chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 92.0
Sex: M
Vaccine: PPV
Symptoms: Hyperhidrosis, Injection site erythema, Injection site pain, Injection site swelling, Syncope
Clinical narrative: This spontaneous report was received from a physician regarding a 92-year-old male patient. His concurrent conditions included hypothyroidism, reflux, and arthritis. The patient's historical conditions included aortic aneurysm, anemia, gastrointestinal bleeding, drug allergy with atenolol and ULTRAM. His past drugs included atenolol and ULTRAM. The patient's concomitant therapies included omeprazole, melatonin and finasteride. On 12-MAR-2019, the patient was vaccinated with PNEUMOVAX 23 (lot # R027299, expiration date 09-APR-2020) (dose, strength, and location were not provided) via intramuscular route for vaccination. On the same day, 3 hours after the injection, the patient began to experience pain (injection site pain), swelling (injection site swelling) and redness (injection site erythema) at the injection site, she was also sweating (hyperhidrosis) and had an episode of syncope. On an unknown date, the patient had gone to an unspecified emergency room and was treated with pain medication. The patient was not admitted to the hospital. The patient was recovering from the events. Causality assessment was not provided by the reporter. There was no involvement of product quality complaint (PQC). Upon internal review, the event syncope was determined to be medically significant.
Sex: F
Vaccine: FLU4
Symptoms: Apgar score normal, Caesarean section, Foetal exposure during pregnancy, Premature baby
Clinical narrative: This is a serious spontaneous case reported by other health professional and initially received on 10-Apr-2019, concerning a female neonate patient. The patient's mother did not have any history of offspring with major congenital malformation. Also, the patient's mother had no maternal or paternal history with major congenital malformations. The patient's mother's obstetrical history included two previous full-term live birth and 2 previous spontaneous abortions. The total number of previous pregnancies were reported as 4 and no birth defects were reported. The father did not receive any medications prior to conception. The patient's mother didn't have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The patient's mother's current condition included severe pre-eclampsia, gestational hypertension and polycystic ovarian syndrome. The concomitant medications included Aspirin (acetyl salicylic acid) as a treatment for severe pre-eclampsia. The patient's mother's last menstrual period (LMP) date was 09-Mar-2018. The type of pregnancy was singleton. On 13-Aug-2018, the patient's mother underwent targeted ultrasound and no major congenital malformation was noted. On 18-Oct-2018, the foetus (gestational age: 32 weeks) was exposed to AFLURIA QUADRIVALENT (batch number: YF40208, route of administration: transplacental, parent route of administration, dose, expiry date and anatomical location: not reported) (explicitly considered as foetus exposure during pregnancy) for an unknown indication. At 35.7-week gestational age, the patient was born (preterm birth). The delivery method was caesarean. Infant body weight was 3884 grams and the appearance, pulse, grimace, activity, and respiration (Apgar) score: 8 at minute 1 and 9 at minute 5. The patient's mother's estimated date of delivery (EDD) was reported as 29-Dec-2018. This case was linked to case: 201805233 (mother case).; Reporter's Comments: A female neonate patient experienced preterm birth at 35.7 week of gestation, 1 month 11 days after maternal receipt of AFLURIA QUADRIVALENT vaccine at 32 weeks of gestation (considered as foetal exposure during pregnancy). Maternal obstetric history included multigravida (previous spontaneous abortions and 2 full term live births) and current gestational complications included gestational hypertension and severe preeclampsia. Considering the risk factors (multigravida, pre-eclampsia, gestational hypertension) and no evidence for a biological mechanism that could cause the event, the event preterm birth assessed as not related to the suspect vaccine. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. Hence, the event of foetal exposure during pregnancy was assessed as not related considering the intended use of the vaccine. The company assessed the event preterm birth as serious (medically significant).
Age: 4.0
Sex: M
Vaccine: DTAP, HEP
Symptoms: Dysstasia, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Within 15 min: Muscle weakness, pain in leg-unable to stand very long due to pain. Within a couple hours: severe vomiting, high fever, lethargic, rash and swelling of entire thigh 1 1/2 times the size of other thigh. 1 week later: still severe vomiting, had to have IV fluids at ER, fever off and on, still lethargic, rash/swelling starts to dissipate, severe itching in both legs.  Weeks later: still bouts of vomiting, lethargy, weight loss. Months later: No more vomiting. things have resolved.
Age: 4.0
Sex: M
Vaccine: DTAP, HEP
Symptoms: Lethargy, Muscular weakness, Pyrexia, Vomiting, Weight decreased
Clinical narrative: Within 15 min: Muscle weakness, pain in leg-unable to stand very long due to pain. Within a couple hours: severe vomiting, high fever, lethargic, rash and swelling of entire thigh 1 1/2 times the size of other thigh. 1 week later: still severe vomiting, had to have IV fluids at ER, fever off and on, still lethargic, rash/swelling starts to dissipate, severe itching in both legs.  Weeks later: still bouts of vomiting, lethargy, weight loss. Months later: No more vomiting. things have resolved.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Hypoaesthesia, Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: Severe muscle pain and weakness in back of both legs from gluts, hamstrings, calves to bottom of heels. Difficulty walking and running. Into my third week, Since SHINGRIX injection, some improvement, but still pain and weakness in both legs. Right heel has no pain. Four days after shot, my fourth and fifth fingers on my right hand were numb. Some tingling still exists. I made an appointment with my primary doctor to discuss adverse effects on April 23, 2019.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Severe muscle pain and weakness in back of both legs from gluts, hamstrings, calves to bottom of heels. Difficulty walking and running. Into my third week, Since SHINGRIX injection, some improvement, but still pain and weakness in both legs. Right heel has no pain. Four days after shot, my fourth and fifth fingers on my right hand were numb. Some tingling still exists. I made an appointment with my primary doctor to discuss adverse effects on April 23, 2019.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis, Erythema, Influenza like illness, Injection site reaction, Urticaria
Clinical narrative: Large red welt, baseball in size. Felt flu like for few days. 2-3 weeks post dose, arthritis symptoms started. Arthritis of left shoulder continues with progressing weakness. Pt first reports this to pharmacy on 4/22/19, has not yet reported to MD. Reported to MD on 4/23/19.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Lip swelling, Rash generalised, Rash pruritic
Clinical narrative: Employee stated that on the Friday 4/19  the day after she received the vaccine, which was 4/18,  she developed swelling to her bottom lip and an itchy rash all over her body.  She sought a medical provider and was prescribed steroid therapy for 5 days and zyrtec.  She states that the itching resolves when she takes the zyrtec.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Concussion, Post-traumatic neck syndrome, Road traffic accident
Clinical narrative: I  was  involved  in  a  traffic  accident  around  12:00  noon  approximately  15  to  20  min   after     leaving  the  doctors  office  after  receiving  the  flu  vaccine  on  01/09/2019.  I  contacted  my  Doctors  office  and  reported  the  accident  approximately  3:00 pm  the  same  day.
Age: 63.0
Sex: F
Vaccine: DT
Symptoms: Arthralgia, Chills, Local reaction, Pyrexia, Vaccination site erythema
Clinical narrative: Pt with previous partial mastectomy and 37 lymph nodes removed on L side. Vaccine was administered to the L arm. She had local pain, chills, fever for 1 day, arthralgias, and then it progressed to erythema, induration, warmth, swelling below the site of the vaccination.
Age: 63.0
Sex: F
Vaccine: DT
Symptoms: Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Pt with previous partial mastectomy and 37 lymph nodes removed on L side. Vaccine was administered to the L arm. She had local pain, chills, fever for 1 day, arthralgias, and then it progressed to erythema, induration, warmth, swelling below the site of the vaccination.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Continued persistent Right upper arm pain at the injection site for >3 months
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Nothing serious but wanted to report since SHINGRIX is fairly new. My arm is very sore - more so than with the flu shot. Woke me up a few times last night. I have been taking OTC Ibuprofen (400 mg) which helps a little, but this is intense. I'm feeling unusually tired, especially after walking the dog this afternoon.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Blood glucose increased, Blood pressure decreased, Dizziness, Headache, Hyperhidrosis
Clinical narrative: Patient waited in the pharmacy for about 10 minutes. Left the pharmacy and husband was driving her home. She got dizzy in the car and husband thinks she may have passed out for about a minute or two.  Husband shook her and she woke right back up and he drove her back to the pharmacy. Patient reported that dizziness was getting better however she complained of headache. Legs were shaky and she was sweating. Clinic NP checked her blood pressure and blood sugar. Blood pressure was 100/60 and blood sugar was 110. NP told the patient to elevate her feet and to go to ER if symptoms are not improving. NP thinks patient's blood pressure may have dropped. Pharmacist has called her doctor's office and reported this reaction.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Loss of consciousness, Tremor
Clinical narrative: Patient waited in the pharmacy for about 10 minutes. Left the pharmacy and husband was driving her home. She got dizzy in the car and husband thinks she may have passed out for about a minute or two.  Husband shook her and she woke right back up and he drove her back to the pharmacy. Patient reported that dizziness was getting better however she complained of headache. Legs were shaky and she was sweating. Clinic NP checked her blood pressure and blood sugar. Blood pressure was 100/60 and blood sugar was 110. NP told the patient to elevate her feet and to go to ER if symptoms are not improving. NP thinks patient's blood pressure may have dropped. Pharmacist has called her doctor's office and reported this reaction.
Sex: F
Vaccine: HPV2, HPV4
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a consumer regarding  unspecified female patients of unknown age. The information on medication history, concurrent conditions, concomitant medicaitons, drug allergies and reactions were unknown. On unknown dates, the patients were vaccinated with GARDASIL (dose, units, frequency, batch and lot# number, expiry date were unknown) for prophylaxis. Other suspect therapy include CERVARIX. On unknown dates, 879 patients experienced disability (from an unspecified adverse event), 99 patients died, 5352 patients did not recover (from an unspecified adverse event), 500 patients had abnormal papsmear, 202 patients experienced cervical dysplasia, 57 patients experienced cervix carcinoma, 502 patients had adverse event which was life threatening, 9545 patients had to visit emergency room (from an unspecified adverse event), 2717 patients were hospitalized and 218 patients extended the hospital stay (from an unspecified adverse event), 3625 experienced serious adverse events (from an unspecified medically significant adverse event), 25636 experienced non serious adverse events. The outcome of "disability (from an unspecified adverse event)", abnormal papsmear, cervical dysplasia, cervix carcinoma, "adverse event which was life threatening", "visit emergency room (from an unspecified adverse event)", "hospitalized and extended the hospital stay (from an unspecified adverse event)", unspecified medically significant adverse event and non serious adverse event was unknown. Causality assessment was unknown. Upon internal review, the events cervix carcinoma was determined to be medically significant. This is one of the multiple reports from the same reporter.
Sex: M
Vaccine: HPV2, HPV4
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a consumer regarding unspecified female patients of unknown age. The patients current condition include prophylaxis. The information on medication history, concurrent conditions, concomitant medicaitons, drug allergies and reactions were unknown. On unknown dates, the patients were vaccinated with GARDASIL (dose, units, frequency, batch and lot# number, expiry date were unknown) for prophylaxis. Other suspect therapy include CERVARIX. On unknown dates, 9 patients experienced disability (from an unspecified adverse event), 8 patients died, 124 patients did not recover (from an unspecified adverse event), 16 patients had adverse event which was life threatening, 354 patients had to visit emergency room (from an unspecified adverse event), 65 patients were hospitalized, 5 patients extended the hospital stay (from an unspecified adverse event), 80 patients experienced serious adverse events (from an unspecified medically significant adverse event), 1169 experienced non serious adverse events. The outcome of "disability (from an unspecified adverse event)","adverse event which was life threatening", "visit emergency room (from an unspecified adverse event)", "hospitalized and extended the hospital stay (from an unspecified adverse event)", unspecified medically significant adverse event and non serious adverse event was unknown. Causality assessment was unknown. This is one of the multiple reports from the same reporter.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Patient states the next day she woke up with a fever, chills, body aches, and fatigue. Most symptoms resolved within a day however the fatigue lasted for 3 days total.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Injection site erythema, Injection site pain, Local reaction
Clinical narrative: The patient had a local reaction of redness and swelling at the time of the injection. After 1 week, the pain and redness at the injection site had gone away, but the patient now has bruising on back of arm and up to shoulder.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: The patient had a local reaction of redness and swelling at the time of the injection. After 1 week, the pain and redness at the injection site had gone away, but the patient now has bruising on back of arm and up to shoulder.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Injection site swelling
Clinical narrative: Pt had headache for 3 days and had arm sweeling and pain for 5 days from the injection site all the way down to the elbow.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Inflammation
Clinical narrative: Pt complained about cellulitis in upper arm which was spreading downwards, it was red and very inflammatory in beginning and was better 04/23/19.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Chest discomfort, Chest pain, Cold sweat, Headache, Heart rate increased
Clinical narrative: Employee called to report a reaction day after getting the vaccination. Employee reports symptoms starting at 3AM on 4/23/19. Symptoms include: headache, fever, cold sweats, increased/ high pulse, pressure in chest area/ chest pain. Employee states symptoms are still present.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Employee called to report a reaction day after getting the vaccination. Employee reports symptoms starting at 3AM on 4/23/19. Symptoms include: headache, fever, cold sweats, increased/ high pulse, pressure in chest area/ chest pain. Employee states symptoms are still present.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site swelling
Clinical narrative: Pt had headache for 3 days and also had swelling at the injection site for 5 days from the injection site to the elbow of their arm.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Influenza
Clinical narrative: I had a flu shot in the morning at around 10am  in center and I started to experience sever symptom of flue in the afternoon and the flue symptom continues last night and now. I don't know how many days it will last. That is why I want to report. I am sure that my flue was triggered by flu shot because I don't have this type of flue symptoms for long time, but immediate after the flu shot.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The site was swollen, red, warm, and hard. It was also painful to the touch.
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Influenza like illness
Clinical narrative: Joint pain and flu-like symptoms
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: After receiving the second dose of the vaccine, the patient experienced a mild shingles outbreak.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site mass, Rash
Clinical narrative: Rash developed on trunk and extremities and a bump developed at the  left thigh injection site.
Age: 0.67
Sex: F
Vaccine: RV1
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 8 month 23 day old baby was administered a 3rd dose of  rotarix by mistake/error. There were NO REACTIONS OR ADVERSE EVENTS.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Concussion, Electrocardiogram, Fall, Head injury, Loss of consciousness
Clinical narrative: Syncope within 30 minutes of injection, she has never experienced syncope episode before but was unconscious following passing out for several minutes. This led to her hitting her head on a glass window, counter top and floor resulting in concussion. Seen in Emergency Room of Medical Center immediately following fall.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Syncope within 30 minutes of injection, she has never experienced syncope episode before but was unconscious following passing out for several minutes. This led to her hitting her head on a glass window, counter top and floor resulting in concussion. Seen in Emergency Room of Medical Center immediately following fall.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Musculoskeletal chest pain, Musculoskeletal pain
Clinical narrative: Pain and bruising in the back between shoulder blades and across the ribs reported by patient.  Advised them to contact their doctor since this is not a reaction in the VIS. No reaction to first dose in series.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Decreased appetite, Fatigue, Hypersomnia, Pain in extremity, Peripheral swelling
Clinical narrative: Starting 4/13/19 AM patient started to feel extremely exhausted and primarily laid in bed and slept most of the next few days.  She didn't feel sick (flu symptoms) but just very very exhausted.  She said she didn't feel like getting up to even eat.  She said she should have gone to the doctor but felt too tired to get up to go.  Her left arm also started to swell 4/13/19 AM...getting red and raised, felt very warm, and hurt very bad.  She monitored it and by Tuesday 4/16/19 the swelling had gone down and was just pink.  She is a nurse and said she watched her harm to make sure it wasn't getting too bad and if it would have gotten any worse she would have gone to the doctor.  After about a week from the vaccine, she felt back to normal.  At no time til today did she report this reaction to us as the pharmacy who gave the vaccine or to any other medical provider.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Starting 4/13/19 AM patient started to feel extremely exhausted and primarily laid in bed and slept most of the next few days.  She didn't feel sick (flu symptoms) but just very very exhausted.  She said she didn't feel like getting up to even eat.  She said she should have gone to the doctor but felt too tired to get up to go.  Her left arm also started to swell 4/13/19 AM...getting red and raised, felt very warm, and hurt very bad.  She monitored it and by Tuesday 4/16/19 the swelling had gone down and was just pink.  She is a nurse and said she watched her harm to make sure it wasn't getting too bad and if it would have gotten any worse she would have gone to the doctor.  After about a week from the vaccine, she felt back to normal.  At no time til today did she report this reaction to us as the pharmacy who gave the vaccine or to any other medical provider.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Muscle spasms, Muscular weakness
Clinical narrative: Five days after the vaccine employee experienced diarrhea,  followed by weakness in her lower extremities,  She is currently having intermittent cramping in her lower extremities and was prescribed Flexeril and B12 complex
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test, Bone scan, Crohn's disease, Gait disturbance, Intestinal resection
Clinical narrative: *I'm not sure what brand of DTaP I was administered in 2010. I had the vaccine and 3 weeks later I had swollen joints bilaterally and couldn't hardly walk. I went to Ortho and they Dx me with sprained ankles and to take large amounts of ibuprofen. That didn't help. I went to rheumatologist a few weeks later and after blood work was completed. I was diagnosed with seronegative Rheumatoid arthritis. Prior to that I was a healthy 20 year old, athletic and was a nurse (active on my feet). I was started on methotrexate and steroids. I did that for years until I started getting worse. I never got a vaccination after that and I just found out the correlation within the past 2 years. I eventually got diagnosed further with Crohn's Disease and tried biologics and had a reaction to them. I have had 2 bowel resections due to this and it all stems from the DTaP vaccination.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Joint swelling, Laboratory test, Ligament sprain, Rheumatoid arthritis, Scan
Clinical narrative: *I'm not sure what brand of DTaP I was administered in 2010. I had the vaccine and 3 weeks later I had swollen joints bilaterally and couldn't hardly walk. I went to Ortho and they Dx me with sprained ankles and to take large amounts of ibuprofen. That didn't help. I went to rheumatologist a few weeks later and after blood work was completed. I was diagnosed with seronegative Rheumatoid arthritis. Prior to that I was a healthy 20 year old, athletic and was a nurse (active on my feet). I was started on methotrexate and steroids. I did that for years until I started getting worse. I never got a vaccination after that and I just found out the correlation within the past 2 years. I eventually got diagnosed further with Crohn's Disease and tried biologics and had a reaction to them. I have had 2 bowel resections due to this and it all stems from the DTaP vaccination.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Vaccination complication
Clinical narrative: Patient presented with a red/swollen arm to our sister store on Easter Sunday, 04/21/2019. After consulting the pharmacist working, the patient followed up at a local clinic. The doctor confirmed that it was probably a reaction to the vaccine but assured her that the reaction was going away. The doctor also advised her against the 2 dose of SHINGRIX vaccine.
Age: 59.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: ACCIDENTALLY ADMINISTERED SHOT INTRAMUSCULARLY INSTEAD OF SUBCUTANEOUSLY
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: she had hives with this injection
Age: 1.17
Sex: F
Vaccine: DTAP
Symptoms: Chest X-ray abnormal, Developmental regression, Immediate post-injection reaction, Influenza A virus test negative, Influenza B virus test
Clinical narrative: Perfectly healthy when went in for vaccine. No sickness. High fever for days (104-104.5) through the 26th. Extremely lethargic and fussy. Called in and went in for x-ray, thickening in lungs. Flu-like symptoms. Immediately following vaccine administration noticable speech regression by all close to Kaylea and has not recovered yet as of April 23, 2019.
Age: 1.17
Sex: F
Vaccine: DTAP
Symptoms: Influenza like illness, Influenza virus test negative, Irritability, Lethargy, Lung disorder
Clinical narrative: Perfectly healthy when went in for vaccine. No sickness. High fever for days (104-104.5) through the 26th. Extremely lethargic and fussy. Called in and went in for x-ray, thickening in lungs. Flu-like symptoms. Immediately following vaccine administration noticable speech regression by all close to Kaylea and has not recovered yet as of April 23, 2019.
Age: 1.17
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia, Speech disorder developmental
Clinical narrative: Perfectly healthy when went in for vaccine. No sickness. High fever for days (104-104.5) through the 26th. Extremely lethargic and fussy. Called in and went in for x-ray, thickening in lungs. Flu-like symptoms. Immediately following vaccine administration noticable speech regression by all close to Kaylea and has not recovered yet as of April 23, 2019.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea
Clinical narrative: Patient is having difficulty breathing, mom called to inform us, patient looked up signs/symptoms of reaction and mom thinks she might be have slight problems breathing, instructed mom to tell daughter to go to ER or MD asap to be seen as this is a severe reaction and possible allergic reaction
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Urticaria, Vaccination site reaction
Clinical narrative: Immediate site reaction with large whelp, within 10 mins both arms and face were red with hives.  Dose of benadryl given after apt. At 12noon Second dose given at 9:30pm. After hives returned. 3rd dose at 4am, 4th dose 11am.  Medicine switched to zyrtec 5mls bid, first dose given at 6pm.  10pm hives continued 5mls of prednisone given.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Erythema, Exposure during pregnancy, Feeling hot, Flushing
Clinical narrative: Patient experienced a flushing sensation and dizziness about 1/2 hour post vaccine. She felt hot and was pink. A couple of hours after vaccination, she felt nauseous. The nausea had subsided but the warmth remained at the time of reporting. Patient is about 31 weeks pregnant. (patient has received TDAP before..about 5 years ago...but does not recall any type of reaction.)
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea
Clinical narrative: Patient experienced a flushing sensation and dizziness about 1/2 hour post vaccine. She felt hot and was pink. A couple of hours after vaccination, she felt nauseous. The nausea had subsided but the warmth remained at the time of reporting. Patient is about 31 weeks pregnant. (patient has received TDAP before..about 5 years ago...but does not recall any type of reaction.)
Age: 1.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives. all over his body. not itchy no fever. Received Benadryl liquid 1/2 tsp p.o every 6 hours.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain of skin
Clinical narrative: This was the booster for the shingles vaccine. Scalp was very sore - no lesions - pain moved around crown of head.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza A virus test negative, Influenza B virus test, Influenza like illness, Influenza virus test negative, Pain
Clinical narrative: 12 days of flu like symptoms and systemic whole body aches.
Sex: U
Vaccine: VARZOS
Symptoms: Anger, Hallucination, Mood altered
Clinical narrative: Hallucinations, moody and angry. No treatment, side effects lasted 3 days.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Injection site reaction, Local reaction
Clinical narrative: Dizziness began 24 hours after vaccine given and lasted for 4 days. Local reaction surrounding injection site that encompassed large area upper arm (20 x 14 cm).
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Hypersomnia, Injection site pain, Injection site swelling
Clinical narrative: Vaccine given afternoon of April 18th. Muscle aches/pain woke patient at 5 am April 19th. Pt was extremely sore (whole body) and slept the entire day and through the night. Pt awoke April 20th feeling normal except "goose-egg" and sore arm where injection was given. Pt also states that arm was/is itching slightly, some diarrhea and upset stomach.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pruritus
Clinical narrative: Vaccine given afternoon of April 18th. Muscle aches/pain woke patient at 5 am April 19th. Pt was extremely sore (whole body) and slept the entire day and through the night. Pt awoke April 20th feeling normal except "goose-egg" and sore arm where injection was given. Pt also states that arm was/is itching slightly, some diarrhea and upset stomach.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Flushing, Palpitations, Spinal pain, Vision blurred
Clinical narrative: Pt. felt flushing of her face, felt things were blurry. Her arms were red. She felt like her heart was racing and had severe pain down her spine. Tx was injection of diphenhydramine, monitoring vitals. Pt. felt better soon & was able to leave.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Diarrhoea, Lethargy, Palpitations, Paraesthesia
Clinical narrative: Approximately 4 hours after vaccination had onset fever, chills, diarrhea, palpitations, tingling left arm and lethargy. 31 hours later (current 458 PM) symptoms continue.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Approximately 4 hours after vaccination had onset fever, chills, diarrhea, palpitations, tingling left arm and lethargy. 31 hours later (current 458 PM) symptoms continue.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Pt received Kinrix & proquad on 4/22/19. Pt came in the next day with redness on left deltoid. VIS was given before vaccination.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm soreness was persistent for 3-4 weeks.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Acute disseminated encephalomyelitis, Lethargy, Nuclear magnetic resonance imaging brain abnormal, Pyrexia
Clinical narrative: About 2 weeks after my daughters vaccine, she developed a fever, lethargy and was  just "off", after numerous visits to doctor and local hospital, she was finally given MRI, she had lesions on her brain and was diagnosed with ADEM. (Acute Disseminated  Encephalomyelitis). 2 years later she is now diagnosed with multi-phasic ADEM. She has to get monthly IVIG infusions to keep lesions from growing.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Body temperature increased, Dizziness, Fatigue, Lymphadenopathy, Paraesthesia
Clinical narrative: On 4/7/2019 at approximately 5:30pm patient noticed an enlarged lymph node on the left side of her neck. It was tender and swelling was noted on the left side of her neck. On 4/8/2019 lymph node continued to be enlarged/ neck swollen and pain with tingling on left side of neck/shoulder area. Moist heat applied and she took ADVIL for discomfort. 4/9/2019 tenderness and tingling in left shoulder, node still swollen and tender. She saw Dr. on 4/9/2019 and treated with AUGMENTIN 500mg bid x7days, Prednisone 40mg qd x3 days then 20mg x 4 days. She continued with warm compresses and ADVIL as needed. Dr.'s office reported adverse reaction last week reference #164754.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Tinnitus
Clinical narrative: On 4/7/2019 at approximately 5:30pm patient noticed an enlarged lymph node on the left side of her neck. It was tender and swelling was noted on the left side of her neck. On 4/8/2019 lymph node continued to be enlarged/ neck swollen and pain with tingling on left side of neck/shoulder area. Moist heat applied and she took ADVIL for discomfort. 4/9/2019 tenderness and tingling in left shoulder, node still swollen and tender. She saw Dr. on 4/9/2019 and treated with AUGMENTIN 500mg bid x7days, Prednisone 40mg qd x3 days then 20mg x 4 days. She continued with warm compresses and ADVIL as needed. Dr.'s office reported adverse reaction last week reference #164754.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site pain, Injection site paraesthesia, Lymph node pain, Lymphadenopathy, Neck pain
Clinical narrative: On 4/7/2019 at approximately 5:30pm patient noticed an enlarged lymph node on the left side of her neck. It was tender and swelling was noted on the left side of her neck. On 4/8/2019 lymph node continued to be enlarged/ neck swollen and pain with tingling on left side of neck/shoulder area. Moist heat applied and she took ADVIL for discomfort. 4/9/2019 tenderness and tingling in left shoulder, node still swollen and tender. She saw Dr. on 4/9/2019 and treated with AUGMENTIN 500mg bid x7days, Prednisone 40mg qd x3 days then 20mg x 4 days. She continued with warm compresses and ADVIL as needed. Dr.'s office reported adverse reaction last week reference #164754.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Swelling
Clinical narrative: On 4/7/2019 at approximately 5:30pm patient noticed an enlarged lymph node on the left side of her neck. It was tender and swelling was noted on the left side of her neck. On 4/8/2019 lymph node continued to be enlarged/ neck swollen and pain with tingling on left side of neck/shoulder area. Moist heat applied and she took ADVIL for discomfort. 4/9/2019 tenderness and tingling in left shoulder, node still swollen and tender. She saw Dr. on 4/9/2019 and treated with AUGMENTIN 500mg bid x7days, Prednisone 40mg qd x3 days then 20mg x 4 days. She continued with warm compresses and ADVIL as needed. Dr.'s office reported adverse reaction last week reference #164754.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Dyspnoea, Headache, Nausea
Clinical narrative: Fever, chills, headache, achy joints, nausea, trouble breathing (have to use inhaler).
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, chills, headache, achy joints, nausea, trouble breathing (have to use inhaler).
Age: 34.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Musculoskeletal stiffness, Peripheral swelling, Rash, Vomiting
Clinical narrative: Headache, rash swollen arm. Numbness and stiffness. Vomiting
Sex: F
Vaccine: HPV9
Symptoms: Pain, Pyrexia
Clinical narrative: This spontaneous report was received from a nurse via company representative and refers to a female patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (exact dose, route of administration, lot# and expiration date were not reported) for routine immunization. On an unknown date, after the patient received GARDASIL 9, she experienced body aches and a fever. The patient did not seek medical attention. It was unknown if a treatment was given for the events. The outcome of the events and causality assessment were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 83-year-old patient of unknown gender. No information was received regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2009, the patient was administered ZOSTAVAX by a pharmacist at a pharmacy (dose, route of administration, vaccination site, lot # and expiration date were not provided). On an unspecified date, the patient was treated by a healthcare provider at the hospital for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The outcome of shingles was unknown. The causality assessment between the event of shingles and ZOSTAVAX was reported as related. The causality assessment for product quality issue was not reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; received an expired dose of properly stored PNEUMOVAX 23; Information has been received from a medical assistant referring to a patient of unknown age and gender.  Information about medical history, concurrent condition and concomitant medication was unknown.      On 15-APR-2019 the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # N024717 with expiration date of 06-APR-2019, 0.5 milliliter/ once, intramuscular) for prophylaxis. No adverse effects were reported.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Immunisation, No adverse event, Underdose
Clinical narrative: no adverse effects reported; Patient was revaccinated with full dose of VARIVAX more than 28 days later; Patient was revaccinated with full dose of VARIVAX more than 28 days later; Syringe inadvertently slipped so dose considered only a partial dose; This spontaneous report was received from a certified medical assistant, and refers to a 12 month old patient of unknown gender. The patient's medical history, cnocurrent conditions, and concomitant therapies were not reported.   On 11-MAR-2019, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R002508, subcutaneous, for prophylaxis. However, the siringe inadvertently slipped and only partial dose was administered (underdose).  On 15-APR-2019, more than 28 days later, the patient was revaccinated with full dose of varicella virus vaccine live (oka/merck) (VARIVAX) (inappropriate schedule of product administration and extra dose administered).  No adverse effects reported.
Sex: F
Vaccine: PPV
Symptoms: Injection site joint pain
Clinical narrative: shoulder joint pain in the same side as the pneumovax 23 injection; This spontaneous report was received from a consumer via company representative, referring on herself a 66-year-old female patient with rheumatoid arthritis as a concurrent condition. There was no information about the patient's concomitant therapies, previous drug reactions, allergies or medical history.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # N019838, with expiration date on 16-FEB-2019 (formulation, strength, dose, frequency, route of administration, anatomical location, were not reported) for vaccination.    On an unknown date (reported as a day or two after the injection), the patient experienced shoulder joint pain in the same side as the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection. The outcome of injection site joint pain was reported as resolved.        The relatedness between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; improperly stored; This spontaneous report as received from a medical assistant referred to a patient of unknown age and gender. The patient concurrent condition, medical history, concomitant therapies and drug reactions/allergies were not reported.     On 12-APR-2019, the patient was vaccinated with one dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # R013859, expiration date 14-JUN-2019) (dose, unit and route were not reported) for prophylaxis (product storage error). No adverse effects were reported. Temperature: 35.42F. Time frame: 18 minutes. There was no previous temperature excursion.; Sender's Comments:  US-009507513-1904USA008552: US-009507513-1904USA008551: US-009507513-1904USA008553:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; improperly stored; This spontaneous report as received from a medical assistant referred to a patient of unknown age and gender. The patient concurrent condition, medical history, concomitant therapies and drug reactions/allergies were not reported.     On 10-APR-2019, the patient was vaccinated with one dose of improperly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # R022879, expiration date 02-AUG-2020) (dose, unit and route were not reported) for prophylaxis (product storage error). No adverse effects were reported. Temperature: 35.42F. Time frame: 18 minutes. There was no previous temperature excursion.; Sender's Comments:  US-009507513-1904USA008552: US-009507513-1904USA008553: US-009507513-1904USA008542:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; improperly stored; This spontaneous report as received from a medical assistant referred to a patient of unknown age and gender. The patient concurrent condition, medical history, concomitant therapies and drug reactions/allergies were not reported.     On 10-APR-2019, the patient was vaccinated with one dose of improperly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # R022879, expiration date 02-AUG-2020) (dose, unit and route were not reported) for prophylaxis (product storage error). No adverse effects were reported. Temperature: 35.42F. Time frame: 18 minutes. There was no previous temperature excursion.; Sender's Comments:  US-009507513-1904USA008551: US-009507513-1904USA008553: US-009507513-1904USA008542:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; improperly stored; This spontaneous report as received from a medical assistant referred to a patient of unknown age and gender. The patient concurrent condition, medical history, concomitant therapies and drug reactions/allergies were not reported.     On 05-APR-2019, the patient was vaccinated with one dose of improperly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # R022879, expiration date 02-AUG-2020) (dose, unit and route were not reported) for prophylaxis (product storage error). No adverse effects were reported. Temperature: 35.42F. Time frame: 18 minutes. There was no previous temperature excursion.; Sender's Comments:  US-009507513-1904USA008542: US-009507513-1904USA008551: US-009507513-1904USA008552:
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test positive, Rubella antibody positive
Clinical narrative: titers drawn for MMR II and employee was immune to mumps and rubella but not measles; This spontaneous report was received from a nurse regarding a female adult patient of unknown age. The patient's historical drug included unspecified penicillin, historical condition included rubella and allergy to penicillin. The patient's concurrent conditions and concomitant therapies were not reported. On an unknown date the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, frequency, route of administration, lot # and expiration date were not provided by the reporter) for prophylaxis. On an unknown date, an employee (patient) at the office had Igg antibody titers test and the employee was immune to mumps and rubella but not to measles (measles antibody negative).  Reporter stated that the patient thought she was vaccinated and was uncertain if she had illness as a child. Patient sought medical attention. Patient had not recovered from the event, measles antibody negative. Causality assessment was not provided by the reporter. There was no involvement of product quality complaint (PQC).
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Inadvertent administration via intramuscular route vs. subcutaneous route; No adverse effect; This spontaneous report as received from a nurse refers to a child patient of unknown age and gender. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent (DILUENT MRK INJ).  On an unknown date, the patient was inadvertently vaccinated with second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # R028623, expiry date: 04-OCT-2020) (dose and frequency were not reported) intramuscularly versus subcutaneous route for prophylaxis (incorrect route of product administration). No adverse effects were reported. No product quality complaint was involved.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: the patient did not experience any adverse reactions; the patient was administered with an expired dose; This spontaneous report was received from a nurse refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were unknown. On 18-APR-2019, the patient was vaccinated with expired (expired product administered) measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose unknown), therapy type: rHA, lot # N009799, expiry: 24-MAR-2019, single injection, subcutaneous in the left thigh for prophylaxis. The patient did not experience any adverse reactions.
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Product administered outside of prescribing information; No adverse effect; This spontaneous report was received from a consumer (office manager) regarding to a 28 year old male patient. The patients relevant medical history, current condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA (recombinant human albumin) (lot # R014354/expiration date: 18-NOV-2019) (unit, frequency, anatomical location: unknown) 1 dosage form via subcutaneous route for prophylaxis (product administered to patient of inappropriate age). The reporter informed that there was no adverse effects.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; multiple patients were administered improperly stored doses; This spontaneous report was received from other healthcare professional (medical assistant) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies were not provided. The patient's concomitant drug therapy include diluent MRK.  On 16-APR-2019 the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX), lot # R023513, with expiration date 16-OCT-2020, (frequency, strength, anatomical location were not provided), administered subcutaneously for prophylaxis (product storage error).   Temperature was reported as -14 degree Celsius to -10 degree Celsius (-11 degree Celsius). Time frame was reported as 30 minutes. -9 degree Celsius to 8 degree Celsius (-7.1 degree Celsius). Time frame was reported as 45 minutes. There was no previous temperature excursion.  No adverse effects were reported. The call was because of a data logger.  This is one of the several reports received from same reporter.; Sender's Comments:  US-009507513-1904USA009842: US-009507513-1904USA009840: