AT DOCTOR FOR RASH THAT STARTED 10/21/18. DIAGNOSIS WAS PITORYASIS ROSEA. 11/1 RASH BECAME ITCHY AND SPREAD THROUGHOUT WHOLE BODY. WENT TO URGENT CARE. WAS TOLD POSSIBLE FUNGAL RASH. GIVEN CREAM AND SHAMPOO. DID NOT HELP 11/2 - FOLLOW UP W DERMATOLOGIST. PITORYOSIS ROSEA RE-CONFIRMS. GIVEN TOPICAL STEROID CREAM. TOLD TO TAKE THIS WITH BENADRYL TO HELP ITCH. 11/4 PATIENT'S HANDS SWELLED UP, ITCHING WOULD NOT STOP WITH BENADRYL FEET SWELLED UP TURNED YELLOWISH COLOR. MIGRATING JOINT PAIN (UNABLE TO CLOSE FINGERS DUE TO PAIN, KNEE HURT, ANKLES AND TOES HURT) TOOK TO ER. WAS ADMITTED FOR 2 DAYS. GIVEN ORAL STEROID, STRONGER ANTI-HISTAMINE (ATARAX 25MG EVERY 6 HRS) 11/7 FOLLOW UP WITH DR PEDIATRICS. GIVEN PREDISONE FOR 5 DAYS. SWELLING WENT DOWN. JOINT PAIN STILL MIGRATING (ONE DAY IT IS KNEE, NEXT DAY SHOULDER, ELBOW ETC TO A POINT WHERE SHE CANNOT MOVE THAT JOINT) 11/15 FOLLOW UP DR. RUNS ANOTHER FULL BLOOD WORK UP ON HER. SAW ALLERGIST. PATIENT IS ALLERGIC TO DUST. THIS WOULD NOT HAVE CAUSED THIS TYPE OR REACTION. (BLOOD WORK COMES BACK WITH NO MARKER FOR LYME, RHEUMATOID ISSUE, ILLNESS, STREP OR ANY OTHER UNDERLYING CONDITION.) TO THIS DAY, PATIENT STILL GETS SLIGHTLY ITCHY DURING COLD CONDITIONS, JOINT PAIN HAS SUBSIDED (LAST FLARE UP WAS 11/29) NO HIVES OR RASHES FOR 1 WEEK. HAS STOPPED TAKING ATARAX. IS STILL TAKING DAILY ZYRTEC AND PEPCID AS PRESCRIBED BY ALLERGIST. HAS FOLLOWED UP WITH 2 OTHER ALLERGY APPOINTMENTS WHERE THEY HAVE FOUND NOTHING AND HAS AN APPOINTMENT WITH INFECTIOUS DISEASE DR TO RULE OUT ANYTHING ELSE.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Peripheral swelling, Pityriasis rosea, Rash generalised, Rash pruritic
Clinical narrative: 10/14/18 GOT THE FLU SHOT 10/24/18 - WAS SEEN AT DOCTOR FOR RASH THAT STARTED 10/21/18. DIAGNOSIS WAS PITORYASIS ROSEA. 11/1 RASH BECAME ITCHY AND SPREAD THROUGHOUT WHOLE BODY. WENT TO URGENT CARE. WAS TOLD POSSIBLE FUNGAL RASH. GIVEN CREAM AND SHAMPOO. DID NOT HELP 11/2 - FOLLOW UP W DERMATOLOGIST. PITORYOSIS ROSEA RE-CONFIRMS. GIVEN TOPICAL STEROID CREAM. TOLD TO TAKE THIS WITH BENADRYL TO HELP ITCH. 11/4 PATIENT'S HANDS SWELLED UP, ITCHING WOULD NOT STOP WITH BENADRYL FEET SWELLED UP TURNED YELLOWISH COLOR. MIGRATING JOINT PAIN (UNABLE TO CLOSE FINGERS DUE TO PAIN, KNEE HURT, ANKLES AND TOES HURT) TOOK TO ER. WAS ADMITTED FOR 2 DAYS. GIVEN ORAL STEROID, STRONGER ANTI-HISTAMINE (ATARAX 25MG EVERY 6 HRS) 11/7 FOLLOW UP WITH DR PEDIATRICS. GIVEN PREDISONE FOR 5 DAYS. SWELLING WENT DOWN. JOINT PAIN STILL MIGRATING (ONE DAY IT IS KNEE, NEXT DAY SHOULDER, ELBOW ETC TO A POINT WHERE SHE CANNOT MOVE THAT JOINT) 11/15 FOLLOW UP DR. RUNS ANOTHER FULL BLOOD WORK UP ON HER. SAW ALLERGIST. PATIENT IS ALLERGIC TO DUST. THIS WOULD NOT HAVE CAUSED THIS TYPE OR REACTION. (BLOOD WORK COMES BACK WITH NO MARKER FOR LYME, RHEUMATOID ISSUE, ILLNESS, STREP OR ANY OTHER UNDERLYING CONDITION.) TO THIS DAY, PATIENT STILL GETS SLIGHTLY ITCHY DURING COLD CONDITIONS, JOINT PAIN HAS SUBSIDED (LAST FLARE UP WAS 11/29) NO HIVES OR RASHES FOR 1 WEEK. HAS STOPPED TAKING ATARAX. IS STILL TAKING DAILY ZYRTEC AND PEPCID AS PRESCRIBED BY ALLERGIST. HAS FOLLOWED UP WITH 2 OTHER ALLERGY APPOINTMENTS WHERE THEY HAVE FOUND NOTHING AND HAS AN APPOINTMENT WITH INFECTIOUS DISEASE DR TO RULE OUT ANYTHING ELSE.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Rheumatoid factor negative, Streptococcus test negative, Viral test negative, Yellow skin
Clinical narrative: 10/14/18 GOT THE FLU SHOT 10/24/18 - WAS SEEN AT DOCTOR FOR RASH THAT STARTED 10/21/18. DIAGNOSIS WAS PITORYASIS ROSEA. 11/1 RASH BECAME ITCHY AND SPREAD THROUGHOUT WHOLE BODY. WENT TO URGENT CARE. WAS TOLD POSSIBLE FUNGAL RASH. GIVEN CREAM AND SHAMPOO. DID NOT HELP 11/2 - FOLLOW UP W DERMATOLOGIST. PITORYOSIS ROSEA RE-CONFIRMS. GIVEN TOPICAL STEROID CREAM. TOLD TO TAKE THIS WITH BENADRYL TO HELP ITCH. 11/4 PATIENT'S HANDS SWELLED UP, ITCHING WOULD NOT STOP WITH BENADRYL FEET SWELLED UP TURNED YELLOWISH COLOR. MIGRATING JOINT PAIN (UNABLE TO CLOSE FINGERS DUE TO PAIN, KNEE HURT, ANKLES AND TOES HURT) TOOK TO ER. WAS ADMITTED FOR 2 DAYS. GIVEN ORAL STEROID, STRONGER ANTI-HISTAMINE (ATARAX 25MG EVERY 6 HRS) 11/7 FOLLOW UP WITH DR PEDIATRICS. GIVEN PREDISONE FOR 5 DAYS. SWELLING WENT DOWN. JOINT PAIN STILL MIGRATING (ONE DAY IT IS KNEE, NEXT DAY SHOULDER, ELBOW ETC TO A POINT WHERE SHE CANNOT MOVE THAT JOINT) 11/15 FOLLOW UP DR. RUNS ANOTHER FULL BLOOD WORK UP ON HER. SAW ALLERGIST. PATIENT IS ALLERGIC TO DUST. THIS WOULD NOT HAVE CAUSED THIS TYPE OR REACTION. (BLOOD WORK COMES BACK WITH NO MARKER FOR LYME, RHEUMATOID ISSUE, ILLNESS, STREP OR ANY OTHER UNDERLYING CONDITION.) TO THIS DAY, PATIENT STILL GETS SLIGHTLY ITCHY DURING COLD CONDITIONS, JOINT PAIN HAS SUBSIDED (LAST FLARE UP WAS 11/29) NO HIVES OR RASHES FOR 1 WEEK. HAS STOPPED TAKING ATARAX. IS STILL TAKING DAILY ZYRTEC AND PEPCID AS PRESCRIBED BY ALLERGIST. HAS FOLLOWED UP WITH 2 OTHER ALLERGY APPOINTMENTS WHERE THEY HAVE FOUND NOTHING AND HAS AN APPOINTMENT WITH INFECTIOUS DISEASE DR TO RULE OUT ANYTHING ELSE.
Age: 45.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Feeling cold, Headache, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Increased systemic muscle aches, myalgia, chills to the point of missed work. Fishbowl headache. No nausea, no vomiting. No irritation at the injection sites.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting, diarrhea.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Allergy to vaccine, Chills, Differential white blood cell count, Full blood count, Metabolic function test
Clinical narrative: Second Dose of BEXSERO given in appropriate time frame and no prior reaction to previous dose of BEXSERO. Mother states child developed fever and chills about 1 hour after receiving vaccine. Mother then proceeded to say another hours passed and patient started to have vomiting. Fever went to 102 and mother called the Nurse Advice line who told her to take child to the emergency room. Mother complied and was sent to Hospital ER--Was given IV Fluids and ZOFRAN. Mother states was told this is an Allergy to the vaccine. Patient was discharged in approximately 2.5 hours later.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia, Vomiting
Clinical narrative: Second Dose of BEXSERO given in appropriate time frame and no prior reaction to previous dose of BEXSERO. Mother states child developed fever and chills about 1 hour after receiving vaccine. Mother then proceeded to say another hours passed and patient started to have vomiting. Fever went to 102 and mother called the Nurse Advice line who told her to take child to the emergency room. Mother complied and was sent to Hospital ER--Was given IV Fluids and ZOFRAN. Mother states was told this is an Allergy to the vaccine. Patient was discharged in approximately 2.5 hours later.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Chills, Diarrhoea, Headache, Influenza like illness
Clinical narrative: Explosive diarrhea, extreme flu like symptoms, headache, felt like my bones were on fire and I was shivering - these lasted for about 30 hours after the vaccine. I stayed in bed for the duration.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Crying, Injection site erythema, Injection site swelling, Loss of personal independence in daily activities, Pain
Clinical narrative: Significant Swelling and redness right deltoid area extending down to 4 cm above elbow. Painful, child crying. Had to be picked up from school.
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Joint range of motion decreased, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Pain and decreased ROM, unable to lift arm higher than shoulder height or towards the mid line started on 11/1/2018. Around 1 week slight improvement to ROM, can lift arm higher than shoulder, but decreased strength noted. Using Ibuprofen and Tylenol daily. Around 11/19 started taking Ibuprofen 800 mg every 6 hours and applying heat to arm for short intervals. Some improvement noted. 12/3 Pain extending to bicep and difficulty dressing and undressing. Decreased strength continues.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Malaise, Pain
Clinical narrative: Fever 102F for 24 hours, sweats, chills, bodyache, headache, malaise.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever 102F for 24 hours, sweats, chills, bodyache, headache, malaise.
Age: 21.0
Sex: F
Vaccine: FLUX, HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a pharmacist refers to a female patient of unknown age. The patient had none concomitant medication, none pertinent medical history and none drug reactions or allergies. The LMP and EDD was not known. On 05-NOV-2018, the pregnant patient was inadvertently vaccinated with GARDASIL 9, 1 dosage form, intramuscularly (exact dose, lot number and expiration date were not reported). Other suspect therapies included influenza virus vaccine (unspecified). Trimester of exposure was unknown. The patient experienced no adverse event. The pregnancy outcome was pending. No treatment was given for the adverse event. None lab diagnostics/studies were performed. The patient did not seek medical attention. No intervention was made to prevent serious criteria. The patient did not die, was not hospitalized. The event was not life threatening. There was no PQC present.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding patient of unknown age and gender. Information on patient's concurrent conditions, medical history, drug allergies and concomitant medications were not reported. On 25-NOV-2018, the patient was inadvertently vaccinated with expired dose of VAQTA (strength and dose were not reported) (lot#  N020951 and expiry 15-OCT-2018) intramuscularly for prophylaxis (expired product administered). No adverse effects was reported. The outcome of the event was unknown. No Product Quality Complaint was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This spontaneous report was received from a lawyer and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies were provided. On an unknown date (reported also as "in 2017"), the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose and anatomical location were not provided) for permanent prevention and protection against shingles and zoster- related injuries at the pharmacy. On an unknown day in December in 2016 (reported also as "on or about December 16, 2016"), the vaccine did not prevent shingles as intended, and the patient subsequently was treated for shingles in medical center. The patient was diagnosed with shingles and/ or zoster-related injuries and suffered serious physical, emotional and economic damages as a result of this injury. The patient has continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering, extensive medical care and treatment for these injuries, significant medical and related expenses as a result of these injuries, including but not limited to medical losses costs include care for hospitalization, physical care, monitoring, treatment, medications and supplies, diminished capacity for enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions, lost wages, loss of earnings capacity and other losses and damages. The outcome of herpes zoster was reported as not recovered. The outcome of vaccination failure is unknown. The reporter considered herpes zoster and vaccination failure to be related to the suspected therapy.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 18-MAY-2013, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2017, the patient was treated by a healthcare provider at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding patient's concomitant medications, concurrent conditions or medical history. On or about 05-APR-2013, the patient was vaccinated with ZOSTAVAX (strength, dose, route, anatomical location, lot number and expiration date were not reported), to obtain permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) as recommended by the healthcare professional. On an unknown date, the patient experienced shingles (Herpes zoster) and on or about 09-NOV-2016, was treated by healthcare providers at a medical clinic. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX (Vaccination failure) and suffered serious physical, emotional, and economic damages (Emotional distress), as a result of patient's injuries on unknown dates. The patient had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering (Emotional distress) (Pain); extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (Condition aggravated); lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The relatedness between ZOSTAVAX and the aforementioned events was assessed as related by the reporter. The reporter determined all the events to be serious due to disability, life-threatening and medically significant.