chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: DTAP
Symptoms: Cough, Nasal pruritus, Rhinorrhoea, Sneezing
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nasal itching in a 5-year-old female patient who received INFANRIX for prophylaxis. Concurrent medical conditions included milk protein allergy (severe). Concomitant products included EPIPEN. On an unknown date, the patient received INFANRIX (intramuscular). On an unknown date, unknown after receiving INFANRIX, the patient experienced nasal itching, runny nose, sneezing and cough. On an unknown date, the outcome of the nasal itching, runny nose, sneezing and cough were recovered/resolved. It was unknown if the reporter considered the nasal itching, runny nose, sneezing and cough to be related to INFANRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had already received 3 doses of INFANRIX since infancy. The patient was due for a booster dose of the INFANRIX at the time of reporting. The patient experienced side effects following the vaccine previously which included itchy and runny nose, sneezing and coughing. The reporter inquired if these side effects occurred each time the patient received this vaccine booster or that she might have had more severe reactions.
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site reaction, Neuralgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a female patient who received FLUARIX QUADRIVALENT 2017-2018 season for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2017-2018 season (intramuscular). On an unknown date, unknown after receiving FLUARIX QUADRIVALENT 2017-2018 season, the patient experienced nerve pain and injection site pain. On an unknown date, the outcome of the nerve pain and injection site pain were unknown. It was unknown if the reporter considered the nerve pain and injection site pain to be related to FLUARIX QUADRIVALENT 2017-2018 season. Additional details were provided as follows: The age at vaccination was not reported. The reporter was husband of patient during call it was mentioned that, the patient had a flu shot years ago and experienced nerve pain in the shoulder where it was given. The reporter was unable to verify name or formulation of the flu shot. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of weakness in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 3rd January 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced weakness, nausea, vomiting, fever and muscle pain. The patient was treated with TYLENOL. On an unknown date, the outcome of the weakness, nausea, vomiting, fever and muscle pain were unknown. It was unknown if the reporter considered the weakness, nausea, vomiting, fever and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 64 or 65 years. The patient received the 1st dose of SHINGRIX vaccine. The patient experienced weakness, nausea, vomiting, fever and muscle pain. She had been taken TYLNEOL every 4 hours and the fever was still persistent.  She had been bed bound all day. No further details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The pharmacist stated that several patients refuse to get the second dose of the SHINGRIX series. The pharmacist did not mention any specific patients.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Gait disturbance, Headache, Myalgia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of myalgia in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 3rd January 2019, the patient received the 1st dose of SHINGRIX. On 3rd January 2019, less than a day after receiving SHINGRIX, the patient experienced myalgia, arthralgia, nausea, vomiting, fever, headache, weakness generalized and walking difficulty. The patient was treated with TYLENOL. On an unknown date, the outcome of the myalgia, arthralgia, nausea, vomiting, fever, headache, weakness generalized and walking difficulty were not recovered/not resolved. It was unknown if the reporter considered the myalgia, arthralgia, nausea, vomiting, fever, headache, weakness generalized and walking difficulty to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient's friend. The health care professional (HCP) was unsure of site or route of administration of SHINGRIX. The HCP was unaware of lot and expiration date for SHINGRIX. The physician reported that, the patient experienced grade 3 myalgia and arthralgia (had difficulty getting out of bed and walking around), general weakness, nausea, vomiting, fever and headache following the 1st dose of SHINGRIX on the day before reporting. The patient received multiple doses of TYLENOL but had not touched the fever. The symptoms developed last night, within 6 hours of receiving SHINGRIX, and have not gotten better. The reporter gave consent to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of myalgia in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 3rd January 2019, the patient received the 1st dose of SHINGRIX. On 3rd January 2019, less than a day after receiving SHINGRIX, the patient experienced myalgia, arthralgia, nausea, vomiting, fever, headache, weakness generalized and walking difficulty. The patient was treated with TYLENOL. On an unknown date, the outcome of the myalgia, arthralgia, nausea, vomiting, fever, headache, weakness generalized and walking difficulty were not recovered/not resolved. It was unknown if the reporter considered the myalgia, arthralgia, nausea, vomiting, fever, headache, weakness generalized and walking difficulty to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient's friend. The health care professional (HCP) was unsure of site or route of administration of SHINGRIX. The HCP was unaware of lot and expiration date for SHINGRIX. The physician reported that, the patient experienced grade 3 myalgia and arthralgia (had difficulty getting out of bed and walking around), general weakness, nausea, vomiting, fever and headache following the 1st dose of SHINGRIX on the day before reporting. The patient received multiple doses of TYLENOL but had not touched the fever. The symptoms developed last night, within 6 hours of receiving SHINGRIX, and have not gotten better. The reporter gave consent to follow up.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season) (batch number NJ37L, expiry date 30th June 2019) for prophylaxis. On 4th October 2018, the patient received the 1st dose of FLUARIX QUADRIVALENT 2018-2019 season (intramuscular). On 4th October 2018, less than a day after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to FLUARIX QUADRIVALNET 2018-2019 season. Additional details were provided as follows: The patient received FLUARIX QUADRIVALENT 2018-2019 season on left arm. The pharmacist reported that the patient was seen by her physician.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: Patient describes local soreness to left arm. Swelling and redness in a 3 inch by 2 inch diameter around the sire. Achiness overall and limited ROM due to sore left arm. She deferred an office visit but was given signs and symptoms of anaphylactic reaction.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site reaction, Weight bearing difficulty
Clinical narrative: Did not want to bear weight on left lower extremity for 24 hrs. Still favoring left leg, but walking well after 24 hours.
Age: 1.0
Sex: M
Vaccine: FLU4, MMRV, PNC13
Symptoms: Pain, Pallor, Pruritus, Rash, Rash erythematous
Clinical narrative: Vaccine(s) administered 12-28-2018, started with rash approximately 01/08/2019 on stomach and face C/O itch/pain -> red speckled rash generalized to entire body - blanches with pressure, no pustules/papules, no excoriation.
Age: 1.0
Sex: M
Vaccine: FLU4, MMRV, PNC13
Symptoms: Rash generalised
Clinical narrative: Vaccine(s) administered 12-28-2018, started with rash approximately 01/08/2019 on stomach and face C/O itch/pain -> red speckled rash generalized to entire body - blanches with pressure, no pustules/papules, no excoriation.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia
Clinical narrative: Muscle Ache, chills.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered
Clinical narrative: Patient came in for PREVNAR 13. Patient didn't realize they already received PREVNAR 13 at MD's office in January.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Dyspnoea, Impaired work ability, Injected limb mobility decreased, Joint range of motion decreased
Clinical narrative: Severe polyarthritis with decreased ROM in left shoulder the site of the vaccine. SOB. Breathing improved after several weeks. Joint pain continues with decreased ROM persistent. Problem so limiting that I resigned from my part time job.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Polyarthritis
Clinical narrative: Severe polyarthritis with decreased ROM in left shoulder the site of the vaccine. SOB. Breathing improved after several weeks. Joint pain continues with decreased ROM persistent. Problem so limiting that I resigned from my part time job.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Gait disturbance, Headache, Lethargy
Clinical narrative: Information has been received from a 69 year old female patient referring to herself. The patient's concurrent condition included asthmatic bronchitis about 2 or 3 years ago. The patient's concomitant medication included fluticasone, rosuvastatin, loratadine and VENTOLIN. The patient had no drug reactions/allergies. On 15-DEC-2018, the patient was vaccinated with PNEUMOVAX 23 (.5ml once, route was reported as injection (unspecified); strength, lot# and expiration date were not reported) for prophylaxis. On the same day, 5 to 6 hours after receiving the vaccination the patient experienced pain, swelling and redness in the arm she received the vaccination in. The patent also stated that she later "came down with extreme chills and uncontrollable shakes and had trouble moving, walking and speaking (significant disability or incapacity was reported on 17-DEC-2018)." The following morning (16-DEC-2018) the patient woke up with a fever, a headache and lethargy. The following Monday the patient spoke with a pharmacist and was told that the PNEUMOVAX 23 probably gave the patient a mild case of pneumonia. The patient also stated that she had seen another patient indicate on social media that the other patient experienced the same AE after getting PNEUMOVAX 23 but it lasted for about a week. The patient did not want to provide any additional AE information for this other patient (captured in MARRS# 1901USA002740). The patient spoke with a pharmacist to seek medical attention. No treatment was given. No lab test was performed. The patient also stated that she at the reporting time took 5mg of generic ezetimibe (manufacturer unknown) daily because she "can't handle" a 10mg dose. The patient also stated that she was "sensitive" to many unspecified medications and often need to take a smaller dose of these other unspecified medications than "other people." The patient did not specify which medications she was sensitive to or what she meant by "sensitive". Action taken with of ezetimibe (manufacturer unknown) was unknown. The outcome of the events was reported as recovered. The causality between the events and PNEUMOVAX 23 and ezetimibe (manufacturer unknown) was not reported. Upon internal review, pneumonia was determined to be medically significant. This is one of two reports which have the same reporter. Sender's Comments: US-009507513-1901USA002740.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling, Pneumonia, Pyrexia
Clinical narrative: Information has been received from a 69 year old female patient referring to herself. The patient's concurrent condition included asthmatic bronchitis about 2 or 3 years ago. The patient's concomitant medication included fluticasone, rosuvastatin, loratadine and VENTOLIN. The patient had no drug reactions/allergies. On 15-DEC-2018, the patient was vaccinated with PNEUMOVAX 23 (.5ml once, route was reported as injection (unspecified); strength, lot# and expiration date were not reported) for prophylaxis. On the same day, 5 to 6 hours after receiving the vaccination the patient experienced pain, swelling and redness in the arm she received the vaccination in. The patent also stated that she later "came down with extreme chills and uncontrollable shakes and had trouble moving, walking and speaking (significant disability or incapacity was reported on 17-DEC-2018)." The following morning (16-DEC-2018) the patient woke up with a fever, a headache and lethargy. The following Monday the patient spoke with a pharmacist and was told that the PNEUMOVAX 23 probably gave the patient a mild case of pneumonia. The patient also stated that she had seen another patient indicate on social media that the other patient experienced the same AE after getting PNEUMOVAX 23 but it lasted for about a week. The patient did not want to provide any additional AE information for this other patient (captured in MARRS# 1901USA002740). The patient spoke with a pharmacist to seek medical attention. No treatment was given. No lab test was performed. The patient also stated that she at the reporting time took 5mg of generic ezetimibe (manufacturer unknown) daily because she "can't handle" a 10mg dose. The patient also stated that she was "sensitive" to many unspecified medications and often need to take a smaller dose of these other unspecified medications than "other people." The patient did not specify which medications she was sensitive to or what she meant by "sensitive". Action taken with of ezetimibe (manufacturer unknown) was unknown. The outcome of the events was reported as recovered. The causality between the events and PNEUMOVAX 23 and ezetimibe (manufacturer unknown) was not reported. Upon internal review, pneumonia was determined to be medically significant. This is one of two reports which have the same reporter. Sender's Comments: US-009507513-1901USA002740.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Speech disorder, Tremor
Clinical narrative: Information has been received from a 69 year old female patient referring to herself. The patient's concurrent condition included asthmatic bronchitis about 2 or 3 years ago. The patient's concomitant medication included fluticasone, rosuvastatin, loratadine and VENTOLIN. The patient had no drug reactions/allergies. On 15-DEC-2018, the patient was vaccinated with PNEUMOVAX 23 (.5ml once, route was reported as injection (unspecified); strength, lot# and expiration date were not reported) for prophylaxis. On the same day, 5 to 6 hours after receiving the vaccination the patient experienced pain, swelling and redness in the arm she received the vaccination in. The patent also stated that she later "came down with extreme chills and uncontrollable shakes and had trouble moving, walking and speaking (significant disability or incapacity was reported on 17-DEC-2018)." The following morning (16-DEC-2018) the patient woke up with a fever, a headache and lethargy. The following Monday the patient spoke with a pharmacist and was told that the PNEUMOVAX 23 probably gave the patient a mild case of pneumonia. The patient also stated that she had seen another patient indicate on social media that the other patient experienced the same AE after getting PNEUMOVAX 23 but it lasted for about a week. The patient did not want to provide any additional AE information for this other patient (captured in MARRS# 1901USA002740). The patient spoke with a pharmacist to seek medical attention. No treatment was given. No lab test was performed. The patient also stated that she at the reporting time took 5mg of generic ezetimibe (manufacturer unknown) daily because she "can't handle" a 10mg dose. The patient also stated that she was "sensitive" to many unspecified medications and often need to take a smaller dose of these other unspecified medications than "other people." The patient did not specify which medications she was sensitive to or what she meant by "sensitive". Action taken with of ezetimibe (manufacturer unknown) was unknown. The outcome of the events was reported as recovered. The causality between the events and PNEUMOVAX 23 and ezetimibe (manufacturer unknown) was not reported. Upon internal review, pneumonia was determined to be medically significant. This is one of two reports which have the same reporter. Sender's Comments: US-009507513-1901USA002740.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In March 2017, a healthcare provider administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. In March 2017, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 13-APR-2009, the patient's healthcare provider at a clinic administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). In August 2017, the patient was treated by her healthcare provider at the same clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Initial information received on 03-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 years old female patient who received 0.25 mL dose of vaccine FLUZONE QUADRIVALENT lot UT6259LA, expiry date 30 June 2019 via unknown route in unknown administration site on 18-Dec-2018. The patient's past vaccination(s) included FLUZONE QUADRIVALENT with 0.5ml, Intramuscularly in left thigh left thigh. No other medications or vaccinations were given either time. It was a case of actual medication error due to vaccine underdose. It was reported that the patient was given the correct dose (.5ml, IM, left thigh). One month later the patient was given incorrect dose of .25 ml. Patient received the correct dose the first time and the incorrect dose the second time. It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Initial information received on 04-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves female patient's arm where the shot was given is still in tremendous pain, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. The patient developed a non-serious arm where the shot was given is still in tremendous pain (vaccination site pain) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. (Other relevant tests included No lab test.) Final diagnosis was arm where the shot was given is still in tremendous pain. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for arm where the shot was given is still in tremendous pain.
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 03-Jan-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves 30 patients (details not reported) who received a dose of FLUBLOK QIV, prefilled syringe (lot number: QFAA1833, expiry date: 30-Jun-2019) (dose in series and site of administration was not reported) via intramuscular route in unknown administration site between 11-Dec-2018 to 25-Dec-2018. The patients past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. No other vaccine was given during that period. It was a case of actual medication error due to product storage error. It was reported that after injecting 30 different patients with FLUBLOK, they then received a letter stating that the FLUBLOK was too long in transit (from 06Dec2018-10Dec2018). The caller states that when they received the FLUBLOK it was cool to touch and 45 degrees according to the thermometer in the box. She adds that the FLUBLOK was immediately placed in the refrigerator upon receipt. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: DTAP, HPV4, MNQ
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 04-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (office staff). This case involves a 11 years old male patient who received a standard dose 0.5 ml vaccine DAPTACEL (lot number: C5190AA, expiry date: 24-apr-2019) via unknown route in the left arm  instead of ADACEL on an unknown date. The Health Care Professional picked up the wrong vial & there were no other factors. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MENACTRA for Immunisation; and GARDASIL for Immunisation. It was a case of actual medication error due to wrong vaccine administered. It was unknown if any adverse event occurred or not following the vaccination. Corrective action: They will correct the medical record to show DAPTACEL was given and per standard the dose should be counted as the adolescent Tdap (ADACEL) booster. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Oedema, Pain
Clinical narrative: Received Tdap 01-07-19 on 01-09-19 noted redness, itching, swelling below injection site. Using Ibuprofen as needed for pain/edema. ZYRTEC as well. Advised to also add famotidine as needed. Apply ice. Notify office if any worsening SSX.
Sex: U
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 04-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 month and 11 days old patient who received vaccine FLUZONE QUADRIVALENT lot number not reported via unknown route in unknown administration site at the end of December. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to Inappropriate age at vaccine administration. The nurse practitioner is not sure if it was the FLUZONE QUADRIVALENT but she states that she knows it was a sanofi-pasteur vaccine and she is outside of her facility today. She states that it was given to a 4 month and 11 day child at the end of December. She states that they have gotten no calls from Mom with any issues or concerns. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Peripheral swelling, Skin warm
Clinical narrative: Red, swelling from shoulder to elbow, pain and hot.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Developed a round pink area about 2.5in below injection site and another smaller one below that.
Age: 25.0
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Autoantibody positive, Fatigue, Fibromyalgia
Clinical narrative: Joint pain (never experienced in my life) began a week or so after the vaccination. After a few months, severe fatigue and tropomyosin autoantibodies detected. No prior history of autoimmunity until I received this vaccination. Fibromyalgia finally diagnosed January 2017. I can pinpoint the vaccination as the event that set all of this in motion.
Age: 26.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: Patient felt lightheaded after both vaccines. Responded well to supine positioning in reclining chair. Eating crackers and peanut butter because patient has not had breakfast. Bp 120/70 and HR=70. Patient complains of feeling "foggy". Dr. called to evaluate patient. Complains of "prickly face feeling". Ordered Cetirizine HCL tablet 10 mgm, p.o. VS stable. Discharged at 1047.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Autoantibody positive, Irritable bowel syndrome
Clinical narrative: About 1 week following the HPV vaccination I began having sudden and ongoing IBS. I had never experienced this in my life. It lasted for about 1 year, and returned when I received the DTaP vaccination and soon after developed tropomyosin autoantibodies. I don't think I would have developed autoimmunity if I had not received these vaccinations.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Drug ineffective, Herpes zoster
Clinical narrative: None- except I got Shingles 4 months later.
Age: 0.42
Sex: M
Vaccine: DTAP
Symptoms: Seizure, White blood cell count increased
Clinical narrative: Multiple seizures 24 hours later.
Age: 71.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Dyspnoea, Eye movement disorder, Feeling abnormal, Loss of consciousness, Nausea
Clinical narrative: As patient was receiving second vaccine (PREVNAR) he said, "I can feel it coming on". The wife then stated that he has had similar reactions in the past. Patient lost conscientiousness for approximately 15 seconds after receiving the PREVNAR. His breathing was labored and his eyes rolled into the back of his head. His wife and the pharmacy intern laid him on  the ground and he regained consciousness and began to breathe more regularly. He  started throwing up approximately 2 minutes later. He remained on the ground with his head down until EMS arrived. EMS said that he was stable and just nauseous in the ambulance. I overheard the wife tell the EMS that he gets "vasovagal" during surgeries and vaccines and that this incident was worse than normal. The patient did answer "no" to the "Has the person ever had a reaction, fainted, or felt dizzy after receiving a vaccine.
Age: 71.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Vomiting
Clinical narrative: As patient was receiving second vaccine (PREVNAR) he said, "I can feel it coming on". The wife then stated that he has had similar reactions in the past. Patient lost conscientiousness for approximately 15 seconds after receiving the PREVNAR. His breathing was labored and his eyes rolled into the back of his head. His wife and the pharmacy intern laid him on  the ground and he regained consciousness and began to breathe more regularly. He  started throwing up approximately 2 minutes later. He remained on the ground with his head down until EMS arrived. EMS said that he was stable and just nauseous in the ambulance. I overheard the wife tell the EMS that he gets "vasovagal" during surgeries and vaccines and that this incident was worse than normal. The patient did answer "no" to the "Has the person ever had a reaction, fainted, or felt dizzy after receiving a vaccine.
Age: 4.0
Sex: F
Vaccine: FLUN4
Symptoms: Eye swelling, Rash, Swelling face
Clinical narrative: Approximately 24 hours after receiving the vaccine, patient developed a swollen rash on her face. No difficulty breathing, no swelling of the tongue or lips. Some swelling of the eyes. Parent gave Benadryl and hydrocortisone. Hydrocortisone helped and rash was gone by morning. The next evening, patient developed same exact reaction. Hydrocortisone applied and rash was gone by the next morning.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Impaired work ability, Influenza like illness
Clinical narrative: Patient had extreme flu like symptoms (fatigued, upset stomach) that night and for the next three days. Patient missed work.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: On 1-8-19 a bump started at injection site. Warmth and sore to touch. Lump raised slightly. Child fussy. No redness. No fever.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Headache, Skin warm, Swelling, Tenderness
Clinical narrative: Redness and swelling below injection site, warm to touch and mildly tender, headache. Started day after. Mild do not think this major reaction, likely more normal reaction but more severe.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Crying, Injection site rash, Injection site swelling, Lethargy, Listless
Clinical narrative: High Fever 104°F. High Pitched Crying. Lethargic. Listless. Rash. Swelling at injection site.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: High Fever 104°F. High Pitched Crying. Lethargic. Listless. Rash. Swelling at injection site.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient has had constant pain, ache in arm since injection, no swelling, no bruising, no itching.
Age: 26.0
Sex: F
Vaccine: FLUN3
Symptoms: Rash generalised
Clinical narrative: A spontaneous report has been received from a health professional. The report concerns a female patient (age 26 years, height 63 in, weight 120 lb). No medical history was reported. No concomitant products were reported. The patient received FLUMIST via nasal route, for flu prevention on an unknown date. During 2017, the patient experienced full body rash. Treatment with FLUMIST was not changed. The patient recovered from the event(s) on an unspecified date. The event was considered non-serious.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Acne, Acne cystic, Basedow's disease, Condition aggravated, Hypersomnia
Clinical narrative: Several weeks after vaccine patient sleeping a lot and losing weight. She had developed a severe case of acne with cyst. Took her to a skin doctor in late December for treatment. Treatment was unsuccessful. Acne devloped and persisted, some acne like cysts, and pox marks that resembled chicken pox. Ran blood work and discoved abnormal levels of varicella zoster virus, and high FT3 which lead to a diagnosis of hyperthyroidism aka Graves disease.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Hyperthyroidism, Rash pustular, Rash vesicular, Tri-iodothyronine free increased, Varicella virus test positive
Clinical narrative: Several weeks after vaccine patient sleeping a lot and losing weight. She had developed a severe case of acne with cyst. Took her to a skin doctor in late December for treatment. Treatment was unsuccessful. Acne devloped and persisted, some acne like cysts, and pox marks that resembled chicken pox. Ran blood work and discoved abnormal levels of varicella zoster virus, and high FT3 which lead to a diagnosis of hyperthyroidism aka Graves disease.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Weight decreased
Clinical narrative: Several weeks after vaccine patient sleeping a lot and losing weight. She had developed a severe case of acne with cyst. Took her to a skin doctor in late December for treatment. Treatment was unsuccessful. Acne devloped and persisted, some acne like cysts, and pox marks that resembled chicken pox. Ran blood work and discoved abnormal levels of varicella zoster virus, and high FT3 which lead to a diagnosis of hyperthyroidism aka Graves disease.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Breath holding, Laboratory test abnormal, Myoclonic epilepsy, Pyrexia, Staring
Clinical narrative: Breath holding spells fever staring.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Loss of personal independence in daily activities, Somnolence
Clinical narrative: Severe headache began about 8 hours after injection. Severe headache continued into the next day--I had to cancel planned activities and spent most of the day sleeping. Severe headache duration was 24 hours.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient was given fifth Dtap dose a month too early, no adverse reaction, no action necessary.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous, Rash generalised
Clinical narrative: Intense itching began in palms of both hands and both feet, red rash broke out over entire body. Got  Allergy Tablets containing Diphenhydramine HCI 25 mg. Took three tablets and itching stopped 30 minutes later.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Pallor, Posture abnormal, Vomiting
Clinical narrative: After administration of vaccine, Patient was alert and talking, color was WNL. When Pt got to car mom stated pt. slumped over and then continued to vomit. Mother came back into clinic, pt. was pale with no signs of distress. Pt was placed in clinic room to monitor breathing and Respirations. all were WNL. Pt. was able to sip on Juice box with no other episodes of emesis. Pt monitored for 20 Mins. Patient left clinic stating she was feeling back to normal.
Age: 0.33
Sex: M
Vaccine: PNC13
Symptoms: Crying, Erythema, Excessive eye blinking, Screaming
Clinical narrative: Inconsolable crying, wincing, screaming for 7 days. Refused to nurse or take bottle until exhausted. Red skin over torso, arms, face, legs.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema, Rash, Skin warm, Sleep study
Clinical narrative: 1-9-19 @ 11:45 AM PATIENT PRESENTED WITH RASH ON TRUNK, NECK, AND FACE THAT HAD EDEMA AND HEAT. SHE SAID IT BEGAN THE NIGHT BEFORE AT HER SLEEP STUDY WHEN ELECTRODES WERE BEING PLACED. PATIENT HAD TAKEN BENADRYL THAT MORNING. SHE WAS INSTRUCTED TO TAKE ANOTHER DOSE AND TO SEE THE DOCTOR IMMEDIATELY. PATIENT WAS SEEN BY PHYSICIAN AT 2PM THAT SAME DAY. THE RASH HAD SPREAD TO BUTTOCKS AND LEGS. SHE WAS GIVEN A DECADRON INJECTION AND STARTED ON ORAL STEROIDS. 1-11-19 AT 9AM PATIENT PRESENTED BACK TO PHARMACY AFTER HER INJECTION AND BEGINNING THE ORAL STEROID. RASH WAS STILL VISIBLE, BUT HAD DECREASED IN SEVERITY.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site pain, Loss of personal independence in daily activities, Mobility decreased, Pain
Clinical narrative: Patient received Tdap (BOOSTRIX) in OB clinic during 3rd trimester of pregnancy on 10/24/18. On 10/29/18 patient notified clinic that she was still experiencing pain at the injection site. The pain was rated as 5 out of 10 and was interfering with movement, sleep, and ADLs. Pain worsens on movement, but does not hurt when pressure is applied to the injection site. Patient feels that the injection was placed too high on the shoulder and that the pain is associated with the joint, not the muscle. The injection site is "2 fingers down from the bone". Patient reports no redness, swelling, or warmth to touch. Patient called again on 11/1/18 reporting that pain had not resolved, and in fact had worsened to 7/10. Patient was completely unable to move arm on 11/1/18. Patient self-treated symptomatically with ice and acetaminophen, but symptoms continued to worsen. Patient followed-up with a provider outside of our organization, so I do not have details of treatment or symptoms between 11/1 and 11/14, but by 11/14/18 symptoms had all resolved.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Sleep disorder
Clinical narrative: Patient received Tdap (BOOSTRIX) in OB clinic during 3rd trimester of pregnancy on 10/24/18. On 10/29/18 patient notified clinic that she was still experiencing pain at the injection site. The pain was rated as 5 out of 10 and was interfering with movement, sleep, and ADLs. Pain worsens on movement, but does not hurt when pressure is applied to the injection site. Patient feels that the injection was placed too high on the shoulder and that the pain is associated with the joint, not the muscle. The injection site is "2 fingers down from the bone". Patient reports no redness, swelling, or warmth to touch. Patient called again on 11/1/18 reporting that pain had not resolved, and in fact had worsened to 7/10. Patient was completely unable to move arm on 11/1/18. Patient self-treated symptomatically with ice and acetaminophen, but symptoms continued to worsen. Patient followed-up with a provider outside of our organization, so I do not have details of treatment or symptoms between 11/1 and 11/14, but by 11/14/18 symptoms had all resolved.
Age: 83.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test normal, Hypoaesthesia, Nuclear magnetic resonance imaging normal
Clinical narrative: NUMBNESS IN FINGERS, HANDS, FEET.
Age: 83.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Loss of personal independence in daily activities
Clinical narrative: NUMBNESS IN FINGERS, HANDS, FEET.
Age: 81.0
Sex: F
Vaccine: TD
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis on Right Arm, from shoulder to elbow. Treated with ATB.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Pt. was in for Establish care appointment. After ARNP was done with pt., came out of room and asked for me to administer an HPV vaccine to pt. I delegated someone else to administer the vaccine. Vaccine was administer. When I was asked to sign for immunization given I realized that the immunization print out from database was not available, I then asked staff to pull the immunization record and at that time I realized that pt. had already had 3 doses of the HPV vaccine. I then informed staff of what had happened and why this was a mistake. My supervisor was informed of the over immunization. I called and spoke with mother and pt. regarding the over immunization and they verbalized understanding and did not have any concerns regarding the over immunization. I then called the CDC and started a phone note in pt. chart regarding the call to pt. and mother along with call to CDC. Per staff with the CDC there is not likely to cause serious problems and there should not cause safety concern regarding the over immunization of the HPV vaccine. CDC staff is emailing me a copy of instructions and recommendations regarding over immunizing children.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Feeling hot, Palpitations
Clinical narrative: Patient complained of being warm, having palpitations, and having chest pains.
Age: 24.0
Sex: M
Vaccine: ANTH, MNQ, YF
Symptoms: Dizziness, Loss of consciousness, Pallor
Clinical narrative: Patient in usual state of health today. Yesterday he received Typhoid vaccine without issue. Today he received his first dose of Anthrax and Yellow Fever vaccines and second dose of Meningococcal (MCV4P). After receiving his vaccines he attempted to stand and became light headed. He was noted to become pale and then lost consciousness for less than 5 seconds. He regained consciousness immediately without loss of bowel/bladder control, convulsions, or confusion. He denies nasal, ocular, cutaneous, laryngeal, pulmonary and GI symptoms. He denies adverse reaction to prior vaccines. He denies prior episodes of fainting/loss of consciousness.
Age: 53.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Fatigue, Hyperhidrosis, Product administered at inappropriate site, Pyrexia
Clinical narrative: Sudden onset of fever and chills with uncontrollable shivers. Lasted approximately 36 hours until I felt some warmth. Fatigue accompanied fever and chills and slept most of that time. Next few days was a back and forth battle between having the chills and breaking out into a sweat. I experienced 2 more episodes of same symptoms on 12/11/18 and on 01/08/19. It should be noted that it appears the vaccine was injected into the shoulder Joint instead of the muscle.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Impaired work ability, Nausea, Pain, Tremor
Clinical narrative: Suffered severe body aches, nausea, extreme shaking/shivering. Was unable to go to work next day.
Age: 48.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Hypersensitivity, Rash erythematous, Rash pruritic
Clinical narrative: Patient called our clinic on 01/10/19 at 1133am stating that on 01/09/19 he started having a small red pruritic rash over his face, back, trunk and arms. Denied fever and any other symptoms. Advised patient to call the doctor who prescribed him MMR and VZV vaccines to notify about the reaction and to have an assessment done. On 01/11/19 at 1600 the patient reported he was evaluated by Dr. and doctor said he had an allergic reaction and prescribed him a topical cream and some pills but he cannot recall the name. Per patient Dr. offered blood test but the patient declined due to lack of money since he doesn't have insurance.
Age: 54.0
Sex: F
Vaccine: FLU4, HEP, PPV
Symptoms: Inflammation, Nausea, Pain in extremity, Vomiting
Clinical narrative: We held an immunization for our overnight associates at our store. She explained that several hours after receiving vaccine she felt pain in her arm and nauseated. She finished shift and went home - went right to sleep and later woke up with lots of pain in arm and vomiting. Her husband took her to the urgent care.  While there she was given a dose of Morphine and also something for inflammation. They also gave he medication for nausea/vomiting and later she was discharged.