chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Muscle spasms
Clinical narrative: 2 HOURS AFTER FLU VACCINE COMPLAINS OF MUSCLE SPASMS AND PAIN AT SITE OF INJECTION.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site warmth, Pain
Clinical narrative: Soreness at injection site, three inch diameter rash, very warm skin temperature, pain upon movement of right arm for four days after initial injection.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Neuralgia
Clinical narrative: Patient describes nerve pain starting in legs and moving through body the following day. She did not seek treatment but stopped by pharmacy to inquire about adverse event. Possible Guillain Barre Syndrome.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fall, Nervousness
Clinical narrative: PATIENT WAS QUITE NERVOUS ABOUT THE SHOT, BECAME FAINT AND FELL DOWN, BUT COULD SPEAK SHORTLY AFTERWARDS. PROMPTLY 911 WAS CALLED AND THE PARAMEDICS ARRIVED WITHIN 10 TO 15 MINUTES, EXAMINED HER AND DECLARED THAT HER BLOOD PRESSURE AND VITAL SIGNS WERE NORMAL AND WITH HER PARENTS SHE WAS ABLE TO WALK OUT OF THE STORE TO GO HOME.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass
Clinical narrative: 1.5 inch lump that's never gone away at injection site.
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Rash, Urticaria
Clinical narrative: Took PREVENAR vaccine and broke out in rash and hives, arms sore after several days.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis allergic, Hypersensitivity
Clinical narrative: Systemic skin allergy.
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: GARDASIL 9 vaccination was administered into my right arm and now months later the pain that once was mild grew over time to now being severe and unbearable.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Patient received the flu shot at his retail pharmacy on 10/17/2017. He reported to the emergency department at hospital with rash and hives. No food allergen exposure or environmental exposure. No difficulty swallowing or breathing.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: C-reactive protein increased, Eosinophil percentage increased, Gait disturbance, Haematocrit normal, Haemoglobin normal
Clinical narrative: Vaccine given at 8 am. That afternoon with onset soreness of swelling. Some limping and difficulty at baseball game but mom told not get to see until home in evening. Sign of induration, edema, tenderness from 2 inch above injection to knee.  Nl CBC, ESR-2, Prednisone started Fri evening with improvement next am at F/U and no symp Monday.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Induration, Lymphocyte percentage, Monocyte percentage increased, Neutrophil percentage decreased, Oedema
Clinical narrative: Vaccine given at 8 am. That afternoon with onset soreness of swelling. Some limping and difficulty at baseball game but mom told not get to see until home in evening. Sign of induration, edema, tenderness from 2 inch above injection to knee.  Nl CBC, ESR-2, Prednisone started Fri evening with improvement next am at F/U and no symp Monday.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Platelet count normal, Red blood cell sedimentation rate normal, Swelling, Tenderness
Clinical narrative: Vaccine given at 8 am. That afternoon with onset soreness of swelling. Some limping and difficulty at baseball game but mom told not get to see until home in evening. Sign of induration, edema, tenderness from 2 inch above injection to knee.  Nl CBC, ESR-2, Prednisone started Fri evening with improvement next am at F/U and no symp Monday.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: White blood cell count increased
Clinical narrative: Vaccine given at 8 am. That afternoon with onset soreness of swelling. Some limping and difficulty at baseball game but mom told not get to see until home in evening. Sign of induration, edema, tenderness from 2 inch above injection to knee.  Nl CBC, ESR-2, Prednisone started Fri evening with improvement next am at F/U and no symp Monday.
Age: 74.0
Sex: F
Vaccine: FLUA3
Symptoms: Cellulitis
Clinical narrative: Patient developed cellulitis on her arm where vaccination was administered.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Injection site erythema, Injection site pain, Myalgia
Clinical narrative: Four side effects to PNEUMOVAX. Pain and redness where shot was given, felt weak and muscle pain.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: 6 hours post high dose flu shot, pt had fever of 102.5 degrees F that lasted 12 hours. TYLENOL 650 mg and MOTRIN 400 mg did not help.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: States that she received FLUZONE in arm, by bedtime, (L) deltoid was red, warm to touch, swollen and painful. Infection preventionist brought her to us on Thurs. 10-12-17. She had just been to ER so PA could look at area. No treatment done. Area measured. 54 mm x 61 mm redness. Saw patient on Tues 10-17-17 - everything gone.
Age: 64.0
Sex: F
Vaccine: PNC13, UNK
Symptoms: Cough, Fatigue, Headache, Nasal congestion, Pyrexia
Clinical narrative: Fatigue, felt feverish (no documented fever), headache, nasal congestion, sinus pain and cough.
Age: 64.0
Sex: F
Vaccine: PNC13, UNK
Symptoms: Sinus pain
Clinical narrative: Fatigue, felt feverish (no documented fever), headache, nasal congestion, sinus pain and cough.
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Hypoaesthesia, Paraesthesia, Sensory loss
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of numbness of extremities in a female patient who received Influenza vaccine. On 11th October 2017, the patient received Influenza vaccine. In October 2017, less than a week after receiving Influenza vaccine, the patient experienced numbness of extremities, tingling, weakness and loss of sensation. On an unknown date, the outcome of the numbness of extremities, tingling, weakness and loss of sensation were unknown. It was unknown if the reporter considered the numbness of extremities, tingling, weakness and loss of sensation to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. On Wednesday, the patient had received the flu shot. The patient had numbness and tingling down to my fingertips and some weakness. On Saturday, the day of reporting, she still had some loss of sensation down to fingertips. The patient hoped the next few days the events would continue to improve. On 16th October 2017, the patient was contacted to clarify her mailing address.
Age: 16.0
Sex: F
Vaccine: FLU4, HPV9, MNQ
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Day following vaccine administration, red, warm rash on (R) forearm and at (R) thumb only on arm where HPV 9 administered.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Urticarial lesions/rash.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Pain
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site swelling a 47-year-old female patient who received FLUARIX QUADRIVALENT (batch number 4799F, expiry date 18th June 2018). On 3rd October 2017, the patient received FLUARIX QUADRIVALENT .5 ml. On 4th October 2017, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site swelling and pain. On an unknown date, the outcome of the injection site swelling and pain were unknown. The reporter considered the injection site swelling and pain to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: This case was previously reported to a doctor. The reporter heard from another nurse mentioning that her patient had experienced side effects also. The patient received the vaccine in the left deltoid. The reporter was told that the injection site swelling was about the size of a small golf ball. The name of the director of the location facility was provided.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Rash
Clinical narrative: Patient broke out in rash on face, trunk and arms. Medicated with BENADRYL (5mL) and ORAPRED (5mL). Rash resolving. Patient referred to Allergy and Asthma for evaluation.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: S/P vaccination 10/12/17 developed erythema, swelling, and pain to proximal L. upper extremity. Next day, she had subjective fever, fatigue, and myalgia's.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: S/P vaccination 10/12/17 developed erythema, swelling, and pain to proximal L. upper extremity. Next day, she had subjective fever, fatigue, and myalgia's.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: 3.5 inch diameter rash reported 3 inches below injection site, rash has itching and redness.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Erythema, Rash, Swelling
Clinical narrative: 3.5 inch diameter rash reported 3 inches below injection site, rash has itching and redness.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Patient presented to the pharmacy 3 days later after flu shot with swelling on her underarm and forearm. Pt was advised to take BENADRYL/cold compress and to seek medical attention.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site discolouration
Clinical narrative: Could not hardly move (L) arm - had to ice. Several hours - inj site black, blue, pink.
Sex: U
Vaccine: FLUC4, PPV, VARZOS
Symptoms: Injection site induration, Injection site mass, Pain in extremity, Peripheral swelling
Clinical narrative: Really bad pain and swelling in arm. Hard lump at injection site (could not touch area).
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site mass
Clinical narrative: Pt noticed lump and bruising in left deltoid on 10/12 - 10/13. Still has bruising 10/24.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Lymphadenopathy
Clinical narrative: Swelling of lymph node to left under arm.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis of left upper extremity.
Age: 74.0
Sex: U
Vaccine: FLU3, PNC13
Symptoms: Mobility decreased
Clinical narrative: Patient complained about not being able to move her arm. Pt refused for us to contact primary MD. .
Age: 59.0
Sex: F
Vaccine: FLU4, PPV, FLU3, PNC13
Symptoms: Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: Within 12 hours the arm had turn red, and a fever of 103. By Saturday sept 30 had gotten worse and went to the clinic and confirmed cellulitis in right arm. Monday went to primary care physician and was again confirmed. Worried about spreading to areas of Cancer. After 4 days of home confinement  the right arm was able to be used.
Age: 59.0
Sex: F
Vaccine: FLU4, PPV, FLU3, PNC13
Symptoms: Cellulitis, Erythema, Laboratory test abnormal, Pyrexia
Clinical narrative: Within 12 hours the arm had turn red, and a fever of 103. By Saturday sept 30 had gotten worse and went to the clinic and confirmed cellulitis in right arm. Monday went to primary care physician and was again confirmed. Worried about spreading to areas of Cancer. After 4 days of home confinement  the right arm was able to be used.
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity
Clinical narrative: Vaccine was given very high on my right shoulder- I don't believe that it was given in the muscle, but possibly in the bursa of my shoulder. On October 2nd, the pain in my arm/shoulder became very bad. It is painful to lift and move. There is a tingling in my fingers and I cannot lift or move items with that arm. I went to urgent care on 10/14/2017 after trying Ibuprofen as recommended. The Dr. found that the injection was give too high and was causing pain. They prescribed Pred which, helped for a few days, and now that I am off it, the pain is returning.
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Drug administered at inappropriate site, Musculoskeletal pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Vaccine was given very high on my right shoulder- I don't believe that it was given in the muscle, but possibly in the bursa of my shoulder. On October 2nd, the pain in my arm/shoulder became very bad. It is painful to lift and move. There is a tingling in my fingers and I cannot lift or move items with that arm. I went to urgent care on 10/14/2017 after trying Ibuprofen as recommended. The Dr. found that the injection was give too high and was causing pain. They prescribed Pred which, helped for a few days, and now that I am off it, the pain is returning.
Age: 42.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity
Clinical narrative: Pain, numbness, and weakness in left arm. Decreased range of motion. Pain during use and inactivity. Pain sometimes extending to elbow and wrist of left arm. Ibuprofen 600 mg three times daily for week, did not help. Currently on course of Prednisone.
Age: 42.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Arthralgia, Hypoaesthesia, Injection site pain, Joint range of motion decreased, Muscular weakness
Clinical narrative: Pain, numbness, and weakness in left arm. Decreased range of motion. Pain during use and inactivity. Pain sometimes extending to elbow and wrist of left arm. Ibuprofen 600 mg three times daily for week, did not help. Currently on course of Prednisone.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Cough, Croup infectious, Febrile convulsion, Neurological examination normal, Speech disorder
Clinical narrative: Our son got very sick after receiving these vaccinations-by the third week he had a seizure life threatening seizure where he stopped breathing for six minutes (lack of oxygen to the brain). These vaccinations nearly killed our son. He immediately lost all speech, spins in circles, walks on tiptoes, babbles->all since this seizure. NO ONE on either side of our family has ever had a seizure. For Dr. to state that seizures are the new "Normal" is absolutely insane! Both of our sons have had seizures after receiving immunizations. Both of our sons turned blue from lack of oxygen to the brain and almost died. Both of our sons have received more than 23 vaccinations each by the time they were 1 1/2 years old. Both of our sons have been adversely affected by these poison, deadly toxic vaccines. The CDC and big pharma must be accountable for the families and lives they are destroying every day. How many lives ruined will be enough for them? Make vaccines safe or STOP GIVING THEM! Please, please STOP the cover-up!
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Stridor
Clinical narrative: Our son got very sick after receiving these vaccinations-by the third week he had a seizure life threatening seizure where he stopped breathing for six minutes (lack of oxygen to the brain). These vaccinations nearly killed our son. He immediately lost all speech, spins in circles, walks on tiptoes, babbles->all since this seizure. NO ONE on either side of our family has ever had a seizure. For Dr. to state that seizures are the new "Normal" is absolutely insane! Both of our sons have had seizures after receiving immunizations. Both of our sons turned blue from lack of oxygen to the brain and almost died. Both of our sons have received more than 23 vaccinations each by the time they were 1 1/2 years old. Both of our sons have been adversely affected by these poison, deadly toxic vaccines. The CDC and big pharma must be accountable for the families and lives they are destroying every day. How many lives ruined will be enough for them? Make vaccines safe or STOP GIVING THEM! Please, please STOP the cover-up!
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Abnormal behaviour, Aphasia, Autism spectrum disorder, Cyanosis, Malaise
Clinical narrative: Our son got very sick after receiving these vaccinations-by the third week he had a seizure life threatening seizure where he stopped breathing for six minutes (lack of oxygen to the brain). These vaccinations nearly killed our son. He immediately lost all speech, spins in circles, walks on tiptoes, babbles->all since this seizure. NO ONE on either side of our family has ever had a seizure. For Dr. to state that seizures are the new "Normal" is absolutely insane! Both of our sons have had seizures after receiving immunizations. Both of our sons turned blue from lack of oxygen to the brain and almost died. Both of our sons have received more than 23 vaccinations each by the time they were 1 1/2 years old. Both of our sons have been adversely affected by these poison, deadly toxic vaccines. The CDC and big pharma must be accountable for the families and lives they are destroying every day. How many lives ruined will be enough for them? Make vaccines safe or STOP GIVING THEM! Please, please STOP the cover-up!
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Respiratory arrest, Seizure, Speech disorder, Toe walking, Tonsillar hypertrophy
Clinical narrative: Our son got very sick after receiving these vaccinations-by the third week he had a seizure life threatening seizure where he stopped breathing for six minutes (lack of oxygen to the brain). These vaccinations nearly killed our son. He immediately lost all speech, spins in circles, walks on tiptoes, babbles->all since this seizure. NO ONE on either side of our family has ever had a seizure. For Dr. to state that seizures are the new "Normal" is absolutely insane! Both of our sons have had seizures after receiving immunizations. Both of our sons turned blue from lack of oxygen to the brain and almost died. Both of our sons have received more than 23 vaccinations each by the time they were 1 1/2 years old. Both of our sons have been adversely affected by these poison, deadly toxic vaccines. The CDC and big pharma must be accountable for the families and lives they are destroying every day. How many lives ruined will be enough for them? Make vaccines safe or STOP GIVING THEM! Please, please STOP the cover-up!
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Vaccination complication
Clinical narrative: Our son got very sick after receiving these vaccinations-by the third week he had a seizure life threatening seizure where he stopped breathing for six minutes (lack of oxygen to the brain). These vaccinations nearly killed our son. He immediately lost all speech, spins in circles, walks on tiptoes, babbles->all since this seizure. NO ONE on either side of our family has ever had a seizure. For Dr. to state that seizures are the new "Normal" is absolutely insane! Both of our sons have had seizures after receiving immunizations. Both of our sons turned blue from lack of oxygen to the brain and almost died. Both of our sons have received more than 23 vaccinations each by the time they were 1 1/2 years old. Both of our sons have been adversely affected by these poison, deadly toxic vaccines. The CDC and big pharma must be accountable for the families and lives they are destroying every day. How many lives ruined will be enough for them? Make vaccines safe or STOP GIVING THEM! Please, please STOP the cover-up!
Age: 48.0
Sex: F
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Dysgeusia, Injection site pain, Lymphadenopathy, Pain in extremity, Paraesthesia oral
Clinical narrative: I have had and continue to have severe pain in the shoulder that received the injections. I'm unsure why, but I received both the flu and tetanus shots in my right arm, even though I'm right-handed and told the tech I was right-handed beforehand. The shoulder pain is constant and intensifies with movement; the pain is at its worst late at night and in the morning (i.e., when I'm trying to sleep - prone and stationary). I went to a GP, on Sept. 26, 2017.  She prescribed a Prednisone 10-day Taper pack for the pain. While on the Prednisone, the pain was dulled; I could feel that something was wrong with my shoulder, but the pain was not as bad. I started the [[Continued below.]]
Age: 48.0
Sex: F
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Streptococcus test negative, Ultrasound scan abnormal
Clinical narrative: I have had and continue to have severe pain in the shoulder that received the injections. I'm unsure why, but I received both the flu and tetanus shots in my right arm, even though I'm right-handed and told the tech I was right-handed beforehand. The shoulder pain is constant and intensifies with movement; the pain is at its worst late at night and in the morning (i.e., when I'm trying to sleep - prone and stationary). I went to a GP, on Sept. 26, 2017.  She prescribed a Prednisone 10-day Taper pack for the pain. While on the Prednisone, the pain was dulled; I could feel that something was wrong with my shoulder, but the pain was not as bad. I started the [[Continued below.]]
Age: 48.0
Sex: F
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Blood test, Dysgeusia, Injection site pain, Lymphadenopathy, Pain
Clinical narrative: I have had and continue to have severe pain in the shoulder that received the injections. I'm unsure why, but I received both the flu and tetanus shots in my right arm, even though I'm right-handed and told the tech I was right-handed beforehand. The shoulder pain is constant and intensifies with movement; the pain is at its worst late at night and in the morning (i.e., when I'm trying to sleep - prone and stationary). I went to a GP, on Sept. 26, 2017.  She prescribed a Prednisone 10-day Taper pack for the pain. While on the Prednisone, the pain was dulled; I could feel that something was wrong with my shoulder, but the pain was not as bad. I started the [[Continued below.]]
Age: 48.0
Sex: F
Vaccine: FLU4, TDAP, FLU4, TDAP
Symptoms: Paraesthesia oral, Periarthritis, Ultrasound scan, X-ray limb
Clinical narrative: I have had and continue to have severe pain in the shoulder that received the injections. I'm unsure why, but I received both the flu and tetanus shots in my right arm, even though I'm right-handed and told the tech I was right-handed beforehand. The shoulder pain is constant and intensifies with movement; the pain is at its worst late at night and in the morning (i.e., when I'm trying to sleep - prone and stationary). I went to a GP, on Sept. 26, 2017.  She prescribed a Prednisone 10-day Taper pack for the pain. While on the Prednisone, the pain was dulled; I could feel that something was wrong with my shoulder, but the pain was not as bad. I started the [[Continued below.]]
Age: 79.0
Sex: F
Vaccine: FLU3, PNC13, PNC13
Symptoms: Nausea
Clinical narrative: Pt experienced sweating, nausea, vomiting, diarrhea, and dizziness at 12 am and was taken by ambulance to hospital around 6am. Pt states she does not know what she was given in the hospital and was there for 1 day.
Age: 79.0
Sex: F
Vaccine: FLU3, PNC13, PNC13
Symptoms: Diarrhoea, Dizziness, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Pt experienced sweating, nausea, vomiting, diarrhea, and dizziness at 12 am and was taken by ambulance to hospital around 6am. Pt states she does not know what she was given in the hospital and was there for 1 day.
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: Arthralgia, Back pain, Injection site pain, Muscular weakness
Clinical narrative: Pain in both knees, weakness in legs pain in the shoulder, just one the right one. Pain in the back. Some times its hard to lie down. Don't have a primary right now. She left the network. In the process off choosing one. I take pain relievers just over the counter. It does ease the pain.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Severe Shoulder Pain and trouble moving the arm.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Arm was swollen and itchy. Reaction was not reported to the pharmacy until 10/24/2017 at which time the swelling and itching had started to subside.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 61 year old female patient. No information on the patient's pertinent medical history, concurrent conditions and concomitant medication was provided. On 21-SEP-2017, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously (dose, frequency, lot# and expiry date were not reported) for prophylaxis. Recently and soon, on approximately 22-SEP-2017 (reported as: "a day or two after receiving"), the patient developed itchy rash near the injection site. No treatment was given for the event. The patient sought for medical attention by calling a pharmacist. The outcome of the events was reported as not recovered/not resolved. The causality assessment was not reported.
Age: 62.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a pharmacist via a field representative and refers to a 62 year old male patient. The patient's concurrent conditions, medical history, and allergies were not reported. On 29-SEP-2017, the patient was vaccinated with an unspecified dose of ZOSTAVAX 19400 PFU, subcutaneous, for prevention of herpes zoster (dosage schedule, anatomical location, lot number, and expiration date were not reported). Concomitant therapies included influenza virus vaccine (reported as "flu shot") on his left arm. On approximately 02-OCT-2017 (reported as "three (3) days later"), the patient experienced one inch red injection site reaction on his right arm. Subsequently, on an unspecified date in October 2017, the patient returned to the pharmacy to sought medical attention; no treatment was reported, and laboratory diagnostic studies were not performed. At the time of reporting, the outcome of injection site erythema was unknown. The relatedness between the event and therapy with ZOSTAVAX was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from an unspecified patient of unknown age, referring to themselves. The patient's medical history, concurrent conditions and concomitant therapy were not reported. On an unspecified date in 2012, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous (dose, lot# and expiration date were not provided) for prophylaxis. On 01-SEP-2017, the patient received another dose of ZOSTAVAX subcutaneous (dose, lot# and expiration date were not provided) for prophylaxis. The patient did not experience any side effects.
Age: 79.0
Sex: F
Vaccine: TTOX, VARZOS
Symptoms: Dizziness, Feeling abnormal, Immediate post-injection reaction, Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report has been received from a pharmacist, concerning a 79 year old female patient. It was reported that the patient had no current conditions as well as drug reactions, allergies or pertinent medical history. Concomitant therapies included CRESTOR, nitroglycerin, EFFEXOR and lorazepam. On 22-AUG-2017, the patient was vaccinated with one dose of ZOSTAVAX subcutaneously, lot number N014019 and expiration date 04-JUL-2018 for prophylaxis which was reconstituted with sterile diluent (manufacturer unknown) lot number N015478 and expiration date 28-SEP-2019. At the same date, the patient was vaccinated with tetanus toxoid (manufacturer unknown). On 22-AUG-2017 (reported as immediately after getting the vaccines), the patient did not feel good, felt light headed and stayed in the pharmacy for a little while. On 23-AUG-2017 (reported as the next day), the reporter stated that the patient still did not feel right. Approximately on 10-OCT-2017 (reported as now it has been 6 weeks since she got the shot), the patient's injection site was still red and warm, she was still irritable and the patient did not feel right. On an unknown date, the patient went to the doctor's office and was treated with PHENERGAN for the adverse event and nausea as well. The reporter stated that the red and warm injection did not look like a rash or rash-like lesion. It was reported that no laboratories were performed. The outcome for malaise, felt light headed, injection site red and warm, irritable and nausea was reported as not recovered. The causal relationship between the adverse events and the therapies of ZOSTAVAX and sterile diluent (manufacturer unknown) was not assessed.
Age: 79.0
Sex: F
Vaccine: TTOX, VARZOS
Symptoms: Irritability, Nausea
Clinical narrative: This spontaneous report has been received from a pharmacist, concerning a 79 year old female patient. It was reported that the patient had no current conditions as well as drug reactions, allergies or pertinent medical history. Concomitant therapies included CRESTOR, nitroglycerin, EFFEXOR and lorazepam. On 22-AUG-2017, the patient was vaccinated with one dose of ZOSTAVAX subcutaneously, lot number N014019 and expiration date 04-JUL-2018 for prophylaxis which was reconstituted with sterile diluent (manufacturer unknown) lot number N015478 and expiration date 28-SEP-2019. At the same date, the patient was vaccinated with tetanus toxoid (manufacturer unknown). On 22-AUG-2017 (reported as immediately after getting the vaccines), the patient did not feel good, felt light headed and stayed in the pharmacy for a little while. On 23-AUG-2017 (reported as the next day), the reporter stated that the patient still did not feel right. Approximately on 10-OCT-2017 (reported as now it has been 6 weeks since she got the shot), the patient's injection site was still red and warm, she was still irritable and the patient did not feel right. On an unknown date, the patient went to the doctor's office and was treated with PHENERGAN for the adverse event and nausea as well. The reporter stated that the red and warm injection did not look like a rash or rash-like lesion. It was reported that no laboratories were performed. The outcome for malaise, felt light headed, injection site red and warm, irritable and nausea was reported as not recovered. The causal relationship between the adverse events and the therapies of ZOSTAVAX and sterile diluent (manufacturer unknown) was not assessed.
Age: 14.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from an X-ray technician and refers to a 14-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 10-OCT-2017, the patient was vaccinated with an adult dose of VAQTA injection, lot # M039055 with expiration date on 22-JUL-2018 (exact dose and route of administration were not reported). No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 77 year old patient of unknown gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. In 2015, the patient was vaccinated with two separate injections of ZOSTAVAX (dose, route, lot number and expiration date were not reported) for prophylaxis (extra dose administered). No adverse events were reported. It was reported that the patient did not receive treatment.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning to a 2 months old female patient. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 04-AUG-2017 at 9:00, the patient was vaccinated with an improperly stored dose of ROTATEQ lot # M038717 for prophylaxis (Dose, strength, frequency and expiration date were not reported). No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA006123.
Age: 87.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Bacterial infection, Blister, Cellulitis, Culture, Hypersensitivity
Clinical narrative: This spontaneous report was received from the patient's daughter and refers to her mother, an 87 year old female patient. The patient's concurrent conditions included Hashimoto's thyroiditis, an unspecified cardiac disorder, diabetes mellitus, an unspecified blood pressure condition and the patient is allergic to iodine. The patient's medical history included cardiac pacemaker insertion. Concomitant mediations included an unspecified medication to "make her blood thinner", and unspecified medications to treat her cardiac disorder, diabetes mellitus and her unspecified blood pressure condition. On an unspecified date in 1995, the patient received her first dose of PNEUMOVAX 23 (dose, route, lot number and expiry date were not reported) for prophylaxis. After that, on an unspecified date in 2016, the patient received a dose of PREVNAR 13. Later, on 12-OCT-2017, the patient was vaccinated with a second dose of PNEUMOVAX 23 injection, lot # N011867, expiration date 08-NOV-2018 (dose and route were not reported) for prophylaxis. On 13-OCT-2017, the patient's arm was reported as "extreme hard and swollen, dark all the way to the elbow and covered with huge blisters." Then, on the same date, the patient was taken to an emergency room (ER), where a diagnosis of cellulitis was made. It was reported that the patient was treated with clindamycin in the ER. In addition, it was reported that an unspecified health professional stated that the patient's reaction was "bacterial", and unspecified cultures were performed, which results were not available. Also, while in the ER, a line was drawn around the perimeter of the affected area, and on the same date, she was released from the ER and was told that if the reaction expanded beyond the drawn line, she should return to ER. On 14-OCT-2017 at 18:00 hours, the patient returned to ER and then she received treatment with intravenous prednisone (manufacturer unknown) and a new line was drawn around the expanded reaction area. It was also reported that an unspecified healthcare provider stated that the reaction was a "severe allergic reaction." Then, on 15-OCT-2017 at 02:00, she was released from ER with a prescription of two prednisone (manufacturer unknown) 20 mg tablet, orally, daily for 4 days.  After that, on an unknown date in October 2017, the patient's reaction was spread out beyond the second drawn line and the patient stated that "the treatment with prednisone (manufacturer unknown) slowed down the spread, but it was still spreading". At the time of reporting the patient was not recovered from the adverse events. No product quality complaint (PQC) was involved. The reporter did not provide a causality assessment between the events and the PNEUMOVAX 23. Upon internal review, the cellulitis and hypersensitivity were considered to be medically significant events.
Age: 87.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Induration, Peripheral swelling, Skin discolouration
Clinical narrative: This spontaneous report was received from the patient's daughter and refers to her mother, an 87 year old female patient. The patient's concurrent conditions included Hashimoto's thyroiditis, an unspecified cardiac disorder, diabetes mellitus, an unspecified blood pressure condition and the patient is allergic to iodine. The patient's medical history included cardiac pacemaker insertion. Concomitant mediations included an unspecified medication to "make her blood thinner", and unspecified medications to treat her cardiac disorder, diabetes mellitus and her unspecified blood pressure condition. On an unspecified date in 1995, the patient received her first dose of PNEUMOVAX 23 (dose, route, lot number and expiry date were not reported) for prophylaxis. After that, on an unspecified date in 2016, the patient received a dose of PREVNAR 13. Later, on 12-OCT-2017, the patient was vaccinated with a second dose of PNEUMOVAX 23 injection, lot # N011867, expiration date 08-NOV-2018 (dose and route were not reported) for prophylaxis. On 13-OCT-2017, the patient's arm was reported as "extreme hard and swollen, dark all the way to the elbow and covered with huge blisters." Then, on the same date, the patient was taken to an emergency room (ER), where a diagnosis of cellulitis was made. It was reported that the patient was treated with clindamycin in the ER. In addition, it was reported that an unspecified health professional stated that the patient's reaction was "bacterial", and unspecified cultures were performed, which results were not available. Also, while in the ER, a line was drawn around the perimeter of the affected area, and on the same date, she was released from the ER and was told that if the reaction expanded beyond the drawn line, she should return to ER. On 14-OCT-2017 at 18:00 hours, the patient returned to ER and then she received treatment with intravenous prednisone (manufacturer unknown) and a new line was drawn around the expanded reaction area. It was also reported that an unspecified healthcare provider stated that the reaction was a "severe allergic reaction." Then, on 15-OCT-2017 at 02:00, she was released from ER with a prescription of two prednisone (manufacturer unknown) 20 mg tablet, orally, daily for 4 days.  After that, on an unknown date in October 2017, the patient's reaction was spread out beyond the second drawn line and the patient stated that "the treatment with prednisone (manufacturer unknown) slowed down the spread, but it was still spreading". At the time of reporting the patient was not recovered from the adverse events. No product quality complaint (PQC) was involved. The reporter did not provide a causality assessment between the events and the PNEUMOVAX 23. Upon internal review, the cellulitis and hypersensitivity were considered to be medically significant events.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Register Nurse and refers to a patient of unknown age and gender. No pertinent medical history, concurrent conditions, drug reactions or allergies were provided. Concomitant therapies included sterile diluent (manufacturer unknown). On 23-OCT-2017, the patient was vaccinated with an unspecified improperly stored dose of VARIVAX (lot # N019820 with an expiration date on 13-JUL-2019) for prophylaxis (strength, dosage schedule, route, indication and anatomical were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 3 hours. Digital data logger was involved. There were no previous excursions reported.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: Pain, Pyrexia, Syncope, Vomiting
Clinical narrative: This spontaneous report was received from a medical assisstant and refers to a 17 year old patient of an unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 02-OCT-2017, the patient was vaccinated with GARDASIL 9 injection (strength, dose, frequency, route of administration were not reported, lot # N017697, expiration date 21-JAN-2020) for prophylaxis. On an unknown date in October 2017 (reported as after vaccination with GARDASIL 9 the patient experienced syncope, abnormal pain, vomiting and fever. The patient was seen at the hospital on an unspecified date in relation to syncope, however hospitalization was not asssessed as serious criteria for the event. The outcome of the events was reported as recovered on an unknown date in October 2017. The causality between the events and GARDASIL 9 was not reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1710USA012280: US-009507513-1710USA002338: US-009507513-1710USA012279:
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Pain, Pyrexia, Syncope, Vomiting
Clinical narrative: This spontaneous report was received from a medical assisstant and refers to a 13 year old patient of an unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 10-JUL-2017, the patient was vaccinated with GARDASIL 9 injection (strength, dose, frequency, route of administration were not reported, lot reported as #M15008, expiration date unknown) for prophylaxis. On an unknown date in 2017 (reported as after vaccination with GARDASIL 9 the patient experienced syncope, abnormal pain, vomiting and fever. The patient was seen at the hospital on an unspecified date in relation to syncope, however hospitalization was not asssessed as serious criteria for the event. No treatment was administered for the events. The outcome of the events was reported as recovered on an unknown date in 2017. The causality between the events and GARDASIL 9 was not reported.  This is one of several reports received from the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 31-MAY-2014, the patient was inoculated at a clinic with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 31-MAY-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed PERCOCET and VALTREX for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Conjunctivitis, Eye discharge, Eye pain
Clinical narrative: Initial unsolicited report received from consumer on 12 Oct 2017 and live follow up received on 12 Oct 2017. This case involves 79 years old female patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH-DOSE (Frequency: once, batch number: UI840AA and expiry date was not reported) intramuscularly in right deltoid on 08 Oct 2017. Patient had seasonal allergy to allegra D and concomitant medication were not reported. On 10 Oct 2017, Tuesday night, 48 hours post vaccination, patient had woke up with her left eye swollen, bloodshot, and her left cheek was puffy and her right eye eventually got that way as well (had a reaction). On 11 Oct 2017, Wednesday morning three days post vaccination, patient's left eye was oozing puss and he was having swelling above and eye. It was like something was in her eye (woke up with problems) and then that night right eye started getting this way with lots of puss and pain. On an unspecified date, post vaccination, she had a temperature last night and some chills. She look so swollen with both her eyes and it hurts to blink eyes. Patient was diagnosed with conjunctivitis. Patient was evaluated 12 Oct 2017 and diagnosed with allergic reaction to something. It was reported that her husband got the same shot and did not have a reaction. Laboratory investigation was not reported. Patient was treated with Cipro eye drops. Patient continued to eye drops and applied ice packs to swollen areas. Outcome of events was not reported. List of documents held by sender: none.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Foreign body sensation in eyes, Hypersensitivity, Ocular hyperaemia, Rash pustular
Clinical narrative: Initial unsolicited report received from consumer on 12 Oct 2017 and live follow up received on 12 Oct 2017. This case involves 79 years old female patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH-DOSE (Frequency: once, batch number: UI840AA and expiry date was not reported) intramuscularly in right deltoid on 08 Oct 2017. Patient had seasonal allergy to allegra D and concomitant medication were not reported. On 10 Oct 2017, Tuesday night, 48 hours post vaccination, patient had woke up with her left eye swollen, bloodshot, and her left cheek was puffy and her right eye eventually got that way as well (had a reaction). On 11 Oct 2017, Wednesday morning three days post vaccination, patient's left eye was oozing puss and he was having swelling above and eye. It was like something was in her eye (woke up with problems) and then that night right eye started getting this way with lots of puss and pain. On an unspecified date, post vaccination, she had a temperature last night and some chills. She look so swollen with both her eyes and it hurts to blink eyes. Patient was diagnosed with conjunctivitis. Patient was evaluated 12 Oct 2017 and diagnosed with allergic reaction to something. It was reported that her husband got the same shot and did not have a reaction. Laboratory investigation was not reported. Patient was treated with Cipro eye drops. Patient continued to eye drops and applied ice packs to swollen areas. Outcome of events was not reported. List of documents held by sender: none.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: Initial unsolicited report received from consumer on 12 Oct 2017 and live follow up received on 12 Oct 2017. This case involves 79 years old female patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH-DOSE (Frequency: once, batch number: UI840AA and expiry date was not reported) intramuscularly in right deltoid on 08 Oct 2017. Patient had seasonal allergy to allegra D and concomitant medication were not reported. On 10 Oct 2017, Tuesday night, 48 hours post vaccination, patient had woke up with her left eye swollen, bloodshot, and her left cheek was puffy and her right eye eventually got that way as well (had a reaction). On 11 Oct 2017, Wednesday morning three days post vaccination, patient's left eye was oozing puss and he was having swelling above and eye. It was like something was in her eye (woke up with problems) and then that night right eye started getting this way with lots of puss and pain. On an unspecified date, post vaccination, she had a temperature last night and some chills. She look so swollen with both her eyes and it hurts to blink eyes. Patient was diagnosed with conjunctivitis. Patient was evaluated 12 Oct 2017 and diagnosed with allergic reaction to something. It was reported that her husband got the same shot and did not have a reaction. Laboratory investigation was not reported. Patient was treated with Cipro eye drops. Patient continued to eye drops and applied ice packs to swollen areas. Outcome of events was not reported. List of documents held by sender: none.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Pyrexia, Vomiting
Clinical narrative: Headache, fever 101.7, vomiting, severe chills.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site reaction, Injection site warmth, Local reaction
Clinical narrative: The patient had a large local reaction at injection site. Warm to the touch. Mother of patient said this happened last year, and symptoms lasted for a couple of days. Site was painful to touch but patient was still able to use arm.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Muscle spasms, Pain in extremity, Peripheral swelling
Clinical narrative: My left arm swelled, was red and very sore for 4 days. Upon the redness and swelling subsiding within the 4 days, my left arm began having a sensation of spasms (or twitch) which began in the left arm and then extended to my entire body, which never happened before this flu shot. It is currently still happening over a month later, as of today's date of Oct 25,2017. I reported the reaction to my doctors office via the web portal, they requested I come in for a follow up office visit of which I did on Oct 18, 2017. I reported that the spasms have possibly slowed down but are not completely gone.