chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in a adult 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 chills. On an unknown date, the outcome of the chills was unknown. It was unknown if the reporter considered the chills to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The healthcare professional stated that, another pharmacist had a patient who reported chills after receiving Shingrix. No other details were provided by the reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a male patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 14 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Shingrix. Additional details were provided as follows: The pharmacist was the vaccine coordinator for pharmacy in her area. She had no details about the patient. The age at vaccination was not reported. The patient had no history of shingles. This case has been linked with the case US2018166391, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 10 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Shingrix. Additional details were provided as follows: The pharmacist was the vaccine coordinator for pharmacy in her area. The age at vaccination was not reported. The patient had no history of shingles. This case has been linked with the case US2018166388, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Feeling cold, Headache, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a female patient who received Shingrix for prophylaxis. On 7th September 2018, the patient received the 2nd dose of Shingrix. On 7th September 2018, 8 hrs after receiving Shingrix, the patient experienced chills, headache and general body pain. On 8th September 2018, the patient experienced feeling abnormal. On an unknown date, the outcome of the chills, headache, general body pain and feeling abnormal were unknown. It was unknown if the reporter considered the chills, headache, general body pain and feeling abnormal to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. At 8:30 AM, the patient received 2nd dose of Shingrix after waiting 6 months for it. Exactly 8 hours after receiving Shingrix, the patient experienced severe body aches, chills and headache. Almost 24 hours after receiving Shingrix, the patient felt like her body just got hit by a train. The patient said that she knew this was common side effects but she would like to know if many people complained about this and really how long should it last and what should she be concerned about. The patient thought that she never got this vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of joint pain in a female patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced joint pain. On an unknown date, the outcome of the joint pain was unknown. It was unknown if the reporter considered the joint pain to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The reporter asked how to treat joint pain from Shingrix shot.
Sex: M
Vaccine: FLU4, MENB
Symptoms: Influenza like illness, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of malaise in a 19-year-old male patient who received Bexsero for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden for prophylaxis. In September 2017, the patient received Bexsero .5 ml and Influenza vaccine Quadrivalent 2017-2018 season. On an unknown date, unknown after receiving Bexsero and Influenza vaccine Quadrivalent 2017-2018 season, the patient experienced malaise, influenza-like symptoms, injection site erythema, injection site swelling, injection site induration and injection site warmth. On an unknown date, the outcome of the malaise, influenza-like symptoms, injection site erythema, injection site swelling, injection site induration and injection site warmth were recovered/resolved. It was unknown if the reporter considered the malaise, influenza-like symptoms, injection site erythema, injection site swelling, injection site induration and injection site warmth to be related to Bexsero and Influenza vaccine Quadrivalent 2017-2018 season. Additional details were provided as follows: The age at the vaccination was not reported. The flu shot was given at the same time as Bexsero. After vaccination, the patient experienced malaise, flu like symptoms and had large red swollen induration on arm at the injection site. The induration was warm to the touch. The symptoms lasted for 4 to 5 days.
Sex: M
Vaccine: FLU4, MENB
Symptoms: Malaise
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of malaise in a 19-year-old male patient who received Bexsero for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden for prophylaxis. In September 2017, the patient received Bexsero .5 ml and Influenza vaccine Quadrivalent 2017-2018 season. On an unknown date, unknown after receiving Bexsero and Influenza vaccine Quadrivalent 2017-2018 season, the patient experienced malaise, influenza-like symptoms, injection site erythema, injection site swelling, injection site induration and injection site warmth. On an unknown date, the outcome of the malaise, influenza-like symptoms, injection site erythema, injection site swelling, injection site induration and injection site warmth were recovered/resolved. It was unknown if the reporter considered the malaise, influenza-like symptoms, injection site erythema, injection site swelling, injection site induration and injection site warmth to be related to Bexsero and Influenza vaccine Quadrivalent 2017-2018 season. Additional details were provided as follows: The age at the vaccination was not reported. The flu shot was given at the same time as Bexsero. After vaccination, the patient experienced malaise, flu like symptoms and had large red swollen induration on arm at the injection site. The induration was warm to the touch. The symptoms lasted for 4 to 5 days.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain in a elderly female patient who received Shingrix for prophylaxis. On 7th June 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported but it could be 82 or 81 years old. The patient experienced pain at injection site and no other symptoms. For the tolerability of 2nd dose, refer linked case US2018GSK170050 reported by the same reporter for same patient.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site swelling, Loss of consciousness, Malaise, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of passed out in a 16-year-old female patient who received BEXSERO (batch number ABX711AA, expiry date 31st December 2019) for prophylaxis. Co-suspect products included MENACTRA for prophylaxis.  On 10th September 2018, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml and the 2nd dose of MENACTRA. On 11th September 2018, 1 days after receiving BEXSERO, the patient experienced passed out (serious criteria GSK medically significant) and fever. In September 2018, the patient experienced injection site swelling and malaise. On an unknown date, the outcome of the passed out was resolved with sequelae and the outcome of the injection site swelling, malaise and fever were not recovered/not resolved. It was unknown if the reporter considered the passed out, injection site swelling, malaise and fever to be related to BEXSERO. Additional details were provided as follows: The patient received the BEXSERO in right deltoid and MENACTRA in left deltoid via intramuscular route. Less than a week after receiving BEXSERO,  the patient experienced swelling at the injection site. Less than a week after receiving BEXSERO and MENACTRA, the patient experienced general malaise. On the morning of reporting date, the patient's body temperature was 104 degree F and in afternoon, it was 102 degree F. The patient passed out at school and at the reporting time he was at home from school. This case has been linked with case US2018GSK165853, reported by same reporter.
Sex: M
Vaccine: MEN
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.  In September 2018, the patient received the 1st dose of Meningococcal B vaccine. In September 2018, less than 2 weeks after receiving Meningococcal B vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Meningococcal B vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient received Meningococcal B vaccine last week from the date of reporting. The patient experienced pain in his arm. The patient was due for the next dose in a month.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site pain, Pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 10th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, headache, injection site pain and general body pain. On an unknown date, the outcome of the influenza-like symptoms, headache, injection site pain and general body pain were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, headache, injection site pain and general body pain to be related to SHINGRIX. Additional details were provided as follows: The reporter is a dentist. He was reporting this event for his wife. The patient experienced body ache, pain at injection site, headache, and flu like symptoms which lasted for total of 3 days. This is one of the 5 cases reported by the same reporter, this case has been linked with case US2018163110 reported by the same reporter for same patient for 2nd dose.
Sex: F
Vaccine: FLU4
Symptoms: Influenza, Influenza A virus test positive, Influenza B virus test positive, Pneumonia, Vaccination failure
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of suspected vaccination failure in a adult female patient who received Influenza vaccine Quadrivalent 2017-2018 season for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent 2017-2018 season at an unknown dose. In March 2018, less than a year after receiving Influenza vaccine Quadrivalent 2017-2018 season, the patient experienced pneumonia (serious criteria GSK medically significant). On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure, pneumonia and influenza were unknown. It was unknown if the reporter considered the vaccination failure, pneumonia and influenza to be related to Influenza vaccine Quadrivalent 2017-2018 season. Additional details were provided as follows: The age at vaccination was not reported. In winter 2017-2018, the patient took flu shot. She later got both types A and B influenza at separate times in the early months of 2018. This case was considered as suspected vaccination failure because the time to onset for influenza was unknown at the time of reporting.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Injection site warmth, Product administered to patient of inappropriate age
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) through a Pfizer sales representative. A 28-year-old female patient received TRUMENBA, (Lot number and expiration date were not reported), with route of administration, on the left arm on 26Jul2018 at a single dose for immunization; and MENACTRA, (Lot number and expiration date were not reported), with route of administration unspecified, on 26Jul2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2018, the patient had site reactions of hot, swollen and red; could not move arm; and received meningococcal group b rlp2086 at 28 years old. The outcome of the events was unknown.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse. A 17-year old male patient received TRUMENBA, (lot number: S26985, expiration date: 31Jan2019) intramuscular on 13Aug2018 at 0.5 ml, single for pre-college admission. The patient was not suffering from any other medical conditions and was not taking any other medications. On 13Aug2018, the patient had fever and body ache for about 24 hours right after taking meningococcal group b rlp2086. The patient did not undergo any lab work or blood test. Therapeutic measures were taken in response to fever and body ache which includes ibuprofen. The patient recovered from fever and body ache both on an unspecified date in Aug2018. The reporter considered fever and body aches related with meningococcal group b rlp2086.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Headache, Insomnia, Nightmare, Pyrexia
Clinical narrative: Within 4 hours patient started with a headache and then overnight had terrible headache, nightmares, fever and chills. She did not sleep due to these symptoms. She feels better the next day.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pt reports injection area continues to be swollen and sore.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Condition aggravated, Dizziness, Fatigue
Clinical narrative: Initially, the following morning, I was weak, dizzy, sick to my stomach and had fatigue and all-over muscle aches and pains plus a very sore left arm. Shortly thereafter I began to have severe pain in my neck and upper shoulders. This pain lasted almost an entire week. I do have degenerative cervical disc disease which was diagnosed in February of this year and had several weeks of physical therapy which helped immensely. The vaccine appeared to exacerbate this condition in my opinion because it occurred the very next day in combination with muscle aches all over.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Intervertebral disc degeneration, Musculoskeletal pain, Myalgia, Neck pain, Pain in extremity
Clinical narrative: Initially, the following morning, I was weak, dizzy, sick to my stomach and had fatigue and all-over muscle aches and pains plus a very sore left arm. Shortly thereafter I began to have severe pain in my neck and upper shoulders. This pain lasted almost an entire week. I do have degenerative cervical disc disease which was diagnosed in February of this year and had several weeks of physical therapy which helped immensely. The vaccine appeared to exacerbate this condition in my opinion because it occurred the very next day in combination with muscle aches all over.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Muscle spasms
Clinical narrative: Back Spasms, Locked up in lower back where it was very painful to move.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Patient stated she had a 101 fever and her arm swelled and felt like it was on fire.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast swelling, Feeling cold, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt reported swelling in her right arm around the injection site. Area of injection is red, raised and pt is reporting it feels hot to touch. The area of swelling is approximately 5" in circumference. The following morning the pt reported the symptoms expanding to her lymph nodes resulting in swelling on the side of her body and her right breast. She also reported the fever and chills for about 12 hours after the injection but this went away the next day.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Swelling
Clinical narrative: Pt reported swelling in her right arm around the injection site. Area of injection is red, raised and pt is reporting it feels hot to touch. The area of swelling is approximately 5" in circumference. The following morning the pt reported the symptoms expanding to her lymph nodes resulting in swelling on the side of her body and her right breast. She also reported the fever and chills for about 12 hours after the injection but this went away the next day.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Sluggishness
Clinical narrative: Muscle pain (legs, button, arms), chills throughout night, seemed to be over in the morning but sluggish all the next day took TYLENOL and ibuprofen.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Malaise, Pyrexia, Vertigo
Clinical narrative: Fever of 101 for 2 days. Felt ill and dizzy for several days. Had an episode of Vertigo - which I never had before.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Administration site rash, Administration site warmth, Injection site pruritus
Clinical narrative: Patient had a rash around the site of administration (itchy, warm to the touch). Rash started on 09/17. Patient was advised to take OTC Benadryl and follow up with her doctor.
Age: 1.08
Sex: F
Vaccine: FLU4
Symptoms: Depressed level of consciousness, Hypotonia, Irritability, Pallor, Peripheral coldness
Clinical narrative: Morning of 9/18, baby awoke fussy, afebrile. Within 15 min of waking up, parents noted that she had an episode that lasted several minutes of looking pale while, cool distal extremities, decreased alertness (but no loss of consciousness), decreased tone. Still alert through this time. Duration of experience was 5-15 min. By the time of the exam approximately an hour later, she had normal exam, stable vital signs. No abnormalities on exam. Discharged to home from clinic.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Feeling abnormal, Flushing, General physical health deterioration, Hypotension
Clinical narrative: PATIENT RECEIVED VACCINE. STATED HE FELT FLUSHED A SHORT TIME AFTER ADMINISTRATION, BUT THIS DID NOT PERSIST. AROUND 2AM NEXT MORNING PATIENT REPORTS FEELING BAD AND HAD 103 DEGREE TEMPERATURE. WENT TO ER. PATIENT'S BLOOD PRESSURE WAS VERY LOW. PATIENT CONTINUED TO DECLINE AND WAS HOSPITALIZED FOR 5 DAYS IN ICU. DOCTORS TOLD PATIENT THEY THOUGHT THIS WAS CAUSED BY REACTION TO VACCINE.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Intensive care, Vaccination complication
Clinical narrative: PATIENT RECEIVED VACCINE. STATED HE FELT FLUSHED A SHORT TIME AFTER ADMINISTRATION, BUT THIS DID NOT PERSIST. AROUND 2AM NEXT MORNING PATIENT REPORTS FEELING BAD AND HAD 103 DEGREE TEMPERATURE. WENT TO ER. PATIENT'S BLOOD PRESSURE WAS VERY LOW. PATIENT CONTINUED TO DECLINE AND WAS HOSPITALIZED FOR 5 DAYS IN ICU. DOCTORS TOLD PATIENT THEY THOUGHT THIS WAS CAUSED BY REACTION TO VACCINE.
Age: 75.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Arthralgia, Chills, Fall, Fatigue, Gait disturbance
Clinical narrative: 1. Extreme muscle weakness in legs and arms. Felt very weak on both sides. 2. A lot of difficulty walking had to hold on to walls and doorway to go to bathroom. Very unsteady. 3. Strong chills, body shaking and teeth chattering for over an hour. 4. Extreme pain in back of right knee. Same as a year ago. Could barely bend my left leg. 5. When tried to get back into bed, legs gave out and I fell. a. Not enough strength in legs to roll over or in arms to get up. b. Took a lot of effort to use arms just to sit up but had to lean against bed. 6. Finally had wife call 911. 7. Lost most of Saturday. Would wake for only about 1  2 hours then felt exhausted and went back to sleep.
Age: 75.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Muscular weakness, Tremor
Clinical narrative: 1. Extreme muscle weakness in legs and arms. Felt very weak on both sides. 2. A lot of difficulty walking had to hold on to walls and doorway to go to bathroom. Very unsteady. 3. Strong chills, body shaking and teeth chattering for over an hour. 4. Extreme pain in back of right knee. Same as a year ago. Could barely bend my left leg. 5. When tried to get back into bed, legs gave out and I fell. a. Not enough strength in legs to roll over or in arms to get up. b. Took a lot of effort to use arms just to sit up but had to lean against bed. 6. Finally had wife call 911. 7. Lost most of Saturday. Would wake for only about 1  2 hours then felt exhausted and went back to sleep.
Age: 45.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Seizure
Clinical narrative: Patient received the FLUZONE QUADRIVALENT vaccine at 10:57am on 9-18-18 and around 1:30pm the husband called and reported to us that his wife was having seizures after receiving the vaccination. The husband said she had to be taken to hospital and kept having seizures while on the way and while at the hospital, the husband also told us they gave her KEPPRA (via IV) to calm the seizures down. Patient was discharged from hospital and at home now.
Age: 59.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Fatigue, Lymphadenopathy, Oropharyngeal pain, Pain
Clinical narrative: Very sore throat, swollen glands, fatigue, body aches. I also received a flu shot at the time I received the shingles vaccine. I get a flu shot every year and have never had a reaction. Went to my doctor and she gave me a prescription for penicillin. She looked at my throat and said it did not look like I have strep throat.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza, Local reaction, Myalgia, Otitis media
Clinical narrative: At 1 AM the morning after the SHINGRIX vaccination, I developed fever and chills up to 100 degrees the following day. I felt like I was coming down with the flu and also had a local erythematous reaction at the vaccinations site as well as a serous otitis media that lasted 3 days. The fever and myalgia were pretty well cleared up at 48 hours.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Vaccination site erythema
Clinical narrative: At 1 AM the morning after the SHINGRIX vaccination, I developed fever and chills up to 100 degrees the following day. I felt like I was coming down with the flu and also had a local erythematous reaction at the vaccinations site as well as a serous otitis media that lasted 3 days. The fever and myalgia were pretty well cleared up at 48 hours.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Pruritus, Rash generalised
Clinical narrative: Rash all over body. Some itching around the neck area, prescribed with Rx Diphenhydramine HCl 12.5 mg/5 mL - Give 3 mL PO every 8 hrs as needed for itch.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Injection site mass, Injection site pain, Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: 10 Sept: Right shoulder deltoid with palpable subcutaneous mass, tender to palpation (Men B vaccine), left shoulder deltoid WNL (HPV vaccine). 7 Sept: Pt started with fever, nasal congestion, throat pain. Today with prolonged exudate.
Age: 69.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Hyperhidrosis, Pallor
Clinical narrative: After pt. was given 2 shots (PNEUMOVAX 23 and FLUAD) pt fell off chair while waiting 15 mins of observation. Pt. was pale and sweaty but very alert. RPh comfort and monitor pt. while another called 911. Pt. stated that this happened to him before but did not mark on immunization form. 5 hrs. later - assistant came by pt. home to check on him: reported back that he was doing well.
Age: 52.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Subjective fever day after admin and local redness, pain and swelling at admin site.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Limb discomfort, Peripheral swelling, Skin warm
Clinical narrative: Pt complained of upper arm red, sore, and swollen, all warm to touch all over her right arm from PNEUMOVAX 23 administered on 9/11/18.
Age: 6.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Clinic went on vacation, vaccine expired while gone. We now have a double check policy in place to prevent this from happen again. Child had not signs or symptoms. Filled out VAERS report secondary to gave shot that was outdated by accident. Patient had no adverse symptoms.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema, Pruritus, Skin warm
Clinical narrative: Pt received SHINGRIX vaccine 3 days ago (9/11/18). Came in 9/14/18 and reported redness at injection site-red area got bigger with each day. Pt reported itchy feeling, warm to touch, some dizziness. Red color decreased from 9/13 to 9/14. Seemed to be improving and less red. This was the second dose in the series. Felt worse at night.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Pain, Rash
Clinical narrative: Patient said to have experienced soreness all over his body, rash developed about 2 days later on arms, trunk, neck. Weakness lasted 2 to 3 days. Patient spouse said Primary physician was contacted. Steroid pack was taking for rashes.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient claims entire arm is hurting. Painful to move it.
Age: 65.0
Sex: M
Vaccine: HEPAB
Symptoms: Limb discomfort, Musculoskeletal discomfort, Skin warm
Clinical narrative: Patient reports sore arm spreading into back, states that it feels hot but not itchy. Began around 5 days ago, has not gotten worse but is not getting better either.
Age: 63.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: Patient states that they had a reaction the day after their shot. Lasted a couple days. Was very red, encompassing most of the upper arm, and was warm to the touch. Patient stated it went away on its own after a couple days.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient stated that the vaccine she received a week ago she was just starting to have a reaction to. She has a little swelling, inflammation, redness, warmth and itching around the injection site. She said that this started just yesterday (~6 days after the vaccine and was getting worse). Told her she could try to ice it, take benadryl and something for the pain and if it continued to get worse to let her doctor know.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth
Clinical narrative: Patient stated that the vaccine she received a week ago she was just starting to have a reaction to. She has a little swelling, inflammation, redness, warmth and itching around the injection site. She said that this started just yesterday (~6 days after the vaccine and was getting worse). Told her she could try to ice it, take benadryl and something for the pain and if it continued to get worse to let her doctor know.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Syncope
Clinical narrative: Patient felt lightheaded, dizzy and faint. We sat her down, then laid her down. After 30 minutes, she walked to her daughter's car and went home. I called her at about 6:30 and her husband said she was doing great.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Discomfort, Hypokinesia, Influenza like illness, Pyrexia
Clinical narrative: Starting 8 hours after vaccine, I had 16 hours of extreme flu conditions: Fever, Chills, Aching, Dizziness. My body felt like it weighed 400 pounds - I had trouble turning over in bed. Im 56 years old an I have never ever had a flu that felt that bad...
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Urticaria
Clinical narrative: Hives on right arm and painful to the touch. Instructed patient to see her doctor, but she said she would use Benadryl for now.
Age: 37.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Nervousness, Skin hyperpigmentation, Tremor
Clinical narrative: C/o dizziness and dark pigmentation around mouth s/p Hep A vaccine received 8/18/2018 AM; Epipen X 1 given on Left upper thigh as orderd by Dr.@ 3:43PM. VS @ 3:47PM - HR-81bpm; BP- 106/53 (L); O2 Sat -99%; RR -16. Pt toleared the procedure well and denied dizziness, palpitation, chest pain, sweating or weakness. @3:53PM: Pt started to c/o shakiness and nervousness. Dr. notified and ordered to have pt lie down to rest and continue to monitor. @4:15PM VS - HR:80bpm; O2 Sat -98%; Pt reports that she feels better - no more shakiness observed. @4:45PM VS- HR: 68bpm; O2Sat -98%; BP-110/74 (L);RR-20. Pt reports that she is doing much better and has no complaint now. Per Dr., pt can go home when asymptomatic. @5:30PM - VS- HR: 71bpm; O2 Sat- 99%; BP- 102/66(L); Pt currenrly A&O x3, self-ambulatory and denies dizziness, headahce, palpitation, SOB, nervousness, or weakness. Dr. came to speak to the family. Per Dr., pt can go home by car service. Car service contacted for pt. Pt left clinic accompanied by her mother @ 6:13PM. Pt left clinic accomapnied by her mom @ 6:13PM but returned c/o recurrence of shakiness and requests 911 called to go to hospital. Pt d/c from hospital  on 8/19/2018.
Sex: U
Vaccine: HEP, HEPA, MMR, RV5
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to unspecified patients of unknown age and gender. There was no information about the patient's concurrent conditions or medical history. The patient's concomitant therapies included sterile diluent. On an unknown date, the patients were vaccinated with an improperly stored doses of VAQTA lot numbers: R006210/R006209, expiration dates: 22-APR-2019/16-MAR-2019 respectively; ROTATEQ lot numbers: N030152/ R003114, expiration dates: 01-SEP-2019/27-SEP-2019 respectively; RECOMBIVAX HB lot numbers: R006746/ R004185, expiration dates: 09-NOV-2020/06-NOV-2020 respectively and M-M-R II lot number: N025892, expiration date: 19-SEP-2019 (dosage schedule, route and anatomical location were not reported for all the vaccines) for prophylaxis. There was no adverse effect reported. The administered doses of vaccines experienced the temperature excursion of 11.5 degrees Celsius for 1 hour 46 minutes. The previous temperature excursion was not reported. Data logger was involved
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, Injection site inflammation, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a 38 year old non-pregnant female patient reporting on herself. She had no medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 16-AUG-2018, the patient was vaccinated with the first dose of M-M-R II intramuscularly (incorrect route of drug administration), as prophylaxis (strength, dose, lot # and expiration date were not reported). On 12-SEP-2018, the patient was vaccinated with the second dose of M-M-R II subcutaneously, lot # N023146, expiration date: 21-AUG-2019, as prophylaxis (strength and dose were not reported). On 13-SEP-2018, the patient experienced really large swelling (injection site swelling), inflammation (injection site inflammation), burning (injection site pain) and warm sensation (injection site warmth) at the injection site. An unspecified treatment was given for the events. No laboratory diagnostic studies were performed. She did not seek medical attention. The outcome of injection site warmth, injection site pain, injection site swelling and injection site inflammation was reported as not recovered/not resolved. The reporter did not provide the causality between the events and M-M-R II.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 25-OCT-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 26-SEP-2016, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 13-DEC-2011, the patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 20-JUL-2015, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2009, the patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date in 2016, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 18-SEP-2018 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 27-AUG-2009, the patient was inoculated with ZOSTAVAX at a medical group (considered physician's office) as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and indication not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 07-MAR-2013, the patient was treated by a physician at the same medical group for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, 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.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 18-SEP-2018 from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and indication not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2016, the patient was treated at a medical office for a blistering vesicular outbreak that was diagnosed as a severe herpetic rash. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, 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.
Sex: U
Vaccine: MENB
Symptoms: Pain, Swelling
Clinical narrative: This is a spontaneous report from a contactable healthcare professional. A 17-year-old patient of unspecified gender received the first single dose of TRUMENBA on an unspecified date, for immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced pain and swelling for 1 week. The events resolved on an unspecified date.   The reporter understood these events were expected.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Eye pruritus, Eye swelling, Nausea, Peripheral swelling
Clinical narrative: 08/18/2018 8:30am Pt's mother called stating that her son received the 2nd HPV the previous day and woke up with dizziness, nausea and vomiting. 8/18/18 9:24am Nurse, LVN called mother and spoke to her, mother denied patient having any SOB, swelling to lips, tongue, nose, hands or feet.  No itching to tongue or throat or difficulty swallowing. No swelling to hands or feet either. Nurse instructed patient to give BENADRYL every 4-6 hours and if that didn't help or if child didn't improve she should take him to his PCP. Mom agreed. 8/18/18 10:40am Mother contacted nurse again and stated the patient's left eye and hand were slightly swollen and itching but that the BENADRYL was helping (she gave BENADRYL at 945am). 08/19/2018 1059am Mother contacted Nurse again stating that she gave ZOFRAN and BENADRYL for the n/v/d that started last night, and gave him ZYRTEC today instead of the BENADRYL because it was too sedating. She also stated she tried to get him seen at clinic, but was refused because they did not administer the immunization.  She is in the process of getting into see his PCP. She denied any respiratory symptoms at this time.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Pruritus, Vomiting
Clinical narrative: 08/18/2018 8:30am Pt's mother called stating that her son received the 2nd HPV the previous day and woke up with dizziness, nausea and vomiting. 8/18/18 9:24am Nurse, LVN called mother and spoke to her, mother denied patient having any SOB, swelling to lips, tongue, nose, hands or feet.  No itching to tongue or throat or difficulty swallowing. No swelling to hands or feet either. Nurse instructed patient to give BENADRYL every 4-6 hours and if that didn't help or if child didn't improve she should take him to his PCP. Mom agreed. 8/18/18 10:40am Mother contacted nurse again and stated the patient's left eye and hand were slightly swollen and itching but that the BENADRYL was helping (she gave BENADRYL at 945am). 08/19/2018 1059am Mother contacted Nurse again stating that she gave ZOFRAN and BENADRYL for the n/v/d that started last night, and gave him ZYRTEC today instead of the BENADRYL because it was too sedating. She also stated she tried to get him seen at clinic, but was refused because they did not administer the immunization.  She is in the process of getting into see his PCP. She denied any respiratory symptoms at this time.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Rash, Skin infection
Clinical narrative: Seen in local ER day following injection: 8/31 for left arm rash ,edema and erythema. Dx with a skin infection and given oral antibiotics and steroids. Erythema, rash, and edema continued to worsen and was past her elbow. Went back to ER on 9/1 and given IV antibiotic. Sent home with additional antibiotics and symptoms started to improve by 9/4.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Fatigue, Feeling hot, Injection site erythema, Injection site nodule
Clinical narrative: Not sure it's truly adverse but she does have a larger than usual red area - most of her upper arm, slightly raised knot at area of injection, no issue lifting arm, the area is warm and red, husband just concerned and wanted it reported. She said she felt warm and tired last night went to bed early.  Area is sore.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Not sure it's truly adverse but she does have a larger than usual red area - most of her upper arm, slightly raised knot at area of injection, no issue lifting arm, the area is warm and red, husband just concerned and wanted it reported. She said she felt warm and tired last night went to bed early.  Area is sore.
Age: 64.0
Sex: M
Vaccine: TDAP, TDAP, TDAP, VARZOS
Symptoms: Middle insomnia, Pain in extremity
Clinical narrative: Patient has ongoing severe arm pain since the date of injection. It wakes him up at night.
Age: 64.0
Sex: M
Vaccine: TDAP, TDAP, TDAP, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient has ongoing severe arm pain since the date of injection. It wakes him up at night.
Age: 64.0
Sex: M
Vaccine: TDAP, TDAP, TDAP, VARZOS
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Patient has ongoing severe arm pain since the date of injection. It wakes him up at night.
Age: 17.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Fever of 102 F, Sore Left arm , headache, nausea.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Angina pectoris, Anxiety, Chest pain, Haemoglobin decreased, Hypotension
Clinical narrative: Patient has had chest pain within days of the vaccine and went to a cardiologist, she had issues with anxiety in the months following. She has had severe menstrual excessive bleeding, she was put on progesterone to control bleeding. She was hospitalized for low hemoglobin of 6.8 with a low blood pressure and received three blood transfusion with no family history of blood disorders.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Menorrhagia, Transfusion
Clinical narrative: Patient has had chest pain within days of the vaccine and went to a cardiologist, she had issues with anxiety in the months following. She has had severe menstrual excessive bleeding, she was put on progesterone to control bleeding. She was hospitalized for low hemoglobin of 6.8 with a low blood pressure and received three blood transfusion with no family history of blood disorders.
Age: 66.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site swelling, Mobility decreased
Clinical narrative: Redness and swelling rt arm at injection site, limited arm movement (pain, control). 3rd day after injection- fever (mild, unmeasured), generalized muscle and joint pain, headache. 4th day side effects lessened.
Age: 66.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Myalgia, Pyrexia
Clinical narrative: Redness and swelling rt arm at injection site, limited arm movement (pain, control). 3rd day after injection- fever (mild, unmeasured), generalized muscle and joint pain, headache. 4th day side effects lessened.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Fatigue, Influenza like illness, Vomiting
Clinical narrative: Pt reports within 20 minutes of leaving the office he felt like he had the flu. Reports dizziness, fatigue, and vomiting that last until the following day at 6pm. Pt contacted office to inform, let illness took its course, and rested, no other treatment occurred. Pt today 9/19/2018 felt back to normal.