chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: This case was reported by a nurse via patient support programs and described the occurrence of death in a 61-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX.5 ml. On 7th March 2019, unknown after receiving SHINGRIX, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The patient died on 7th March 2019. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death to be related to SHINGRIX. Additional details were reported as follows: This case received from the healthcare provider via the vaccine patient assistance program. The age at vaccination was not reported. The patient passed away in hospice care, cause was unknown. The reporter declined consent for follow up.; Reported Cause(s) of Death: Death NOS.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 72-year-old female patient who received SHINGRIX (batch number DK9L5, expiry date 4th September 2021) for prophylaxis. On 27th March 2019, the patient received the 2nd dose of SHINGRIX (subcutaneous). In March 2019, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain and injection site swelling. On 27th March 2019, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site swelling and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site erythema, injection site pain and injection site swelling to be related to SHINGRIX. Additional information was provided as follows: The batch number was reported for SHINGRIX diluent. The batch number was updated from DKNL5 to DK9L5 as per sales data sheet. SHINGRIX was administered to the back side of the left arm, looked like it was subcutaneous, which led to incorrect route of vaccine administration. The injection site was red, patient complained of swelling and pain in the area, as well.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Impaired work ability, Malaise, Myalgia
Clinical narrative: Received the new Zoster vaccine at doctors office and 6 hours later had severe headache, malaise, myalgia to the point that I couldn't get out of bed and missed work the following day. No fever or respiratory symptoms. Treated with acetaminophen. Cleared in 48 hours. No local reaction.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Areflexia, Dizziness, Headache, Lethargy, Lumbar puncture
Clinical narrative: On 3/21/19 my 12 yr old son received his 2nd HPV vaccine. On 3/25/19 he was hospitalized with loss of reflexes to lower extremities, dizziness, headache, lethargic - had spinal tap done - released on 3/26/19. On 3/27/19 he hospitalized again and had to have 2 MRIs performed - on this day he lost reflexes in lower extremities and arms, along with dizziness, lethargic and headache. Was finally released on 3/30/19 from the hospital.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: On 3/21/19 my 12 yr old son received his 2nd HPV vaccine. On 3/25/19 he was hospitalized with loss of reflexes to lower extremities, dizziness, headache, lethargic - had spinal tap done - released on 3/26/19. On 3/27/19 he hospitalized again and had to have 2 MRIs performed - on this day he lost reflexes in lower extremities and arms, along with dizziness, lethargic and headache. Was finally released on 3/30/19 from the hospital.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Chills, Discomfort, Flatulence, Myalgia
Clinical narrative: I received my first dose SHINGRIX on the afternoon of April 2, at my local pharmacy. SHINGRIX 50 Mg/0.5 ml Inj Glax. Within 12 hours I awoke with chills and a low fever (0.5). Fever, chills, general aches and muscle pain persist, 24 hours since injection. I also experienced unusual bloating and explosive gas within 2 hours of the shot, that continued for about 6 hours. I am 61 years. I have taken TYLENOL to ease the chills and discomfort. I have reached out to report this to my doctors office, and wanted to report it here as well. This is not what the pharmacist told me to prepare for. Thank you.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: I received my first dose SHINGRIX on the afternoon of April 2, at my local pharmacy. SHINGRIX 50 Mg/0.5 ml Inj Glax. Within 12 hours I awoke with chills and a low fever (0.5). Fever, chills, general aches and muscle pain persist, 24 hours since injection. I also experienced unusual bloating and explosive gas within 2 hours of the shot, that continued for about 6 hours. I am 61 years. I have taken TYLENOL to ease the chills and discomfort. I have reached out to report this to my doctors office, and wanted to report it here as well. This is not what the pharmacist told me to prepare for. Thank you.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, RV5, DTAPHEPBIP
Symptoms: Injection site reaction, Rash maculo-papular
Clinical narrative: Papular macular eruption rash moderate on the left upper outer thigh. Child appears other wise well with stable vital signs, good appetite alert and happy disposition, in no acute distress.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, RV5, DTAPHEPBIP
Symptoms: Injection site papule, Injection site reaction, Injection site streaking, Rash erythematous
Clinical narrative: Papular macular eruption rash moderate on the left upper outer thigh. Child appears other wise well with stable vital signs, good appetite alert and happy disposition, in no acute distress.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was given the diluent only in error. No adverse signs or symptoms. Patient will need additional immunization.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Rash
Clinical narrative: Patient reported she had inflammation and tenderness on left deltoid area where PREVNAR 13 was injected. On right deltoid where AFLURIA was injected did not have any dermatologic reaction. On Sunday March 30 she ate codfish and she is allergic to it. That same day after eating codfish, her left arm where she had a little inflammation because of the vaccine became more inflamed, more red and tender.  She had Medrol, Xyxal, Cephalexin 500mg to prevent any allergy or infection. Om April 2 she reported a rash on her face and her arm was still inflamed. On 4/4/2019 she continued to use the medicines and start to feel better and her arm was not inflamed any more.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Malaise, Pruritus, Pruritus generalised
Clinical narrative: Pain at injection site began within an hour of receiving vaccine. Feeling of general malaise on 4/2 and 4/3. Intense itching of hands started morning of 4/2 and persisted through evening of 4/3. Topical BENADRYL had no effect on itching. 50 mg of oral BENADRYL before bed on 4/3 controlled itching overnight. Red rash below injection site on left arm appeared 4/3 and still present on 4/4.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Pain in extremity
Clinical narrative: Pain at injection site, fatigue, pain in upper thighs both sides, tiredness.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Started with pain at injection site Tuesday morning. As the day progressed, my neck became stiff, headache, body aches and stiffness, nausea, fever of 102.2. Wednesday, body aches and headache continued, no fever, injection site still sore with visible swollen spot, redness and warm to touch.  Thursday, body aches and headache gone, injection site still sore, swollen and red, not as warm to the touch.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Nausea, Pain, Pyrexia
Clinical narrative: Started with pain at injection site Tuesday morning. As the day progressed, my neck became stiff, headache, body aches and stiffness, nausea, fever of 102.2. Wednesday, body aches and headache continued, no fever, injection site still sore with visible swollen spot, redness and warm to touch.  Thursday, body aches and headache gone, injection site still sore, swollen and red, not as warm to the touch.
Age: 61.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Patient reported pain the next day and swelling at the site of injection. She felt overtired and achy as well. She reported no fever. When she came into the pharmacy a week after the injection on 3/26/19, she had a 4 inch diameter red spot over the injection site. She said the pain was still there but not as bad. She denied fever at that time as well.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Measles antibody, Pruritus, Rash erythematous, Rash generalised
Clinical narrative: On 4/3/19 developed one vesicle on his forehead. Soon after became covered in a pink/red macular rash over neck, trunk, and arms. Slightly itchy. Not very bothered by it. No fever or cold sx. Seen here in our office that day (4/3). Mom pregnant and due to deliver any day. Rash has worsened over night 4/4/19 had spread to his face and has more spots all over. Still with no other sx of fever or irritability or cold sx. Consulted with Mom's OB- she had a measles titer drawn here in office. Consulted with public health specialists. Made an appointment with pediatric dermatology for today.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash macular
Clinical narrative: On 4/3/19 developed one vesicle on his forehead. Soon after became covered in a pink/red macular rash over neck, trunk, and arms. Slightly itchy. Not very bothered by it. No fever or cold sx. Seen here in our office that day (4/3). Mom pregnant and due to deliver any day. Rash has worsened over night 4/4/19 had spread to his face and has more spots all over. Still with no other sx of fever or irritability or cold sx. Consulted with Mom's OB- she had a measles titer drawn here in office. Consulted with public health specialists. Made an appointment with pediatric dermatology for today.
Age: 1.58
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Blood test normal, Dysstasia, Gait inability, Laboratory test, Pain in extremity
Clinical narrative: Mom reported event on 04/02/2019-The child received vaccines on 12/20/2018 on the evening of 12/21/18 mother noticed the child to have "resistance in legs during clothing and diaper changes, like she was hurting. Mom states on 12/22/18 she took the child to hospital where they completed blood work and x-rays but determined that there was nothing wrong with the child. Mom states they traveled for vacation on January 4th -11th and that while on vacation the child could not walk or bear weight and had to use assistance when attempting to stand. Mom states she took the child to the ER where they did blood work and x-rays and also told there was nothing wrong with child. She took child to Dr when she returned from trip, she stated the doctor examined the child and told her it was related to the vaccines. Mother stated he told her to call the health department so we could report the child's reaction. Mom did not state if child was still experiencing symptoms. Dr told her to give the child selenium, cilantro extract, and a pill called End the Pain and she is unsure of its contents. Mom states she gives all the above twice a day. Mom states when she does not give these pills she sees a huge regression to where she was prior.
Age: 1.58
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Weight bearing difficulty, X-ray normal
Clinical narrative: Mom reported event on 04/02/2019-The child received vaccines on 12/20/2018 on the evening of 12/21/18 mother noticed the child to have "resistance in legs during clothing and diaper changes, like she was hurting. Mom states on 12/22/18 she took the child to hospital where they completed blood work and x-rays but determined that there was nothing wrong with the child. Mom states they traveled for vacation on January 4th -11th and that while on vacation the child could not walk or bear weight and had to use assistance when attempting to stand. Mom states she took the child to the ER where they did blood work and x-rays and also told there was nothing wrong with child. She took child to Dr when she returned from trip, she stated the doctor examined the child and told her it was related to the vaccines. Mother stated he told her to call the health department so we could report the child's reaction. Mom did not state if child was still experiencing symptoms. Dr told her to give the child selenium, cilantro extract, and a pill called End the Pain and she is unsure of its contents. Mom states she gives all the above twice a day. Mom states when she does not give these pills she sees a huge regression to where she was prior.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash, Scab
Clinical narrative: Blisters on lower arms and hands. Hydrocortisone, Rash scabbed over and healed in one week.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Electrocardiogram, Mobility decreased, Pain in extremity
Clinical narrative: On March 11 at 1:50 PM I got the shingle shot at the Pharmacy. Instead of just a prick when I got the shot, I felt the complete injection. At 3:30 PM we went to the Movie Theater. At about 4:30 PM my upper left arm began to hurt while at the theatre. By 5:00 PM, I started having trouble breathing. And by 5:30 PM my whole arm was sore, I couldn't lift it, and I was having a harder time breathing. I had to put my head down low in front of me to get my breath at all. At about 5:50 pm I asked my husband to call 911 for EMS. At about 6:00 PM the EMS arrived; I was put on a gurney, put into the EMS vehicle, and taken to Medical Center. During the 30 minute drive to the hospital, EMS gave me oxygen and an intravenous solution as my blood pressure was very low, prox 90 over 48. As I was still having trouble breathing, the oxygen level was increased above normal. They were also monitoring my heart. My breathing finally became easier just before arriving at the hospital about 6:40 PM. Dr. was my emergency physician at the hospital. The left arm continued to be very sore and I could not lift it on my own without actually pulling it up with my right arm. ER gave me an IV, an EKG and upon my request TYLENOL for the pain. They also were taking my blood pressure regularly. The TYLENOL helped some, but I still could not lift my left arm. I was released about 8:30 PM and told not to get the 2nd Shingles shot. The next day I reported my experience to my pharmacist of Pharmacy, and he was going to report it to the drug company. He also advised me not to get the 2nd shot. 3 days after the shot, on Mar 14th, I saw my physician, Dr., as ER told me to. He had access to all my ER records. Since my only known allergy in 82 yrs has been sulfa, he felt I must have had a reaction to one of the fillers in the shot. It was noted that I had had the live vaccine shot for shingles several yrs ago with no reaction at all. He also advised me not to get the 2nd shot. It took a whole week before the arm was not painful and until I could raise the arm up somewhat higher. I did exercises with the arm every day to try and increase my ability to move it up and around my left hip and up to my right shoulder. I took 2 TYLENOL every morning and every night for 10 days. My left arm mobility has improved, but still not normal 3.5 weeks after the shot. Fortunately I am right handed!
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Irritability, Pyrexia
Clinical narrative: High fever of 102.9, irritability.
Age: 51.0
Sex: F
Vaccine: MMR, VARZOS
Symptoms: Acne, Pain
Clinical narrative: Painful lump on the back of the arm. Pimple like in characteristic with no head.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Shivering, fever (99.7).
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Rash erythematous, Rash pruritic
Clinical narrative: Felt very ill for days before rash broke out. Rash on several locations on body. Very itchy and red. No LARGE blisters. Still have some rash. Dr. gave cream for itchy rash.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: MenACWY powder vial was pre-mixed with sterile diluent instead of MENVEO packaged diluent. MENVEO powder/sterile diluent combination was administered in the patient's left arm IM. After vaccine was administered staff RN immediately realized that mistake was made. Charge nurse was notified immediately. Charge nurse and staff RN who administered the vaccine explained the situation to the patient's mother. Education was provided to the mother regarding the medical error and that vaccine needed to be repeated. Education on possible side effects was provided and mother was asked to call 911 if patient experienced any shortness of breath, trouble swallowing, or tongue swelling occurs. Mother became very upset and emotional support was provided. Client was at the clinic under supervision for 15minutes after vaccine was administered. No acute distress noted. Typical local side effects explained to mom. Supervisor was notified.
Age: 60.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Blister, Gait inability, Musculoskeletal pain
Clinical narrative: Joint pains, wrists, shoulders knees, couldn't walk for couple days, worst symptoms lasted 48 hours. Mostly resolved 4 days later also has small blisters on R hand no fevers. Took TYLENOL.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Body temperature increased, Dizziness, Headache, Presyncope
Clinical narrative: Health Department nurse gave immunizations around 11:30 am at School. Call to Health Department nurse from School Nurse at 1255 stating that student was in her office with complaints of headache and dizziness. Upon request by this health department nurse, school nurse took vital signs. Temp 100.6, BP 133/73 P 127. No respiratory distress noted, No hives, edema at this time. This health department nurse advised nurse to have student lay down on left side and to call mom for notification with request to call pediatrician for further instruction. Health Department nurse attempted to call mom as well. Left message on voicemail to return call. Follow up call made by Health Department nurse to School Nurse @1326. Patient Temp 100.8, BP 120/76, P118. Patient still c/o headache, dizziness improving, no edema, no respiratory distress, no hives at this time. School Nurse stated that she did get in touch with mom who is coming to pick up student and will call pediatrician's office. 14:18- call from school nurse, mother picked up student and has not heard back from pediatrician. Call to mother from this health department nurse. Mother did call pediatrician who states the patient probably had a vasovagal response. Advised parent to have patient eat and rest. Call if temp >102. Mother states that the patient is feeling better at this time.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Herpes zoster, Pain, Pruritus, Rash
Clinical narrative: Patient started having itching on back and shoulder the day after vaccination. Shingles rash developed within the next few days. Pain and increased blood pressure caused patient to seek medical attention at local hospital.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient stated that arm became and continues to be painful with limited mobility.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient said she has had pain in her arm where she received the vaccine since she has received it. This was about 6 weeks ago. She has taken ibuprofen which seems to help but it doesn't completely go away. I advised her to try warm compress and ALEVE along with an antihistamine in case it is some type of allergic reaction. I told her if the pain continues. She needs to be seen by a doctor.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Injection site pain, Musculoskeletal pain
Clinical narrative: Pain at injection site radiating to back and shoulder for multiple days after vaccination administered.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, redness, tenderness, heat in approximately 4 in circumference below injection site. Began 12 hrs after injection, peaked at 48 hrs, subsiding with TYLENOL and local ice applications.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Bladder pain, Penile pain, Urinary retention
Clinical narrative: PATIENT STATES THAT AT NIGHT (THE SAME DAY OF HIS VACCINE) HE SUDDENLY COULD NOT URINATE. HE HAD THE URGE TO GO AND WHENEVER HE TRIED, HE WOULD BE UNABLE TO AND HAD PAIN IN HIS BLADDER AND PENIS. THE SIDE EFFECT WENT AWAY THE FOLLOWING DAY AND HE IS GOING TO GET EVALUATED BY HIS PHYSICIAN.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site pain, Vaccination site swelling
Clinical narrative: On 2 April he received his fifth Anthrax dose and over the next 48 hours developed pain, redness, swelling, and itching around the vaccination site. He denies fever/chills, chest pain, headache, fatigue, malaise, arthralgias/myalgias, and generalized cutaneous and systemic symptoms. He has used cool compresses and yesterday took a dose of ibuprofen without benefit.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Influenza, Malaise, Nodule, Skin warm
Clinical narrative: Swelled knot, red and hot. Patient was very sick with flu symptoms.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Itching and Redness on arm.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Woke up with muscle aches and took 2 ibuprofen and warm bath to help soothe muscles and almost got stuck in bath tub because everything hurt. Was feeling really tired at night and felt like she had fever but was not able to take temperature since she was at work.
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Patient presented with redness and swelling of the left arm distal to the injection site. She said she was itchy upon initial symptom development but it isn't anymore. It is getting better, but she was still concerned so she came in and had me look at it.
Age: 23.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Back pain, Bone pain, Dyspnoea, Headache
Clinical narrative: Patient called 4/4/19 wondering about side effects of TDaP vaccine. Pt received ADACEL 4/3/19. Pt reported at about 9:00am on 4/4/19, he started to experience "bone aches," headaches, and shortness of breath. Pharmacist questioned him regarding his SOB. After questioning, pt stated he was not experiencing inflammation in the airway and he did not feel like his throat was closing off. The "shortness of breath" he reported was due to his low energy state he was experiencing (i.e. tiredness). He reported getting out of breathe sooner when he was active. It was harder for him to be active today (i.e. bending up and down during his painting job). Patient had no shortness of breath at rest. Pharmacist questioned patient regarding presence of rash or hives. Pt checked his body and reported no rash or hives. Allergy including anaphylaxis was not suspected by pharmacist. Pharmacist told patient he is welcome to see a physician, however I recommended patient to give it some time to see if he feels better over time. On the phone, patient stated he will give it some time to see if he feels better. Pharmacist told him I would call him tomorrow to see how he was feeling. Pharmacist also told patient if he ends up seeing a provider and it is determined that his symptoms were due to the vaccine, Pharmacy will "take care of him." I told him Pharmacy has insurance to cover anything corporate determines requires reimbursement. Patient decided to wait and see how he felt later on. Patient's wife called back later in the day and reported the patient was experiencing worsening headache, back pain, tiredness, rib pain and SOB. She stated patient was considering being seen by physician. He encouraged patient to be seen if patient thought he needed to seek treatment/diagnosis. He reiterated that Pharmacist will call tomorrow to see how patient is feeling. Wife did not state whether patient was or was not going to see a physician.
Age: 23.0
Sex: M
Vaccine: TDAP
Symptoms: Musculoskeletal chest pain
Clinical narrative: Patient called 4/4/19 wondering about side effects of TDaP vaccine. Pt received ADACEL 4/3/19. Pt reported at about 9:00am on 4/4/19, he started to experience "bone aches," headaches, and shortness of breath. Pharmacist questioned him regarding his SOB. After questioning, pt stated he was not experiencing inflammation in the airway and he did not feel like his throat was closing off. The "shortness of breath" he reported was due to his low energy state he was experiencing (i.e. tiredness). He reported getting out of breathe sooner when he was active. It was harder for him to be active today (i.e. bending up and down during his painting job). Patient had no shortness of breath at rest. Pharmacist questioned patient regarding presence of rash or hives. Pt checked his body and reported no rash or hives. Allergy including anaphylaxis was not suspected by pharmacist. Pharmacist told patient he is welcome to see a physician, however I recommended patient to give it some time to see if he feels better over time. On the phone, patient stated he will give it some time to see if he feels better. Pharmacist told him I would call him tomorrow to see how he was feeling. Pharmacist also told patient if he ends up seeing a provider and it is determined that his symptoms were due to the vaccine, Pharmacy will "take care of him." I told him Pharmacy has insurance to cover anything corporate determines requires reimbursement. Patient decided to wait and see how he felt later on. Patient's wife called back later in the day and reported the patient was experiencing worsening headache, back pain, tiredness, rib pain and SOB. She stated patient was considering being seen by physician. He encouraged patient to be seen if patient thought he needed to seek treatment/diagnosis. He reiterated that Pharmacist will call tomorrow to see how patient is feeling. Wife did not state whether patient was or was not going to see a physician.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Nasopharyngitis, Pain in extremity
Clinical narrative: Patient called clinic to report cold symptoms and L arm pain and joint pain after receiving vaccination and PPD test yesterday. pt denies cp, sob, swelling, numbness or tingling. pt was instructed to call tomorrow morning if not improving for an urgent care appt. pt verbalized understanding.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Developed area around injection site that became very red and warm on day 2. On day 3, redness had reduced some but it was swollen more (down to elbow) and still warm. She called her doctor, who prescribed BACTRIM DS as a precaution. Will follow up with patient in 2 days.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Arthralgia, Erythema, Lymph node pain, Lymphadenopathy, Neck pain
Clinical narrative: Patient presenting on 3/18/2019 with severely enlarged left axillary lymph node that was excruciatingly painful to touch. Node smaller but still present today, 4/4/19. On 4/1/19, Samuel presented with left elbow redness, swelling and pain as well as what he described as "neck pain" only when turning his head to the left.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Pain
Clinical narrative: Patient presenting on 3/18/2019 with severely enlarged left axillary lymph node that was excruciatingly painful to touch. Node smaller but still present today, 4/4/19. On 4/1/19, Samuel presented with left elbow redness, swelling and pain as well as what he described as "neck pain" only when turning his head to the left.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Tremor
Clinical narrative: Around 6 hours after the vaccine was given, the patient experienced severe shivering/shaking which last approximately 2 hours. After it ended she had a general feeling of soreness for several days.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral coldness
Clinical narrative: PT CAME IN FOR 1ST DOSE IN MORNING AROUND 11:15AM. SHE STATED THAT NIGHT IS WHEN SHE EXPERIENCED COLD EXTREMETIES. IT WAS JUST HER LEFT PALM THAT SHE SAID WAS VERY COLD. PATIENT SAID SHE USED A HEATED RICE PACK TO HEAT UP THE AREA. IT EVENTUALLY RESOLVED THAT NIGHT. She also mentioned that her extremities are usually always cold. but this night, It was just the arm that she received the vaccine.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain in extremity, Tendonitis
Clinical narrative: Patient said after 1 hour she had severe pain in her arm/ shoulder and tried taking tylenol for it. That did not relieve the pain so she went to the ER and they diagnosed her with tendonitis from the shot and gave her tylenol with codeine. As of yester day when she came into our store to talk with employee who was not here, but had administered the shot she was still sore in that arm/shoulder. She only wanted to speak with the RPh that administered the shot not get anyone in trouble.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Peripheral swelling, Pyrexia
Clinical narrative: PATIENT SAYS FEVER FOR ONE WEEK, ARM WAS SWOLLEN TWICE IT'S SIZE AND COULD NOT MOVE IT.
Age: 1.5
Sex: F
Vaccine: MMRV
Symptoms: Food allergy, Streptococcal infection
Clinical narrative: She got strep and began having her food allergies and health issues.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Rash on face and neck. Red flat like bumps that itch. Did a detox bath with apple cider vinegar, bentonite clay, and had her drink alkaline water.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Hyperhidrosis, Syncope
Clinical narrative: Patient began to experience syncope with diaphoresis. We had the patient rest for 15 minutes and gave him cold water and fruit smoothie.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Decreased appetite, Diarrhoea, Lethargy, Pain
Clinical narrative: On 12/6, Patient received the influenza vaccine. As of 5:00 PM Valery was complaining on pain and did not want to leave her bed. Patient ran a high fever, had chills, diarrhea, lethargy, loss of appetite, and body aches. This continued for multiple days. On 12/10 we contacted our pediatrician for a follow up appointment and was informed by the doctor that there was the possibility of this occurring, after being informed at our initial visit that this was not a possibility. These symptoms continued until 12/13 when Valery was finally able to return to school. The doctor did not recommend any treatment, or suggest any course of action for attempting to deal with Patient's illness.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: On 12/6, Patient received the influenza vaccine. As of 5:00 PM Valery was complaining on pain and did not want to leave her bed. Patient ran a high fever, had chills, diarrhea, lethargy, loss of appetite, and body aches. This continued for multiple days. On 12/10 we contacted our pediatrician for a follow up appointment and was informed by the doctor that there was the possibility of this occurring, after being informed at our initial visit that this was not a possibility. These symptoms continued until 12/13 when Valery was finally able to return to school. The doctor did not recommend any treatment, or suggest any course of action for attempting to deal with Patient's illness.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Fever 101, extreme body ache, nausea, mild heachache x4days, injection site swelling, redness and pain.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Fever 101, extreme body ache, nausea, mild heachache x4days, injection site swelling, redness and pain.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Fever 101, extreme body ache, nausea, mild heachache x4days, injection site swelling, redness and pain.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain
Clinical narrative: Fever 101, extreme body ache, nausea, mild heachache x4days, injection site swelling, redness and pain.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenopia, Extraocular muscle paresis, Influenza like illness, Pain
Clinical narrative: 4 hours after shot flu like symptoms, eyes feels lethargic, dull pain and weakness in eyes. Flu like symptoms resolved after 36 hours after taking TYLENOL three times daily. Eyes still weak after 6 days. Patient will follow up with dr tomorrow.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Hyperaesthesia, Rash
Clinical narrative: Skin sensitivity left torso, abdomen and back 10 days post injection. Rash and blisters appearing left torso abdomen and back 15 days post injection. Valtrex prescribed.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Crying, Pyrexia, Vaccination complication
Clinical narrative: Acute high fever increased 105 (Ax). Inconsolable crying 3-4 hrs. Infant's father had the same reaction as a baby with dose #2 and 3. Paternal grandfather is an MD and baby's PCP. Requested DT pediatric dose #4.
Age: 3.0
Sex: M
Vaccine: DT, HEP, HIBV, IPV, MMRV
Symptoms: Anger, Asthenia, Gait disturbance, Influenza virus test negative, Pyrexia
Clinical narrative: Fever 103.5 - TYLENOL/IBP at ED - decreased T - 97.8 on discharge. T - 104.5 - continued alternating IBP and TYLENOL. Episode of vomiting after lunch. Gait - uncoordinated with periods of weakness. Outbursts of anger - unprovoked. Recommended hospital after reporting above symptoms to ER Doc.
Age: 3.0
Sex: M
Vaccine: DT, HEP, HIBV, IPV, MMRV
Symptoms: Vomiting
Clinical narrative: Fever 103.5 - TYLENOL/IBP at ED - decreased T - 97.8 on discharge. T - 104.5 - continued alternating IBP and TYLENOL. Episode of vomiting after lunch. Gait - uncoordinated with periods of weakness. Outbursts of anger - unprovoked. Recommended hospital after reporting above symptoms to ER Doc.
Age: 1.25
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: (L) thigh red, warm to touch, raised, hard. MOTRIN OTC, per mom. Cool compresses. TYLENOL, PM.
Age: 2.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Cyanosis, Rash macular, Skin discolouration
Clinical narrative: Child began coughing uncontrollably with some facial color change, circumoral cyanosis and red blotches on chest and back. PCP made aware/positive breath sounds auscultated. BENADRYL 2.5 ml given (12-5mg/5ml) symptoms resolved.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chest pain, Headache, Injection site pain, Musculoskeletal pain
Clinical narrative: Severe muscle pain radiating from (R) deltoid up to neck and to (R) scapula, also down (R) thorax to hip area. Developed headache and low grade fever. Arm sensitive with any movement for next 36-48 hours. Gradually resolved.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: Severe muscle pain radiating from (R) deltoid up to neck and to (R) scapula, also down (R) thorax to hip area. Developed headache and low grade fever. Arm sensitive with any movement for next 36-48 hours. Gradually resolved.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity
Clinical narrative: Patient complained of sore arm and at later date (11-23-18) says was diagnosed with shingles; received Tx of Acyclovir 800mg 5x day x 10d. Today 4-4-19 says arm still sore.
Age: 3.0
Sex: M
Vaccine: MMRV
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster virus after receiving 2 previous doses of varicella vaccine (varicella - 08/20/12, MMRV - 08/01/14).
Sex: M
Vaccine: ANTH
Symptoms: Decreased immune responsiveness, Gastritis, Overgrowth bacterial
Clinical narrative: Gastritis; Bacteria overgrowth; Weakened immune system; Cross reference VAERS #186825 Spontaneous report received via telephone on 13Feb2019 from a consumer.   An approximately 25 year old male reported ongoing gastritis, bacteria overgrowth and weakened immune system since receiving 4 doses of Biothrax vaccines beginning in 1996 - 1999. Patient stated he has not felt normal since that time.    Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Herpes zoster, Post herpetic neuralgia
Clinical narrative: Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient. The patient's medical history, concurrent conditions and concomitant medication use were not provided. In or about 05-MAR-2017, the patient was inoculated with ZOSTAVAX, (lot# and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). One day after receiving ZOSTAVAX, the patient suffered herpes zoster, cellulitis and postherpetic neuralgia. As a direct and proximate result of ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a direct and proximate result, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Upon internal review cellulitis was considered medically significant. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Feeling hot, Pallor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID 693441). This spontaneous report was received via FDA regarding 14-year-old male patient. The concurrent condition included Cyclic neutropenia and patient was lactose intolerant. The historical condition and concomitant medications were not reported. On 17-APR-2017, the patient was vaccinated with GARDASIL 9 dose 1, administered to the right arm as prophylaxis (lot # M003659). Approximately 10 minutes after the vaccination, the patient became lightheaded, dizzy, hot and pale. Patient was placed in chair, tolerating apple juice and cookies, cool rags placed on patient. Outcome of the events was resolved (unknown date in 2017). Reporter did not provide any causality assessment. Follow-up information has been received from a registered nurse from the FDA under the Freedom of Information Act on 25-FEB-2019. On an unknown date, the patient was vaccinated with first dose of GARDASIL 9 as prophylaxis (lot # unknown). On 17-APR-2017 (at 15.45), the patient was vaccinated with GARDASIL 9 dose 2, administered to the right arm (deltoid) at military clinic/hospital by the physician. On the same day at 16.00, patient experienced the aforementioned events. Follow-up information was received from a nurse from pediatric clinic regarding the reported events of dizziness, feeling hot, and pallor following the administration of the Merck vaccination of GARDASIL 9. Reporter was unable to identify the patient on this report due to lack of patient identification information. Additional details were unable to be provided. No additional information collected at the time of the call.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Circumstance or information capable of leading to medication error, Dizziness, Feeling abnormal, Nervousness
Clinical narrative: Initial report was identified from a line listing obtained on request by the Company from the FDA under the Act and follow up information was received from a healthcare professional via the agency. The patient's medical history was not reported. The patient had no current illnesses. On 05-OCT-2017, the patient was vaccinated with GARDASIL 9 (lot# N00326 not valid) dose 2, intramuscular in the left arm for prophylaxis. Other suspect therapies included VARIVAX (lot#; M035140 expiry date: 03-AUG-2018) dose 2 Subcutaneously, left Arm, BOOSTRIX (Batch#: ZN937) dose2, intramuscular, right Arm, HAVRIX (Batch#:32YJ3) dose 2; Intramuscular, right arm, MENACTRA (Batch #: U5557AB) dose2, intramuscular; right arm. It was reported that he was very nervous and kept moving around to prevent administration of vaccinations. Both he and his mother spoke different language so it was hard to communicate but a coworker translated and mother wanted him to have all five vaccines. Mother raised her voice to him to cooperate and sit still, although as soon as he would sit for the vaccination he would move away and jump up out of the chair. Finally his mother convinced him to sit still for the vaccinations. Few minutes later she asked if he was feeling dizzy as he looked a little dazed (translator not in the room anymore and other nurses busy with clients so I did the best I could to communicate). On the same day, (On 05-OCT-2017) he was also feeling abnormal. He shook his head yes, so she utilized an ammonia packet which seemed to bring him to alertness and an ice pack for the back of his neck and forehead. After a minute or two he shook it off and indicated he was fine. When she went out to pay at the front desk asked the desk person to translate to mom to have him sit down in the lobby while she paid. The patient was fine and they left. The outcome of dizziness and feeling abnormal was reported as recovered/resolved. Causality was not reported. Follow up information was received from nurse on 02-APR-2019: The nurse stated that without the patient's complete demographics, no further information was available at time of call. Shared the patient had been vaccinated on 05-OCT-2017 with multiple vaccines, including VARIVAX and GARDASIL 9. She stated if any further information would be available in the future; she would call back.
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: swollen; numbness; left arm pain; warm to touch; Initial information regarding an unsolicited valid non-serious case downloaded from the VAERS database received on 29-Mar-2019 from consumer of Health Authorities under reference 734111-1.   This case involves a 7 years old male patient who experienced swollen, numbness, left arm pain and warm to touch, while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history included Allergy to vaccine (Allergy to vaccine). The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 18-Dec-2018, the patient received a 6thdose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT5936KA via intramuscular route in the left arm.  On 18-Dec-2018, on same date after the vaccination the patient experienced peripheral swelling, hypoaesthesia, pain in arm (pain in extremity) and skin warm.  No lab data was reported.  Final diagnosis was peripheral swelling, hypoaesthesia, pain in arm (pain in extremity) and skin warm.  It was not reported if the patient received a corrective treatment.  The outcome of the events was not reported.  List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: itching red and swollen left arm; itching red and swollen left arm; itching red and swollen left arm; Initial information received on 29-Mar-2019 regarding an unsolicited valid non-serious case received from consumer of Health Authorities, VAERS ID: 741883-1.  This case involves a 54 years old female patient who experienced itching red and swollen left arm, while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history was not reported and medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 17-Mar-2018, the patient received a 1stdose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5771AA via intramuscular route in the left arm.  On 19-Mar-2018, 2 days after the vaccination the patient experienced erythema, peripheral swelling and pruritus.  No lab data was reported.  Final diagnosis was erythema, peripheral swelling and pruritus.  Corrective treatment included equate brand diphenhydramine 2% and zinc 0.1% cream.  The outcome of the events was not reported.  List of documents held by sender: none.
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness below injection site; swelling below injection site; Initial information regarding an unsolicited valid non-serious case downloaded from the VAERS database received on 29-Mar-2019 from other healthcare professional via Health Authorities under reference 775527-1.  This case involves a 33 years old female patient who experienced redness below injection site and swelling below injection site, while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history included Rubber sensitivity and Food allergy with Bananas. The patient's past medical treatment included KEFLEX with allergy. The patient's past vaccination(s) and family history were none.  On 03-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1805 via intramuscular route in the right arm.  On 03-Oct-2018, the patient developed a non-serious redness below injection site (injection site erythema) and swelling below injection site (injection site swelling) same day following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Other relevant tests not reported.    Final diagnosis was injection site erythema and injection site swelling.  The patient was treated with intermittent ice, ZYRTEC and ibuprofen PRN.  The patient outcome was unknown for injection site erythema and injection site swelling.  List of documents held by sender- none.