chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMRV
Symptoms: Autopsy, Blood lead normal, Death, Full blood count normal, Pathology test
Clinical narrative: Received vaccines 10/1/18. Patient developed fever on of 10/3/18. Tmax 101. Mom gave Motrin before bed that night. Checked on him before she went to bed and his temp was 99. Next morning he was found dead in crib. No blankets, stuffed animals in crib. Autopsy found no signs of trauma. Tox screen, tissue samples still pending.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMRV
Symptoms: Pyrexia, Toxicologic test
Clinical narrative: Received vaccines 10/1/18. Patient developed fever on of 10/3/18. Tmax 101. Mom gave Motrin before bed that night. Checked on him before she went to bed and his temp was 99. Next morning he was found dead in crib. No blankets, stuffed animals in crib. Autopsy found no signs of trauma. Tox screen, tissue samples still pending.
Age: 55.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Diarrhoea, Myalgia, Pyrexia, Vomiting
Clinical narrative: Fever chills muscle pain vomiting diarrhea.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash pruritic
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 30-SEP-2016, for routine health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving the ZOSTAVAX, on or about 30-SEP-2016, the patient presented to a medical group with complaints of a painful, itchy rash, along with other symptoms (unspecified). The patient was evaluated and diagnosed as suffering from shingles. The outcome of the events is unknown. 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. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with doses of improperly stored Oka/Merck VARIVAX lot # R017642, expiration date 20-JUN-2020 (dose and route of administration were not reported) for prophylaxis. It was reported that sterile diluent used for reconstitution of the vaccines was properly stored. The suspect doses of Oka/Merck VARIVAX were stored in temperature range from 6 to 14 degrees Fahrenheit for 30 minutes (date unspecified). There was no previous temperature excursion recorded. A digital data logger was involved. No adverse effects were reported.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dizziness, Dysstasia, Fatigue, Gait inability
Clinical narrative: Received a seasonal flu shot. The next morning I woke up and couldn't stand or walk due to severe dizziness, weakness and extreme fatigue. Intermittent headaches. The symptoms have persisted and although they seem to be improving they are not going away.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Headache
Clinical narrative: Received a seasonal flu shot. The next morning I woke up and couldn't stand or walk due to severe dizziness, weakness and extreme fatigue. Intermittent headaches. The symptoms have persisted and although they seem to be improving they are not going away.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Vaccination site oedema, Vaccination site warmth
Clinical narrative: REDNESS AND EDEMA AT VACCINE SITE WITH  EXTRA WARMTH NOTED.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dry eye, Fatigue, Ocular hyperaemia, Pyrexia
Clinical narrative: Tight throat, dry red eyes, fever, and severe vomiting including dry heaves, exhaustion, dizziness. It lasted about 48 hours.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Retching, Throat tightness, Vomiting
Clinical narrative: Tight throat, dry red eyes, fever, and severe vomiting including dry heaves, exhaustion, dizziness. It lasted about 48 hours.
Age: 63.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: PATIENT CAME INTO THE PHARMACY ON 10/07/18 COMPLAINING OF RED, SWOLLEN ARM THAT IS WARM TO TOUCH. SHE SAID IT WAS PAINFUL AND STARTED ON 10/06/2018. SHE BELIEVED IT WAS FROM A VACCINATION.  SHE WAS SENT TO THE MD PER THE PHARMACIST. THE MD PRESCRIBED HER KEFLEX AND SAID IT WAS NOT A REACTION FROM A VACCINE BUT INSTEAD WAS CELLULITIS.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Nausea, Pain
Clinical narrative: Extreme chills, headache, body ache, nausea.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Hallucination, Malaise, Pyrexia
Clinical narrative: Patient reports having a high fever for approximately 48 hours and feeling ill. His wife believes he was having hallucinations - patient claims to have had spoke to his deceased sister during the time of the high fever. Patient reports feeling much better today when I spoke to him.
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site bruising, Injection site nodule, Injection site pain
Clinical narrative: Severe bruising and "knot" and pain at injection site.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling around injections site. Warm to the touch.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Both shots were given in left arm. Approximately 24-72 hours after shot left arm turned red and warm to touch around shot areas. Then symptoms resolved themselve.
Age: 1.58
Sex: F
Vaccine: DTAP, FLUX, HEPA
Symptoms: Posture abnormal, Tremor
Clinical narrative: My Daughter was fine Saturday morning running around playing being a toddler...she.climbed on her Dads lap her head dropped and she.just started shaking.
Age: 38.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Chills, Hyperhidrosis, Injection site pain, Injection site swelling, Musculoskeletal disorder
Clinical narrative: My history with the Anthrax shot has always resulted in what I could call Severe symptoms. During the immunization I was asked if I had any severe symptoms in the past and I said Yes. I was then given a sheet that showed this reporting avenue (www.vaers.hhs.gov). Historical symptoms include fever for 24 to 48 hours. Severe aches, chills, sweat at night and at times mild nausea. I have experienced these symptoms with every Anthrax vaccination. In general I now clear the next 48 hours after a vaccination because I am unable to do anything else. During this most recent vaccination (6th in series) symptoms were the same. I call them severe because they are the most-sick I feel I have ever experienced by any illness at any time in my life. Fever started at about 2230 hrs on Thursday 27SEPT2018 and at its highest measured with our electronic ear thermometer in each ear and averaged peaked at 101.8°F (Friday ~2200 hrs). Wife is aware of reactions and is under instructions to take me to ER if fever uncontrollable or hits 102°F. Again had severe aches and pains. Had moderate swelling and pain at injection site. Generally unable to use that arm. My other injection site (Typhoid) was very mild and recovered nicely. Treated fever with over the counter methods and able to eventually get control of it. Fever started to go down at about 0100 hrs, Saturday 29SEPT2018.
Age: 38.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: My history with the Anthrax shot has always resulted in what I could call Severe symptoms. During the immunization I was asked if I had any severe symptoms in the past and I said Yes. I was then given a sheet that showed this reporting avenue (www.vaers.hhs.gov). Historical symptoms include fever for 24 to 48 hours. Severe aches, chills, sweat at night and at times mild nausea. I have experienced these symptoms with every Anthrax vaccination. In general I now clear the next 48 hours after a vaccination because I am unable to do anything else. During this most recent vaccination (6th in series) symptoms were the same. I call them severe because they are the most-sick I feel I have ever experienced by any illness at any time in my life. Fever started at about 2230 hrs on Thursday 27SEPT2018 and at its highest measured with our electronic ear thermometer in each ear and averaged peaked at 101.8°F (Friday ~2200 hrs). Wife is aware of reactions and is under instructions to take me to ER if fever uncontrollable or hits 102°F. Again had severe aches and pains. Had moderate swelling and pain at injection site. Generally unable to use that arm. My other injection site (Typhoid) was very mild and recovered nicely. Treated fever with over the counter methods and able to eventually get control of it. Fever started to go down at about 0100 hrs, Saturday 29SEPT2018.
Age: 1.83
Sex: M
Vaccine: FLU4
Symptoms: Seizure
Clinical narrative: Child experienced a seizure at home, was admitted to hospital for workup.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Loss of personal independence in daily activities, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Weakness, soreness, and pain in upper arm/shoulder. Trouble doing medial tasks like changing clothes, putting on car seat belt, raising arms above head, moving things with only right arm.  Some movements hurt more than others. Weakness and pain still persist currently. Have had a Tetanus booster roughly 10-11 years ago without issue. Possible that vaccine was injected too high?
Age: 6.0
Sex: F
Vaccine: FLUC4
Symptoms: Vomiting
Clinical narrative: Repeated vomiting overnight.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Bone pain, Chills, Musculoskeletal stiffness, Myalgia
Clinical narrative: Stiffness and soreness in left arm within 60 min. The next day, woke up with chills, pain in muscles, bones, joints, etc.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Stiffness and soreness in left arm within 60 min. The next day, woke up with chills, pain in muscles, bones, joints, etc.
Age: 80.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain in extremity, Vaccination complication
Clinical narrative: Note 1: Reviewed PDMP, patient not found, NORCO 5/325 #10 2-day supply: 30mg/day, acute initial fill for pain due to vaccinations (PREVNAR 13 and FLUZONE) given 10/5/18, okay to fill, will ask if patient tried other medications prior to visiting physician. Note 2:  patient did not complain about pain following administration of vaccinations, provided appropriate counseling leading up to and following vaccine administrations, daughter dropped off prescription. Note 3: verified patient's identification with the patient's daughter, double checked patient's circumstances with ER staff, per (nurse) - unknown if patient attempted to treat pain prior to ER visit, patient was seen by Dr. around 4 PM (10/5/18) due to pain in arm and was experiencing an adverse reaction due to vaccine administration (PREVNAR and FLUZONE HD), initially given TORADOL injection and diphenhydramine, patient was then given NORCO inpatient and saw improvement and prescription was sent to pharmacy, per Dr. notes patient is to reserve NORCO for severe pain, and to take TYLENOL and/or ibuprofen for pain management for mild/moderate pain, patient did not receive epinephrine injection (did not experience an allergic reaction). Spoke to patient's daughter and her husband about the situation and relayed to them I wanted to understand the full story and circumstances because I administered the vaccinations, both in the same arm, and was concerned for the patient's well-being; explained to them the rationale to give both vaccination in one arm (to maintain full-function in dominant arm for daily activities), both verified understanding and accepted counseling of patient's prescription and would convey the counseling information to the patient.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Patient said he developed a rash the size of a small pancake that comes and goes and is very itchy.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Patient stated that she had a fever within the first 24 hours after receiving the shot, she said that she was okay with that but a few days later she broke out into a rash.
Age: 38.0
Sex: M
Vaccine: FLU4, HEP, MMR, TDAP
Symptoms: Loss of consciousness
Clinical narrative: Patient alleges that he wanted to get four vaccines in the pharmacy consultation room. After the third dose (Engerix-B) he passed out for about 10 seconds. I held the patient so that he would not fall off his chair. I gave him some water after he regained his consciousness. I asked if he wanted me to call 911 and he declined. He sat in the vaccination room for 10 minutes and after that got a fourth vaccine at his consent. I called him on 09/24/2018 to check up on him and he stated that he didn't have any problems after that.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Patient experienced redness and blistering at injection sight. Return contact made to clinic on 10/5/2018 and patient returned for evaluation and treatment.
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Cough, Headache, Influenza like illness, Respiratory tract infection
Clinical narrative: Next day, after this flu shot, I began feeling flu like symptoms. This got progressively worst & for the next 10 days, I had a moderate case of respiratory infection which included: runny nose, sneezing, coughing, vomiting, achy joints & headaches.
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Rhinorrhoea, Sneezing, Vomiting
Clinical narrative: Next day, after this flu shot, I began feeling flu like symptoms. This got progressively worst & for the next 10 days, I had a moderate case of respiratory infection which included: runny nose, sneezing, coughing, vomiting, achy joints & headaches.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient had redness and swelling about 2 inches below the injection site, tenderness, no anaphylactic reaction. Area was treated with ice, Benadryl, OTC allergy medication and Tylenol as needed for discomfort. Symptoms resolved by 10/8/18. Upon inspection it appears shot may have been given to low in the deltoid resulting in SQ injection. Patient has gotten the flu shot over the past 7 years with no issues.
Age: 66.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Myalgia
Clinical narrative: Joint pain, widespread muscle pain, headache, fatigue; onset 5 hours after injection; ibuprofen for headache and pain; 24 hours after injection symptoms improving.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Pyrexia
Clinical narrative: I had a headache most of the day and then woke up at 1AM with a  fever of 102.5 and no other symptoms.
Age: 71.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Asthenia, Feeling abnormal
Clinical narrative: P.M. after shot: feeling really bad-had to lie down and felt like just couldn't get up. All thru night-called Pharmacy next day and asked if I could take ALEVE and was told symptoms would be ok in 2-3 days. No energy, no fever; just put me down. Do I go ahead and take 2nd vaccine as instructed (2 months from 1st vaccine per Pharmacy) but instructions by your Dept says 2-6 months after 1st injection-Please notify me. I do not have internet-Live in a very rural area on a mountain top and do not qualify for Hi-speed interned-Can be reached by phone or address. Could reaction I had have been caused by my getting shingles shot and flu shot at same time? Pharmacy said it would not. Let me know.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Patient experience redness and blistering at site of administration. Just over 24 hours after injection.
Age: 67.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Headache, Pain in extremity, Pyrexia, Rash, Skin warm
Clinical narrative: Patient said she had fever, rash on arm that was warm, headache, and sore arm for two days post vaccination.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Pain
Clinical narrative: Pain radiating down to left wrist.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Inflammation, Injected limb mobility decreased, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Left arm Pain, swelling, inflammation, unable to lift arm, tingling to left fingers.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Pt. felt light-headed and passed out ~5 minutes after flu shot administration. He passed out up front in the store and an ambulance was called. Pt. woke up and felt better after water. The EMT's then took him for an EKG and that is the last he was in our care.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Decreased appetite, Dyspnoea, Feeling abnormal, Feeling cold
Clinical narrative: About 8:30pm, out of blue, muscles got very rigid and stiff. Patient started shaking so bad that jaw shut and could hardly open mouth. Pt. could not stop shaking, got super cold and felt weird. By 1:30 am fever started at about 101, heart was racing/beating hard, and had shortness of breath. By the morning, fever was 102. Muscles were hurting, pt. felt nauseous and had migraine headache. Patient had doctor visit on 10/2 and doctor specified it was an allergic reaction to the flu shot. Doctor prescribed steroid Prednisone (8 days). Today, patient reports getting better but still does not feel right. She is weak, with not much of appetite, and not sleeping much yet. Patient commented that the episode was scary because it was so sudden, progressed fast and felt like she was having heart attack.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Heart rate increased, Hypersensitivity, Insomnia, Jaw disorder, Migraine
Clinical narrative: About 8:30pm, out of blue, muscles got very rigid and stiff. Patient started shaking so bad that jaw shut and could hardly open mouth. Pt. could not stop shaking, got super cold and felt weird. By 1:30 am fever started at about 101, heart was racing/beating hard, and had shortness of breath. By the morning, fever was 102. Muscles were hurting, pt. felt nauseous and had migraine headache. Patient had doctor visit on 10/2 and doctor specified it was an allergic reaction to the flu shot. Doctor prescribed steroid Prednisone (8 days). Today, patient reports getting better but still does not feel right. She is weak, with not much of appetite, and not sleeping much yet. Patient commented that the episode was scary because it was so sudden, progressed fast and felt like she was having heart attack.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Muscle rigidity, Musculoskeletal stiffness, Myalgia, Nausea, Palpitations
Clinical narrative: About 8:30pm, out of blue, muscles got very rigid and stiff. Patient started shaking so bad that jaw shut and could hardly open mouth. Pt. could not stop shaking, got super cold and felt weird. By 1:30 am fever started at about 101, heart was racing/beating hard, and had shortness of breath. By the morning, fever was 102. Muscles were hurting, pt. felt nauseous and had migraine headache. Patient had doctor visit on 10/2 and doctor specified it was an allergic reaction to the flu shot. Doctor prescribed steroid Prednisone (8 days). Today, patient reports getting better but still does not feel right. She is weak, with not much of appetite, and not sleeping much yet. Patient commented that the episode was scary because it was so sudden, progressed fast and felt like she was having heart attack.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Tremor
Clinical narrative: About 8:30pm, out of blue, muscles got very rigid and stiff. Patient started shaking so bad that jaw shut and could hardly open mouth. Pt. could not stop shaking, got super cold and felt weird. By 1:30 am fever started at about 101, heart was racing/beating hard, and had shortness of breath. By the morning, fever was 102. Muscles were hurting, pt. felt nauseous and had migraine headache. Patient had doctor visit on 10/2 and doctor specified it was an allergic reaction to the flu shot. Doctor prescribed steroid Prednisone (8 days). Today, patient reports getting better but still does not feel right. She is weak, with not much of appetite, and not sleeping much yet. Patient commented that the episode was scary because it was so sudden, progressed fast and felt like she was having heart attack.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Erythema, Hypoacusis, Immediate post-injection reaction, Nasal congestion
Clinical narrative: At Pharmacy, FLUARIX (influenza, mfr GSK #4zy53) vaccine was administered and employee's arm immediately turned red and became swollen. The pharmacist provided the employee Benadryl 25 mg 2 tablets from the pharmacy. Employee's arm improved but her throat became itchy and she reported her breathing "felt funny." The pharmacist immediately walked the employee over to the clinic. The pharmacist and employee went straight to a nurse, who immediately brought the employee to an exam room. Nursing supervisor, was consulted; she looped in a clinician, NP for consultation. Employee's vitals were monitored; BP, HR, and oxygen were all within normal limits. The employee was offered 2 options: 1) Epipen injection or 2) an additional 50 mg of liquid Benadryl. The employee selected the Benadryl. The pharmacist remained with patient the entire time. RN and NP frequently checked in on employee. This incident initially occurred at 3:30pm; I am the employee's supervisor and was notified about ~5 minutes afterwards. I immediately went to the clinic. I contacted our HR department,  who advised me to have patient go to be seen at Occupational Health. Because they close at 4:30, pt was advised to go to Hospital emergency department. Employee's sister came to pick her up to bring her to hospital at ~4:15. Symptoms were mildly improving at this time. Employee has received the flu shot in the past almost every year; she received it last year as well (received Fluvirin Lot #1720701). Her only allergies is mushroom. She has no egg allergy. For about a week after the initial reaction, the employee experience joint soreness and difficulty hearing from her left ear (flu administered on left arm). However, employee has recovered from the hearing completely and only slight joint soreness remains. She currently is having nasal congestion and is taking cetirizine for it.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Respiration abnormal, Throat irritation
Clinical narrative: At Pharmacy, FLUARIX (influenza, mfr GSK #4zy53) vaccine was administered and employee's arm immediately turned red and became swollen. The pharmacist provided the employee Benadryl 25 mg 2 tablets from the pharmacy. Employee's arm improved but her throat became itchy and she reported her breathing "felt funny." The pharmacist immediately walked the employee over to the clinic. The pharmacist and employee went straight to a nurse, who immediately brought the employee to an exam room. Nursing supervisor, was consulted; she looped in a clinician, NP for consultation. Employee's vitals were monitored; BP, HR, and oxygen were all within normal limits. The employee was offered 2 options: 1) Epipen injection or 2) an additional 50 mg of liquid Benadryl. The employee selected the Benadryl. The pharmacist remained with patient the entire time. RN and NP frequently checked in on employee. This incident initially occurred at 3:30pm; I am the employee's supervisor and was notified about ~5 minutes afterwards. I immediately went to the clinic. I contacted our HR department,  who advised me to have patient go to be seen at Occupational Health. Because they close at 4:30, pt was advised to go to Hospital emergency department. Employee's sister came to pick her up to bring her to hospital at ~4:15. Symptoms were mildly improving at this time. Employee has received the flu shot in the past almost every year; she received it last year as well (received Fluvirin Lot #1720701). Her only allergies is mushroom. She has no egg allergy. For about a week after the initial reaction, the employee experience joint soreness and difficulty hearing from her left ear (flu administered on left arm). However, employee has recovered from the hearing completely and only slight joint soreness remains. She currently is having nasal congestion and is taking cetirizine for it.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling hot, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Swelling of hands and feet, Hives on head, Itching, Feeling of warmth.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: Pain in shoulder.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth, Malaise
Clinical narrative: PATIENT FELT SICK THE NIGHT OF 10/4/18 THEN ON 10/6/18 ARM BECAME RED AND WARM BELOW THE INJECTION SITES.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Flushing, Pruritus, Urticaria
Clinical narrative: 1 hour after receiving flu shot, began having hives, itching, flushing, small amount of shortness of breath.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Body temperature, Erythema, Peripheral swelling
Clinical narrative: I injected the PNEUMOVAX23 first, once I injected the FlLUZONE into her arm it swoll up and was red. It was a little smaller then a dime. Over the weekend the patient became weak and had a temperature. She is now feeling much better (3 days later).
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Axillary pain, Chest pain, Lymph node pain, Musculoskeletal pain
Clinical narrative: Around 11:30 the evening of the vaccine pain radiated down the entire arm of vaccine site and to the chest and neck. The entire shoulder blade. The pain improved and has settled into the shoulder joint. The arm pit and shoulder joint and neck lymph node remain tender and painful on day 4 post vaccination. Ibuprofen and ice packs have been used for treatment.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Neck pain, Pain in extremity, Vaccination site pain
Clinical narrative: Around 11:30 the evening of the vaccine pain radiated down the entire arm of vaccine site and to the chest and neck. The entire shoulder blade. The pain improved and has settled into the shoulder joint. The arm pit and shoulder joint and neck lymph node remain tender and painful on day 4 post vaccination. Ibuprofen and ice packs have been used for treatment.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: My son's left arms swelled up to the size of his bicep. It was red and hot and painful. Swelling went down and was almost gone by 5:30 pm. He got the shot before lunch. The school nurse applied ice and gave him TYLENOL then monitored him.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Balance disorder, Dizziness, Headache, Impaired work ability, Muscle twitching
Clinical narrative: She reports that symptoms started about 30 minutes after the injection. She reports feeling dizziness, loss of balance, headache, muscle twitches in her arms, and nausea that worsened that evening and continued into the next day. She had to miss work due to symptoms. Her symptoms had "lessened" 2 days later.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea
Clinical narrative: She reports that symptoms started about 30 minutes after the injection. She reports feeling dizziness, loss of balance, headache, muscle twitches in her arms, and nausea that worsened that evening and continued into the next day. She had to miss work due to symptoms. Her symptoms had "lessened" 2 days later.
Age: 51.0
Sex: M
Vaccine: FLUR4
Symptoms: Facial paralysis
Clinical narrative: The patient started having Bells Palsy symptoms, diagnosed by the doctor, two days after receiving the immunization. He went to Dr. and they prescribed prednisone. The patient has recovered fully.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site, patient thinks it may be due to undisclosed scar tissue in area.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Pain in right shoulder.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist and refers to an unknown age and gender patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 15-SEP-2018, the patient was vaccinated with an expired dose of PNEUMOVAX 23, lot number M032635, expiration date 02-MAY-2018 (anatomical location, dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a 15 year old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On an unspecified day in July 2017 the patient was vaccinated with the first dose of GARDASIL 9 indicated as prophylaxis (route of administration, anatomical location, lot number and expiration date were not reported). On an unspecified day in July 2018, the patient received the second dose of GARDASIL 9 indicated as prophylaxis (route of administration, lot number, anatomical location and expiration date were not reported). There were no adverse events reported.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 21-SEP-2018, the patient was vaccinated with PROQUAD (recombinant human albumin)(lot # R011803 with a expiration date on 21-OCT-2019), by intramuscular route for prophylaxis, no adverse effects were reported.
Age: 0.67
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a nurse prescriber (also reported as a pharmacist) concerning an 8.5 months patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VAQTA, at the age of 8.5 months rather than after 12 months of age, for prophylaxis (dose, frequency, route of administration, anatomical location, lot number and expiry date were not reported). The vaccine was administered at prior pediatrician's office. Patient presented at office with parent requesting if dose needed to be repeated. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an administrator and refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies, concomitant medications or concurrent conditions were reported. On 20-JUN-2018, the patient was vaccinated with a dose of improperly stored subcutaneously VARIVAX (which had a lot # of N027619 and an expiration date of 04-OCT-2019); however, dosage number were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccines experienced the following temperature excursions: -14 degrees C to -10 degrees C for an unknown time and -9 degrees C to 8 degrees C for 1 hour, on unspecified dates. Reportedly, there had been multiple other unknown previous temperature excursions, and the aforementioned ones were identified due to a data logger.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On 03-OCT-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ lot # R002521, expiry date 18-SEP-2019, orally for prophylaxis. The doses of vaccine were stored between 47 degrees Fahrenheit (F) to 77F for 6 hours. No previous temperature excursions were detected. Digital data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1810USA002701.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On 03-OCT-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ, lot # R002521, expiry date 18-SEP-2019, orally for prophylaxis. The doses of vaccine were stored between 47 degrees Fahrenheit (F) to 77F for 6 hours. No previous temperature excursions were detected. Digital data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1810USA002697.
Age: 34.0
Sex: F
Vaccine: FLUN4
Symptoms: Documented hypersensitivity to administered product, Influenza
Clinical narrative: A spontaneous report has been received from a health professional. The report concerns a female patient (age 34 years, height 66 in). No medical history was reported. No concomitant products were reported. The patient received FLUMIST QUADRIVALENT (intranasal) 0.2 ml once/single administration, via nasal route, for for flu vaccination during 2014. The report described a medication error for FLUMIST QUADRIVALENT. The reported term was "used flumist quadrivalent with a history of allergic reaction to flu vaccine but had no problems (medication error)".  On 29-JAN-2018, the patient experienced the flu. Treatment with FLUMIST QUADRIVALENT (intranasal) was not changed.   The patient recovered from the event(s) of the flu on an unspecified date. The outcome of the event(s) of used flumist quadrivalent with a history of allergic reaction to flu vaccine but had no problems (medication error) was unknown. Additional description of the event(s) was as follows: allergic reactions to other flu vaccines and injectibles. The events were considered non-serious.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chest pain, Costochondritis
Clinical narrative: This is a spontaneous report from a contactable consumer. A 65-year-old female patient received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient previously took thiomersal and experienced an unspecified adverse reaction; diphtheria vaccine and experienced drug allergy and swollen lymph nodes under arm; and flu vaccine and experienced swollen lymph nodes under arm. The patient experienced chest pain for a week and also had costochondritis or ribs inflamed on an unspecified date.
Sex: M
Vaccine: PNC13
Symptoms: Dry mouth, Extra dose administered, Paraesthesia oral
Clinical narrative: This is a spontaneous report from a contactable consumer. A male patient of an unspecified age receive PREVNAR 13 (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient received PREVNAR 13 yesterday and after that, remembered that he had received PREVNAR 13 July 2017. Patient said he got two shots of PREVNAR 13 in one year and he recently has felt dry mouth, and "like burning and tingling" in the mouth for a couple of days. Patient wanted to know if there is any danger in getting two doses of PREVNAR 13. The outcome of the events was unknown. Information on lot number, batch number and expiration date has been requested.
Sex: F
Vaccine: MENB
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable physician via a sales representative. A female patient of an unspecified age (Age: 17; Unit: Unspecified) received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced rash under both eyes and abdomen. The outcome of the event was unknown. Information on the lot number has been requested.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Pharyngeal oedema, Photophobia, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable healthcare professional received via a Pfizer sales representative. A 17-year-old male patient received TRUMENBA, via an unspecified route of administration on 20Sep2018 at single dose for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that 5 days later, went to ER with fever, felt like throat was swelling, light sensitivity. Outcome of the events was unknown. No follow up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Headache, Hyperhidrosis, Loss of consciousness
Clinical narrative: Initial information received on 03-Oct-2018 regarding an unsolicited valid serious case received from a a Pharmacist. This case involves a 66 years old male patient who experienced profuse sweating, had a little bit of headache, became very light headed and passes out while he received vaccine FLUZONE HIGH DOSE. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapies received. On 25-Sep-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot UJ000AA and 28-MAR-2019) via unknown route in the left deltoid. On 25-Sep-2018, the patient developed a serious loss of consciousness 3 hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant. On 25-Sep-2018, the patient developed a non-serious profuse sweating and became very light headed same day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date (when patient went home), the patient developed a little bit of headache (latency unknown) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was reported that, patient got a FLUZONE HD shot, he went home went out for dinner about 3 hours later and passes out. Also he states that he started sweating and became very light headed with profuse sweating about 1/2 way through dinner - he then blacked out laying over on the booth. His friend shook him for about 10 seconds and then he came back awake. He states he felt ok after that except when got home he had a little bit of headache. Once home he relaxed and didn't take anything for the headache. He reports that he's never had any reaction to flu vaccine in the past, he didn't obtain any medical attention from EMS or his HCP and has been fine since then. No information about relevant tests reported. Final diagnosis was Mild headache, profuse sweating and loss of consciousness. As a corrective treatment patients friend shook him for about 10 seconds and then he came back awake and the patient did not take anything for headache. The patient recovered from reported events on an unknown date. List of documents held by sender: none. Sender's Comments: This case involves a 66 years old patient who experienced profuse sweating, light headedness and passes out 3 hours post vaccination with FLUZONE HIGH DOSE. Patient also had a little bit of headache. Time to onset is compatible. More details regarding patient's medical history, condition at the time of vaccination, vaccination technique, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Muscle contractions involuntary
Clinical narrative: When vaccine was given, patient noted muscle twinge/contraction in left arm and as the day progressed the upper arm started getting more sore radiating up into posterior shoulder and intermittent numbness/tingling into left 5th finger. Now having difficulty with abduction of left shoulder--pain and weakness.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Pain, Paraesthesia
Clinical narrative: When vaccine was given, patient noted muscle twinge/contraction in left arm and as the day progressed the upper arm started getting more sore radiating up into posterior shoulder and intermittent numbness/tingling into left 5th finger. Now having difficulty with abduction of left shoulder--pain and weakness.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Injection site erythema, Injection site warmth
Clinical narrative: A severe headache, overall muscle pain, and weakness, nausea, slight fever, warmth and redness in the area of injection, tired. It was much better 2 days later.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: A severe headache, overall muscle pain, and weakness, nausea, slight fever, warmth and redness in the area of injection, tired. It was much better 2 days later.
Age: 6.0
Sex: F
Vaccine: FLUC4
Symptoms: Abdominal pain upper, Chills, Decreased appetite, Pyrexia, Vomiting
Clinical narrative: Stomach pain, vomiting, fever, loss of appetite, chil.
Age: 40.0
Sex: F
Vaccine: FLU4, HEPA, TDAP
Symptoms: Injection site erythema, Pain, Swelling
Clinical narrative: Client noted increased soreness on 10/07/18. She then noted on Monday 10/08/18 that it was more sore with redness noted about 1-2 inches below the site of vaccine administration. She also felt it was slightly more swollen.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain
Clinical narrative: For the first 24 hours after vaccination, pt reports having 10 out of 10 pain in area where previous shingles had occurred approximately 3.5 months prior to vaccination. After 24 hours pain in that area was lower than before the vaccination was given. He reports his arm being swollen at injection site and a 5 inch "chord" of swelling running down arm from the injections site.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Soreness at injection site. Unable to move arm due to pain.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: Day after on 10/4/18 patient had bad headache and soreness on arm. On the weekend so 10/6/18 she experienced redness at injection site and is warm to touch. On 10/8/18 I was informed of this on 10/8/18 suggested this is normal adverse event but contacted her physician who agreed but would like to see her just in case.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash 48 hours after vaccines.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient's arm has hurt for some time after the vaccination especially when arm is raised above the head.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Paraesthesia oral, Throat irritation, Throat tightness
Clinical narrative: Patient complained of throat itching and perioral tingling with eventual throat tightness.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient stated that a couple of days post flu shot his upper arm and shoulder began to ache and over the next several days he has noticed a generlized shoulder weakness. He stated he did not have redness or soreness at the injection site.
Sex: U
Vaccine: HEP, HEPA, MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse prescriber and refers to an unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with doses of improperly stored M-M-R II, lot # N023024 with expiration date : 23-AUG-2019 and lot # N014485 with expiration date: 10-MAY-2019, RECOMBIVAX HB, lot # R004185 with expiration date: 06-NOV-2020, VAQTA, lot # R002086 and expiration date: 22-APR-2019 (route of administration was not specified for all the vaccines), and the patients were administered doses of improperly stored ROTATEQ orally, lot # N030965 with expiration date: 25-AUG-2019 (exact doses and frequency were not reported for all the vaccines). The vaccines were stored in temperature frame between 9 Celsius degrees (C) and 25 for 2 hours and 30 minutes and between 2 C and 8 C for 30 minutes. There was no previous temperature excursion. The temperature excursion was detected because of Digital Data Logger. No adverse effects were reported.
Sex: U
Vaccine: FLUX
Symptoms: Incorrect route of drug administration, Wrong drug administered
Clinical narrative: Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case was linked with 2018SA274273 (same reporter). This case involves 46 year old of unknown age who was accidently administered TUBERSOL (batch number: C5482AB) by intramuscular route instead of INFLUENZA VACCINE (batch number not reported) (expiration date, dose and site of administration were not reported for both the vaccine) on an unspecified date. The patients' medical history and concomitant medications were not reported. Patient had previous Positive PPD result. It was an actual medication error due to incorrect route of drug administration and Wrong vaccine administered. No information about any adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Follow up information received on 27-Sep-2018 from a pharmacist. Patient demographic updated. Previous vaccination was updated. Wrong vaccine administered event was added. List of documents held by sender: none.