chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 31-OCT-2018 regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were 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. In 2016, a pharmacist administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. In 2016, the patient was treated by a physician 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.  The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue 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 include 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. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 68-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 24-OCT-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # R006466, expiration date 24-OCT-2019 (dose and route of administration were not reported) for prophylaxis (also reported as "over 65 years old"). The patient came to the pharmacy on 26-OCT-2018 and reported that on 25-OCT-2018, the patient experienced erythema, pain and swelling several inches below the injection site. The patient notified her healthcare professional (HCP) by phone on an unspecified date in October 2018 and no treatment was ordered. The outcome of the events was not reported. The relatedness between the events and PNEUMOVAX 23 was not reported.
Sex: U
Vaccine: FLUN4
Symptoms: Influenza
Clinical narrative: A spontaneous report has been received from a consumer. The report concerns a patient of unknown gender (age not provided). The patient's past and current medical history included flu (2017).  No concomitant products were reported. The patient received FLUMIST QUADRIVALENT (intranasal) unknown, via nasal route, for nr on an unknown date. On an unknown date, the patient experienced got the flu. It is unknown if any action was taken with FLUMIST QUADRIVALENT (intranasal). The outcome of the event was unknown. The event was considered non-serious.
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Asthenia, Bacterial infection, Bacterial test positive, Bronchitis, Chills
Clinical narrative: This is a spontaneous report from a contactable Nurse via Pfizer Sales Representative. An 87-year-old male patient received PREVNAR 13 at single dose, FLUZONE at unknown dose, both via an unspecified route of administration on 16Oct2018 at different arms for immunization. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing, ongoing current smoker. The patient's concomitant medications were not reported. The patient came for physical, healthy. The patient administered high dose FLUZONE and pneumococcal 13-val conj vac (dipht crm197 protein) on different arms 16Oct2018. On 22Oct2018, the patient was taken to ER (emergency room), could not get out of bed, had a cough and discharged same day with antibiotics, diagnosed as bronchitis at ER. Returned to clinic for follow up on 25Oct2018, the patient was still generalized weakness (Oct2018), still had cough (Oct2018), fever of 101 degrees with chills the night before on 24Oct2018; also low blood pressure at time of visit on 25Oct2018. Dr. diagnosed as septic after review lab culture from ER, which indicated gram positive cocci on 25Oct2018.The outcome of 'Bronchitis/Cough' and 'Generalized weakness' was not recovered, the outcome of other events was unknown. Sender's Comments: Bronchitis/Cough and Sepsis with lab culture indicative of gram positive cocci are associated with the incurrent bacterial infection secondary to the underlying chronic obstructive pulmonary disease unrelated to PREVENAR 13. Hypotension, fever with chill and asthenia are compatible with the symptoms of sepsis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Cough, Hypotension, Mobility decreased, Pyrexia, Sepsis
Clinical narrative: This is a spontaneous report from a contactable Nurse via Pfizer Sales Representative. An 87-year-old male patient received PREVNAR 13 at single dose, FLUZONE at unknown dose, both via an unspecified route of administration on 16Oct2018 at different arms for immunization. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing, ongoing current smoker. The patient's concomitant medications were not reported. The patient came for physical, healthy. The patient administered high dose FLUZONE and pneumococcal 13-val conj vac (dipht crm197 protein) on different arms 16Oct2018. On 22Oct2018, the patient was taken to ER (emergency room), could not get out of bed, had a cough and discharged same day with antibiotics, diagnosed as bronchitis at ER. Returned to clinic for follow up on 25Oct2018, the patient was still generalized weakness (Oct2018), still had cough (Oct2018), fever of 101 degrees with chills the night before on 24Oct2018; also low blood pressure at time of visit on 25Oct2018. Dr. diagnosed as septic after review lab culture from ER, which indicated gram positive cocci on 25Oct2018.The outcome of 'Bronchitis/Cough' and 'Generalized weakness' was not recovered, the outcome of other events was unknown. Sender's Comments: Bronchitis/Cough and Sepsis with lab culture indicative of gram positive cocci are associated with the incurrent bacterial infection secondary to the underlying chronic obstructive pulmonary disease unrelated to PREVENAR 13. Hypotension, fever with chill and asthenia are compatible with the symptoms of sepsis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Blindness, Crying, Dizziness, Headache, Visual impairment
Clinical narrative: Sat in chair for flu shot. Started crying and became faint with headache, dizziness, loss of vision. Assisted to lay down with legs elevated and ice pack to neck. Vitals were assessed. Fluids were encouraged. Was slow to arouse and complained of not being able to see. Vitals were WNL. Mother is an RN and was able to take child home after 40 minutes. Was given TYLENOL and fluids at home. Napped when returned home and woke feeling some better with continued complaints of a headache. Was able to return to school the next day without any problems.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: Shoulder pain after vaccination.
Age: 34.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Musculoskeletal pain
Clinical narrative: Shoulder pain after flu vaccine.
Age: 34.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Pain in extremity, Product administered at inappropriate site
Clinical narrative: Shoulder pain after flu vaccine.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis
Clinical narrative: Cellulitis requiring antibiotics.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Mobility decreased, Pain in extremity
Clinical narrative: 24 hrs. after injection developed left arm pain with radiation to elbow. Difficulty lifting arm with pain. No swelling redness or signs of infection. Seen in clinic on 10/31/2018 with persistent symptoms.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: Shoulder pain in arm after vaccination.
Age: 66.0
Sex: F
Vaccine: FLUR4
Symptoms: Areflexia, Bilevel positive airway pressure, Carbon dioxide increased, Dyspnoea, Functional gastrointestinal disorder
Clinical narrative: Symptoms started having trouble walking within a few days and vaccine was given 9/17/18, then few days without issues and then 9/24/18 muscle weakness worsened, 9/30/18 she lost ability to walk, paralysis waist down, ended up on bipap, now in skilled nursing home to recover strength, diagnosed with Guillain Barre.
Age: 66.0
Sex: F
Vaccine: FLUR4
Symptoms: Gait disturbance, Gait inability, Guillain-Barre syndrome, Hypoaesthesia, Loss of control of legs
Clinical narrative: Symptoms started having trouble walking within a few days and vaccine was given 9/17/18, then few days without issues and then 9/24/18 muscle weakness worsened, 9/30/18 she lost ability to walk, paralysis waist down, ended up on bipap, now in skilled nursing home to recover strength, diagnosed with Guillain Barre.
Age: 66.0
Sex: F
Vaccine: FLUR4
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging brain abnormal, Paralysis
Clinical narrative: Symptoms started having trouble walking within a few days and vaccine was given 9/17/18, then few days without issues and then 9/24/18 muscle weakness worsened, 9/30/18 she lost ability to walk, paralysis waist down, ended up on bipap, now in skilled nursing home to recover strength, diagnosed with Guillain Barre.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site pain, Pyrexia, Tremor
Clinical narrative: Fever, pain in shot area, shakes, bad feeling.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: Shoulder pain after flu vaccine administered.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Low fever and body aches for approximately 12 hours.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: I received the flu vaccine on Oct 18, 2018. The day after I received the flu vaccine, my left shoulder and upper left arm were sore. The soreness and dull pain has continued non-stop for 3 weeks now. Today is Nov 7, 2018. Last week on Oct 31, 2018, I contacted my Primary Care Physician to report my symptoms. They advised me to take ALEVE for 10 days which I am doing. Today I contacted the pharmacy where I received the flu vaccination to file a report with them. I am still experiencing dull pain in my upper left arm and shoulder.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Discomfort, Erythema, Pain, Skin warm, Swelling
Clinical narrative: Red, swollen, warm to touch, sore and tender. Mom watched area if it was getting bigger, it did not. Cool cloth applied, TYLENOL for discomfort. Lasted 2 days.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Tenderness
Clinical narrative: Red, swollen, warm to touch, sore and tender. Mom watched area if it was getting bigger, it did not. Cool cloth applied, TYLENOL for discomfort. Lasted 2 days.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Computerised tomogram, Hyperaesthesia, Rash, Scan with contrast
Clinical narrative: Sore lower back and hip on left side, Rash on lower left back near hip. Very tender sensitive skin at site of rash.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Sore lower back and hip on left side, Rash on lower left back near hip. Very tender sensitive skin at site of rash.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Joint range of motion decreased, X-ray limb
Clinical narrative: Patient reported left shoulder pain that began immediately following vaccine administration and continuing for weeks before she called/returned to clinic for repeat evaluation. Patient reported decreased range of motion, and consistent pain to left shoulder affecting daily activities. No signs of infection or inflammation were present at any time following vaccine administration. Patient re-evaluated in clinic on 10/5/18. Referred to Ortho for follow up. Ultimately followed up with Sports Medicine on 10/24/18.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Dyspnoea, Electrocardiogram, Injection site pain, Insomnia
Clinical narrative: I got flu shot 10/17/2018 around 11:30am at work during a wellness on site event. After shot, wound was bleeding, thought was okay. After received shot felt pain in left arm where shot was taken-normal. That night took Tylenol and felt pain the next day had to take Tylenol  the whole day. The night I couldn't sleep, woke up with pain in middle of night. Friday, I felt severe pain on and off on my left side shoulder/arm/chest area and couldn't breathe with pain and at this point Tylenol was helping only a little. Again at night couldn't sleep and had pain. Saturday had the worse pain. It was my left side chest to shoulder area, pain was constant, any bump in car hurt, couldn't really speak or breathe and Tylenol did not work. So went to a Urgent Care facility. Did an EKG to make sure it was not my heart. Give me Naproxen. Had alittle bit of pain then and got actual icy hot to rub on -helped too. By Sunday had soreness but hardly any pain. Went to work on Monday with some soreness but no pain.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Speech disorder, Wound haemorrhage
Clinical narrative: I got flu shot 10/17/2018 around 11:30am at work during a wellness on site event. After shot, wound was bleeding, thought was okay. After received shot felt pain in left arm where shot was taken-normal. That night took Tylenol and felt pain the next day had to take Tylenol  the whole day. The night I couldn't sleep, woke up with pain in middle of night. Friday, I felt severe pain on and off on my left side shoulder/arm/chest area and couldn't breathe with pain and at this point Tylenol was helping only a little. Again at night couldn't sleep and had pain. Saturday had the worse pain. It was my left side chest to shoulder area, pain was constant, any bump in car hurt, couldn't really speak or breathe and Tylenol did not work. So went to a Urgent Care facility. Did an EKG to make sure it was not my heart. Give me Naproxen. Had alittle bit of pain then and got actual icy hot to rub on -helped too. By Sunday had soreness but hardly any pain. Went to work on Monday with some soreness but no pain.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain
Clinical narrative: Neck pain - was hospitalized.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rhinorrhoea, Throat irritation
Clinical narrative: C/O itchy hands/feet/neck at 3 mins after vaccine given - VS remained stable throughout 45 mins of observation - Did have throat clearing and runny nose at 1610 -given BENADRYL at 1605 = symptoms resolved by 1640
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Fall, Heart rate decreased, Immediate post-injection reaction, Pallor
Clinical narrative: Patient was into office for well child check up. Hepatitis A and GARDASIL given. Venipuncture started immediately after vaccines given. While doing 1 vial of blood for venipuncture, patient complained of "lightheadedness" and "dizzy". Withdrew needle and patient immediately fell forward. Laid patient back on exam table. Awoke within 30 seconds. Pallor and low heart rate monitored patient in office for approximately 20 mins after the incident and patient symptoms improved. Repeat venipuncture done at end of visit with no adverse effects.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness
Clinical narrative: Flu like sx-was hospitalized.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Injection site pain, Insomnia, Musculoskeletal pain, Pain
Clinical narrative: Chronic pain in arms mostly at night while trying to sleep, very sore around the area where there is a knot from the shot. Impossible to sleep on my sides/shoulder constant pain. I as being a man, didn't go to doctor right away, try to take the pain thinking it will go away. I've been using Lidocaine patches 5% my doctor gave me a strip for Physical Therapy for evaluation and treatment Plus MRI Right/Left shoulder. The knot is on the (Lower) part of my Right shoulder. I've been using a Tens Unit as well Tramadol 50mg tablets. I don't know if you know what it's like to pray to get a full night of sleep. The pain is so severe I can't get a full night rest. I can't sleep on my back because I have a breathing problem due to my heart condition. I wake up between 2:30 an 3AM can't go back to sleep because my mind start to wondering, during the day I have (headache) I take sleeping pill to try to get a good night sleep it is hard on my body I need to sleep more but the pain in my shoulders is so devastating.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Chronic pain in arms mostly at night while trying to sleep, very sore around the area where there is a knot from the shot. Impossible to sleep on my sides/shoulder constant pain. I as being a man, didn't go to doctor right away, try to take the pain thinking it will go away. I've been using Lidocaine patches 5% my doctor gave me a strip for Physical Therapy for evaluation and treatment Plus MRI Right/Left shoulder. The knot is on the (Lower) part of my Right shoulder. I've been using a Tens Unit as well Tramadol 50mg tablets. I don't know if you know what it's like to pray to get a full night of sleep. The pain is so severe I can't get a full night rest. I can't sleep on my back because I have a breathing problem due to my heart condition. I wake up between 2:30 an 3AM can't go back to sleep because my mind start to wondering, during the day I have (headache) I take sleeping pill to try to get a good night sleep it is hard on my body I need to sleep more but the pain in my shoulders is so devastating.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, Irritability, Pyrexia, Rash vesicular
Clinical narrative: Noted vaccine error, contacted Mother at 14:25 on 10/31/18, advised to monitor child, to bring child to the clinic if a fever of 101.) occurs. Administer TYLENOL every four hours during the day, may potentially develop a chicken pox type rash, monitor for any shortness of breath, to take child to urgent care if it occurs, reassured it most likely will not occur, I would follow up with the Mother 11/1/18 to evaluate out come. 11/1/18 unable to contact Mother after three calls, contacted Mother 11/2/18-  Informed child ran a low grade fever of 99.8, was cranky for two days. No other symptoms reported.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Heart rate increased, Musculoskeletal stiffness, Presyncope, Tension
Clinical narrative: Within 5 minutes of receiving the flu vaccine, patient told mom she didn't feel good. She got tense, with eyes wide open and body was stiff. Patient was placed flat on floor until symptoms improved. EMS was called. BP=92/60, P=84, T=98.4, PO2=98%. Pulse increased to 103. EMS and parent agreed patient had a vasovagal reaction. EMS did not transport to hospital, patient was feeling better and left clinic at 5 PM with parents.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Lethargy, Myalgia
Clinical narrative: After receiving the shot, my daughter started having significant muscle burning, feelings of lethargy, and joint pain.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin plaque, Somnolence, Urticaria
Clinical narrative: 3 x 1-2 cm erythematous plaques on chest consistent with hives. Sleepiness. Pruritis. No local injection reaction. Total duration of adverse effect was about 30 minutes. No respiratory or other systemic symptoms.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Swelling, Tenderness
Clinical narrative: Swelling, and tenderness to area about 2 inches below injection site about 4-5 cm x 3 cm, and tenderness to area beneath armpit.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Urticaria
Clinical narrative: Patient had hives all over legs and a large red spot on his neck.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Inflammatory marker test, Injection site pain, Laboratory test, Musculoskeletal disorder
Clinical narrative: Immediate severe pain in left shoulder. Continuous intense deep pain in left shoulder, affecting my bicep function. Although I have full ROM my shoulder has been incredibly sore for 5 WEEKS! Pain has been between 6-8 on a 1-10 scale and has kept me up at night and has hurt both with and without movement.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, X-ray
Clinical narrative: Immediate severe pain in left shoulder. Continuous intense deep pain in left shoulder, affecting my bicep function. Although I have full ROM my shoulder has been incredibly sore for 5 WEEKS! Pain has been between 6-8 on a 1-10 scale and has kept me up at night and has hurt both with and without movement.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Patient was 14+ weeks pregnant when getting the flu shot. In the days following, patient experienced a miscarriage.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date in October 2018 (reported as between 08-OCT-2018 and 15-OCT-2018), the patient received unspecified doses of GARDASIL 9 (lot # R003557 with expiration date 20-NOV-2020; strength, dose and route were not reported) for prophylaxis, which was improperly stored. Current temperature excursion was 7.7 Fahrenheit degrees for 1 hours and 6 minutes. No previous temperature excursion was reported. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter (linked case # 1810USA007934; case # 1810USA008298). Sender's Comments: US-009507513-1810USA007934; US-009507513-1810USA008298.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 31-OCT-2018 regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were 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 04-JUN-2014, the patient's healthcare provider administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 21-NOV-2016, the patient was treated by a physician 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. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue 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 include 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. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered
Clinical narrative: This initial spontaneous report was received from a lawyer who was representing a patient who was a minor (also reported as a child) of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications. On an unspecified date, the patient received a double dose of PROQUAD (route and lot # not provided). The lawyer asked where he could find out if this was dangerous to the minor. He stated he was going to ask the patient's provider to call the Company "tonight" (he stated "we need to know tonight"). The lawyer declined when asked if he wanted the address of the legal department. The outcome was unknown. The lawyer did not provide his contact information.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Cardiac disorder, Heart rate increased
Clinical narrative: Fast heart beat lasting at least 9 hours. Heart felt odd in the beginning for a few hours. Rested, drank water. Went to bed and appeared fine the next morning.
Age: 65.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Arthralgia, Chills, Injection site pain, Injection site swelling, Pain
Clinical narrative: Body aching, pain and swelling where the shot was given, chills, sore joints.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient arm swelled from shoulder to elbow, very sore and hot to touch. Patient received vaccine 11/5/18 in am and swelling was present by evening.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Blood culture, Blood test, Cold sweat, Decreased appetite, Diarrhoea
Clinical narrative: Immediately following injection I felt lightheaded. I left the store and went home. At 9:30pm I was very tired and light sensitive. At 1030pm I was vomiting, had cold sweats and diarrhea. I went to the hospital and was told it was a coincidence and that I had a gastro issue. Blood was taken and a blood culture was taken before I was discharged. The blood test appeared normal the culture would take 48 hrs to come back. I went home at 4:30am. Saturday 11/3 and Sunday 11/4 I was tired, no appetite and laid around mostly. Monday 11/5 I went to work and felt tingling in my left hand and wrist. It was tingling continuously and I went to the medical hospital 630pm 11/5. Dr performed neurological exam, reviewed blood work and told me to follow up with my primary. Still having tingling feelings in my arm and now both feet is happening on Tuesday and now developing lightheaded and dizzy feelings as well. I took nothing for it. 11/7 I went to my primary who reported that it appears I had a reaction and I was told to rest and take an antihistamine.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fatigue, Immediate post-injection reaction, Neurological examination, Paraesthesia
Clinical narrative: Immediately following injection I felt lightheaded. I left the store and went home. At 9:30pm I was very tired and light sensitive. At 1030pm I was vomiting, had cold sweats and diarrhea. I went to the hospital and was told it was a coincidence and that I had a gastro issue. Blood was taken and a blood culture was taken before I was discharged. The blood test appeared normal the culture would take 48 hrs to come back. I went home at 4:30am. Saturday 11/3 and Sunday 11/4 I was tired, no appetite and laid around mostly. Monday 11/5 I went to work and felt tingling in my left hand and wrist. It was tingling continuously and I went to the medical hospital 630pm 11/5. Dr performed neurological exam, reviewed blood work and told me to follow up with my primary. Still having tingling feelings in my arm and now both feet is happening on Tuesday and now developing lightheaded and dizzy feelings as well. I took nothing for it. 11/7 I went to my primary who reported that it appears I had a reaction and I was told to rest and take an antihistamine.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Photophobia, Vomiting
Clinical narrative: Immediately following injection I felt lightheaded. I left the store and went home. At 9:30pm I was very tired and light sensitive. At 1030pm I was vomiting, had cold sweats and diarrhea. I went to the hospital and was told it was a coincidence and that I had a gastro issue. Blood was taken and a blood culture was taken before I was discharged. The blood test appeared normal the culture would take 48 hrs to come back. I went home at 4:30am. Saturday 11/3 and Sunday 11/4 I was tired, no appetite and laid around mostly. Monday 11/5 I went to work and felt tingling in my left hand and wrist. It was tingling continuously and I went to the medical hospital 630pm 11/5. Dr performed neurological exam, reviewed blood work and told me to follow up with my primary. Still having tingling feelings in my arm and now both feet is happening on Tuesday and now developing lightheaded and dizzy feelings as well. I took nothing for it. 11/7 I went to my primary who reported that it appears I had a reaction and I was told to rest and take an antihistamine.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site swelling, Myalgia
Clinical narrative: Mild flu like symptoms: muscle aches, headache, arm swollen at site. Began the following morning and lasted 1 day. Had similar reaction for first shot. Took VANQUISH for the headache. No further problems.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Pt states she is having muscular pain shooting from neck to shoulder since getting flu shot.
Age: 84.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Pts biceps became red and swollen, still a little red today. He also said he spent the day in bed with a low grade fever.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, FLU4
Symptoms: Wrong product administered
Clinical narrative: Pt was given PENTACEL instead of QUADRACEL. I spoke with staff at the health department and she states that pt isn't going to be harmed by this- just an extra dose of HIB and that this will count on registry.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Dizziness, Eye movement disorder, Nausea, Syncope, Tremor
Clinical narrative: Patient given vaccine. Patient stood up from table and walked around the room for a few seconds. Patient then sat down on the chair and within seconds patient had an episode of syncope. Patient began to shake, eyes rolled back. Within 20-30 seconds patient came out of it. Was then very light headed, dizzy, nauseous.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Patient developed pain and redness several hours after vaccinations. This became increasingly swollen and painful; by next day streaking present.
Age: 42.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Injection site swelling, Lymphadenopathy, Pyrexia, Skin warm
Clinical narrative: Injection site pain and swelling within 2 1/2 hours. Of vaccination. This morning lymph node under left arm is very swollen and warm. This morning also running a low grade fever.
Age: 42.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Blood test, Chest X-ray, Lymphadenopathy, Mammogram, Oedema
Clinical narrative: Injection site pain and swelling within 2 1/2 hours. Of vaccination. This morning lymph node under left arm is very swollen and warm. This morning also running a low grade fever.
Age: 42.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pyrexia, Ultrasound scan
Clinical narrative: Injection site pain and swelling within 2 1/2 hours. Of vaccination. This morning lymph node under left arm is very swollen and warm. This morning also running a low grade fever.
Age: 67.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Computerised tomogram, Facial paralysis, Headache, Hypoaesthesia, Nuclear magnetic resonance imaging
Clinical narrative: Bell's palsy. Facial paralysis. Numbness on one side of face. Strong headaches and pain behind ear.
Age: 67.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Pain
Clinical narrative: Bell's palsy. Facial paralysis. Numbness on one side of face. Strong headaches and pain behind ear.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient called the day after vaccination. She said that her arm was red around the injection site (about a 4X4 area) and slightly warm to the touch. No swelling. It was slightly itchy. No pain. No other effects. I told her she could take some BENADRYL by mouth and use cold compresses (if she wanted or felt she needed the cold compresses). I also asked her to contact me if it got any worse.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Patient called the day after vaccination. She said that her arm was red around the injection site (about a 4X4 area) and slightly warm to the touch. No swelling. It was slightly itchy. No pain. No other effects. I told her she could take some BENADRYL by mouth and use cold compresses (if she wanted or felt she needed the cold compresses). I also asked her to contact me if it got any worse.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site warmth, Local reaction, Rash macular
Clinical narrative: Patient called the day after vaccination. She said that her arm was red around the injection site (about a 4X4 area) and slightly warm to the touch. No swelling. It was slightly itchy. No pain. No other effects. I told her she could take some BENADRYL by mouth and use cold compresses (if she wanted or felt she needed the cold compresses). I also asked her to contact me if it got any worse.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Syringe issue
Clinical narrative: Gave the patient Fluzone Quad IM in the Left Arm about 75% of the vaccine went into the patient's arm but the last 25% came out the back of the syringe at the plunger.
Age: 24.0
Sex: F
Vaccine: FLU4, HEP, HPV9, MMR, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: There was NO adverse event, however the dose was incorrect because it was a pediatric dose given to an adult patient.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity, Syringe issue
Clinical narrative: When the shot was being administered the plunger was jammed and had problems being pushed down to inject. About 36 hours after the shot, the patient started having shooting pain in his arm, and he has had trouble lifting his arm. He has been in pain when trying to sleep. He is still having pain, but it is getting better. He is taking ibuprofen for it and said it feels best when in a warm shower.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: Ache all over, headache.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Immediate post-injection reaction, Myalgia, Pain
Clinical narrative: The pharmacist gave a painless shot. However, when the flu vaccine was injected, I immediately felt a sickening and burning feeling (I get flu shots every year but this was the Senior version) but the sensation passed as I walked out. However, within three hours, I could barely move my left arm without pain (especially if I raised my arm) which increased throughout the night. Finally took ALEVE about 4am which helped a bit. The pain was constant and only lessened three days later. I tried to play tennis (I usually play 2-3 times weekly) but it was still bad. Today (Wednesday) is my first "good day" with only a hint of muscular pain when I raise my arm.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Patient is a pleasant 27 year old female who presents today with complaints of left lateral shoulder pain with gradual onset on 10/11/18, the day after she received the yearly influenza vaccine. She describes the pain as a sharp pain. For one week after the immunization, she states her symptoms gradually worsened, with pain noted only with certain arm/shoulder movements (none at rest) then reached a plateau, not worsening but not improving. Is being seen today because her pain in her shoulder worsened again this past weekend while she was playing ball with her son. At its worst, she rates it as an 8-9/10; this is only with certain movements. At rest, it continues to be a 0-1/10. She is a weight lifter and has been avoiding lifting weights due to her current condition. She denies any particular activities that she may have done recently to worsen the pain. Her pain has been present for 3 weeks now.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal pain, Diarrhoea, Dizziness, Hyperhidrosis, Syncope
Clinical narrative: Patient c/o dizziness and had a syncopal episode. She became diaphoretic and c/o severe abdominal pain; no LOC noted. She stated she needed to go to bathroom and have "diarrhea", but no diarrhea, only normal BM. Epinephrine ordered and paramedic transport to ER; patient refused and signed out AMA. Monitored patient for 1 1/2 hours following vaccination. Patient stable by the end of that time and denied any pain. ER warning signs given and patient discharged.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Infection, Skin warm
Clinical narrative: "Left arm hot to touch, langered circle, bruised, infected" per client.
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Head discomfort, Hot flush, Influenza like illness, Musculoskeletal stiffness, Rash
Clinical narrative: Patient developed rash, swelling of airway, flu-like symptom (99.5 degree, runny nose, stiff neck, hot flashes, high pressure in head). Rash and swelling of airway was not reported and asked by the pharmacist at the first patient call (patient has tolerated FLUZONE QUAD the year before and not allergic to egg) and patient was advised to keep watching instead of going to ER. Patient went to ER at self-will on 11/5/2018 and was prescribed EPIPEN and cetirizine and advised no future flu vaccinations.
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Rhinorrhoea, Swelling
Clinical narrative: Patient developed rash, swelling of airway, flu-like symptom (99.5 degree, runny nose, stiff neck, hot flashes, high pressure in head). Rash and swelling of airway was not reported and asked by the pharmacist at the first patient call (patient has tolerated FLUZONE QUAD the year before and not allergic to egg) and patient was advised to keep watching instead of going to ER. Patient went to ER at self-will on 11/5/2018 and was prescribed EPIPEN and cetirizine and advised no future flu vaccinations.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site haemorrhage, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: 5 1/2 x 4 1/2 area of ecchymosis and induration on upper lateral aspect of left shoulder. Area warm and Tender to touch.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site mass, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received PREVNAR 13, (Lot number and Expiration date: Unknown), via an unspecified route of administration at the arm on 23Oct2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date after receiving PREVNAR 13 the patient had reaction. The patient's was arm swollen, red and developed lump at site. The doctor recommended to ice it and take BENADRYL and recommended steroid shot. The patient declined the steroid shot. The outcome of the events was not reported. Information on the lot number has been requested.
Age: 1.42
Sex: F
Vaccine: DTAP
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: There was a hard spot at the injection site, as expected, for the first 24 hours. At 48 hours, a large area around the injection site turned bright red, almost purple in some spots, was hot to the touch and was the size of an adult's palm. Went to Urgent Care and was told it was a vaccine reaction, to give Benadryl and use Hydrocortisone cream. It faded in about 3 days.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Myalgia
Clinical narrative: Sharp, repeated headache; muscle pain; tiredness that evening and next day. Also upset stomach next day. Emailed doctor, took TYLENOL. Felt better 48 hours later.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Pruritus, Swelling
Clinical narrative: Patient's arm is red all the way around radiating down to the elbow from the upper arm. She states it's itchy, swelling and getting hard.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt was inadvertently given adult dose. However she is only 17 years old. CDC was consulted regarding this, as was the clinic NP.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Myalgia
Clinical narrative: Same as first time; sharp, repeated headache; muscle pain, tiredness that evening and next day. Less upset stomach took TYLENOL as first time, better in 48 hours.
Age: 72.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Dysstasia, Mobility decreased, Musculoskeletal pain, Musculoskeletal stiffness, Myalgia
Clinical narrative: Muscular soreness to the point that I could barely roll over in bed or stand up from a sitting position without assistance from my husband. I am a nurse, I work, I play golf several times a month, and I walk about 3 miles per day. I was almost incapacitated. I am not much improved, but my shoulder still is "sore" and I have a crick in my neck. I just thought this should be reported so it can be monitored in other patients. I hope I will soon be over these symptoms. I did not attribute this to the flu shot until a fellow nurse who also had the vaccination about the same time, reported the SAME adverse effects and the same 'crick' in her neck. She is also a nurse at medical center in the behavioral unit where I work.
Age: 72.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Neck pain
Clinical narrative: Muscular soreness to the point that I could barely roll over in bed or stand up from a sitting position without assistance from my husband. I am a nurse, I work, I play golf several times a month, and I walk about 3 miles per day. I was almost incapacitated. I am not much improved, but my shoulder still is "sore" and I have a crick in my neck. I just thought this should be reported so it can be monitored in other patients. I hope I will soon be over these symptoms. I did not attribute this to the flu shot until a fellow nurse who also had the vaccination about the same time, reported the SAME adverse effects and the same 'crick' in her neck. She is also a nurse at medical center in the behavioral unit where I work.
Age: 1.0
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given an immunization that was for the age 4-6 years, which she was to young for. She did not have any adverse reaction to the immunization.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Chest X-ray normal, Chest pain, Discomfort, Electrocardiogram normal
Clinical narrative: States arm was sore after receiving vaccine, used ibuprofen. Two days later developed chest and back pain, arm was tingly, uncomfortable. Went to see medical provider, EKG, chest x-ray, and labs were done. Other than showing an elevated WBC count everything was ok. She is feeling better at present, symptoms have subsided but not completely gone.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Laboratory test, Pain in extremity, Paraesthesia, White blood cell count increased
Clinical narrative: States arm was sore after receiving vaccine, used ibuprofen. Two days later developed chest and back pain, arm was tingly, uncomfortable. Went to see medical provider, EKG, chest x-ray, and labs were done. Other than showing an elevated WBC count everything was ok. She is feeling better at present, symptoms have subsided but not completely gone.
Age: 64.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Body temperature increased, Dizziness, Feeling abnormal, Malaise, Middle insomnia
Clinical narrative: Pt started feeling ill within a few hours of the vaccinations. She went to bed early due to just not feeling good all over. She woke up in the middle of the night and had a temp of 103 and felt very dizzy. She even awoke her husband to have her get some washcloths to cool her down. The next morning she felt the same, but at about the 24 hour mark for imz, she felt better.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient reported small, red area; slight itching; and warmth at injection site.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Welts all over body. Prednisolone and BENADRYL sent to the pharmacy.
Age: 8.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Headache, Influenza virus test negative, Pyrexia, Streptococcus test negative, Vomiting
Clinical narrative: Severe Temperature 103.3 then 103.5. Gave TYLENOL...Called pediatrician on call service, was told to go to urgent care for evaluation. Went to Urgent Care, fever decreased to 101.9, with with complaints of severe headache. Headache resolved but then temperature increased back to 103.3. Was given MOTRIN. Was seen by Urgent Care pediatric physician and told that this was most likely a concurrent viral illness. Denied needing to report adverse reaction. Temperature decrease to 100.9 and was discharged home. Heart rate was between 150 and 130 during Urgent Care stay. Patient vomited at home in the middle of night with continued fever of a 102.8. Receive TYLENOL in the morning at 7 a.m. and eventually developed a fever of 104.5 with severe headache again. Vomited one more time. Received MOTRIN and TYLENOL for fever. Patient remain to have a temperature between 101 and one or two throughout the second day. On the third day temperature was 101.8 but feeling better. Nausea no vomiting. Approximately 80 hours after vaccination patient appears to no longer have fever.
Age: 51.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Feeling abnormal, Swelling of eyelid
Clinical narrative: FLUCELVAX administered at 10:40am. Pt stated she was feeling "funny" at 10:42. Observed swelling around eyes. Pharmacist administered EPIPEN at 10:43. Nurse practioner on site checked blood pressure and monitor pulse from 10:43 until EMS arrived to take over. Pt left on stretcher with EMS.
Age: 51.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Eye swelling, Heart rate increased, Rash
Clinical narrative: FLUCELVAX administered at 10:40am. Pt stated she was feeling "funny" at 10:42. Observed swelling around eyes. Pharmacist administered EPIPEN at 10:43. Nurse practioner on site checked blood pressure and monitor pulse from 10:43 until EMS arrived to take over. Pt left on stretcher with EMS.