chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Nasopharyngitis, Pyrexia, Tremor
Clinical narrative: Fever, body tremors with teeth chattering, dizziness, fatigue. The dizziness and fatigue lasted 4 days. The body tremors woke me up at 5AM 6/15 after the vaccination at 2pm 6/14. The injection of the vaccine itself was very painful. And I barely had any of these symptoms after the first dose except some symptoms of malaise. But the tremors and fever that woke me up at 5 a.m. after I received my 2nd injection the previous day at 2 p.m. were severe. My teeth were chattering and my whole body was shaking. I could barely hold my cup of tea to my mouth. I went back to bed with 2 blankets to recover. It took me 5 - 6 days to recover. Then I caught a cold afterwards which I believe was a consequence of my immune system being compromised. I am fully recovered now after 2 weeks. In spite of all this, I still would rather get the vaccine vs. getting the disease. Please make people aware that these symptoms are possible.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Urticaria
Clinical narrative: 5 x 2 1/2" red warm Hives
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Cardiac monitoring, Dizziness, Hyperhidrosis, Influenza like illness
Clinical narrative: Had some light flu-light symptoms the day after injection.  On second day after injection, was getting a haircut when began sweating profusely.  When stood, became very dizzy and had to sit down and immediately passed out.  Upon returning to consciousness became very nauseated and had to vomit.  Was transported by ambulance to emergency room.  All vitals were fine.  Could find no cause of loss of consciousness.  As a precaution, was given a heart monitor to continue for several days and made an appointment with cardiologist.  Still experiencing some dizziness on day three.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of consciousness, Nausea, Vomiting
Clinical narrative: Had some light flu-light symptoms the day after injection.  On second day after injection, was getting a haircut when began sweating profusely.  When stood, became very dizzy and had to sit down and immediately passed out.  Upon returning to consciousness became very nauseated and had to vomit.  Was transported by ambulance to emergency room.  All vitals were fine.  Could find no cause of loss of consciousness.  As a precaution, was given a heart monitor to continue for several days and made an appointment with cardiologist.  Still experiencing some dizziness on day three.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Loss of personal independence in daily activities
Clinical narrative: Patient experienced severe flu like symptoms to the point he was "unable to do much of anything." Patient is an MD, and took Acetaminophen for his discomfort. These symptoms lasted for 3 days.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Lethargy, Pain in extremity
Clinical narrative: Upper left arm sore for3 days, very lethargic for one day, diarrhea for two days (started the next day)
Age: 22.0
Sex: F
Vaccine: HEPAB
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: patient experinced syncope directly after adminastrion lasting about 40 to 60 seconds.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red swelling and soreness at the site of injection a few hours after injection. Swelling increasing to 2 inches in 24hrs. In 48 hrs redness and swelling is 3.5 inches at the time of reporting. Soreness at site of injection and warm. Fever 36 hours post injection subsequently subsided.  Took benadryl at 36 and 48 hrs post injection and ibuprofin 24 hrs post injection.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 66-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 06-OCT-2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster and was treated by a physician. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live ( ZOSTAVAX).     Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Lymphadenopathy
Clinical narrative: Tender axillary lymphadenopathy; crescent shaped rash at injection site; This case was reported by a physician via call center representative and described the occurrence of lymphadenopathy axillary in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 1 day after receiving Shingrix, the patient experienced lymphadenopathy axillary and injection site rash. On an unknown date, the outcome of the lymphadenopathy axillary and injection site rash were unknown.   It was unknown if the reporter considered the lymphadenopathy axillary and injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The physician wanted to advice on how to manage the side effect. The physician reported that the patient experienced tender axillary lymphadenopathy the morning after the shot was given, it was on the same side as the injection. Less than a day after vaccination the patient experienced crescent shaped rash developed last night in the area of the injection site.
Sex: U
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Mild nausea; This case was reported by a consumer via call center representative and described the occurrence of nausea in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st July 2019, the patient received Shingrix. On 3rd July 2019, 2 days after receiving Shingrix, the patient experienced nausea. On an unknown date, the outcome of the nausea was not recovered/not resolved.   It was unknown if the reporter considered the nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix immunization and experienced mild nausea. The patient asked how long the side effect would last.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Fatigue; myalgia; headache; This case was reported by a nurse via sales rep and described the occurrence of fatigue in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue, myalgia and headache. On an unknown date, the outcome of the fatigue, myalgia and headache were recovered/resolved.   It was unknown if the reporter considered the fatigue, myalgia and headache to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife who herself was a Nurse. The patient received a dose of Shingrix at his primary care location. The patient had similar reactions on both dose 1 and 2, which were fatigue, myalgia, headache and it lasted approximately one day. The reporter said that prior to receiving the vaccine she told the patient that the side effects could be expected from many vaccines, including Shingrix and does attribute the side effects to vaccination. The reporter did not agree for follow-up. This is 1 of the 2 cases reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: headache; upset stomach; muscle aches; Tiredness; ill; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd July 2019, the patient received Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced headache, upset stomach, muscle pain, tiredness and unwell. On an unknown date, the outcome of the headache, upset stomach, muscle pain, tiredness and unwell were unknown.   It was unknown if the reporter considered the headache, upset stomach, muscle pain, tiredness and unwell to be related to Shingrix.  Additional information was provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient received Shingrix and experienced headache, upset stomach, muscle pain and tiredness. The patient was not seriously ill; however the patient was wondering if the patient would be contagious.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: fever; muscle pain; Joint pain; swelling; soreness; couldn't move arm; Product Complaint; This case was reported by a nurse via call center representative and described the occurrence of fever in a 20-year-old female patient who received Men B NVS (Bexsero) (batch number ABX795AA, expiry date 31st August 2020) for prophylaxis. This case was associated with a product complaint.   On 28th June 2019, the patient received the 1st dose of Bexsero .5 ml. On an unknown date, less than a week after receiving Bexsero, the patient experienced fever, muscle pain, joint pain, injection site swelling, injection site pain, injected limb mobility decreased and pharmaceutical product complaint. The patient was treated with intravenous fluid (nos) (Intravenous Fluids). On an unknown date, the outcome of the fever, muscle pain, joint pain, injection site swelling, injection site pain and injected limb mobility decreased were recovering/resolving and the outcome of the pharmaceutical product complaint was unknown.   The reporter considered the fever, muscle pain, joint pain, injection site swelling, injection site pain and injected limb mobility decreased to be related to Bexsero.  Additional details were provided as follows: This case was reported by the Registered Nurse (RN). The reporter administered the 1st dose of Bexsero vaccine to the patient in her left arm. The patient had significant fever, muscle ache and joint pain, swelling and soreness at the injection site and she could not move her arm.   The patient was down for the entire weekend and she was taken to the emergency room and they put her on Intravenous (IV) fluids. The patient was released the same day.   On the day before reporting date, the patient's symptoms had improved.  The emergency room physician believed that, the patient's reaction was related to the vaccination.   The physician of the pediatric practice had a concern that there could be quality issue with the box of Bexsero because two separate patients had similar reactions to the vaccine .  They had three doses remaining in the Bexsero box that they would return to GlaxoSmithKline for investigation. They were not requesting replacement of the vaccine because the physician would not administer the Bexsero again.   The reporter consented to follow up and also provided physician's details. This is 1 of the 2 cases reported by the same reporter.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Product complaint, Pyrexia
Clinical narrative: fever; muscle pain; Joint pain; swelling; soreness; couldn't move arm; Product Complaint; This case was reported by a nurse via call center representative and described the occurrence of fever in a 20-year-old female patient who received Men B NVS (Bexsero) (batch number ABX795AA, expiry date 31st August 2020) for prophylaxis. This case was associated with a product complaint.   On 28th June 2019, the patient received the 1st dose of Bexsero .5 ml. On an unknown date, less than a week after receiving Bexsero, the patient experienced fever, muscle pain, joint pain, injection site swelling, injection site pain, injected limb mobility decreased and pharmaceutical product complaint. The patient was treated with intravenous fluid (nos) (Intravenous Fluids). On an unknown date, the outcome of the fever, muscle pain, joint pain, injection site swelling, injection site pain and injected limb mobility decreased were recovering/resolving and the outcome of the pharmaceutical product complaint was unknown.   The reporter considered the fever, muscle pain, joint pain, injection site swelling, injection site pain and injected limb mobility decreased to be related to Bexsero.  Additional details were provided as follows: This case was reported by the Registered Nurse (RN). The reporter administered the 1st dose of Bexsero vaccine to the patient in her left arm. The patient had significant fever, muscle ache and joint pain, swelling and soreness at the injection site and she could not move her arm.   The patient was down for the entire weekend and she was taken to the emergency room and they put her on Intravenous (IV) fluids. The patient was released the same day.   On the day before reporting date, the patient's symptoms had improved.  The emergency room physician believed that, the patient's reaction was related to the vaccination.   The physician of the pediatric practice had a concern that there could be quality issue with the box of Bexsero because two separate patients had similar reactions to the vaccine .  They had three doses remaining in the Bexsero box that they would return to GlaxoSmithKline for investigation. They were not requesting replacement of the vaccine because the physician would not administer the Bexsero again.   The reporter consented to follow up and also provided physician's details. This is 1 of the 2 cases reported by the same reporter.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Asthenia, Joint stiffness, Loss of personal independence in daily activities, Myalgia, Product complaint
Clinical narrative: Product Complaint; pain/ muscle pain in arms and legs; fever; stiffness; debilitating; This case was reported by a nurse via call center representative and described the occurrence of muscle pain in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABX795AA, expiry date 31st August 2020) for prophylaxis. This case was associated with a product complaint.   On 1st July 2019, the patient received the 1st dose of Bexsero .5 ml. On 1st July 2019, less than a day after receiving Bexsero, the patient experienced muscle pain and fever. In July 2019, the patient experienced stiff joint and weakness. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the muscle pain and stiff joint were not recovered/not resolved and the outcome of the fever, weakness and pharmaceutical product complaint were unknown.   The reporter considered the muscle pain, fever, stiff joint and weakness to be related to Bexsero.  Additional details were provided as follows: This case was reported by the Registered Nurse (RN). The reporter administered the 1st dose of Bexsero to the patient in his left arm. The patient experienced pain, joint stiffness and fever. The patient started to experience muscle pain in his arms and legs around 6:00 PM the day of the vaccination and he has a 101 fever.  The patient's experience was debilitating and it took him away from his normal activities. He could not attend sports camp this week due to these symptoms.   The physician of the pediatric practice had a concern that there could be quality issue with the box of Bexsero because two separate patients had similar reactions to the vaccine (refer case US2019119401).  They had three doses remaining in the Bexsero box that they would return to GlaxoSmithKline for investigation. They were not requesting replacement of the vaccine because the physician would not administer the Bexsero again.   The reporter consented to follow up and also provided physician's details. There is a discrepancy with respect to the outcome of the events muscle pain and stiff joint . In source document, the outcome is reported as recovering/ resolving for all the symptoms, however as per narrative description it is not recovered/ not resolved. The outcome of all the symptoms retains as per the narrative description. This is 1 of the 2 cases reported by the same reporter.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: Product Complaint; pain/ muscle pain in arms and legs; fever; stiffness; debilitating; This case was reported by a nurse via call center representative and described the occurrence of muscle pain in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABX795AA, expiry date 31st August 2020) for prophylaxis. This case was associated with a product complaint.   On 1st July 2019, the patient received the 1st dose of Bexsero .5 ml. On 1st July 2019, less than a day after receiving Bexsero, the patient experienced muscle pain and fever. In July 2019, the patient experienced stiff joint and weakness. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the muscle pain and stiff joint were not recovered/not resolved and the outcome of the fever, weakness and pharmaceutical product complaint were unknown.   The reporter considered the muscle pain, fever, stiff joint and weakness to be related to Bexsero.  Additional details were provided as follows: This case was reported by the Registered Nurse (RN). The reporter administered the 1st dose of Bexsero to the patient in his left arm. The patient experienced pain, joint stiffness and fever. The patient started to experience muscle pain in his arms and legs around 6:00 PM the day of the vaccination and he has a 101 fever.  The patient's experience was debilitating and it took him away from his normal activities. He could not attend sports camp this week due to these symptoms.   The physician of the pediatric practice had a concern that there could be quality issue with the box of Bexsero because two separate patients had similar reactions to the vaccine (refer case US2019119401).  They had three doses remaining in the Bexsero box that they would return to GlaxoSmithKline for investigation. They were not requesting replacement of the vaccine because the physician would not administer the Bexsero again.   The reporter consented to follow up and also provided physician's details. There is a discrepancy with respect to the outcome of the events muscle pain and stiff joint . In source document, the outcome is reported as recovering/ resolving for all the symptoms, however as per narrative description it is not recovered/ not resolved. The outcome of all the symptoms retains as per the narrative description. This is 1 of the 2 cases reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes virus infection
Clinical narrative: herpes outbreak; This case was reported by a nurse via call center representative and described the occurrence of herpes virus infection in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced herpes virus infection. On an unknown date, the outcome of the herpes virus infection was unknown.   It was unknown if the reporter considered the herpes virus infection to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced herpes outbreak. The healthcare professional would like to receive the Valtrex suppression dose due to herpes outbreak. The patient was due for 2nd dose of Shingrix.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: soreness in left arm; bruising left arm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 497D9, expiry date 11th September 2021) for prophylaxis.   On 15th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th June 2019, 14 days after receiving Shingrix, the patient experienced injection site bruising. On an unknown date, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain and injection site bruising were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and injection site bruising to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix on the left arm. The patient experienced soreness in the left arm. On Saturday, less than month after vaccination, the patient developed bruising on the left arm . The outcome of injection site pain and injection site bruising were reported as not recovered/not resolved in the Argus however in source document, it was mentioned as recovering/resolving with sequel.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Impaired work ability, Inappropriate schedule of product administration, Injection site pain, Injection site swelling
Clinical narrative: inappropriate schedule of vaccine; pain at injection site; swelling at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In March 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. In March 2018, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain and injection site swelling to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient received his 1st dose of Shingrix in March 2018. The patient experienced pain and swelling at the site of injection to the point where he missed one day of work and it was intense for about 2 to 3 days and resolved within 5 days.  Till the time of reporting the patient was not received the 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Age: 62.0
Sex: M
Vaccine: RAB
Symptoms: Eyelid rash, Oral mucosal eruption, Petechiae, Rash
Clinical narrative: rash on face/rash on arms/rash on legs/forehead/pinpoint spots; rash on eyelid; rash on mouth palate; pinpoint spots, or petechiae-like; This case was reported by a other health professional via call center representative and described the occurrence of rash in a 62-year-old male patient who received Rabies NVS (RabAvert) (batch number ARBA221A, expiry date 31st July 2022) for prophylaxis.   On 14th June 2019, the patient received RabAvert (intramuscular). On 14th June 2019, 20 min after receiving RabAvert, the patient experienced rash, eyelid rash, rash mouth and petechial rash. The patient was treated with antihistamine (Antihistamines). On an unknown date, the outcome of the rash, eyelid rash, rash mouth and petechial rash were recovered/resolved.   It was unknown if the reporter considered the rash, eyelid rash, rash mouth and petechial rash to be related to RabAvert.  Additional details were provided as follows:  On 14th June, 2019 at 11:00 AM, the physician assistant reported that the patient receive the Rabavert for prophylaxis.  About 20 to 30 minutes later, the patient returned to the office and reported rash about the face, forehead, and eyelids. The rash then spread to the upper and lower extremities. The patient also experienced rash on the upper palate of the mouth. The rash was described as appearing like pinpoint spots, or petechiae-like.  The patient was given antihistamines and monitored and began to improve. The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site swelling
Clinical narrative: swelling around injection site; redness around injection site; This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 95LX9, expiry date 22nd February 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several hours after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The nurse reported that within hours after the injection, the patient experienced very large reaction of redness and swelling (5 inches diameter) around the injection site, which lasted for 5 days. The reporter consented to follow up.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Dermatitis contact, Rash vesicular
Clinical narrative: Left forearm: Contact Dermatitis; Left Forearm: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of contact dermatitis in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis.   On 20th March 2019, the patient received the 1st dose of Shingrix. On 2nd July 2019, 104 days after receiving Shingrix, the patient experienced contact dermatitis and vesicular rash. On an unknown date, the outcome of the contact dermatitis and vesicular rash were unknown.   It was unknown if the reporter considered the contact dermatitis and vesicular rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The reporter gathered the patient information. The healthcare professional stated the patient received Shingrix on 20th March 2019, but report 2nd July rash that appears like contact dermatitis or Shingles.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Mobility decreased, Musculoskeletal stiffness
Clinical narrative: stiff arm; hard time moving arm; This case was reported by a consumer via call center representative and described the occurrence of limbs stiffness in a 16-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 2nd July 2019, the patient received the 1st dose of Bexsero and the 1st dose of Menveo. On 2nd July 2019, less than a day after receiving Bexsero and Menveo, the patient experienced mobility decreased. On 3rd July 2019, the patient experienced limbs stiffness. On an unknown date, the outcome of the limbs stiffness and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the limbs stiffness and mobility decreased to be related to Bexsero and Menveo.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the mother of the patient. Her son received two vaccines one day before reporting. The patient received Bexsero and Menveo vaccines. One was given in the arm and the other one on the thigh. The reporter did not know which one was which. The arm was stiff on the day of reporting and having a hard time moving his arm. As per narrative it seems that the patient experienced hard time moving his arm' on same day of reporting but event onset date was reported as 2nd July 2019 so kept as it is with time to event onset less than a day. The reporter did not have dosing nor lot numbers. The reporter gave consent to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Injected limb mobility decreased, Nausea
Clinical narrative: Started Friday after vaccine. Arm pain (Lt)  Proceeded to inability to move or lift arm Abdominal pain, severe nausea progressed to vomiting. Increased fatigue, and sleep.  Diarrhea This day Wednesday 6/26/19 continue to have abdominal pain.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Somnolence, Vomiting
Clinical narrative: Started Friday after vaccine. Arm pain (Lt)  Proceeded to inability to move or lift arm Abdominal pain, severe nausea progressed to vomiting. Increased fatigue, and sleep.  Diarrhea This day Wednesday 6/26/19 continue to have abdominal pain.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: 7/9 Pt stated her arm was a little sore the day following injection. Her arm continued to get more red & swollen & hot to touch & painful.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Loss of personal independence in daily activities
Clinical narrative: Patient is reporting that she had sever flu type symptoms the 3 days following the dose of the vaccine. Reported that symptoms were so severe that she was unable to do anything other than lay around.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Headache, fever for 48 hrs- 101.6, shivering, aches
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Vaccination site red, swollen, painful  down deltoid toward elbow. Day of vaccination- no problem reported. Day after vaccination symptoms as described. Day#2 after vaccination, things improving, pain less, swelling decreasing.
Age: 20.0
Sex: M
Vaccine: HEPA
Symptoms: Loss of consciousness, Nausea, Syncope
Clinical narrative: Patient fainted within one minute of receiving the injection.  Patient was sitting down and I held the patient so they did NOT hit their head or fall in any way.  Patient awoke within a minute of fainting and felt nauseous but did NOT throw up.  Had the patient lay down for ~15 minutes and gave them a sports drink.  Patient felt normal within 15 minutes and left after 25 minutes with no further complications.  Patient did state they had not had anything to eat for several hours.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: fever >100F, whole body aches, chills, "extremely" sore arm
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash vesicular
Clinical narrative: Shingles type rash on left side of face and arounbd left eye with itching
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Injection site inflammation, Muscle mass, Pain in extremity, Pyrexia
Clinical narrative: Patient got her 2nd  Shingrix shot on Saturday afternoon around 4pm and her arm started hurting at 7:30. It bacame really badly inflammed arounf tje injection site on Sunday. She had a fever of 100.2 and her arm muscle had a knot in it. It was warm and red. On that Tuesday she went to see a DR and he prescribed an antibiotic for her to take. She was not able to work her regular shift on Monday
Age: 18.0
Sex: M
Vaccine: UNK
Symptoms: Decreased appetite, Dizziness, Headache, Nausea
Clinical narrative: nausea, headache, dizziness, loss of appetite. 4 days. Patient self reports receiving meningococcal vaccine (MCV4 listed on immunization record from health department)
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Day 2: tired,muscle pain,shivering,fever,foot cramps - Day 3: redness, pain and swelling at injection site. Tylenol taken day 2 and at bedtime.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Myalgia, Pyrexia
Clinical narrative: Day 2: tired,muscle pain,shivering,fever,foot cramps - Day 3: redness, pain and swelling at injection site. Tylenol taken day 2 and at bedtime.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth, Local reaction, Pyrexia, Vaccination complication
Clinical narrative: Parent called clinic (805 am), stated child had a temp of 101.7 and the injection sites were red and spanned across child's thighs.  Mom noted the areas felt hot to touch-nurse advised parent to have child seen.  Child presents to clinic with parent, afebrile at the time (1115 am), child assessed by Dr. Provider dx reaction to varicella immunization and local reaction to immunizations with MMR vaccine, fever.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Circumstance or information capable of leading to medication error, Exposure via skin contact, Immediate post-injection reaction
Clinical narrative: Immediately after piercing patient's skin to administer the MMR vaccination, patient jerked his leg strongly away, dislodging the needle.  Large amount of clear fluid dripped down patient's leg.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 71-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 17-JUN-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster and was treated by a physician. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live ( ZOSTAVAX).   Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Polyarteritis nodosa, Skin lesion
Clinical narrative: Polyarteritis nodosa; lesions in the feet; This case was reported in a literature article and described the occurrence of polyarteritis nodosum in a patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, 21 days after receiving Hepatitis B vaccine, the patient experienced polyarteritis nodosum (serious criteria GSK medically significant) and skin lesion. On an unknown date, the outcome of the polyarteritis nodosum and skin lesion were unknown.   The reporter considered the polyarteritis nodosum and skin lesion to be related to Hepatitis B vaccine.  Additional information was provided.  This case was reported in a literature article and described the occurrence of polyarteritis nodosa in a patient of unspecified age and gender, who was vaccinated with unspecified hepatitis B virus (HBV) vaccine (manufacturer unknown) for prophylaxis.  No information on patient's medical history, family history, concurrent condition and concomitant medication were provided.  On unspecified date, the patient received unspecified HBV vaccine (administration route and site unspecified; dosage unknown; batch number not provided). The age at vaccination was not provided.  On an unspecified date, 3 weeks after vaccination the patient presented with systemic features of the disease and with characteristic lesions in the feet. The patient was diagnosed with polyarteritis nodosa.   Treatment was unknown.  The outcome of the event was not reported.  The authors commented, "polyarteritis nodosa following vaccination against hepatitis B virus with lower-extremity manifestations".
Age: 0.08
Sex: F
Vaccine: HEP, HEP
Symptoms: Death, Decreased appetite
Clinical narrative: Death / Death NOS; Had not eaten; This case was reported by a physician via call center representative and described the occurrence of unknown cause of death in a 6-week-old female patient who received HBV (Engerix B) (batch number 4RB3J, expiry date unknown) for prophylaxis.   On 1st July 2019, the patient received Engerix B. On 2nd July 2019, 1 days after receiving Engerix B, the patient experienced unknown cause of death (serious criteria death and GSK medically significant) and appetite absent. On 2nd July 2019, the outcome of the unknown cause of death was fatal and the outcome of the appetite absent was recovered/resolved. The patient died on 2nd July 2019. The reported cause of death was unknown cause of death.   The reporter considered the unknown cause of death to be related to Engerix B. It was unknown if the reporter considered the appetite absent to be related to Engerix B.  Additional details were provided as follows: The patient was not known to have any pre-existing health conditions. The patient had not eaten since the morning of 2nd July 2019 (for 12 hours) and died on the way to the hospital. The patient's parents believed that, the patient's death was due to the vaccine. But the physician stated that, the patient could had passed away due to other reasons, of which she did not provide. The reporter also stated that, two other patients received vaccines of the same lot and nothing had been reported. The physician would like to be followed up with as soon as possible so she would know what the next steps would be for investigation. No other details were provided.; Reported Cause(s) of Death: Unknown cause of death
Age: 0.08
Sex: F
Vaccine: HEP, HEP
Symptoms: Death, Lethargy
Clinical narrative: Death / Death NOS; Had not eaten; This case was reported by a physician via call center representative and described the occurrence of unknown cause of death in a 6-week-old female patient who received HBV (Engerix B) (batch number 4RB3J, expiry date unknown) for prophylaxis.   On 1st July 2019, the patient received Engerix B. On 2nd July 2019, 1 days after receiving Engerix B, the patient experienced unknown cause of death (serious criteria death and GSK medically significant) and appetite absent. On 2nd July 2019, the outcome of the unknown cause of death was fatal and the outcome of the appetite absent was recovered/resolved. The patient died on 2nd July 2019. The reported cause of death was unknown cause of death.   The reporter considered the unknown cause of death to be related to Engerix B. It was unknown if the reporter considered the appetite absent to be related to Engerix B.  Additional details were provided as follows: The patient was not known to have any pre-existing health conditions. The patient had not eaten since the morning of 2nd July 2019 (for 12 hours) and died on the way to the hospital. The patient's parents believed that, the patient's death was due to the vaccine. But the physician stated that, the patient could had passed away due to other reasons, of which she did not provide. The reporter also stated that, two other patients received vaccines of the same lot and nothing had been reported. The physician would like to be followed up with as soon as possible so she would know what the next steps would be for investigation. No other details were provided.; Reported Cause(s) of Death: Unknown cause of death
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Nausea, Pyrexia, Rash, Rash pruritic, Vomiting
Clinical narrative: Pt presented with rash on upper chest and face - then continued to spread and itch, low grade fever of 100.3, and nausea/vomiting.  Pt was taking fluids well by the time she was seen in clinic, no current vesicles present at the time seen.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Pyrexia, Rash vesicular, Tremor
Clinical narrative: Fever of 101 Shakes  Heart rate up to 123   Rash with blisters appeared next day, 7/12/2019 on ankle
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Influenza like illness, Injection site erythema, Pyrexia
Clinical narrative: 7/10/19 Symptoms started within 2 hours, red at injection site. The next day 7/11/2019 05:00pm patient had fever, cold chills flu like symptoms. At 02:00am 7/11/19 patient took 2 Tylenol and was sweating.  on 7/12/2019 symptoms have resolved as of 01:11pm except redness at injection site.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MNQ, VARCEL
Symptoms: Wrong product administered
Clinical narrative: Menactra was given instead of MMR. CDC, DHS and Parent were contacted.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Feeling cold, Hypotension, Injection site erythema
Clinical narrative: Excessive dizziness, extreme feeling of being cold, stiffness, muscle aches, fever (starting morning after), diarrhea (starting morning after 11am, )  Injection site was indurated, raised and pink.  Skin was pale in appearance.  Physician determined that blood pressure was a little low.   Cool compresses were used on injection site.  Some side effects have lessened with time.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site swelling, Musculoskeletal stiffness, Myalgia, Pallor
Clinical narrative: Excessive dizziness, extreme feeling of being cold, stiffness, muscle aches, fever (starting morning after), diarrhea (starting morning after 11am, )  Injection site was indurated, raised and pink.  Skin was pale in appearance.  Physician determined that blood pressure was a little low.   Cool compresses were used on injection site.  Some side effects have lessened with time.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Excessive dizziness, extreme feeling of being cold, stiffness, muscle aches, fever (starting morning after), diarrhea (starting morning after 11am, )  Injection site was indurated, raised and pink.  Skin was pale in appearance.  Physician determined that blood pressure was a little low.   Cool compresses were used on injection site.  Some side effects have lessened with time.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Nerve injury, Pain in extremity
Clinical narrative: Patient's parent reported to manager that his daughter had nerve damage from receiving the shot. Her arm is in pain and getting progressively worse since receiving the vaccine. She has to wear a sling.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Cellulitis, Erythema, Inflammation, Skin warm
Clinical narrative: the pt has a inflamed, red , hot to the touch  arm and was diagnosis-ed  with cellulitis
Age: 43.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Fatigue, Headache, Lymphadenitis, Malaise, Pyrexia
Clinical narrative: Swollen lymph nodes in neck, headaches, fatigue, malaise, daily fevers (up to 102 degrees F) , chills and feeling unwell, ongoing for 2 weeks now.  Treating with ibuprofen 400mg-800mg and tylenol 1000mg
Age: 43.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Chills, Fatigue, Headache, Lymphadenopathy, Muscular weakness
Clinical narrative: Swollen lymph nodes in neck, headaches, fatigue, malaise, daily fevers (up to 102 degrees F) , chills and feeling unwell, ongoing for 2 weeks now.  Treating with ibuprofen 400mg-800mg and tylenol 1000mg
Age: 43.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Pyrexia
Clinical narrative: Swollen lymph nodes in neck, headaches, fatigue, malaise, daily fevers (up to 102 degrees F) , chills and feeling unwell, ongoing for 2 weeks now.  Treating with ibuprofen 400mg-800mg and tylenol 1000mg
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine was supposed to be given intramuscularly but was given subcutaneously.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Erythema, Pain, Peripheral swelling
Clinical narrative: Left arm redness, swelling, body aches, chills
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Chills, Injection site pain, Laboratory test, Pyrexia
Clinical narrative: Left arm redness, swelling, body aches, chills
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Decreased appetite, Dizziness, Impaired driving ability, Influenza like illness
Clinical narrative: Aching began day after injection, nausea, dizziness, shaking, general flu-like muscle and joint pain, fever, no appetite. Lasted approximately 4 days. Patient could not drive. Day after patient was seen by Dr and received Benadryl, steroid (methylprednisolone dosepack), after 4-5 days from the injection it resolved.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Myalgia, Nausea, Pain, Pyrexia, Tremor
Clinical narrative: Aching began day after injection, nausea, dizziness, shaking, general flu-like muscle and joint pain, fever, no appetite. Lasted approximately 4 days. Patient could not drive. Day after patient was seen by Dr and received Benadryl, steroid (methylprednisolone dosepack), after 4-5 days from the injection it resolved.
Age: 23.0
Sex: M
Vaccine: TDAP
Symptoms: Dehydration, Retrograde ejaculation
Clinical narrative: Patient called stating he has experienced retrograde ejaculation, was extremely dehydrated all day after the vaccine.
Age: 1.42
Sex: M
Vaccine: DTAP
Symptoms: Eczema
Clinical narrative: Eczema on inner arms. Prolonged gets worse with each additional dtap shot
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Confusional state, Dyspnoea, Erythema, Fatigue, Loss of consciousness
Clinical narrative: Patient reported that she developed a rash which we had discussed as a potential adverse event. She reported she also went unconscious and was brought to the hospital as she was non-responsive. She was held overnight for observation then released the next day. Per patient she didn't remember which pharmacy she received the shot at (it was ours) and she said she was also taking a medication (did not elaborate on what it was) and wasn't sure if that could have been the cause as we discussed that it would be rare to have that kind of side effect. The rash was still present and did not look like hives but rather a mild redness over her forearm - resembling sunburn. I asked the patient if she had had any difficulty breathing - swelling in her throat - and she said "well I went unresponsive, so yes". Patient still appeared fatigued and a little confused when reporting the incident. I asked if she felt okay and she said not really. I offered to call someone for her, check her pulse, oxygen, and blood pressure but she refused. I gave her the VIS form she requested as well as a receipt from the shot to show the date of her immunization. She did not specify what date she went into/got out of the hospital. Before I could ask more questions she left because she wasn't feeling well and wanted her husband to take her home.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pharyngeal swelling, Rash, Rash erythematous, Unresponsive to stimuli
Clinical narrative: Patient reported that she developed a rash which we had discussed as a potential adverse event. She reported she also went unconscious and was brought to the hospital as she was non-responsive. She was held overnight for observation then released the next day. Per patient she didn't remember which pharmacy she received the shot at (it was ours) and she said she was also taking a medication (did not elaborate on what it was) and wasn't sure if that could have been the cause as we discussed that it would be rare to have that kind of side effect. The rash was still present and did not look like hives but rather a mild redness over her forearm - resembling sunburn. I asked the patient if she had had any difficulty breathing - swelling in her throat - and she said "well I went unresponsive, so yes". Patient still appeared fatigued and a little confused when reporting the incident. I asked if she felt okay and she said not really. I offered to call someone for her, check her pulse, oxygen, and blood pressure but she refused. I gave her the VIS form she requested as well as a receipt from the shot to show the date of her immunization. She did not specify what date she went into/got out of the hospital. Before I could ask more questions she left because she wasn't feeling well and wanted her husband to take her home.