chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia, Loss of personal independence in daily activities, Musculoskeletal discomfort, Neuralgia
Clinical narrative: Soreness at the injection site; Can hardly hold her head up; Nerve pain; Feeling Weak; Flu-like symptoms; Chills; Feeling Achy; Fatigue; Cannot sleep on the side of her body where she received the vaccination because the injection site is "super sore; Missed work; This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 3rd November 2019, less than a day after receiving Shingrix, the patient experienced injection site pain and neck discomfort. In November 2019, the patient experienced nerve pain, feelings of weakness, influenza-like symptoms, chills, pain, fatigue, sleeplessness and activities of daily living impaired. On an unknown date, the outcome of the nerve pain, feelings of weakness, influenza-like symptoms, chills, pain, fatigue, sleeplessness, activities of daily living impaired, injection site pain and neck discomfort were not recovered/not resolved.   It was unknown if the reporter considered the nerve pain, feelings of weakness, influenza-like symptoms, chills, pain, fatigue, sleeplessness, activities of daily living impaired, injection site pain and neck discomfort to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient, The patient received dose of Shingrix in the left arm. The patient stated that, around 3:30 pm or 4:00 pm on Sunday 3rd November 2019 received dose of Shingrix. Around midnight, the patient experienced nerve pain, feelings of weakness, influenza-like symptoms, chills, pain, fatigue, sleeplessness, inability to work, injection site pain and neck discomfort. The patient experienced nerve pain down the side of the body that would alternate from  the left side to the right side. The patient also stated that, could not sleep on the side of the body where received the vaccination because the injection site was super sore. On 4th November 2019, the patient could not go to work because of symptoms. No additional details were provided.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Soreness at the injection site; Can hardly hold her head up; Nerve pain; Feeling Weak; Flu-like symptoms; Chills; Feeling Achy; Fatigue; Cannot sleep on the side of her body where she received the vaccination because the injection site is "super sore; Missed work; This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 3rd November 2019, less than a day after receiving Shingrix, the patient experienced injection site pain and neck discomfort. In November 2019, the patient experienced nerve pain, feelings of weakness, influenza-like symptoms, chills, pain, fatigue, sleeplessness and activities of daily living impaired. On an unknown date, the outcome of the nerve pain, feelings of weakness, influenza-like symptoms, chills, pain, fatigue, sleeplessness, activities of daily living impaired, injection site pain and neck discomfort were not recovered/not resolved.   It was unknown if the reporter considered the nerve pain, feelings of weakness, influenza-like symptoms, chills, pain, fatigue, sleeplessness, activities of daily living impaired, injection site pain and neck discomfort to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient, The patient received dose of Shingrix in the left arm. The patient stated that, around 3:30 pm or 4:00 pm on Sunday 3rd November 2019 received dose of Shingrix. Around midnight, the patient experienced nerve pain, feelings of weakness, influenza-like symptoms, chills, pain, fatigue, sleeplessness, inability to work, injection site pain and neck discomfort. The patient experienced nerve pain down the side of the body that would alternate from  the left side to the right side. The patient also stated that, could not sleep on the side of the body where received the vaccination because the injection site was super sore. On 4th November 2019, the patient could not go to work because of symptoms. No additional details were provided.
Sex: M
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Cardiac function test normal, Cardioversion, Heart rate increased, Pain in extremity
Clinical narrative: atrial fibrillation; tachycardia/ fast heart rate; sore arm; knot/ large knot on arm; This case was reported by a consumer via call center representative and described the occurrence of atrial fibrillation in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of pain in extremity (for tolerance, refer linked case) and Tetanus vaccine with an associated reaction of pain in extremity.   On 22nd June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 25th June 2019, 3 days after receiving Shingrix, the patient experienced atrial fibrillation (serious criteria hospitalization and GSK medically significant) and tachycardia (serious criteria hospitalization). On an unknown date, the patient experienced pain in arm and skin mass. On an unknown date, the outcome of the atrial fibrillation and tachycardia were recovered/resolved and the outcome of the pain in arm was recovering/resolving and the outcome of the skin mass was unknown.   It was unknown if the reporter considered the atrial fibrillation, tachycardia, pain in arm and skin mass to be related to Shingrix.  Additional details were provided as follows: The patient provided only his first name and would not provide his last name or any contact information. The patient stated that, in the evening of Saturday, he received the Shingrix vaccine in left deltoid.  On Tuesday morning, he started experiencing a very fast heart rate, over 200. The patient went to the emergency room and was admitted to the hospital for atrial fibrillation. The patient never had atrial fibrillation.  He was shocked 3 times while at the hospital but he did not go back into normal rhythm. He finally went back into normal rhythm on his own. The patient had a few periods of tachycardia since this experience, but they did not last long enough to need treatment. The patient's heart tests were performed and it showed he was clear of blockages. He also noted that, less than a month after Shingrix vaccination, he had a large knot on his arm after the injection and his arm was very sore for 3.5 to 4 months and was a little sore till the reporting date. The patient mentioned his arm often hurts for 2 weeks after getting the flu shot (refer case ) and sometimes he would get that after the tetanus vaccine. The patient did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Skin mass, Tachycardia
Clinical narrative: atrial fibrillation; tachycardia/ fast heart rate; sore arm; knot/ large knot on arm; This case was reported by a consumer via call center representative and described the occurrence of atrial fibrillation in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of pain in extremity (for tolerance, refer linked case) and Tetanus vaccine with an associated reaction of pain in extremity.   On 22nd June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 25th June 2019, 3 days after receiving Shingrix, the patient experienced atrial fibrillation (serious criteria hospitalization and GSK medically significant) and tachycardia (serious criteria hospitalization). On an unknown date, the patient experienced pain in arm and skin mass. On an unknown date, the outcome of the atrial fibrillation and tachycardia were recovered/resolved and the outcome of the pain in arm was recovering/resolving and the outcome of the skin mass was unknown.   It was unknown if the reporter considered the atrial fibrillation, tachycardia, pain in arm and skin mass to be related to Shingrix.  Additional details were provided as follows: The patient provided only his first name and would not provide his last name or any contact information. The patient stated that, in the evening of Saturday, he received the Shingrix vaccine in left deltoid.  On Tuesday morning, he started experiencing a very fast heart rate, over 200. The patient went to the emergency room and was admitted to the hospital for atrial fibrillation. The patient never had atrial fibrillation.  He was shocked 3 times while at the hospital but he did not go back into normal rhythm. He finally went back into normal rhythm on his own. The patient had a few periods of tachycardia since this experience, but they did not last long enough to need treatment. The patient's heart tests were performed and it showed he was clear of blockages. He also noted that, less than a month after Shingrix vaccination, he had a large knot on his arm after the injection and his arm was very sore for 3.5 to 4 months and was a little sore till the reporting date. The patient mentioned his arm often hurts for 2 weeks after getting the flu shot (refer case ) and sometimes he would get that after the tetanus vaccine. The patient did not consent to follow-up.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Fatigue, Headache, Injection site pain, Malaise
Clinical narrative: Malaise headache! Body ache! cough Tired! > 12 days.  its been 3 weeks now & arm - injection site still aches!!! I Feel unwell still
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Malaise headache! Body ache! cough Tired! > 12 days.  its been 3 weeks now & arm - injection site still aches!!! I Feel unwell still
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Cough, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: 6h after Shingrix #2 onset fever 102'F, chills, Myalgias. The following day cough, sore throat.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia, Nausea
Clinical narrative: Muscle aches/joint aches nausea x 24 hours
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Chest discomfort, Ear swelling, Injection site pain, Injection site swelling, Lip swelling
Clinical narrative: Approximately 12 hours after injection complained of localized pain/swelling in both injection sites,  with more pain, and itching on left side (Bexsero).  Reported hives, mild chest tightness and swelling of lips and left ear.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Pain, Urticaria
Clinical narrative: Approximately 12 hours after injection complained of localized pain/swelling in both injection sites,  with more pain, and itching on left side (Bexsero).  Reported hives, mild chest tightness and swelling of lips and left ear.
Age: 19.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema
Clinical narrative: localized erythema, edema
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Pain in extremity, Vomiting
Clinical narrative: Patient said around 8 or 9 at night that his arm was starting to ache then sometime after midnight he started having severe diarrhea and vomiting. Patient had a similiar reaction last year and it lasted for 3 days.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Headache, Lip blister, Lip swelling, Oral discomfort
Clinical narrative: Pt reported lower lip blistering, 3-4 blisters with swelling and burning, fatigue and headache. Pt is an employee of the facility and was assessed by Dr. at the time of the event.  No additional outside clinic or office visit.
Age: 42.0
Sex: M
Vaccine: TYP
Symptoms: Cough, Pyrexia, Rash, Rash papular
Clinical narrative: Presented with generalized raised rash throughout extremities and trunk.  This is accompanied with Minor fever for 100 and coughing.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Amenorrhoea, Blood follicle stimulating hormone, Fatigue, Headache, Hot flush
Clinical narrative: I was vaccinated with GARDASIL. After the vaccine I started having night-sweats, insomnia, fatigue, and headaches. The same year I had started birth control everything was normal but after the vaccine I realized I would spot before my period. I went to the doctor a couple times they would always check my thyroid but that was normal. Until this year June 2019 I stopped my birth control I started having hot flushes and my period never came back. I went to the doctor they check my FSH levels and diagnosed me with premature menopause. Before the Gardasil Vaccine I would get my periods religiously every month .
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Insomnia, Night sweats, Premature menopause
Clinical narrative: I was vaccinated with GARDASIL. After the vaccine I started having night-sweats, insomnia, fatigue, and headaches. The same year I had started birth control everything was normal but after the vaccine I realized I would spot before my period. I went to the doctor a couple times they would always check my thyroid but that was normal. Until this year June 2019 I stopped my birth control I started having hot flushes and my period never came back. I went to the doctor they check my FSH levels and diagnosed me with premature menopause. Before the Gardasil Vaccine I would get my periods religiously every month .
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal discomfort, Musculoskeletal stiffness, Skin warm, Tinea capitis
Clinical narrative: Day after the injection patient's right arm, right index finger, middle finger and thumb felt warm, numb and tingling.  Patient applied ice to the site, took 400mg Ibuprofen which helped relieve his symptoms.  He was seen in the office for a stiff shoulder and discomfort along the median nerve.  Treatment of Ibuprofen every 8 hours for 2 to 3 days then as needed.  Shoulder stretching exercises given. Patient to follow up if no improvement.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Bacterial infection, Injection site erythema, Injection site paraesthesia, Injection site reaction, Injection site swelling
Clinical narrative: red, swollen, blotchy, hot, tingling at injection site. said doctor told her she has a bacterial infection from vaccine and gave her "antibiotic and prednisone"
Age: 52.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site warmth, Rash macular, Vaccination complication
Clinical narrative: red, swollen, blotchy, hot, tingling at injection site. said doctor told her she has a bacterial infection from vaccine and gave her "antibiotic and prednisone"
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Pruritus
Clinical narrative: C/o Dizziness and itching all over body after receiving influenza vaccine. Alert, oriented Treatment Dexamethasome IM, Benadryl IM
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Rash, Rash erythematous, Rhinorrhoea
Clinical narrative: 2 wks after MMR, varicella vaccine developed red rash over all of body without vesicles. Had runny nose several days before rash, 0 fever, 0 malaise
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Tremor
Clinical narrative: Extreme chills, could not stop extreme shaking for about 45 mins.
Age: 77.0
Sex: U
Vaccine: VARZOS
Symptoms: Chest pain, Cough, Dizziness, Headache, Influenza like illness
Clinical narrative: 9/23 (liver) Dizziness (very quickly); headache; flu type aches; lower chest soreness with breathing, causing cough; very sore, swollen glands under left arm for 4-6 days. Symptoms gradually went away within a week.
Age: 77.0
Sex: U
Vaccine: VARZOS
Symptoms: Lymph node pain, Lymphadenopathy, Painful respiration
Clinical narrative: 9/23 (liver) Dizziness (very quickly); headache; flu type aches; lower chest soreness with breathing, causing cough; very sore, swollen glands under left arm for 4-6 days. Symptoms gradually went away within a week.
Age: 70.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Urticaria
Clinical narrative: Patient experienced moderate hives after receiving the Shingrix vaccine. Took Benadryl + symptoms improved
Age: 37.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Diarrhoea, Injection site warmth, Pain, Pruritus, Rash
Clinical narrative: Rash and itching to arms bilaterally Body aches Vomiting Diarrhea  Heat at injection site (Right side)
Age: 37.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Vomiting
Clinical narrative: Rash and itching to arms bilaterally Body aches Vomiting Diarrhea  Heat at injection site (Right side)
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Scab
Clinical narrative: Patient has a scab that turned a brown color about the size of a dime.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Aura, Clonus, Confusional state, Fatigue, Generalised tonic-clonic seizure
Clinical narrative: Extremely sore arm, Fatigue, and general malaise, low grade fever (started day after injection, lasted 3-4 days after immunization) Tonic-clonic seizure on Wednesday 11/7/2019 Symptoms- aura, visual disturbance (bright spots intensified until loss of consciousness), felt body tense up, low moan, and felt clonic full body shaking before losing consciousness. Was able to lay down because I felt like I was losing consciousness. Have a blank of around 45 minutes. In which time I moved from living room floor to bed without any recollection of the movement. Came to with all my muscles in my body very sore and a throbbing headache focalized in occipital region of my head. Very confused during post-ictal period. Confusion and soreness lasted throughout the rest of the day. Finally felt a sense of normalcy after a night?s rest.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Loss of consciousness, Malaise, Moaning, Myalgia
Clinical narrative: Extremely sore arm, Fatigue, and general malaise, low grade fever (started day after injection, lasted 3-4 days after immunization) Tonic-clonic seizure on Wednesday 11/7/2019 Symptoms- aura, visual disturbance (bright spots intensified until loss of consciousness), felt body tense up, low moan, and felt clonic full body shaking before losing consciousness. Was able to lay down because I felt like I was losing consciousness. Have a blank of around 45 minutes. In which time I moved from living room floor to bed without any recollection of the movement. Came to with all my muscles in my body very sore and a throbbing headache focalized in occipital region of my head. Very confused during post-ictal period. Confusion and soreness lasted throughout the rest of the day. Finally felt a sense of normalcy after a night?s rest.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Postictal state, Pyrexia, Tension
Clinical narrative: Extremely sore arm, Fatigue, and general malaise, low grade fever (started day after injection, lasted 3-4 days after immunization) Tonic-clonic seizure on Wednesday 11/7/2019 Symptoms- aura, visual disturbance (bright spots intensified until loss of consciousness), felt body tense up, low moan, and felt clonic full body shaking before losing consciousness. Was able to lay down because I felt like I was losing consciousness. Have a blank of around 45 minutes. In which time I moved from living room floor to bed without any recollection of the movement. Came to with all my muscles in my body very sore and a throbbing headache focalized in occipital region of my head. Very confused during post-ictal period. Confusion and soreness lasted throughout the rest of the day. Finally felt a sense of normalcy after a night?s rest.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Tremor, Visual impairment
Clinical narrative: Extremely sore arm, Fatigue, and general malaise, low grade fever (started day after injection, lasted 3-4 days after immunization) Tonic-clonic seizure on Wednesday 11/7/2019 Symptoms- aura, visual disturbance (bright spots intensified until loss of consciousness), felt body tense up, low moan, and felt clonic full body shaking before losing consciousness. Was able to lay down because I felt like I was losing consciousness. Have a blank of around 45 minutes. In which time I moved from living room floor to bed without any recollection of the movement. Came to with all my muscles in my body very sore and a throbbing headache focalized in occipital region of my head. Very confused during post-ictal period. Confusion and soreness lasted throughout the rest of the day. Finally felt a sense of normalcy after a night?s rest.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: C-reactive protein increased, Chills, Hot flush, Inflammation, Joint range of motion decreased
Clinical narrative: Client reports pain and limited range of motion beginning the evening of vaccination and continuing to worsen over the next 10 days.  C/O chills and hot flashes for approx 2 days following vaccination, denies fever.  Client reported reaction to Health Department on 10/28 and was advised to try heat and cold intermittently and to return if pain doesn't resolve.  Client reports went to Urgent  Care 10/29/2019 and was treated with 5 days Prednisone, and advised likely moderate to severe reaction to injection or vaccine.  On 11/6/2018 client reported to HD that she improved with medication but pain and limited ROM returned when discontinued meds.  Client stated she returned to Urgent Care (same HCP) 11/5/19. see below  Client reports blood test ordered to R/O infection (negative result) and treatment with 12 days of Prednisone was given.  Client reports she is scheduled to have Ultrasound of her arm on 11/8/2019.  On 11/8, client reported to HD that she received notice that test for CRP (C reactive protein) is elevated from normal.  This shows there is inflammation. 11/14/2019 - Report from client that ultrasound of her arm is WNL.  States she has been referred back to PCP for discussion of any further testing.  States she is currently being weaned off prednisone and is noticing pain slightly increasing.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Serology negative, Ultrasound scan normal, Vaccination complication
Clinical narrative: Client reports pain and limited range of motion beginning the evening of vaccination and continuing to worsen over the next 10 days.  C/O chills and hot flashes for approx 2 days following vaccination, denies fever.  Client reported reaction to Health Department on 10/28 and was advised to try heat and cold intermittently and to return if pain doesn't resolve.  Client reports went to Urgent  Care 10/29/2019 and was treated with 5 days Prednisone, and advised likely moderate to severe reaction to injection or vaccine.  On 11/6/2018 client reported to HD that she improved with medication but pain and limited ROM returned when discontinued meds.  Client stated she returned to Urgent Care (same HCP) 11/5/19. see below  Client reports blood test ordered to R/O infection (negative result) and treatment with 12 days of Prednisone was given.  Client reports she is scheduled to have Ultrasound of her arm on 11/8/2019.  On 11/8, client reported to HD that she received notice that test for CRP (C reactive protein) is elevated from normal.  This shows there is inflammation. 11/14/2019 - Report from client that ultrasound of her arm is WNL.  States she has been referred back to PCP for discussion of any further testing.  States she is currently being weaned off prednisone and is noticing pain slightly increasing.
Age: 35.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Blood culture, Blood test, Cellulitis, Chills, Decreased appetite
Clinical narrative: At 11am the morning after (10/22) the pneumonia vaccine I had a complete lack of appetite and an increasing fever. Shortly after that I started to have deep full body muscle aches, chills and my right arm pain/redness/swelling was intensifying. By 6pm that day my fever was 102.6 and I started to vomit uncontrollably. I knew something was very wrong and went to Urgent Care. Between my fever, high pulse rate and elevated WBC count they sent me to the ER with what they perceived to be an infection. The ER got me in right away and were hesitant to diagnose an infection so quickly and indicated my immune system might just be having a strong reaction to the vaccine. They wanted me to keep an eye on the injection site and if it got worse I could start taking antibiotics but they warned me not to panic and often times it could look worse the next day. The next morning all my symptoms escalated/returned even worse than before and I had to be rushed back to the ER. This time I was diagnosed with Cellulitis and given IV antibiotics and a full work up of tests. After 7-10 days on 2 different antibiotics all my symptoms cleared up.
Age: 35.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Heart rate increased, Infection, Myalgia, Pain in extremity
Clinical narrative: At 11am the morning after (10/22) the pneumonia vaccine I had a complete lack of appetite and an increasing fever. Shortly after that I started to have deep full body muscle aches, chills and my right arm pain/redness/swelling was intensifying. By 6pm that day my fever was 102.6 and I started to vomit uncontrollably. I knew something was very wrong and went to Urgent Care. Between my fever, high pulse rate and elevated WBC count they sent me to the ER with what they perceived to be an infection. The ER got me in right away and were hesitant to diagnose an infection so quickly and indicated my immune system might just be having a strong reaction to the vaccine. They wanted me to keep an eye on the injection site and if it got worse I could start taking antibiotics but they warned me not to panic and often times it could look worse the next day. The next morning all my symptoms escalated/returned even worse than before and I had to be rushed back to the ER. This time I was diagnosed with Cellulitis and given IV antibiotics and a full work up of tests. After 7-10 days on 2 different antibiotics all my symptoms cleared up.
Age: 35.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Peripheral swelling, Pyrexia, Ultrasound scan, Vomiting, White blood cell count increased
Clinical narrative: At 11am the morning after (10/22) the pneumonia vaccine I had a complete lack of appetite and an increasing fever. Shortly after that I started to have deep full body muscle aches, chills and my right arm pain/redness/swelling was intensifying. By 6pm that day my fever was 102.6 and I started to vomit uncontrollably. I knew something was very wrong and went to Urgent Care. Between my fever, high pulse rate and elevated WBC count they sent me to the ER with what they perceived to be an infection. The ER got me in right away and were hesitant to diagnose an infection so quickly and indicated my immune system might just be having a strong reaction to the vaccine. They wanted me to keep an eye on the injection site and if it got worse I could start taking antibiotics but they warned me not to panic and often times it could look worse the next day. The next morning all my symptoms escalated/returned even worse than before and I had to be rushed back to the ER. This time I was diagnosed with Cellulitis and given IV antibiotics and a full work up of tests. After 7-10 days on 2 different antibiotics all my symptoms cleared up.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Joint range of motion decreased, Pain
Clinical narrative: Client reports she felt pain in shoulder area immediately upon administration.  Stated she's had previous flu vaccinations and never experienced this sensation before.  Reports she continued to feel pain and noted that when movement and range of motion was initiated, an increase in pain was experienced and consequently limited her range of motion from then on.  Client states she has not seen a HCP and has not had any testing or treatment.  As of 11/14/2019, she continues to have pain with arm movement but states it is a bit less.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction, Pruritus
Clinical narrative: Swelling, erythema, and increased warmth developed 2 days ago on L arm around site of Menactra vaccine. Patient's mother reports a small reaction to previous vaccination, resulting in a small area of erythema. Patient's mother reports he applied ice to the area last night.         Erythema: yes, mild        Drainage: none        Pain: none        Pruritus: yes        Last Tdap:         Denies fever or respiratory sx such as SOB or palpitations. EXTREMITIES: L upper arm:         Mild localized erythema and increased warmth noted.         11cm x 22 cm region.         No TTP.         Neurovascular signs intact. NL turgor.         FROM of arm intact.   Reassured mother local reaction, though larger then usual. Advised to use benadryl 25 mg three times per day if needed for itching or swelling. Use cool compresses as directed..
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Blood test, Dizziness, Influenza like illness, Influenza virus test, Limb discomfort
Clinical narrative: Patient had extremely sore arms within an hour after the vaccines.  Within 24 hours she began feeling flu like symptoms with light headed feelings and general bad body aches.  Thirsty.
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Thirst
Clinical narrative: Patient had extremely sore arms within an hour after the vaccines.  Within 24 hours she began feeling flu like symptoms with light headed feelings and general bad body aches.  Thirsty.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient's husband said she developed shingles and started having a painful rash, which is now being treated with valacyclovir.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity, Peripheral swelling
Clinical narrative: Patient received pneumonia vaccine yesterday in right arm.  She states she has had pain in her arm since the injection. Her right arm extending from shoulder to finger tips are swollen and warm to touch. She also has some swelling to the right side of her neck.   Her hand and wrist is dusky in color.  She does have a positive pulse in both wrists.  It is tender to palpate throughout arm and hand. Cap refill >3 seconds.  Patient denies shortness of breath, mucosal edema, or rash.  Gave patient 25 mg benadryl with no relief of symptoms.  Directed patient to go to emergency department immediately.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Skin discolouration, Skin warm, Swelling, Tenderness
Clinical narrative: Patient received pneumonia vaccine yesterday in right arm.  She states she has had pain in her arm since the injection. Her right arm extending from shoulder to finger tips are swollen and warm to touch. She also has some swelling to the right side of her neck.   Her hand and wrist is dusky in color.  She does have a positive pulse in both wrists.  It is tender to palpate throughout arm and hand. Cap refill >3 seconds.  Patient denies shortness of breath, mucosal edema, or rash.  Gave patient 25 mg benadryl with no relief of symptoms.  Directed patient to go to emergency department immediately.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, RV
Symptoms: Intestinal obstruction
Clinical narrative: INTESTINAL OBSTRUCTION; Information was downloaded from database (8-99216-008L).  This spontaneous report was received from a physician and refers to a 2 month old female patient. The patient's concurrent conditions, medical history and concomitant therapies were unknown.  On 30-APR-1999, the patient was vaccinated with hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot # reporter as "0602" (dose, frequency, vaccination site, route and indication were not provided).   On 27-MAY-1999, the patient was vaccinated with other suspect therapies that  included hib conj vaccine (unspecified carrier)(HIB-TITER ) injection dose duration: 1 doses, interval unit: day, intramuscularly, batch#402203A, for immunisation, diphtheria toxoid, pertussis acellular biken vaccine, tetanus toxoid(TRIPEDIA) batch # 0089570 (dose, frequency, vaccination site, route and indication were not provided), polio vaccine inactivated (unspecified) (POLIO VACCINE "PASTEUR") batch # M1295, (dose, frequency, vaccination site, route and indication were not provided) and rotavirus g1 g2 g3 g4 reassortant vaccine live (human-rhesus)(ROTASHIELD) oral solution, batch# 4988055 (dose, frequency, vaccination site, route and indication were not provided).  On 30-MAY-1999, the patient experienced intestinal obstruction which caused hospitalization approximately in 1999. At the time of reporting, the patient had recovered from intestinal obstruction on an unspecified date. The reporter did not provide a causality assessment between the vaccines and intestinal obstruction.  Lot number 0602 is an invalid lot number for hepatitis b vaccine (recombinant).  The Agency considered intestinal obstruction to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: Dizziness, Nausea, Pyrexia, Rash, Vomiting
Clinical narrative: fever; nausea; vomiting; dizziness; unspecified rash; This spontaneous report was received from a school nurse and refers to an unknown patient of unknown age gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown dates, the patient was vaccinated with two doses of varicella virus vaccine live (oka/merck) (VARIVAX) (route of administration, lot # and expiration date were not reported) for varicella prevention.  On an unknown date, the patient experienced fever, vomiting, nausea dizziness then an unspecified rash. The patient has had a doctor visit The outcome of the events was not reported. The causality assessment between the events and suspect therapy was not provided.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: The patient experienced a syncope episode while in the office; This spontaneous report was received from a nurse, via company representative, referring to a 11 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. Her previous drug reactions or allergies included amoxicillin.  On 29-OCT-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, route of administration and anatomical injection site were not reported) as prophylaxis (lot number 1637641 expiration date not reported, but upon internal validation established as 16-FEB-2022). On the same day, while in the office, the patient experienced syncope for 20 seconds and then recovered.  The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the event of syncope was not provided.  Upon internal review, the event of syncope was determined to be medically significant.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Injection site erythema, Injection site induration
Clinical narrative: Severe Stomach pain; 3 in red hard spot where my injection was given; Injection site hard; This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site induration. On 28th October 2019, the patient experienced stomach pain. On an unknown date, the outcome of the stomach pain, injection site erythema and injection site induration were unknown.   It was unknown if the reporter considered the stomach pain, injection site erythema and injection site induration to be related to Shingrix.  Additional details were provided as follows: The patient experienced about a 3 in red hard spot where injection was given. The patient also experienced severe stomach pain. The patient was concerned about stomach pains and asked whether it is normal.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Chest pain, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Severe Stomach pain; 3 in red hard spot where my injection was given; Injection site hard; This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site induration. On 28th October 2019, the patient experienced stomach pain. On an unknown date, the outcome of the stomach pain, injection site erythema and injection site induration were unknown.   It was unknown if the reporter considered the stomach pain, injection site erythema and injection site induration to be related to Shingrix.  Additional details were provided as follows: The patient experienced about a 3 in red hard spot where injection was given. The patient also experienced severe stomach pain. The patient was concerned about stomach pains and asked whether it is normal.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Burning sensation, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness/reddened area is an irregular shape measuring 10.5 cm in length and 15 cm in width and that is the area that was warm with swelling; warmth/reddened area is an irregular shape measuring 10.5 cm in length and 15 cm in width and that is the area that was warm with swelling; swelling/reddened area is an irregular shape measuring 10.5 cm in length and 15 cm in width and that is the area that was warm with swelling; pain like a burning sensation; pain like a burning sensation; This is a spontaneous report from a contactable health care professional.  A 17-year-old female patient received THE first dose of meningococcal group b rlp2086 (TRUMENBA, lot number: ABXA13CA, expiry date: 20Feb2021, NDC number: 58160097620), intramuscular on the right deltoid on 31Oct2019 at 0.5 ml  at a single dose for preventative. The patient had no medical history nor concomitant medications. The nurse practitioner called to report the patient's reactions following the administration of the meningococcal group b rlp2086 vaccine. The patient received the vaccine and had some pain that is like a burning sensation that began after the injection on 31Oct2019. It was also  reported that the patient experienced redness, warmth and swelling at her injection site that began on Monday, 04Nov2019. The reporter said that usually after the injection she has seen redness but this is the first time she's seen where it was there a few days after. She stated that the size of the reddened area is an irregular shape measuring 10.5 cm in length and 15 cm in width and that is the area that was warm with swelling. The pain like burning sensation is ongoing but intermittent. The patient's treatment included some steroids, an anti-inflammatory and some Keflex. The reporter stated that this was the patient's first time dose and the patient is supposed to receive one more in 6 months. The reporter told the patient that she will see her next week if it has improved she will move forward with the next dose. The outcome of the event vaccination site erythema, pain and burning sensation was recovering while the outcome of the other events was not recovered. The reporter assessed the event pain, burning sensation and vaccination site warmth to be related to the suspect drug.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Limb mass, Peripheral swelling, Pruritus, Rash erythematous
Clinical narrative: It is still itchy and still has pink rash with dots in them. So it is definitely a rash; It is still itchy and still has pink rash with dots in them. So it is definitely a rash; She has a lump on other side of elbow now; First dose of Prevnar 13 in 2013 but before this one on 05Nov2019; Left Arm blown up after receiving; It hurt where it was put in; This is a spontaneous report from a contactable consumer.   A 74-year-old female patient received second dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) , on 05Nov2019 at single dose in her left arm as routine vaccination.  Concomitant medication were not reported. In 2013 patient took first dose of pneumococcal 13-val conj vaccine for immunization and she did not blow up after that one. Medical history included right arm surgery on an unspecified date in 2013 (after she received the first dose of vaccine in 2013). On 28Oct2019 a surgery in her right arm was done and she had a cast on it and she did not feel good.  She needed her left arm really bad. She was not hospitalized and it was done in a surgery center. She had a Fiberclast cast on it and 22 stiches were pulled out. She was still recovering from that and she believed this cast will be on for two weeks. She said her arms were really skinny normally, she never had heavy arms. On 05Nov2019 patient stated it hurt where vaccine was put in, her left arm got all blown up; since an unspecified date she had  rash and lump. On 07Nov2019 patient saw her doctor who told her to take diphenhydramine hydrochloride (BENADRYL). She did not take it and she went to his office. He gave her two Prednisone 20 mg each, and she took it at 2 tablets by mouth once daily. She said the swelling has gotten a little better since then. Since an unknown date she had "a lump on other side of elbow". The doctor drew it with magic marker but moved from one side to the other side of the left elbow.  She said "there was one on one side of the elbow and one on the other side of the elbow and one where biceps are.  She doesn't have any biceps." It was still itchy and still had pink rash with dots in them. So it was definitely a rash. There were about 10 dots there where the one rash was. Patient was recovering from Swelling arm; outcome of the other events was unknown.Information on batch number has been requested.
Sex: U
Vaccine: MENB
Symptoms: Headache
Clinical narrative: Headaches/chronic headaches; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A patient of an unspecified age(reported as 18-19 years old) and gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date in 2018 at single dose for immunization. The patient medical history and concomitant medications were not reported. It was reported that a patient received her first dose of meningococcal group b rlp2086 about 1 year ago at a pharmacy, was not sure which pharmacy. The patient experienced headaches after the first dose in 2018, and those headaches did not go away. The patient had to see a Neurologist for treatment of the chronic headaches. The outcome of the event was unknown.  No follow-up attempts are possible; information on the lot number cannot be obtained. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Headache, Injected limb mobility decreased, Malaise, Peripheral swelling
Clinical narrative: she could not use her arm; Headache/My head hurt so bad; Sick; Swelling up; Rash/This rash is spreading/ little spot on the side of her nose, on the side of her face; she came home and she felt her arm was a little swollen up; she could not eat anything; Itch; scratching; This is a spontaneous report from a contactable consumer (patient). A 70-year-old (as reported) female patient received first dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) , via an unspecified route of administration in Oct2019 at single dose for not to get sick.  Medical history included asthma, cholesterol. Concomitant medication included simvastatin (Expiration Date: 04Mar2020) at 20 mg, once daily at night at bed time for cholesterol, montelukast sodium (SINGULAIR, Expiration Date: 03Mar2020) at 10 mg, by mouth at bed time once a day for asthma. The patient previously took unspecified medications (pneumonia shot). Consumer stated, when she got the shot (pneumococcal 13-val conj vac (dipht crm197 protein)) in Oct2019 and this was not her first pneumonia shot (Unspecified medications), at that night she could not use her arm and it was like bad and she had to put it in the front so, she was thinking that and the headaches she had and she had it for like three or four days she was very sick, the headache, the swelling up, it was just horrible but, she felt it was okay but, she noticed she kept scratching this little spot on the side of her nose not on her nose but, on the side of her face and she was looking in the mirror and she did put Vaseline on it again but, it looked like it had got bigger so, she looked at it and it was a rash which she thought it was okay and it would go away. At time of the report,  it had been going on for three weeks and the rash had taken over her face, it was slowly taking over her face. She had been very sick and she was old and when you get that sick it was scary. The patient had an appointment with Primary Care tomorrow and she could call back with more details. The patient was just given pneumococcal 13-val conj vac (dipht crm197 protein) and she came home and she felt her arm was a little swollen up so, she put ice and stuff and by the night time she could not use it and she was sick. Treatment included she took something for her headache because, her head hurt so bad and she could not eat anything. The patient had an appointment that was Friday. She have an appointment on Monday morning at 09 o'clock so, they have already put in for a dermatologist so, they can get a closer look at it because, it had spread and they could see how it had spread since she was there Friday. They just squeezed her in and lady told her did not put anything on it, if it itches or so put cold compress because, it did itched and wait till she come in Monday so they can get a look at it and try to figure out what had happened here or was it something else and not the pneumococcal 13-val conj vac (dipht crm197 protein). The outcome of the events was unknown.