chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: TD
Symptoms: Peripheral swelling, Skin warm, Swelling, Tendon rupture, X-ray
Clinical narrative: Immediately the shot hurt.  The arm swelled up and was hot to the touch.  Headache started the following day and has not gone away since.  Entire body hurts and has muscle cramping and spasms that need to be controlled by muscle relaxers.  Physicians believe there is now an autoimmune disorder from the reaction to the tetanus vaccine and my tendons are now susceptible to tearing, my posterior tibial tendon is now torn and needs surgery.  I have had blood work, MRI's, Xrays.  I now have Lyme disease and several courses of antibiotics have not been successful in treating it.  I still test positive for multiple strains.  They are putting me in the infectious disease unit to do IV antibiotics now.  I have to take HCTZ for weird parts of my body that suddenly swell.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: Shoulder Pain.
Age: 57.0
Sex: F
Vaccine: RAB
Symptoms: Bone pain, Crying, Depression, Memory impairment, Pain
Clinical narrative: I am unsure of the day in June of 2015 that I first received the rabies vaccine but the day after I received my first shot I developed symptoms of increased depression, uncontrollable crying, shooting electricity shock like pains all over my body, suicidal thoughts, generalized body aches, bone aches, and increased forgetfulness. I had begun taking Pristiq 50 mg by mouth daily on March 27, 2015 and I took my first of three rabies vaccinations in June of 2015. These symptoms lasted until approximately 2 and 1/2 to 3 weeks after the last vaccination was given.
Age: 57.0
Sex: F
Vaccine: RAB
Symptoms: Paraesthesia, Suicidal ideation
Clinical narrative: I am unsure of the day in June of 2015 that I first received the rabies vaccine but the day after I received my first shot I developed symptoms of increased depression, uncontrollable crying, shooting electricity shock like pains all over my body, suicidal thoughts, generalized body aches, bone aches, and increased forgetfulness. I had begun taking Pristiq 50 mg by mouth daily on March 27, 2015 and I took my first of three rabies vaccinations in June of 2015. These symptoms lasted until approximately 2 and 1/2 to 3 weeks after the last vaccination was given.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Cough, Erythema, Neck pain, Pain in extremity
Clinical narrative: Arm pain and redness, increasing over 3 days, high fever (101.7) and chills occurred next 2 days, near faint sensation, cough, wheezing, pain in left neck.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Presyncope, Pyrexia, Wheezing
Clinical narrative: Arm pain and redness, increasing over 3 days, high fever (101.7) and chills occurred next 2 days, near faint sensation, cough, wheezing, pain in left neck.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Impaired driving ability, Injected limb mobility decreased, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: My arm was very sore the morning after. Normally, my arm is a little tender but I didn't think anything of it. Then as days passed it got worse. I couldn't drive, brush my hair, change, lift things ETC. Eventually ended up getting an MRI. I got my results today (3/22/2016 - over 3 months after vaccine) they found tendinitis in my right shoulder along with a tear in my tendon. I attended PT 4 times prior to my MRI. PT did not help. I still to this day have limited range of motion.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Tendon rupture, Tendonitis
Clinical narrative: My arm was very sore the morning after. Normally, my arm is a little tender but I didn't think anything of it. Then as days passed it got worse. I couldn't drive, brush my hair, change, lift things ETC. Eventually ended up getting an MRI. I got my results today (3/22/2016 - over 3 months after vaccine) they found tendinitis in my right shoulder along with a tear in my tendon. I attended PT 4 times prior to my MRI. PT did not help. I still to this day have limited range of motion.
Age: 25.0
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Cough, Diarrhoea, Fatigue, Injection site pain
Clinical narrative: Significant arm pain at and near injection site, lifting arm above head was VERY painful, avoided if at all possible - 3/12 until 3/16. Fatigue 3/14 until 3/20. Mild diarrhea 3/15 mid-day until evening. General muscle and joint pain 3/15 - 3/16ish. Sore throat and cough - 3/15 to present (3/22/2016).
Age: 25.0
Sex: F
Vaccine: DTAP
Symptoms: Myalgia, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Significant arm pain at and near injection site, lifting arm above head was VERY painful, avoided if at all possible - 3/12 until 3/16. Fatigue 3/14 until 3/20. Mild diarrhea 3/15 mid-day until evening. General muscle and joint pain 3/15 - 3/16ish. Sore throat and cough - 3/15 to present (3/22/2016).
Age: 32.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Loss of consciousness, Seizure
Clinical narrative: Passed out with convulsions in the shower.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 70 year old female patient. The patient did not have any pertinent medical history, drug reactions or allergies. On 08-MAR-2016, the patient was vaccinated with PNEUMOVAX 23 (lot # L018503 and expiry date 16-MAR-2017) (dose, route and site administration were not reported). On 09-MAR-2016, following the administration the patient could not lift her arm. The patient called the physician's office to seek medical attention. There were no lab diagnostics studies performed. The outcome of the event was unknown. The relatedness between the events and suspect therapy was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning multiple unspecified patients of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. On an unknown date, the patients received improperly stored (Oka/Merck) VARIVAX (lot # L034370 with expire date 08-SEP-2017) (dosage and route not reported) which was reconstituted with improperly stored sterile diluent (sterile water diluent) (confirmed Lot # L015076 and expire date 04-MAR-2018). The conditions storage of (Oka/Merck) VARIVAX was 40 F for 100 hours then was back in range. The conditions storage of sterile diluent was: maximum temperature 47 F for 21 hours and minimum temperature 29 F for 273 hours (multiple cycles, more than 3). There was no previous temperature excursion. No adverse effects were reported. This is one of three reported received from the same reporter. Additional information has been requested.
Age: 30.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Blood glucose, Dizziness, Electrocardiogram, Loss of consciousness
Clinical narrative: Patient was feeling lightheaded and passed out for a few seconds. Came to and then passed out again for a few more seconds. Paramedics were called. Paramedics checked patient's BP, glucose level and did an EKG. Recommended patient follow up with doctor.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no concurrent condition or medical history reported. On 16-MAR-2016 the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # L006383, expiration date 23-FEB-2017)(dosage, strength and route unknown) (temperature 25.3 degree F, time frame: 3 hours and 30 minutes). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unknown number of patients of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. On 08-MAR-2016, the patients were vaccinated with improperly stored VAQTA (lot # L045713 and expiry date 14-JAN-2017) (dosing details unspecified). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Details of temperature excursion: Temperature: 47.8F for 1 hour and 10 minutes. Previous temperature excursion: No. Data logger: Yes. Outcome: Supported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning multiple unspecified patients of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. On an unknown date the multiple unspecified patients received improperly stored PNEUMOVAX 23 (lot # L019835 with expire date 23-MAR-2017) (dosage and route not reported). The conditions storage of the vaccine was: maximum temperature 47 F for 21 hours and minimum temperature 29 F for 273 hours (multiple cycles, more than 3). There was no previous temperature excursion. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unknown number of patients of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. On 08-MAR-2016, the patients were vaccinated with improperly stored ROTATEQ (lot # L020859 and expiry date 19-JANp-2017; lot# L029617 and expiry date 19-MAY-2017) (dosing details unspecified). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Details of temperature excursion: Temperature: 47.8F for 1 hour and 10 minutes. Previous temperature excursion: no. Data logger: Yes. Outcome: Supported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unknown number of patients of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. On 08-MAR-2016, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L025738 and expiry date 14-AUG-2017; lot # L033343 and expiry date 17-SEP-2017) (dosing details unspecified). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Details of temperature excursion: Temperature: 47.8F for 1 hour and 10 minutes. Previous temperature excursion: No. Data logger: Yes. Outcome: Supported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Headache, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Fever increased 102 (ax) headache, neck stiffness and was referred to ED. Improvement noted within 12 hours when followed up at PMD office. Treatment recommended was ibuprofen, rest w/ fluids. Complete resolution of all symptoms within 48 hours.
Sex: U
Vaccine: FLUX
Symptoms: Carbohydrate antigen 125 increased, Influenza
Clinical narrative: The patient is taking AVASTIN and stated their chemo numbers went up after taking the flu shot and getting the flu, numbers changed from CA61 to CA125.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal discomfort, Abdominal pain upper, Chest pain, Dyspnoea, Erythema
Clinical narrative: 3-17-16 patient reported having soreness across chest and shortness of breath for a week after getting pneumonia shot. She was told to go to E.R. 3-18-16. Patient came to office with left chest and shoulder pain. Left arm had red area the size of a tennis ball. She didn't feel right and gets sick in stomach with pain. Was told to go to E.R. On 3-18-16 patient went to ER for pain over chest region and down into elbow. States site is itchy. No redness, sores or lesions. Discharge instructions: ice affected area, NSAIDS as directed. F/u PCP. Light R.O.M. exercises, RTC if worsening s/s.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Musculoskeletal pain
Clinical narrative: 3-17-16 patient reported having soreness across chest and shortness of breath for a week after getting pneumonia shot. She was told to go to E.R. 3-18-16. Patient came to office with left chest and shoulder pain. Left arm had red area the size of a tennis ball. She didn't feel right and gets sick in stomach with pain. Was told to go to E.R. On 3-18-16 patient went to ER for pain over chest region and down into elbow. States site is itchy. No redness, sores or lesions. Discharge instructions: ice affected area, NSAIDS as directed. F/u PCP. Light R.O.M. exercises, RTC if worsening s/s.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a multiple unspecified patients of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. On an unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot # L039297 and expiry date 19-JUN-2017) (dosing details unspecified). No adverse effects were reported. Details of temperature excursion: Temperature: 33F for 9.5 hours; 35F for 14.5 hours; 35F for 9.5 hours; 35F for 14.5 hours; 34F for 72 hours; 34F for 9.5 hours; 35F for 48 hours. Cumulative: 33F for 177.5 hours. Previous temperature excursion: No. Data logger: Yes. No additional doses administered since 07-MAR-2016. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a multiple unspecified patients of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (Lot# L037339 and expiry date 09-FEB-2018) (dosing details unspecified). No adverse effects were reported. Details of temperature excursion: Temperature: 33F for 9.5 hours; 35F for 14.5 hours; 35F for 0.5 hours; 35F for 14.5 hours; 34F for 72 hours; 34F for 9.5 hours; 35F for 48 hours. Cumulative: 33F for 177.5 hours; Previous temperature excursion: No; Data logger: yes; No additional doses administered since 07-MAR-2016. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Asthenia, Decreased appetite, Nausea
Clinical narrative: Nausea, weakness, loss of appetite. Treatment (1) prochlorperazine 10mg 1 tab Q6 hours PRN, PEPCID 20mg 1 tab BID.
Age: 65.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Dizziness, Erythema, Nausea
Clinical narrative: Nausea, weakness, loss of appetite. Treatment (1) prochlorperazine 10mg 1 tab Q6 hours PRN, PEPCID 20mg 1 tab BID.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored MMRII (rHA, Lot # L012481 with expiration 10-APR-2017, Lot # L008684 with expiration 13-MAR-2017, Lot # K024824 with expiration 02-DEC-2016, lot# L024265 with expiration 01-JUL-2017, dose and route were not reported). The vaccines were exposed to two excursions: 9.8 Centigrade for 40 minutes and -1.7 Centigrade for 1 hour and 50 minutes. No adverse effect was reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 (lot # K020215, expiration 15-MAY-2016, dose and route were not reported). The vaccines were exposed to two excursions: 9.8 Centigrade and -1.7 Centigrade for 1 hour and 50 minutes. No adverse effects was reported. This is one of several cases received from the same source. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt said the next day her left deltoid muscle area was swollen, red and itching. The following days the swelling/redness spread to the entire upper left arm. Advised pt to make appt with her PCP ASAP.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist and concerns to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were unknown. It was reported that an unspecified number of patients received improperly stored doses of RECOMBIVAX HB lot number L007558, expiry date 10-NOV-2016 and lot number L008660, expiry date 10-NOV-2016 (dose and route were not reported) were given to the patients sometime after 23-JUN-2015. It was reported that the vaccine was at 48 Fahrenheit of temperature and its time frame was 1 hour and 33 minutes, there was not previous excursion. No symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist and concerns to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were unknown. It was reported that an unspecified number of patients received improperly stored doses of ROTATEQ oral liquid, lot number J015689, expiry date 11-NOV-2015 (dose and route were not reported) were given to the patients sometime after 23-JUN-2015. The reporter was not aware of any doses of ROTATEQ were administered after labeled expiration date. It was reported that the vaccine was at 48 Fahrenheit of temperature and its time frame was 1 hour and 33 minutes, there was not previous excursion. No symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested.
Age: 1.11
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a 23 month old male patient with no drug reactions or allergies and no pertinent medical history. On 20-JUL-2015, the patient was vaccinated (by an unspecified physician) with a single dose of (Oka/Merck) VARIVAX, 0.5 ml, subcutaneous (lot number and expiration date were not provide). There were no concomitant medications. On an unspecified date in 2016 (reported as "sometime last week"), the patient presented to the physician's office with herpes zoster reported as "shingles rash" (exact onset date unknown). After seeking medication attention, the patient was prescribed with ACYCLOVIR and the shingles rash has cleared up. No laboratory diagnostics studies were performed. There was no product quality complaint (PQC) reported. The outcome of herpes zoster was reported as recovering. The primary reports did not provide the causality between (Oka/Merck) VARIVAX and herpes zoster. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On an unknown date, the unspecified number of patients were vaccinated with unspecified number of doses of improperly stored (Oka/Merck) VARIVAX, lot # L039092, expiration date 06-OCT-2017. No adverse effects reported. The reporter stated that the doses were exposed to -13.3C during 11 days. On 16-MAR-2016, a phone call was received from the reporting licensed practical nurse, who stated that was unable to share any patient identifiers or dates of vaccination the time of this report. This is one of several reported received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: This spontaneous report was received from a healthcare worker via a company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL (route of administration, anatomical location, lot number and expiration date were not provided). There were no concomitant medications reported. On an unknown date, the patient developed "chronic" headaches. The outcome of headache was not reported. The reporter did not assess the relatedness of headache with GARDASIL. This is one of several reports from the same reporter. Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: RAB
Symptoms: Chest discomfort, Cough, Headache, Malaise, Pain
Clinical narrative: Case number PHEH2015US004669, is an initial spontaneous report received from a nurse on 09 Mar 2015 and a follow up report from the nurse received on 22 May 2015. This report refers to a 48 year old male patient. Historical condition and concomitant medication were not reported. His vaccination history included received two unspecified vaccines and had no adverse reactions to them. The patient was vaccinated with the first dose of RABAVERT (batch number: 556011A) intramuscularly at a dose of 0.5 ml on 02 Mar 2015 (at 01:20 pm). The patient was feeling well after vaccination. On 07 Mar 2015, he experienced headache, not feeling well, vomiting, chest congestion and tightness, loose cough, little fever and body aches. Final outcome of the events reported as recovered on 22 Mar 2015. The seriousness and causality of the events were not reported. Follow up report from the nurse received on 22 May 2015: Added vaccination history, events (chest congestion and tightness, loose cough, little fever and body aches) and outcome of the events.
Age: 48.0
Sex: M
Vaccine: RAB
Symptoms: Pyrexia, Respiratory tract congestion, Vomiting
Clinical narrative: Case number PHEH2015US004669, is an initial spontaneous report received from a nurse on 09 Mar 2015 and a follow up report from the nurse received on 22 May 2015. This report refers to a 48 year old male patient. Historical condition and concomitant medication were not reported. His vaccination history included received two unspecified vaccines and had no adverse reactions to them. The patient was vaccinated with the first dose of RABAVERT (batch number: 556011A) intramuscularly at a dose of 0.5 ml on 02 Mar 2015 (at 01:20 pm). The patient was feeling well after vaccination. On 07 Mar 2015, he experienced headache, not feeling well, vomiting, chest congestion and tightness, loose cough, little fever and body aches. Final outcome of the events reported as recovered on 22 Mar 2015. The seriousness and causality of the events were not reported. Follow up report from the nurse received on 22 May 2015: Added vaccination history, events (chest congestion and tightness, loose cough, little fever and body aches) and outcome of the events.
Age: 57.0
Sex: M
Vaccine: RAB
Symptoms: Chest discomfort, Cough, Malaise, Pyrexia, Respiratory tract congestion
Clinical narrative: Case number PHEH2015US004666 is an initial spontaneous report received from a nurse on 09 Mar 2015 and a follow up report from the nurse received on 22 May 2015. This report refers to a 57 years old male patient. His medical history and concomitant medications were not reported. His vaccination history included two unspecified vaccines and had no adverse reactions to them. He was vaccinated with first dose of RABAVERT (batch number: 556011A) pre-exposure series intramuscularly at a dose of 0.5 ml of 02 Mar 2015 (at 03:30 pm). The nurse report that the patient was not feeling well on 05 Mar 2015. The patient had high fever of 102 degree Fahrenheit, cough, chest congestion and tightness. The outcome of events was reported as resolved on 08 Mar 2015. The events were reported as non-serious. The causality of the events was not reported. Follow up report from the nurse received on 22 May 2015: Added event chest tightness and vaccination history. Updated outcome of the events.
Age: 64.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Fatigue, Paraesthesia
Clinical narrative: Case number PHEH2015US022074 is an initial spontaneous report received from a consumer (patient's husband) on 19 Oct 2015. This report refers to a 64 year old female patient. Past medical history and concomitant medications were not reported. There was a bat in patient's house and hence the doctor recommended vaccination for protection in the event the patient was bitten. Her vaccination history included administration of two doses of post exposure RABAVERT (batch number: 556011A) (for first and second doses) following which she experienced fatigue, tiredness and needles poking on her skin (see related case numbers: PHEH2015US022072 and PHEH2015US022073). She was vaccinated with third dose of RABAVERT (batch number: 559011A) on an unspecified date. On an unknown date after injection, she experienced fatigue and was very tired. She also felt like she had needles poking on her skin all throughout the day after the vaccination. The events outcome, seriousness and causality were not reported. She further received fourth dose of RABAVERT (batch number: 559011A) on an unknown date following which she experienced fatigue, tiredness and needles poking on her skin (see related case number: PHEH2015US021398). No further information was provided.
Age: 64.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Fatigue, Paraesthesia
Clinical narrative: Case number PHEH2015US022072 is an initial spontaneous report received from a consumer (patient's husband) on 19 OCT 2015. This report refers to a 64 year old female patient. Past medical history and concomitant medications were not reported. There was a bat in patient's house and hence the doctor recommended vaccination for protection in the event the patient was bitten. She was vaccinated with first dose of post exposure RABAVERT (batch number: 556011A) on an unknown date. On an unknown date after injection, experienced fatigue and was very tired. She also felt like she had needles poking on her skin all throughout the day after the vaccination. The events outcome, seriousness and causality were not reported. She further received three doses of RABAVERT (batch number: 556011A) (for second dose), 559011A (for third and fourth dose) on unknown dates following which she experienced fatigue, tiredness and needles poking on her skin (see related case numbers: PHEH2015US022073, PHEH2015US022074 and PHEH2014US021398 respectively. No further information was provided.
Age: 40.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Erythema, Neuralgia, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 40 year old female patient with allergy to oxycodone and unspecified tricyclic antidepressants. The patient's medical history included an episode of shingles on 23-FEB-2016, which was treated by acyclovir. The reporter stated that, the patient had finished the acyclovir therapy, but had developed neuropathy pain in her right arm and right hand (on an unknown date in 2016, prior to or after she received the acyclovir). The patient was also "3 time breast cancer survivor". On 15-MAR-2016, the patient was vaccinated with ZOSTAVAX (lot # L040445, expiration date 15-JAN-2017, dose 0.65 ml, subcutaneously in the right arm. Concomitant therapies included CYMBALTA. On 16-MAR-2016, she experienced a red area and an oval shaped raised bump around the injection site, that was achy. The pre-existing neuropathy pain in her right hand and right arm was intensified. No treatment was given and no lab diagnostic studies were performed. The outcome of the events was reported as not recovered. The patient sought medical attention and called to reporting pharmacist on 17-MAR-2016. The relatedness between the events and ZOSTAVAX was not reported. Additional information is not expected as there was no consent for follow up.
Age: 40.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Injection site erythema, Injection site pain, Injection site swelling, Neuralgia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 40 year old female patient with allergy to oxycodone and unspecified tricyclic antidepressants. The patient's medical history included an episode of shingles on 23-FEB-2016, which was treated by acyclovir. The reporter stated that, the patient had finished the acyclovir therapy, but had developed neuropathy pain in her right arm and right hand (on an unknown date in 2016, prior to or after she received the acyclovir). The patient was also "3 time breast cancer survivor". On 15-MAR-2016, the patient was vaccinated with ZOSTAVAX (lot # L040445, expiration date 15-JAN-2017, dose 0.65 ml, subcutaneously in the right arm. Concomitant therapies included CYMBALTA. On 16-MAR-2016, she experienced a red area and an oval shaped raised bump around the injection site, that was achy. The pre-existing neuropathy pain in her right hand and right arm was intensified. No treatment was given and no lab diagnostic studies were performed. The outcome of the events was reported as not recovered. The patient sought medical attention and called to reporting pharmacist on 17-MAR-2016. The relatedness between the events and ZOSTAVAX was not reported. Additional information is not expected as there was no consent for follow up.
Age: 16.0
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Alopecia, Anxiety, Arthralgia, Fatigue, Headache
Clinical narrative: This spontaneous report as received from the patient's mother refers to her daughter, a 16 year old female patient with asthma, Hashimoto's thyroiditis and seasonal allergy. On unspecified dates, the patient was vaccinated with doses of RECOMBIVAX HB, (dose, route of administration, injection site, lot number and expiration date were not reported). On an unknown date, the patient showed a negative titer toward Hepatitis B virus. As the patient volunteered at an unspecified hospital, she was recommended a re-vaccination of the three series of RECOMBIVAX HB. On 24-NOV-2015, the patient received her first re-vaccination dose of RECOMBIVAX HB injection, dose, route of administration, lot number and expiration date were not reported. The second dose was administered on 19-FEB-2016. There were no concomitant medications reported. On 29-FEB-2016, about ten days after receiving the second dose of RECOMBIVAX HB, the patient started to experienced severe hair loss. The reporter stated that her "daughter's hair started coming out in clumps". It was also reported that the patient had "anxiety, fatigue and headaches" (since an unknown date in approximately 2016). The patient sought medical attention via calling her primary care physician. No other laboratory diagnostic studies were performed. The patient was given oral contraception for the treatment of severe hair loss, fatigue, anxiety and headaches. It was also reported that the patient's physician advised against the patient being administered a third dose of RECOMBIVAX HB. Therefore, therapy with RECOMBIVAX HB was discontinued on 19-FEB-2016 and the vaccine was not reintroduced. At the time of the report, the patient did not recover from the events of anxiety, fatigue, headache and severe hair loss and had been referred to a dermatologist. The outcome of showing a negative titer toward Hepatitis B virus was unknown. The relatedness between the events and suspect therapy was not provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Malaise
Clinical narrative: This spontaneous report as received from the patient's mother refers to her daughter, a 16 year old female patient with asthma, Hashimoto's thyroiditis and seasonal allergy. On unspecified dates, the patient was vaccinated with doses of RECOMBIVAX HB, (dose, route of administration, injection site, lot number and expiration date were not reported). On an unknown date, the patient showed a negative titer toward Hepatitis B virus. As the patient volunteered at an unspecified hospital, she was recommended a re-vaccination of the three series of RECOMBIVAX HB. On 24-NOV-2015, the patient received her first re-vaccination dose of RECOMBIVAX HB injection, dose, route of administration, lot number and expiration date were not reported. The second dose was administered on 19-FEB-2016. There were no concomitant medications reported. On 29-FEB-2016, about ten days after receiving the second dose of RECOMBIVAX HB, the patient started to experienced severe hair loss. The reporter stated that her "daughter's hair started coming out in clumps". It was also reported that the patient had "anxiety, fatigue and headaches" (since an unknown date in approximately 2016). The patient sought medical attention via calling her primary care physician. No other laboratory diagnostic studies were performed. The patient was given oral contraception for the treatment of severe hair loss, fatigue, anxiety and headaches. It was also reported that the patient's physician advised against the patient being administered a third dose of RECOMBIVAX HB. Therefore, therapy with RECOMBIVAX HB was discontinued on 19-FEB-2016 and the vaccine was not reintroduced. At the time of the report, the patient did not recover from the events of anxiety, fatigue, headache and severe hair loss and had been referred to a dermatologist. The outcome of showing a negative titer toward Hepatitis B virus was unknown. The relatedness between the events and suspect therapy was not provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Alopecia, Anxiety, Fatigue, Headache, Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from the patient's mother refers to her daughter, a 16 year old female patient with asthma, Hashimoto's thyroiditis and seasonal allergy. On unspecified dates, the patient was vaccinated with doses of RECOMBIVAX HB, (dose, route of administration, injection site, lot number and expiration date were not reported). On an unknown date, the patient showed a negative titer toward Hepatitis B virus. As the patient volunteered at an unspecified hospital, she was recommended a re-vaccination of the three series of RECOMBIVAX HB. On 24-NOV-2015, the patient received her first re-vaccination dose of RECOMBIVAX HB injection, dose, route of administration, lot number and expiration date were not reported. The second dose was administered on 19-FEB-2016. There were no concomitant medications reported. On 29-FEB-2016, about ten days after receiving the second dose of RECOMBIVAX HB, the patient started to experienced severe hair loss. The reporter stated that her "daughter's hair started coming out in clumps". It was also reported that the patient had "anxiety, fatigue and headaches" (since an unknown date in approximately 2016). The patient sought medical attention via calling her primary care physician. No other laboratory diagnostic studies were performed. The patient was given oral contraception for the treatment of severe hair loss, fatigue, anxiety and headaches. It was also reported that the patient's physician advised against the patient being administered a third dose of RECOMBIVAX HB. Therefore, therapy with RECOMBIVAX HB was discontinued on 19-FEB-2016 and the vaccine was not reintroduced. At the time of the report, the patient did not recover from the events of anxiety, fatigue, headache and severe hair loss and had been referred to a dermatologist. The outcome of showing a negative titer toward Hepatitis B virus was unknown. The relatedness between the events and suspect therapy was not provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Alopecia, Alopecia areata, Anxiety, Arthralgia, Fatigue
Clinical narrative: This spontaneous report as received from the patient's mother refers to her daughter, a 16 year old female patient with asthma, Hashimoto's thyroiditis and seasonal allergy. On unspecified dates, the patient was vaccinated with doses of RECOMBIVAX HB, (dose, route of administration, injection site, lot number and expiration date were not reported). On an unknown date, the patient showed a negative titer toward Hepatitis B virus. As the patient volunteered at an unspecified hospital, she was recommended a re-vaccination of the three series of RECOMBIVAX HB. On 24-NOV-2015, the patient received her first re-vaccination dose of RECOMBIVAX HB injection, dose, route of administration, lot number and expiration date were not reported. The second dose was administered on 19-FEB-2016. There were no concomitant medications reported. On 29-FEB-2016, about ten days after receiving the second dose of RECOMBIVAX HB, the patient started to experienced severe hair loss. The reporter stated that her "daughter's hair started coming out in clumps". It was also reported that the patient had "anxiety, fatigue and headaches" (since an unknown date in approximately 2016). The patient sought medical attention via calling her primary care physician. No other laboratory diagnostic studies were performed. The patient was given oral contraception for the treatment of severe hair loss, fatigue, anxiety and headaches. It was also reported that the patient's physician advised against the patient being administered a third dose of RECOMBIVAX HB. Therefore, therapy with RECOMBIVAX HB was discontinued on 19-FEB-2016 and the vaccine was not reintroduced. At the time of the report, the patient did not recover from the events of anxiety, fatigue, headache and severe hair loss and had been referred to a dermatologist. The outcome of showing a negative titer toward Hepatitis B virus was unknown. The relatedness between the events and suspect therapy was not provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Headache, Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from the patient's mother refers to her daughter, a 16 year old female patient with asthma, Hashimoto's thyroiditis and seasonal allergy. On unspecified dates, the patient was vaccinated with doses of RECOMBIVAX HB, (dose, route of administration, injection site, lot number and expiration date were not reported). On an unknown date, the patient showed a negative titer toward Hepatitis B virus. As the patient volunteered at an unspecified hospital, she was recommended a re-vaccination of the three series of RECOMBIVAX HB. On 24-NOV-2015, the patient received her first re-vaccination dose of RECOMBIVAX HB injection, dose, route of administration, lot number and expiration date were not reported. The second dose was administered on 19-FEB-2016. There were no concomitant medications reported. On 29-FEB-2016, about ten days after receiving the second dose of RECOMBIVAX HB, the patient started to experienced severe hair loss. The reporter stated that her "daughter's hair started coming out in clumps". It was also reported that the patient had "anxiety, fatigue and headaches" (since an unknown date in approximately 2016). The patient sought medical attention via calling her primary care physician. No other laboratory diagnostic studies were performed. The patient was given oral contraception for the treatment of severe hair loss, fatigue, anxiety and headaches. It was also reported that the patient's physician advised against the patient being administered a third dose of RECOMBIVAX HB. Therefore, therapy with RECOMBIVAX HB was discontinued on 19-FEB-2016 and the vaccine was not reintroduced. At the time of the report, the patient did not recover from the events of anxiety, fatigue, headache and severe hair loss and had been referred to a dermatologist. The outcome of showing a negative titer toward Hepatitis B virus was unknown. The relatedness between the events and suspect therapy was not provided. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Asthenia, Headache, Limb discomfort, Pain, Paraesthesia
Clinical narrative: Case number PHEH2015US010210 is an initial combined spontaneous report received from a consumer on 19 May 2015 with a follow up information received from the consumer on 20 May 2015. This report refers to a 60 year old male patient. His medical history and concomitant medications were not reported. His vaccination history were reported as follows: He had a complete post exposure prophylaxis series with RABAVERT (batch number: not reported) 5 years ago after a bat attack and he experienced events (see related case number: PHEH2015US010209). He had a bat exposure and was vaccinated with first dose of post exposure RABAVERT (batch number: 556011A) intramuscularly on 12 May 2015 at 10:40 am following which he experienced headache, feeling of heaviness in arms, weakness and soreness all over the body (see related case number: PHEH2015US009845). He was further vaccinated with second dose of post exposure (batch number: 556011A) intramuscularly on 19 May 2015 at 10:45 am (see case number: PHEH2015US010211 for schedule deviation). On the same date after second dose, he experienced tingling. The consumer reported that the events persisted longer than the last time. The events outcome, seriousness and causality were not reported. No further information was provided.
Age: 60.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Paraesthesia
Clinical narrative: Case number PHEH2015US010210 is an initial combined spontaneous report received from a consumer on 19 May 2015 with a follow up information received from the consumer on 20 May 2015. This report refers to a 60 year old male patient. His medical history and concomitant medications were not reported. His vaccination history were reported as follows: He had a complete post exposure prophylaxis series with RABAVERT (batch number: not reported) 5 years ago after a bat attack and he experienced events (see related case number: PHEH2015US010209). He had a bat exposure and was vaccinated with first dose of post exposure RABAVERT (batch number: 556011A) intramuscularly on 12 May 2015 at 10:40 am following which he experienced headache, feeling of heaviness in arms, weakness and soreness all over the body (see related case number: PHEH2015US009845). He was further vaccinated with second dose of post exposure (batch number: 556011A) intramuscularly on 19 May 2015 at 10:45 am (see case number: PHEH2015US010211 for schedule deviation). On the same date after second dose, he experienced tingling. The consumer reported that the events persisted longer than the last time. The events outcome, seriousness and causality were not reported. No further information was provided.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Abasia, Balance disorder, Crying, Fall, Peripheral swelling
Clinical narrative: Leg swelled so badly, he couldn't walk on it for 3 days; cried for several hours; had a fever; fell down frequently afterwards; lost equilibrium.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: Leg swelled so badly, he couldn't walk on it for 3 days; cried for several hours; had a fever; fell down frequently afterwards; lost equilibrium.
Age: 1.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Decreased appetite, Irritability, Lethargy, Malaise, Pyrexia
Clinical narrative: Fever, vomiting, general crankiness. Lethargic, disagreeable, lack of appetite. Generally not feeling well.
Age: 1.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Vomiting
Clinical narrative: Fever, vomiting, general crankiness. Lethargic, disagreeable, lack of appetite. Generally not feeling well.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, FLU4, MENB
Symptoms: Chills, Dizziness, Headache, Pain, Pyrexia
Clinical narrative: Chills, bodyache, fever, dizzy, headache.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, FLU4, MENB
Symptoms: Chills, Dizziness, Headache, Neck pain, Pain
Clinical narrative: Chills, bodyache, fever, dizzy, headache.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, FLU4, MENB
Symptoms: Photophobia, Pyrexia
Clinical narrative: Chills, bodyache, fever, dizzy, headache.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Chills, Muscle spasms, Tremor
Clinical narrative: Chills, leg cramps, shaky.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Chills, Muscle spasms
Clinical narrative: Chills, leg cramps, shaky.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Pt describes unusual pain at time of vaccine and said the pain only got worse throughout the day.  She now reports additional pain throughout her arm.  No swelling, no redness, no site tenderness.  Told pt to f/u in am and she states that overnight she took 3 IBU 200 and a Vicodin and still in immense pain.  Referred her to talk to her PCP because pt reported calling her orthopedist who told her it wasn't in their scope.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: 3/17/16: Fever at 102.8, Tylenol given, lowered temp somewhat ED visit 3/18/16 0213: temp 104.3 at midnight, Tylenol given.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to multiple, different unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medication were not reported. On an unknown dates, the patients were vaccinated with improperly stored (-14 degrees Celsius (C), for 2 hours and 48 minutes) VARIVAX injection, lot # L029466, expiry date 06-AUG-2017, (dose and frequency not reported). Vaccine had previous temperature excursion (-14 C) for 32.5 hours, with call because of "data logger". No adverse effects were reported. No product quality complaint (PQC) was involved. Follow up information has been received from the nurse on 11-MAR-2016. She provided the patients identifiers. On 16-FEB-2016, a patient of unknown age and gender received one dose of improperly stored VARIVAX (stored in -14 degrees C, for 56 hours). This same vaccine was previously exposed to a high temperature of -14C for a cumulative total of 91 hours, 18 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.