chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Insomnia, Pain in extremity
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 60-year-old male patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020) for prophylaxis. On 2nd May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm, influenza-like symptoms and sleeplessness. On an unknown date, the outcome of the pain in arm, influenza-like symptoms and sleeplessness were recovered/resolved. It was unknown if the reporter considered the pain in arm, influenza-like symptoms and sleeplessness to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The call center representative stated that the patient was not able to sleep on his arm for a week since it was sore. The patient had flu like symptoms that lasted for couple days.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Paraesthesia, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of headache in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced headache, electric shock sensation and fever. On an unknown date, the outcome of the headache, electric shock sensation and fever were unknown. It was unknown if the reporter considered the headache, electric shock sensation and fever to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced electric feeling down the leg, headache and fever.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Headache, Heart rate increased, Rash
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of heartbeats increased in a adult female patient who received SHINGRIX (batch number B9739, expiry date unknown) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, several hours after receiving SHINGRIX, the patient experienced heartbeats increased, rash, weakness, joint pain and headache. On an unknown date, the outcome of the heartbeats increased, rash, weakness, joint pain and headache were unknown. The reporter considered the heartbeats increased, rash, weakness, joint pain and headache to be related to SHINGRIX. Additional details were provided as follow: The age at vaccination was not reported. Few hours after receiving SHINGRIX, the patient reported rash on back, shoulders and torso. The patient had weakness and her heart beat was rapidly increased. She also had joint aches and headache, reporteted by her. The nurse reported that, 2nd dose of SHINGRIX would not be administered and the adverse events were related to SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of myalgia in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced myalgia. On an unknown date, the outcome of the myalgia was not recovered/not resolved. The reporter considered the myalgia to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient received a SHINGRIX vaccine at a pharmacy. The patient experienced myalgia and weeks later, still felt myalgia. To his knowledge, her symptoms had not resolved. The physician reported this patient's experience to VAERS. The physician does think her symptoms are due to the SHINGRIX injection.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a male patient who received SHINGRIX (batch number Z9RR4, expiry date unknown) for prophylaxis. On 6th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were unknown. The reporter considered the injection site erythema and injection site warmth to be related to SHINGRIX. Additional information reported as follows: The reporter provided the name of the nurse who had given the vaccine, for follow up communication. The patient was called on the day of reporting, with complaints of redness at the injection site approximately 4 inches in diameter, and warm to the touch. They were evaluating whether to had the patient come in for appointment. They (reporter) think it was due to the vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that, 24 hours after receiving SHINGRIX, the patient experienced local pain, swelling, redness at injection site, which resolved within 5 days.
Sex: M
Vaccine: VARZOS
Symptoms: Impaired work ability, Injection site pain, Loss of personal independence in daily activities, Myalgia, Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. On 9th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, myalgia, injection site pain and activities of daily living impaired. On an unknown date, the outcome of the fever, myalgia, injection site pain and activities of daily living impaired were recovered/resolved. It was unknown if the reporter considered the fever, myalgia, injection site pain and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had fever, Myalgia, pain at the injection site and was not able to work. They did complete VAERS report. All symptoms were resolved. The reporter had several patients develop side effects from the vaccine. Clarification has been raised for creation of master case for several patients.
Sex: F
Vaccine: MNQ
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of unwell in a female patient who received Men ACWY-CRM NVS (Meningitis ACWY vaccine (potential Menveo)) for prophylaxis. On an unknown date, the patient received Meningitis ACWY vaccine (potential MENVEO) at an unknown dose. On an unknown date, unknown after receiving Meningitis ACWY vaccine (potential MENVEO), the patient experienced unwell. On an unknown date, the outcome of the unwell was unknown. It was unknown if the reporter considered the unwell to be related to Meningitis ACWY vaccine (potential MENVEO). Additional details were provided as follows: The age at vaccination was not reported. The parent of the patient posted on the social media that they knew how ill the vaccine would make there daughter (patient). The patient could not get out of bed for a week. The parent said that if they know how Meningitis would be much worse, then would be more prepared.
Sex: U
Vaccine: MENB
Symptoms: Pruritus, Urticaria
Clinical narrative: This is a spontaneous report from a contactable Physician via Pfizer sales representative. A patient of unspecified age (reported as 18) and gender received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced hives on skin/ itching on an unspecified date with outcome of unknown.
Sex: F
Vaccine: PNC13
Symptoms: Skin exfoliation
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A 60-year-old female patient received PREVNAR 13, via an unspecified route of administration on an unspecified date for immunization. Medical history included allergy. The patient's concomitant medications were not reported. The patient had some peeling after the shot but no other problems with outcome of unknown.
Sex: U
Vaccine: MENB
Symptoms: Dyspnoea, Heart rate increased, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse practitioner. A 17-year-old patient of an unspecified gender received TRUMENBA in Jul2018 at single dose for immunization. Medical history included ongoing latex sensitivity (a Band Aid sensitivity, it was not anaphylactic). The patient's concomitant medications were not reported. In Jul2018, after receiving the vaccine, the patient experienced shortness of breath, heart rate increased and fever. Events were non serious. The patient still had increased heart rate and fever. Outcome of shortness of breath was unknown.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: FEVER X2 DAYS AND REDNESS AND SWELLING X2 DAYS.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: Arm pain, swelling and redness.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site erythema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: 2-3 weeks ago I noticed a raised red dime sized circle on the injection area. It does seem to be sore. I do not know if it was there longer. Today on the lower part of my arm I had an itchy liquid filled small spot. I did take photos if there is a place I can send them. I am on vacation.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and refers to a male patient of unknown age. The patient's medical history, concurrent condition and concomitant medication were not reported. On 18-JUN-2018, the patient was vaccinated with a dose of PROQUAD (strength, dose, lot #, batch, expiration date not reported) and with a dose of VARIVAX (strength, dose, lot #, batch, expiration date not reported) subcutaneously for prophylaxis. Not known adverse event was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2015, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. In 2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 16-SEP-2012, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. On or about 30-JUN-2014 the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 09-JUL-2018 from a lawyer regarding a case in litigation. A female patient, age unspecified, was inoculated with ZOSTAVAX in 2012 by a physician as recommended for routine adult health maintenance for prevention of shingles. It did not prevent shingles as intended and subsequently the patient contracted a persistent strain of herpes zoster. On or about 24-JUL-2016 the patient was treated at a medical center for a blistering vesicular outbreak which was then diagnosed as herpes zoster, or shingles. The patient was treated with valacyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
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. In 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2015, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
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. In 2007, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 14-OCT-2010, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The patient was prescribed VALTREX for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
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 concomitant medications, concurrent conditions or medical history. On or about 03-DEC-2015, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 20-MAY-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed valacyclovir hydrochloride (VALTREX) and (topiramate (TOPAMAX) for the management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
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 concomitant medications, concurrent conditions or medical history. On or about 28-JUN-2013, the patient was inoculated with ZOSTAVAX at a medical facility as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 08-SEP-2015, the patient was treated at the same medical facility for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
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 concomitant medications, concurrent conditions or medical history. On or about 28-OCT-2013, the patient was inoculated with ZOSTAVAX by a physician at the physician's office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2014, the patient was treated by another physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patient may have received an improperly stored dose of PROQUAD per subcutaneous route (dose and frequency were not provided) lot # R001540 expiration date on 15-JUL-2019 for prophylaxis. No adverse effects were provided. This was the first temperature excursion. The Data Logger registered an excursion between 15 Fahrenheit degrees and 46 Fahrenheit degrees along 384 hours.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an other referring to a 15 month old patient of unknown gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 09-NOV-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection (strength, dose, frequency and route were not reported) (lot # N020013 and expiry date: 17-JUL-2019) for prophylaxis. The administered dose of VARIVAX was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot# and expiry date were not reported). The vaccine was stored in between -14 degrees Celsius (C) to -10 C (-14.37 C) for 15 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1802USA008334.
Age: 13.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an other referring to a 13 year old patient of unknown gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 27-NOV-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection (strength, dose, frequency and route were not reported) (lot # N020013 and expiry date: 17-JUL-2019) for prophylaxis. The administered dose of VARIVAX was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot# and expiry date were not reported). The vaccine was stored in between -14 degrees Celsius (C) to -10 C (-14.37 C) for 15 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1802USA008334.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an other referring to a 4 year old patient of unknown gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 09-DEC-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection (strength, dose, frequency and route were not reported) (lot # N020013 and expiry date: 17-JUL-2019) for prophylaxis. The administered dose of VARIVAX was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot# and expiry date were not reported). The vaccine was stored in between -14 degrees Celsius (C) to -10 C (-14.37 C) for 15 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1802USA008334.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an other referring to a 4 year old patient of unknown gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 30-JAN-2018, the patient was vaccinated with improperly stored dose of VARIVAX injection (strength, dose, frequency and route were not reported) (lot # N020013 and expiry date: 17-JUL-2019) for prophylaxis. The administered dose of VARIVAX was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot# and expiry date were not reported). The vaccine was stored in between -14 degrees Celsius (C) to -10 C (-14.37 C) for 15 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1802USA008334.
Sex: F
Vaccine: HPV9
Symptoms: Feeling abnormal, Headache, Hypotonia, Muscle fatigue
Clinical narrative: This spontaneous report was received from a physician via field representative refers to a 24 year old female patient. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 09-JUL-2018, the patient was vaccinated with first dose of GARDASIL 9, intramuscularly for prophylaxis (lot#, expiry date and dosage details were not reported). On the same day, the patient experienced symptoms of "feeling like a limp noodle, mental fogginess, chronic headache, muscle fatigue". The patient's mother called physician. The outcome of the event "feeling like a limp noodle" was unknown and the outcome of other events was reported as not recovered. The reporter did not provide any causality assessment.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Vomiting
Clinical narrative: Initial information received on 22-Jun-2018 regarding an unsolicited valid serious case received from a consumer/non-HCP. This case involves 18-year-old male patient who experienced vomiting, while he received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 13-Jun-2018, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5848A via intramuscular route in the left deltoid. On an unspecified date, the patient developed a serious vomiting, 30 minutes following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event during 2 days. The patient was discharged on 19-Jun-2018 (hospitalization during 2 days). Laboratory investigation was not reported. Final diagnosis was vomiting. It was not reported if the patient received a corrective treatment. The patient outcome is reported as unknown for vomiting. Documents held by sender: None. Sender's Comments: This case involves an adult patient who experienced vomiting 30 minutes' post vaccination with MENACTRA. Time to onset is compatible with the role of vaccine. Vomiting is expected with MENACTRA vaccination. However, patient's medical history, medical condition at the time of vaccination, previous vaccination and its tolerance and lab investigation excluding other etiology were not provided. Based upon the available information, the role of vaccine cannot be assessed.
Sex: M
Vaccine: DTAPIPVHIB, HEP, PPV
Symptoms: Expired product administered
Clinical narrative: Initial unsolicited report received from a medical assistant on 06-Jul-2018. This case involves an eight months old male patient who was vaccinated once with an 0.5 ml expired dose of PENTACEL (batch number: C5188AA, expiration date: 12-Mar-2018, dose in series was not reported) via intramuscular route on 12-Mar-2018 by mistake. The patient's concomitant medications include HEPATITIS B VACCINE, PNEUMOCOCCAL 13 VALENT VACCINE (Batch number, expiry date, dose, dose in series, route and site of administration was not reported). It was a case of actual medication error due to expired vaccine used and inappropriate age at vaccine administration. It was not reported whether the patient had experienced any adverse events 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. Documents held by sender: none.
Age: 0.75
Sex: M
Vaccine: DTAPIPV, HEP
Symptoms: Wrong drug administered
Clinical narrative: Initial unsolicited report received from medical assistant on 09-Jul-2018. This case involves a nine-months old male patient who was vaccinated once with a 0.5 ml dose of QUADRACEL (batch number: C5248AA, expiration date: 21-Aug-2019, dose in series and route of administration was not reported) in the right vastus lateralis instead of PENTACEL on an unspecified date (reported as today). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included HEPATITIS B VACCINE (Lot number, expiry date, dose, dose in series, route and site of administration was not reported). It was a case of actual medication error due to wrong vaccine administered. It was not reported whether the patient had experienced any adverse events 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. Documents held by sender: none.
Age: 14.0
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 09-Jul-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 14 years old male patient who received vaccine IPOL which was stored incorrectly. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Jul-2018, the patient received a dose of suspect IPV (VERO) (lot N1G411M, expiry date: 28-Jul-2019) in the left arm. It was a case of actual medication error due to incorrect product storage. The patient was administered with IPOL that was not valid due to temperature stability. It was not reported if the patient experienced any adverse event 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. Documents held by sender: none.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: Initial information received on 09-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 2 months old male patient who received only the Hib portion of the PENTACEL, while he received vaccine PENTACEL. 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 0.5 mL dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine, lot C5440AA, expiry date: 29-Oct-2018. It was a case of actual medication error due to inappropriate reconstitution technique as the DTAP-IPV portion was not given at the same time as the HIB. The patient visited the ER on 09-Jul-2018. It was not reported if the patient experienced any adverse event 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. Documents held by sender: none.
Age: 8.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Initial information received on 09-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA189752 (same reporter). This case involves an eight-years old male patient who was vaccinated with a 0.5 mL Booster dose of QUADRACEL (lot C532BA, expiry date: 14-Nov-2019) intramuscularly in left arm on 02-Jul-2018. 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. It was reported that this was patients fourth polio and fourth DTAP dose. No other vaccines were given at the same time. The doctor was aware of this. It was not reported if the patient experienced any adverse event 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. Documents held by sender: none.
Age: 0.08
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Initial information received on 09-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA189745 (same reporter). This case involves a one-month old male patient who was vaccinated with a 0.5 mL Booster dose of QUADRACEL (lot C532BA, expiry date: 14-Nov-2019) intramuscularly in left arm on 02-Jul-2018. 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. It was reported that this was patients fourth polio and fourth DTAP dose. No other vaccines were given at the same time. The doctor was aware of this. It was not reported if the patient experienced any adverse event 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. Documents held by sender: none.
Age: 4.0
Sex: F
Vaccine: HEP, HEPA, DTAPIPVHIB, HEP, HEPA
Symptoms: Dermatitis allergic, Injection site cellulitis
Clinical narrative: 7-7-18 ED; Left leg cellulitis. 7-9-18 UC; Allergic Reaction.
Age: 4.0
Sex: F
Vaccine: HEP, HEPA, DTAPIPVHIB, HEP, HEPA
Symptoms: Erythema, Peripheral swelling, Skin discolouration
Clinical narrative: 7-7-18 ED; Left leg cellulitis. 7-9-18 UC; Allergic Reaction.
Age: 40.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling cold, Headache, Hyperhidrosis
Clinical narrative: Shivering, cold, sweating, headache, light (photo) sensitivity, sore injection site, nausea, tired, body ache.
Age: 40.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea, Pain, Photophobia
Clinical narrative: Shivering, cold, sweating, headache, light (photo) sensitivity, sore injection site, nausea, tired, body ache.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Headache, Injection site pain, Myalgia
Clinical narrative: 2nd shingles vaccine. Feel like I got hit by a truck. Muscle aches, headache, nausea, slight shivering but that went away pretty quickly. Sore at the injection site (upper shoulder).
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: 2nd shingles vaccine. Feel like I got hit by a truck. Muscle aches, headache, nausea, slight shivering but that went away pretty quickly. Sore at the injection site (upper shoulder).
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Chills, Headache, Influenza like illness, Pain, Pain in extremity
Clinical narrative: Shivering, total body aches, headache. Flu like symptoms. Also arm very sore and difficult to lift arm because of pain.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Chills, Dizziness, Headache, Pain, Pyrexia
Clinical narrative: Shivering, total body aches, headache. Flu like symptoms. Also arm very sore and difficult to lift arm because of pain.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: Shivering, total body aches, headache. Flu like symptoms. Also arm very sore and difficult to lift arm because of pain.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Shivering, total body aches, headache. Flu like symptoms. Also arm very sore and difficult to lift arm because of pain.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Headache, Injection site pain, Myalgia, Paraesthesia
Clinical narrative: Tingling in hands; headache; pain in back muscles; fever; pain at injection site.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Tingling in hands; headache; pain in back muscles; fever; pain at injection site.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Malaise, Pain, Pain in extremity
Clinical narrative: Fevers, aches, chills, general malaise sore, red swollen arm since vaccine -treated with prednisone.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Fevers, aches, chills, general malaise sore, red swollen arm since vaccine -treated with prednisone.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Peripheral swelling
Clinical narrative: Pt arm swelled, redness and not able to move her arm.
Age: 43.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Hypoaesthesia, Pain in extremity, Rash
Clinical narrative: Pt C/O rashes on her arm, soreness and numbness on the arm radiates to the tip of her fingers started last night. Advised to move around her arms.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB, MNQ, TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Pain in extremity, Skin warm
Clinical narrative: On 7/16/2018 at 2:45 pm, I received phone call from client's mother, stating her daughter greceived shots last week here, and once she got home that same day, was complaining of pain in her Right arm, woke up next morning, area was reddened and swollen at injection site, and could not lift arm. States arm is warm to touch. Mother applied warm compresses and rubbing alcohol to area. As of this afternoon, client still complains of not being able to lift arm, with pain, still reddened and swollen at site. Encouraged to try cool compresses, and take patient to her PCP for evaluation and mother is to follow up with me after client is seen. I attempted to call client this morning, at 3 different phone numbers that were in the CARES system, 2 numbers were under client's name had no answer and no voicemail set up. Third number was emergency contact number of sister. There was no answer, and no message left as no information available as to okay to leave a message with that number.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pain in extremity, Peripheral swelling
Clinical narrative: Patient had significant arm swelling, redness and pain the evening she got the shot. It lasted about 1 month. She then got an active shingles outbreak on 7/9/18.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Influenza like illness, Myalgia
Clinical narrative: 10 hours later at 10 PM, I was experiencing a severe headache accompanied by chills. Then my extremities became so cold that I couldn't warm them up the entire night. My entire body was experiencing the worse flu-like symptoms with severe muscle and joint aches for the next 24 hours. That next day, I noticed that my feet and hands were now feeling a noticeable warmth.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral coldness
Clinical narrative: 10 hours later at 10 PM, I was experiencing a severe headache accompanied by chills. Then my extremities became so cold that I couldn't warm them up the entire night. My entire body was experiencing the worse flu-like symptoms with severe muscle and joint aches for the next 24 hours. That next day, I noticed that my feet and hands were now feeling a noticeable warmth.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Conjunctivitis bacterial, Dyskinesia, Hyperreflexia, Muscle spasms
Clinical narrative: They notice him having "muscle spasms" or jumping of his arms and legs (like startle reflex, but these occur more severely than previous and more frequency. Only last a few seconds. No crying outbursts. Eyes are open. No distress noted. Feeding normally. Parents also noted drainage from R eye, no edema or redness. PROVIDER TREATED EYES FOR ACUTE BACTERIAL CONJUNCTIVITIS AND DID REFERRAL FOR ENT FOR MUSCLE SPASMS (PAIN RESPONSE).
Age: 48.0
Sex: M
Vaccine: HEPA
Symptoms: Asthenia, Injection site pain, Joint range of motion decreased, X-ray normal
Clinical narrative: Left shoulder pain with onset decreased range of motion and weakness.
Age: 33.0
Sex: F
Vaccine: TYP
Symptoms: Anaphylactoid reaction, Intensive care
Clinical narrative: Anaphlyactoid reaction requiring ICU admission.
Age: 34.0
Sex: M
Vaccine: HEPAB
Symptoms: Dizziness, Hyperhidrosis, Hypotension, Immediate post-injection reaction, Pallor
Clinical narrative: Immediately after the vaccine was administered he began to feel lightheaded. Over the next 10 minutes he became dizzy, pale, diaphoretic, and hypotensive. He was moved to a supine position. Three attempts were made to place an IV, but was difficult to place due to history of drug use. He began to improve without IV fluids. Offered fluids and food. The symptoms began to resolve in a few minutes and within 20 minutes he felt back to baseline. He was observed in the medical area for the next hour.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Hypoaesthesia, Paraesthesia
Clinical narrative: Patient described a supersensitivity that lasted 2 days in the arm that the immunization was administered. She also described it as a numbness and tingly feeling about a week after the immunization.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Basedow's disease, Dry eye, Dyspnoea, Exophthalmos, Eye irritation
Clinical narrative: Sore arm, severe fatigue, shortness of breath, numbness and tingling in lower half of arm and last 3 fingers on right hand, showing symptoms of Grave's disease (burning, red and dry/gritty eyes, left eye bulging).
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Foreign body sensation in eyes, Hypoaesthesia, Ocular hyperaemia, Pain in extremity
Clinical narrative: Sore arm, severe fatigue, shortness of breath, numbness and tingling in lower half of arm and last 3 fingers on right hand, showing symptoms of Grave's disease (burning, red and dry/gritty eyes, left eye bulging).
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia
Clinical narrative: Sore arm, severe fatigue, shortness of breath, numbness and tingling in lower half of arm and last 3 fingers on right hand, showing symptoms of Grave's disease (burning, red and dry/gritty eyes, left eye bulging).
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, raised, hot, rash 3-4 inches around injection site.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an other referring to a 4 year old patient of unknown gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 24-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX injection (strength, dose, frequency and route were not reported) (lot # N020013 and expiry date: 17-JUL-2019) for prophylaxis (product storage error). The administered dose of VARIVAX was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot# and expiry date were not reported). The vaccine was stored in between -14 degrees Celsius (C) to -10 C (-14.37 C) for 15 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1802USA008334: