chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis, Aspiration joint normal, Blood test, Condition aggravated, Dehydration
Clinical narrative: At 12: 35 PM about 2 hours after vaccine injection severe pain in left leg, knee swollen more than usual, calf swollen, leg couldn't take weight to walk, pain level a started at a 9 and progressed to a 10 . Pain when moving leg or knee. Never felt that type of pain before, very different from the occasional arthritis pain. Felt feverish, very thirsty and drank water continuously, couldn't quench thirst. Transported to emergency room 6/27/2019 @12:30 AM by ambulance, unable to walk. Multiple bloodtests taken. was dehydrated, running a low grade fever, 99.6F, given 1/2 liter of saline drip. ultra sound for blood clot - negarive, fluid drawn from knee to check for infection - negative, low on sodium and chloride.. Couldn't take a step for Physical therapist and by noon it I had to go to rehab facility. Transported on a gurney. Needed a pillow under knee as I couldn't straighten it without severe pain during the whole time since this episode started. Couldn't move leg without pain. After midnite on  6/28/2019 was able to turn on my right side by grabbing the metal bars on the side of the bed. That was a sign of improvement. By morning about 6:00 AM I was able to exert pressure again the nurse's hand to help slide myself up on the bed as I was sliding toward the foot of the bed. At about 9:30 AM the occupational therapist asked me to try to stand with the walker. I could stand and walk and  that severe pain was gone and I was able to walk up the hall using a walker for safety until they tested me. This whole experience lasted a few hours short of 48 hours. My arthritis got a little worse from what it was before I had the vaccine, but it was a familiar discomfort. My calf is sensitive and needs some recovery, that's new. I still have occasional pain at the site the doctor drew the fluid from my knee for an infection check. I can't walk  as long a distance that I could before the vaccine without tiring the leg. Additionally my scalped itched on  6/28/2019 through 7/01/2019 and my hair which had been permed a month ago suddenly lost the curl.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Gait inability, Inflammatory marker increased, Injection site pain, Joint swelling
Clinical narrative: At 12: 35 PM about 2 hours after vaccine injection severe pain in left leg, knee swollen more than usual, calf swollen, leg couldn't take weight to walk, pain level a started at a 9 and progressed to a 10 . Pain when moving leg or knee. Never felt that type of pain before, very different from the occasional arthritis pain. Felt feverish, very thirsty and drank water continuously, couldn't quench thirst. Transported to emergency room 6/27/2019 @12:30 AM by ambulance, unable to walk. Multiple bloodtests taken. was dehydrated, running a low grade fever, 99.6F, given 1/2 liter of saline drip. ultra sound for blood clot - negarive, fluid drawn from knee to check for infection - negative, low on sodium and chloride.. Couldn't take a step for Physical therapist and by noon it I had to go to rehab facility. Transported on a gurney. Needed a pillow under knee as I couldn't straighten it without severe pain during the whole time since this episode started. Couldn't move leg without pain. After midnite on  6/28/2019 was able to turn on my right side by grabbing the metal bars on the side of the bed. That was a sign of improvement. By morning about 6:00 AM I was able to exert pressure again the nurse's hand to help slide myself up on the bed as I was sliding toward the foot of the bed. At about 9:30 AM the occupational therapist asked me to try to stand with the walker. I could stand and walk and  that severe pain was gone and I was able to walk up the hall using a walker for safety until they tested me. This whole experience lasted a few hours short of 48 hours. My arthritis got a little worse from what it was before I had the vaccine, but it was a familiar discomfort. My calf is sensitive and needs some recovery, that's new. I still have occasional pain at the site the doctor drew the fluid from my knee for an infection check. I can't walk  as long a distance that I could before the vaccine without tiring the leg. Additionally my scalped itched on  6/28/2019 through 7/01/2019 and my hair which had been permed a month ago suddenly lost the curl.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: At 12: 35 PM about 2 hours after vaccine injection severe pain in left leg, knee swollen more than usual, calf swollen, leg couldn't take weight to walk, pain level a started at a 9 and progressed to a 10 . Pain when moving leg or knee. Never felt that type of pain before, very different from the occasional arthritis pain. Felt feverish, very thirsty and drank water continuously, couldn't quench thirst. Transported to emergency room 6/27/2019 @12:30 AM by ambulance, unable to walk. Multiple bloodtests taken. was dehydrated, running a low grade fever, 99.6F, given 1/2 liter of saline drip. ultra sound for blood clot - negarive, fluid drawn from knee to check for infection - negative, low on sodium and chloride.. Couldn't take a step for Physical therapist and by noon it I had to go to rehab facility. Transported on a gurney. Needed a pillow under knee as I couldn't straighten it without severe pain during the whole time since this episode started. Couldn't move leg without pain. After midnite on  6/28/2019 was able to turn on my right side by grabbing the metal bars on the side of the bed. That was a sign of improvement. By morning about 6:00 AM I was able to exert pressure again the nurse's hand to help slide myself up on the bed as I was sliding toward the foot of the bed. At about 9:30 AM the occupational therapist asked me to try to stand with the walker. I could stand and walk and  that severe pain was gone and I was able to walk up the hall using a walker for safety until they tested me. This whole experience lasted a few hours short of 48 hours. My arthritis got a little worse from what it was before I had the vaccine, but it was a familiar discomfort. My calf is sensitive and needs some recovery, that's new. I still have occasional pain at the site the doctor drew the fluid from my knee for an infection check. I can't walk  as long a distance that I could before the vaccine without tiring the leg. Additionally my scalped itched on  6/28/2019 through 7/01/2019 and my hair which had been permed a month ago suddenly lost the curl.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Synovial cyst, Thirst, Ultrasound Doppler, Ultrasound scan abnormal, Urine analysis
Clinical narrative: At 12: 35 PM about 2 hours after vaccine injection severe pain in left leg, knee swollen more than usual, calf swollen, leg couldn't take weight to walk, pain level a started at a 9 and progressed to a 10 . Pain when moving leg or knee. Never felt that type of pain before, very different from the occasional arthritis pain. Felt feverish, very thirsty and drank water continuously, couldn't quench thirst. Transported to emergency room 6/27/2019 @12:30 AM by ambulance, unable to walk. Multiple bloodtests taken. was dehydrated, running a low grade fever, 99.6F, given 1/2 liter of saline drip. ultra sound for blood clot - negarive, fluid drawn from knee to check for infection - negative, low on sodium and chloride.. Couldn't take a step for Physical therapist and by noon it I had to go to rehab facility. Transported on a gurney. Needed a pillow under knee as I couldn't straighten it without severe pain during the whole time since this episode started. Couldn't move leg without pain. After midnite on  6/28/2019 was able to turn on my right side by grabbing the metal bars on the side of the bed. That was a sign of improvement. By morning about 6:00 AM I was able to exert pressure again the nurse's hand to help slide myself up on the bed as I was sliding toward the foot of the bed. At about 9:30 AM the occupational therapist asked me to try to stand with the walker. I could stand and walk and  that severe pain was gone and I was able to walk up the hall using a walker for safety until they tested me. This whole experience lasted a few hours short of 48 hours. My arthritis got a little worse from what it was before I had the vaccine, but it was a familiar discomfort. My calf is sensitive and needs some recovery, that's new. I still have occasional pain at the site the doctor drew the fluid from my knee for an infection check. I can't walk  as long a distance that I could before the vaccine without tiring the leg. Additionally my scalped itched on  6/28/2019 through 7/01/2019 and my hair which had been permed a month ago suddenly lost the curl.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Walking aid user, Weight bearing difficulty, X-ray limb, X-ray limb abnormal
Clinical narrative: At 12: 35 PM about 2 hours after vaccine injection severe pain in left leg, knee swollen more than usual, calf swollen, leg couldn't take weight to walk, pain level a started at a 9 and progressed to a 10 . Pain when moving leg or knee. Never felt that type of pain before, very different from the occasional arthritis pain. Felt feverish, very thirsty and drank water continuously, couldn't quench thirst. Transported to emergency room 6/27/2019 @12:30 AM by ambulance, unable to walk. Multiple bloodtests taken. was dehydrated, running a low grade fever, 99.6F, given 1/2 liter of saline drip. ultra sound for blood clot - negarive, fluid drawn from knee to check for infection - negative, low on sodium and chloride.. Couldn't take a step for Physical therapist and by noon it I had to go to rehab facility. Transported on a gurney. Needed a pillow under knee as I couldn't straighten it without severe pain during the whole time since this episode started. Couldn't move leg without pain. After midnite on  6/28/2019 was able to turn on my right side by grabbing the metal bars on the side of the bed. That was a sign of improvement. By morning about 6:00 AM I was able to exert pressure again the nurse's hand to help slide myself up on the bed as I was sliding toward the foot of the bed. At about 9:30 AM the occupational therapist asked me to try to stand with the walker. I could stand and walk and  that severe pain was gone and I was able to walk up the hall using a walker for safety until they tested me. This whole experience lasted a few hours short of 48 hours. My arthritis got a little worse from what it was before I had the vaccine, but it was a familiar discomfort. My calf is sensitive and needs some recovery, that's new. I still have occasional pain at the site the doctor drew the fluid from my knee for an infection check. I can't walk  as long a distance that I could before the vaccine without tiring the leg. Additionally my scalped itched on  6/28/2019 through 7/01/2019 and my hair which had been permed a month ago suddenly lost the curl.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Influenza like illness, Peripheral swelling, Pyrexia
Clinical narrative: Within 24 hours following vaccine patient complained of flu-like symptoms, fatigue, upper arm warmth/redness/swelling, and fever of 101*F.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Within 24 hours following vaccine patient complained of flu-like symptoms, fatigue, upper arm warmth/redness/swelling, and fever of 101*F.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Erythema, Influenza like illness, Pain, Peripheral swelling
Clinical narrative: Patient's wife described flu-like symptoms such as aches & chills and significant upper arm pain/redness/swelling.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Pruritus, Somnolence
Clinical narrative: PATIENT said her arm was itchy and it was burning and felt a little drowsy..  Had her sit awhile.   she said she was feeling a little better.  Told her to put on a cold compress when she got home.  I called her at 8 oclock and she said it still itched but it was getting better. will follow up with her tomorrow
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Nausea, Pain
Clinical narrative: Extreme chills, headache, nausea, achiness, soreness at injection site
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Injection site pain, Myalgia
Clinical narrative: Fever, chills, myalgias, arthralgias, fatigue. Injection site pain
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, chills, myalgias, arthralgias, fatigue. Injection site pain
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Dermatitis atopic, Dry skin, Eczema, Immediate post-injection reaction
Clinical narrative: Patient was crying inconsolably for 2 week or more immediately after vaccines were given. She broke out in rough, dry, red, inflammed rash all over her head and body within a week to two weeks after vaccines were given. Patient was taken back to the pediatrician on 3/13/2018 and diagnosed with eczema.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Inflammation, Rash erythematous, Rash generalised
Clinical narrative: Patient was crying inconsolably for 2 week or more immediately after vaccines were given. She broke out in rough, dry, red, inflammed rash all over her head and body within a week to two weeks after vaccines were given. Patient was taken back to the pediatrician on 3/13/2018 and diagnosed with eczema.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: patient reported redness, itching and rash
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Confusional state, Speech disorder, Thinking abnormal
Clinical narrative: Patient states his arm was not sore after 2nd shot given on 7/1/19 but he realized at 8am on 7/2/19 that he felt confused and was having trouble completing thoughts and sentences with  a tradesperson that came to his house at 8:30am and with a neighbor later in the day. He states that when he woke up on 7/3/19 he felt normal and went to work at 10am as usual and worked all day with no problems.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site swelling, Malaise, Rash macular
Clinical narrative: Swelling at injection site. Diffuse maculosquamous eruption of abdomen and chest. Generalized fatigue  and malaise.
Age: 13.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Dyspnoea, Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Red, swollen at injection site, trouble breathing, hives upper body and neck
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Influenza like illness, Pain, Rash, Rash pruritic
Clinical narrative: Started right after receiving vaccine. that evening pt felt achy w/ flu like sx. In the morning she developed rash on left torso (itchy + painful) one day later she went to Dr Appt and was diagnosed w/Shingles. She was given antiviral pills + prednisone. One week later she is improving but rash still itchy.
Age: 1.08
Sex: U
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Lymphadenopathy, Rash, Rash maculo-papular
Clinical narrative: PATIENT DEVELOPED RASH MACULOPAPULAR STARTING ON FACE THEN TO BODY, ARMS, & LEGS NOTED 9 DAYS AFTER RECEIVING VACCINES. HE ALSO DEVELOPED LYMPHADENOPATHY ON NECK AND GROIN AREA. NO FEVER, NO OTHER SYMPTOMS THE KID IS OTHERWISE WELL. ON 3RD DAY OF RASH IT STARTED GETTING BETTER
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pain in extremity, Tenderness
Clinical narrative: Patient had a red sore arm after she received her vaccine on 07/03/19 pt had blisters but put hydrocortisone cream and took a benadryl. Patient will continue to take hydrocortisone cream. Patient still has red arm and tender.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea
Clinical narrative: Patient Complained felt sick to his stomach. Nausea and a little pain at the injection Site. After Resting and Visiting Bathroom, he said he Felt Better Also drunk water. [He felt bad with First per Patient]
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash, Pyrexia, Rash, Skin lesion, Varicella post vaccine
Clinical narrative: Varicella rash in left arm/chest/buttocks/legs 48 hrs after vaccine. Fever >100 lesions TX: anti-itch baths and calamine lotion
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Hyperhidrosis, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu-Like SX. Fever-102' Chills Sweats Bodyaches.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Depressed mood
Clinical narrative: food poisoning; being sick; depression; This case was reported by a consumer via call center representative and described the occurrence of depression in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included depression. Previously administered products included Prozac (started to receive at the age of 50 years) and Flu vaccine with an associated reaction of chronic fatigue syndrome (1st dose received 10 years ago, for tolerance refer case US2019AMR122677).   On 26th March 2019, the patient received the 1st dose of Shingrix. On 29th March 2019, 3 days after receiving Shingrix, the patient experienced depression. On an unknown date, the patient experienced food poisoning and sickness. On an unknown date, the outcome of the depression was recovered/resolved and the outcome of the food poisoning and sickness were recovering/resolving.   It was unknown if the reporter considered the depression, food poisoning and sickness to be related to Shingrix.  Additional details were provided as follows: The patient had experienced depression periodically throughout her entire life but as she started taking Prozac at 50 years old, she had not been depressed since.  10 years ago, the patient experienced chronic fatigue syndrome after getting a flu vaccine. She did not remember what flu vaccine it was. It took 9 months to recover from the fatigue. About 3 days after getting Shingrix, the patient felt depressed.  She had recovered from the depression and was currently recovering from being sick over the past few days.  The patient thought it might be food poisoning. The patient did not consent to follow up. There is a discrepancy with respect to the outcome of the events depression, sickness and food poisoning. In source document, the outcome is reported as recovered/resolved with sequel for depression, sickness and unknown for food poisoning, however as per narrative description it is recovered for the event depression and recovering for sickness and food poisoning. The outcome of all the symptoms retains as per the narrative description.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Depression, Food poisoning, Malaise
Clinical narrative: food poisoning; being sick; depression; This case was reported by a consumer via call center representative and described the occurrence of depression in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included depression. Previously administered products included Prozac (started to receive at the age of 50 years) and Flu vaccine with an associated reaction of chronic fatigue syndrome (1st dose received 10 years ago, for tolerance refer case US2019AMR122677).   On 26th March 2019, the patient received the 1st dose of Shingrix. On 29th March 2019, 3 days after receiving Shingrix, the patient experienced depression. On an unknown date, the patient experienced food poisoning and sickness. On an unknown date, the outcome of the depression was recovered/resolved and the outcome of the food poisoning and sickness were recovering/resolving.   It was unknown if the reporter considered the depression, food poisoning and sickness to be related to Shingrix.  Additional details were provided as follows: The patient had experienced depression periodically throughout her entire life but as she started taking Prozac at 50 years old, she had not been depressed since.  10 years ago, the patient experienced chronic fatigue syndrome after getting a flu vaccine. She did not remember what flu vaccine it was. It took 9 months to recover from the fatigue. About 3 days after getting Shingrix, the patient felt depressed.  She had recovered from the depression and was currently recovering from being sick over the past few days.  The patient thought it might be food poisoning. The patient did not consent to follow up. There is a discrepancy with respect to the outcome of the events depression, sickness and food poisoning. In source document, the outcome is reported as recovered/resolved with sequel for depression, sickness and unknown for food poisoning, however as per narrative description it is recovered for the event depression and recovering for sickness and food poisoning. The outcome of all the symptoms retains as per the narrative description.
Age: 20.0
Sex: M
Vaccine: JEV1
Symptoms: Fall, Loss of consciousness, Muscle spasms, Presyncope
Clinical narrative: A 21 year old male received his first dose of IXIARO (Japanese encephalitis vaccine, batch number JEV18A66G) on 07 May 2019. After administration he developed vagal shock. Outcome was not reported. Further vaccination included another dose of IXIARO on 14 May 2019 (rapid schedule). This case is linked to cases CA-INTERCELLP-4780, CA-INTERCELLP-4787 and CA-INTERCELLP-4788 (same reporter). Follow up information was received from a nurse via service provider 03 July 2019. The vaccinee lost consciousness twice. He was sitting down and fell on the ground and also experienced muscle spasms. After regeneration of the first unconsciousness he passed out again and was hospitalised. No use of concomitant medication or information on past medical history.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: swelling at injection site; redness at injection site; minimal use of arm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 53RF3, expiry date 17th October 2021) for prophylaxis.   On 27th June 2019, the patient received Shingrix (intramuscular). On 28th June 2019, 1 days after receiving Shingrix, the patient experienced injection site swelling, injection site erythema and injected limb mobility decreased. On an unknown date, the outcome of the injection site swelling, injection site erythema and injected limb mobility decreased were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The pharmacist reports that the patient experienced significat swelling and redness in her left bicep where the vaccine was given, and she had minimal use of her arm. The symptoms improved over the next several days.  When the pharmacist saw her, about 1 week after the injection, she still had some redness and a little swelling.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: swelling at injection site; redness at injection site; minimal use of arm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 53RF3, expiry date 17th October 2021) for prophylaxis.   On 27th June 2019, the patient received Shingrix (intramuscular). On 28th June 2019, 1 days after receiving Shingrix, the patient experienced injection site swelling, injection site erythema and injected limb mobility decreased. On an unknown date, the outcome of the injection site swelling, injection site erythema and injected limb mobility decreased were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The pharmacist reports that the patient experienced significat swelling and redness in her left bicep where the vaccine was given, and she had minimal use of her arm. The symptoms improved over the next several days.  When the pharmacist saw her, about 1 week after the injection, she still had some redness and a little swelling.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Autism spectrum disorder, Decreased eye contact, Diarrhoea, Dyskinesia, Food aversion
Clinical narrative: My son was born absolutely perfect, full term and healthy who weighted 7 pounds and had been meeting all his milestones prior to his 12 months' shots. He had perfect eye contact and would socialize perfectly. After MMR and other vaccines at his 12 months, he became silent. After his 15 months shots, more adverse effects appeared. He had a short nap and became diarrhea and was constantly vomiting. He lost his eye contact and stopped responding to his name. He started walking on a tip toe and spinning and had been showing severe hand flapping. He would put everything into his mouth like his 8 months. He was staring at lights for several minutes and showed many repetitive behaviors like opening and closing doors for several minutes. He would eat only puree food. He had loved fruits prior to his 12 months but he stopped even touching them. He would hate new textures. Generally what happened after the vaccination he suddenly and immediately showed all the Autism symptoms.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Speech disorder, Staring, Stereotypy, Toe walking, Unresponsive to stimuli
Clinical narrative: My son was born absolutely perfect, full term and healthy who weighted 7 pounds and had been meeting all his milestones prior to his 12 months' shots. He had perfect eye contact and would socialize perfectly. After MMR and other vaccines at his 12 months, he became silent. After his 15 months shots, more adverse effects appeared. He had a short nap and became diarrhea and was constantly vomiting. He lost his eye contact and stopped responding to his name. He started walking on a tip toe and spinning and had been showing severe hand flapping. He would put everything into his mouth like his 8 months. He was staring at lights for several minutes and showed many repetitive behaviors like opening and closing doors for several minutes. He would eat only puree food. He had loved fruits prior to his 12 months but he stopped even touching them. He would hate new textures. Generally what happened after the vaccination he suddenly and immediately showed all the Autism symptoms.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Vomiting
Clinical narrative: My son was born absolutely perfect, full term and healthy who weighted 7 pounds and had been meeting all his milestones prior to his 12 months' shots. He had perfect eye contact and would socialize perfectly. After MMR and other vaccines at his 12 months, he became silent. After his 15 months shots, more adverse effects appeared. He had a short nap and became diarrhea and was constantly vomiting. He lost his eye contact and stopped responding to his name. He started walking on a tip toe and spinning and had been showing severe hand flapping. He would put everything into his mouth like his 8 months. He was staring at lights for several minutes and showed many repetitive behaviors like opening and closing doors for several minutes. He would eat only puree food. He had loved fruits prior to his 12 months but he stopped even touching them. He would hate new textures. Generally what happened after the vaccination he suddenly and immediately showed all the Autism symptoms.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Dysarthria, Facial paralysis, Palpitations, Paraesthesia, Speech disorder
Clinical narrative: Pt reports facial droop to left side, inability to speak/slurred speech, 'fat' tongue, tremors to left arm, generalized tingling, and 'racing' heart.  A&Ox4, denies lightheadedness/dizziness, chest pain or shortness of breath
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Swollen tongue, Tremor
Clinical narrative: Pt reports facial droop to left side, inability to speak/slurred speech, 'fat' tongue, tremors to left arm, generalized tingling, and 'racing' heart.  A&Ox4, denies lightheadedness/dizziness, chest pain or shortness of breath
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Diarrhoea, Headache, Muscle spasms, Myalgia
Clinical narrative: Diarrhea and cramps, headache, muscle aches. Tylenol, fluids, rest.
Sex: F
Vaccine: MMR
Symptoms: Blood immunoglobulin G normal, Exposure during pregnancy, False negative investigation result, Immunoglobulins normal, Measles antibody negative
Clinical narrative: the patient was negative for immunity to measles; patient was administered a dose of M-M-R II after each of the three pregnancies; positive for immunity to mumps and diphtheria; positive for immunity to mumps and diphtheria; patient was administered a dose of M-M-R II after each of the three pregnancies; This spontaneous retrospective pregnancy report was received from a physician referring to a 38 years old female patient. The patient had a history of 3 previous pregnancies and 3 live births. The patient's pertinent medical history included long-standing essential thrombocytopenia. The patient's current condition included pregnant. Information about concomitant medication and drug reaction/allergy was not provided.  On an unknown date, the patient's obstetrician drew bloodwork to check titers, and the results showed the patient was negative for immunity to measles (measles antibody negative), the titers showed the patient was positive for immunity to mumps and diphtheria. So the patient was administered a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis (vaccine exposure during pregnancy). Sterile diluent for the vaccine (lot # and expiration date were not reported) was also reported as suspect therapy.   On an unknown dates, the patient had the second and third pregnancy, the patient's obstetrician drew bloodwork to check titers, and the results showed the patient was negative for immunity to measles (measles antibody negative), the titers showed the patient was positive for immunity to mumps and diphtheria. So the patient was administered a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, route, lot # and expiration date were not reported) each of the pregnancies for prophylaxis.   In May, 2019(reported as about a month ago), the patient's titers were most recently rechecked, following the three doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and showed the same results - negative for immunity to measles but positive for immunity to mumps and diphtheria.    The physician reported that all of the patient's other immunoglobulins and IgG subclasses are normal and that the patient did not take any immunosuppressive medications and did not have any history of infections, so he believed the patient's measles immunoglobulin could be extraordinarily high and the negative titer result was spurious.  The LMP and EDD was not known. The pregnancy outcome was live birth.  The outcome of measles antibody negative was reported as not recovered. The outcome of rest events was unknown. The causality of the events was not provided.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: female patient was administered the first dose, in a three-dose series, of GARDASIL 9 6 years ago, the patient missed all following subsequent doses; No adverse effects reported; This spontaneous report was received from a pharmacy student refering to a female patient of currently 24 years old. The patient's concurrent conditions, past medical history and concomitant medications were not reported.  On 06-JUN-2013 (reported as 6 years ago), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route, lot/batch # and expiration date were not provided) for prophylaxis. The reporter stated that the patient missed all following subsequent doses. No adverse effects reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Skin ulcer
Clinical narrative: Herpes Zoster; Information was received from a lawyer regarding a case in litigation involving a female patient of unknown age.  On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  Shortly after receiving the vaccine the patient suffered a painful outbreak of open sore rashes on both legs from her groin to her feet which then progressed to her back.  She presented to her medical provider who diagnosed her with herpes zoster. Despite receiving treatment she continued to suffer from herpes zoster.  As a direct and proximate result of receiving zoster vaccine live (ZOSTAVAX) the patients symptoms have resulted in physical limitations not present prior to using the product.  She also experienced mental and emotional distress due to resulting physical limitations and seriousness of condition.  As a result of zoster vaccine live (ZOSTAVAX) the patient suffered severe and permanent personal injuries.    Herpes zoster was considered to be disabling.    Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 24-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally (LOT# R034700, expiry date 16-JUN-2020) for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees (F) for 4 hours and 54 minutes. Digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA000862: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1906USA011674:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 28-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally (LOT# R034700, expiry date 16-JUN-2020) for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees (F) for 4 hours and 54 minutes. Digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA000862: US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1906USA011674:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 17-DEC-2018, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number N034400 with expiration date in 10-MAY-2019) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011434: US-009507513-1907USA001848: US-009507513-1907USA001847: US-009507513-1907USA001849: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA000952: US-009507513-1907USA000953: US-009507513-1907USA000954: US-009507513-1907USA000959: US-009507513-1907USA000962: US-009507513-1907USA000963: US-009507513-1907USA000964: US-009507513-1907USA000965: US-009507513-1907USA000966: US-009507513-1907USA000967: US-009507513-1907USA000968: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000988: US-009507513-1907USA000989:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 30-JAN-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number N034400 with expiration date in 10-MAY-2019) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011434: US-009507513-1907USA001848: US-009507513-1907USA001847: US-009507513-1907USA001849: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA000952: US-009507513-1907USA000953: US-009507513-1907USA000954: US-009507513-1907USA000959: US-009507513-1907USA000962: US-009507513-1907USA000963: US-009507513-1907USA000964: US-009507513-1907USA000965: US-009507513-1907USA000966: US-009507513-1907USA000967: US-009507513-1907USA000968: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000988: US-009507513-1907USA000989:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 20-FEB-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number N034400 with expiration date in 10-MAY-2019) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011434: US-009507513-1907USA001847: US-009507513-1907USA001849: US-009507513-1907USA001848: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA000952: US-009507513-1907USA000953: US-009507513-1907USA000954: US-009507513-1907USA000959: US-009507513-1907USA000962: US-009507513-1907USA000963: US-009507513-1907USA000964: US-009507513-1907USA000965: US-009507513-1907USA000966: US-009507513-1907USA000967: US-009507513-1907USA000968: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000988: US-009507513-1907USA000989: