chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Tendonitis, Weight bearing difficulty
Clinical narrative: The shot was administered into the left shoulder (extremely high on the arm) and immediately felt pain. Severe pain all day, and by the end of the day, any movement with left arm caused extreme pain and was not able to sleep due to pain. The next day (6/14), I called the nurse to ask about pain and described my symptoms of feeling nauseous and not being able to move my arm. I was told nausea was possibly from the pain and to take TYLENOL and it should be better by the weekend and if not to call back. During the remainder of the week, I was in excruciating pain and could not move my arm, bear weight on it, or sleep well. Friday (6/16) I called back because I was still in pain and there was no sign of improvement. I was told to see an orthopedic. On 6/27 I was able to see the orthopedic and was given oral steroids to help with the inflammation and hopefully solve the issue. Pain had diminished some at this point, but I was not able to bear much weight, or move my left arm above my head or across my body. I was icing my shoulder and taking ALEVE for pain relief. I was told if the problem still persisted I would need an MRI. On 8/3, I had an MRI showing tendonitis and bursitis in the left shoulder. On 8/10 I received a Cortisone shot and was prescribed physical therapy. After completing physical therapy at the end of September, I regained movement and can now move my arm above my head and across my body. Certain movements with my arm/shoulder still cause some pain, carrying heavier items causes some pain, and most days there is still a dull persistent pain in my shoulder.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash
Clinical narrative: Rash on left arm and left side of the body.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Headache, Influenza A virus test positive, Pain, Pyrexia
Clinical narrative: Patient c/o headache, fever, chills, bodyaches.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: PATIENT CALLED SEVERAL DAYS AFTER FLU SHOT COMPLAINING THAT HER ARM WAS VERY SORE AND HAD TROUBLE LIFTING HER ARM - PHARMACIST ON DUTY ADVISED HER TO APPLY WARM COMPRESS AND TAKE OTC PAIN RELIEVER (IE IBUPROFEN). TO CALL US BACK IF STILL HAVING PROBLEMS. PATIENT CAME IN TO PHARMACY TODAY AND SAID HER ARM WAS VERY PAINFUL AND SHE STILL HAD TROUBLE LIFTING IT. SHE SAID SHE RECENTLY SAW HER DR AND HER DR SAID SHE COULD NOT RECOMMEND ANYTHING MORE THAN WHAT THE PHARMACIST ALREADY DID. I INFORMED HER I WOULD COMPLETE THIS VAERS AND ALSO MAKE A NOTE THAT SHE DOES NOT WANT THE HIGH DOSE IN THE FUTURE.
Age: 29.0
Sex: M
Vaccine: HEPAB
Symptoms: Blood glucose decreased, Dizziness, Loss of consciousness, Pallor
Clinical narrative: Pt was given vaccine, 5 min after pt became dizzy and face became pale, pt passed out for a few second, 911 was called pt declined EMT attention, pt states he was fine after resting for 10 min.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Musculoskeletal pain, Pain in extremity, Peripheral swelling
Clinical narrative: Pain, swelling and redness with pain extending up into shoulder and continuing for 1 week after vaccine administration. Patient did not allow pharmacist to examine her. She refused recommedation of pain medication or applying ice to painful area. Patient did not intend to seek any further medical attention and reported she'd deal with the pain.
Age: 1.92
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: Fever with temp high of 102.1 and Rash (Generalized red raised rash covering body and face. Consisting of both confluent and discrete spots).
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Per pt's grandmother, patient began having swelling and redness of the right upper arm down to the elbow soon after the vaccine was given. They consulted with the pediatrician the next day who advised that the swelling should go down in the next few days. They gave him BENADRYL due to some itching that occurred in the next few days. She states that the swelling and redness did go away eventually, but it took about 3 days.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Pruritus, Pyrexia
Clinical narrative: He received the vaccine during a medication review that afternoon, developed a fever (101 degrees F) and moderate to severe itching on the inside of the arm the injection was given into. He went to sleep and woke up with no other effects the following morning except continued deltoid muscle pain. The pain went away in about 2 days.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Rash, Vaccination complication
Clinical narrative: Patient came in for her flu shot yesterday and when she went to bed her left arm started itching really bad. Today after work she noticed her deltoid had noticable raised rash and redness down her arm. She wanted to have someone evaluate her arm to see if she did have a reaction to the vaccination. It was confirmed she had a reaction. Patient denies SOB, fever or swelling of her tongue or throat. She was advised to take Benadryl, ice the area and use Benadryl or some anti itching cream. She was also advised if any symptoms discussed above occur she is to go to ED. This will be reported to the VAERS. Patient understands the instructions provided.
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 5 year old male patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 16-OCT-2017, the patient was inadvertently vaccinated with a dose of GARDASIL 9 lot number M036059 and expiration date of 03-JUN-2019 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The reporter stated that this was outside the recommendations per GARDASIL 9 prescribing information. No adverse effects were reported.
Sex: M
Vaccine: RV5
Symptoms: Laboratory test, Listless, Seizure
Clinical narrative: This spontaneous report was received from a medical assistant via company representative, referring to an approximately 6 month old male patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On an unknown date in 2017, the patient was vaccinated with ROTATEQ, oral for prevention of rotavirus gastroenteritis (strength, dose, frequency, lot # and expiration date were not reported). On an unspecified date in August 2017 (also reported as couple of days later), the patient experienced seizure and was listless. On an unspecified date in 2017, the patient was taken to a hospital and was admitted for a couple of days. On an unknown date, neurology tests were performed (resulted not provided). It was unknown if intervention to prevent serious criteria was performed or if events were life threatening. It was also unknown if there was a significant disability or incapacity. At the time of reporting, the outcome of seizure and listless was reported as recovering. Additionally, the causality assessment between seizure and listless with ROTATEQ was not reported. Upon internal review seizure was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Rash macular, Swelling
Clinical narrative: This spontaneous report was received from a nurse referring to a currently 78 year old female patient with type 2 diabetes mellitus, hypertension, hyperlipidaemia, and allergy to morphine. On an unknown date, the patient was vaccinated with PNEUMOVAX 23) for prophylaxis (lot # N010109, expiry date: 20-NOV-2018). Concomitant therapies included metformin, Lisinopril, glipizide and aspirin (manufacturer unknown). On an unknown date, the patient sought medical attention by office visit since she experienced redness, swelling, heat, and red blotches. Therapy for the adverse events was administered (details unspecified). The nurse verified the vaccine was stored properly. No laboratory diagnostics were performed. The outcome of swelling, rash macular, feeling hot and erythema was reported as recovering. The causality assessment between suspect therapy and the aforementioned adverse events was unknown. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1710USA010632.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Rash macular, Swelling
Clinical narrative: This spontaneous report was received from a nurse referring to a currently 68 year old female patient with hypertension and hyperlipidemia. The patient had no known allergies. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (lot # N010109, expiry date: 20-NOV-2018). Concomitant therapies included losartan potassium (manufacturer unknown), potassium, simvastatin (manufacturer unknown), omeprazole, enalapril (manufacturer unknown) and aspirin (manufacturer unknown). On an unknown date, the patient sought medical attention by office visit since she experienced redness, swelling, heat, and red blotches. Therapy for the adverse events was administered (details unspecified). The nurse verified the vaccine was stored properly. No laboratory diagnostics were performed. The outcome of swelling, rash macular, feeling hot and erythema was reported as recovering. The causality assessment between suspect therapy and the aforementioned adverse events was unknown. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1710USA010408.
Age: 17.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Antinuclear antibody, Blood immunoglobulin A, Blood lactate dehydrogenase, Blood uric acid, Full blood count
Clinical narrative: Rash started on 10/19/17 in AM - started on chest then spreading rapidly to extremities. They were advised to have seen - out of town - took to urgent care and advised to go to hospital - admitted. Pt was diagnosed with Thrombocytopenia secondary to ITP - given IVIG.
Age: 17.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Immune thrombocytopenic purpura, Immunoglobulin therapy, Rash, Thrombocytopenia
Clinical narrative: Rash started on 10/19/17 in AM - started on chest then spreading rapidly to extremities. They were advised to have seen - out of town - took to urgent care and advised to go to hospital - admitted. Pt was diagnosed with Thrombocytopenia secondary to ITP - given IVIG.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Hypersensitivity, Rash generalised, Stomatitis, Throat tightness
Clinical narrative: Allergic reaction / Rash all over body / Sores in mouth / throat began closing and began having trouble breathing approx. 4  hours after injection.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Inflammation, Mobility decreased, Pain in extremity
Clinical narrative: Patient states she was given the vaccine and felt an immediate pain in her arm. About two hours after vaccine administration, she was unable to lift her arm to drink from a cup. The pain persisted for about 2-3 weeks. She then saw her primary care physician who prescribed her prednisone for the pain/inflammation. She states the pain in her arm has lessened but she still has pain in that arm.
Age: 60.0
Sex: F
Vaccine: FLUR3
Symptoms: Diarrhoea, Erythema, Headache, Injection site pruritus, Injection site vesicles
Clinical narrative: Patient reports having a 3x3" area of redness, swelling, hot to the touch starting 1/2" below injection site. She states that the day following the injection he had headache, diarrhea. She says that now the area where injected is itchy and blistered.
Age: 60.0
Sex: F
Vaccine: FLUR3
Symptoms: Skin warm, Swelling
Clinical narrative: Patient reports having a 3x3" area of redness, swelling, hot to the touch starting 1/2" below injection site. She states that the day following the injection he had headache, diarrhea. She says that now the area where injected is itchy and blistered.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Hypoaesthesia, Muscular weakness, Musculoskeletal pain, Pain in extremity
Clinical narrative: The shot was injected extremely high up on my left shoulder, and since I received the flu shot, I have had severe shoulder/arm pain, weakness of the left arm, and some numbness and tingling in my left hand.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, X-ray limb
Clinical narrative: The shot was injected extremely high up on my left shoulder, and since I received the flu shot, I have had severe shoulder/arm pain, weakness of the left arm, and some numbness and tingling in my left hand.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Anal incontinence, Hypersomnia, Loss of consciousness, Urinary incontinence
Clinical narrative: Patient's description is when he got home he had loss of control of bladder and bowel and then was "unconscious" for a "couple hours". They did not call 911 or seek emergency care. He then slept the next day. He called today so that it could be put in his records.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Anxiety, Condition aggravated, Fatigue, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Patient fainted just after injection of the PREVNAR 13. She was unconscious for a few seconds. Received cold compresses initially, then cool water later. She has a history of fainting during blood draws and injections and anxiety. Treated patient and she remained under watch for next 20-30 minutes. Patient stated she was fine when she left, just a little drained from the anxiety buildup.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Syncope
Clinical narrative: Patient fainted just after injection of the PREVNAR 13. She was unconscious for a few seconds. Received cold compresses initially, then cool water later. She has a history of fainting during blood draws and injections and anxiety. Treated patient and she remained under watch for next 20-30 minutes. Patient stated she was fine when she left, just a little drained from the anxiety buildup.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Erythema, Pruritus
Clinical narrative: Cheeks red, itchy, chest feeling heavy.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: 10/19/17 0600 C/O Stiff neck, headache, Aching body all over, Low grade fever of 99. 10/21/17 Fever jumped to 102, spent all day on the couch, aching all over, stiff neck, headache. Treated with TYLENOL and Ibuprofen. 10/23/2017 no fever, no headache, still has a stiffness in his neck. Returned to school.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Painful arm. Cannot lift up the arm.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Body temperature increased, Lip blister, Rash erythematous
Clinical narrative: Patient woke up the following am with red spots to face, which spread throughout the day, including developing a blister on his lip. The second am following vaccines, woke up with a 101 degree temp.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain
Clinical narrative: Systemic body aches and chills.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site induration, Injection site pruritus
Clinical narrative: Patient developed itching and induration at the site of the injection (right deltoid area).
Age: 23.0
Sex: F
Vaccine: FLU4, MMR
Symptoms: Arthralgia, Cold sweat, Decreased appetite, Headache, Muscle spasms
Clinical narrative: "Woke up that night to extreme cramping in legs and feet. Toes couldn't relax. Sore muscles all over body and knees (joints) hurt. Jaw kept locking up when I yawned. Nausea and cold sweats, headache.  Loss of appetite and couldn't keep food down. Sunday 10/15/17 symptoms subsided".
Age: 23.0
Sex: F
Vaccine: FLU4, MMR
Symptoms: Myalgia, Nausea, Trismus, Vomiting
Clinical narrative: "Woke up that night to extreme cramping in legs and feet. Toes couldn't relax. Sore muscles all over body and knees (joints) hurt. Jaw kept locking up when I yawned. Nausea and cold sweats, headache.  Loss of appetite and couldn't keep food down. Sunday 10/15/17 symptoms subsided".
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation
Clinical narrative: Unusual localized inflammation, which disapated within 4 hours of adminstration.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Urticaria, generalized, without angioedema, lasting 1 hr responded to diphenhydramine.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Peripheral swelling, Pruritus
Clinical narrative: Pt arm started to swell and get red later that night. The next day it began to itch. The red area spread from site toward the inner arm. No rash.
Age: 28.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Breast oedema, Breast pain, Dysphonia, Erythema, Oedema peripheral
Clinical narrative: Patient stated that her throat began to swell up, had a raspy voice and right sided throat soreness about 1.5 hours after administration. She stated he right arm blood vessels became very prominent as well as right arm edema and redness. For these symptoms the patient took 50mg PO of Benedryl and 4 hours later another 50mg. The following day 10/23/17 (appointment date at doctors office)  she only has right sided arm pain, accompanied with edema as well as pain to right breast.
Age: 28.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Oropharyngeal pain, Pain in extremity, Pharyngeal oedema
Clinical narrative: Patient stated that her throat began to swell up, had a raspy voice and right sided throat soreness about 1.5 hours after administration. She stated he right arm blood vessels became very prominent as well as right arm edema and redness. For these symptoms the patient took 50mg PO of Benedryl and 4 hours later another 50mg. The following day 10/23/17 (appointment date at doctors office)  she only has right sided arm pain, accompanied with edema as well as pain to right breast.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Myalgia
Clinical narrative: Approx 4 hours post vaccine, patient became dizzy and lightheaded. Resolved the next day. Some muscle soreness as well.
Age: 43.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: Extreme pain for 5 days now and still be pain can't lift left arm above shoulder even after 5 days.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash, Rash erythematous
Clinical narrative: Red rash around entire left arm.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Decreased appetite, Fatigue, Feeling abnormal, Headache
Clinical narrative: I got a PNEUMOVAX 23 pneumonia shot about 6 pm on Tuesday October 17, 2017. I felt fine afterwards, but woke up about 3 am Wednesday with a painful left arm especially in the area of the shot and painful limited motion of left arm. The area of skin around the shot - about 3 inches parallel to the arm and about 1.5 inches across - was slightly swelled and slightly more pink than the surrounding skin. I felt very tired and weak with a slight headache and in a slight daze with a loss of appetite through Wednesday afternoon. Breathing was fine. No gastrointestinal problems. No fever. The symptoms remained most of Wednesday and I rested a lot. My left arm was nearly back to normal about 24 hours after the shot, except that the shot area was still sensitive, slightly pink and slightly swelled.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Hyperaesthesia, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: I got a PNEUMOVAX 23 pneumonia shot about 6 pm on Tuesday October 17, 2017. I felt fine afterwards, but woke up about 3 am Wednesday with a painful left arm especially in the area of the shot and painful limited motion of left arm. The area of skin around the shot - about 3 inches parallel to the arm and about 1.5 inches across - was slightly swelled and slightly more pink than the surrounding skin. I felt very tired and weak with a slight headache and in a slight daze with a loss of appetite through Wednesday afternoon. Breathing was fine. No gastrointestinal problems. No fever. The symptoms remained most of Wednesday and I rested a lot. My left arm was nearly back to normal about 24 hours after the shot, except that the shot area was still sensitive, slightly pink and slightly swelled.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: I got a PNEUMOVAX 23 pneumonia shot about 6 pm on Tuesday October 17, 2017. I felt fine afterwards, but woke up about 3 am Wednesday with a painful left arm especially in the area of the shot and painful limited motion of left arm. The area of skin around the shot - about 3 inches parallel to the arm and about 1.5 inches across - was slightly swelled and slightly more pink than the surrounding skin. I felt very tired and weak with a slight headache and in a slight daze with a loss of appetite through Wednesday afternoon. Breathing was fine. No gastrointestinal problems. No fever. The symptoms remained most of Wednesday and I rested a lot. My left arm was nearly back to normal about 24 hours after the shot, except that the shot area was still sensitive, slightly pink and slightly swelled.
Age: 53.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Her arm got swollen about 3 inches and red. She went to the walkin clinic next day and got diagnosed with cellulitis and got put on Keflex and Percocet.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left arm swollen upto elbow from injection site it is pink patient state it hurts we told her to consult md if not comfortable. Pt is already on pain pills and is taking Benadryl.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Influenza like illness, Musculoskeletal pain, Pain in extremity, Pyrexia
Clinical narrative: Shoulder and arm pain 7 days. Fever, Temperature max 101, 2 days. Flu like symptoms 5 days.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Pain, Pain in extremity
Clinical narrative: Patient had prolonged pain, weakness and soreness in same arm as flu shot on 10-3-17.  After 2 and 1/2 weeks, presented to her Doctor regarding pain, and Dr stated it may be a result of the actual injection i.e. location, depth or angle of needle. On 10-18-17 Patient then called pharmacy to report the issue.
Age: 1.5
Sex: M
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: On 10/16, 2 injections were given into the right thigh (Dtap and Flu). On 10/17, Mom called to report red hard circle approximately 3 inches in diameter around injection sites. Patient not bothered by this reaction, happy and playful. Recommended warm compresses and to call back if worsened. On 10/18/17, patient brought into office for worsening of reaction. Area of erythema was 9 x 11cm, oval that included the injection sites, slightly swollen and warm to touch, painful to palpation. The area was marked with surgical marker and started on AUGMENTIN due to concern about possible infection vs local reaction. He was also given ibuprofen and BENADRYL. Evening of 10/18/17, mom called to report the area had extended about 1/2 inch below marked area. Still no fever, child was happy, playful. On 10/19/17, child seen in office. Area of redness now extended down leg slightly and slightly posterior thigh. Initial area of injection was lighter and with patches of clear skin. At this time, it was felt by the Provider, that is was more of a local reaction. Parent was uncomfortable stopping antibiotics and it was continued. Throughout the reaction, patient had intermittent fussiness but was afebrile. Patient continued antibiotics through 10/23/17. Mom reported today 10/23 that reaction resolved.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Sx- rash and swelling at site, warm to touch.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Erythema, Pharyngeal oedema, Speech disorder, Swelling
Clinical narrative: Patient notice trouble swallowing and trouble with speech. When she went into the Emergency department at about 7:30 pm they pointed out the external redness and swelling on her neck and throat.
Age: 25.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Pain
Clinical narrative: Patient called with vague symptoms of soreness, Said he has full range of motion in arm,  Said he has not seen a doctor.
Age: 25.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Injection site bruising, Injection site pain
Clinical narrative: Patient called with vague symptoms of soreness, Said he has full range of motion in arm,  Said he has not seen a doctor.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Injection site erythema, Injection site swelling
Clinical narrative: Large redness and swelling at injection site, shortness of breath.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Drug administered at inappropriate site, Headache, Immediate post-injection reaction, Inflammation
Clinical narrative: Possible SIRVA. Injection was high on shoulder, possibly in bursa. Received flu vaccine in left arm. Felt pop when injected followed by burning, stinging sensation down arm to elbow. Pain began an hour later. By 5PM couldn't lift arm. Took 2 TYLENOL and went to bed. By 11:30 extreme pain and vomiting, headache nausea and weakness went to the emergency room. Was diagnosed as allergic reaction. Called Dr next morning at 8AM advised to see immediately. Dr said misdiagnosed by ER, was inflammatory reaction not allergic reaction. Severe pain persists along with headache and nausea thru Friday. Received a shot of Tramadol and took ZOFRAN and prescription for TORADOL. Told to exercise twice a day of left arm to keep from getting frozen shoulder, scheduled next appointment for October 23. Friday morning October 20 was vomiting called Dr to see about nausea and headache and requested MRI. Advised to stop TORADOL and see in office on Monday. By mid afternoon vomiting and headache unbearable and Dr office was closed. Went to Convenient care. Received shot of STADOL and ordered MRI to be done Monday. Saturday October 21 Headache persists. Convenient care prescribed FIORICET. Severe pain in shoulder has been persistent since shot.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Nausea, Nuclear magnetic resonance imaging, Vomiting
Clinical narrative: Possible SIRVA. Injection was high on shoulder, possibly in bursa. Received flu vaccine in left arm. Felt pop when injected followed by burning, stinging sensation down arm to elbow. Pain began an hour later. By 5PM couldn't lift arm. Took 2 TYLENOL and went to bed. By 11:30 extreme pain and vomiting, headache nausea and weakness went to the emergency room. Was diagnosed as allergic reaction. Called Dr next morning at 8AM advised to see immediately. Dr said misdiagnosed by ER, was inflammatory reaction not allergic reaction. Severe pain persists along with headache and nausea thru Friday. Received a shot of Tramadol and took ZOFRAN and prescription for TORADOL. Told to exercise twice a day of left arm to keep from getting frozen shoulder, scheduled next appointment for October 23. Friday morning October 20 was vomiting called Dr to see about nausea and headache and requested MRI. Advised to stop TORADOL and see in office on Monday. By mid afternoon vomiting and headache unbearable and Dr office was closed. Went to Convenient care. Received shot of STADOL and ordered MRI to be done Monday. Saturday October 21 Headache persists. Convenient care prescribed FIORICET. Severe pain in shoulder has been persistent since shot.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Nervousness, Pallor
Clinical narrative: 4:35 pm patient became pale after injection. Patient was very nervous. He never lost consciousness, assisted to lie down for 10 minutes and then was feeling better. 4:45 left clinic with mother and went home and had something to eat. Spoke to mom via phone call and no further problems were noted.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Arthralgia, Diarrhoea, Fatigue, Pyrexia
Clinical narrative: Had stomach ache, starting 24 hours after vaccination, then diarrhea, then vomiting from 7:00 pm til 2:00 am. Joint pain, 100.0 fever the next day, fatigue.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Had stomach ache, starting 24 hours after vaccination, then diarrhea, then vomiting from 7:00 pm til 2:00 am. Joint pain, 100.0 fever the next day, fatigue.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Feeling jittery, Hypoaesthesia, Muscle twitching
Clinical narrative: About 30 minutes after vaccination, after returning to class, the student had complaints of being jittery and lightheaded. Patient stated Left arm was numb and twitchy and Left leg was numb also.  10:58 am BP =104/78, P = 80, R = 17, Temp = 99. Had banana to eat and drank 16 oz of water. Patient instructed to lie down on cot in nurses office. neuro checks were normal. 11:15 patient was recovered and spoke with parent over the phone.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Injection site erythema, Injection site nodule, Injection site pruritus, Injection site warmth
Clinical narrative: Patient presented with welts on injected lower forearm complaining of itching at injection site which has moved down her lower arm. Gave patient 20 ml of Benadryl 12.5mg/5ml (50mg) by mouth at 3:32pm.  Visited the patient at 3:52pm on same day in the classroom. Her husband came to pick her up at 4:20 pm and she stated that the itching had gotten better, however she was sleepy. Called patient on 10/19/17 to verify she was ok and did not have another reaction. She stated she took another 50mg on 10/18/17 and was feeling fuzzy. She later emailed about the area being warm, red, itchy, and a knot is present. Have not had communication since 10/19/2017.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Somnolence, Urticaria
Clinical narrative: Patient presented with welts on injected lower forearm complaining of itching at injection site which has moved down her lower arm. Gave patient 20 ml of Benadryl 12.5mg/5ml (50mg) by mouth at 3:32pm.  Visited the patient at 3:52pm on same day in the classroom. Her husband came to pick her up at 4:20 pm and she stated that the itching had gotten better, however she was sleepy. Called patient on 10/19/17 to verify she was ok and did not have another reaction. She stated she took another 50mg on 10/18/17 and was feeling fuzzy. She later emailed about the area being warm, red, itchy, and a knot is present. Have not had communication since 10/19/2017.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Had a fairly large red swollen area around the injection site. Told patient to take benadry and to put ice on it several times a day to help with the reaction and swelling.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Had a fairly large red swollen area around the injection site. Told patient to take benadry and to put ice on it several times a day to help with the reaction and swelling.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness, Pallor
Clinical narrative: A few minutes after vaccination, patient lost consciousness. She was gently lowered to floor, patient did not hit head or get injured. Skin was pale. Patient had not eaten or had anything to drink that day.  9:45 am BP= 86/50, P= 68, R=16, Patient was unconscious for approx 45 seconds then started to come around and open eyes. 9:48 am eyes open and more alert. Skin color improved. Alert and oriented x3, She knew her name, place, parents names etc. Transported to nurses office via wheelchair. Was given juice and crackers and instructed to lie down, 10:00 am BP= 94/68, P= 68, R=16. Patient continued to rest sitting up and was feeling better.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dizziness, Dysphagia, Dyspnoea, Electrocardiogram normal
Clinical narrative: About 2 1/2 hours after the shot, I began having discomfort in my chest. I first thought it was heartburn (which I don't typically experience, in fact, haven't outside of pregnancy.) However, the feeling did not ease up. I went down to ask the school nurse if it could be a side effect of the shot, but as I walked, I began to get lightheaded. She checked my blood pressure and found it to be unusually high (180/90), but it lowered on a subsequent check to about 150/90 (still atypically high for me.) She suggested I get checked out. I went to the emergency room where they ran a series of tests that all came back negative (see below). All told, my symptoms included: -Tightness/discomfort in my chest - lasted about 8 hours -Difficulty swallowing (like a lump in my throat) - lasted about 8 hours -Shortness of breath - lasted about 8 hours -Redness in the eyes - lasted about 8 hours -My right eye was crusted shut two mornings later. Just that one morning. Two days after the shot, all symptoms had cleared up without treatment.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Eyelid margin crusting, Fibrin D dimer normal, Hypertension, Metabolic function test normal, Ocular hyperaemia
Clinical narrative: About 2 1/2 hours after the shot, I began having discomfort in my chest. I first thought it was heartburn (which I don't typically experience, in fact, haven't outside of pregnancy.) However, the feeling did not ease up. I went down to ask the school nurse if it could be a side effect of the shot, but as I walked, I began to get lightheaded. She checked my blood pressure and found it to be unusually high (180/90), but it lowered on a subsequent check to about 150/90 (still atypically high for me.) She suggested I get checked out. I went to the emergency room where they ran a series of tests that all came back negative (see below). All told, my symptoms included: -Tightness/discomfort in my chest - lasted about 8 hours -Difficulty swallowing (like a lump in my throat) - lasted about 8 hours -Shortness of breath - lasted about 8 hours -Redness in the eyes - lasted about 8 hours -My right eye was crusted shut two mornings later. Just that one morning. Two days after the shot, all symptoms had cleared up without treatment.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Troponin I normal
Clinical narrative: About 2 1/2 hours after the shot, I began having discomfort in my chest. I first thought it was heartburn (which I don't typically experience, in fact, haven't outside of pregnancy.) However, the feeling did not ease up. I went down to ask the school nurse if it could be a side effect of the shot, but as I walked, I began to get lightheaded. She checked my blood pressure and found it to be unusually high (180/90), but it lowered on a subsequent check to about 150/90 (still atypically high for me.) She suggested I get checked out. I went to the emergency room where they ran a series of tests that all came back negative (see below). All told, my symptoms included: -Tightness/discomfort in my chest - lasted about 8 hours -Difficulty swallowing (like a lump in my throat) - lasted about 8 hours -Shortness of breath - lasted about 8 hours -Redness in the eyes - lasted about 8 hours -My right eye was crusted shut two mornings later. Just that one morning. Two days after the shot, all symptoms had cleared up without treatment.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient returned to pharmacy on the fifth day after shot was given with chief complaint of redness, swelling, warm to touch, and pain at and surrounding area of site of injection. Site of adverse reaction was at the deltoid muscle of the left arm. The size of adverse reaction was approximately 2.5 inches in height and 3.5 inches in width on 10/20/2017. Patient was advised to take Ibuprofen 200 mg, CHLOR-TAB 4 mg, iced the area for 15 minutes. Patient has been taking Ibuprofen 200 mg every 4 hours as needed, CHLOR-TAB 4 mg every 5 to 6 hours as needed. Patient iced adverse reaction area every 10 minutes per every hour as needed. Today 10/23/2017 the redness increased in size. Her primary doctor was notified and she have made an appointment to see her doctor on 10/24/2017.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: HIVES.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pain, Pruritus
Clinical narrative: Patient mentioned swelling/redness/itching/pain for a day following administration (10/21/17).  Upon notifying the pharmacy (10/23/17), she just had swelling and redness around the deltoid region of right arm.  Counseled patient to use cold compress and NSAIDs to relief and to contact primary doctor if symptoms worsen.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Swelling
Clinical narrative: Patient mentioned swelling/redness/itching/pain for a day following administration (10/21/17).  Upon notifying the pharmacy (10/23/17), she just had swelling and redness around the deltoid region of right arm.  Counseled patient to use cold compress and NSAIDs to relief and to contact primary doctor if symptoms worsen.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Tremor, Vomiting
Clinical narrative: Fever, vomiting, and shaking.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site hypoaesthesia, Injection site nodule, Injection site pain
Clinical narrative: Patient reported to the pharmacy on 10/19/17 that she was feeling numbness and significant pain in her arm at the injection site and had trouble moving her arm. She was asked when the pain started and she reported it started on 9/24/17 after receiving the vaccination and steadily got worse of the next 3 weeks. Patient did not report sooner because she felt it would go away. She also reported a knot forming at the injection site that may or may not have gone away.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site bruising
Clinical narrative: Patient received the high dose flu shot and pneumovax shot on the same day. After two days patients left arm was severely bruised from upper deltoid to elbow. Patient took benadryl and reaction subsided.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient developed small red itchy bumps: 2 on her thumb, 2 on her inner arm, 4 on her ring finger, and 2 above her eyebrow, 1 and 1/2 weeks after receiving ZOSTAVAX. She said these bumps were not blistered and reminded her of when she had chickenpox as a child. She called the pharmacy to ask if a person could develop chickenpox from the shingles vaccine. I called the Merck consultant and they said that there was nothing in their files that spoke of this as a possibility. They are sending this to the global medical unit and will be contacting me back with any further information. I informed the patient to check with her doctor to see if they think that this is chickenpox also.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Rash erythematous, Rash pruritic
Clinical narrative: Patient developed small red itchy bumps: 2 on her thumb, 2 on her inner arm, 4 on her ring finger, and 2 above her eyebrow, 1 and 1/2 weeks after receiving ZOSTAVAX. She said these bumps were not blistered and reminded her of when she had chickenpox as a child. She called the pharmacy to ask if a person could develop chickenpox from the shingles vaccine. I called the Merck consultant and they said that there was nothing in their files that spoke of this as a possibility. They are sending this to the global medical unit and will be contacting me back with any further information. I informed the patient to check with her doctor to see if they think that this is chickenpox also.
Age: 72.0
Sex: M
Vaccine: FLUA3
Symptoms: Condition aggravated, Continuous positive airway pressure, Headache, Pharyngeal oedema, Sleep apnoea syndrome
Clinical narrative: Approximately 28 hours after the injection, upon going to bed at a friend's house, the throat was swollen and a headache ensued. It was severe enough that it caused Sleep Apnea episodes that awoke me. I was required to drive over an hour in the middle of the night to get back home so I could sleep with my CPAP to prevent further episodes. I had previously always been able to sleep elsewhere besides home without the CPAP, and no further episodes occurred once I went back to sleep at home using the CPAP. When I awoke the following morning my throat was still swollen, the headache was worse, and I had ringing in my ears. Fifty-two hours later, now my throat is still swollen, there is still ringing, but I have worked.
Age: 72.0
Sex: M
Vaccine: FLUA3
Symptoms: Tinnitus
Clinical narrative: Approximately 28 hours after the injection, upon going to bed at a friend's house, the throat was swollen and a headache ensued. It was severe enough that it caused Sleep Apnea episodes that awoke me. I was required to drive over an hour in the middle of the night to get back home so I could sleep with my CPAP to prevent further episodes. I had previously always been able to sleep elsewhere besides home without the CPAP, and no further episodes occurred once I went back to sleep at home using the CPAP. When I awoke the following morning my throat was still swollen, the headache was worse, and I had ringing in my ears. Fifty-two hours later, now my throat is still swollen, there is still ringing, but I have worked.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Arm swollen, red from immunization site down to elbow.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 17-year-old male patient who received BEXSERO (batch number 15E301A, expiry date 31st May 2018. Concomitant products included HPV vaccine. On 9th October 2017, the patient received BEXSERO .5 ml. On 9th October 2017, less than a day after receiving BEXSERO, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown. The reporter considered the injection site erythema to be possibly related to BEXSERO. Additional details were received as follows: On 9th October 2017, the patient received HPV vaccine (non GSK), with batch number NO12093 and expiry date as 13th January 2020 in left deltoid. At 10:00, the patient received a dose of BEXSERO in right deltoid. The patient's mother sent a photo of the patient's right arm showing a large area of erythema that covered the whole right deltoid area. The patient was not seen in the office but given instructions to come in if the area did not improve. This case was one of the 3 cases, reported by the same reporter for the patients who experienced events after the same lot number of BEXSERO.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Rash macular
Clinical narrative: Left leg swelling, erythema at site and surrounding area by approx. 5 in diameter associated with macular rash on thigh.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Incorrect dose administered, Mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a nurse and described the occurrence of cellulitis in a 4-year-old female patient who received FLULAVAL QUADRIVALENT (batch number PN75E, expiry date 31st May 2018). On an unknown date, the patient received FLULAVAL QUADRIVALENT. On an unknown date, several hours after receiving FLULAVAL QUADRIVALENT, the patient experienced cellulitis (serious criteria GSK medically significant), pain in arm and mobility decreased. The patient was treated with antibiotics nos (Brand Names Not Known) On an unknown date, the outcome of the cellulitis, pain in arm and mobility decreased were unknown. It was unknown if the reporter considered the cellulitis, pain in arm and mobility decreased to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: On an unknown date on Friday morning, the patient received FLULAVAL QUADRIVALENT and in the evening, the patient had pain and could not move the arm. On Saturday morning, the patient's mother took the patient to the emergency room (ER). The patient was diagnosed with cellulitis. The patient was prescribed with antibiotics. The emergency room physician informed the mother that the influenza dose given was too high for her age. As per nurse, the patient was okay at the time of reporting.
Age: 80.0
Sex: M
Vaccine: FLUA3
Symptoms: Blood pressure fluctuation, Blood pressure increased
Clinical narrative: On 10/3/17 rec'd "Senior" flu-vaccine about 12 hrs later my blood pressure spiked to over 180/95. B.P. went UP and down following 3-4 days. M.D. prescribed add'l meds took 6/7 days to return to normal. Never had problem, never had side effects with reg. vaccine.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Shoulder pain-patient is taking TYLENOL.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Lethargy
Clinical narrative: Chills, lethargy greater than for 2 weeks since vaccination.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Vomiting projectile
Clinical narrative: Mother called 6 hours after child got immunized states child had projectile vomiting. Advised to consult Dr.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Blindness transient, Erythema, Nausea, Pain, Pyrexia
Clinical narrative: Pain, redness, extreme swelling nausea, faint, fever, temporary loss of site.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Swelling, Syncope
Clinical narrative: Pain, redness, extreme swelling nausea, faint, fever, temporary loss of site.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Dizziness, Fatigue, Groin pain, Injection site pain
Clinical narrative: Dizziness, pain in right arm at immunization sight, pain in right groin, all in pain, swelling at inj. site, fatigue, mild fever, chills.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Dizziness, pain in right arm at immunization sight, pain in right groin, all in pain, swelling at inj. site, fatigue, mild fever, chills.
Age: 0.17
Sex: M
Vaccine: IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received PENTACEL 10/06/17. IPOL administered today 10/19/17 in error, 13 days after receiving PENTACEL. Not aware of any adverse advent. Vaccination given in error.
Age: 63.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Nausea, Nodule, Pain, Pyrexia
Clinical narrative: Pain, redness, swelling, nausea, faintness, tightness, knot in arm size of ball, fever!
Age: 63.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Skin tightness, Swelling, Syncope
Clinical narrative: Pain, redness, swelling, nausea, faintness, tightness, knot in arm size of ball, fever!
Age: 97.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dyspnoea, Gait disturbance, Pyrexia
Clinical narrative: Sudden onset of feeling feverish (temp. normal), weak all over, staggering, out of breath. Subsided gradually during evening. Meanwhile called Advice nurse, Doctor recomm. ER. Did not go because of spontaneous recovery.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Erythema, Headache, Hyperaesthesia, Pain
Clinical narrative: Severe rigors (chills), severe headache, body turned bright red and hot to the touch, no sleep no fever, touching anywhere on body was painful, sheet and blankets were painful. Next day was better, but at 7PM symptoms began again, not as severe.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm
Clinical narrative: Severe rigors (chills), severe headache, body turned bright red and hot to the touch, no sleep no fever, touching anywhere on body was painful, sheet and blankets were painful. Next day was better, but at 7PM symptoms began again, not as severe.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Skin discolouration, Skin warm
Clinical narrative: 4-5 days - 4" x 3" upper arm dark red/purple. Very hot. Sore.