chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Condition aggravated, Hypoaesthesia, Pyrexia, Tic, Vomiting
Clinical narrative: Started with a fever on the night of 10/20/17 up to 103.8. Patient was given MOTRIN. Woke up a 3 am and vomiting 1 time. Around 7:15 pm on the night of 10/20/17 parents noticed left side of face to be numb and his Tics increased. Mom stated it looked like he had dental work done. The numbness started improving after a few hours but last around his left eye for a day and a half. On 10/26 patient saw Dr., his pediatric neurologist. Patient was cleared by Dr. per mom.
Age: 76.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Patient contacted his primary care team and reported that 3 days after receiving the PREVNAR 13 vaccine, he developed a reddened, itchy area at the site of injection. He has taken BENADRYL OTC which he states relieves the itching. Primary care team instructed patient to come to urgent care if rash or itching worsens.
Age: 23.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pain, Swelling
Clinical narrative: area " swollen, red, and sore". TX- Benadryl.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Injected limb mobility decreased, Injection site pain
Clinical narrative: Increasing pain and decreasing range of motion to right shoulder in days/weeks following injection. Diagnosed with bursitis by occupational health physician.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Cellulitis, Malaise, Pain in extremity, Peripheral swelling
Clinical narrative: Evening after shot, I started feeling ill, running low grade temp, arm sore and swollen. Next evening I went back to the pharmacist, who involved the Clinic Nurse who suggested I go to the emergency room at Hospital. I was seen in the emergency room by doctor who diagnosed Cellulitis, and I was given 7 days of KEFLEX 500 mg. I also have photos of condition of left arm.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Neck pain, Pain in extremity, Tetanus
Clinical narrative: On the arm where the vaccine administered: soreness in arm and hand, initially. Proceeded to  tetanus  in fingers on that hand. Since 10/20, pain has spread from right arm up to right side of neck.
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Periarthritis, Rotator cuff syndrome
Clinical narrative: Developed early, adhesive capsulitis of left shoulder with impingement. Experiencing significant pain and limited range of motion.
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: X-ray
Clinical narrative: Developed early, adhesive capsulitis of left shoulder with impingement. Experiencing significant pain and limited range of motion.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Impaired work ability, Insomnia, Laboratory test, Muscle spasms, Pain
Clinical narrative: Horrible calf muscle cramps most every night for 3 weeks (skipped 2 nights), feels like electrical current in my leg right before it grabs my muscle, I will jump from bed & put weight on that leg until it releases. Sometimes it doesn't release for 5-10 minutes producing horrible pain! I missed work on 10/13/17 due to lack of sleep because of NUMEROUS cramps that night. I eat mustard, drink pickle juice, eat salt, eat more potassium foods, NP prescribed potassium & recently started tonic water. I started sleeping with 2 heating pads on both calf muscles to keep them warm & relaxed. I keep turning them back on all through the night. My cramps have been less painful and less duration since using the heating pads.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Horrible calf muscle cramps most every night for 3 weeks (skipped 2 nights), feels like electrical current in my leg right before it grabs my muscle, I will jump from bed & put weight on that leg until it releases. Sometimes it doesn't release for 5-10 minutes producing horrible pain! I missed work on 10/13/17 due to lack of sleep because of NUMEROUS cramps that night. I eat mustard, drink pickle juice, eat salt, eat more potassium foods, NP prescribed potassium & recently started tonic water. I started sleeping with 2 heating pads on both calf muscles to keep them warm & relaxed. I keep turning them back on all through the night. My cramps have been less painful and less duration since using the heating pads.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Day 1: Patient reports redness, swelling, and pain at injection site and felt achy later in day of injection. Awoke middle of night 3am injection arm pain, redness, and swelling. She describes as 9 inches from top of shoulder to bottom of redness/swollen area and 4-6 inches wide. She took ibuprofen and iced area. Day 2: Next day, patient felt much worse with joint pain, full body aching, and fever 101 and R arm swollen, red, and tender. L arm (non-inj arm) now experiencing "throbbing" pain in area of lymph node which she describes as "like a muscle spasm". Day 3: Patient reports felt better but still with R shoulder (inj site) swollen more at top vs. bottom of upper arm. Day 4: Patient called me today to report. She has not yet notified her Dr. I told her to notify Dr and I would submit report, and send copy to patient and PCP.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Lymph node pain, Middle insomnia, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Day 1: Patient reports redness, swelling, and pain at injection site and felt achy later in day of injection. Awoke middle of night 3am injection arm pain, redness, and swelling. She describes as 9 inches from top of shoulder to bottom of redness/swollen area and 4-6 inches wide. She took ibuprofen and iced area. Day 2: Next day, patient felt much worse with joint pain, full body aching, and fever 101 and R arm swollen, red, and tender. L arm (non-inj arm) now experiencing "throbbing" pain in area of lymph node which she describes as "like a muscle spasm". Day 3: Patient reports felt better but still with R shoulder (inj site) swollen more at top vs. bottom of upper arm. Day 4: Patient called me today to report. She has not yet notified her Dr. I told her to notify Dr and I would submit report, and send copy to patient and PCP.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Tenderness
Clinical narrative: Day 1: Patient reports redness, swelling, and pain at injection site and felt achy later in day of injection. Awoke middle of night 3am injection arm pain, redness, and swelling. She describes as 9 inches from top of shoulder to bottom of redness/swollen area and 4-6 inches wide. She took ibuprofen and iced area. Day 2: Next day, patient felt much worse with joint pain, full body aching, and fever 101 and R arm swollen, red, and tender. L arm (non-inj arm) now experiencing "throbbing" pain in area of lymph node which she describes as "like a muscle spasm". Day 3: Patient reports felt better but still with R shoulder (inj site) swollen more at top vs. bottom of upper arm. Day 4: Patient called me today to report. She has not yet notified her Dr. I told her to notify Dr and I would submit report, and send copy to patient and PCP.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Infection, Skin reaction, Swelling
Clinical narrative: Localized skin reaction and infection; Swelling, increased warmth, redness; Being treated with Keflex.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Muscle spasms, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: Pt. was woken by muscle spasming on L arm (elbow area) and then over the following 48 hours - arm was getting continued weakness and pain throughout the L arm with tingling of thumb, first 2 fingers and 1/3 of the 3rd finger (ring finger).
Age: 46.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Pain
Clinical narrative: Three days after the shot, they called complained with with pain, numb and can't  move on his left arm.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Rash generalised
Clinical narrative: On Thursday, Oct 26th, patient was showing some slight rashes that grew and continued to spread over his whole body. We took him to the ER and at 9:30PM he was given a dose of Prednisone and BENADRYL. The following morning his symptoms look like they had gone away.
Age: 0.17
Sex: F
Vaccine: DTAP, RV5
Symptoms: Diarrhoea, Irritability, Vomiting
Clinical narrative: Vomiting, diarrhea and fussiness.
Sex: F
Vaccine: FLU4
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of adverse event in a female patient who received FLUARIX QUADRIVALENT. On 6th October 2017, the patient received FLUARIX QUADRIVALENT. In October 2017, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced adverse event (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to FLUARIX QUADRIVALENT. Additional details were provided as follow: The age at vaccination was not reported. The representative reported that, he overheard an adverse event and the hospitalization in the hospital clinic with a female patient. On 10th October 2017, the patient was hospitalised. The representative did not know if the hospitalization was related to the vaccine. The representative was unable to get any more information than was reported here. The representative had informed the person that mentioned the adverse event to please call the GlaxoSmithKline to provide a full report. The GSK receipt date was reported as 16th September 2017, however it was considered as a typo error and the date was considered as 16th October 2017. The clarification was requested for the same, however, it was not obtained.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Chills, Cough, Dizziness, Headache
Clinical narrative: Sore throat/cough/joint pains/headache/chills/nasal congestion/dizziness. Took DIMETAPP/BENADRYL/TYLENOL PM which made her feel better except for cough/nasal congestion/sore throat. TESSALON PERLES/warm saline gargles. Improved but not yet completely recovered.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Nasal congestion, Oropharyngeal pain
Clinical narrative: Sore throat/cough/joint pains/headache/chills/nasal congestion/dizziness. Took DIMETAPP/BENADRYL/TYLENOL PM which made her feel better except for cough/nasal congestion/sore throat. TESSALON PERLES/warm saline gargles. Improved but not yet completely recovered.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Stated that it started hurting approx. 1 hour after injection. Then the evening of 10/18 and into 10/19- (24 hours after) c/o of pain into forearm and stated pain was "throbbing". She stated that she took ADVIL and has been placing ice on the shoulder. She also stated that it has gotten better-now approx. 1 week after injection, the shoulder still is sore-she also stated that she is "babying" the arm. Denies any problem with movement and states she has full range of motion.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This is a report of a vaccine error by RN. Patient denies having any adverse event from the injection.
Age: 17.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Erythema, Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: REDNESS & ITCHING STARTED EVENING OF INJECTION. PARENT USED COOL COMPRESS AND MOTRIN FOR COMFORT MEASURES. 10/26/2017 REDNESS AND ITCHING DIMINISHED. 10/27/2017 REDNESS & ITCHING, HEAT AT SITE OF INJECTION INCREASED. PATIENT ADMITS TO SCRATCHING AREA LATE ON THE EVENING OF 10/26/2017. MEASUREMENTS OF REDNESS & SWELLING ARE 110 MM WIDE BY 120 MM LONG. PNP PRESCRIBED AUGMENTIN 875 MG BID FOR 10 DAYS, PREDNISONE 20 MG BID FOR 5 DAYS, BENADRYL 25MG CAPSULES Q 6 HOURS FOR ALLERGIC REACTION.
Age: 17.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Pruritus
Clinical narrative: REDNESS & ITCHING STARTED EVENING OF INJECTION. PARENT USED COOL COMPRESS AND MOTRIN FOR COMFORT MEASURES. 10/26/2017 REDNESS AND ITCHING DIMINISHED. 10/27/2017 REDNESS & ITCHING, HEAT AT SITE OF INJECTION INCREASED. PATIENT ADMITS TO SCRATCHING AREA LATE ON THE EVENING OF 10/26/2017. MEASUREMENTS OF REDNESS & SWELLING ARE 110 MM WIDE BY 120 MM LONG. PNP PRESCRIBED AUGMENTIN 875 MG BID FOR 10 DAYS, PREDNISONE 20 MG BID FOR 5 DAYS, BENADRYL 25MG CAPSULES Q 6 HOURS FOR ALLERGIC REACTION.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Eye irritation, Ocular hyperaemia, Pharyngeal oedema, Tremor
Clinical narrative: Eyes burning and blood red. Uncontrollable shaking. Coughing. Tthroat swelling, not enough to cut off air.
Age: 23.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Chills, Pain
Clinical narrative: Body aches, chills, temp 100.6 in clinic. Sent home from work for 48 hours. Otherwise benign exam.
Age: 1.33
Sex: F
Vaccine: FLU4
Symptoms: Febrile convulsion
Clinical narrative: Apparent Febrile Seizure.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea, Wrong technique in product usage process
Clinical narrative: On 10/11/17, patient received a flu shot from me. She requested that she get about 1/2 half of the total vaccine in each arm to reduce soreness. The vaccination occurred without any problems and she left probably 10 minutes afterwards. On 10/16/17, the patient called the Pharmacy to tell me that about 1 hour after she left the pharmacy, she developed chest pain and shortness of breath. She went to the emergency Dept at Hospital for treatment where she says she received several doses of epipen and remained under observation until her discharge around 4AM 10/12/17.  She claims she was discharged with prescriptions for Prednisone, Benadryl and Famotidine to take over the next 4 days. They also told not to get any future flu shots in the future. She reported feeling "ok" at the time she called me.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ear discomfort
Clinical narrative: PATIENT CALLED A FEW HOURS LATER COMPLAINING OF PRESSURE IN THE EAR. PATIENT WAS ADVISED IF SYMPTOMS BECAME WORSE OVERNIGHT TO GO TO ER OR IF THEY CONTINUE THE NEXT DAY TO GO TO HER DOCTOR. THE PROBLEM RESOLVED THE NEXT DAY.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Full blood count normal, Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Patient presented to office 10/26/17 with lump, redness, tenderness and warm of right upper arm. Patient notes that several days prior she received her PPSV in that arm.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Ultrasound scan normal
Clinical narrative: Patient presented to office 10/26/17 with lump, redness, tenderness and warm of right upper arm. Patient notes that several days prior she received her PPSV in that arm.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Joint range of motion decreased, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Stiff neck with reduced range of motion to 10 degrees left, 30 degrees right. Fatigue, chills, low fever. Tooth sensitivity.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Sensitivity of teeth
Clinical narrative: Stiff neck with reduced range of motion to 10 degrees left, 30 degrees right. Fatigue, chills, low fever. Tooth sensitivity.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Left arm reddened area, bump, warm to touch.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Pain, Pain in extremity
Clinical narrative: Patient comes today 10/27/2017 for an annual PPD and mentioned her left arm continues to be "sore" from an Influenza Vaccine administered in this Clinic on 4/10/2017. The vaccine was administered in the left deltoid according to the CDC guidelines. This is the first report on symptoms. The patient complained of soreness when moving left arm over head, behind her back, and across her chest. She did state there may be some slight weakness in the arm also. There was no redness or edema in the left upper arm. The symptoms have decreased but she still complains of soreness with movement.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Influenza like illness, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Received a FLUZONE HD PF 17-18 PFS immunization. Pain, swelling, hardness, ache at place of injection and small hole about 2 hours after injection. Felt extreme pain in joints and muscles enough to interrupt sleep. Felt similar flu-like symptoms (aches and pains) and felt ill for 48 hours after injection. This was the most extreme joint/muscle pain I've ever felt. I've had similar reactions, but not so extreme to other flu vaccinations.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Myalgia, Pain, Sleep disorder
Clinical narrative: Received a FLUZONE HD PF 17-18 PFS immunization. Pain, swelling, hardness, ache at place of injection and small hole about 2 hours after injection. Felt extreme pain in joints and muscles enough to interrupt sleep. Felt similar flu-like symptoms (aches and pains) and felt ill for 48 hours after injection. This was the most extreme joint/muscle pain I've ever felt. I've had similar reactions, but not so extreme to other flu vaccinations.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Bedridden, Chills, Decreased appetite, Fatigue, Feeling cold
Clinical narrative: Received senior flu shot, FLUZONE High-Dose 2017-18 0.5ml SYR and 3. hours later developed severe shivers and feeling of cold and felt nauseous for about 5 hours with a slight fever. Called doctor and checked for inflammation at injection site, there was none. Had no appetite and remained bedridden and exhausted for about 24 hours. Returned to normal. I am a 73 year old female.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pyrexia
Clinical narrative: Received senior flu shot, FLUZONE High-Dose 2017-18 0.5ml SYR and 3. hours later developed severe shivers and feeling of cold and felt nauseous for about 5 hours with a slight fever. Called doctor and checked for inflammation at injection site, there was none. Had no appetite and remained bedridden and exhausted for about 24 hours. Returned to normal. I am a 73 year old female.
Sex: U
Vaccine: HEP, HEPA, HIBV, HPV9, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a health care professional referring to multiple unspecified patients of unknown demographics. The patients' medical history was not reported. On unknown dates, the patients were vaccinated with improperly stored VAQTA (Lot number N003401 (invalid lot number), expiration date: 13-OCT-2018), ROTATEQ orally (Lot number N005618, expiration date: 04-OCT-2018, Lot number N005617, expiration date: 03-OCT-2018 and Lot number M043836, expiration date: 17-JUN-2018), RECOMBIVAX HB (Lot numbers unspecified), GARDASIL 9 (Lot number N010497, expiration date: 15-JAN-2020, Lot number N019923, expiration date: 28-APR-2019 and Lot number N021475 (invalid lot number), expiration date: 31-JAN-2020) and PEDVAXHIB (Lot number N003537, expiration date: 17-NOV-2019, Lot number N007749, expiration date: 29-NOV-2019 and Lot number N007751, expiration date: 30-NOV-2019) all vaccines administered for prophylaxis. There were no concomitant therapies reported. It was also reported that the call was due to a data logger. The vaccines VAQTA, RECOMBIVAX HB, GARDASIL 9 and PEDVAXHIB had temperature excursion of 31 degrees Fahrenheit or colder (22 degrees Fahrenheit) for 15 hours. The vaccines of hepatitis a vaccine, VAQTA, ROTATEQ, RECOMBIVAX HB, GARDASIL 9 and PEDVAXHIB underwent a previous temperature excursion of 32 degree Fahrenheit to 35 degree Fahrenheit for 12 hours. No adverse effects reported. The case is considered to be non-valid as there are no patient identifiers, therefore it is being sent to Distribution for one last time to notify all recipients.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies for the patients involved were not reported. The nurse reported that on unspecified dates an unspecified number of patients received an improperly stored dose of ROTATEQ lot number: M038744 (expiration date: 26-APR-2018), lot number: M046000 (expiration date: 27-JUN-2018), lot number: M046006 (expiration date: 28-JUN-2018), lot number: N005618 (expiration date: 04-OCT-2018) for prophylaxis (strength, route, dose or units were not provided). There was digital data logger involved. The administrated doses underwent temperature excursion between 0 Celsius degrees to 1 Celsius degrees (also reported as "0.4 Celsius degrees") for 35 hours and 29 minutes and between 2 Celsius degrees to 8 Celsius degrees (1.6 Celsius degrees) for 6 hours and 7 minutes. There was no previous temperature excursion. No adverse events were reported. Follow up information has been received from the reporting nurse concerning a 5-month-old male patient. At the time of the vaccination the patient had no illness according to 4 month child exam. On 26-SEP-2017, the patient was vaccinated with the first dose of ROTATEQ orally, lot # N005618, expiry date 04-OCT-2018 (dose was not reported) for prophylaxis. Concomitant therapies included PENTACEL and PREVNAR. It was reported that medication error occurred during storage in clinical Practice. No treatment was given due to the event. The patient was vaccinated at public health or hospital and the vaccine was purchased with public funds. No symptoms or adverse effects were reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a newborn patient of unknown gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with improperly stored RECOMBIVAX HB pediatric, lot # N020613, expiration date 05-MAY-2020 (dose and route were not reported) for prophylaxis. No adverse effects were reported. The patient did not received treatment. The temperature involved was 47 grades Fahrenheit to 77 grades Fahrenheit for four hours. There was no previous temperature excursion reported and a data logger was not involved.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Musculoskeletal discomfort, Peripheral swelling, Vaccination complication
Clinical narrative: This spontaneous report has been received from a female patient of unknown age with diabetes mellitus and sulfa drugs hypersensitivity as current conditions. On an unspecified date in April 2012, the patient was vaccinated with PNEUMOVAX 23, intramuscularly (strength, dose, frequency, lot# and expiration date were provided) "as a precaution". It was reported that on an unknown date, the patient overnight developed a violent reaction causing her arm to swell and became hot, and the reaction also affected her shoulder. The outcome of peripheral swelling, musculoskeletal discomfort, vaccination complication and feeling hot was reported as recovered. At the time of this report the causality between the aforementioned events and PNEUMOVAX 23 was not reported.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 68 year old male patient. The patient's had no pertinent medical history. The patient's concurrent conditions included allergy to CRESTOR, LIPITOR, pravastatin and ZOCOR. The patient's concomitant therapies were not reported. On 16-OCT-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 0.5 ml intramuscularly in the right arm, lot# N022703 and expiration date: 27-FEB-2019 as "preventative". In October 2017, the patient developed redness and swelling that started from the deltoid and traveled down the arm from his bicep to his elbow on his right arm. The patient did not receive any treatment for the event. The outcome of the events was reported as not recovered. The relatedness between the events and PNEUMOVAX 23 was not reported. This is one of two reports received from the same reporter. The event of "allergy to ZOCOR" was captured in the MARRS # 1710USA014478. Sender's Comments: US-009507513-1710USA009764.
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Inflammation, Injection site erythema, Injection site induration
Clinical narrative: This spontaneous report was received from a physician assistant via a company representative and refers to a 65-year-old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 10-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 (dose and route of administration, lot# and expiration date were not reported) for prophylaxis. On 11-OCT-2017, the patient experienced soreness of the left deltoid, inflamed left lymph node and axilla, redness, tenderness and induration at the injection site. On an unknown date in October 2017 (reported as "then"), the patient developed a zig-zag streak from her neck to her axilla, headache and chills. The patient has improved at only had a pink spot at the injection site at the time of the reporting. The outcome of the events was recovering. The causality assessment was not provided. Upon internal review, the event of Lymphangitis was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Lymphadenitis, Myalgia, Skin disorder
Clinical narrative: This spontaneous report was received from a physician assistant via a company representative and refers to a 65-year-old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 10-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 (dose and route of administration, lot# and expiration date were not reported) for prophylaxis. On 11-OCT-2017, the patient experienced soreness of the left deltoid, inflamed left lymph node and axilla, redness, tenderness and induration at the injection site. On an unknown date in October 2017 (reported as "then"), the patient developed a zig-zag streak from her neck to her axilla, headache and chills. The patient has improved at only had a pink spot at the injection site at the time of the reporting. The outcome of the events was recovering. The causality assessment was not provided. Upon internal review, the event of Lymphangitis was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (strength, dose, frequency, route of administration, lot# and expiration date were not reported). On an unknown date, the patient experienced a pain on an unspecified arm and cellulitis. The patient sought unspecified medical attention and was given clindamycin as treatment. The outcome of pain on arm and cellulitis was unknown. The relatedness between the events and PNEUMOVAX 23 was not reported.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Eye swelling, Eyelid oedema
Clinical narrative: Initial unsolicited case received from a consumer on 16 Oct 2017. This case involves 67-year-old female patient who was vaccinated with 0.5 ml one dose of FLUZONE QUADRIVALENT (Batch number, expiry date were unknown) intramuscularly in right deltoid on 06 Sep 2017. Patient medical history was not reported. Concomitant medications were not reported (it was also reported that patient had not received any other vaccines). On 06 Sep 2017, within three hours after the vaccination, patient developed difficulty in breathing with eyes were swollen and puff. The patient went to ER and had unspecified steroids which helped. Relevant lab tests and other corrective treatment were not reported. On an unknown date, patient recovered from both the events. Upon internal review the company decided to consider the case as serious due to important medical events difficulty breathing and eyes were swollen and puff. List of documents held by sender: none.; Sender's Comments: The patient experienced difficulty breathing, eyes were swolledn and puff post vaccination with FLUZONE QUADRIVALENT. Time to onset was compatible and was indicative of an anaphylactic response. Patients medical histroy should be requested along with any allergic testing reports from past. Information regarding patients previous vaccinations and their tolerance should also be requested. ABsed upon reported information it looks like an allergic response but alternate etiologies should also be investigated. No conclusive inference could be drawn untill additional information is received.
Sex: F
Vaccine: FLU4
Symptoms: Allergy to vaccine, Feeling abnormal, Pyrexia, Vomiting
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of vomiting in a adult female patient who received Influenza vaccine Quadrivalent unspecified season. Concurrent medical conditions included drug allergy (ciprofloxacin, sulfa antibiotics, duloxetine HCL, metronidazole, alo-gabapentin, amitriptyline, bupropion, escitalopram oxalate, lactose, loratadine, meloxicam, nitrofurantoin monohydrate macrocrystals, phenobarbital and venlafaxine hydrochloride). On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vomiting, fever, allergy to vaccine and feels awful. On an unknown date, the outcome of the vomiting, fever, allergy to vaccine and feels awful were unknown. It was unknown if the reporter considered the vomiting, fever, allergy to vaccine and feels awful to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were reported as follows: On 17th August 2017, outpatient medication list for the patient were as follows- Alprazolam 0.3 mg oral tablets taken by mouth 2 times daily as needed for anxiety, chlorpheniramine 4 mg  oral tablets taken 4 mg by mouth every 6 hours as needed, LASIX 20 mg. taken 1 tablet by mouth daily, NORCO 5-325 mg taken 1 tablet by mouth every 8 hours as needed for pain, PLAQUENIL 200 mg, taken 1 tablet by mouth 2 times daily, ibuprofen 800 mg oral tablets taken 1 tablet by mouth 3 times daily as needed, lactase enzyme orally daily as needed, SINGULAIR 10 mg tablet taken 1 tablet by mouth every evening, NORFLEX 100 mg, 12 hours, taken 1 tablet by mouth twice daily as needed for pain, LYRICA 75 mg capsule taken 1 capsule by mouth 2 times daily, PROAIR HFA 108 (90 base) mcg/act aerosol solution use 1-2 inhalations by mouth every 6 hours as needed for wheezing.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Cardiac stress test, Chest pain, Chills, Computerised tomogram
Clinical narrative: 104 degree Temp., shaking uncontrollably; shivering. Chest Pain - Infection of unknown origin. Sepsis. Mild heart attack.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Echocardiogram, Electrocardiogram, Infection, Myocardial infarction, Pyrexia
Clinical narrative: 104 degree Temp., shaking uncontrollably; shivering. Chest Pain - Infection of unknown origin. Sepsis. Mild heart attack.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Sepsis, Tremor
Clinical narrative: 104 degree Temp., shaking uncontrollably; shivering. Chest Pain - Infection of unknown origin. Sepsis. Mild heart attack.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Mom called regarding patient's arms - both arms red, warm to touch, swollen, itchy, "hard ball" where shots were given. Advised massing area, ice packs, BENADRYL, TYLENOL/MOTRIN for pain, arm movement.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Hospitalisation, Malaise
Clinical narrative: Severely ill, malaise, inpatient stay.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture, Muscular weakness
Clinical narrative: Patient presented to Hospital with acute onset of muscle and lower extremity weakness 25 days after receiving vaccine. Patient diagnosed with Guillain-Barre Syndrome due to acute onset and recent vaccination. Questionable if other virus related, described as "suspicious" due to recent flu vaccination.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Induration, Pain, Swelling
Clinical narrative: " hurt, swollen and hard."
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia, Seizure
Clinical narrative: Patient experienced fever, seizure the same night vaccines given. Tylenol prescribed and advised to take Diastat if seizure occurs.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Injection site erythema, Injection site rash, Malaise, Nausea
Clinical narrative: By the night the day of vaccination the following started: chills, nausea, red rash by vax site, itchy, fell ill. Next morning went to walk-in clinic, did not get any recommendations. By the next day, did not take any medicine.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus
Clinical narrative: By the night the day of vaccination the following started: chills, nausea, red rash by vax site, itchy, fell ill. Next morning went to walk-in clinic, did not get any recommendations. By the next day, did not take any medicine.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: " arm read to touch, swollen, and sore to touch/ not to touch."
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Client second dose in Hep A series provided outside of recommended range; Given too soon.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain
Clinical narrative: " area sore & red"
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: The patient said her arm is still sore after 5 days and she cannot lift it. She has been taking Tylenol to relieve pain.
Age: 9.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and redness at injection site. Skin temperature hot to touch at injection site.
Age: 57.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Aggression, Delirium, Nausea, Pyrexia, Vomiting
Clinical narrative: Around 8:00 PM patient started to become nauseous/vomiting and had a fever. Patient then became delirious and combative. Ambulance was called and patient was taken to Hospital and was given IV TYLENOL. By the next morning the patient broke the fever and was coherent. Patient received CORTROSYN 0.25 injection on 9/18/2017- no reaction.
Age: 40.0
Sex: F
Vaccine: UNK
Symptoms: Feeling abnormal, Headache, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: 9:15 AM: ITCHING ON AND AROUND INJECTION SITE SPREADING TO MY NECK, RED/HOT SKIN ON AND AROUND INJECTION SITE, NAUSEA, HEADACHE, MENTAL FUZZINESS. TAKEN TO EMERGENCY DEPT, GIVEN BENADRYL. ITCHING STILL OCCURING ON BODY.
Age: 40.0
Sex: F
Vaccine: UNK
Symptoms: Nausea, Pruritus
Clinical narrative: 9:15 AM: ITCHING ON AND AROUND INJECTION SITE SPREADING TO MY NECK, RED/HOT SKIN ON AND AROUND INJECTION SITE, NAUSEA, HEADACHE, MENTAL FUZZINESS. TAKEN TO EMERGENCY DEPT, GIVEN BENADRYL. ITCHING STILL OCCURING ON BODY.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Full blood count, Pain in extremity
Clinical narrative: Right arm pain after injection x 1 month. Treated with course of Prednisone.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Immunisation, Underdose
Clinical narrative: Patient was given a pediatric dose (6-35months) 0.25ml. This adverse event was caught before patient left office and she did receive another dose of 0.25ml per MD order.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Patient got a rash on her neck. No reaction at the injection site.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Neck pain
Clinical narrative: Left shoulder and neck pain S/P vaccine administration.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Back pain, Hypoaesthesia, Injection site erythema, Injection site swelling, Musculoskeletal pain
Clinical narrative: Shoulder pain, mild back pain, mild numbness to arm, mild erythema and small bump at injection site.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Body temperature increased, Disturbance in attention, Dizziness, Immediate post-injection reaction
Clinical narrative: Immediate discomfort in arm, unable to lift arm. 48 hrs following injection became very lightheaded and dizzy, heart racing, palpitations, nausea, weakness, temp was 99.8. Symptoms continued for another day. Today is 1 week out, patient still dizzy and lightheaded with weakness and not able to mentally focus, trouble reading text.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Limb discomfort, Mobility decreased, Nausea, Palpitations, Reading disorder
Clinical narrative: Immediate discomfort in arm, unable to lift arm. 48 hrs following injection became very lightheaded and dizzy, heart racing, palpitations, nausea, weakness, temp was 99.8. Symptoms continued for another day. Today is 1 week out, patient still dizzy and lightheaded with weakness and not able to mentally focus, trouble reading text.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Paraesthesia, Throat irritation, Throat tightness
Clinical narrative: Employee states that approximately one hour after vaccination, she developed tingling to the right arm, cough with some throat tightness and irritation.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Local reaction, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pain in the entire arm, mild swelling, minimal erythema and warmth. Vaccine taken 0630 that day and symptoms started 2300. ER physician suggested, cool compress, TYLENOL and MOTRIN.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Dizziness within hours from getting injections.
Age: 72.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, itching, and swelling at injection site of PNEUMOVAX 23.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC13
Symptoms: Diarrhoea, Muscular weakness, Neutropenia, Pyrexia
Clinical narrative: Weakness of both lower extremities. Neutropenia. Fever/diarrhea 6/14/17. Mother believes his symptoms are associated with vaccines.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Full blood count, Headache, Hyperhidrosis, Malaise, Urinary incontinence
Clinical narrative: Sweating profusely, H/A's, 1 episode of urinary incontinence, malaise.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: White blood cell count normal
Clinical narrative: Sweating profusely, H/A's, 1 episode of urinary incontinence, malaise.
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Pyrexia
Clinical narrative: Chills, fever >102, EMT called.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Pain in extremity, Urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fatigue in a 44-year-old female patient who received FLAURIX QUADRIVALENT (batch number JC9E9, expiry date 30th June 2018). In October 2017, the patient received FLUARIX QUADRIVALENT. In October 2017, less than a week after FLUARIX QUADRIVALENT, the patient experienced fatigue, welts and leg pain. On an unknown date, the outcome of the fatigue, welts and leg pain were unknown. It was unknown if the reporter considered the fatigue, welts and leg pain to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The patient who was also an employee at the facility received a dose of FLUARIX TETRA on last Thursday and developed fatigue, stomach welts and aching legs. The patient visited to physician the following day, however the physician did not believe symptoms were related by the vaccine. No further information was reported regarding this event. This case has been linked with case US2017159873, reported by the same reporter for same events.
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Pain, Swelling
Clinical narrative: This spontaneous report as received from a nurse manager via company representative refers to a 87 years old female patient. The patient did not have medical history and current conditions. On 12-OCT-2017 the patient was vaccinated with PNEUMOVAX 23 (unspecified dose and route of administration, lot # N011867, expiration date: 08-NOV-2017) for Pneumonia prevention. Concomitant therapies included FLUZONE. On 12-OCT-2017, the patient developed extreme swelling and pain. The patient, approximately two days after getting the vaccine, ended up going to an unknown Emergency Room (ER) as a result of the adverse events, however the patient was not hospitalized on her first ER visit because the ER sent the patient home. The patient's adverse reaction continued to persist so the patient went to the ER a second time on an unspecified date for an unknown duration and on the second visit to the ER, the patient was diagnosed with cellulitis. The patient was prescribed some antibiotics and steroids. The outcome of the events was reported as not recovered/not resolved. Causality assessment was not reported. Upon internal review, the event of cellulitis was considered to be medically significant. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Head injury, Syncope
Clinical narrative: Fainted - EMT 911 called, possible seize, hit head on ground.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site pain, Injection site pruritus, Rhinorrhoea
Clinical narrative: Immediately after vaccination itching started at injection site, it progressively got worse with burning and bruising started at injection site and then spread. Also nose running, clear water. Did not take anything. All the symptoms continue through today. A week after injection, at flu clinic in facility, spoke to nurse at site and he mentioned that it could be normal but if it persist call us. Sent email to doctor on 10/22 and explained the situation and staff encouraged pt to make doctor appointment. Took BENADRYL on 10/22 did not help with any of the symptoms. Tried topical cortisone cream and it did not work. Bruising, improves and then reappears in different spot in the same area. Area extremely tender to the touch and it feels like it burns from inside.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Generalised tonic-clonic seizure, Headache, Muscle spasticity
Clinical narrative: 2 days after Flu vaccine, had bad headaches (not migraines). 3 days after started w/ tonic-clonic seizures that were under control for past 4 yrs. This lasted daily (twice a day) for 2.5 weeks. Increase and constant muscle spasticity. 2 weeks post vaccine and seizures have stopped, but muscle spasms have not.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Skin warm
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of erythema of extremities in a 4-year-old male patient who received FLUARIX QUADRIVALENT. On 13th October 2017, the patient received FLUARIX QUADRIVALENT. In October 2017, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced erythema of extremities and skin warm. The patient was treated with BENADRYL (nos). On 16th October 2017, the outcome of the erythema of extremities and skin warm were recovered/resolved. It was unknown if the reporter considered the erythema of extremities and skin warm to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The patient received FLUARIX QUADRIVALENT in right arm and experienced localized redness at the injection site. The redness then continued to spread form the top of the patient's shoulder to the elbow, covered 3 by 4th of the patient's arm and was hot to touch. The affected area was outlined with a marker by the healthcare professional and the area and the area continued to grow. The patient used BENADRYL as treatment. On 15th October 2017, the patient was seen in the emergency department where the patient was given BENADRYL and discharged.
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fatigue in a adult female patient who received FLUARIX Tetra (batch number JC9E9, expiry date 30th June 2018). In October 2017, the patient received FLUARIX Tetra. In October 2017, less than a week after receiving FLUARIX Tetra, the patient experienced fatigue and generalized urticaria were unknown. It was unknown if reporter considered the fatigue and urticaria to be related to FLUARIX Tetra. Additional details were reported as follows: The patient who was also an employee within the facility received a dose of FLUARIX Tetra on Thursday and developed fatigue and welts all over body. The patient visited physician, however it was reported that the doctor did not believe symptoms were related to patient receiving the vaccine. No further information was reported regarding this event. This case has been linked with case US2017159875, reported by the same reporter for same events.
Age: 15.0
Sex: U
Vaccine: FLUX
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Approximately 30 minutes after injection, patient said that she was feeling dizzy or light-headed. She slumped, and appeared unconscious for a few seconds. A cold cloth was placed on her forehead and a blood pressure cuff placed on her arm. She appeared better within 5-10 minutes
Age: 73.0
Sex: M
Vaccine: FLUX
Symptoms: Contusion, Myalgia
Clinical narrative: Extreme bruising on left arm. Muscle pain, especially legs/thigh.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: (L) deltoid. Red area with edema 3" x 2 1/2". Warm to touch. Raised area the diameter of red area. Pain, 1/1-10. When pressure applied.
Age: 86.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain, Skin warm
Clinical narrative: Very sore, feel warm, used ice Right arm. 10/7/17 7pm: S/W pt; (He is doing better).
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Burning sensation, Herpes zoster, Rash
Clinical narrative: 6 hrs after receiving the vaccine, patient had pain, burning and rash on her back. She went to urgent care and was diagnosed with shingles.
Age: 91.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Pain in extremity, Pyrexia
Clinical narrative: Redness, fever, pain in left arm. Started day you got shot. Got better. And got worse.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Pyrexia
Clinical narrative: Reported fever of 101.8 when awoke later the same day of receiving vaccine- "felt  like I was hit by a truck". "Slept it off and felt better" next day. Reported is breastfeeding-she contacted physician who recommended to stop breastfeeding secondary to receiving high dose flu vaccine.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Immediate post-injection reaction, Injection site pain, Pyrexia, Vomiting
Clinical narrative: PATIENT STATED THE VACCINE BURNED GOING IN AND THEN WITHIN 4 HOURS, PATIENT EXPERIENCED FEVER OF 103, VOMITING AND CHILLS. FEVER WENT AWAY THE NEXT MORNING AND FINALLY FELT BETTER ON 10/26/17.
Age: 8.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching at injection site.
Age: 0.17
Sex: M
Vaccine: DTAPIPV, HEP, HIBV, PNC13, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: The patient did not have an adverse reaction or any complications to vaccinations administered. However, the patient was given KINRIX at 2 mo of age and he should have been given PEDIARIX which is appropriate for his age.