chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Vaccination site warmth
Clinical narrative: Sore arm, unable to move it. Pain stayed at vaccination site and is still warm to touch on 9/9/12. Low grade fever onset on 9/6/12 and still continues through 9/9/12. Taken ibuprofen (800-1000mg daily for pain). Rest. Missed work (left at half day) on 9/8/12 due to symptoms. Able to complete full day work on 9/9/12.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Redness, swelling and warmth on arm below injection site.
Age: 23.0
Sex: F
Vaccine: TYP
Symptoms: Discomfort, Hypersensitivity, Pain in extremity, Rash, Swelling
Clinical narrative: Immunized on 8/4/2012, 2 weeks later approx the 18th, noticed swelling and an "uncomfortable" feeling in both hands. On the 19th she started having small "bumps" on her hands starting at her knuckles. On the 20th the bumps were progressively worse and had spread to her hands and between her fingers, and eventually up both arms to the extent of the medial bicep region. She was out of the area and had called the clinic to report her symptoms. At that time she stated she was having severe pain in her hands and Public Health Tech had advised that if the pain was that severe she should be seen by a civilian provider and when she returned to the area to report into the clinic for follow-up. On 8/23/12 she was seen by a provider who in turn consulted with an allergist about her symptoms. She was dx with an allergic rxn to smallpox. Prescribed 40 mg Prednisone PO daily x 5 days, Vicodin 1 tab Q 6 hrs PRN pain, Cimetidine and Allegra BID daily, f/u PRN. Returned to f/u on 8/28 with provider who in turn continued her on 20 mg Prednisone PO daily x 4 days, d/c'd Cimetidine, continued with Allegra.  Sx cleared at that time, however on 8/5/2012 member noticed one bump reoccurring on her finger with significant pain.  She reported into the clinic for her Tdap and Anthrax vaccination and upon asking her the screening questions about previous rxn, she reported the above events.  Member referred to provider.
Age: 23.0
Sex: F
Vaccine: TYP
Symptoms: Vaccination complication
Clinical narrative: Immunized on 8/4/2012, 2 weeks later approx the 18th, noticed swelling and an "uncomfortable" feeling in both hands. On the 19th she started having small "bumps" on her hands starting at her knuckles. On the 20th the bumps were progressively worse and had spread to her hands and between her fingers, and eventually up both arms to the extent of the medial bicep region. She was out of the area and had called the clinic to report her symptoms. At that time she stated she was having severe pain in her hands and Public Health Tech had advised that if the pain was that severe she should be seen by a civilian provider and when she returned to the area to report into the clinic for follow-up. On 8/23/12 she was seen by a provider who in turn consulted with an allergist about her symptoms. She was dx with an allergic rxn to smallpox. Prescribed 40 mg Prednisone PO daily x 5 days, Vicodin 1 tab Q 6 hrs PRN pain, Cimetidine and Allegra BID daily, f/u PRN. Returned to f/u on 8/28 with provider who in turn continued her on 20 mg Prednisone PO daily x 4 days, d/c'd Cimetidine, continued with Allegra.  Sx cleared at that time, however on 8/5/2012 member noticed one bump reoccurring on her finger with significant pain.  She reported into the clinic for her Tdap and Anthrax vaccination and upon asking her the screening questions about previous rxn, she reported the above events.  Member referred to provider.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Erythema, Induration, Skin warm, Urticaria
Clinical narrative: Large red welt - about 2 inches in diameter. Hot to the touch, hard. When I researched this online, I realized the intradermal shot is only approved for ages 18-64, so she should not have received it!
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Joint effusion
Clinical narrative: The patient's right knee developed a large effusion (fluid collection).  There was no pain or redness.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper, Diarrhoea, Pain, Vomiting
Clinical narrative: About 12 hours later, he woke from sleep, and spent an hour vomiting and having diarrhea.  He was able to eat by 6 hours later, light food.  His body still ached, and tummy was sore for 24 hours.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Shortness of breath with wheezing.  Required 3 nebulizer treatments, prednisone, and Benadryl.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pruritus, Skin warm, Swelling
Clinical narrative: Skin warm to the touch, swelling,pruritus, pain over 3 days. Treatment: clindamycin and prednisone.
Age: 0.24
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site mass, Injection site swelling, Vaccination site induration
Clinical narrative: My baby was vaccinated on the upper thigh and a few days after she developed hard lumps that was very obvious on the vaccinated area. We went to another doctor, and at clinic, the doctor did not make any official record; and she just ignored our concern.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Arthropathy, Back pain, Dyspnoea, Fatigue
Clinical narrative: My symptoms began the morning after I woke up from having the flu shot the previous afternoon with a finger that I could not move and breathing difficulty. This progressed over the following months to incredible pain and immobility in all of the joints and muscles throughout my entire body along with incredible fatigue, muscle spasms and twitches and a host of other symptoms affecting every organ, muscle, joint and nervous system. Almost two years after the flu shot, I am still dealing with the muscle/joint pain in my entire neck and back.  It took 9 doctors and 8 months for someone to figure out what the flu shot had done to me which was an inflammatory response of the peripheral nervous system which impacted the facia throughout my body. Previous to the diagnosis I had seen rheumatologists, neurologists and other doctors to try and figure out how to rid my body of this terrible pain and the impact that it was having on my life. I had symptoms similar to Lyme disease, MS etc but I did not have a disease, I had a reaction. I was repeatedly tested for these. I have spent almost every single week since that flu shot going to a doctors appointment, chiropractic appointments and physical massage therapy appointments to relieve the constant pain, stiffness and soreness in my muscles. This has taken not only my time but a great deal of out of pocket money spent on trying to get better from this. Thousands of dollars have been spent through insurance and personal funds to improve the damage that the flu shot has caused. It has been an absolutely terrible experience to be a perfectly healthy person one day and to have this much daily pain the two years since then. I would like for someone from VAERS to contact me to discuss my case. I will be able to provide all medical information, records and expenses as a result of this experience.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Immobile, Inflammation, Mobility decreased, Multi-organ disorder, Muscle disorder
Clinical narrative: My symptoms began the morning after I woke up from having the flu shot the previous afternoon with a finger that I could not move and breathing difficulty. This progressed over the following months to incredible pain and immobility in all of the joints and muscles throughout my entire body along with incredible fatigue, muscle spasms and twitches and a host of other symptoms affecting every organ, muscle, joint and nervous system. Almost two years after the flu shot, I am still dealing with the muscle/joint pain in my entire neck and back.  It took 9 doctors and 8 months for someone to figure out what the flu shot had done to me which was an inflammatory response of the peripheral nervous system which impacted the facia throughout my body. Previous to the diagnosis I had seen rheumatologists, neurologists and other doctors to try and figure out how to rid my body of this terrible pain and the impact that it was having on my life. I had symptoms similar to Lyme disease, MS etc but I did not have a disease, I had a reaction. I was repeatedly tested for these. I have spent almost every single week since that flu shot going to a doctors appointment, chiropractic appointments and physical massage therapy appointments to relieve the constant pain, stiffness and soreness in my muscles. This has taken not only my time but a great deal of out of pocket money spent on trying to get better from this. Thousands of dollars have been spent through insurance and personal funds to improve the damage that the flu shot has caused. It has been an absolutely terrible experience to be a perfectly healthy person one day and to have this much daily pain the two years since then. I would like for someone from VAERS to contact me to discuss my case. I will be able to provide all medical information, records and expenses as a result of this experience.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Muscle spasms, Muscle twitching, Musculoskeletal stiffness, Myalgia, Neck pain
Clinical narrative: My symptoms began the morning after I woke up from having the flu shot the previous afternoon with a finger that I could not move and breathing difficulty. This progressed over the following months to incredible pain and immobility in all of the joints and muscles throughout my entire body along with incredible fatigue, muscle spasms and twitches and a host of other symptoms affecting every organ, muscle, joint and nervous system. Almost two years after the flu shot, I am still dealing with the muscle/joint pain in my entire neck and back.  It took 9 doctors and 8 months for someone to figure out what the flu shot had done to me which was an inflammatory response of the peripheral nervous system which impacted the facia throughout my body. Previous to the diagnosis I had seen rheumatologists, neurologists and other doctors to try and figure out how to rid my body of this terrible pain and the impact that it was having on my life. I had symptoms similar to Lyme disease, MS etc but I did not have a disease, I had a reaction. I was repeatedly tested for these. I have spent almost every single week since that flu shot going to a doctors appointment, chiropractic appointments and physical massage therapy appointments to relieve the constant pain, stiffness and soreness in my muscles. This has taken not only my time but a great deal of out of pocket money spent on trying to get better from this. Thousands of dollars have been spent through insurance and personal funds to improve the damage that the flu shot has caused. It has been an absolutely terrible experience to be a perfectly healthy person one day and to have this much daily pain the two years since then. I would like for someone from VAERS to contact me to discuss my case. I will be able to provide all medical information, records and expenses as a result of this experience.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Nervous system disorder, Pain
Clinical narrative: My symptoms began the morning after I woke up from having the flu shot the previous afternoon with a finger that I could not move and breathing difficulty. This progressed over the following months to incredible pain and immobility in all of the joints and muscles throughout my entire body along with incredible fatigue, muscle spasms and twitches and a host of other symptoms affecting every organ, muscle, joint and nervous system. Almost two years after the flu shot, I am still dealing with the muscle/joint pain in my entire neck and back.  It took 9 doctors and 8 months for someone to figure out what the flu shot had done to me which was an inflammatory response of the peripheral nervous system which impacted the facia throughout my body. Previous to the diagnosis I had seen rheumatologists, neurologists and other doctors to try and figure out how to rid my body of this terrible pain and the impact that it was having on my life. I had symptoms similar to Lyme disease, MS etc but I did not have a disease, I had a reaction. I was repeatedly tested for these. I have spent almost every single week since that flu shot going to a doctors appointment, chiropractic appointments and physical massage therapy appointments to relieve the constant pain, stiffness and soreness in my muscles. This has taken not only my time but a great deal of out of pocket money spent on trying to get better from this. Thousands of dollars have been spent through insurance and personal funds to improve the damage that the flu shot has caused. It has been an absolutely terrible experience to be a perfectly healthy person one day and to have this much daily pain the two years since then. I would like for someone from VAERS to contact me to discuss my case. I will be able to provide all medical information, records and expenses as a result of this experience.
Age: 82.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: Red area warm to touch.
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: 1 1/2 inch x 2 inch raised red area and warm to touch.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Malaise, Nausea, Rash, Rash erythematous
Clinical narrative: Pt came in on Friday (9/7/12) for other meds and she claimed that she had an allergic rxn to FLUZONE. Pt stated that she felt sick and nauseated the afternoon post vaccination. She went to the ER that day but ER did nothing. Visited her MD the following day, got a shot and felt better. Pt developed rash (hives) on arm with red bumps for 5 days.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Pt came in on Friday (9/7/12) for other meds and she claimed that she had an allergic rxn to FLUZONE. Pt stated that she felt sick and nauseated the afternoon post vaccination. She went to the ER that day but ER did nothing. Visited her MD the following day, got a shot and felt better. Pt developed rash (hives) on arm with red bumps for 5 days.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal mass, Induration, Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: Around weekend of the 1st of September she developed some redness and swelling at injection site. Whole upper arm swollen could barely move arm. She also reported a hard lump on her lower abdomen.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient given flu vaccine I.M. within 10 minutes she developed itching arms, torso and face. Some hives were visible on face. Patient given 1 d: Phenhydramine 25 mg and observed for 20-30 minutes. No additional adverse effects.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Cyanosis, Erythema, Oedema peripheral, Skin discolouration
Clinical narrative: Patient returned on 9/9/12 (had shot on 9/7/12). Arm is black & blue as well as swollen & red in an area approximately 4 inches long.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash vesicular
Clinical narrative: Presented on 9/8/12 with zosters type rash w/outside rash with hole in the middle where shot was given. Returned on 9/9/12 zoster type rash was smaller, but outside <- rash larger.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a female of unknown age. The reporter reported that stated the patient "received her first dose of GARDASIL (lot # was unknown) on 22-MAR-2011 and her second dose of GARDASIL (lot # was unknown) on 02-AUG-2012". No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. The patient was vaccinated with expired lot # (669475/0547AA) dose 1 oral ROTATEQ (expired date 1-SEP-2012) (dose and route were unknown) on 04-SEP-2012. No adverse symptoms reported. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of 15 years old. The reporter reported that "client got the third dose of GARDASIL (lot# was unknown) too early. The third dose of GARDASIL (lot # was unknown) was administered 8 weeks after the second dose". No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with an expired dose of oral ROTATEQ on 29-AUG-2012. Lot number was unspecified but the expiration date was 23-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No symptoms reported. It was unspecified id the patient had sought medical attention. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to a patient of unknown age. The reporter reported that the patient was vaccinated with GARDASIL (lot# was unknown) on the following dates: 27-JUL-/2007, 11-DEC-2008, 05-SEP-2012. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Oedema peripheral
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to 3 patients of unknown age. The patients were subcutaneously vaccinated with 0.65 ml ZOSTAVAX (Lot# reported as H009779, Exp date: March 2013). No other co-suspects were reported. No concomitant medications were reported. Subsequently, all 3 patients had "heated, raised swelling with redness in the entire upper arm" on an unknown date. The patients had sought unspecified medical attention. No treatment information was reported. The outcome was unknown. Lot check has been requested for Lot#H009779. This is one report of several reports received from the same source. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist to a 64 years old female patient with no drug reactions/allergies. The patient was subcutaneously vaccinated with a dose of 0.65 ml ZOSTAVAX (Lot# unspecified) on 03-SEP-2012. Then the patient returned to the pharmacy on 05-SEP-2012 to report that on the day following the vaccination (04-SEP-2012) she developed a rash, with pruritus and erythema at the injection site. The patient had sought medical attention via returning to pharmacy. No treatment was given for the adverse event. The outcome was reported as not recovered/not resolved. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 12 years old female patient. The patient was vaccinated with VARIVAX (merck) (lot # 667291/0753Z; expired date: 20-MAY-2012) on 25-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was not reported if the patient had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Oedema peripheral
Clinical narrative: This spontaneous report as received from a nurse and the doctor's office refers to a patient of unknown age. The patient was subcutaneously vaccinated with 0.65 ml ZOSTAVAX (Lot #0240AE, Exp date: April 2013). No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient received ZOSTAVAX and had "heated, raised swelling with redness in the entire upper arm" on am unknown date. The patient had sought unspecified medical attention. No treatment information was reported. The outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Amylase increased, Mumps antibody test positive, Parotid gland enlargement
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. The patient was vaccinated with the first dose of MMR II (lot # 641722/0127M) on 23-SEP-2002 and the second dose of MMR II (lot# 651930/1053R) on 29-JUN-2006. No other co-suspects were reported. No concomitant medications were reported. The patient developed bilateral swelling of the parotid glands on an unknown date and was seen in the office on 16-AUG-2012. The medical assistant reported the following lab results from blood work that was performed on 16-AUG-2012: "positive amylase - 495, mumps IgG = 4.62, IgM = less than 1:10 ratio". The patient's mother reported to the office on 29-AUG-2012 that the patient "is all better." No treatment information was given. Additional information is not expected.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of 78 years old (as reported). The patient was vaccinated with 0.65 ml ZOSTAVAX (lot# was reported as 00768ae, exp. not available) subcutaneously on right arm on 27-AUG-2012. There were no other immunizations provided at the time of ZOSTAVAX. It was reported that the patient was seen in the office with a swollen right arm at the injection site one week after receiving ZOSTAVAX. The adverse event onset date was reported as On 27-AUG-2012. The outcome of patient was unknown. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (also reported as healthcare worker) refers to a patient of unknown age. The patient was vaccinated subcutaneously with a dose of 0.5 ml VARIVAX 1350 U (lot number not reported) that had been improperly stored on 24-AUG-2012. No other co-suspects or concomitant medications were reported. The dose of VARIVAX (Merck) had been exposed to unknown temperatures, possibly above 77 degrees F. due to shipping issue. When this shipment of VARIVAX (Merck) arrived, 4-5 days after the date it was shipped from Merck, the medical assistant stated that the "cold packs"' felt hot. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: This spontaneous report as received from a nurse and the doctor's office refers to a patient of unknown age. The patient was subcutaneously vaccinated with 0.65 ml ZOSTAVAX (Lot# reported as 0468AE, Exp date : April 2013). No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient received ZOSTAVAX and had "heated, raised swelling with redness in the entire upper arm" on an unknown date. The patient had sought unspecified medical attention. No treatment information was reported. The outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle tightness
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 years old female patient with Bells Palsy "20 years ago". The patient had no drug reactions or allergies. The patient was vaccinated with 0.65 ml ZOSTAVAX (lot number 0618AE; expired date 23-JUN-2013) subcutaneously in the left deltoid region on 04-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On 04-SEP-2012 the patient experienced neck and ear region "tightness up". The patient was diagnosed with Bells Palsy "20 years ago", and the tightness that she was presently experiencing in her neck and ear region was the same area of her face and neck that had been effected by the Bells Palsy. At the time of the call the patient was still in the pharmacy and continuing to experience the neck tightness. The pharmacist believed that the patient's neck tightness was improving, and patient would contact her primary healthcare provider. There was no treatment given for the adverse event and no laboratory diagnostics study performed. The patient was recovering at the time of report. The patient had consulted with pharmacist for medical attention. Additional information has been requested.
Age: 1.04
Sex: M
Vaccine: MMR
Symptoms: Diarrhoea, Lymphadenopathy, Upper respiratory tract congestion, Vomiting
Clinical narrative: This spontaneous report was received from a physician refers to his 1 years old grandson who on 02-OCT-1998, was vaccinated with a dose of M-M-R II (dose, route and lot number not reported).. No other co-suspects were reported. No concomitant medications were reported. The physician reported that her grandson on 13-OCT-1998, developed upper respiratory congestion, swollen glands, vomiting and diarrhea. These symptoms resolved on an unspecified date. No treatment information was reported. It was unspecified if the patient sought medical attention. The relatedness for upper respiratory congestion, diarrhea, vomiting and swollen glands was unknown for M-M-R II. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Headache, Neck pain, Pain, Paraesthesia
Clinical narrative: This spontaneous report was received from a physician refers to a 57 years old male patient with hypertension, hypercholesterolaemia and no allergies to gelatin. The patient's medical history included herpes, anxiety and cervical radiculopathy in left arm. The patient was vaccinated with in a left arm with single dose of ZOSTAVAX (dose, route and lot number not reported) on 07-AUG-2012. Concomitant medications included acetaminophen, VICODIN, lisinopril, VYTORIN, WELLBUTRIN, XANAX, aspirin, vitamins (unspecified) and glucosamine. On 09-AUG-2012 the patient experienced a feeling of a hair on his arm that was tickling him. He related that he then began to experience neuritis and neuropathy at the injection site. There were no visual clues at the site like a rash. It was unknown if there was any relevant laboratory data. As of 11-AUG-2012, it was unknown if the patient continues to take ZOSTAVAX and was still experiencing the feeling of a hair on his arm that was tickling him, neuritis and neuropathy at the injection site and no visible signs of a reaction. The outcome was not reported. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus
Clinical narrative: This spontaneous report was received from a physician refers to a 57 years old male patient with hypertension, hypercholesterolaemia and no allergies to gelatin. The patient's medical history included herpes, anxiety and cervical radiculopathy in left arm. The patient was vaccinated with in a left arm with single dose of ZOSTAVAX (dose, route and lot number not reported) on 07-AUG-2012. Concomitant medications included acetaminophen, VICODIN, lisinopril, VYTORIN, WELLBUTRIN, XANAX, aspirin, vitamins (unspecified) and glucosamine. On 09-AUG-2012 the patient experienced a feeling of a hair on his arm that was tickling him. He related that he then began to experience neuritis and neuropathy at the injection site. There were no visual clues at the site like a rash. It was unknown if there was any relevant laboratory data. As of 11-AUG-2012, it was unknown if the patient continues to take ZOSTAVAX and was still experiencing the feeling of a hair on his arm that was tickling him, neuritis and neuropathy at the injection site and no visible signs of a reaction. The outcome was not reported. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Neuritis, Neuropathy peripheral, Paraesthesia
Clinical narrative: This spontaneous report was received from a physician refers to a 57 years old male patient with hypertension, hypercholesterolaemia and no allergies to gelatin. The patient's medical history included herpes, anxiety and cervical radiculopathy in left arm. The patient was vaccinated with in a left arm with single dose of ZOSTAVAX (dose, route and lot number not reported) on 07-AUG-2012. Concomitant medications included acetaminophen, VICODIN, lisinopril, VYTORIN, WELLBUTRIN, XANAX, aspirin, vitamins (unspecified) and glucosamine. On 09-AUG-2012 the patient experienced a feeling of a hair on his arm that was tickling him. He related that he then began to experience neuritis and neuropathy at the injection site. There were no visual clues at the site like a rash. It was unknown if there was any relevant laboratory data. As of 11-AUG-2012, it was unknown if the patient continues to take ZOSTAVAX and was still experiencing the feeling of a hair on his arm that was tickling him, neuritis and neuropathy at the injection site and no visible signs of a reaction. The outcome was not reported. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Activated partial thromboplastin time, Diarrhoea, Diarrhoea haemorrhagic, Enema administration, Flatulence
Clinical narrative: Mother states that this morning patient started acting fussier than usual and had decreased PO intake and few wet diapers (mom reports a total of three prior to presentation to the ED). At around 2 pm he vomited which mom described as milky appearing (non-bloody, non-bilious). At around 4 pm he had one episode of diarrhea (non-bloody) followed by another 3 episodes of vomiting. Mom decided to bring him into the ED at that time. Of note, patient had a recent episode of viral URI for which he presented to the ED on 8/28. Supportive measures were provided and mom was instructed to f/u with PMD and use anti-pyretics for fever reduction. In the ED, the patient had an episode of grossly bloody diarrhea. The patient was bolused x 2, and labs sent including PT/PTT, T+S, CBC and venous panel. A KUB was done which showed a paucity of bowel gas. An abdominal US was performed which was consistent with intussusception. Surgery was consulted. The patient underwent successful reduction of his intussusception via air enema prior to being transferred to the floor.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Full blood count, Hypophagia, Intussusception, Irritability, Laboratory test
Clinical narrative: Mother states that this morning patient started acting fussier than usual and had decreased PO intake and few wet diapers (mom reports a total of three prior to presentation to the ED). At around 2 pm he vomited which mom described as milky appearing (non-bloody, non-bilious). At around 4 pm he had one episode of diarrhea (non-bloody) followed by another 3 episodes of vomiting. Mom decided to bring him into the ED at that time. Of note, patient had a recent episode of viral URI for which he presented to the ED on 8/28. Supportive measures were provided and mom was instructed to f/u with PMD and use anti-pyretics for fever reduction. In the ED, the patient had an episode of grossly bloody diarrhea. The patient was bolused x 2, and labs sent including PT/PTT, T+S, CBC and venous panel. A KUB was done which showed a paucity of bowel gas. An abdominal US was performed which was consistent with intussusception. Surgery was consulted. The patient underwent successful reduction of his intussusception via air enema prior to being transferred to the floor.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Prothrombin time, Pyrexia, Ultrasound abdomen abnormal, Urinary system X-ray, Urine output decreased
Clinical narrative: Mother states that this morning patient started acting fussier than usual and had decreased PO intake and few wet diapers (mom reports a total of three prior to presentation to the ED). At around 2 pm he vomited which mom described as milky appearing (non-bloody, non-bilious). At around 4 pm he had one episode of diarrhea (non-bloody) followed by another 3 episodes of vomiting. Mom decided to bring him into the ED at that time. Of note, patient had a recent episode of viral URI for which he presented to the ED on 8/28. Supportive measures were provided and mom was instructed to f/u with PMD and use anti-pyretics for fever reduction. In the ED, the patient had an episode of grossly bloody diarrhea. The patient was bolused x 2, and labs sent including PT/PTT, T+S, CBC and venous panel. A KUB was done which showed a paucity of bowel gas. An abdominal US was performed which was consistent with intussusception. Surgery was consulted. The patient underwent successful reduction of his intussusception via air enema prior to being transferred to the floor.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Viral upper respiratory tract infection, Vomiting
Clinical narrative: Mother states that this morning patient started acting fussier than usual and had decreased PO intake and few wet diapers (mom reports a total of three prior to presentation to the ED). At around 2 pm he vomited which mom described as milky appearing (non-bloody, non-bilious). At around 4 pm he had one episode of diarrhea (non-bloody) followed by another 3 episodes of vomiting. Mom decided to bring him into the ED at that time. Of note, patient had a recent episode of viral URI for which he presented to the ED on 8/28. Supportive measures were provided and mom was instructed to f/u with PMD and use anti-pyretics for fever reduction. In the ED, the patient had an episode of grossly bloody diarrhea. The patient was bolused x 2, and labs sent including PT/PTT, T+S, CBC and venous panel. A KUB was done which showed a paucity of bowel gas. An abdominal US was performed which was consistent with intussusception. Surgery was consulted. The patient underwent successful reduction of his intussusception via air enema prior to being transferred to the floor.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Enema administration, Intestinal operation, Intussusception
Clinical narrative: Mother states that this morning patient started acting fussier than usual and had decreased PO intake and few wet diapers (mom reports a total of three prior to presentation to the ED). At around 2 pm he vomited which mom described as milky appearing (non-bloody, non-bilious). At around 4 pm he had one episode of diarrhea (non-bloody) followed by another 3 episodes of vomiting. Mom decided to bring him into the ED at that time. Of note, patient had a recent episode of viral URI for which he presented to the ED on 8/28. Supportive measures were provided and mom was instructed to f/u with PMD and use anti-pyretics for fever reduction. In the ED, the patient had an episode of grossly bloody diarrhea. The patient was bolused x 2, and labs sent including PT/PTT, T+S, CBC and venous panel. A KUB was done which showed a paucity of bowel gas. An abdominal US was performed which was consistent with intussusception. Surgery was consulted. The patient underwent successful reduction of his intussusception via air enema prior to being transferred to the floor.
Sex: F
Vaccine: TTOX
Symptoms: Apparent life threatening event
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 29 August 2012 under reference number 1-395824135. A female patient (age not reported) had received a dose of Tetanus Toxoid (manufacturer, lot number, route, site and date not reported) in the 1940s and an unspecified amount of time later "almost died". No additional information was provided. The patient's outcome was not reported. Documents held by sender: None.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Pruritus, Swelling
Clinical narrative: Itchy hands & swelling - several hours. Pt took OTC allergy meds w/ resolve.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Confusional state, Delirium, Incoherent, Laboratory test, Pyrexia
Clinical narrative: A 52 yr old female experienced fever 3 hours and delirium 5 hours later after receiving a flu shot. The delirium episode lasted for 8 hours. Patient was incoherent and confused. She was rushed to the hospital where she was admitted for 3 days and stabilized. Battery of tests were ordered but patient is not sure of lab work ordered. Patient is currently doing fine.
Age: 13.0
Sex: M
Vaccine: MMR, MNQ, TDAP, VARCEL
Symptoms: Convulsion, Headache, Herpes simplex serology negative, Loss of consciousness, Meningitis viral
Clinical narrative: Headache Tues 8/14/12 & fever. 5:30 Seizure Wed (went uncon.) 8/15/12 was ambulance / air to hospital then to hospital in another city by air.
Age: 13.0
Sex: M
Vaccine: MMR, MNQ, TDAP, VARCEL
Symptoms: Pyrexia, Viral test negative, West Nile virus test negative
Clinical narrative: Headache Tues 8/14/12 & fever. 5:30 Seizure Wed (went uncon.) 8/15/12 was ambulance / air to hospital then to hospital in another city by air.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, MMR, PNC, VARCEL
Symptoms: Injection site erythema
Clinical narrative: In 24 hours reddened vaccine site. Treatment: BENADRYL TID 1 1/2 tsp by mouth.
Age: 1.85
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR
Symptoms: Body temperature increased, Crying, Hypotonia, Rash generalised
Clinical narrative: Aug 7 - vaccinations at hospital. Aug 14 - temp about 101 with nml activity. Aug 15- temp 103-104.7. Aug 16 - temp 102 103 - crying, limp, cheeks begin to speckle. Aug 17-19- rash head to toe decrease in temp.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: CSF virus identified, Herpes zoster, Injection site reaction, Meningitis, Nervous system disorder
Clinical narrative: Information has been received from a literature article. The following neurological complications of varicella vaccine have been reported. Case 3: A healthy patient (gender unspecified) who was vaccinated with varicella virus vaccine live (manufacturer unknown) (dose not reported) at 16 months of age. At 4 years, a zoster rash developed on the right arm, followed by meningitis (important medical event, upon internal review). The article does not state where the patient was vaccinated. Cerebrospinal Fluid (CSF) DNA was sent to the Centers for Disease Control (CDC), GA for strain typing, and the presence of Oka Varicella-zoster-virus (VZV) was confirmed. Polymerase Chain Reaction (PCR) of zoster lesions also identified VZV, but genotyping was not performed. Of note, in several cases, the zoster event occurred in the same extremity as had received the varicella vaccination or was the likely site of vaccination. Since 4 million children are immunized yearly in the country, the neurovirulence of the live attenuated vaccine is dramatically less than that of the wild-type infection. Only a few cases of zoster and meningitis secondary to vaccine virus have been reported since 1995. Nevertheless, these cases illustrate that vaccine virus can occasionally establish latency in the dorsal root ganglia, especially those providing sensory fibers to the arm. Of note, at least 4 children with wild-type Central Nervous System (CNS) disease had had one varicella vaccination. The authors now know that one dose is insufficient to assure immunity throughout childhood. Therefore, these children undoubtedly had breakthrough varicella. Two doses of varicella vaccine during early childhood are now recommended to avoid the problem of breakthrough infection with wild-type varicella. In summary, the aforementioned data from the most populous state in the country demonstrate a dramatic reduction in the CNS complications of wild-type varicella in children. Implementation of the 2-dose varicella vaccination policy should eliminate the few cases of breakthrough disease. The detection of only one case of vaccine virus-related zoster demonstrates a diminished neurovirulence of the live attenuated vaccine. Additional information has been requested. This is one of several cases from the same source.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Polymerase chain reaction, Rash, Varicella post vaccine, Varicella virus test positive, Viral test positive
Clinical narrative: Information has been received from a literature article. The following neurological complications of varicella vaccine have been reported. Case 3: A healthy patient (gender unspecified) who was vaccinated with varicella virus vaccine live (manufacturer unknown) (dose not reported) at 16 months of age. At 4 years, a zoster rash developed on the right arm, followed by meningitis (important medical event, upon internal review). The article does not state where the patient was vaccinated. Cerebrospinal Fluid (CSF) DNA was sent to the Centers for Disease Control (CDC), GA for strain typing, and the presence of Oka Varicella-zoster-virus (VZV) was confirmed. Polymerase Chain Reaction (PCR) of zoster lesions also identified VZV, but genotyping was not performed. Of note, in several cases, the zoster event occurred in the same extremity as had received the varicella vaccination or was the likely site of vaccination. Since 4 million children are immunized yearly in the country, the neurovirulence of the live attenuated vaccine is dramatically less than that of the wild-type infection. Only a few cases of zoster and meningitis secondary to vaccine virus have been reported since 1995. Nevertheless, these cases illustrate that vaccine virus can occasionally establish latency in the dorsal root ganglia, especially those providing sensory fibers to the arm. Of note, at least 4 children with wild-type Central Nervous System (CNS) disease had had one varicella vaccination. The authors now know that one dose is insufficient to assure immunity throughout childhood. Therefore, these children undoubtedly had breakthrough varicella. Two doses of varicella vaccine during early childhood are now recommended to avoid the problem of breakthrough infection with wild-type varicella. In summary, the aforementioned data from the most populous state in the country demonstrate a dramatic reduction in the CNS complications of wild-type varicella in children. Implementation of the 2-dose varicella vaccination policy should eliminate the few cases of breakthrough disease. The detection of only one case of vaccine virus-related zoster demonstrates a diminished neurovirulence of the live attenuated vaccine. Additional information has been requested. This is one of several cases from the same source.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Erythema, Feeling hot, Induration, Pain
Clinical narrative: RED, HOT, SWOLLEN (INDURATION 6 CM), PAINFUL. BLISTERLIKE W/O FLUID. WARM COMPRESSES AND ICE ROTATING A COUPLE TIMES.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: RED, HOT, SWOLLEN (INDURATION 6 CM), PAINFUL. BLISTERLIKE W/O FLUID. WARM COMPRESSES AND ICE ROTATING A COUPLE TIMES.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Muscular weakness, Myalgia, Pruritus, Skin warm
Clinical narrative: Muscle soreness and weakness, severe swelling, hot to touch, itching, diarrhea.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Swelling
Clinical narrative: Muscle soreness and weakness, severe swelling, hot to touch, itching, diarrhea.
Age: 33.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash generalised, Rash vesicular
Clinical narrative: Developed vesicular rash all over body and had fever, 101 degrees.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Red, raised rash developed over body starting on face and moving down body.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Diarrhoea, Gastrointestinal pain, Nausea, Pyrexia
Clinical narrative: Intestinal pain, diarrhea, nausea, fever and chills for 24 hours.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Middle insomnia, Myelitis transverse, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging spinal cord abnormal
Clinical narrative: My daughter woke in the middle of the night and was paralyzed from the waist down. I rushed her to the ER, and she was later diagnosed with Transverse Myelitis.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Paralysis, Spinal cord injury
Clinical narrative: My daughter woke in the middle of the night and was paralyzed from the waist down. I rushed her to the ER, and she was later diagnosed with Transverse Myelitis.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Chills, Cough, Fatigue, Full blood count
Clinical narrative: Woke up in AM with flu like symptoms: headache, myalgia, joint pain, general malaise, slight nausea, slight cough...by 10:00 AM, symptoms intensified, additional fatigue, developed chills and low grade temperature. At 1:30 pm, developed generalized macular papular rash at MD office. Flu test and Strep test were negative. MD diagnosed allergic reaction and administered Decadron injection (6 mg, IM).  Began antihistamines and oral Medrol Dose pack next morning.  Continued with myalgia, fatigue, and dermatological symptoms into late afternoon, early evening with chest appearing sunburned or scalded....also developed itching. By 7 or 8 pm, myalgia, headache, chills reduced and gradually improving. In 24 hours, energy level improved, myalgia, headache, joint pain gone...continued with uticaria and skin appearing scalded, sunburned....this lasted about 4 or 5 days....gradually resolving.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Hypersensitivity, Influenza like illness, Influenza virus test, Liver function test
Clinical narrative: Woke up in AM with flu like symptoms: headache, myalgia, joint pain, general malaise, slight nausea, slight cough...by 10:00 AM, symptoms intensified, additional fatigue, developed chills and low grade temperature. At 1:30 pm, developed generalized macular papular rash at MD office. Flu test and Strep test were negative. MD diagnosed allergic reaction and administered Decadron injection (6 mg, IM).  Began antihistamines and oral Medrol Dose pack next morning.  Continued with myalgia, fatigue, and dermatological symptoms into late afternoon, early evening with chest appearing sunburned or scalded....also developed itching. By 7 or 8 pm, myalgia, headache, chills reduced and gradually improving. In 24 hours, energy level improved, myalgia, headache, joint pain gone...continued with uticaria and skin appearing scalded, sunburned....this lasted about 4 or 5 days....gradually resolving.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Malaise, Myalgia, Nausea, Pruritus, Pyrexia
Clinical narrative: Woke up in AM with flu like symptoms: headache, myalgia, joint pain, general malaise, slight nausea, slight cough...by 10:00 AM, symptoms intensified, additional fatigue, developed chills and low grade temperature. At 1:30 pm, developed generalized macular papular rash at MD office. Flu test and Strep test were negative. MD diagnosed allergic reaction and administered Decadron injection (6 mg, IM).  Began antihistamines and oral Medrol Dose pack next morning.  Continued with myalgia, fatigue, and dermatological symptoms into late afternoon, early evening with chest appearing sunburned or scalded....also developed itching. By 7 or 8 pm, myalgia, headache, chills reduced and gradually improving. In 24 hours, energy level improved, myalgia, headache, joint pain gone...continued with uticaria and skin appearing scalded, sunburned....this lasted about 4 or 5 days....gradually resolving.