chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Tremor
Clinical narrative: After having the flu shot AFLURIA QUAD PF injected at pharmacy at 12:45 PM on October 30, 2018, five hours later, my body was shaking so bad I was freezing and could not get warm, had low-grade fever 99.2. The following day I have very sore muscles, even my eyelids ache. I have never experienced the uncontrollable shaking. This was not just a chill where you would get a random tremor this was so bad I could not even hold a spoon to eat. Was weak and had no appetite until 24 hours later. I contacted the pharmacy the next day and they told me that there had been another case of this exact thing two weeks prior. I'm just wondering how many people actually call the pharmacy after they go through something like this perhaps the amount of people affected is much greater than is thought.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Patient given adult dose .50 rather than <3 dose.25.
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Discomfort, Immediate post-injection reaction, Injection site pain, Pain in extremity
Clinical narrative: Immediate discomfort, pain in left arm and shoulder.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Induration, erythema, pain under injection site; injection site not in deltoid, but below so vaccine given subcut instead of IM.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Nausea, Pyrexia
Clinical narrative: Flu like symptoms- aches, low fever (100), nausea.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Dysphonia, Feeling abnormal, Flushing, Oropharyngeal pain
Clinical narrative: Associate stated about an hour and half after he had the flu vaccine administered; he developed a cough, 15 minutes later his face, head, neck and ears were flushed. During the next 15 minutes, his cough became worse and he felt his throat was constricted. He did not feel normal and there was a change in his voice. His co worker had him taken to the ER where he was evaluated and treated with medication (fexofenadine, famotidine), monitored and was released after his symptoms resolved and his blood pressure was normal. His throat was sore for a few days after.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Throat tightness
Clinical narrative: Associate stated about an hour and half after he had the flu vaccine administered; he developed a cough, 15 minutes later his face, head, neck and ears were flushed. During the next 15 minutes, his cough became worse and he felt his throat was constricted. He did not feel normal and there was a change in his voice. His co worker had him taken to the ER where he was evaluated and treated with medication (fexofenadine, famotidine), monitored and was released after his symptoms resolved and his blood pressure was normal. His throat was sore for a few days after.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Seizure, Unresponsive to stimuli, Vital functions abnormal
Clinical narrative: After receiving flu shot patient was walking away and another customer saw her fall to the ground. The pharmacist was notified and the patient was slighlty convulsing and after about a minute she became responsive and alert. She was not complaining of any pain anywhere. Paramedics were called and they took her vitals which were elevated and the patient was transferred to the hospital.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patent of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 01-SEP-2018, the patient was inadvertently administered a dose of PREVNAR 13 ((Lot# S58702, expiration date 31-AUG-2019; strength, dose, frequency, route and indication were not reported). On 30-SEP-2018, the patient was inadvertently administered a dose of PNEUMOVAX 23 (lot # R002085, expiration date 31-OCT-2018; strength, dose, frequency and route were not reported) for prophylaxis. No adverse effect reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-OCT-2018, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N016993, expiration date 29-NOV-2018, subcutaneously for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of -14 to -10 degrees Celsius for 28 minutes. There was previous excursion reported of -14 to -10 degrees Celsius for 44 minutes. Data logger was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 11-OCT-2013, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 19-AUG-2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 27-SEP-2007, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2015, the patient was treated at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased, Loss of personal independence in daily activities, Pain
Clinical narrative: Patient reported tenderness to the site for 2 days post injection and got better. Patient reported today that he noticed that he was having increasing tenderness 12 days later and today has profound limited ROM and a lot of pain. Site does not appear swollen in comparison to opposite arm, strength is equal bilaterally but patient unable to perform independent or passive ROM with pain.
Age: 66.0
Sex: F
Vaccine: FLUR3, PPV
Symptoms: Chills, Erythema, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Patient reports: Had pneumonia vaccine and flu vaccine yesterday in office; no documentation of Pneumonia vaccine given yesterday); States both were given in LD; Had a large red circle around the area of injection after she got home; Swollen like an egg, itchy; Today swollen down the elbow; Hot to touch, painful; More redness and has spread around the arm; Used ice packs on it all night; A lot of muscle aching in the arm last night, could barely sleep; Has the chills today; Very nauseated today;  Is currently on amoxicillin for sinus infection; Too nauseated to take her ABX today; Thinks she is having a reaction to the vaccines.
Age: 66.0
Sex: F
Vaccine: FLUR3, PPV
Symptoms: Injection site swelling, Injection site warmth, Insomnia, Myalgia, Nausea
Clinical narrative: Patient reports: Had pneumonia vaccine and flu vaccine yesterday in office; no documentation of Pneumonia vaccine given yesterday); States both were given in LD; Had a large red circle around the area of injection after she got home; Swollen like an egg, itchy; Today swollen down the elbow; Hot to touch, painful; More redness and has spread around the arm; Used ice packs on it all night; A lot of muscle aching in the arm last night, could barely sleep; Has the chills today; Very nauseated today;  Is currently on amoxicillin for sinus infection; Too nauseated to take her ABX today; Thinks she is having a reaction to the vaccines.
Age: 66.0
Sex: F
Vaccine: FLUR3, PPV
Symptoms: Sinusitis
Clinical narrative: Patient reports: Had pneumonia vaccine and flu vaccine yesterday in office; no documentation of Pneumonia vaccine given yesterday); States both were given in LD; Had a large red circle around the area of injection after she got home; Swollen like an egg, itchy; Today swollen down the elbow; Hot to touch, painful; More redness and has spread around the arm; Used ice packs on it all night; A lot of muscle aching in the arm last night, could barely sleep; Has the chills today; Very nauseated today;  Is currently on amoxicillin for sinus infection; Too nauseated to take her ABX today; Thinks she is having a reaction to the vaccines.
Age: 18.0
Sex: F
Vaccine: FLU4, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Facial paralysis, Swelling face
Clinical narrative: Pt presented to the office 11/1/18 complaining of left sided facial swelling. Started 10/30/18 in the am and she believes related to vaccines she received 10/29/18. Was sent to the Urgent care and was dx with right sided Bells Palsy.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Gait inability, Laboratory test
Clinical narrative: Patient started having knee pain shortly after getting the vaccine. She went to the ER and was admitted to the hospital. Patient's daughter stated her mom could not walk and Drs were testing her for Guillain Barre Syndrome and other autoimmune disorders.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Seizure
Clinical narrative: MOTHER FOUND CHILD HAVING A SEIZURE ON HIS BED AT 6:20AM ON 11/2/2018. CHILD TAKEN TO HOSPITAL FOR EVALUATION.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Pain, Pruritus
Clinical narrative: The patient stated she had redness from her neck to her wrist on her left arm, swelling of her upper arm, wide spread pain, itching, shivering/chills, and fevers. She said she tried taking ibuprofen and Benadryl with little to moderate relief. The patient stated this started the day after the vaccine, was "really bad" for 3 days, and then persisted for 2 weeks until it was completely resolved.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: The patient stated she had redness from her neck to her wrist on her left arm, swelling of her upper arm, wide spread pain, itching, shivering/chills, and fevers. She said she tried taking ibuprofen and Benadryl with little to moderate relief. The patient stated this started the day after the vaccine, was "really bad" for 3 days, and then persisted for 2 weeks until it was completely resolved.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Patient with injection site reaction red swollen and warm next morning last 2 days and rash that comes and goes for 1 month.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema, Oedema peripheral, Skin warm
Clinical narrative: Edema, redness and warmth. The edema on the left arm is 5 cm greater than the unvaccinated arm.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Cold sweat, Contusion, Fatigue, Induration
Clinical narrative: He had a pneumococcal vaccine on his right arm on 10/30/2018. He 3-4 hard lumps across his bicep. That evening he had chills. Cold sweats that evening. Fatigue. Arm was swollen. Arm still a little swollen and looks bruised. Arm is better today. Today the muscle aches.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Limb mass, Myalgia, Peripheral swelling
Clinical narrative: He had a pneumococcal vaccine on his right arm on 10/30/2018. He 3-4 hard lumps across his bicep. That evening he had chills. Cold sweats that evening. Fatigue. Arm was swollen. Arm still a little swollen and looks bruised. Arm is better today. Today the muscle aches.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient began complaining of pain at injection site approximately 30 min after injection, 45 min after injection patient was found to have moderate swelling of her left upper arm with extreme tenderness, no respiratory problems, MD notified, patient was given Benadryl 50 mg orally and Solumedrol 125 mg IM.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Injection site pain, Injection site pruritus, Injection site swelling, Skin tightness
Clinical narrative: Pt has swelling, itching and tenderness at injection site. Tightness and redness down the arm.
Age: 44.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Peripheral swelling, Urticaria
Clinical narrative: She had 3 welts welt the day after. Now she has a bigger welt size of a quarter. Redness. Arm still a little swollen.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness around injection site, spreading to shoulder.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Swollen arm of soft tissue at injection site with arm and shoulder pain. Unknown time of onset as information was given from a different clinic. I asked when symptoms started and clinic staff said it started after the injection and has progressively gotten worse.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Angiogram normal, Computerised tomogram head normal, Drug screen negative, Dysgeusia, Facial paralysis
Clinical narrative: Headache and hearing difficulty to right side 2 days prior to vaccination. Day of vaccination HA again prior to vaccination; after vaccination at 1:00 AM, other employees started noticing changes to patient's face; at 4:30 AM noticeable right side facial droop and patient sent to the ER for evaluation; other symptom noted on evaluation were right sided facial weakness, abnormal taste to the right side, left sided upper extremity numbness, headache, nausea, not able to move facial muscles on right side of face.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Facial paresis, Full blood count normal, Headache, Hypoaesthesia, Laboratory test normal
Clinical narrative: Headache and hearing difficulty to right side 2 days prior to vaccination. Day of vaccination HA again prior to vaccination; after vaccination at 1:00 AM, other employees started noticing changes to patient's face; at 4:30 AM noticeable right side facial droop and patient sent to the ER for evaluation; other symptom noted on evaluation were right sided facial weakness, abnormal taste to the right side, left sided upper extremity numbness, headache, nausea, not able to move facial muscles on right side of face.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Neurological examination, Nuclear magnetic resonance imaging brain normal, Urine analysis normal
Clinical narrative: Headache and hearing difficulty to right side 2 days prior to vaccination. Day of vaccination HA again prior to vaccination; after vaccination at 1:00 AM, other employees started noticing changes to patient's face; at 4:30 AM noticeable right side facial droop and patient sent to the ER for evaluation; other symptom noted on evaluation were right sided facial weakness, abnormal taste to the right side, left sided upper extremity numbness, headache, nausea, not able to move facial muscles on right side of face.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Patient saw this reporter at a church function on 10/10/2018 and reported she could not lift her arm 4-5 hours after receiving the flu shot. This reported ask that she call the health department the next day to make a report. The patient did not notify this reporter again until 10-29-18 and this was a phone call after hours to my cell phone. Client was asked to call the health department the next day so a proper report can be taken. Pt. did call the next day and reported she saw her doctor on 10-29-18 because the pain in her arm was getting worse- she reported the pain was going up into her neck and shoulder.  She reports the doctor gave her an injection of Toradol and a steroid shot. She was also given a Medrol pack. Patient reported that the pain had improved on the morning of 10-30-18.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: On 10/29/2018 patient called this nurse to report she was going to see her doctor on 10-30-2018 because she was still having problems with pain after receiving the flu shot. Pt. reports she was having pain "every now and then", especially when putting on her bra and getting her shirt off. Pt. reports she has experienced this pain starting on the day she received the flu shot but it did not get better. Patient call back on 10-30-18 at 3:20 pm and reported she saw her doctor and received a steroid and Toradol shot about 9:30 a.m. and that her arm was already feeing better.
Age: 7.0
Sex: M
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Hives gave Benadryl.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Rash generalised
Clinical narrative: Per MD office, I received a FLUCELVAX QUAD 2018-2019 0.5.
Age: 1.25
Sex: M
Vaccine: FLU4, MMR, PNC13
Symptoms: Diarrhoea, Fatigue, Rash, Swelling of eyelid
Clinical narrative: Mom reports patient seemed more tired than usual x4 days and developed rash x1 day. Initial rash to face, most prominent on left cheek, now spreading to trunk, arms and legs. Eyes appear more puffy than usual. Child also developed loose stools on day of assessment (11/02/18). Mom had been giving Tylenol at home. Child given Benadryl at PCP office- 11/02/18 at 11:00 AM.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Feeling abnormal, Feeling cold, Feeling hot, Headache
Clinical narrative: Injection site abnormally sore and got a lot worse. By 9:00 pm I basically had the flu -- body aches, chills and shaking, hard to get warmed up and then I got too hot, skin sensitivity and whopping headache. Tried to sleep and had a really bad night. Woke up at 5:00 am and realized that flu symptoms had ended and I was left with headache and feeling like I'd been beaten up. Soreness in arm still beyond normal but subsiding.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Hyperaesthesia, Influenza, Injection site pain, Pain, Pain in extremity
Clinical narrative: Injection site abnormally sore and got a lot worse. By 9:00 pm I basically had the flu -- body aches, chills and shaking, hard to get warmed up and then I got too hot, skin sensitivity and whopping headache. Tried to sleep and had a really bad night. Woke up at 5:00 am and realized that flu symptoms had ended and I was left with headache and feeling like I'd been beaten up. Soreness in arm still beyond normal but subsiding.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Poor quality sleep, Tremor
Clinical narrative: Injection site abnormally sore and got a lot worse. By 9:00 pm I basically had the flu -- body aches, chills and shaking, hard to get warmed up and then I got too hot, skin sensitivity and whopping headache. Tried to sleep and had a really bad night. Woke up at 5:00 am and realized that flu symptoms had ended and I was left with headache and feeling like I'd been beaten up. Soreness in arm still beyond normal but subsiding.
Age: 58.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Mobility decreased, Pain, Product administered at inappropriate site
Clinical narrative: Patient received flu shot and PNEUMOVAX in same deltoid area one inch apart. Patient claims PNEUMOVAX was too high up into the shoulder area and she has been experiencing pain and motility issues ever since. This is especially bad when she moves in certain ways. Patient has requested medical treatment.
Age: 72.0
Sex: M
Vaccine: FLUR4
Symptoms: Asthenia, Chills, Fatigue, Pyrexia
Clinical narrative: Heavy chills & fever commencing approx 7 hours following injection and lasting approx 6 hours with weakness and fatigue lasting throughout the following day.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: "Extreme" swelling and soreness at site of injection.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Hypersomnia, Malaise, Nausea
Clinical narrative: I felt a little queasy before going to bed on the 31st, but I was't surprised because I had a similar reaction to the first vaccine. I woke up sometime after 3 AM violently ill. I was extremely weak as I tried to get to the toilet to throw up. I could not throw up. I had chills and became shakier, took my fever. It was slightly over 100 degrees, which is a high temperature for me. I did not even run a temperature of note when I had pneumonia (which, by the way, I contracted within a week of the 1st shingles shot. I blamed the shot. I was able to drink a little water. I considered calling 911 since I live alone. Finally, I was able to doze off. I slept most of the next day.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: I felt a little queasy before going to bed on the 31st, but I was't surprised because I had a similar reaction to the first vaccine. I woke up sometime after 3 AM violently ill. I was extremely weak as I tried to get to the toilet to throw up. I could not throw up. I had chills and became shakier, took my fever. It was slightly over 100 degrees, which is a high temperature for me. I did not even run a temperature of note when I had pneumonia (which, by the way, I contracted within a week of the 1st shingles shot. I blamed the shot. I was able to drink a little water. I considered calling 911 since I live alone. Finally, I was able to doze off. I slept most of the next day.
Age: 76.0
Sex: M
Vaccine: FLUA3
Symptoms: Abdominal pain, Back pain, Borrelia test negative, Burning sensation, Chest pain
Clinical narrative: Developed upper back pain which radiated bilaterally to the chest and abdomen from the level of the nipples to the lower abdomen. This was accompanied by a burning feeling and skin hypersensitivity. It radiated anteriorly to about the nipple level. Did not involve the sternal area.
Age: 76.0
Sex: M
Vaccine: FLUA3
Symptoms: Dermatitis allergic, Full blood count normal, Nuclear magnetic resonance imaging spinal, Pain, Red blood cell sedimentation rate normal
Clinical narrative: Developed upper back pain which radiated bilaterally to the chest and abdomen from the level of the nipples to the lower abdomen. This was accompanied by a burning feeling and skin hypersensitivity. It radiated anteriorly to about the nipple level. Did not involve the sternal area.
Age: 76.0
Sex: M
Vaccine: FLUA3
Symptoms: Thrombocytopenia, Vitamin B12 normal, West Nile virus test negative
Clinical narrative: Developed upper back pain which radiated bilaterally to the chest and abdomen from the level of the nipples to the lower abdomen. This was accompanied by a burning feeling and skin hypersensitivity. It radiated anteriorly to about the nipple level. Did not involve the sternal area.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dyspnoea, Throat tightness
Clinical narrative: Rapid development of cough, "throat closing" and shortness of breath. Epinephrine 0.3 mg SQ, 50 mg diphenhydramine IM, DUONEB nebulizer and 60 mg prednisone PO given shortly after reaction began. Transferred to ED via ambulance and observed over 2 hrs with resolution of symptoms.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site discharge, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Pt received FLUARIX QD preservated free 10/31/18 pt calls office 11/2/18 stating patient rt arm was red and pain yesterday 11/1/18 but this morning when pt woke up pt had Rt red swollen and had drainage around injection site.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Hypertension
Clinical narrative: Per wife pt experienced high blood pressure moring after shot and felt dizzy.. just spoke with wife..per  Pt Cardiologist.. flu shot did not cause this reaction..reporting it anyway.
Age: 77.0
Sex: M
Vaccine: FLUA3
Symptoms: Dizziness, Pallor
Clinical narrative: After administration of vaccine, patient became light headed. He laid down on the bench that we have outside the pharmacy. His color was very pale and he kept saying how light headed he felt. He did not faint, but remained laying down for a good 20 minutes. I took his blood pressure and it read 97/64 with a pulse of 50. Gave him two bottles of water as well as something to eat. He and his wife decided that they wanted me to call 9-1-1. I did and the paramedics came within 10 minutes. They asked him questions and decided to put him on a stretcher and take him to the hospital.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site warmth, Sensory disturbance
Clinical narrative: Two days after vaccination, patient came to clinic as noted a 6 cm by 5 cm patch of warm reddened skin which was 3 cm distal to the injections site. Reported that did feel a sensation of medication dripping down inside arm when vaccine had been administered into area showing redness two days after initial injection.
Age: 0.75
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Information has been received from a medical assistant referring to a 9 month old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, current condition and concomitant medication were not provided. On 05-OCT-2018, the patient was vaccinated with VAQTA (dose, frequency, route, lot number R013858 and expiration date 12-JUN-2019) for prophylaxis (drug administered to patient of inappropriate age). No adverse effects reported.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site warmth, Limb mass, Peripheral swelling
Clinical narrative: This spontaneous report was received from a medical assistant, regarding a 79 year old female patient. The patient's drug reaction allergies included erythromycin and cefuroxime. No concomitant medication or pertinent medical history were provided. On 23-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscularly in the left arm, lot # R018735 with expiration date 06-APR-2020, for prophylaxis (strength, dose and frequency were not provided). On 24-OCT-2018, the patient was experiencing redness (erythema) and swelling which extended from the left inner arm to the elbow(swelling of vaccinated limb), an unspecified lump on the inner arm (limb mass) and the injection site area was hot (vaccination site warmth). On 25-OCT-2018, the patient was examined by physician and treated with oral doxycycline. At the reporting time, the outcome of limb mass, vaccination site warmth, extensive swelling of vaccinated limb and erythema was resolving as upon examination patient stated that her arm had improved (also reported as not recovered). The reporter requested a lot checked. No laboratory studies were performed. The reported did not assess the relatedness between PNEUMOVAX 23 and the aforementioned events.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 15-JUN-2015 the patient was administered ZOSTAVAX by a pharmacist at a pharmacy (dose, route, and lot # not provided).  The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 02-NOV-2016, the patient was treated by a physician at a medical center for shingles. She was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries.  As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of staphylococcal infection in a 15-year-old female patient who received FLULAVAL QUADRIVALENT 2018-2019 season) (batch number LB34Z, expiry date unknown) for prophylaxis. On 24th September 2018, the patient received the 1st dose of FLULAVAL QUADRIVALENT 2018-2019 season (intramuscular) .5 ml. On 8th October 2018, 14 days after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced staphylococcal infection (serious criteria GSK medically significant), injection site rash, injection site warmth, injection site itching, injection site lump, injection site erythema and injection site pain. The patient was treated with sulfamethoxazole + trimethoprim (Bactrim Ds). On an unknown date, the outcome of the staphylococcal infection, injection site rash, injection site warmth, injection site itching, injection site lump, injection site erythema and injection site pain were not recovered/not resolved.  It was unknown if the reporter considered the staphylococcal infection, injection site rash, injection site warmth, injection site itching, injection site lump, injection site erythema and injection site pain to be related to FluLaval Quadrivalent 2018-2019 season. Additional details were provided as follows: The case was reported by the patient's father. The patient received FLULAVAL QUADRIVALENT 2018-2019 season in the left deltoid. The product's expiration date was unknown. The patient presented lump on her arm that was as large as a tennis ball. The father reported that her daughter was seen by her physician and was prescribed Bactrim DS for a possible Staphylococcal infection. The father reported that his daughter planned to continue follow up with her physician on an unknown date.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Staphylococcal infection
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of staphylococcal infection in a 15-year-old female patient who received FLULAVAL QUADRIVALENT 2018-2019 season) (batch number LB34Z, expiry date unknown) for prophylaxis. On 24th September 2018, the patient received the 1st dose of FLULAVAL QUADRIVALENT 2018-2019 season (intramuscular) .5 ml. On 8th October 2018, 14 days after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced staphylococcal infection (serious criteria GSK medically significant), injection site rash, injection site warmth, injection site itching, injection site lump, injection site erythema and injection site pain. The patient was treated with sulfamethoxazole + trimethoprim (Bactrim Ds). On an unknown date, the outcome of the staphylococcal infection, injection site rash, injection site warmth, injection site itching, injection site lump, injection site erythema and injection site pain were not recovered/not resolved.  It was unknown if the reporter considered the staphylococcal infection, injection site rash, injection site warmth, injection site itching, injection site lump, injection site erythema and injection site pain to be related to FluLaval Quadrivalent 2018-2019 season. Additional details were provided as follows: The case was reported by the patient's father. The patient received FLULAVAL QUADRIVALENT 2018-2019 season in the left deltoid. The product's expiration date was unknown. The patient presented lump on her arm that was as large as a tennis ball. The father reported that her daughter was seen by her physician and was prescribed Bactrim DS for a possible Staphylococcal infection. The father reported that his daughter planned to continue follow up with her physician on an unknown date.
Sex: U
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Syringe issue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number 4MA57, expiry date 11th June 2019) for prophylaxis. This case was associated with a product complaint. On 11th October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. On 11th October 2018, immediately after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced injection site pain. On an unknown date, the patient experienced syringe issue and pharmaceutical product complaint. On an unknown date, the outcome of the injection site pain, syringe issue and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the injection site pain to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: This case was reported by the pharmacist for her colleague. The age at vaccination was not reported. The patient noted the unusual amount of air in syringe, as well as, experienced pain during the vaccination and could feel the vaccine being injected. The reporter did not provide more information about colleague at the time of reporting. This case has been linked with the case US2018185671 and US2018185712, reported by same reporter.
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from a other health care professional via phone. This case involves a 17 years old male patient who was vaccinated with a 0.5 ml dose of FLUBLOK QIV (Batch number: QFAA1801, expiration date: 29-May-2019, site of administration: left deltoid and route was not reported) on 18-Sep-2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration (FLUBLOK QUADRIVALENT given to 17 year old patient). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 4.0
Sex: U
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site pain, Product storage error
Clinical narrative: Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case is linked with 2018SA298525 (same reporter). This case involves a four-years old patient of unknown gender who complaint of leg hurt a couple days after the injection with IPOL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included VIRASAL; MMR; and DAPTACEL. On 16-Oct-2018 (also reported as 18-Oct-2018), the patient received a single 0.5 ml dose of suspect IPV (VERO) lot N1F931M (expiry date: 05-Jul-2019) via intramuscular route in the left thigh. On an unknown date, the patient complaint that the leg hurt, couple of days following the administration of IPV (VERO). It was also a case of actual medication error due to incorrect product storage because there was a temperature excursion of 56.3 Degrees for 2 hours and 52 minutes on Sept 29th before the vaccine was administered. No lab tests reported. Final diagnosis was limb injury. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for limb injury. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUR4
Symptoms: Rash
Clinical narrative: Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves patient (age and gender not reported) who experienced systemic rash reaction, while he/she received vaccine FLUBLOK QIV. The patient's past medical history included food allergy (egg allergy). The patient's past medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in 2014, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot 441253F, expiry date: 22 Feb 2015. On an unspecified date, the patient developed a non-serious systemic rash reaction (rash), unknown latency following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. (Other relevant tests included no lab test.) Final diagnosis was systemic rash reaction. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for systemic rash reaction. List of documents held by sender: none.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 26-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 64 years old female patient who received an expired dose of 0.5 mL FLUZONE HIGH DOSE lot UJ042AA expiry date: 19-May-2018 via unknown route in the right deltoid on 23-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is an actual medication error case due to expired vaccine used, inappropriate age at vaccine administration and overdose. It was reported that the patient received FLUZONE HD a few days before her 65 birthday. It was not reported whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 37.0
Sex: M
Vaccine: HEPAB, JEV1, RAB, TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: Initial information received on 26-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 37 years old male patient who received first dose of IMOVAX RABIES (batch number, expiry date, route and site of administration was not reported) on 15 June 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication were IXIARO, TWINRIX, TYPHIM VI. It was a case of actual medication error due to incomplete course of vaccination as patient received the first dose in series for IMOVAX pre-exposure vaccination but then left for a trip and did not received second or third doses in series in June 2018. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: RAB
Symptoms: Expired product administered
Clinical narrative: Initial information received on 27-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves patient who received a first dose of an expired vaccine IMOVAX RABIES (lot number not reported M15651M, expiration date 23-Oct-2018) via unknown route in unknown administration site on 24-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used. It was not reported if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: Initial information received on 26-Oct-2018 regarding an unsolicited valid non-serious case received from a healthcare provider. This case is linked to case 2018SA299778 same reporter. This case involves 81 years old patient who received vaccine FLUZONE HIGH DOSE (batch number, expiry date, dose, route and site of administration were not reported) on 26-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to Expired vaccine used. It was reported that give a high dose flu vaccine on September 26, 2018 and it was discovered during charting that the shots were from 2017-2018 flu season. It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: Initial information received on 26-Oct-2018 regarding an unsolicited valid non-serious case received from a healthcare provider. This case is linked to case 2018SA299777 same reporter. This case involves 87 years old patient who received vaccine FLUZONE HIGH DOSE (batch number, expiry date, dose, route and site of administration were not reported) on 26-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to Expired vaccine used. It was reported that give a high dose flu vaccine on September 26, 2018 and it was discovered during charting that the shots were from 2017-2018 flu season. It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.