chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding patient's concomitant medications, concurrent conditions or medical history. On or about 2014, the patient was vaccinated with ZOSTAVAX (strength, dose, route, anatomical location, lot number and expiration date were not reported), to obtain permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) as recommended by the healthcare professional. On an unknown date, the patient experienced shingles (Herpes zoster) and on or about 2016, was treated at the physician's office. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX (Vaccination failure) and suffered serious physical, emotional, and economic damages (Emotional distress), as a result of patient's injuries on unknown dates. The patient had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering (Emotional distress) (Pain); 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 included 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 (Condition aggravated); lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The relatedness between ZOSTAVAX and the aforementioned events was assessed as related by the reporter. The reporter determined all the events to be serious due to disability, life-threatening and medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-MAR-2011, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 01-APR-2011, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a nurse prescriber, referring to a 18 year old female patient. The patient's historical drugs, medical history and concomitant therapies were not reported. The patient's concurrent conditions included low or no titers. On an unknown date, the patient, who was attending college, was vaccinated with PROQUAD for prophylaxis  (strength, dose, route, frequency, lot#, expiration date were not reported).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding patient's concomitant medications, concurrent conditions or medical history. On or about 17-OCT-2014, the patient was vaccinated with ZOSTAVAX (strength, dose, route, anatomical location, lot number and expiration date were not reported), to obtain permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) as recommended by the healthcare professional. On an unspecified date, the patient experienced shingles (Herpes zoster) and on or about 16-SEP-2015, was treated by a physician at a convenient care. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX (Vaccination failure) and suffered serious physical, emotional, and economic damages (Emotional distress), as a result of patient's injuries on unknown dates. The patient had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering (Emotional distress) (Pain); 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 included 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 (Condition aggravated); lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The relatedness between ZOSTAVAX and the aforementioned events was assessed as related by the reporter. The reporter determined all the events to be serious due to disability, life-threatening and medically significant.
Age: 53.0
Sex: F
Vaccine: FLUR4
Symptoms: Diarrhoea, Feeling cold, Hyperhidrosis, Impaired work ability, Throat irritation
Clinical narrative: EE here today regarding symptoms that occurred after getting the flu vaccine. She received the FLUBLOK vaccine in the left deltoid (Lot number QFAA1820 Manufacturer Sanofi Pasteur) at 7:44am on 11/30/18. That same day she began with forceful vomiting at 1:00pm. 45 minutes later she was vomiting again. The episodes of vomiting then were only 15 minutes apart until about 5pm she had to leave work. She continued intermittent vomiting on 12/1, 12/2, 12/3, and 12/4. On 12/5 the vomiting stopped but she began having severe diarrhea. On that day she had 6-8 episodes. Since 12/4 she has also been experiencing feeling extremely cold but then breaking out in a sweat at intermittent times. She tried taking PEPTO BISMOL since the vomiting began but could not keep anything down. She is still trying to take it as the vomiting has subsided. She states her throat is very raw from the vomiting causing her to cough a lot and she is having to use her inhaler more often. Per EE she had a written note from her doctor that she should not have the flu vaccine as 15 years ago she stopped taking them due to these symptoms. Per EE she was told by someone that she could not do a medical exemption unless it had to to do with Guillian Barre. She did not complete a medical exemption form and turn it in. She had no illness or virus before receiving the flu vaccination. She stated she missed 2 and a half days of work due to her symptoms.
Age: 53.0
Sex: F
Vaccine: FLUR4
Symptoms: Vomiting
Clinical narrative: EE here today regarding symptoms that occurred after getting the flu vaccine. She received the FLUBLOK vaccine in the left deltoid (Lot number QFAA1820 Manufacturer Sanofi Pasteur) at 7:44am on 11/30/18. That same day she began with forceful vomiting at 1:00pm. 45 minutes later she was vomiting again. The episodes of vomiting then were only 15 minutes apart until about 5pm she had to leave work. She continued intermittent vomiting on 12/1, 12/2, 12/3, and 12/4. On 12/5 the vomiting stopped but she began having severe diarrhea. On that day she had 6-8 episodes. Since 12/4 she has also been experiencing feeling extremely cold but then breaking out in a sweat at intermittent times. She tried taking PEPTO BISMOL since the vomiting began but could not keep anything down. She is still trying to take it as the vomiting has subsided. She states her throat is very raw from the vomiting causing her to cough a lot and she is having to use her inhaler more often. Per EE she had a written note from her doctor that she should not have the flu vaccine as 15 years ago she stopped taking them due to these symptoms. Per EE she was told by someone that she could not do a medical exemption unless it had to to do with Guillian Barre. She did not complete a medical exemption form and turn it in. She had no illness or virus before receiving the flu vaccination. She stated she missed 2 and a half days of work due to her symptoms.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: High fever (102-103) for approximately a day and a half, severe headache, neck ache, injection site painful, red, warm to touch and swollen.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pyrexia
Clinical narrative: High fever (102-103) for approximately a day and a half, severe headache, neck ache, injection site painful, red, warm to touch and swollen.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Pruritus, Skin irritation, Skin warm
Clinical narrative: Patient had large red area below the vaccination injection site that started out about the size of a quarter then grew over the next couple days to approximately 6 inches in diameter at the time she consulted the physician. Patient stated that the area had been warm to the touch and that she experienced itchiness between her fingers and around her neck. Patient self-medicated with BENADRYL and Hydrocortisone cream but it had no effect. Patient was prescribed Clindamycin 300mg three times a day for ten days for cellulitis. Pt was started on clindamycin 300mg three times a day and states the cellulitis is much better. She states that it is half the original size and that it is no longer hot to the touch and the redness had turned to a pink color.
Age: 11.0
Sex: F
Vaccine: FLU4, MNQ, TDAP
Symptoms: Abdominal pain, Blood bilirubin, Blood pressure orthostatic, C-reactive protein, Cold sweat
Clinical narrative: Patient received vaccines 11/13/18. Pt was seen at the ER on 11/14/18 for blurred vision, dizziness, nausea, diarrhea, abdominal cramping, cold sweats. Patient was treated with IV fluids and her headache and abdominal pain improved. Labs improved. Patient was discharged from the ER later that day. Patient was seen at primary care office 11/16/18, reported feeling much better.
Age: 11.0
Sex: F
Vaccine: FLU4, MNQ, TDAP
Symptoms: Diarrhoea, Dizziness, Electrocardiogram, Full blood count, Headache
Clinical narrative: Patient received vaccines 11/13/18. Pt was seen at the ER on 11/14/18 for blurred vision, dizziness, nausea, diarrhea, abdominal cramping, cold sweats. Patient was treated with IV fluids and her headache and abdominal pain improved. Labs improved. Patient was discharged from the ER later that day. Patient was seen at primary care office 11/16/18, reported feeling much better.
Age: 11.0
Sex: F
Vaccine: FLU4, MNQ, TDAP
Symptoms: Human chorionic gonadotropin, Metabolic function test, Nausea, Urine analysis, Vision blurred
Clinical narrative: Patient received vaccines 11/13/18. Pt was seen at the ER on 11/14/18 for blurred vision, dizziness, nausea, diarrhea, abdominal cramping, cold sweats. Patient was treated with IV fluids and her headache and abdominal pain improved. Labs improved. Patient was discharged from the ER later that day. Patient was seen at primary care office 11/16/18, reported feeling much better.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Migraine
Clinical narrative: Migraine.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Headache, Nausea
Clinical narrative: Mild headache for approximately 6 hours, followed by nausea for 4-5 hours, followed by stomach pain for a period of less than 1 hour. All symptoms gone 12 hours after beginning.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Myalgia, Pain
Clinical narrative: At about 11:30 AM, I had extreme stomach cramps and then diarrhea. At the time, I hadn't eaten anything since 8 AM. At about 3 PM, I felt mild muscle pain. At about 5:30 PM, I experienced body aches (sort of flu-like symptoms) and fairly extreme shivering. The same thing happened around 2:30 AM (middle of the night). At both 5:30 PM and 2:30 AM, I took 1000 mg acetaminophen and 600 mg ibuprofen to combat the symptoms - they worked after about 15 minutes. I did not seek the help of a medical professional. It's now 8:30 AM the next morning and I'm feeling OK - and am hopeful the symptoms won't come back.
Age: 69.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Body aches, chills, tired.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Per patient both sides above hip area have pain when laying down.
Age: 1.08
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Ataxia, Brain oedema, C-reactive protein, Computerised tomogram head, Conjunctivitis
Clinical narrative: Patient woke up the 11/28/18 with ataxia, inability to engage in eye contact, and increased fussiness. Parents called our office and were advised to go to the ER. They went to ER where they suspected an ear infection and labyrinthitis. They treated her with amoxicillin and sent her home. They followed up with me 11/29/18, where she was observed in the waiting room to have upper extremity tremors, and poor eye contact. She would not walk during clinic visit and was sent back to ER. They did a head CT and MRI. The attending physician suspects she had brain swelling when her symptoms started, but the swelling may have resolved spontaneously by the time the imaging studies were done.
Age: 1.08
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Decreased eye contact, Ear infection, Full blood count, Gait inability, Irritability
Clinical narrative: Patient woke up the 11/28/18 with ataxia, inability to engage in eye contact, and increased fussiness. Parents called our office and were advised to go to the ER. They went to ER where they suspected an ear infection and labyrinthitis. They treated her with amoxicillin and sent her home. They followed up with me 11/29/18, where she was observed in the waiting room to have upper extremity tremors, and poor eye contact. She would not walk during clinic visit and was sent back to ER. They did a head CT and MRI. The attending physician suspects she had brain swelling when her symptoms started, but the swelling may have resolved spontaneously by the time the imaging studies were done.
Age: 1.08
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Labyrinthitis, Metabolic function test, Nuclear magnetic resonance imaging brain, Red blood cell sedimentation rate, Tremor
Clinical narrative: Patient woke up the 11/28/18 with ataxia, inability to engage in eye contact, and increased fussiness. Parents called our office and were advised to go to the ER. They went to ER where they suspected an ear infection and labyrinthitis. They treated her with amoxicillin and sent her home. They followed up with me 11/29/18, where she was observed in the waiting room to have upper extremity tremors, and poor eye contact. She would not walk during clinic visit and was sent back to ER. They did a head CT and MRI. The attending physician suspects she had brain swelling when her symptoms started, but the swelling may have resolved spontaneously by the time the imaging studies were done.
Age: 1.08
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Upper respiratory tract infection, Urine analysis
Clinical narrative: Patient woke up the 11/28/18 with ataxia, inability to engage in eye contact, and increased fussiness. Parents called our office and were advised to go to the ER. They went to ER where they suspected an ear infection and labyrinthitis. They treated her with amoxicillin and sent her home. They followed up with me 11/29/18, where she was observed in the waiting room to have upper extremity tremors, and poor eye contact. She would not walk during clinic visit and was sent back to ER. They did a head CT and MRI. The attending physician suspects she had brain swelling when her symptoms started, but the swelling may have resolved spontaneously by the time the imaging studies were done.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia
Clinical narrative: Muscle soreness in bottom going down legs, almost like did 100 squats day before. Ok when walking, but difficult to sit down. Started day after shot, has not gotten better.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dizziness, Erythema, Flushing, Malaise
Clinical narrative: Discharge instructions per Dr. to have pt receive influenza vaccine today. RN spoke with mother, reviewed and completed and Influenza Vaccination Nursing Note prior to administration of Influenza Vaccine. 1555- influenza vaccine administered to left arm. 1605- mother noted prior to leaving clinic that pt's neck and facial cheeks appeared red and flushed. HR-100 RR-20 B/P 92/62. Pt given cool water to drink and crackers to ingest. 1612- redness to neck and facial cheeks subsiding, pt quiet, when asked states she feels dizzy- pt assisted to laying down on cot. 1620-Dr. informed. VS laying down HR-82 RR-20 B/P-110/64, then VS sitting up HR-88 RR-20 B/P-118/78. Lung sounds clear bilaterally per auscultation. Dr. in to assess pt. Pt states she continues to feel light headed. When asked, pt stated she would prefer to sit in chair (with armrests). Cool cloths to head and back of neck. Pt had few intermittent barky coughs. 1630- pt neck and facial cheeks red and flushed, states she continue to feel sick. 1650-frequency of cough increases, Dr. informed and in to assess pt. 1700- HR- 84 RR-20  B/P-124/84 O2 SAT=99%, Dr. in to assess pt. 911 Emergency Services Called. 1703- BENADRYL 50 mg oral medication given by RN - per Dr. 1705- Albuterol 2.5mg/3ml  nebulizer medication initiated by RN-per Dr. 1708-Epinephrine 0.3mg IM medication given to left thigh by RN per Dr. Pt coughing and had emesis of mucous X1. 1712- 911 Emergency Services arrived to take pt to Hospital Emergency Dept.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Secretion discharge, Vomiting
Clinical narrative: Discharge instructions per Dr. to have pt receive influenza vaccine today. RN spoke with mother, reviewed and completed and Influenza Vaccination Nursing Note prior to administration of Influenza Vaccine. 1555- influenza vaccine administered to left arm. 1605- mother noted prior to leaving clinic that pt's neck and facial cheeks appeared red and flushed. HR-100 RR-20 B/P 92/62. Pt given cool water to drink and crackers to ingest. 1612- redness to neck and facial cheeks subsiding, pt quiet, when asked states she feels dizzy- pt assisted to laying down on cot. 1620-Dr. informed. VS laying down HR-82 RR-20 B/P-110/64, then VS sitting up HR-88 RR-20 B/P-118/78. Lung sounds clear bilaterally per auscultation. Dr. in to assess pt. Pt states she continues to feel light headed. When asked, pt stated she would prefer to sit in chair (with armrests). Cool cloths to head and back of neck. Pt had few intermittent barky coughs. 1630- pt neck and facial cheeks red and flushed, states she continue to feel sick. 1650-frequency of cough increases, Dr. informed and in to assess pt. 1700- HR- 84 RR-20  B/P-124/84 O2 SAT=99%, Dr. in to assess pt. 911 Emergency Services Called. 1703- BENADRYL 50 mg oral medication given by RN - per Dr. 1705- Albuterol 2.5mg/3ml  nebulizer medication initiated by RN-per Dr. 1708-Epinephrine 0.3mg IM medication given to left thigh by RN per Dr. Pt coughing and had emesis of mucous X1. 1712- 911 Emergency Services arrived to take pt to Hospital Emergency Dept.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Pain in extremity, Peripheral swelling, Pruritus generalised, Urticaria
Clinical narrative: Pain in left arm, left arm swelling, itching all over body, hives, fatigue.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood test, Muscle spasms, Pyrexia, Urticaria
Clinical narrative: Hives on trunk, extremities, and face. Fever up to 103. Abdominal muscle spasms.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: 12/3/18 patient received flu shot in Left Arm at MD office per patient. 12/5/18 patient received SHINGRIX in left deltoid at Pharmacy. 12/7/18 Patient woke up with rash all over trunk, chest, back, stomach, and arms. Patient called MD and they told her to take cetirizine and to call pharmacy to log reaction. Patient called Pharmacy on 12/7/18, said she was fine now but wanted to report the reaction.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of pain in arm in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 12th November 2018, the patient received the 2nd dose of SHINGRIX. In November 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm and fever. On an unknown date, the outcome of the pain in arm and fever were unknown. It was unknown if the reporter considered the pain in arm and fever to be related to SHINGRIX. Additional details were received as follows; The age at vaccination was not reported but it could be 71 or 72 years. Monday at 5pm, the patient received a dose of SHINGRIX. The patient presented with arm hurt, he could feel air the amount of water.  The patient went bed about nine (1 or 2 was normal). At the time of reporting, the patient had eat two, drank more and sat and read. I started taking my temp at three. should not be given if there was a strong reaction. This case was linked with case US2018GSK208789, reported by the same reporter for the same patient.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 66-year-old male patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In September 2018, 1 day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follow: The patient was a physician. The patient received SHINGRIX on the left deltoid, 6 to 8 weeks before the time of reporting. In 2018, after vaccination the patient experienced arm pain. For tolerance to next dose, refer case US2018208377.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza virus test negative, Pain in extremity, Streptococcus test negative
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (and redness experienced after receiving 1st dose on 15th September 2018, refer case US2018208389).  On 14th November 2018, the patient received the 2nd dose of SHINGRIX 50 mcg/mg. On 15th November 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm, headache and chills. On an unknown date, the outcome of the pain in arm, headache and chills were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, headache and chills to be related to SHINGRIX. Additional details were received as follows: At the day of reporting, in the morning the patient presented with soreness in am along with headache and chills. With the headache and chills she was concerned if she was getting the flu so she saw her health care professional (HCP). Flu and strep tests were both negative. Emergency visit was required.  The reporter did not consent to follow up.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site rash
Clinical narrative: Night thigh rash.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Pyrexia
Clinical narrative: Arm was very sore and red. Fever 102 degrees.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Back pain, Bladder dysfunction, CSF protein increased, Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling in the fingers and the hands went numb. Patient eventually got back pain. Bladder slowed down.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Back pain, Bladder dysfunction, Bladder pain, Computerised tomogram kidney normal, Guillain-Barre syndrome
Clinical narrative: Tingling in the fingers and the hands went numb. Patient eventually got back pain. Bladder slowed down.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture abnormal, Nuclear magnetic resonance imaging brain, Paraesthesia
Clinical narrative: Tingling in the fingers and the hands went numb. Patient eventually got back pain. Bladder slowed down.
Age: 38.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Injection site pruritus, Injection site warmth, Swelling
Clinical narrative: Allergic response- large semicircular reaction with redness and swelling with a diameter of 5 inches- developed within hours of original shot, worsened over time and stopped growing in size on the 7th. Site puts off heat and itches. Responds to BENADRYL cream and oral BENADRYL.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: Pt developed urticaria 23 hrs after receiving vaccine.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Asthenia, Chest pain, Discomfort, Dyspnoea
Clinical narrative: Got the shot on Thursday evening. On Friday, my left arm up to my neck hurt. I felt like I was getting sick with a cold. On Saturday, I felt worse and worse on Sunday. On Monday, my hands and joints hurt me so bad. I felt weak, heavy and a ton of pain all over. On Tuesday, I missed work due to feeling so bad. I ached in different areas mostly in my chest. I went to the emergency room that evening. I went home with no outcome. I took over the counter ibuprofen which helped with the pain. On Wednesday, I experience shortness of breath and pain in my chest around 3:00 pm lasting about an hour. My symptoms seem to be slowly improving.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Loss of personal independence in daily activities, Malaise, Pain, Pain in extremity
Clinical narrative: Got the shot on Thursday evening. On Friday, my left arm up to my neck hurt. I felt like I was getting sick with a cold. On Saturday, I felt worse and worse on Sunday. On Monday, my hands and joints hurt me so bad. I felt weak, heavy and a ton of pain all over. On Tuesday, I missed work due to feeling so bad. I ached in different areas mostly in my chest. I went to the emergency room that evening. I went home with no outcome. I took over the counter ibuprofen which helped with the pain. On Wednesday, I experience shortness of breath and pain in my chest around 3:00 pm lasting about an hour. My symptoms seem to be slowly improving.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Purpura
Clinical narrative: Patient's wife says he had a purpura reaction to vaccine, starting the day after vaccination, in which he was hospitalized. She states he had a similar reaction when younger after flu vaccination as well.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Allergy test, Asthenia, Cough, Injection site pain, Injection site swelling
Clinical narrative: Pt started complaining of cough and weakness about 30 minutes after the administration of flu shot. Pt had hives on his abdomen and buttocks, and also swelling of left thigh where flu shot was administered. Gave pt 5 ml of BENADRYL, administered 0.15mg of epinephrine on his right thigh, and administered albuterol via nebulizer. Then cough and hives subsided and went home around 2:15pm. Pt went to ER since pt started having fever, cough, rash, pain and swelling of his left thigh again around 7pm at night.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Urticaria
Clinical narrative: Pt started complaining of cough and weakness about 30 minutes after the administration of flu shot. Pt had hives on his abdomen and buttocks, and also swelling of left thigh where flu shot was administered. Gave pt 5 ml of BENADRYL, administered 0.15mg of epinephrine on his right thigh, and administered albuterol via nebulizer. Then cough and hives subsided and went home around 2:15pm. Pt went to ER since pt started having fever, cough, rash, pain and swelling of his left thigh again around 7pm at night.
Age: 71.0
Sex: F
Vaccine: FLUR4
Symptoms: Arthralgia, Arthritis, Blood test abnormal, Joint swelling, Peripheral swelling
Clinical narrative: Within 24 hours, sudden onset of severe joint pain/arthritis, swelling in joints, hands and feet, arms, overall body, continues daily without relief to present.
Age: 71.0
Sex: F
Vaccine: FLUR4
Symptoms: Rheumatoid arthritis, Swelling
Clinical narrative: Within 24 hours, sudden onset of severe joint pain/arthritis, swelling in joints, hands and feet, arms, overall body, continues daily without relief to present.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Adenovirus test, Bacterial test negative, Bordetella test negative, Brain natriuretic peptide increased, Cardiac tamponade
Clinical narrative: Pressure like chest pain with rad to left shoulder onset 08 Nov while cleaning. No relief from ALKA SELTZER. Presented to ED on 12 Nov with inc pain worse with laying flat. Pos enzymes and BNP, pos EKG. Neg heart cath, + pericardial tamponade. DX myocarditis with pericardial effusion. Neg card hx. Was not ill prior to imz. Symptoms: CHEST PAIN, UNSPECIFIED, DYSPNEA, UNSPECIFIED.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Catheterisation cardiac normal, Chest X-ray abnormal, Chest pain, Chlamydia test negative, Clostridium test
Clinical narrative: Pressure like chest pain with rad to left shoulder onset 08 Nov while cleaning. No relief from ALKA SELTZER. Presented to ED on 12 Nov with inc pain worse with laying flat. Pos enzymes and BNP, pos EKG. Neg heart cath, + pericardial tamponade. DX myocarditis with pericardial effusion. Neg card hx. Was not ill prior to imz. Symptoms: CHEST PAIN, UNSPECIFIED, DYSPNEA, UNSPECIFIED.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Ejection fraction decreased, Electrocardiogram abnormal, Enterovirus test negative, Escherichia test negative
Clinical narrative: Pressure like chest pain with rad to left shoulder onset 08 Nov while cleaning. No relief from ALKA SELTZER. Presented to ED on 12 Nov with inc pain worse with laying flat. Pos enzymes and BNP, pos EKG. Neg heart cath, + pericardial tamponade. DX myocarditis with pericardial effusion. Neg card hx. Was not ill prior to imz. Symptoms: CHEST PAIN, UNSPECIFIED, DYSPNEA, UNSPECIFIED.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Giardia test negative, Helicobacter test negative, Human metapneumovirus test, Human rhinovirus test, Influenza A virus test negative
Clinical narrative: Pressure like chest pain with rad to left shoulder onset 08 Nov while cleaning. No relief from ALKA SELTZER. Presented to ED on 12 Nov with inc pain worse with laying flat. Pos enzymes and BNP, pos EKG. Neg heart cath, + pericardial tamponade. DX myocarditis with pericardial effusion. Neg card hx. Was not ill prior to imz. Symptoms: CHEST PAIN, UNSPECIFIED, DYSPNEA, UNSPECIFIED.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Influenza B virus test, Influenza virus test negative, Malaria antibody test negative, Musculoskeletal pain, Mycoplasma test negative
Clinical narrative: Pressure like chest pain with rad to left shoulder onset 08 Nov while cleaning. No relief from ALKA SELTZER. Presented to ED on 12 Nov with inc pain worse with laying flat. Pos enzymes and BNP, pos EKG. Neg heart cath, + pericardial tamponade. DX myocarditis with pericardial effusion. Neg card hx. Was not ill prior to imz. Symptoms: CHEST PAIN, UNSPECIFIED, DYSPNEA, UNSPECIFIED.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Myocardial necrosis marker increased, Myocardial oedema, Myocarditis, Norovirus test, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Pressure like chest pain with rad to left shoulder onset 08 Nov while cleaning. No relief from ALKA SELTZER. Presented to ED on 12 Nov with inc pain worse with laying flat. Pos enzymes and BNP, pos EKG. Neg heart cath, + pericardial tamponade. DX myocarditis with pericardial effusion. Neg card hx. Was not ill prior to imz. Symptoms: CHEST PAIN, UNSPECIFIED, DYSPNEA, UNSPECIFIED.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging thoracic abnormal, Pain, Parasite stool test negative, Pericardial effusion, Pleural effusion
Clinical narrative: Pressure like chest pain with rad to left shoulder onset 08 Nov while cleaning. No relief from ALKA SELTZER. Presented to ED on 12 Nov with inc pain worse with laying flat. Pos enzymes and BNP, pos EKG. Neg heart cath, + pericardial tamponade. DX myocarditis with pericardial effusion. Neg card hx. Was not ill prior to imz. Symptoms: CHEST PAIN, UNSPECIFIED, DYSPNEA, UNSPECIFIED.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Polymerase chain reaction, Pulmonary oedema, Respiratory syncytial virus test negative, Respiratory viral panel, Rotavirus test negative
Clinical narrative: Pressure like chest pain with rad to left shoulder onset 08 Nov while cleaning. No relief from ALKA SELTZER. Presented to ED on 12 Nov with inc pain worse with laying flat. Pos enzymes and BNP, pos EKG. Neg heart cath, + pericardial tamponade. DX myocarditis with pericardial effusion. Neg card hx. Was not ill prior to imz. Symptoms: CHEST PAIN, UNSPECIFIED, DYSPNEA, UNSPECIFIED.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Salmonella test negative, Stool analysis normal, Troponin increased, Ventricular hypokinesia, Viral test negative
Clinical narrative: Pressure like chest pain with rad to left shoulder onset 08 Nov while cleaning. No relief from ALKA SELTZER. Presented to ED on 12 Nov with inc pain worse with laying flat. Pos enzymes and BNP, pos EKG. Neg heart cath, + pericardial tamponade. DX myocarditis with pericardial effusion. Neg card hx. Was not ill prior to imz. Symptoms: CHEST PAIN, UNSPECIFIED, DYSPNEA, UNSPECIFIED.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Yersinia test negative
Clinical narrative: Pressure like chest pain with rad to left shoulder onset 08 Nov while cleaning. No relief from ALKA SELTZER. Presented to ED on 12 Nov with inc pain worse with laying flat. Pos enzymes and BNP, pos EKG. Neg heart cath, + pericardial tamponade. DX myocarditis with pericardial effusion. Neg card hx. Was not ill prior to imz. Symptoms: CHEST PAIN, UNSPECIFIED, DYSPNEA, UNSPECIFIED.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Skin test
Clinical narrative: Patient developed a rash approximately 2 weeks after receiving 1st dose of SHINGRIX. He went to Dr., a dermatologist, who took a scraping of the rash and diagnosed him with shingles.
Age: 67.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Asthenia, Injection site erythema, Injection site swelling, Malaise, Skin warm
Clinical narrative: Redness and swelling below injection site, and 1/4 around arm on inside of upper arm. Skin hot, feeling sick and weak. Anti-inflammatories used. No improvement for several days until I tried BENADRYL. Felt like I had a very bad infection. Pharmacist and doctor consulted.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site bruising, Injection site erythema, Lip swelling, Urticaria
Clinical narrative: Lip swelling - better with BENADRYL bruise/red at injection site hives on arm x 2.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash 13 days after vaccine given.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Bone pain, Injection site reaction, Myalgia
Clinical narrative: She still has muscle pain in left arm. No visible rash or bruising noted. Also reports bone pain in upper left arm.
Age: 60.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain
Clinical narrative: Left arm started to be painful x 2 days, mostly deltoid area into left shoulder joint. Heat is helpful, worse in the AM. Left deltoid; no pain on palpation, no rash, no swelling.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Electrocardiogram normal, Full blood count normal, Hyperventilation, Metabolic function test normal, Myalgia
Clinical narrative: Tachycardia, hyperventilation, myalgias. Received ATIVAN and TORADOL in ER.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Tachycardia
Clinical narrative: Tachycardia, hyperventilation, myalgias. Received ATIVAN and TORADOL in ER.
Age: 41.0
Sex: F
Vaccine: FLUC4, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling in both deltoids.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2017, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Bursitis, Musculoskeletal pain, Neck pain, Sleep disorder
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of shoulder pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, several weeks after receiving SHINGRIX, the patient experienced shoulder pain, neck pain and bursitis. On an unknown date, the outcome of the shoulder pain, neck pain and bursitis were unknown. It was unknown if the reporter considered the shoulder pain, neck pain and bursitis to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced severe shoulder pain up into the neck weeks after vaccination. The patient had bursitis feeling, enough to where patient was unable to sleep on that side.
Sex: U
Vaccine: VARZOS
Symptoms: Ear infection
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of ear infection in a adult patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced ear infection. The patient was treated with antibiotics nos and steroids nos (Steroids). On an unknown date, the outcome of the ear infection was unknown.  The reporter considered the ear infection to be unrelated to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX 3 months before the time of reporting. The patient was due for 2nd dose of SHINGRIX, but the patient was being treated with steroids and antibiotics to fight an ear infection. The patient wanted to know, would these medicines interfere with the SHINGRIX booster or should the patient wait until done with the antibiotics and steroids. The patient would prefer not to give personal information out. The call center representative arranged the call back to the patient with product specialists.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via other manufacturer and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (had every 4 times a year). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Concomitant medication, medical history and laboratory tests were not reported. After receiving SHINGRIX, the patient experienced Shingles and it was making it worst. The 2nd dose of SHINGRIX was still pending. Other needed information was not reported since when pharmacist heard that she was calling company, she said she got a wrong number. This was the only information received from the pharmacist regarding the adverse event.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of chills in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced chills, fever and malaise. On an unknown date, the outcome of the chills, fever and malaise were recovered/resolved. It was unknown if the reporter considered the chills, fever and malaise to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced general adverse reactions like, chills, fever, malaise for approximately 7 days. The pharmacist recommended the patient not to receive the 2nd dose. The reporter agreed to be followed up.
Sex: M
Vaccine: FLU4
Symptoms: Injection site cellulitis
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site cellulitis in a child male patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number AM5N3, expiry date unknown) for prophylaxis. On 14th November 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. On an unknown date, less than a month after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced injection site cellulitis. On an unknown date, the outcome of the injection site cellulitis was unknown. It was unknown if the reporter considered the injection site cellulitis to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: This case was reported by the patient's mother. The age at the vaccination was not reported. The reporter reported that the patient developed cellulitis where the injection was given. The reporter had contacted the school where it was given, the company that gave it and the company that made it. The reporter was so upset and reported that this was a lifelong battle for them that he did not have before this vaccine. The reporter would be getting an attorney to move forward to help cover any cost in future for medical bills, hospital stays etc. if needed. This was going to cause more loss of time at work for her and possible loss of school days for the patient if it flares up again. This was so heartbreaking to know that her child was healthy before this and now had something in his body that would last a lifetime. The reporter wanted GlaxoSmithKline should look into this shot because whether or not it happens to anymore children, it should have never happened to anyone.
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of rash pruritic (1st dose received in June 2018, refer case US2018214095). In September 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced itchy rash. The patient was treated with hydrocortisone. On an unknown date, the outcome of the itchy rash was not recovered/not resolved. It was unknown if the reporter considered the itchy rash to be related to SHINGRIX. Additional details were reported as follows: The patient experienced an itchy rash after SHINGRIX. The 2nd dose of SHINGRIX was given at the end of September 2018 and the rash again began about a week later but was on the right arm and spread to the legs.  During the daytime, the rash was tolerable but it worsens after showering in the evening.   Hydrocortisone cream was being used with success but symptoms have not fully abated.   The reporter consented to follow up. The member of public adverse event collected by Medical Affairs Contact Center (MACC).
Sex: M
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Flu vaccine for prophylaxis. On an unknown date, the patient received Flu vaccine. On an unknown date, less than a year after receiving Flu vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to Flu vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that his arm was sore for only 1 to 1.5 days after receiving flu vaccines in past. The reporter did not consent to follow-up. This case has been linked to the case US2018216091 (SHINGRIX vaccine), reported by same reporter for same patient.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Fatigue, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 62-year-old female patient who received SHINGRIX (batch number EY93J, expiry date 13th April 2021) for prophylaxis. On 4th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In November 2018, 1 day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site warmth, injection site pain and tiredness. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site warmth were not recovered/not resolved and the outcome of the injection site pain and tiredness were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site warmth, injection site pain and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. About a day or two after vaccination, the patient experienced soreness and swelling about 2 inches below the injection site down to her elbow and her wrist (extensive swelling of vaccinated limb). The patient felt tired and the area below the injection site was hot. The patient had recovered from the tiredness and soreness but the swelling and hot injection site was still persistent. No further details were provided by the reporter.