chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history.   On an unspecified date in 2015, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the patient's vaccine inoculation, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.   The outcome of the events was unknown. Causality assessment was related.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unspecified date in 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number and route not specified) by a pharmacist for long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Bells Palsy; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.  On 11-DEC-2017, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (dose, frequency, route, lot # and expiration date were not reported).        On an unknown date, the patient was treated by a healthcare provider for Bells Palsy. The outcome of event was unknown. As a direct and proximate result of Plaintiff's use of the zoster vaccine live (ZOSTAVAX) vaccine, plaintiff has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damaged in the future. The reporter considered the event to be related to Zoster Vaccine Live(ZOSTAVAX).  Upon internal review, the event of Bells Palsy was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, dose#, lot#, expiration date and route of administration were not provided) for the long-term prevention of shingles and/or zoster-related conditions at the pharmacy. Subsequent to patient's inoculation, the patient was treated by a physician for shingles. As a direct and proximate result of patient's use of zoster vaccine live (ZOSTAVAX) vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: patient experienced pain, & swelling in his left arm that spread to medial portion of the forearm; patient experienced pain, & swelling in his left arm that spread to medial portion of the forearm; This spontaneous report was received from a physician via a company representative referring to a 75-year-old male patient.  The patient's concomitant medication, pertinent medical history and drug reactions/allergies was unknown. On 24-JUL-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), (lot # S002582 with expiration date 10-AUG-2020; dose and route were unknown) for prophylaxis at his upper left arm. On the same day, the patient experienced pain, & swelling in his left arm that spread to medial portion of the forearm. On 26-JUL-2019, the patient visited physician office for medical attention and was treated with prednisone and benadryl. There was no lab diagnostic/study.The patient was recovered from the adverse events (AEs) on unknown date in 2019. The causality was not provided.
Sex: U
Vaccine: MMR, UNK, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse effects; patient received one dose ofVARlVAX instead of MMR II.; patient received one dose ofVARlVAX instead of MMR II.; This spontaneous report was received from a medical assistant referring to a 54-year-old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  On 01-AUG-2019, the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck)(VARIVAX), lot number R035221 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck), expiration date reported as 04-DEC-2020, but upon internal validation established as 04-DEC-2019, for prophylaxis (dose, route of administration, and anatomical location were not reported), instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and sterile diluent.  It was unspecified if the patient received varicella virus vaccine live (oka/merck)(VARIVAX) or measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) prior to this. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: an unspecified 5 year old patient was inadvertently administered a dose of PROQUAD intramuscularly rather than subcutaneously; No adverse effects were reported in the message; This spontaneous report was received from a physician, referring to a 5 year old patient of unknown gender. The patient's pertinent medical history, concomitant medications, concurrent conditions, and drug reactions or allergies were not reported.  On an unknown date,  the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis, this dose was inadvertently administered intramuscularly rather than subcutaneously (incorrect route of product administration) (strength, dose number, anatomical location of injection, lot # and expiration date were not reported). No adverse effects were reported.
Age: 8.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient had first dose of GARDASIL 9 at the age of 8 years old and administered with second dose of GARDASIL 9 on 08/05/2019; No adverse effects reported; On 06-JUL-2015, patient had first dose of GARDASIL 9 at the age of 8 years old and administered with second dose of GARDASIL 9 on 05-AUG-2019; This spontaneous report was received from an other reporter referring to a 8- year-old child patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications and drug reactions/allergies were not reported.  On 06-JUL-2015, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, unit, route, anatomical location, lot # and expiration date were not reported) (product administered to patient of inappropriate age). On 05-AUG-2019, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, unit, route, anatomical location, lot # and expiration date were not reported) (inappropriate schedule of product administration). No adverse effects were reported. The outcome of product administered to patient of inappropriate age and inappropriate schedule of product administration was unknown. No product quality complaint (PQC) was involved.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test negative
Clinical narrative: the patient received the second dose of VARIVAX  (lot number R026715, expiration date 9/18/2020) on 7/31/2019 and then "called the next day, reporting that she was pregnant".; This spontaneous prospective pregnancy report was received from a registered nurse, concerning a 27-year old female patient. The patient had no concomitant medication, pertinent medical history, drug reactions or allergies.   On 20-MAR-2019, the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), subcutaneously, for varicella vaccination (anatomical location, lot # and expiration date were not reported), without incidence.   On 29-JUL-2019, the patient visited the health department and stated that it was unconfirmed if she was pregnant. On 31-JUL-2019, she returned to the health department stating that she took a pregnancy test on an unspecified date in July 2019, and the result was negative; therefore, on that day the patient was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), lot # R026715 and expiration date on 18-SEP-2020, for the same indication. On 01-AUG-2019 (reported as "the next day"), the patient called back reporting that she was in fact pregnant. The pregnancy was confirmed by the health department when she visited on 06-AUG-2019. The last menstrual period (LMP), estimated date of conception (EDC) and estimated date of delivery (EDD) were not known and could not be calculated. The pregnancy outcome was pending by the time of reporting.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; An unknown number of unspecified patients may have been administered vaccines improperly stored; This spontaneous report was received from a nurse and an office manager and referrs to an unknown number of patients of unknown age and gender. There was no information provided about the patients' concurrent conditions, concomitant therapies, historical drugs, drug reactions or allergies, or medical history.  On multiple unspecified dates, the patients were vaccinated with improperly stored doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# R025725, expiration date 25-MAY-2021) (exact dose, frequency, route and site of administration were not reported); with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) (lot# R000550, expiration date 08-JAN-2020) (exact dose, frequency, route and site of administration were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate (LIQUID PEDVAXHIB) (lot# R000877, expiration date 24-SEP-2020) (exact dose, frequency, route and site of administration were not reported) all administered for prophylaxis. The administered doses were exposed to a temperature below 36 Fahrenheit degrees (F): 31.6 F for 2 hours and 13 minutes and 25.7 F for 1 hour and 35 minutes, and temperature above 47 F: 50.5 F for 18 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.  Follow-up information was received from a physician's receptionist on 01-AUG-2019. The patient was a 13-year-old female. On 04-JUN-2019, she was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# R025725, expiration date 25-MAY-2021) 0.5 mg in left deltoid (frequency and route of administration were not reported). It was clarified that no patient received measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) and haemophilus b conjugate vaccine (meningococcal protein conjugate (LIQUID PEDVAXHIB). The reported temperature excursion occurred from 30-MAY-2019 to 22-JUL-2019. The reporter stated that the temperature probe was misplaced, which resulted in an incorrect reading. No adverse effects were reported.  This is one of 3 reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA011013: US-009507513-1908USA003825:
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; An unknown number of unspecified patients may have been administered vaccines improperly stored; This spontaneous report was received from a nurse and an office manager and refers to an unknown number of patients of unknown age and gender. There was no information provided about the patients' concurrent conditions, concomitant therapies, historical drugs, drug reactions or allergies, or medical history.  On multiple unspecified dates, the patients were vaccinated with improperly stored doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# R025725, expiration date 25-MAY-2021) (exact dose, frequency, route and site of administration were not reported); with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) (lot# R000550, expiration date 08-JAN-2020) (exact dose, frequency, route and site of administration were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate (LIQUID PEDVAXHIB) (lot# R000877, expiration date 24-SEP-2020) (exact dose, frequency, route and site of administration were not reported) all administered for prophylaxis. The administered doses were exposed to a temperature below 36 Fahrenheit degrees (F): 31.6 F for 2 hours and 13 minutes and 25.7 F for 1 hour and 35 minutes, and temperature above 47 F: 50.5 F for 18 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.  Follow-up information was received from a physician's receptionist on 01-AUG-2019. The patient was a 11-year-old female. On 16-JUN-2019, she was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# R025725, expiration date 25-MAY-2021) 0.5 mg in left deltoid (frequency and route of administration were not reported). It was clarified that no patient received measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) and haemophilus b conjugate vaccine (meningococcal protein conjugate (LIQUID PEDVAXHIB). The reported temperature excursion occurred from 30-MAY-2019 to 22-JUL-2019. The reporter stated that the temperature probe was misplaced, which resulted in an incorrect reading. No adverse effects were reported.  This is one of 3 reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA003824: US-009507513-1907USA011013:
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's sister. Additional information was not available. For tolerances of 2nd dose, refer case US2019AMR142256. The reporter did not consent to follow up.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site pain
Clinical narrative: Injection site tenderness; big pale pink rectangular area / Slight reaction; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site tenderness and injection site discoloration. On an unknown date, the outcome of the injection site tenderness and injection site discoloration were unknown.   It was unknown if the reporter considered the injection site tenderness and injection site discoloration to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced a slight reaction which was tender at the injection site with a big pale pink rectangular area around it which faded within 3-4 days.   The reporter consented to follow up. This case has been linked with US2019AMR138299, reported by the same reporter for the same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 7 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: The reporter did not provide any patient/vaccine details. The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication.  The patient get shingles a week after their first Shingrix vaccine. The reporter gave adverse event information over chat. The reporter gave permission to follow up.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypersensitivity, Myalgia, Pain, Rash erythematous
Clinical narrative: Allergic reaction; Pain; redness; Swelling; Itchy rash; Red dots on the upper arm; Headache; Muscle ache; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th July 2019, the patient received the 1st dose of Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced allergic reaction, pain, erythema, swelling, itchy rash, red rash, headache and muscle pain. On an unknown date, the outcome of the allergic reaction, pain, erythema, swelling, itchy rash, red rash, headache and muscle pain were recovered/resolved.   It was unknown if the reporter considered the allergic reaction, pain, erythema, swelling, itchy rash, red rash, headache and muscle pain to be related to Shingrix.  Additional case details were reported as follows: The patient reported an allergic reaction after the Shingrix vaccination.  The patient experienced pain, redness, swelling, muscle aches, headache and an itchy rash with red dots on the upper arm. The symptoms were lasted approximately 5 days to 1 week. The patient was misdirected to medical information and did not understand that the product could not be discussed between her and medical information. The patient did not provide the healthcare professional information when asked.  They did not confirm that a healthcare professional information was consulted when asked if it was reported. The reporter gave permission to follow up.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Swelling
Clinical narrative: Allergic reaction; Pain; redness; Swelling; Itchy rash; Red dots on the upper arm; Headache; Muscle ache; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th July 2019, the patient received the 1st dose of Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced allergic reaction, pain, erythema, swelling, itchy rash, red rash, headache and muscle pain. On an unknown date, the outcome of the allergic reaction, pain, erythema, swelling, itchy rash, red rash, headache and muscle pain were recovered/resolved.   It was unknown if the reporter considered the allergic reaction, pain, erythema, swelling, itchy rash, red rash, headache and muscle pain to be related to Shingrix.  Additional case details were reported as follows: The patient reported an allergic reaction after the Shingrix vaccination.  The patient experienced pain, redness, swelling, muscle aches, headache and an itchy rash with red dots on the upper arm. The symptoms were lasted approximately 5 days to 1 week. The patient was misdirected to medical information and did not understand that the product could not be discussed between her and medical information. The patient did not provide the healthcare professional information when asked.  They did not confirm that a healthcare professional information was consulted when asked if it was reported. The reporter gave permission to follow up.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity, Pyrexia
Clinical narrative: Arm pain; Fever; didn't feel good; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number FG2D4, expiry date 19th September 2021) for prophylaxis.   On 24th May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 25th May 2019, 1 days after receiving Shingrix, the patient experienced pain in arm, fever and feeling unwell. On 25th May 2019, the outcome of the pain in arm, fever and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the pain in arm, fever and feeling unwell to be related to Shingrix.  Additional information received were as follows: The pharmacist on the line reporting after receiving 1st dose of Shingrix in the right deltoid, the patient experienced arm pain, fever and just didn't feel good the following day, which lasted about a day. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a other health professional via sales rep and described the occurrence of shingles in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2018, the patient received the 1st dose of Shingrix. On an unknown date, several months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information received were as follows: This case was reported by the Physician's Assistant (PA). The age at vaccination was not reported. A couple of months after receiving Shingrix, the patient experienced shingles. The reporter consented to follow up.  The reporter reminded of 24 hour time frame to report.    The reporter stated an MSL spoke with the PA on Wednesday.
Sex: F
Vaccine: UNK, UNK
Symptoms: Allergy to vaccine, Drug hypersensitivity
Clinical narrative: Allergies: Hydrochlorothiazide, Pneumococcal Vaccines, Latex and Sulfa Drugs; This is a spontaneous report from two contactable nurses. A 72-year-old female patient received pneumococcal vaccines (manufacturer unknown), via an unspecified route of administration on an unspecified date at single dose for immunization, received hydrochlorothiazide (manufacturer unknown) and unspecified sulfa drugs, via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced allergies: hydrochlorothiazide, pneumococcal vaccines, latex and sulfa drugs on an unspecified date with outcome of unknown. The action taken in response to the event for pneumococcal vaccines was not applicable, for hydrochlorothiazide was unknown.  Pfizer is a marketing authorization holder of [Pneumococcal Conj Vac, 13-Val] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [Pneumococcal Conj Vac, 13-Val] has submitted the same report to the regulatory authorities.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Blood thyroid stimulating hormone normal, Full blood count normal, Joint lock, Metabolic function test normal, Musculoskeletal pain
Clinical narrative: Capsulitis of the left shoulder/currently having a shoulder pain and she was got like locked joint in her shoulder; This is a spontaneous report from a contactable consumer. An 84-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13, lot number X49147, expiration date 30Nov2020), intramuscular in left deltoid on 29Jan2019 at 0.5 ml, single for preventative measures for the vaccine. Medical history was none. Concomitant medications were not reported. It was reported that the patient was currently having a shoulder pain and she was got like locked joint in her shoulder. She had the capsulitis of the left shoulder, which she was diagnosed with. The patient received diclofenac potassium (VOLTAREN) topical gel but she just started that today with the visit, she had given that for the shoulder pain, so it was just prescribed today. She was also started the physical therapy. It was stated that on 28Mar2019 was her last blood work which included a CMP, CBC and TSH and results were all normal. The reporter further mentioned that there were panels of lab work and it was going to take while to give the original panel. The outcome of the event was unknown.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Periarthritis
Clinical narrative: Capsulitis of the left shoulder/currently having a shoulder pain and she was got like locked joint in her shoulder; This is a spontaneous report from a contactable consumer. An 84-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13, lot number X49147, expiration date 30Nov2020), intramuscular in left deltoid on 29Jan2019 at 0.5 ml, single for preventative measures for the vaccine. Medical history was none. Concomitant medications were not reported. It was reported that the patient was currently having a shoulder pain and she was got like locked joint in her shoulder. She had the capsulitis of the left shoulder, which she was diagnosed with. The patient received diclofenac potassium (VOLTAREN) topical gel but she just started that today with the visit, she had given that for the shoulder pain, so it was just prescribed today. She was also started the physical therapy. It was stated that on 28Mar2019 was her last blood work which included a CMP, CBC and TSH and results were all normal. The reporter further mentioned that there were panels of lab work and it was going to take while to give the original panel. The outcome of the event was unknown.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: was given Adacel and Menactra on 17-Sep-2018 and again today; Initial information received on 31-Jul-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional (Office staff) by phone.  This case involves a 13 years old female patient who was vaccinated with 0.5 ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (batch number and expiry date not reported) in the left deltoid and 0.5 ml dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (batch number: U6220AA and expiry date: 31-May-2020) in the right deltoid via intramuscular route on 31 July 2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE) on an 31 July 2019.  It was a case of actual medication error due to extra dose administered. The patient received dose of Adacel and Menactra on 17 Sep 2019 in the past and again received on 31 July 2019.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.   Information on batch number was requested.  Documents held by the sender: none.
Sex: M
Vaccine: IPV, UNK, UNK, UNK, UNK
Symptoms: Product storage error
Clinical narrative: the refrigerator door was not closed all the way resulting in a temperature excursion at 54.6 degrees F for 10 hours involving medication Lantus, Lantus Solostar, Admelog, Toujeo and Polio vaccine; Initial information received on 31-Jul-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age male patient.  This case involves a refrigerator door was not closed all the way resulting in a temperature excursion at 54.6 degrees f for 10 hours involving medication IPV (VERO) [IPOL] lot N1K931M and expiry date: 19-Nov-2019, INSULIN GLARGINE [LANTUS] (lot - 8F036B, expiry date: 30-Jun-2021), INSULIN GLARGINE [LANTUS SOLOSTAR] (lot - 9F6180A, expiry date: 30-Nov-2021), INSULIN LISPRO [ADMELOG] (lot - 9F105A, expiry date: 28-Feb-2021) and INSULIN GLARGINE [TOUJEO SOLOSTAR] (lot - 9f217A, expiry date: 31-Jan-2021) and with the use of medical devices SOLOSTAR U30 and SOLOSTAR.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a potential medication error due to incorrect product storage.  It was unknown whether the products was administered to the patient or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: Adacel and Menactra was given on 09/17/2018 and again today; Initial information received on 31-Jul-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (office staff).  This case involves a 13 years old female patient who received vaccines MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] twice.  The patient's past vaccination(s) included Adacel on 17-SEP-2018 and Menactra on 17-SEP-2018.  The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medications included HPV VACCINE (HPV VACCINE) for Immunisation.  On an unknown date, the patient received a dose of suspect 0.5 ml DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot 2YY25 and expiry date: 28-Mar-2020 via intramuscular route in the left deltoid.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via intramuscular route in the right deltoid.  It was a case of actual medication error due to extra dose administered.  It was not reported if any adverse event occurred or not.  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.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: pain and swelling at the injection site; swelling at the injection site; pain at the injection site; Initial information received on 31-Jul-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 58 years old female patient who experienced pain and swelling at the injection site, while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past vaccination(s) included Tenivac on 01-JAN-2011. The patient's past medical history, medical treatment(s) and family history were not provided.  On 25-Jul-2019, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6273AA, expiry date- 21-Apr-2024 via intramuscular route in Right Upper Gluteus.  On 31-Jul-2019, the patient developed a non-serious pain and swelling at the injection site (vaccination site inflammation), (vaccination site swelling) and (vaccination site pain) 6 days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was pain and swelling at the injection site.  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for pain and swelling at the injection site.
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered at inappropriate site, Product administered to patient of inappropriate age
Clinical narrative: a 7 year old female patient received Quadracel vaccine in thigh/No AE; a 7 year old female patient received Quadracel vaccine/No AE; Initial information received on 31-Jul-2019 regarding an unsolicited valid non-serious case received from a physician (practitioner).  This case involves a seven and a half years old female patient received a 0.5ml dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] vaccine lot number: C5500CA,expiry date 16-Aug-2020 via intramuscular route at right thigh on 04-Jun-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a actual medication error due to inappropriate age at vaccine administration and vaccine administered at inappropriate site.  No adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  Follow up information received on 02-Aug-2019 regarding an unsolicited valid non-serious case received from a physician (practitioner).  Batch number, expiry date, route and dose of vaccine was updated.  List of documents held by sender: none.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: No adverse event, Product administered at inappropriate site, Product dose omission, Wrong product administered
Clinical narrative: incorrectly vaccinated a patient with Pentacel instead of Quadracel, No AE reported; The patient had received Pentacel at age 2 months, 4 months, 6 months, missed age 15, No AE reported; 5.5 year patient was vaccinated with Pentacel on left thigh, No AE reported; Initial information received on 01-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a five years old female patient who received 0.5 ml dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot U6216AA and Exp. Date 30-Sep-2020) via intramuscular route in the left thigh, on 31-Jul-2019 instead of vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past vaccination(s) included Pentacel at 2 months, 4 months and 6 months. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  It was an actual medication error case due to wrong vaccine administered, missed dose and vaccine administered at inappropriate site.  It was reported that that she incorrectly vaccinated a patient with Pentacel instead of Quadracel. The patient had received Pentacel at age 2 months, 4 months, 6 months, missed age 15 months and then received a dose at age 5.5 years.   No AE reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: patient received an expired Menactra vaccine; Initial information received on 01-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown demographic patient who was vaccinated with a dose of expired vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U5866BC and Exp. Date 22-May-2019) via unknown route in unknown administration site on an unknown date.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used.  It was unknown whether the patient experienced any adverse event post vaccination.  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.
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Dose 2 was 48 hours late and dose 3 was 24 hours late/ no AE; Initial information received on 01-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 31 years old male patient who received third dose of RABIES (HDC) VACCINE [IMOVAX RABIES RABIES (HDC) VACCINE lot P1D60 (Expiry date 02-OCT-2020) via intramuscular route in the left deltoid, on 01-Aug-2019 which was 24 hours late.  The patient's other past medical history, medical treatment(s), vaccination(s) and family history were not reported.  The patient was scratched by a monkey in another country.   No other vaccine was given.  It was an actual medication error case due to inappropriate schedule of vaccine administered.  It was reported that while in another country, the patient started his dose 1 and dose 2 of of Imovax. The pharmacist states that Dose 2 was 48 hours late. The patient came home and was 24 hours late for Dose 3.   No AE and No signs of rabies was reported at time of reporting .  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  Information on the batch number for first and second was requested.  List of documents held by sender- none.
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Quadracel was given to a two-year old patient in the left thigh; Initial information received on 01-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 2 years old patient who received 0.5 ml fourth dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] lot C5532AA, expiry date 09-Oct-2020 via unknown route in the left thigh, on 01-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate age at vaccine administration.  It was unknown whether the patient had any adverse event.  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: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: physician administered a 4th dose of ActHIB too early; Initial information received on 02-Aug-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 15-month old female patient who was vaccinated with a fourth dose of HIB (PRP/T) VACCINE [ACT-HIB] lot UJ079AA (expiry date: 26-Oct-2020) via unknown route in the left thigh on 02-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was an actual medication error due to Inappropriate schedule of vaccine administered. It was reported that the physician administered a 4th dose of Act-HIB too early, the interval between the third and present dose was of two weeks only.  It was not known whether the patient had any adverse event.  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.