chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: Right after receiving the shot, patient complained of pain at the injection site, and feeling a little dizzy. Patient was advised to remain seated, and was given a cup of water. Approximately 2 minutes after that, patient fainted for about 30 seconds. Patient regained consciousness. We called 911, and the EMT came and checked on patient (blood pressure was 120/50, blood sugar was normal, EKG was normal). Patient said she feels fine and did not want to go to the hospital. Clinical RPh and PDM was contacted. Incident report was filed. Primary care MD was notified.
Age: 1.0
Sex: M
Vaccine: MMR, MMRV, HEPA, MMR, MMRV
Symptoms: Extra dose administered
Clinical narrative: NONE stated.
Age: 1.0
Sex: M
Vaccine: MMR, MMRV, HEPA, MMR, MMRV
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: NONE stated.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Pain, Pallor, Syncope
Clinical narrative: Within a few minutes after administration of HPV vaccine patient felt dizzy (BP 84/44, Pulse 144), turned pale and then had a syncopal convulsion (per Dr.) that lasted about 5 seconds. Patient was laid down on the exam table, given a cool compress, orange juice and water and she was assessed by Dr. (pulse 60). Patient felt better after laying down, cool compress was applied, orange juice and water were given. BP 111/72 Pulse 70. Mother reported to Dr. that when patient was 5 years old she had a vasovagal episode where patient turned blue from pain after cutting her chin and she called the paramedics. Mother forgot to mention this prior to administration of the vaccine when asked if she has ever fainted, felt dizzy or did not feel well after vaccines or procedures. Patient was given a sucker prior to the vaccine. Patient was assessed again by Dr. and discharged home. Patient left the office with Mom. Mother aware to have patient eat prior to her future vaccines and to always tell the nurses and doctors about her past history of feeling faint and syncope with pain and vaccines.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Arthralgia, C-reactive protein increased, Coordination abnormal, Decreased activity, Differential white blood cell count abnormal
Clinical narrative: My son woke up totally normal full of energy Friday April 13th, 2018. He had his annual 4 year old wellness visit and he was looking perfectly healthy. About a hour after vaccination my son complained of both of his legs hurting really bad and then said he was "really tired" words never spoken by my active 4 year old boy, who will never admit he is tired even if he is. He no longer naps and when we got home he took a 2-3 hour nap and woke up with a fever of 102.5 F. He complained of bilateral leg pain but still wanted to go to the park to play with friends, so we took him and he was unable to keep up and play with the other kids something I've never witnessed in him. His legs appeared heavy and stiff and he was tripping while trying to run around with the other kids. Later that night he was having a lot of trouble walking. He crawled upstairs to bed and he was screaming uncontrollably saying his "brain hurt." He cried himself to sleep and still had a fever in the morning. He woke up screaming of bilateral wrist and hand pain. He could not walk or stand up on his own at all. His lower limbs were limp and when I stood him up to urinate he peed all over the place because he couldn't stand up on his own. We rushed to the Emergency Room and we were there for 8 plus hours. He was given ibuprofen and later that night he was able to stand up again and somewhat walk. He was stumbling very badly and doing a weird skip/run and he is normally very coordinated. Sunday and Monday he wasn't very active, which is very out of the ordinary for him. He tried to ride his bike and go for a walk but he didn't last more than 100 feet before wanting to be carried. Today he is walking so much better.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Dysstasia, Fatigue, Full blood count abnormal, Gait disturbance, Gait inability
Clinical narrative: My son woke up totally normal full of energy Friday April 13th, 2018. He had his annual 4 year old wellness visit and he was looking perfectly healthy. About a hour after vaccination my son complained of both of his legs hurting really bad and then said he was "really tired" words never spoken by my active 4 year old boy, who will never admit he is tired even if he is. He no longer naps and when we got home he took a 2-3 hour nap and woke up with a fever of 102.5 F. He complained of bilateral leg pain but still wanted to go to the park to play with friends, so we took him and he was unable to keep up and play with the other kids something I've never witnessed in him. His legs appeared heavy and stiff and he was tripping while trying to run around with the other kids. Later that night he was having a lot of trouble walking. He crawled upstairs to bed and he was screaming uncontrollably saying his "brain hurt." He cried himself to sleep and still had a fever in the morning. He woke up screaming of bilateral wrist and hand pain. He could not walk or stand up on his own at all. His lower limbs were limp and when I stood him up to urinate he peed all over the place because he couldn't stand up on his own. We rushed to the Emergency Room and we were there for 8 plus hours. He was given ibuprofen and later that night he was able to stand up again and somewhat walk. He was stumbling very badly and doing a weird skip/run and he is normally very coordinated. Sunday and Monday he wasn't very active, which is very out of the ordinary for him. He tried to ride his bike and go for a walk but he didn't last more than 100 feet before wanting to be carried. Today he is walking so much better.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Haemolysis, Headache, Hypotonia, Influenza virus test negative, Injection site pain
Clinical narrative: My son woke up totally normal full of energy Friday April 13th, 2018. He had his annual 4 year old wellness visit and he was looking perfectly healthy. About a hour after vaccination my son complained of both of his legs hurting really bad and then said he was "really tired" words never spoken by my active 4 year old boy, who will never admit he is tired even if he is. He no longer naps and when we got home he took a 2-3 hour nap and woke up with a fever of 102.5 F. He complained of bilateral leg pain but still wanted to go to the park to play with friends, so we took him and he was unable to keep up and play with the other kids something I've never witnessed in him. His legs appeared heavy and stiff and he was tripping while trying to run around with the other kids. Later that night he was having a lot of trouble walking. He crawled upstairs to bed and he was screaming uncontrollably saying his "brain hurt." He cried himself to sleep and still had a fever in the morning. He woke up screaming of bilateral wrist and hand pain. He could not walk or stand up on his own at all. His lower limbs were limp and when I stood him up to urinate he peed all over the place because he couldn't stand up on his own. We rushed to the Emergency Room and we were there for 8 plus hours. He was given ibuprofen and later that night he was able to stand up again and somewhat walk. He was stumbling very badly and doing a weird skip/run and he is normally very coordinated. Sunday and Monday he wasn't very active, which is very out of the ordinary for him. He tried to ride his bike and go for a walk but he didn't last more than 100 feet before wanting to be carried. Today he is walking so much better.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Limb discomfort, Mean platelet volume abnormal, Metabolic function test abnormal, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: My son woke up totally normal full of energy Friday April 13th, 2018. He had his annual 4 year old wellness visit and he was looking perfectly healthy. About a hour after vaccination my son complained of both of his legs hurting really bad and then said he was "really tired" words never spoken by my active 4 year old boy, who will never admit he is tired even if he is. He no longer naps and when we got home he took a 2-3 hour nap and woke up with a fever of 102.5 F. He complained of bilateral leg pain but still wanted to go to the park to play with friends, so we took him and he was unable to keep up and play with the other kids something I've never witnessed in him. His legs appeared heavy and stiff and he was tripping while trying to run around with the other kids. Later that night he was having a lot of trouble walking. He crawled upstairs to bed and he was screaming uncontrollably saying his "brain hurt." He cried himself to sleep and still had a fever in the morning. He woke up screaming of bilateral wrist and hand pain. He could not walk or stand up on his own at all. His lower limbs were limp and when I stood him up to urinate he peed all over the place because he couldn't stand up on his own. We rushed to the Emergency Room and we were there for 8 plus hours. He was given ibuprofen and later that night he was able to stand up again and somewhat walk. He was stumbling very badly and doing a weird skip/run and he is normally very coordinated. Sunday and Monday he wasn't very active, which is very out of the ordinary for him. He tried to ride his bike and go for a walk but he didn't last more than 100 feet before wanting to be carried. Today he is walking so much better.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Pyrexia, Screaming, Synovitis, Ultrasound scan abnormal, Urine ketone body present
Clinical narrative: My son woke up totally normal full of energy Friday April 13th, 2018. He had his annual 4 year old wellness visit and he was looking perfectly healthy. About a hour after vaccination my son complained of both of his legs hurting really bad and then said he was "really tired" words never spoken by my active 4 year old boy, who will never admit he is tired even if he is. He no longer naps and when we got home he took a 2-3 hour nap and woke up with a fever of 102.5 F. He complained of bilateral leg pain but still wanted to go to the park to play with friends, so we took him and he was unable to keep up and play with the other kids something I've never witnessed in him. His legs appeared heavy and stiff and he was tripping while trying to run around with the other kids. Later that night he was having a lot of trouble walking. He crawled upstairs to bed and he was screaming uncontrollably saying his "brain hurt." He cried himself to sleep and still had a fever in the morning. He woke up screaming of bilateral wrist and hand pain. He could not walk or stand up on his own at all. His lower limbs were limp and when I stood him up to urinate he peed all over the place because he couldn't stand up on his own. We rushed to the Emergency Room and we were there for 8 plus hours. He was given ibuprofen and later that night he was able to stand up again and somewhat walk. He was stumbling very badly and doing a weird skip/run and he is normally very coordinated. Sunday and Monday he wasn't very active, which is very out of the ordinary for him. He tried to ride his bike and go for a walk but he didn't last more than 100 feet before wanting to be carried. Today he is walking so much better.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: X-ray normal
Clinical narrative: My son woke up totally normal full of energy Friday April 13th, 2018. He had his annual 4 year old wellness visit and he was looking perfectly healthy. About a hour after vaccination my son complained of both of his legs hurting really bad and then said he was "really tired" words never spoken by my active 4 year old boy, who will never admit he is tired even if he is. He no longer naps and when we got home he took a 2-3 hour nap and woke up with a fever of 102.5 F. He complained of bilateral leg pain but still wanted to go to the park to play with friends, so we took him and he was unable to keep up and play with the other kids something I've never witnessed in him. His legs appeared heavy and stiff and he was tripping while trying to run around with the other kids. Later that night he was having a lot of trouble walking. He crawled upstairs to bed and he was screaming uncontrollably saying his "brain hurt." He cried himself to sleep and still had a fever in the morning. He woke up screaming of bilateral wrist and hand pain. He could not walk or stand up on his own at all. His lower limbs were limp and when I stood him up to urinate he peed all over the place because he couldn't stand up on his own. We rushed to the Emergency Room and we were there for 8 plus hours. He was given ibuprofen and later that night he was able to stand up again and somewhat walk. He was stumbling very badly and doing a weird skip/run and he is normally very coordinated. Sunday and Monday he wasn't very active, which is very out of the ordinary for him. He tried to ride his bike and go for a walk but he didn't last more than 100 feet before wanting to be carried. Today he is walking so much better.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Rash pruritic, Scab
Clinical narrative: Pt reported pimple-like bumps on hand and arm opposite arm receiving shot about one week after receiving vaccine. She stated the bumps itched and then scabbed over in about a week. No pain with bumps.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Hypersensitivity, Throat tightness
Clinical narrative: ER called to inform physician pt's was having an allergic reaction and throat was closing.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Injection site swelled, became red and very sore. She had a fever, stomach upset, headache (rather severe) and fatigue for 7 days.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Injection site swelled, became red and very sore. She had a fever, stomach upset, headache (rather severe) and fatigue for 7 days.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Vaccination complication
Clinical narrative: PATIENT CAME IN WITH REDNESS AT THE INJECTION SITE AS WELL AS RADIATING REDNESS 4-5 INCHES IN DIAMETER. SHE STATES THAT THIS HAD HAPPENED TO HER IN THE PAST WHEN SHE RECEIVED A PNEUMOVAX AND FLU SHOT TOGETHER LAST YEAR. I SUGGESTED THAT SHE WATCH THE MARGINS TO MAKE SURE THAT IT DOESN'T GROW LARGER AND THAT SHE SHOULD SEE HER DOCTOR TO DETERMINE TREATMENT. PREVIOUS TREATMENT FOR A SIMILAR REACTION WITH ANTIBIOTICS WORKED. AT THE TIME THE DOCTOR HAD DETERMINED THAT IT WAS CELLULITIS BROUGHT ON BY THE VACCINATION.    I WILL FOLLOW UP WITH THE PATIENT ON THURSDAY TO MAKE SURE SHE IS OKAY AND IF SHE WAS ABLE TO SPEAK WITH HER PHYSICIAN.
Age: 62.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Asthenia, Blood pressure increased, Cardiac stress test normal, Dizziness, Laboratory test normal
Clinical narrative: I collapsed and fainted the morning after having the two vaccines. My husband observed that I was unresponsive for less than 30 seconds. When I woke up, I felt very sick. My blood pressure, usually around 100, shot up to over 200 and stayed high for several repeated tests. I became extremely nauseated and weak, but suffered no pain, no chest or arm pain, and no difficulty breathing. One reading of my Tropinin I level was high at 0.11 ng/mL but then reverted to normal range. My blood pressure, oxygen absorption, heart rate and other readings were normal. I was admitted overnight for observation and passed a stress test and other test.  I had slept very poorly the night before due to the pain in my arms from the two vaccines. I also had leg and ankle cramps many times throughout the night, which is rare for me. I felt fine when I first got up and was going through normal morning activities when I became faint and had to sit down. I passed out onto a table top and did not fall or hit my head.
Age: 62.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Loss of consciousness, Malaise, Muscle spasms, Nausea, Pain in extremity
Clinical narrative: I collapsed and fainted the morning after having the two vaccines. My husband observed that I was unresponsive for less than 30 seconds. When I woke up, I felt very sick. My blood pressure, usually around 100, shot up to over 200 and stayed high for several repeated tests. I became extremely nauseated and weak, but suffered no pain, no chest or arm pain, and no difficulty breathing. One reading of my Tropinin I level was high at 0.11 ng/mL but then reverted to normal range. My blood pressure, oxygen absorption, heart rate and other readings were normal. I was admitted overnight for observation and passed a stress test and other test.  I had slept very poorly the night before due to the pain in my arms from the two vaccines. I also had leg and ankle cramps many times throughout the night, which is rare for me. I felt fine when I first got up and was going through normal morning activities when I became faint and had to sit down. I passed out onto a table top and did not fall or hit my head.
Age: 62.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Poor quality sleep, Syncope, Troponin I increased
Clinical narrative: I collapsed and fainted the morning after having the two vaccines. My husband observed that I was unresponsive for less than 30 seconds. When I woke up, I felt very sick. My blood pressure, usually around 100, shot up to over 200 and stayed high for several repeated tests. I became extremely nauseated and weak, but suffered no pain, no chest or arm pain, and no difficulty breathing. One reading of my Tropinin I level was high at 0.11 ng/mL but then reverted to normal range. My blood pressure, oxygen absorption, heart rate and other readings were normal. I was admitted overnight for observation and passed a stress test and other test.  I had slept very poorly the night before due to the pain in my arms from the two vaccines. I also had leg and ankle cramps many times throughout the night, which is rare for me. I felt fine when I first got up and was going through normal morning activities when I became faint and had to sit down. I passed out onto a table top and did not fall or hit my head.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Extreme redness and swelling in arm from elbow to shoulder.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Migraine, Nausea, Vomiting
Clinical narrative: Nausea and vomiting starting on day 2 after getting shot. On day 3 patient had a severe migraine headache requiring a trip to the Emergency Room with continued headache and nausea lasting aproximately 4 days.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: 4/14/18: patient reports dizziness/lightheadedness...severe swelling and warmth at the injection site (wheal and flare)...reports to ER on 4/14, is prescribed Cephalexin 500mg QID x 7d, begins this treatment 4/14. On 4/16 the reaction is improved but patient follows up with primary practitioner, who discontinues Cephalexin and replaces with Levofloxacin 500mg QD x 5d, plus Prednisone 3-day taper. Patient is significantly improved with no further CNS symptoms on 4/17; dermatologic reaction is greatly improved.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Heart rate increased, Nausea, Pyrexia
Clinical narrative: High fever, fast heartbeat, dizziness, weakness, nausea.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, MMR
Symptoms: Abnormal behaviour, Blood test, Disturbance in social behaviour, Encephalitis, Encephalopathy
Clinical narrative: Leading up to the date of 6-18-2015, patient had several episodes of ear infections treated with Amoxicillin. On 6/18, his pediatrician at that time injected pt with 8 combination vaccines (listed above) while pt still had an active ear infection. After this, pt slowly lost his ability to verbally communicate. Before the vaccines, pt had a vocabulary of around 50 words and after he is only able to verbalize about 5 words. By the beginnning of 2016, pt lost verbal communication and social skills. He began stimming, spinning in circles and engaging in repetitive behavior. Today, he is still almost completely nonverbal and struggles with social skills. He was diagnosed by Hospital with Encephalopathy and by Dr. with Encephalitis.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, MMR
Symptoms: Hair metal test, Laboratory test, Speech disorder, Stereotypy, Urine analysis
Clinical narrative: Leading up to the date of 6-18-2015, patient had several episodes of ear infections treated with Amoxicillin. On 6/18, his pediatrician at that time injected pt with 8 combination vaccines (listed above) while pt still had an active ear infection. After this, pt slowly lost his ability to verbally communicate. Before the vaccines, pt had a vocabulary of around 50 words and after he is only able to verbalize about 5 words. By the beginnning of 2016, pt lost verbal communication and social skills. He began stimming, spinning in circles and engaging in repetitive behavior. Today, he is still almost completely nonverbal and struggles with social skills. He was diagnosed by Hospital with Encephalopathy and by Dr. with Encephalitis.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Blood thyroid stimulating hormone, Decreased appetite, Differential white blood cell count, Full blood count, Injection site erythema
Clinical narrative: Swelling, erythema, and pain to L deltoid extending to left side of upper and mid back. Also reporting malaise and decreased appetite since had vaccine 6 days ago.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Injection site pain, Injection site swelling, Malaise, Metabolic function test
Clinical narrative: Swelling, erythema, and pain to L deltoid extending to left side of upper and mid back. Also reporting malaise and decreased appetite since had vaccine 6 days ago.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Gait disturbance, Joint swelling, Pain, Peripheral swelling
Clinical narrative: Patient told me on 4/17/18 that a couple of days after her vaccination, she gradually started to get pain and swelling on the back of her foot and ankles. It happened to both feet, but the left foot is worse than the right. She said the swelling was pain and it made it hard to walk for a few days. Today she said it was feeling a bit better and was taking ibuprofen for it. I told her to continue the ibuprofen and ice the areas. Told her to give me and update and call her doctor if it gets any worse.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Redness at injection site, swollen at injection site. Patient stated she had a 101 deg. F fever starting the day after the injection and lasting 3 days. Upon visual inspection, the injection site was red, swollen and warm. There was ~3" diameter affected area.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Cough, Decreased appetite, Fatigue, Hyperaesthesia
Clinical narrative: Nothing occurred that was incapacitating. Repeated or constant symptoms starting the day after the injection, and continuing for two days after that (3 days of symptoms): Soreness at injection site, General malaise, Fatigue, Sensitive scalp, Minor muscle aches, Slightly depressed appetite, Dry cough, Shivering (one time, for 5 minutes; resolved by covering up with a blanket).
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Myalgia
Clinical narrative: Nothing occurred that was incapacitating. Repeated or constant symptoms starting the day after the injection, and continuing for two days after that (3 days of symptoms): Soreness at injection site, General malaise, Fatigue, Sensitive scalp, Minor muscle aches, Slightly depressed appetite, Dry cough, Shivering (one time, for 5 minutes; resolved by covering up with a blanket).
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Pain and redness around injection site, warmth to the touch, itchy around injection site. Patient is using Hydrocortisone 1% cream OTC and it is alleviating her itchiness.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Abdominal pain upper, Dyspnoea, Injection site rash, Pyrexia, Rash
Clinical narrative: Shortness of breath - difficulty breathing. Rash to (R) and (L) armpits and ankles. Rash at injection sites on (R) and (L) deltoid. Low grade fever. C/O stomach ache.
Sex: M
Vaccine: FLU4
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a male patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine quadrivalent unspecified season, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to Influenza vaccine quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist said that the consumer's spouse had filled out a form at the pharmacy that her husband had had a long time ago a previous allergic reaction to a flu shot. No further specific details were provided to the pharmacist regarding product or type of allergic reaction. The consumer had no record of the referenced vaccination at her pharmacy, and she did not know the manufacturer of the product referenced. The call was transferred to the GSK medical information team regarding the reporter's current inquiry of whether or not there would be any issue in terms of the ingredients of SHINGRIX in administering SHINGRIX to a consumer with a history of allergy reaction to a flu vaccine. The pharmacist gave permission for follow up contact for. No further details were known, so there would be no further detail beyond this information.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Left arm indurated area, red and warm, about 15 cm.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site reaction, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Pt reports on 4/13/18 his bicep began to swell. (LA) it was red and swollen. The bicep was stiff and ROM was limited. Pt was advised to go to ED, but declined.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Immediate post-injection reaction, Injection site pain, Pain, Pyrexia
Clinical narrative: Painful in area immediately upon injection. Swelling. Redness. Low grade fever. Body aches. Approximately 100.4 F.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Painful in area immediately upon injection. Swelling. Redness. Low grade fever. Body aches. Approximately 100.4 F.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Diarrhoea
Clinical narrative: Prolonged diarrhea starting 2 days after immunization and lasting 4-5 weeks.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Arm was red, soreness at site of injection. Felt fever, fatigue.
Age: 10.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: 4/12-swelling to back of left arm at injection site. Redness and warm. Swelling about the size of 3 quarters together per mom. Mom called 4/13 to let us known and ask about what to do for itching. Told her to try an ice pack. BENADRYL gel. 4/16-mom states it's much better. Small amount of swelling and redness still but going down.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Seen 11/13/17-initially bilat thighs red, raised at injection sites and resolved in 2 days. 11-21-17 2 red, hard lumps upper right thigh. Fever. Worsened 11-22-17 2 red raised lumps, warm to touch. Fever 11-24-17 no fever tiny red dots covering body and face-not itchy. Not warm to touch at injection site. Hydrocortisone cream mixed with baby lotion 1/2 and 1/2.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: Seen 11/13/17-initially bilat thighs red, raised at injection sites and resolved in 2 days. 11-21-17 2 red, hard lumps upper right thigh. Fever. Worsened 11-22-17 2 red raised lumps, warm to touch. Fever 11-24-17 no fever tiny red dots covering body and face-not itchy. Not warm to touch at injection site. Hydrocortisone cream mixed with baby lotion 1/2 and 1/2.
Age: 70.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Pain in extremity, Rash, Swelling
Clinical narrative: Patient stated had reaction which included rash, swelling, and pain in the arm the following day.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Nodule
Clinical narrative: Knot has formed on her arm. Influenza vaccine was given over six months ago. Knot first appeared and has not receded.
Age: 10.0
Sex: M
Vaccine: TDAP, VARCEL, TDAP, VARCEL
Symptoms: Abdominal pain, Blood glucose normal, Dysphagia, Eyelid oedema, Hypoaesthesia oral
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 10 year old male patient. The patient's pertinent medical history included Henoch-Schonlein purpura at age of 18 months and again between 4 to 5 years. The patient's concurrent conditions were not reported. The patient had not drug/reactions allergies. His concomitant medications included fluoride. On 19-MAR-2018 at 15:45, the patient was vaccinated with the second dose of VARIVAX lot # N025935 with expiration date 19-SEP-2019, subcutaneously; and a dose of BOOSTRIX (route of administration, lot # and expiration date were not reported); both for prophylaxis. Subsequently, the patient left the nurse office with his mother, and the mother reported the patient ate a "Dum Dum lollipop" and a snack size bag of "LAYS" potato chips on the way home in the car. The patient then developed abdominal pain, a "tickle in his throat" and swelling at the injection site where VARIVAX was administered. Later on the same date, at the time the patient arrived home, the patient's lips felt numb and the patient had swelling on the left side of his face. On the same date at 16:16, the patient's mother called to the nurse office and he was prescribed and was subsequently administered with 2 teaspoon (tsp) of BENADRYL by his mother. At 16:49, his mother called again to the nurse office and stated the patient's eyelids were swollen and the patient was having difficulty swallowing. The mother was instructed to call the 911 and the patient was taken to the emergency room and was treated with intravenous fluids, epinephrine intramuscularly, BENADRYL intramuscularly, and SOLU-MEDROL intravenously in the emergency room. An unspecified blood work was performed to the patient (results not reported). On the same date at 19:00, the patient recovered from the events and was discharged from the emergency room. It was reported that the patient was instructed to take BENADRYL every 6 hours for 24 hours and prednisone (no details were provided) after leaving the emergency room. Additionally, it was reported that the patient went to the school on the next day. The causality assessment between the events and VARIVAX was not provided as well as the causality assessment between the events and BOOSTRIX. The reporter considered the reported events to be serious due to life threatening. Upon internal review, abdominal pain, throat irritation, injection site swelling, hypoaesthesia oral, swelling face, eyelid oedema and dysphagia; were considered medically significant events as the patient required treatment with epinephrine.
Age: 10.0
Sex: M
Vaccine: TDAP, VARCEL, TDAP, VARCEL
Symptoms: Laboratory test normal, Swelling face, Throat irritation
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 10 year old male patient. The patient's pertinent medical history included Henoch-Schonlein purpura at age of 18 months and again between 4 to 5 years. The patient's concurrent conditions were not reported. The patient had not drug/reactions allergies. His concomitant medications included fluoride. On 19-MAR-2018 at 15:45, the patient was vaccinated with the second dose of VARIVAX lot # N025935 with expiration date 19-SEP-2019, subcutaneously; and a dose of BOOSTRIX (route of administration, lot # and expiration date were not reported); both for prophylaxis. Subsequently, the patient left the nurse office with his mother, and the mother reported the patient ate a "Dum Dum lollipop" and a snack size bag of "LAYS" potato chips on the way home in the car. The patient then developed abdominal pain, a "tickle in his throat" and swelling at the injection site where VARIVAX was administered. Later on the same date, at the time the patient arrived home, the patient's lips felt numb and the patient had swelling on the left side of his face. On the same date at 16:16, the patient's mother called to the nurse office and he was prescribed and was subsequently administered with 2 teaspoon (tsp) of BENADRYL by his mother. At 16:49, his mother called again to the nurse office and stated the patient's eyelids were swollen and the patient was having difficulty swallowing. The mother was instructed to call the 911 and the patient was taken to the emergency room and was treated with intravenous fluids, epinephrine intramuscularly, BENADRYL intramuscularly, and SOLU-MEDROL intravenously in the emergency room. An unspecified blood work was performed to the patient (results not reported). On the same date at 19:00, the patient recovered from the events and was discharged from the emergency room. It was reported that the patient was instructed to take BENADRYL every 6 hours for 24 hours and prednisone (no details were provided) after leaving the emergency room. Additionally, it was reported that the patient went to the school on the next day. The causality assessment between the events and VARIVAX was not provided as well as the causality assessment between the events and BOOSTRIX. The reporter considered the reported events to be serious due to life threatening. Upon internal review, abdominal pain, throat irritation, injection site swelling, hypoaesthesia oral, swelling face, eyelid oedema and dysphagia; were considered medically significant events as the patient required treatment with epinephrine.
Age: 10.0
Sex: M
Vaccine: TDAP, VARCEL, TDAP, VARCEL
Symptoms: Abdominal pain, Blood test, Dysphagia, Eyelid oedema, Hypoaesthesia oral
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 10 year old male patient. The patient's pertinent medical history included Henoch-Schonlein purpura at age of 18 months and again between 4 to 5 years. The patient's concurrent conditions were not reported. The patient had not drug/reactions allergies. His concomitant medications included fluoride. On 19-MAR-2018 at 15:45, the patient was vaccinated with the second dose of VARIVAX lot # N025935 with expiration date 19-SEP-2019, subcutaneously; and a dose of BOOSTRIX (route of administration, lot # and expiration date were not reported); both for prophylaxis. Subsequently, the patient left the nurse office with his mother, and the mother reported the patient ate a "Dum Dum lollipop" and a snack size bag of "LAYS" potato chips on the way home in the car. The patient then developed abdominal pain, a "tickle in his throat" and swelling at the injection site where VARIVAX was administered. Later on the same date, at the time the patient arrived home, the patient's lips felt numb and the patient had swelling on the left side of his face. On the same date at 16:16, the patient's mother called to the nurse office and he was prescribed and was subsequently administered with 2 teaspoon (tsp) of BENADRYL by his mother. At 16:49, his mother called again to the nurse office and stated the patient's eyelids were swollen and the patient was having difficulty swallowing. The mother was instructed to call the 911 and the patient was taken to the emergency room and was treated with intravenous fluids, epinephrine intramuscularly, BENADRYL intramuscularly, and SOLU-MEDROL intravenously in the emergency room. An unspecified blood work was performed to the patient (results not reported). On the same date at 19:00, the patient recovered from the events and was discharged from the emergency room. It was reported that the patient was instructed to take BENADRYL every 6 hours for 24 hours and prednisone (no details were provided) after leaving the emergency room. Additionally, it was reported that the patient went to the school on the next day. The causality assessment between the events and VARIVAX was not provided as well as the causality assessment between the events and BOOSTRIX. The reporter considered the reported events to be serious due to life threatening. Upon internal review, abdominal pain, throat irritation, injection site swelling, hypoaesthesia oral, swelling face, eyelid oedema and dysphagia; were considered medically significant events as the patient required treatment with epinephrine.
Age: 10.0
Sex: M
Vaccine: TDAP, VARCEL, TDAP, VARCEL
Symptoms: Injection site swelling, Swelling face, Throat irritation
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 10 year old male patient. The patient's pertinent medical history included Henoch-Schonlein purpura at age of 18 months and again between 4 to 5 years. The patient's concurrent conditions were not reported. The patient had not drug/reactions allergies. His concomitant medications included fluoride. On 19-MAR-2018 at 15:45, the patient was vaccinated with the second dose of VARIVAX lot # N025935 with expiration date 19-SEP-2019, subcutaneously; and a dose of BOOSTRIX (route of administration, lot # and expiration date were not reported); both for prophylaxis. Subsequently, the patient left the nurse office with his mother, and the mother reported the patient ate a "Dum Dum lollipop" and a snack size bag of "LAYS" potato chips on the way home in the car. The patient then developed abdominal pain, a "tickle in his throat" and swelling at the injection site where VARIVAX was administered. Later on the same date, at the time the patient arrived home, the patient's lips felt numb and the patient had swelling on the left side of his face. On the same date at 16:16, the patient's mother called to the nurse office and he was prescribed and was subsequently administered with 2 teaspoon (tsp) of BENADRYL by his mother. At 16:49, his mother called again to the nurse office and stated the patient's eyelids were swollen and the patient was having difficulty swallowing. The mother was instructed to call the 911 and the patient was taken to the emergency room and was treated with intravenous fluids, epinephrine intramuscularly, BENADRYL intramuscularly, and SOLU-MEDROL intravenously in the emergency room. An unspecified blood work was performed to the patient (results not reported). On the same date at 19:00, the patient recovered from the events and was discharged from the emergency room. It was reported that the patient was instructed to take BENADRYL every 6 hours for 24 hours and prednisone (no details were provided) after leaving the emergency room. Additionally, it was reported that the patient went to the school on the next day. The causality assessment between the events and VARIVAX was not provided as well as the causality assessment between the events and BOOSTRIX. The reporter considered the reported events to be serious due to life threatening. Upon internal review, abdominal pain, throat irritation, injection site swelling, hypoaesthesia oral, swelling face, eyelid oedema and dysphagia; were considered medically significant events as the patient required treatment with epinephrine.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Musculoskeletal stiffness, Neck pain, Pain, Paraesthesia
Clinical narrative: Patient reported being diagnosed with shingles one week after vaccination, states painful itching and burning rash on neck and scalp started weekend after initial vaccine. Patient is concerned that shingles diagnosis is directly related to vaccination.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Patient reported being diagnosed with shingles one week after vaccination, states painful itching and burning rash on neck and scalp started weekend after initial vaccine. Patient is concerned that shingles diagnosis is directly related to vaccination.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Rash pruritic
Clinical narrative: Patient reported being diagnosed with shingles one week after vaccination, states painful itching and burning rash on neck and scalp started weekend after initial vaccine. Patient is concerned that shingles diagnosis is directly related to vaccination.
Age: 43.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Bundle branch block, Chest pain, Chills, Electrocardiogram normal, Myocardial necrosis marker normal
Clinical narrative: Patient presented with pains in left arm and left chest x 2-3 days. She was instructed by her superior to report to ER. Patient currently without pain. No nausea, vomiting, diarrhea, rash or abdominal pain. Patient vital signs and physical exam OK. Patient prescribed iron supplement x 30 days, B-12 (PO) x 30 days, atorvastatin 10 mg #90, and ferrous sulfate 325 mg #90. Patient discharged from ER after 2 hours observation to home. F/up with family physician in 3-5 days.
Age: 43.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Pain, Troponin normal
Clinical narrative: Patient presented with pains in left arm and left chest x 2-3 days. She was instructed by her superior to report to ER. Patient currently without pain. No nausea, vomiting, diarrhea, rash or abdominal pain. Patient vital signs and physical exam OK. Patient prescribed iron supplement x 30 days, B-12 (PO) x 30 days, atorvastatin 10 mg #90, and ferrous sulfate 325 mg #90. Patient discharged from ER after 2 hours observation to home. F/up with family physician in 3-5 days.
Age: 43.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Chest X-ray normal, Chest pain, Electroencephalogram normal, Pain in extremity
Clinical narrative: Patient presented with pains in left arm and left chest x 2-3 days. She was instructed by her superior to report to ER. Patient currently without pain. No nausea, vomiting, diarrhea, rash or abdominal pain. Patient vital signs and physical exam OK. Patient prescribed iron supplement x 30 days, B-12 (PO) x 30 days, atorvastatin 10 mg #90, and ferrous sulfate 325 mg #90. Patient discharged from ER after 2 hours observation to home. F/up with family physician in 3-5 days.
Age: 46.0
Sex: M
Vaccine: ANTH
Symptoms: Hypoaesthesia, Mobility decreased, Pain, Paraesthesia
Clinical narrative: Inability to lift right arm/severe pain (lasted one day). Continuous tingling/numbness on right side of body (presently ongoing).
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a consumer referring to her mother, a female patient of unknown age. Information about concurrent condition, concomitant medication and medical history was not provided. In approximately 2015 (reported about three years  ago), the patient received an initial dose of ZOSTAVAX (dose, lot# and expiration date were not reported) subcutaneously for prophylaxis. The patient asked for a dose of mammalian) SHINGRIX, but she received a dose of ZOSTAVAX 19400 plaque forming units (PFU) (1 dose format (DF); lot# and expiration date were not reported) subcutaneously for prophylaxis at an unspecified clinic on 30-MAR-2018. No adverse effects had been reported.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site pain, Muscle swelling
Clinical narrative: This spontaneous report was received from a pharmacy technician referring to a 66 year old female patient. The patient's pertinent medical history was not provided. Concurrently, she had a drug reaction/allergy to penicillin. Concomitant therapies included an unspecified statin, fluticasone propionate (FLONASE) and progesterone (manufacturer unknown). On 23-MAR-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly, lot # N013521, expiration date on 23-JAN-2019, as routine vaccination (strength was not reported). On 24-MAR-2018, reported as "the next day", the patient started to experience discomfort and pain at the injection site (injection site discomfort and injection site pain). Additionally, there was swelling in the muscle that was the size of a baseball (muscle swelling). After the injection, on an unspecified date in 2018, the pain and discomfort became very severe. The patient went to an unspecified emergency clinic and it was unknown if she was hospitalized. She received an unspecified medication as treatment but it was unknown if any laboratory study was performed. At the reporting time, the outcome of muscle swelling, injection site discomfort and injection site pain was unknown. The causality assessment between the aforementioned adverse events and PNEUMOVAX 23 was not provided. The pharmacy technician requested a lot check on PNEUMOVAX 23 lot number provided.
Sex: F
Vaccine: HPV9
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a female patient of unknown age. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy were unknown.  On an unknown date the patient was vaccinated with a dose of GARDASIL 9 INJ, (strength, lot# and expiration date unknown) subcutaneously (incorrect route of drug administration). No adverse effect was reported. No product quality complaint was reported.
Sex: M
Vaccine: PPV
Symptoms: Influenza
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a male patient of unknown age. The patient's concurrent conditions, concomitant medication, pertinent medical history, drug reactions or allergies were unknown by the reporter. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose #, route, lot number and expiration date were not informed) for prophylaxis. On an unknown date (reported as "later that night"), the patient had the "flu" and was hospitalized for an unspecified amount of time. The patient sought medical attention, and received treatment for the adverse. It was unknown if laboratory diagnostics or studies were performed. The outcome of ""flu" was reported as not recovered. The causality assessment between "flu" and therapy with PNEUMOVAX 23 was not provided.