chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: First 24 hours: Sore arm, swelling, tenderness to touch, redness around injection site, fatigue, stomach upset, headache, sore neck on left side. After 36 hours: Warmth and swelling around injection site which spread further below the injection site. Increased swelling, tenderness to touch, less soreness in arm, continuing fatigue. After 48 hours: Warmth, swelling somewhat reduced, redness spread further down from injection site, itching, still tender to touch.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Neck pain, Pruritus, Skin warm
Clinical narrative: First 24 hours: Sore arm, swelling, tenderness to touch, redness around injection site, fatigue, stomach upset, headache, sore neck on left side. After 36 hours: Warmth and swelling around injection site which spread further below the injection site. Increased swelling, tenderness to touch, less soreness in arm, continuing fatigue. After 48 hours: Warmth, swelling somewhat reduced, redness spread further down from injection site, itching, still tender to touch.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Hypersomnia, Influenza like illness
Clinical narrative: Severe Headache, Flu-Like Symptoms, Fever, Aches Chills, Weakness, general malaise lasting 3 days.  Symptoms worsened on the afternoons of days 2 and 3. Needed to stay in bed for the whole 3 days. Unable to go about my daily business. Slept most of the time.   Based on my experience, no one should take this immunization unless they are prepared and able to spend 3 days sick in bed.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Malaise, Pain, Pyrexia
Clinical narrative: Severe Headache, Flu-Like Symptoms, Fever, Aches Chills, Weakness, general malaise lasting 3 days.  Symptoms worsened on the afternoons of days 2 and 3. Needed to stay in bed for the whole 3 days. Unable to go about my daily business. Slept most of the time.   Based on my experience, no one should take this immunization unless they are prepared and able to spend 3 days sick in bed.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Pruritus
Clinical narrative: Patient presented to pharmacy on 9/1/19 at 1pm reporting a side effect she thought due to the Shingrix vaccine. She said redness started on the back of her left knee on Friday 8/30/19 morning. She reports the area is not painful, but has been itchy. Patient showed a picture of the knee showing ~3x4inch square area of redness. She does not believe it was a bug bite, but was concerned about Lyme Disease. She did not have any reaction at the injection site besides tenderness the day of the vaccination.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling abnormal, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Patient came in on Sept 1st to report that after given first shingrix vaccine she had really bad pain.  It hurt badly as it was being administered and for a week she couldn't lift her arm any higher than her shoulder. It was very painful and burning and still doesn't feel right.  She still had a red spot on her arm.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site warmth, Pyrexia, Rash
Clinical narrative: Patient came in on Thursday 8/23/19 after receiving immunization and at the site of immunization she had a lump on her arm.  I told her to come back or let me know if it got worse.  She returned on Friday 8/24/19 and her upper arm was red and was hot to the touch.  Patient stated arm was hot to the touch for 2-3 days and she had a fever for 2-3 days.  Then she ended up with spots all over her body.  Everything resolved after 3 days. Upon talking with patient on the phone 9/2/19 everything is back to normal and no long term adverse reactions.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction, Incomplete course of vaccination
Clinical narrative: Pt didn't specify rxs but pt went to MD office and was told not to get 2nd dose as rxns were bad.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Depressed level of consciousness, Dyskinesia, Heart rate decreased, Hypopnoea, Loss of consciousness
Clinical narrative: 10:09: Shingrix Administered to RD, patient instructed about ADE's and to stay within pharmacy range for 15 - 20 minutes 10:14: Saw that patient was rocking/swaying in his chair in the waiting area. Wife states to call EMS, my technician does so as I go out with an epinephrine pen and assess the patient. His eyes closed, unresponsive, consciousness fading, breathing was shallow, faint into no breathing.  Wife states that the pulse was low after assessment (she is a nurse). Epinephrine indicated, administered 0.3mg pen into the upper left thigh for 10 seconds. Patient regained consciousness and responsiveness.  10:25 am: EMS arrived  and began their assessment, loaded patient onto a gurney as he experienced a second bout of syncope and headed to Hospital.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: 10:09: Shingrix Administered to RD, patient instructed about ADE's and to stay within pharmacy range for 15 - 20 minutes 10:14: Saw that patient was rocking/swaying in his chair in the waiting area. Wife states to call EMS, my technician does so as I go out with an epinephrine pen and assess the patient. His eyes closed, unresponsive, consciousness fading, breathing was shallow, faint into no breathing.  Wife states that the pulse was low after assessment (she is a nurse). Epinephrine indicated, administered 0.3mg pen into the upper left thigh for 10 seconds. Patient regained consciousness and responsiveness.  10:25 am: EMS arrived  and began their assessment, loaded patient onto a gurney as he experienced a second bout of syncope and headed to Hospital.
Age: 79.0
Sex: M
Vaccine: FLUA3
Symptoms: Dizziness, Fall, Vomiting
Clinical narrative: Pt reported that she felt dizzy, fell, and vomitted about 5 hours after vaccine administration when we was at home.  Vaccine as administered in the pharmacy around 1pm.   She was taken to the ER later at 7 or 8pm on same day flu shot was given.  Pt has no previous history of problems with flu vaccines in past and gets flu shots annually.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Influenza like illness, Injected limb mobility decreased, Joint range of motion decreased, Loss of personal independence in daily activities
Clinical narrative: Evening of 8/26 I started to have flu like symptoms along with muscle. The flu like symptoms worsened on 8/27. I was nausea, dizzy and feverish. I slept all day. The muscle pain worsened on 8/27 & 8/28. I had limited range of motion for 2 day. The flu like symptoms went away on 8/28. As the week, progressed, muscle pain improved. As of today 9/2, I still have muscle pain and having difficulty dressing using my left arm. I'm not totally recovered. I expected some muscle pain but is a week since the shot.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Evening of 8/26 I started to have flu like symptoms along with muscle. The flu like symptoms worsened on 8/27. I was nausea, dizzy and feverish. I slept all day. The muscle pain worsened on 8/27 & 8/28. I had limited range of motion for 2 day. The flu like symptoms went away on 8/28. As the week, progressed, muscle pain improved. As of today 9/2, I still have muscle pain and having difficulty dressing using my left arm. I'm not totally recovered. I expected some muscle pain but is a week since the shot.
Age: 1.0
Sex: M
Vaccine: MMRV, PNC13
Symptoms: Pyrexia, Respiratory arrest, Seizure
Clinical narrative: 2 seizures less than 8 hours after. My son seized for about 2 minutes, stopped breathing, and fever spiked to 102 degrees. 2nd seizure less than 45 minutes after 1st while in hospital. Again stopped breathing, full body seizure, fever at 102 degrees.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Injection site erythema
Clinical narrative: Day after injection:fatigue, chills, headache, loss of appetite. Injection site had 3x3 inch, warm, red and painful welt.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: Day after injection:fatigue, chills, headache, loss of appetite. Injection site had 3x3 inch, warm, red and painful welt.
Age: 91.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Rash
Clinical narrative: Patient was diagnosed at urgent care.  Sign and symptoms: mild rash on left face especially the cheeks and was given antivirals to treat the rash. Rash was recovered in 3 days and patient is currently experiencing mild numbness on the left face.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Pt ran over 101 degree fever.  She had chills, aches, nausea, arm extremely sore.  Lasted about 24 hours.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site reaction, Rash erythematous
Clinical narrative: Patient developed red rash and knot on left arm at injection site
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Patient came back to pharmacy to get her antibiotic filled for the cellulitis and showed me the reaction site and said dr diagnosed her with cellulitis/infection on the arm pneumovax was administered.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyskinesia, Gynaecological examination normal, Muscle contractions involuntary, Muscle spasms, Muscle twitching
Clinical narrative: First injection was 01/06/2019 and second injection was 03/09/2019.  Starting 04/14/2019, I started having spasms.  First strong, jerking spasms in my abdomen.  Then they started happening all over my body at varying intensities (jerk, twitch, flutter).  They usually happen when I'm resting or sleeping, but can happen any time. They usually happen quickly (one to three times) and then stop.  Spasm intensity has been improving over time.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Parasite stool test negative
Clinical narrative: First injection was 01/06/2019 and second injection was 03/09/2019.  Starting 04/14/2019, I started having spasms.  First strong, jerking spasms in my abdomen.  Then they started happening all over my body at varying intensities (jerk, twitch, flutter).  They usually happen when I'm resting or sleeping, but can happen any time. They usually happen quickly (one to three times) and then stop.  Spasm intensity has been improving over time.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Muscle contractions involuntary, Muscle spasms, Muscle twitching
Clinical narrative: First injection was 01/06/2019 and second injection was 03/09/2019.  Starting 04/14/2019, I started having spasms.  First strong, jerking spasms in my abdomen.  Then they started happening all over my body at varying intensities (jerk, twitch, flutter).  They usually happen when I'm resting or sleeping, but can happen any time. They usually happen quickly (one to three times) and then stop.  Spasm intensity has been improving over time.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Limb mass, Skin warm, Swelling
Clinical narrative: patient described to have a lump larger than usual in her arm.  it is swollen and hot to the touch.  She stated she has a large bruise around the injection site.  after questioning she stated she does not have any limitations in movement or pain in her arm.  Explained it may be normal injection reaction but to watch for fever or any unusual pain/ limitation to movement
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Head discomfort, Lethargy, Pain
Clinical narrative: 12 hours after shot.  Lethargic, achy, heavy head
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Headache, Influenza like illness, Injection site pain
Clinical narrative: Swollen, hot and sore at injection site; Terrible muscle and body aches and pain flu-like; fatigue, lethargy and headache; loss of appetite
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Lethargy, Myalgia, Pain
Clinical narrative: Swollen, hot and sore at injection site; Terrible muscle and body aches and pain flu-like; fatigue, lethargy and headache; loss of appetite
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Condition aggravated, Headache, Lethargy, Nausea
Clinical narrative: Nausea, fever, lethargy, headache, weakness for 12 hours.  Then first oral herpes outbreak in 5+ years followed 2 days later.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Oral herpes, Pyrexia
Clinical narrative: Nausea, fever, lethargy, headache, weakness for 12 hours.  Then first oral herpes outbreak in 5+ years followed 2 days later.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: Patient had grade 3 diarrhea (CTCAE) approximately 27 hours after vaccine administration. Symptoms subsided about 5 hours after they began and after a dose of loperamide (imodium) and an increase in fluid intake. Given the patient's age, hospitalization would have been necessary if symptoms had continued.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Swelling, Urticaria
Clinical narrative: Swelling. Hives. Sore Throat. 10 days Treated with Steroid taper (Prednisone).
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Fatigue, Paraesthesia, Pruritus, Somnolence
Clinical narrative: Fatigue & Sleepiness on the afternoon of 8/30/19  On Morning of 9/1/19, tingling of feet, lower legs & hands (as well as itching)  On Afternoon of 9/1/19, difficulty breathing, gasping for air, decreased lung capacity, Pt went to ER following these symptoms
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Total lung capacity decreased
Clinical narrative: Fatigue & Sleepiness on the afternoon of 8/30/19  On Morning of 9/1/19, tingling of feet, lower legs & hands (as well as itching)  On Afternoon of 9/1/19, difficulty breathing, gasping for air, decreased lung capacity, Pt went to ER following these symptoms
Sex: F
Vaccine: PPV, PPV
Symptoms: Arthritis, Blood test normal, Discomfort, Fall, Injection site pain
Clinical narrative: severe pain after receiving vaccine; Information has been received from a pharmacist referring to an 88-year-old female patient. The patient's pertinent medical history, concurrent condition and concomitant therapy were not reported.      On 07-AUG-2019, the patient was vaccinated with 1 dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # R012501, expiration date: 08-JAN-2020) intramuscularly for prophylaxis in patient over 65 years and received pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13).   After vaccination, the patient experienced severe pain. The pharmacist reported she would call back after speaking with the pharmacist who administered the vaccine with additional information. The pharmacist requested a lot check and was requesting the response quickly, because they didn't know if they should administer the remaining vaccine. Outcome of the severe pain was unknown.  The reporter did not provide causal relationship between the event and suspected vaccine.
Sex: F
Vaccine: PPV, PPV
Symptoms: Insomnia, Loss of consciousness, Pain in extremity, Ultrasound scan abnormal, X-ray limb abnormal
Clinical narrative: severe pain after receiving vaccine; Information has been received from a pharmacist referring to an 88-year-old female patient. The patient's pertinent medical history, concurrent condition and concomitant therapy were not reported.      On 07-AUG-2019, the patient was vaccinated with 1 dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # R012501, expiration date: 08-JAN-2020) intramuscularly for prophylaxis in patient over 65 years and received pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13).   After vaccination, the patient experienced severe pain. The pharmacist reported she would call back after speaking with the pharmacist who administered the vaccine with additional information. The pharmacist requested a lot check and was requesting the response quickly, because they didn't know if they should administer the remaining vaccine. Outcome of the severe pain was unknown.  The reporter did not provide causal relationship between the event and suspected vaccine.
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain
Clinical narrative: severe pain after receiving vaccine; Information has been received from a pharmacist referring to an 88-year-old female patient. The patient's pertinent medical history, concurrent condition and concomitant therapy were not reported.      On 07-AUG-2019, the patient was vaccinated with 1 dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # R012501, expiration date: 08-JAN-2020) intramuscularly for prophylaxis in patient over 65 years and received pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13).   After vaccination, the patient experienced severe pain. The pharmacist reported she would call back after speaking with the pharmacist who administered the vaccine with additional information. The pharmacist requested a lot check and was requesting the response quickly, because they didn't know if they should administer the remaining vaccine. Outcome of the severe pain was unknown.  The reporter did not provide causal relationship between the event and suspected vaccine.
Age: 16.0
Sex: F
Vaccine: MNQ, MENB, MNQ
Symptoms: Asthenia, Extra dose administered, Fatigue, Malaise
Clinical narrative: Couldn?t walk 6 hrs after injection, achy soreness all over, slept 20-22 hrs a day for a week. Shaking inside for days, heart palpitations.
Age: 16.0
Sex: F
Vaccine: MNQ, MENB, MNQ
Symptoms: Electrocardiogram, Gait inability, Hypersomnia, Laboratory test, Pain
Clinical narrative: Couldn?t walk 6 hrs after injection, achy soreness all over, slept 20-22 hrs a day for a week. Shaking inside for days, heart palpitations.
Age: 16.0
Sex: F
Vaccine: MNQ, MENB, MNQ
Symptoms: Palpitations, Tremor
Clinical narrative: Couldn?t walk 6 hrs after injection, achy soreness all over, slept 20-22 hrs a day for a week. Shaking inside for days, heart palpitations.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Cerebrovascular accident, Gait inability, Head discomfort, Headache
Clinical narrative: Adverse event; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccinae indication. After vaccination, the patient experienced adverse events. This case was 1 of 3 linked cases.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Adverse event
Clinical narrative: Adverse event; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccinae indication. After vaccination, the patient experienced adverse events. This case was 1 of 3 linked cases.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Cerebrovascular accident, Gait inability, Head discomfort, Headache
Clinical narrative: Adverse events; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccinae indication. After vaccination, the patient experienced adverse events. This case was 1 of 3 linked cases.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Adverse event
Clinical narrative: Adverse events; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccinae indication. After vaccination, the patient experienced adverse events. This case was 1 of 3 linked cases.
Age: 28.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Induration, Pain in extremity, Swelling
Clinical narrative: Upper arm is red, hard swollen and hard to the touch and very painful
Age: 35.0
Sex: F
Vaccine: ANTH
Symptoms: Joint range of motion decreased, Musculoskeletal stiffness, Swelling
Clinical narrative: Limiting range of motion, stiffness, and swelling.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Musculoskeletal pain, Pain
Clinical narrative: Left arm pain at site. Also shoulder pain. This is week 3 of the pain and it is not getting any better. Can't lift arm without it hurting my arm and shoulder
Age: 67.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Dyskinesia, Headache
Clinical narrative: Day of vaccines: Extreme headache, blurry vision, loss of muscle control, fever, chills and extreme loss of bladder control (could barely make it to bathroom) Day after vaccines: chills, slight fever, no energy, and no appetite
Age: 67.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Pyrexia, Urinary incontinence, Vision blurred
Clinical narrative: Day of vaccines: Extreme headache, blurry vision, loss of muscle control, fever, chills and extreme loss of bladder control (could barely make it to bathroom) Day after vaccines: chills, slight fever, no energy, and no appetite
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain in extremity
Clinical narrative: Patient has been experiencing arm pain radiating down the length of the arm.
Age: 51.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Eye pain, Headache, Pyrexia, Vision blurred
Clinical narrative: Fever, Hard to focus(Vision), Chills, Headache, sore eyes
Age: 16.0
Sex: F
Vaccine: HPV9, IPV, TDAP
Symptoms: Loss of consciousness, Somnolence, Syncope
Clinical narrative: Tdap and Ipol were administered first to left deltoid and then Gardasil to the right deltoid, Pt. was sitting in chair in nurses office for administration. About 15-30 seconds after all immunizations were administered patient fainted. Patient's mother, interpreter, and 2 nurses were present with patient. Patient was unconscious for less that 15 seconds and then appeared drowsy afterwards. Patient was monitored by nurse for 30 minutes, cold wet towels applied to patients forehead and neck. Patient was also given a coke to drink. After about 30 minutes patient requested to use the bathroom and was assisted by the nurse to the restroom. After using the restroom patient stated that she was feeling better and left with her mother.  Patient was assisted out to the car in the parking lot by the interpreter.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Arthralgia, Erythema, Joint swelling, Urticaria
Clinical narrative: Presented with non-pruritic urticaria scattered on trunk and arms with right ankle swelling and pain. Mother gave Benadryl 5mL the evening that hives appeared which provided relief. On exam on 8/31/19: wheals scattered on back of leg, abdomen, flank - flat, raised wheals on inner right arm.  erythema of anterior right ankle, no swelling or pain. Ankle erythema may have been secondary to irritation from tight shoes that she wore that day. Spoke to mother on 9/2/19, rash gradually resolved after office visit. No further doses of Benadryl.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Anogenital warts, Biopsy, Foreign travel
Clinical narrative: Pt had 3 shot series: 1/3/17: M034780 (exp 4-15-19), 9/28/16: M016193 (exp 4-24-18), and 8/9/16 M)11840 (exp 2-1-18.  No h/o sexual contact at all, no intimate skin to skin contact.  Dx condyloma accuminata June 18, 2019.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Heart rate increased, Injection site erythema, Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: Irritability followed by rapid heart beat that took place every 6 to 8 hours and lasted for about 2 hours each time. Next day redness at site of injection about 2.5 inches in diameter that welted up and was itchy. Injection site was also extremely warm to touch.  This all lasted for 8 days.  At present time injection site is still itchy. Took Benadryl to relieve symptoms.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Irritability, Urticaria
Clinical narrative: Irritability followed by rapid heart beat that took place every 6 to 8 hours and lasted for about 2 hours each time. Next day redness at site of injection about 2.5 inches in diameter that welted up and was itchy. Injection site was also extremely warm to touch.  This all lasted for 8 days.  At present time injection site is still itchy. Took Benadryl to relieve symptoms.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Developed hives 10 days after shot.
Age: 3.0
Sex: M
Vaccine: HEP
Symptoms: Rash, Streptococcus test negative, Vaccination complication
Clinical narrative: Developed rash all over body 4 hours after receiving vaccine.  Was taken to urgent car, rapid strep test done to rule out scarlet fever.  Rapid strep test negative.  Visited with Dermatology specialist who confirmed adverse reaction to Hepatitis B vaccine.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Lethargy, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Soreness in arm that felt like my arm was hit with a sledge hammer that latest 4 days,  low grade fever, lethargy and nausea all that lasted for 4 days.  Still not feeling 100% after 5 days (extremely tired and feeling run down).
Age: 78.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Magnetic resonance imaging normal, X-ray limb normal
Clinical narrative: pain in the last shoulder and it makes lift the left arm very hurtfull, it is going away with time or pain medication
Age: 78.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Hypokinesia, Injection site pain, Loss of personal independence in daily activities, Magnetic resonance imaging normal, Myalgia
Clinical narrative: pain in the last shoulder and it makes lift the left arm very hurtfull, it is going away with time or pain medication
Age: 78.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Pain, Pain in extremity, X-ray normal
Clinical narrative: pain in the last shoulder and it makes lift the left arm very hurtfull, it is going away with time or pain medication
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Confusional state, Diarrhoea, Dizziness, Muscular weakness
Clinical narrative: Abdominal pain, loose stools, light headedness, upper extremity weakness and slight confusion. Symptoms lasted 16 hours. recipient contacted PMD . Nurse called back and advised rest, bland diet , water and Gatorade for hydration for rest of weekend and to contact if worsening of symptoms or no improvement. Recipient reported that she recovered completely within 16 to 24 hours after onset of symptoms.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia
Clinical narrative: Full day of fatigue and full-body muscle aches starting about 6 hours after injection and lasting ~30 hours. Bad enough to put me in bed for a day. Symptoms cleared on their own after the second day.
Sex: F
Vaccine: HEP, PNC13
Symptoms: Full blood count normal, Injection site discomfort, Injection site erythema, Injection site warmth, White blood cell count normal
Clinical narrative: Patient states after vaccine she felt discomfort and warm at site. Patient states she noticed redness the next day that kept growing in size. Patient states if keeps getting bigger and warmer. Patient states she tried rinsing her arm with warm water.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date in 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions in a clinic. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future  The outcome of the event of shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 10.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: injection site redness; injection site swelling; injection site heat; This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 10-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA151A, expiry date 31st July 2020) for prophylaxis.   On 14th August 2019, the patient received Menveo. On 16th August 2019, 2 days after receiving Menveo, the patient experienced injection site erythema, injection site swelling and injection site warmth. The patient was treated with benadryl (nos) (Benadryl) and ibuprofen. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to Menveo.  Additional details were provided as follows: The patient had redness, swelling and heat at the injection site 2days post vaccination. At the time of reporting the patient told to continue Benadryl and Ibuprofen. The reporter did not agree to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Pain in extremity, Rash pruritic
Clinical narrative: itching at rash sites; Sore arm; pain at injection site; Injection site redness; Injection site rash/ Rash on arm/ rash spread down to just above the elbow/worsening rash; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 14th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 14th August 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site erythema and injection site rash. On 15th August 2019, the patient experienced pain in arm. On 21st August 2019, the patient experienced itchy rash. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site rash, pain in arm and itchy rash were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site rash, pain in arm and itchy rash to be related to Shingrix.  Additional case details were provided as follows: The patient received Shingrix in the right arm. The patient had injection site pain.  She also reported redness and rash at injection site which began on the day of vaccination.  The next day, her arm was sore.  One week after the injection, the rash remained and had become itchy.  The patient also stated that, the rash had now spread down to just above the elbow.  The patient did not consent to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash, Scab, Varicella
Clinical narrative: Chicken Pox; Rash; Vesicles; vesicles started to crust over; This case was reported by a pharmacist via call center representative and described the occurrence of chickenpox in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number L7SY9, expiry date 4th July 2021) for prophylaxis.   On 1st July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 15th August 2019, 45 days after receiving Shingrix, the patient experienced chickenpox, rash, vesicles and scab. On an unknown date, the outcome of the chickenpox, vesicles and scab were not recovered/not resolved and the outcome of the rash was unknown.   It was unknown if the reporter considered the chickenpox, rash, vesicles and scab to be related to Shingrix.  Additional information received were as follows: 1.5 months after receiving Shingrix, the patient experienced a rash around her neck, on her face, and down both legs. The rash progressed to vesicles that have started to crust over. The patient's physician thought that the patient had chicken pox. The reporter did not had any additional details but described the physician indicated that he thought it was chicken pox, not shingles. The reporter provided the physician's information. The physician was at the same address and telephone number as the reporter.
Age: 17.0
Sex: M
Vaccine: HEP, HEPA, MNQ
Symptoms: Dizziness, Muscle twitching, Pallor, Syncope
Clinical narrative: Client became lightheaded and pale s/p first vaccine given (Hepatitia A).  Client was assisted to cot to rest w/head back and cool compress to back of neck.  Client stated he felt better after several minutes.  2 more vaccines were then administered Hepatitis B, and then MCV4.  Client then fainted momentarily, and had twitching of extremities (lasting approx.5-10 seconds).  BP- 100/57, pulse-58.  BP rechecked manually 99/68.  BP rechecked after client  rested approx. 20 minutes 98/70, pulse 60.  Client stated he was feeling better (he drank water and ate a fruit chew snack).  Client stated he only had cereal to eat earlier in day.  Client stated he fainted x1 while donating blood.  After approx. 1/2 hour, client ambulated to waiting room with mother w/out difficulty.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Pain in extremity, Tenderness
Clinical narrative: DONOR REPORTED BY PHONE  TODAY, SEPT. 3, 2019 REGARDING RIGHT ARM PAIN/TENDERNESS FOLLOWING  Tdap SHOT WHICH WAS GIVEN ON AUG. 20, 2019. THE PAIN STARTED ON THE FOLLOWING DAY, AUG. 21, 2019 AFTER THE  SHOT AND IS GETTING WORSE AND UNABLE TO MOVE THE AFFECTED ARM FREELY. NO RESPIRATORY DISTRESS/FEVER. NO MEDICATION TAKEN WAS TAKEN. SHE WAS ADVICED TO SEEK IMMEDIATE MEDICAL CARE & EVALUATION.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: Mom alerted RN of welt forming after the administration of MMR vaccine on right thigh. 15 mm x 15 mm in size, red, raised. Patient under no distress.
Age: 12.0
Sex: F
Vaccine: HIBV
Symptoms: Wrong product administered
Clinical narrative: Administered a Hib vaccine instead of Meningococcal  Conjugate. Outcome was Meningococcal was given as well.
Age: 3.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event
Clinical narrative: no adverse events, treatment, or outcomes
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood culture, Chest X-ray, Decreased appetite, Electrocardiogram, Full blood count
Clinical narrative: Pt mother reported fever, decreased appetite, decreased urinary output and irritability to our office on 8/9/19. She notes that the symptoms started on 8/7/19. She was referred to the ER the same day to Hospital on 8/9/19. She was then transferred to other due to seizures and the diagnosis of pneumococcal meningitis. Patient is still admitted there. It was recommended per the PA Department of Health to complete the VAERS form at this time.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Irritability, Meningitis pneumococcal, Metabolic function test, Pyrexia, Seizure
Clinical narrative: Pt mother reported fever, decreased appetite, decreased urinary output and irritability to our office on 8/9/19. She notes that the symptoms started on 8/7/19. She was referred to the ER the same day to Hospital on 8/9/19. She was then transferred to other due to seizures and the diagnosis of pneumococcal meningitis. Patient is still admitted there. It was recommended per the PA Department of Health to complete the VAERS form at this time.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Urine output decreased
Clinical narrative: Pt mother reported fever, decreased appetite, decreased urinary output and irritability to our office on 8/9/19. She notes that the symptoms started on 8/7/19. She was referred to the ER the same day to Hospital on 8/9/19. She was then transferred to other due to seizures and the diagnosis of pneumococcal meningitis. Patient is still admitted there. It was recommended per the PA Department of Health to complete the VAERS form at this time.
Age: 50.0
Sex: F
Vaccine: TYP
Symptoms: Balance disorder, Diarrhoea, Dizziness, Dysstasia, Gait disturbance
Clinical narrative: Disequilibrium in the late evening. Unable to stand or move without assistance the next morning due to extreme dizziness, accompanied by diarrhea. Extreme vertigo lasted for a full day. Lingering balance issues for about a week.
Age: 50.0
Sex: F
Vaccine: TYP
Symptoms: Vertigo
Clinical narrative: Disequilibrium in the late evening. Unable to stand or move without assistance the next morning due to extreme dizziness, accompanied by diarrhea. Extreme vertigo lasted for a full day. Lingering balance issues for about a week.
Age: 7.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Client's age was 7 years at time of immunization. Instead of receiving fifth dose of Dtap and fourth dose of IPV, client should have received Tdap and IPV in separate immunizations.  No adverse events, symptoms, signs, treatment, etc to report.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: Patient was given an expired IPV IM to right thigh
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; patients have been administered doses of vaccine which were improperly stored; This non-valid spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates (reported as since 29-NOV-2018), the patients were vaccinated with improperly stored doses of hepatitis b vaccine (recombinant)(RECOMBIVAX HB)(therapy types, exact doses, injection sites, routes of administration, lot numbers and expiration dates were not provided), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9))(exact doses, injection sites, routes of administration, lot numbers and expiration dates were not provided), hepatitis a vaccine, inactivated (VAQTA) )(exact doses, injection sites, routes of administration, lot numbers and expiration dates were not provided) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (exact doses, injection sites, lot numbers and expiration dates were not provided) for prophylaxis. Administered doses of vaccines experienced the temperature excursions of 47 degrees Fahrenheit to 77 degrees Fahrenheit (48.2 degrees Fahrenheit) for 13 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No adverse effects were reported.  This is a non-valid report due to lack of the patients' identifiers.  Follow-up information was received from the healthcare worker on 30-AUG-2019.   On 30-AUG-2019, a phone call was placed to the reporter. The phone call was answered by the medical assistant. The medical assistant stated that she would additional need time to conduct her research on the patient(s) who were administered the vaccines. A request was made for patient identifiers, lot and vaccine received and on what date. The company contact information was shared.  Additional information has been requested.  The patient's identifiers were provided. The reporter referred to a patient of unknown age and gender.  On 30-NOV-2018, the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot number N021092, expiration ate was not provided, but upon an internal verification was established on 11-MAR-2019 (exact dose was not reported) for prophylaxis. Excursion of 29-NOV-2018 when the refrigerator temperature dropped was of 45.7 degrees Fahrenheit to 48.2 degrees Fahrenheit for 13 minutes.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA000371: US-009507513-1909USA000370:
Age: 1.25
Sex: F
Vaccine: MMR, UNK
Symptoms: Allergy to vaccine, Underdose, Urticaria
Clinical narrative: Hypersensitivity; Development of hives after 0.1cc of vaccine; hives; "patient reacted after 0.1cc and remaining .4cc was not used and determined patient is allergic; Vaccination site reaction; This spontaneous report was received from a nurse and refers to a 4-year-old female patient. The patients current condition included unspecified food allergies and milk intolerance. The patient's historical condition included febrile seizures as an infant. Concomitant therapies included epinephrine hydrochloride (EPIPEN).  On 07-AUG-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, subcutaneously, lot # R035702, expiration date 09-DEC-2020, for measles, mumps, rubella prevention. Other suspect therapies included sterile diluent subcutaneously, lot # S008564, expiration date 05-AUG-2021.  The reporter considered that, 4-year-old patient received second dose in measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) immunization series in quarter increments at 10 minute intervals by unspecified allergist and experienced a hive after 0.1cc of vaccine administered. Nurse stateed a certain (unspecified) process including dilution occurs in skin testing. The reported considered that, prior to actual dose, allergist did skin testing and results were negative. Nurse stated that the patient did have measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) at 15 months of age and did have an unspecified local reaction. Allergist report stated that patient reacted after 0.1cc and remaining. 4cc was not used and determined that the patient was allergic to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) The outcome of the events was reported as recovering. The event of allergy to vaccine was considered to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and sterile diluent. The causality assessment between the remaining events and suspect therapies was not provided.; Sender's Comments:  US-009507513-1908USA003510:
Sex: F
Vaccine: MMR
Symptoms: Abdominal distension, Exposure during pregnancy, Nasopharyngitis, Pregnancy test positive
Clinical narrative: Patient received second dose ofM-M-R II on 07/22/2019; bloating; head-cold; This spontaneous prospective pregnancy report was received from a 25-year-old female patient who was referring to herself. Her concurrent condition included psoriasis. Concomitant therapies included betamethasone. She had no drug allergies or reactions.      On 21-JUN-2019, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, (strength, exact dose, frequency, rout of administration, anatomical location, lot # and expiration date were not provided) and on 22-JUL-2019, she received the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, (strength, exact dose, frequency, rout of administration, anatomical location, lot # and expiration date were not provided) for indication reported as vaccination. The vaccines were dissolved in sterile diluent (DILUENT MRK INJ) (strength, dose, frequency, route of administration, lot # and expiration date were not reported) . On 20-JUL-2019 (reported as adverse event onset date), the patient experienced "normal" pregnancy symptoms including bloating as well as a head cold. On 04-AUG-2019 after having the pregnancy test, she found out that she was pregnant. The patient's last menstruation period (LMP) was on 07-JUL-2019, she believed the conception date was on 20-JUL-2019 and estimated due date (EDD) was calculated as 12-APR-2020. The patient was treated with amoxicillin for the head cold since an unknown date.  The pregnancy outcome was outcome pending.  The outcome of bloating and head cold was reported as not recovered. The causality assessment was not provided.
Age: 0.75
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse effects; administered in error to a nine month old patient; patient was supposed to be given the hepatitis B vaccine by GSK (Engerix B) but instead was administered GARDASIL 9 (R017624 3/17/2021) in error; This spontaneous report was received from a licensed practical nurse and refers to a 9-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.     On 13-AUG-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R017624, expiration date: 17-MAR-2021 (exact dose, site and route of administration were not reported) for prophylaxis. The nurse reported the patient was supposed to be given hepatitis b virus vaccine rhbsag (yeast) (ENGERIX-B) but instead was administered hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in error. No adverse effects were reported.