chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling, Middle insomnia, Myosclerosis, Pain
Clinical narrative: On 2/20 woke up in middle of night crying in pain, would not move or ambulate on (L) thigh where immunizations given. Father gave APAP for pain. (L) leg/upper thigh visibly swollen, mild erythema at injection site, and muscle hardness at site today (2/20/18) at 1100 on exam. Will go ice and MOTRIN to help with swelling.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Injection site swelling, Peripheral swelling, Skin warm
Clinical narrative: Left arm redness, swelling, warmth. Patient received Tdap and MENACTRA on 2/14/18 (LD) after speaking with guardian and informed of no past history of reactions to vaccines. School nurse called next day 2/15/18 due to 3x2" redness w/upper arm swelling-family took to see MD and antibiotics started. F/U on 2/16/18 and 2/20/18-swelling resolved of Left arm. Right arm fine.
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Induration, Product administered at inappropriate site, Pruritus, Skin warm
Clinical narrative: Noticed reaction 1-30-18, swelling w/hardness, hot feeling, spreading redness, itching. C/O vaccine given too low. Recommended heat and acetaminophen and use arm to decrease soreness. TC to father, issue resolved.
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Noticed reaction 1-30-18, swelling w/hardness, hot feeling, spreading redness, itching. C/O vaccine given too low. Recommended heat and acetaminophen and use arm to decrease soreness. TC to father, issue resolved.
Age: 51.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: C-reactive protein, Computerised tomogram, Injection site pain, Pain in extremity, Red blood cell sedimentation rate
Clinical narrative: Patient with persistent pain to left deltoid area, plus tender to palpation and pain radiates down the arm. No previous pain or injury to arm.
Age: 1.58
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Body temperature increased, Bronchitis, Decreased appetite, Immediate post-injection reaction
Clinical narrative: Immediately after, low energy, lethargic and loss of appetite. Slightly elevated temperature. About a week after - nasal congestion and wheezing. Diagnosed bronchitis and given nebulizer for treatment.
Age: 1.58
Sex: F
Vaccine: FLU4
Symptoms: Lethargy, Nasal congestion, Wheezing
Clinical narrative: Immediately after, low energy, lethargic and loss of appetite. Slightly elevated temperature. About a week after - nasal congestion and wheezing. Diagnosed bronchitis and given nebulizer for treatment.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Cold sweat, Headache, Injected limb mobility decreased, Injection site erythema
Clinical narrative: Cold sweats, chills, possible fever started 11-12 hours after the vaccine was given. Patient also with body aches. The patient developed headache and a swollen, hot, sore injection site in addition to the other symptoms. There was a large red circle around the vaccine site, which persisted for six days. The patient was unable to use the arm in sports for two weeks.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Cold sweats, chills, possible fever started 11-12 hours after the vaccine was given. Patient also with body aches. The patient developed headache and a swollen, hot, sore injection site in addition to the other symptoms. There was a large red circle around the vaccine site, which persisted for six days. The patient was unable to use the arm in sports for two weeks.
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 3 x 4 cm erythema, mild firmness/warmth left thigh after PROQUAD injection. BENADRYL was given 2.5 ml (12.5 mg/5m).
Age: 5.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Rash, Rash pruritic, Skin test, Urticaria
Clinical narrative: Approximately 2 days later had rash/hives, pruritic to axillae, groin.
Age: 72.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling, warm to touch for a week. TYLENOL OTC. Still red after a week.
Sex: M
Vaccine: FLU3
Symptoms: Dizziness postural
Clinical narrative: Patient received flu shot, sat for 5 min afterwards but got dizzy and almost fainted when he stood up and tried to walk.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Patient had Varicella and MMR as well as Dtap and Hep A. Had welts on both legs given 01/09/18.
Sex: F
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of Guillain Barre Syndrome in a female patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced Guillain Barre Syndrome (serious criteria disability and GSK medically significant). On an unknown date, the outcome of the Guillain Barre Syndrome was unknown. It was unknown if the reporter considered the Guillain Barre Syndrome to be related to Influenza vaccine Quadrivalent unspecified. Additional details were provided as follows: This case was received from patient's son in law. The brand name and manufacturer of the flu vaccine was unknown. The event occurred years before the date of reporting, specific date was not provided. The reporter declined to proceed with safety report. This case has been linked to the US2018025095, reported by the same reporter.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Insomnia, Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: I had a flu shot through pharmacy on 10/12/17 at School at the end of the school day, at approximately 2:30. I started having a very sore arm within a half an hour. The pain got increasingly more intense the longer time went by. By morning I couldn't lift my left arm any higher than my hip. The pain was excruciating. I could not do any daily tasks, like washing my hair, brushing my teeth, doing dishes, driving, etc.  Sleeping was the most excruciating. I had the shot on Thursday and know that there can be a little pain and that it usually wears off, but this did not. I made an appointment at the emergency clinic time on Saturday. The doctor there told me that the shot had created a bursitis and that it had also frozen my shoulder. The doctor said that I may have to go to physical therapy if it doesn't get better. I had many out of pocket expenses with this flu shot. They are as follows: Chiropractic - 10/13/17, 10/20/17, 10/25/17, 10/27/17, 10/30/17 all $20 copays, Health Services-10/21 10/21/17 $20 copay. Was hoping that I might be reimbursed for some of the expenses that occurred. Also the pain and lack of ability to do anything. Thank you.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Periarthritis
Clinical narrative: I had a flu shot through pharmacy on 10/12/17 at School at the end of the school day, at approximately 2:30. I started having a very sore arm within a half an hour. The pain got increasingly more intense the longer time went by. By morning I couldn't lift my left arm any higher than my hip. The pain was excruciating. I could not do any daily tasks, like washing my hair, brushing my teeth, doing dishes, driving, etc.  Sleeping was the most excruciating. I had the shot on Thursday and know that there can be a little pain and that it usually wears off, but this did not. I made an appointment at the emergency clinic time on Saturday. The doctor there told me that the shot had created a bursitis and that it had also frozen my shoulder. The doctor said that I may have to go to physical therapy if it doesn't get better. I had many out of pocket expenses with this flu shot. They are as follows: Chiropractic - 10/13/17, 10/20/17, 10/25/17, 10/27/17, 10/30/17 all $20 copays, Health Services-10/21 10/21/17 $20 copay. Was hoping that I might be reimbursed for some of the expenses that occurred. Also the pain and lack of ability to do anything. Thank you.
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: Patient had 3rd dose of vaccine 20Feb18 and presented to clinic 21Feb18. States this morning @0600 the site felt warm to touch, tender to touch, swollen and stiff. Site was marked 5cmx7cm and patient was given MOTRIN, ZYRTEC and 3 day course of Prednisone. Pt was told to f/u tomorrow.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions, concomitant therapies and drug reactions or allergies were not reported. From 14-NOV-2017 through 07-DEC-2017, the patients were administered improperly stored doses of PROQUAD injection, lot# N021726 with expiration date on 06-FEB-2019 (doses and routes of administration were not reported) and VARIVAX injection, lot# M010485 with expiration date on 01-MAR-2018 (doses and routes of administration were not reported). Administered doses of vaccines underwent a temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit, which lasted for 1 hour. There was a previous temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit, which lasted for 2 hours. A digital data logger was involved in recording the excursions. There were no adverse effects reported. Follow-up information has been received from the vaccine coordinator on 15-FEB-2018. It was reported that a 12 months old male patient received a dose of the PROQUAD on 07-DEC-2017, lot # N021726 with expiration date 06-FEB-2019. The patient did not experience any adverse events following administration of PROQUAD. There was no information available regarding VARIVAX. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test negative
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse, and refers to a currently 26 year old female patient. The patient's concurrent conditions included asthma and nausea. Concomitant therapies included metoclopramide hydrochloride(REGLAN), mometasone furoate (+) formoterol fumarate(DULERA) and levalbuterol hydrochloride(XOPENEX). She had no drug reactions or allergies. On 10-MAY-2017, the patient was vaccinated with the first dose of GARDASIL 9 0.5 ml, per intramuscular route, for Human Papillomavirus prevention (lot number N017833, expiration date 16-NOV-2019). On 12-JUL-2017, she was vaccinated with the second dose of GARDASIL 9. On 09-NOV-2017, the patient was vaccinated with the third dose of GARDASIL 9 at which time pregnancy test was negative. The patient did not have her menstrual cycle in December 2017. On 29-JAN-2018 it was determined that patient was pregnant with twins, gestation 8 weeks and 3 days. Last menstrual period was on 06-NOV-2017. Estimated date of delivery was 13-AUG-2018. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of Oka/Merck VARIVAX lot # N023961; expiry date 01-SEP-2019 (dose, frequency, route of administration were not provided). The Oka/Merck VARIVAX was reconstituted with properly stored sterile diluent (manufacturer unknown). No adverse effect was reported. The vaccines was stored in -14 Celsius degrees for 4 minutes. The previous excursion was n -14 1 C for 7 minutes and 55 seconds. Data logger was involved.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided. On 13-FEB-2018, the patient was vaccinated inadvertently received with an expired dose of Oka/Merck VARIVAX lot # M006726; expiry date 08-FEB-2018, subcutaneously (strength and dose were not reported). No adverse effects were reported.
Sex: M
Vaccine: PPV
Symptoms: Cough
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 16-FEB-2018, the patient was vaccinated with PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date in February 2018, the patient developed a cough. The outcome of cough was unknown. The reporter considered cough to be related to PNEUMOVAX 23.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, and  concurrent conditions was not reported. Concomitant therapies included sterile diluent. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N012135 with expiration date on 14-JUN-2018 by subcutaneous route, for prophylaxis (strength, anatomical location and dose were not provided). No adverse effects were reported. The vaccine was exposed to a temperature range between -9°C to 8°C (-5.9°C), during a time frame of 5 hours and 40 minutes, which was called by a data logger. Previous temperature excursions included -9°C to 8°C (-9°C) for 50 hours. This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-1802USA009695:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to a patient of unknown age and gender. Information on medical history, past drugs, concurrent conditions and concomitant medications were not provided. On 22-AUG-2017, the patient was vaccinated with GARDASIL 9, (lot # N021571, Exp date: 29-APR-2020), dose 1, 1 DF, intramuscularly for prophylaxis. On 19-FEB-2018, the patient was vaccinated with second dose of GARDASIL 9, (lot # N021571, Exp date: 29-APR-2020), 1 dosage form (DF), intramuscularly for prophylaxis (Drug administration interval too long). It was reported that the second dose was received three days too early. No adverse effects were reported. No additional information was provided. No product quality compliant (PQC) was present.
Sex: F
Vaccine: HPV4
Symptoms: Drug ineffective, Papilloma viral infection
Clinical narrative: This spontaneous report as received from a physician refers to a 21 year old female patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in February 2017 (reported as a year ago') the patient was vaccinated with GARDASIL (dose, frequency, lot # and expiry date were not reported) via intramuscular route for human papilloma virus (HPV) vaccination. On an unknown date the patient developed HPV after receiving GARDASIL. The patient received an unspecified treatment for HPV by an unspecified physician. No product quality complaint was involved. The outcome of papilloma viral infection and drug ineffective was reported as recovered. The relationship between events and GARDASIL was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 24 years old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 05-FEB-2018 and 12-FEB-2018, the patient was vaccinated with first and second dose of GARDASIL 9 (dose was not reported) (Lot # N013698, Expiry date :19-DEC-2019) for prophylaxis (inappropriate schedule of drug administration). There was no adverse effect reported. There was no product quality complaint reported.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Oka/Merck VARIVAX (lot # N017700, expiry date: 09-JUN-2019) intramuscularly instead of subcutaneously for prophylaxis (incorrect route of drug administration). No adverse effects reported. Other suspect therapies included sterile diluent. No product quality complaint was involved.
Age: 44.0
Sex: M
Vaccine: HEP
Symptoms: Feeling abnormal, Injection site pain, Malaise, Musculoskeletal pain, Myalgia
Clinical narrative: Plasma donor contacted the plasmapheresis center via telephone and spoke with the Center Medical Specialist at 15:00 on 02/12/18 regarding a post immunization reaction to a Hepatitis B vaccination given on 02/07/18 (lot KK357). According to the donor, after he left the center, his right arm began to have significant pain at the injection site. The pain then spread to his right upper buttock and anterior thigh. The donor stated that he also felt general malaise, as his entire body felt "bad." He described his pain as being more than a muscle ache. The donor was contacted on 02/14/18, and he stated that he is doing better. He had generalized body ache, but no fever or any other symptoms.
Age: 44.0
Sex: M
Vaccine: HEP
Symptoms: Pain, Pain in extremity
Clinical narrative: Plasma donor contacted the plasmapheresis center via telephone and spoke with the Center Medical Specialist at 15:00 on 02/12/18 regarding a post immunization reaction to a Hepatitis B vaccination given on 02/07/18 (lot KK357). According to the donor, after he left the center, his right arm began to have significant pain at the injection site. The pain then spread to his right upper buttock and anterior thigh. The donor stated that he also felt general malaise, as his entire body felt "bad." He described his pain as being more than a muscle ache. The donor was contacted on 02/14/18, and he stated that he is doing better. He had generalized body ache, but no fever or any other symptoms.
Age: 6.0
Sex: F
Vaccine: PPV
Symptoms: Blood culture negative, Cellulitis, Culture urine negative, Hyperaesthesia, Injection site pain
Clinical narrative: Cellulitis symptoms began 2 days After vaccination. Site continued to grow with streaking from 2-5 days and was extremely sensitive and painful to even the slightest touch. Not able to move arm due to pain. Child began to feel sick with nausea and low grade fever.
Age: 6.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Injection site streaking, Malaise, Nausea, Pyrexia
Clinical narrative: Cellulitis symptoms began 2 days After vaccination. Site continued to grow with streaking from 2-5 days and was extremely sensitive and painful to even the slightest touch. Not able to move arm due to pain. Child began to feel sick with nausea and low grade fever.
Age: 6.0
Sex: F
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: Cellulitis symptoms began 2 days After vaccination. Site continued to grow with streaking from 2-5 days and was extremely sensitive and painful to even the slightest touch. Not able to move arm due to pain. Child began to feel sick with nausea and low grade fever.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Cheilitis, Guillain-Barre syndrome
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of Guillain Barre syndrome in a 63-year-old female patient who received SHINGRIX (batch number 79N59, expiry date 30th January 2020). Concurrent medical conditions included skin cancer. Concomitant products included Vitamin B12 injection. On 1st February 2018, the patient received SHINGRIX (intramuscular). In February 2018, less than a month after receiving SHINGRIX, the patient experienced Guillain Barre syndrome (serious criteria hospitalization, disability, GSK medically significant and other: as per reporter) and sores lip (serious criteria hospitalization, disability and other). On an unknown date, the outcome of the Guillain Barre syndrome and sores lip were unknown. The reporter considered the Guillain Barre syndrome and sores lip to be probably related to SHINGRIX. Additional details were reported as follows: The patient answered a question concerning her immune system as having skin cancer. The patient received SHINGRIX on left arm. Within 4 weeks of vaccination, the patient received B12 shot. The healthcare professional had no further details at time of reporting. The pharmacist stated he would let the pharmacist who had administered the vaccine to the patient, make the decision whether to provide his details. The reporter might call back with additional details.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a 64-year-old male patient who received SHINGRIX. On 2nd February 2018, the patient received the 1st dose of SHINGRIX. In February 2018, 1 hr after receiving SHINGRIX, the patient experienced pain in arm, fever and shivering. In February 2018, the outcome of the pain in arm and shivering were recovered/resolved. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the pain in arm, fever and shivering to be related to SHINGRIX. Additional details were reported as follows: The patient came into the pharmacy and got his first dose of SHINGRIX in left deltoid. The patient had symptoms which began an hour after the injection with heavy pain in his left arm radiated down his entire arm. The pain lasted approximately for 72 hours and then began to dissipate. The patient experienced fever (body temperature 101 degree C). The patient experienced shivering 4 hours after the vaccination and discontinued about 48 hours after the vaccination.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity, Pruritus, Rash erythematous
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a 50-year-old female patient who received SHINGRIX. On 6th February 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 6th February 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and pain in arm. On 13th February 2018, the patient experienced erythematous rash and pruritus. On an unknown date, the outcome of the injection site pain, pain in arm, erythematous rash and pruritus were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, pain in arm, erythematous rash and pruritus to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 50 or 51 year old. The patient experienced arm hurt and was sore at the injection site (unknown deltoid) and 7 days after receiving SHINGRIX, experienced red rash on her chest and arm and itching on her chest and arm. Limited information was provided by the sales representative from the registered pharmacist.   It was unknown if the reporter considered the injection site pain, pain in arm, erythematous rash and pruritus to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 50 or 51 year old. The patient experienced arm hurt and was sore at the injection site (unknown deltoid) and 7 days after receiving SHINGRIX, experienced red rash on her chest and arm and itching on her chest and arm. Limited information was provided by the sales representative from the registered pharmacist.
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of cold sores in a 50-year-old female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced cold sores. On an unknown date, the outcome of the cold sores was unknown. It was unknown if the reporter considered the cold sore to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient was a nurse. The patient was vaccinated at the health department.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Influenza like illness, Insomnia, Pyrexia, Tremor
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On an unknown date, the patient received SHINGRIX. On an unknown date, 5 hrs after receiving SHINGRIX, the patient experienced fever, difficulty sleeping, chills, tremor and influenza-like symptoms. On an unknown date, the outcome of the fever, chills and tremor were recovered/resolved and the outcome of the difficulty sleeping and influenza-like symptoms were unknown. The reporter considered the fever, difficulty sleeping, chills, tremor and influenza-like symptoms to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that the patient experienced flu-like symptoms beginning the night of SHINGRIX vaccination and resolving by the following morning. The patient chills and shaking. The call with health care professional was disconnected during report and the conversation was unable to resume.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On an unknown date, the patient received SHINGRIX. On an unknown date, 5 hrs after receiving SHINGRIX, the patient experienced fever, difficulty sleeping, chills, tremor and influenza-like symptoms. On an unknown date, the outcome of the fever, chills and tremor were recovered/resolved and the outcome of the difficulty sleeping and influenza-like symptoms were unknown. The reporter considered the fever, difficulty sleeping, chills, tremor and influenza-like symptoms to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that the patient experienced flu-like symptoms beginning the night of SHINGRIX vaccination and resolving by the following morning. The patient chills and shaking. The call with health care professional was disconnected during report and the conversation was unable to resume.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 78-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On 12th February 2018, the patient received SHINGRIX (subcutaneous) .5 ml. On 12th February 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. In February 2018, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema and intramuscular formulation administered by other route were unknown. The reporter considered the injection site erythema to be related to SHINGRIX. Additional details were reported as follows: This case was reported by a Medical Assistant. The patient received SHINGRIX subcutaneously in the right arm, which led to incorrect route of vaccine administration. Later, less than a week after vaccination, the patient developed redness at the injection site. The healthcare professional did not give patient's initials. The healthcare professional (HCP) did not know how long after vaccine administration the reaction started or how long it lasted or if it was resolved.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hives in a 69-year-old female patient who received SHINGRIX. On 10th February 2018, the patient received SHINGRIX .5 ml. In February 2018, less than a week after receiving SHINGRIX, the patient experienced hives and rash. On an unknown date, the outcome of the hives and rash were not recovered/not resolved. The reporter considered the hives and rash to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient had not received other vaccines within the last 4 weeks before reporting and took no other medication. The patient was administered SHINGRIX in the right arm. She did not know the lot number of the vaccine. The patient stated she normally wears long sleeves so she was not aware of the hives. The night before reporting date, the patient wore a short sleeve shirt and her daughter told her about the rash on her arm. The patient said it did not bother her, there was no pain or itching. The patient took pictures of it if it could be reported. The patient did not provide the name of her physician as the physician did not prescribe the vaccine.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HEP, PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PEDIARIX combination vaccine with the Hep. B was administered plus a single dose of ENGERIX B Ped. dose, giving the client an extra dose of Hep. B and not administering the 1st HIB dose. Client had no adverse events or unusual signs and symptoms.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Crying, Irritability, Neck mass, Pyrexia, Rash generalised
Clinical narrative: On 02/17 evening a mild fever of 100 began and on 2/18/20108 the rash began and was all over body looking like measles by that night. 2/20 daycare provider noticed a small 1cmX1cm lump on the left side of her neck.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Rash morbilliform, Vaccination complication
Clinical narrative: On 02/17 evening a mild fever of 100 began and on 2/18/20108 the rash began and was all over body looking like measles by that night. 2/20 daycare provider noticed a small 1cmX1cm lump on the left side of her neck.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Limb discomfort
Clinical narrative: Staff member received flu vaccination on 1/29/18, reported on 2/20/18 that she went to workmen's comp clinic with complaint of arm discomfort that she believes is related to flu vaccine.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abnormal behaviour, Decreased appetite, Developmental regression, Irritability, Motor dysfunction
Clinical narrative: Mother and Father report Regress in development, loss of grasp reflex for seven days. (this has not resolved) Not interactive, poor sleep, increased irritability,  decreased appetite. All of this for 7 days. Then she was back to her normal self.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Poor quality sleep
Clinical narrative: Mother and Father report Regress in development, loss of grasp reflex for seven days. (this has not resolved) Not interactive, poor sleep, increased irritability,  decreased appetite. All of this for 7 days. Then she was back to her normal self.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site warmth, Miliaria, Pain in extremity
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of rash in a female patient who received SHINGRIX. The patient's past medical history included heat rash (The patient had a heat rash or virus rash before). In January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, immediately after receiving SHINGRIX, the patient experienced rash, pain in arm, injection site erythema and injection site warmth. On an unknown date, the outcome of the rash, pain in arm, injection site erythema and injection site warmth were recovered/resolved. It was unknown if the reporter considered the rash, pain in arm, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a hospital buyer. The age at vaccination was not reported. The patient received SHINGRIX into deltoid muscle, approximately 4 weeks before the date of reporting. The patient had a rash developed on her stomach shortly after receiving SHINGRIX. The patient said that, rash was similar to a heat rash or virus rash she has had before. The rash had resolved without any medical attention. The patient said she thought it was related to the vaccine. On an unknown date, less than a month after receiving SHINGRIX, the patient had very sore arm for a few days and redness at the injection site that was warm to the touch. The patient had no fever.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Viral rash
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of rash in a female patient who received SHINGRIX. The patient's past medical history included heat rash (The patient had a heat rash or virus rash before). In January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, immediately after receiving SHINGRIX, the patient experienced rash, pain in arm, injection site erythema and injection site warmth. On an unknown date, the outcome of the rash, pain in arm, injection site erythema and injection site warmth were recovered/resolved. It was unknown if the reporter considered the rash, pain in arm, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a hospital buyer. The age at vaccination was not reported. The patient received SHINGRIX into deltoid muscle, approximately 4 weeks before the date of reporting. The patient had a rash developed on her stomach shortly after receiving SHINGRIX. The patient said that, rash was similar to a heat rash or virus rash she has had before. The rash had resolved without any medical attention. The patient said she thought it was related to the vaccine. On an unknown date, less than a month after receiving SHINGRIX, the patient had very sore arm for a few days and redness at the injection site that was warm to the touch. The patient had no fever.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Had PNEUMOVAX L arm 1/25. Now with swelling and pain above and below elbow. Has had prior PNEUMOVAX w/o SE. No SOB. Painful, not itchy. Plan: Doxy, prednisone, ZANTAC, BENADRYL. Rest, sling, elevate. Myalgia and Swelling around injection site. Diphenhydramine 25 mg once, methylprednisone 125 mg once, famotidine 20 mg once.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Oral herpes
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). Concomitant products included pantoprazole, CELEXA and PREMPRO. On 2nd February 2018 15:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 2nd February, less than a day after receiving SHINGRIX, the patient experienced injection site pain and injected limb mobility decreased. On 3rd February 2018, the patient experienced cold sores. In February 2018, the outcome of the injection site pain and injected limb mobility decreased were recovered/resolved. On an unknown date, the outcome of the cold sores was recovering/resolving. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to SHINGRIX. The reporter considered the cold sores to be possibly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left deltoid. The pharmacist reported that a patient experienced extreme the arm where she received the SHINGRIX vaccine starting the day of the dose. The severe pain lasted 2 days and during that time it was enough to make her cry and she could not lift her arm. The pain had resolved. The patient also developed a cold sore the day after the vaccine. The patient had no history of cold sores and over the counter treatment did not improve it. The patient had to visit the physician to get a prescription for VALTREX and it was now resolving.
Sex: F
Vaccine: VARZOS
Symptoms: Frustration tolerance decreased, Herpes zoster, Rash, Skin ulcer
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of shingles in a female patient who received Shingles vaccine. In January 2018, the patient received shingles vaccine. In January 2018, less than a month after receiving Shingles vaccine, the patient experienced skin ulcer. On 4th February 2018, the patient experienced shingles, frustration and rash. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles, frustration, skin ulcer and rash were unknown. It was unknown if the reporter considered the shingles, frustration, skin ulcer and rash to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient did not recall the vaccine name. The patient clarified that she received shingles shot three weeks ago from the date of reporting, and started experiencing shingles rash. Less than a month after receiving Shingles vaccine, the patient was absolutely broken out in shingles and her whole face was a one huge rash from one side and it was actually starting to travel over my nose to the other side of her face. It was in her eye. Less than a month after receiving Shingles vaccine, the patient was really frustrated. The patient reported that she did not have shingles and she thought because she was getting older, and she would have a shingles shot. Less than a month after receiving Shingles vaccine, this was became absolutely horrific and horrible. The patient went to the doctors and they had given her a medication but the medication was not working so it was continuously spreading. The patient was prescribed with acyclovir tablets as a treatment medication. Less than a month after receiving Shingles vaccine, the patient was broken out in sores like 6 days ago from the date of reporting. The patient asked, it would be great if somebody could called her back and might gave her something else or advise her something else to do. The patient denied the permission for follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Hyperglycaemia, Mass, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2019). The patient's past medical history included diabetes. On 6th February 2018, the patient received SHINGRIX (intramuscular). On 6th February 2018, 20 min after receiving SHINGRIX, the patient experienced pain in arm, mass, hyperglycemia, sleepiness and tiredness. On 7th February 2018, the patient experienced throat swelling and foggy feeling in head. On an unknown date, the outcome of the pain in arm, mass, hyperglycemia, sleepiness, throat swelling, foggy feeling in head and tiredness were unchanged. The reporter considered the pain in arm, mass, hyperglycemia, sleepiness, throat swelling, foggy feeling in head and tiredness to be almost certainly related to SHINGRIX. Additional details were provided as follows: The reporter reported herself that she experienced arm pain described as fiery and with a lump on it. The patient reported that her throat felt swollen up. On 6th February 2018, less than a day, the patient experienced mass, hyperglycemia, sleepiness and tiredness. On 7th February 2018, 1 day after vaccination, the patient experienced throat swelling and foggy feeling in head. The patient reported brain fog, described as not being with it. The patient reported that she was sleeping too long and tired. The patient reported that she felt hyperglycemic, but did not test her glucose levels.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pharyngeal oedema, Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2019). The patient's past medical history included diabetes. On 6th February 2018, the patient received SHINGRIX (intramuscular). On 6th February 2018, 20 min after receiving SHINGRIX, the patient experienced pain in arm, mass, hyperglycemia, sleepiness and tiredness. On 7th February 2018, the patient experienced throat swelling and foggy feeling in head. On an unknown date, the outcome of the pain in arm, mass, hyperglycemia, sleepiness, throat swelling, foggy feeling in head and tiredness were unchanged. The reporter considered the pain in arm, mass, hyperglycemia, sleepiness, throat swelling, foggy feeling in head and tiredness to be almost certainly related to SHINGRIX. Additional details were provided as follows: The reporter reported herself that she experienced arm pain described as fiery and with a lump on it. The patient reported that her throat felt swollen up. On 6th February 2018, less than a day, the patient experienced mass, hyperglycemia, sleepiness and tiredness. On 7th February 2018, 1 day after vaccination, the patient experienced throat swelling and foggy feeling in head. The patient reported brain fog, described as not being with it. The patient reported that she was sleeping too long and tired. The patient reported that she felt hyperglycemic, but did not test her glucose levels.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: Information has been received from a medical assistant concerning a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history or concomitant medications. On 12-FEB-2018, the patient was inadvertently vaccinated with an expired dose of PROQUAD lot # M035689 and expiration date of 06-FEB-2018, (route of administration and anatomical location were not reported) for prophylaxis. Vaccine was reconstituted with sterile diluent(MERCK STERILE DILUENT) lot # L034400 and expiration date of 17-APR-2018.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Balance disorder, Gait inability, Impaired driving ability, Nausea, Neuritis
Clinical narrative: Initial unsolicited report received from a physician (patient's husband) on 06-Feb-2018. This case involves a 66-year-old female patient, who was vaccinated with 0.5 ml dose of FLUZONE HIGH-DOSE once (batch number, expiration date and dose in series were not reported) via intramuscular route in the left arm on 25-Oct-2017. Medical history and concomitant medications were not reported. On 4-Nov-2017, 10 days following the vaccination, the patient awoke suddenly at 1.00 am with nausea, vomiting, the room spinning, unable to walk due to a loss of equilibrium. The patient wasn't hospitalized due to having her husband at home to care for her. The patient was diagnosed by an ENT with Vestibular Neuritis on her left side, she had 70% loss following her 8th cranial nerve. She was currently undergoing vestibular therapy. While she was showing some improvement, she was still unable to drive at this time. Laboratory investigations and other corrective treatment was not reported. The outcome of the event was recovering at the time of reporting. List of documents held by sender: none
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vomiting
Clinical narrative: Initial unsolicited report received from a physician (patient's husband) on 06-Feb-2018. This case involves a 66-year-old female patient, who was vaccinated with 0.5 ml dose of FLUZONE HIGH-DOSE once (batch number, expiration date and dose in series were not reported) via intramuscular route in the left arm on 25-Oct-2017. Medical history and concomitant medications were not reported. On 4-Nov-2017, 10 days following the vaccination, the patient awoke suddenly at 1.00 am with nausea, vomiting, the room spinning, unable to walk due to a loss of equilibrium. The patient wasn't hospitalized due to having her husband at home to care for her. The patient was diagnosed by an ENT with Vestibular Neuritis on her left side, she had 70% loss following her 8th cranial nerve. She was currently undergoing vestibular therapy. While she was showing some improvement, she was still unable to drive at this time. Laboratory investigations and other corrective treatment was not reported. The outcome of the event was recovering at the time of reporting. List of documents held by sender: none
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Auditory nerve disorder, Vestibular function test, Vestibular neuronitis
Clinical narrative: Initial unsolicited report received from a physician (patient's husband) on 06-Feb-2018. This case involves a 66-year-old female patient, who was vaccinated with 0.5 ml dose of FLUZONE HIGH-DOSE once (batch number, expiration date and dose in series were not reported) via intramuscular route in the left arm on 25-Oct-2017. Medical history and concomitant medications were not reported. On 4-Nov-2017, 10 days following the vaccination, the patient awoke suddenly at 1.00 am with nausea, vomiting, the room spinning, unable to walk due to a loss of equilibrium. The patient wasn't hospitalized due to having her husband at home to care for her. The patient was diagnosed by an ENT with Vestibular Neuritis on her left side, she had 70% loss following her 8th cranial nerve. She was currently undergoing vestibular therapy. While she was showing some improvement, she was still unable to drive at this time. Laboratory investigations and other corrective treatment was not reported. The outcome of the event was recovering at the time of reporting. List of documents held by sender: none
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: I received a pneumococcal shot in AM of 1/24/2018. My arm swelled up, was very red and warm all the way from my upper arm where shot was given to my wrist. I waited a day and the swelling and redness did not go away. I went to urgent care and the Dr. there said "Oh my". She prescribed an antibiotic. She didn't seem to know what it was, an infection or something else.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: I received a pneumococcal shot in AM of 1/24/2018. My arm swelled up, was very red and warm all the way from my upper arm where shot was given to my wrist. I waited a day and the swelling and redness did not go away. I went to urgent care and the Dr. there said "Oh my". She prescribed an antibiotic. She didn't seem to know what it was, an infection or something else.