chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eyelid oedema, Headache, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nausea in a 79-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (very mild case of shingles on the back). Concurrent medical conditions included drug allergy (allergy to DEMEROL) and penicillin allergy. On 4th July 2018 10:30, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th July 2018 18:00, 7 hrs 30 min after receiving SHINGRIX, the patient experienced nausea, diarrhea, headache, injection site erythema, injection site swelling, dehydration, shivering, fever, abdominal pain, swelling of eyelid, weakness, vomiting and muscle pain. The patient was treated with BENADRYL and TYLENOL. On 10th July 2018, the outcome of the swelling of eyelid was recovered/resolved. On an unknown date, the outcome of the nausea, diarrhea, headache, injection site erythema and weakness were recovering/resolving and the outcome of the injection site swelling, dehydration, shivering, fever, abdominal pain, vomiting and muscle pain were recovered/resolved. It was unknown if the reporter considered the nausea, diarrhea, headache, injection site erythema, injection site swelling, dehydration, shivering, fever, abdominal pain, swelling of eyelid, weakness, vomiting and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. By 6:00 PM, the patient started to experience adverse reactions that were worse in the next morning. The patient experienced swelling on the top of her eyelids. The patient was dehydrated and went to the emergency room via the ambulance. The patient received fluids for rehydration and BENADRYL while in the emergency room. The patient was not admitted to the hospital. The patient had reported the event to her doctor and decided to not get the 2nd dose. The patient was taking TYLENOL for the headache. The patient provided contact details of the physician.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nausea in a 79-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (very mild case of shingles on the back). Concurrent medical conditions included drug allergy (allergy to DEMEROL) and penicillin allergy. On 4th July 2018 10:30, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th July 2018 18:00, 7 hrs 30 min after receiving SHINGRIX, the patient experienced nausea, diarrhea, headache, injection site erythema, injection site swelling, dehydration, shivering, fever, abdominal pain, swelling of eyelid, weakness, vomiting and muscle pain. The patient was treated with BENADRYL and TYLENOL. On 10th July 2018, the outcome of the swelling of eyelid was recovered/resolved. On an unknown date, the outcome of the nausea, diarrhea, headache, injection site erythema and weakness were recovering/resolving and the outcome of the injection site swelling, dehydration, shivering, fever, abdominal pain, vomiting and muscle pain were recovered/resolved. It was unknown if the reporter considered the nausea, diarrhea, headache, injection site erythema, injection site swelling, dehydration, shivering, fever, abdominal pain, swelling of eyelid, weakness, vomiting and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. By 6:00 PM, the patient started to experience adverse reactions that were worse in the next morning. The patient experienced swelling on the top of her eyelids. The patient was dehydrated and went to the emergency room via the ambulance. The patient received fluids for rehydration and BENADRYL while in the emergency room. The patient was not admitted to the hospital. The patient had reported the event to her doctor and decided to not get the 2nd dose. The patient was taking TYLENOL for the headache. The patient provided contact details of the physician.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Nausea, Pain in extremity, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nausea in a 79-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (very mild case of shingles on the back). Concurrent medical conditions included drug allergy (allergy to DEMEROL) and penicillin allergy. On 4th July 2018 10:30, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th July 2018 18:00, 7 hrs 30 min after receiving SHINGRIX, the patient experienced nausea, diarrhea, headache, injection site erythema, injection site swelling, dehydration, shivering, fever, abdominal pain, swelling of eyelid, weakness, vomiting and muscle pain. The patient was treated with BENADRYL and TYLENOL. On 10th July 2018, the outcome of the swelling of eyelid was recovered/resolved. On an unknown date, the outcome of the nausea, diarrhea, headache, injection site erythema and weakness were recovering/resolving and the outcome of the injection site swelling, dehydration, shivering, fever, abdominal pain, vomiting and muscle pain were recovered/resolved. It was unknown if the reporter considered the nausea, diarrhea, headache, injection site erythema, injection site swelling, dehydration, shivering, fever, abdominal pain, swelling of eyelid, weakness, vomiting and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. By 6:00 PM, the patient started to experience adverse reactions that were worse in the next morning. The patient experienced swelling on the top of her eyelids. The patient was dehydrated and went to the emergency room via the ambulance. The patient received fluids for rehydration and BENADRYL while in the emergency room. The patient was not admitted to the hospital. The patient had reported the event to her doctor and decided to not get the 2nd dose. The patient was taking TYLENOL for the headache. The patient provided contact details of the physician.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash papular
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of papular rash in a 65-year-old male patient who received SHINGRIX for prophylaxis. On 28th June 2018, the patient received SHINGRIX. On 9th July 2018, 11 days after receiving SHINGRIX, the patient experienced papular rash. On an unknown date, the outcome of the papular rash was not recovered/not resolved. It was unknown if the reporter considered the papular rash to be related to SHINGRIX. Additional details were reported as follows: On the day of reporting, the patient visited the physician's office with a 3 day history of papules on the top and bottom of his hands and feet, under his arms and around his knees.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 57-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020) for prophylaxis. On 26th April 2018, the patient received the 1st dose of SHINGRIX. On 26th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site pain were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX on an unknown deltoid and experienced warmth, achiness, soreness, and redness on her entire deltoid for six days. The symptoms had since resolved. The reporting pharmacist had declined to provide further information. The batch number reported for SHINGRIX (C5Z3T) did not exist and was updated to C523T as per sales database.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a adult patient who received 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 injection site rash. On an unknown date, the outcome of the injection site rash was unknown. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported adverse event via click to chat forum. The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The healthcare professional reported that they had a patient with previous reaction to SHINGRIX and would not classify as severe but described as a significant rash at injection site. No further information was reported regarding the event.
Age: 57.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Contusion, Erythema, Herpes zoster, Neuralgia, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 57-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included PNEUMONIA VACCINE for prophylaxis. The patient's past medical history included shingles (in hip area, 4 years before the reporting date). Concomitant products included PROZAC. On 9th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml and PNEUMONIA VACCINE. On 9th July 2018, less than a day after receiving SHINGRIX, the patient experienced shingles, pain in arm, localized erythema, skin warm, contusion, local swelling, erythematous rash and blotchy. On 10th July 2018, the patient experienced fever and nerve pain. The patient was treated with Valacyclovir and levofloxacin. On an unknown date, the outcome of the shingles, pain in arm, localized erythema, skin warm, contusion, local swelling, erythematous rash, nerve pain and blotchy were unknown and the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the shingles, pain in arm, localized erythema, skin warm, contusion, fever, local swelling, erythematous rash, nerve pain and blotchy to be related to SHINGRIX. Additional details were provided as follows: The patient SHINGRIX on the left arm along with a Pneumonia vaccine that was given in same arm on same day about a half inch apart. On the same day of the vaccinations, but later, the patient had swelling of the upper arm in the size of a softball. The whole top of her upper arm area was hot, red, painful and bruised. Late Tuesday, on 10th July 2018 into Wednesday, 11July 2018, the patient began to experience pain that was the nerve pain that usually accompanies shingles. She also noted a fever of 103 that started on Tuesday (latency of 1 day after vaccination). On 12th July 2018, the patient went to the local emergency room and after 5 hours she was diagnosed with shingles on her arm and released with a prescription for Valacyclovir 500 mg 2 tablets by mouth 3 times daily and Levofloxacin 750 mg 7 tablets total. The patient stated she had red, rash, blotches on her left arm. A 50 cent piece size area just below the injections and then a dime size one and another quarter size one with smaller red spots that were not all connected going up to top of her arm. The contact details of physician was provided. It was unknown if the reporter considered the shingles, arm pain, localized erythema, skin warm, contusion, fever, local swelling, erythematous rash, blotchy and nerve pain to be related to Pneumonia vaccine.
Age: 57.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pyrexia, Rash erythematous, Rash macular, Skin warm, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 57-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included PNEUMONIA VACCINE for prophylaxis. The patient's past medical history included shingles (in hip area, 4 years before the reporting date). Concomitant products included PROZAC. On 9th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml and PNEUMONIA VACCINE. On 9th July 2018, less than a day after receiving SHINGRIX, the patient experienced shingles, pain in arm, localized erythema, skin warm, contusion, local swelling, erythematous rash and blotchy. On 10th July 2018, the patient experienced fever and nerve pain. The patient was treated with Valacyclovir and levofloxacin. On an unknown date, the outcome of the shingles, pain in arm, localized erythema, skin warm, contusion, local swelling, erythematous rash, nerve pain and blotchy were unknown and the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the shingles, pain in arm, localized erythema, skin warm, contusion, fever, local swelling, erythematous rash, nerve pain and blotchy to be related to SHINGRIX. Additional details were provided as follows: The patient SHINGRIX on the left arm along with a Pneumonia vaccine that was given in same arm on same day about a half inch apart. On the same day of the vaccinations, but later, the patient had swelling of the upper arm in the size of a softball. The whole top of her upper arm area was hot, red, painful and bruised. Late Tuesday, on 10th July 2018 into Wednesday, 11July 2018, the patient began to experience pain that was the nerve pain that usually accompanies shingles. She also noted a fever of 103 that started on Tuesday (latency of 1 day after vaccination). On 12th July 2018, the patient went to the local emergency room and after 5 hours she was diagnosed with shingles on her arm and released with a prescription for Valacyclovir 500 mg 2 tablets by mouth 3 times daily and Levofloxacin 750 mg 7 tablets total. The patient stated she had red, rash, blotches on her left arm. A 50 cent piece size area just below the injections and then a dime size one and another quarter size one with smaller red spots that were not all connected going up to top of her arm. The contact details of physician was provided. It was unknown if the reporter considered the shingles, arm pain, localized erythema, skin warm, contusion, fever, local swelling, erythematous rash, blotchy and nerve pain to be related to Pneumonia vaccine.
Age: 61.0
Sex: U
Vaccine: FLU4
Symptoms: Decreased appetite, Fungal skin infection, Gait disturbance, Malaise, Muscle fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of malaise in a 61-year-old patient who received FLUARIX QUADRIVALENT (batch number UI709AB ?, expiry date 30th June 2017) for prophylaxis. On 9th January 2017, the patient received the 1st dose of FLUARIX QUADRIVALENT (intramuscular) 1 dosage form(s). In January 2017, 7 days after receiving FLUARIX QUADRIVALENT, the patient experienced malaise, leg dragging, paronychia, photosensitivity, rash, fungal foot infection, muscle fatigue and appetite absent. On an unknown date, the outcome of the malaise, leg dragging, photosensitivity, muscle fatigue and appetite absent were recovered/resolved and the outcome of the paronychia, rash and fungal foot infection were unknown. It was unknown if the reporter considered the malaise, leg dragging, paronychia, photosensitivity, rash, fungal foot infection, muscle fatigue and appetite absent to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The caller stated that one week after receiving the vaccine she experience malaise, light sensitivity, muscle fatigue, dragging of the right leg and no appetite. The caller stated these symptoms lasted between 2 to 3 weeks. The caller stated sometime during the last year, she developed an infection of cuticles of all 10 nails, a rash on both shins, a rash the size of a fifty cent piece on the left foot and a fungus on three toes on the left foot. The caller stated she has gone to her health care professional and these symptoms were getting better. The patient had denied permission to contact their physician. The caller stated employee at the Hospital Employee health department would be the best person to speak with pertaining to this adverse event. The caller did not had the email address. No additional information was provided.
Age: 61.0
Sex: U
Vaccine: FLU4
Symptoms: Paronychia, Photophobia, Photosensitivity reaction, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of malaise in a 61-year-old patient who received FLUARIX QUADRIVALENT (batch number UI709AB ?, expiry date 30th June 2017) for prophylaxis. On 9th January 2017, the patient received the 1st dose of FLUARIX QUADRIVALENT (intramuscular) 1 dosage form(s). In January 2017, 7 days after receiving FLUARIX QUADRIVALENT, the patient experienced malaise, leg dragging, paronychia, photosensitivity, rash, fungal foot infection, muscle fatigue and appetite absent. On an unknown date, the outcome of the malaise, leg dragging, photosensitivity, muscle fatigue and appetite absent were recovered/resolved and the outcome of the paronychia, rash and fungal foot infection were unknown. It was unknown if the reporter considered the malaise, leg dragging, paronychia, photosensitivity, rash, fungal foot infection, muscle fatigue and appetite absent to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The caller stated that one week after receiving the vaccine she experience malaise, light sensitivity, muscle fatigue, dragging of the right leg and no appetite. The caller stated these symptoms lasted between 2 to 3 weeks. The caller stated sometime during the last year, she developed an infection of cuticles of all 10 nails, a rash on both shins, a rash the size of a fifty cent piece on the left foot and a fungus on three toes on the left foot. The caller stated she has gone to her health care professional and these symptoms were getting better. The patient had denied permission to contact their physician. The caller stated employee at the Hospital Employee health department would be the best person to speak with pertaining to this adverse event. The caller did not had the email address. No additional information was provided.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old male patient who received SHINGRIX for prophylaxis. On 18th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 18th April 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. The reporter considered the pain in arm to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient developed a sore arm that lasted for about 3 days. He would be emailing his experience to Centers for Disease Control and Prevention (CDC), the pharmacy and to GlaxoSmithKline. This case was linked with the case US2018127822, reported for the same patient.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of therapy non-responder in an unspecified number of patients who received ENGERIX B for prophylaxis. Co-suspect products included ENGERIX B for prophylaxis and ENGERIX B for prophylaxis. On an unknown date, the patient received the 1st dose of ENGERIX B, the 2nd dose of ENGERIX B and the 3rd dose of ENGERIX B. On an unknown date, unknown after receiving ENGERIX B, ENGERIX B and ENGERIX B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B, ENGERIX B and ENGERIX B. Additional details were provided as follows: The physician stated that there had been instances where people have completed a series of hepatitis-B vaccination but did not establish protective titers and required a 4th dose. This statement was said in passing, unrelated to the original purpose of the phone call. It was unclear if this was exclusively related to ENGERIX-B or number of patients that might not have achieved a protective antibody response after 3 doses.
Sex: F
Vaccine: VARZOS
Symptoms: Hepatic enzyme increased
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of elevated liver enzymes in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced elevated liver enzymes. On an unknown date, the outcome of the elevated liver enzymes was unknown. It was unknown if the reporter considered the elevated liver enzymes to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced raised liver enzymes. The other manufacturer asked to communicate with reporter or patient's physician for further information.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site swelling, Poor quality sleep
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling 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, less than a year after receiving SHINGRIX, the patient experienced injection site swelling, injection site bruising and poor sleep. On an unknown date, the outcome of the injection site swelling, injection site bruising and poor sleep were unknown. It was unknown if the reporter considered the injection site swelling, injection site bruising and poor sleep to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Two and a half months prior to the second dose, the patient received 1st dose of SHINGRIX on left arm. The patient experienced bruising and not sleeping well at night. The patient said that he had a bruise and swelling at the injection site on his left arm. The patient said that the bruise and swelling was about the size of a baseball. For tolerance of 2nd dose of SHINGRIX refer linked case US2018127891.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Half of patient's arm was swollen and red. It was the same arm the vaccine was administered.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Nausea
Clinical narrative: PATIENT IS FEELING NAUSEATED, GIVEN AN ICE PACK AND HAS BEEN SEATED IN THE OFFICE WITH MEDICAL STAFF FOR THE LAST HOUR.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Injection site erythema
Clinical narrative: Patient developed fever of 102, joint pain, fatigue, vomiting and nausea, headache, dizziness and local site reaction of pain, swelling, redness and heat.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Local reaction, Nausea
Clinical narrative: Patient developed fever of 102, joint pain, fatigue, vomiting and nausea, headache, dizziness and local site reaction of pain, swelling, redness and heat.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient developed fever of 102, joint pain, fatigue, vomiting and nausea, headache, dizziness and local site reaction of pain, swelling, redness and heat.
Age: 15.0
Sex: F
Vaccine: HEP
Symptoms: Syncope
Clinical narrative: Shortly after the patient received the vaccination, the patient fainted briefly. She was caught by her brother and laid on the floor. He got the attention of the pharmacist. She was already awake when the pharmacist arrived. He had her lay on the ground for about 5 minutes. After that, she was helped over to a bench where she finished recovering.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Auditory disorder, Dizziness, Pallor
Clinical narrative: Patient had pallor, severe dizziness and complaints of change in auditory perception approximately 15 minutes following administration of vaccines. Patient returned with assistance to exam room and placed in supine position with legs raised above head. Assessed HR 72 BPM, BP 88/48 left arm, SpO2 98% room air 13:15 PM. At 13:25 PM returned patient to sitting position and gave hydration via oral route. Assessed HR 88 BPM, BP 92/58 left arm, SpO2 98% room air. Assessed by MD and dismissed in mother's care without further complications.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Syncope
Clinical narrative: Syncope, faint feeling, dizzy.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: 7 cm red, painful and swollen area on left arm. Noticed today.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Nausea, Pain
Clinical narrative: He said he was nauseated all night after the shot and he had body pain too, also very tired for 1-2 days.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Limb mass, Pruritus, Rash erythematous
Clinical narrative: Red rash with lumps in leg. Minor itch.
Age: 17.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Anaphylactic reaction, Seizure
Clinical narrative: The HEP A vaccine was administered first then BEXSERO was the second vaccine administered. Within 10 minutes child developed seizure activity and anaphylaxis.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Anxiety, Balance disorder, Gait disturbance, Presyncope
Clinical narrative: After immunization, patient left the room walking and started wobbling and lost balance. MA and MD caught patient prior to falling. Patient was taken back to a room and laid down, vitals within normal limits, and gave patient apple juice. After lying down for a few minutes patient was feeling better. Patient did not loose consciousness or have a allergic reaction, MD states patient had a vaso-vagal/anxiety response after immunization.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Rash
Clinical narrative: Rash to abd and back area patient treated with BENADRYL and triamcinolone cream.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Arthralgia, Influenza like illness, Malaise, Myalgia, Pyrexia
Clinical narrative: Flu-like symptoms, fever, muscle and joint pain, malaise.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Food allergy, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Swollen and red at injection site. Tired. Nauseous. Muscle paint. Head ache.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Swollen and red at injection site. Tired. Nauseous. Muscle paint. Head ache.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Patient received injection at 1705, reported lightheadiness at 1715, BP was 172/114, 62. Patient denied any other symptoms, would not allow us to call 911, would not lay down to elevate feet. Patient stated that sometimes his sugar is low and he uses sugar tablets. He ingested one at approximately 1730. Patient left at 1745 and called at 1800 reporting that he was home and felt better.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Pain
Clinical narrative: Pain all over, joints hurt, drained of energy for 2 days after the vaccination.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Feeling abnormal, Headache, Herpes zoster, Injection site pain
Clinical narrative: Injection site really sore and swollen; sore to the touch. Patient felt horrible; no energy and headache. Started feeling somewhat better later in the afternoon, but it took a while. On 7-19-2018, patient woke up with 3 red splotches around the injection site and injection site was still really sore. I recommended that patient seek medical attention. Doctor diagnosed patient with Shingles.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Rash macular
Clinical narrative: Injection site really sore and swollen; sore to the touch. Patient felt horrible; no energy and headache. Started feeling somewhat better later in the afternoon, but it took a while. On 7-19-2018, patient woke up with 3 red splotches around the injection site and injection site was still really sore. I recommended that patient seek medical attention. Doctor diagnosed patient with Shingles.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Leukaemia, Myositis, Pain
Clinical narrative: Pain, Muscle inflammation, Leukemia.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Urticaria
Clinical narrative: Patient had red welts after her 2nd SHINGRIX dose. She tried a warm compress, and it didn't help. She also reported that it was very painful. We advised her to call her doctor, unsure if she went in to be seen or not.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Nausea
Clinical narrative: Pt claims nauseated and very uncomfortable all day Monday 7/16/18. She felt better by 7/17.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: Pt claims nauseated and very uncomfortable all day Monday 7/16/18. She felt better by 7/17.
Age: 35.0
Sex: M
Vaccine: DTAP
Symptoms: Rash
Clinical narrative: Rash.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Induration, Mass, Pain, Rash
Clinical narrative: Hard lump/swollen, warmth, rash/redness, sore.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: Hard lump/swollen, warmth, rash/redness, sore.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose decreased, Unresponsive to stimuli
Clinical narrative: Patient stayed in the store after receiving vaccine shopping. An hour after patient had received her shot, we were notified she was unresponsive sitting in her walker with a chair seat. Patient was breathing, good pulse but not responsive. Paramedics that were called to scene stated good airway. Blood glucose was at 25 mg/dL.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Neck pain, Neuralgia, Swelling
Clinical narrative: Severe swelling, continuing pain which has climbed from shoulder to neck. Trouble raising left arm to shoulder height. My nerve pain by shot.
Age: 15.0
Sex: M
Vaccine: HPVX, MENB
Symptoms: Headache, Injection site erythema, Injection site warmth
Clinical narrative: HA 6-28 and 6-29. (R) deltoid had red area hot to touch.
Age: 56.0
Sex: F
Vaccine: FLUR4
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash and UrticarialPruritus.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Angioedema, Throat tightness
Clinical narrative: 45 minutes post injection called patient who reported 3/10 tightness in throat. Patient was able to vocalize reaction and sent to NP in employee health for further f/u. Angioedema.
Age: 49.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Skin Rash and Urticaria Pruritus. Diphenhydramine 25 mg once.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Asthenia, Impaired work ability, Myalgia
Clinical narrative: Began to have sx the evening of injection and was unable to come to work the next day d/t sx. Myalgia, Arthralgia and weakness.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Arm is swollen and itchy and painful.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Skin warm, Tenderness
Clinical narrative: Pt had #2 SHINGRIX vaccine at local pharmacy 1-x13 cm firm, red warm tender area (L) upper arm.
Sex: F
Vaccine: HPVX
Symptoms: Unevaluable event
Clinical narrative: See additional page(s) for complete text.
Age: 1.25
Sex: M
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Given in error, should have been DTaP.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Vaccination site warmth
Clinical narrative: Area of redness and warm to touch x2 days. Redness measures 15 cm in length and 18 cm wide to LUE (site of vaccination). Penicillin prescribed.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Local reaction, Pain in extremity, Rash
Clinical narrative: Left arm local reaction; pain, redness - 5 cm x 5 cm circular rash.
Age: 16.0
Sex: U
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling, redness of (R) arm at injection site.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Muscle spasms, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Approx 36h after administration and improving after 18 hours-sudden onset achy joints, stiff neck, "bad" leg cramping, fever. Patient improved with Ibuprofen.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Rash
Clinical narrative: Rash on chest and arm (L) increased fatigue.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth, Local reaction
Clinical narrative: Pt developed localized reaction. Redness at injection site approx. 3 inches circular diameter. Minor itching to the area. Warmth upon touch sore. Pt also noted body aches in addition to arm soreness. Pain and itching improving but redness not resolved.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Pt developed localized reaction. Redness at injection site approx. 3 inches circular diameter. Minor itching to the area. Warmth upon touch sore. Pt also noted body aches in addition to arm soreness. Pain and itching improving but redness not resolved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 14-OCT-2013, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. Approximately two weeks post (27-OCT-2013) ZOSTAVAX vaccine, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles.  As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of raised rash in a 67-year-old male patient who received SHINGRIX for prophylaxis. On 20th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 21st May 2018, 1 days after receiving SHINGRIX, the patient experienced raised rash. On an unknown date, the outcome of the raised rash was recovered/resolved. It was unknown if the reporter considered the raised rash to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the right arm. The patient developed a raised, but not itchy, rash on the right side of his neck, extending a little onto his back, and also in a symmetrical distribution in the antecubital and popliteal fossa of both arms and legs.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Blood pressure increased, Confusional state, Disorientation, Fatigue, Heart rate increased
Clinical narrative: 6/16/18 at 1127 pt called c/o L arm heavy, fatigued, struggling to focus, needs to focus on speach, nausea and shooting pain from shoulder to wrist. Sent to ER. ER c/o above + anxiety, palpitations, chest tightness and dry mouth. Per pt was given IVF. 7/18/18 Called office c/o continued fatigue and bruising from wrist going up arm. States had IV in ED but it is not near the IV site. MD advised Tylenol for pain and continue to watch. Pt states confusion and other symptoms have resolved.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: 6/16/18 at 1127 pt called c/o L arm heavy, fatigued, struggling to focus, needs to focus on speach, nausea and shooting pain from shoulder to wrist. Sent to ER. ER c/o above + anxiety, palpitations, chest tightness and dry mouth. Per pt was given IVF. 7/18/18 Called office c/o continued fatigue and bruising from wrist going up arm. States had IV in ED but it is not near the IV site. MD advised Tylenol for pain and continue to watch. Pt states confusion and other symptoms have resolved.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Anxiety, Chest discomfort, Confusional state, Contusion, Disturbance in attention
Clinical narrative: 6/16/18 at 1127 pt called c/o L arm heavy, fatigued, struggling to focus, needs to focus on speach, nausea and shooting pain from shoulder to wrist. Sent to ER. ER c/o above + anxiety, palpitations, chest tightness and dry mouth. Per pt was given IVF. 7/18/18 Called office c/o continued fatigue and bruising from wrist going up arm. States had IV in ED but it is not near the IV site. MD advised Tylenol for pain and continue to watch. Pt states confusion and other symptoms have resolved.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Dry mouth, Fatigue, Limb discomfort, Nausea, Pain
Clinical narrative: 6/16/18 at 1127 pt called c/o L arm heavy, fatigued, struggling to focus, needs to focus on speach, nausea and shooting pain from shoulder to wrist. Sent to ER. ER c/o above + anxiety, palpitations, chest tightness and dry mouth. Per pt was given IVF. 7/18/18 Called office c/o continued fatigue and bruising from wrist going up arm. States had IV in ED but it is not near the IV site. MD advised Tylenol for pain and continue to watch. Pt states confusion and other symptoms have resolved.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Pain in extremity, Palpitations
Clinical narrative: 6/16/18 at 1127 pt called c/o L arm heavy, fatigued, struggling to focus, needs to focus on speach, nausea and shooting pain from shoulder to wrist. Sent to ER. ER c/o above + anxiety, palpitations, chest tightness and dry mouth. Per pt was given IVF. 7/18/18 Called office c/o continued fatigue and bruising from wrist going up arm. States had IV in ED but it is not near the IV site. MD advised Tylenol for pain and continue to watch. Pt states confusion and other symptoms have resolved.
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Asthenia, Cold sweat, Cough, Diarrhoea, Dizziness
Clinical narrative: Patient received the VARIVAX vaccine on 7/12/18. Sometime that evening she developed a "mild fever". She reported to work the following day and went home, she stated she wasn't feeling well. She stated she fell asleep on Friday at 4:30pm, and did not wake up until Saturday10:30pm. She stated she couldn't see, had a high fever, and had difficulty walking. Her husband called 911 and she was transported to the hospital where she was admitted. While admitted she called EH and said the neurologist told her that it was Aseptic Meningitis related to the VARIVAX Vaccine she received.
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Headache, Injection site erythema, Injection site pain, Musculoskeletal stiffness, Nausea
Clinical narrative: Patient received the VARIVAX vaccine on 7/12/18. Sometime that evening she developed a "mild fever". She reported to work the following day and went home, she stated she wasn't feeling well. She stated she fell asleep on Friday at 4:30pm, and did not wake up until Saturday10:30pm. She stated she couldn't see, had a high fever, and had difficulty walking. Her husband called 911 and she was transported to the hospital where she was admitted. While admitted she called EH and said the neurologist told her that it was Aseptic Meningitis related to the VARIVAX Vaccine she received.
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Oropharyngeal pain, Photophobia, Pyrexia, Sensation of foreign body, Vomiting
Clinical narrative: Patient received the VARIVAX vaccine on 7/12/18. Sometime that evening she developed a "mild fever". She reported to work the following day and went home, she stated she wasn't feeling well. She stated she fell asleep on Friday at 4:30pm, and did not wake up until Saturday10:30pm. She stated she couldn't see, had a high fever, and had difficulty walking. Her husband called 911 and she was transported to the hospital where she was admitted. While admitted she called EH and said the neurologist told her that it was Aseptic Meningitis related to the VARIVAX Vaccine she received.
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Gait disturbance, Hypersomnia, Malaise, Meningitis aseptic, Pyrexia
Clinical narrative: Patient received the VARIVAX vaccine on 7/12/18. Sometime that evening she developed a "mild fever". She reported to work the following day and went home, she stated she wasn't feeling well. She stated she fell asleep on Friday at 4:30pm, and did not wake up until Saturday10:30pm. She stated she couldn't see, had a high fever, and had difficulty walking. Her husband called 911 and she was transported to the hospital where she was admitted. While admitted she called EH and said the neurologist told her that it was Aseptic Meningitis related to the VARIVAX Vaccine she received.
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Vaccination complication, Visual impairment
Clinical narrative: Patient received the VARIVAX vaccine on 7/12/18. Sometime that evening she developed a "mild fever". She reported to work the following day and went home, she stated she wasn't feeling well. She stated she fell asleep on Friday at 4:30pm, and did not wake up until Saturday10:30pm. She stated she couldn't see, had a high fever, and had difficulty walking. Her husband called 911 and she was transported to the hospital where she was admitted. While admitted she called EH and said the neurologist told her that it was Aseptic Meningitis related to the VARIVAX Vaccine she received.
Sex: U
Vaccine: MEN, MEN
Symptoms: Chills, Fatigue, Nausea, Pain
Clinical narrative: This is a spontaneous report from a contactable nurse. This Nurse reported similar events for 3 patients on behalf of a physician. This is the second of 3 reports. A patient of unspecified age and gender received meningococcal group B rlp2086, via an unspecified route of administration on 06Jun2018 at a single dose for immunization at the physician's office. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines with meningococcal group b rlp2086. The patient woke up with pain, chills, tired, nausea on 07Jun2018. The patient recovered from the events on an unspecified date in 2018. Pfizer is a marketing authorization holder of meningococcal group b rlp2086 in the reporter's country. This may be a duplicate report in situations where another marketing authorization holder of meningococcal group b rlp2086 has submitted the same report to the regulatory authorities. No follow-up attempts are possible, information about batch number cannot be obtained. Sender's Comments: Linked Report(s): US-PFIZER INC-2018288887 Same reporter/drugs/events different patients. US-PFIZER INC-2018288752 Same reporter/drugs/events different patients.
Age: 75.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Asthenia, Balance disorder, Blood culture, Chills, Fatigue
Clinical narrative: Fever arm pain headache fatigue -systemic Inflammatory response syndrome.
Age: 75.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Headache, Injected limb mobility decreased, Injection site pain, Insomnia, Laboratory test
Clinical narrative: Fever arm pain headache fatigue -systemic Inflammatory response syndrome.
Age: 75.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Nausea, Pain in extremity, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Fever arm pain headache fatigue -systemic Inflammatory response syndrome.
Age: 75.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Tenderness, Tremor, White blood cell count increased
Clinical narrative: Fever arm pain headache fatigue -systemic Inflammatory response syndrome.
Age: 75.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Blood culture, Fatigue, Headache, Laboratory test, Pain in extremity
Clinical narrative: Fever arm pain headache fatigue -systemic Inflammatory response syndrome.
Age: 75.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Pyrexia, Systemic inflammatory response syndrome
Clinical narrative: Fever arm pain headache fatigue -systemic Inflammatory response syndrome.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Nystagmus, Tachycardia, Vertigo
Clinical narrative: Light-headed sensation starting the day after vaccinations and intermittent episodes of very brief vertigo (several seconds) with nystagmus noted by parents during the times of vertigo. No overt viral symptoms at the time. Had been swimming in the heat and not adequately hydrating for several days leading up to the symptoms. On the 3rd day of symptoms (7/13/18) came to the office for assessment and had orthostatic tachycardia noted, but otherwise appeared well and had a normal exam. Increased hydration was recommended along with salty snacks and rest. Returned on 7/16/18 due to heightened parental concern (and to follow up with primary MD who was not available for the 7/13 appointment). At that time, the symptoms had resolved and the exam was normal. Discussed that it was not clear if the symptoms were a vaccination side effect or from a combination of dehydration and anxiety exacerbating symptoms as this patient and mother both have significant anxiousness.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Fatigue, Headache, Mobility decreased, Nausea, Pain
Clinical narrative: At time of shot - pain in arm, syncope. Within hours - headache, fatigue,  nausea, pain in arm with movement. Next morning - increased nausea, fevers, pain in arm - cannot lift her arm.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Pain in extremity, Pyrexia, Syncope
Clinical narrative: At time of shot - pain in arm, syncope. Within hours - headache, fatigue,  nausea, pain in arm with movement. Next morning - increased nausea, fevers, pain in arm - cannot lift her arm.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling cold, Feeling hot, Injection site pain
Clinical narrative: Started to become tired around 3:00 pm. The site of the injection was sore. At 8:00 pm I started feeling cold and that went right into the chills where I could not warm up. Went to bed at 10 pm with extra blankets. No fever. At 12:15 am I woke up very hot. I had a fever of 100.7. I researched online and took (3) 200 mg of ibuprofen at 12:45 am. Within 15 minutes I started feeling slightly better.  Went to bed and woke up at 7 am back to normal.