chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 9 week old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 07-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012726 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the number US-009507513-1610USA014706 has been changed from Company Number to Linked Report. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Vaccination error
Clinical narrative: This spontaneous report as received from a consumer refers to a 13 year-old female patient. On an unknown date, the patient was vaccinated with GARDASIL 9, one unspecified dose (dose number, exact dose and route of administration were not reported; lot # L036245 with the expiration date of 09-FEB-2018), for prophylaxis. The patient's mother did not authorize the physician's office to vaccinate the patient with GARDASIL 9.
Sex: F
Vaccine: VARZOS
Symptoms: Hepatic enzyme abnormal, Injection site vesicles
Clinical narrative: This spontaneous report was received from a Registered nurse refers to a 70 year old female patient. The patient had no pertinent medical history and drug reactions/allergies. There were no concomitant medications. On an unspecified date, the patient was vaccinated with ZOSTAVAX (strength, dose, lot/batch# and expiration date were not reported) subcutaneously for prevention of shingles. On 16-AUG-2017, the patient experienced blisters around the injection site. On an unknown date, lab diagnostics/studies were performed, which showed "abnormal liver enzymes". No treatment was given for the adverse events. The patient did not seek medical attention. Nurse declined Varicella-Zoster Virus (VZV) packet. There was no product quality complaint (PQC) involved. The outcome of the event blisters around the injection site was reported as recovering. The outcome of the event abnormal liver enzymes was unknown. The causality assessment was not provided by the reporter. No further information was provided.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to an unspecified number of patients of unknown demographics. The patients' concurrent conditions, medical history, drug reaction or allergies and concomitant medications were not reported. On unknown dates in June 2017, (reported as within last month), the patients were vaccinated with PNEUMOVAX23 (dosing details, route, lot/batch# were unknown) for prophylaxis.  On unknown dates in 2017, the patients experienced redness and soreness that extended beyond the injection site which lasted for a couple of days. The events had usually resolved after a couple of days (unknown date in 2017). Causality assessment was not provided by the reporter. No product quality complaint was involved. Follow up information was received from the pharmacist on 30-AUG-2017. This report refers to a female patient. The patient was vaccinated with PNEUMOVAX23 with lot# N003997. Other suspect therapies included PREVENAR 13 administered on an unknown date, prior to vaccination with PNEUMOVAX23. On an unknown date in approximately June 2017, the patient experienced severe injection site reaction within hours of receiving vaccination. The patient experienced redness and swelling which extended to elbow of involved arm. Complete recovery occurred within 48 hours. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1707USA012158.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Death, Resuscitation, Unresponsive to stimuli
Clinical narrative: Patient received vaccines in office 8/30/17. Patient was found unresponsive by parents at home 8/31/17 and was unable to resuscitate and resulted in death.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Chills, Dyspnoea, Erythema, Peripheral swelling, Pruritus
Clinical narrative: 4 hours after shots got chills, SOB, throat tightness, right arm swelling. Next day red hive all over the whole upper arm, red swollen, very itchy. Seen in urgent care 8/29 given KENALOG shot, BENADRYL, and cold compresses. Seen in our office 9/1 improving continue BENADRYL and cool compresses.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Swelling, Throat tightness, Urticaria
Clinical narrative: 4 hours after shots got chills, SOB, throat tightness, right arm swelling. Next day red hive all over the whole upper arm, red swollen, very itchy. Seen in urgent care 8/29 given KENALOG shot, BENADRYL, and cold compresses. Seen in our office 9/1 improving continue BENADRYL and cool compresses.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 07-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012727 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the number US-009507513-1610USA014706 has been changed from Company Number to Linked Report.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; patients received improperly stored doses, exposed to a temperature of 34.5 Fahrenheit for 100 minutes; This spontaneous report as received from a registered nurse refers to a 6 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 09-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012732 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the number US-009507513-1610USA014706 has been changed from Company Number to Linked Report.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 13-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012733 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the number US-009507513-1610USA014706 has been changed from Company Number to Linked Report. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 14-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012735 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the number US-009507513-1610USA014706 has been changed from Company Number to Linked Report.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 14-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012736 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the number US-009507513-1610USA014706 has been changed from Company Number to Linked Report.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 9 week old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 14-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012738 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the number US-009507513-1610USA014706 has been changed from Company Number to Linked Report. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 10 week old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 15-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012740 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the number US-009507513-1610USA014706 has been changed from Company Number to Linked Report. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacy intern refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-AUG-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 subcutaneously (dose, lot# and expiration date were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 55 Fahrenheit degrees for 48 hours. Data logger was involved. There were no previous excursions reported.
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Information was received from a registered nurse concerning a male patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the adult patient was inadvertently administered a dose of pediatric VAQTA 25/0.5 (units not provided) lot # N012324, expiration date 05-APR-2018 (route of administration unknown). No adverse effects were reported. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: This spontaneous report was received from 63 year old male patient, who was also a physician and refers to himself, via a company representative. On an unknown date, the patient was vaccinated with ZOSTAVAX subcutaneously (dose, frequency, lot # and expiration date were not reported) for prophylaxis. On an unknown date, approximately 13 to 15 days later, the patient experienced pruritus generalised which lasted for about ten days. The outcome of pruritus generalised was unknown. The relatedness between the event and ZOSTAVAX was not reported.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number patients of unknown age. From 21-JUL-2017 to 07-AUG-2017 the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # N002202 for prophylaxis. Sender's Comments: US-009507513-1708USA005022.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Balance disorder, Cyanosis, Disorientation, Injury, Loss of consciousness
Clinical narrative: This spontaneous report as received from a medical assistant refers to an 11 year old male patient. The patient had no pertinent medical history and drug reactions/allergies. On 28-AUG-2017, the patient was vaccinated with GARDASIL 9 (strength, dose and route of administration were not reported) lot/batch#N010497, expiration date 15-JAN-2020 for prophylaxis. Concomitant therapy included methylphenidate hydrochloride(CONCERTA but reported as CONCENTRA). On 28-AUG-2017, approximately 1 minute after receiving GARDASIL 9, the patient didn't "feel good" and he became "disorientated, stood up and walked into a wall". The patient "then became unconscious and his lips and nose turned blue". It was reported that the physician "began cardiopulmonary resuscitation(CPR) and continued until the patient woke up which was about 30 seconds later". Emergency Medical Services(EMS) had been called "but the patient did not go to hospital and eventually walked out of the office on his own. The patient was given treatment for the reported adverse events. No lab diagnostics/studies were performed. The outcome of the events was reported as recovered approximately on 28-AUG-2017. The causality assessment was not provided by the reporter. There was no product quality complaint (PQC) involved. The reporter considered the events to be medically significant and life threatening.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Malaise, Resuscitation
Clinical narrative: This spontaneous report as received from a medical assistant refers to an 11 year old male patient. The patient had no pertinent medical history and drug reactions/allergies. On 28-AUG-2017, the patient was vaccinated with GARDASIL 9 (strength, dose and route of administration were not reported) lot/batch#N010497, expiration date 15-JAN-2020 for prophylaxis. Concomitant therapy included methylphenidate hydrochloride(CONCERTA but reported as CONCENTRA). On 28-AUG-2017, approximately 1 minute after receiving GARDASIL 9, the patient didn't "feel good" and he became "disorientated, stood up and walked into a wall". The patient "then became unconscious and his lips and nose turned blue". It was reported that the physician "began cardiopulmonary resuscitation(CPR) and continued until the patient woke up which was about 30 seconds later". Emergency Medical Services(EMS) had been called "but the patient did not go to hospital and eventually walked out of the office on his own. The patient was given treatment for the reported adverse events. No lab diagnostics/studies were performed. The outcome of the events was reported as recovered approximately on 28-AUG-2017. The causality assessment was not provided by the reporter. There was no product quality complaint (PQC) involved. The reporter considered the events to be medically significant and life threatening.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown ages and genders. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot # N008827 with the expiration date of 16-MAR-2019; exact doses and route of administration were not reported), for prophylaxis. No adverse symptoms were reported.  The administered doses of vaccine experienced a temperature excursion between 6 and 14 Fahrenheit degrees (7.5 F) for 2 hours and between 6 and 14 Fahrenheit degrees (7.3 F) for 13 minutes.  Previous temperature excursion, between 6 and 14 Fahrenheit degrees (10.9 F), occurred for 1 hour. Digital data logger was involved to capture the temperature excursion.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with ROTATEQ lot # M044030, oral for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ.
Age: 33.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Injection site warmth, Skin warm
Clinical narrative: This spontaneous report as received from a other refers to a 33 year old male patient with colitis ulcerative. On 22-AUG-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N010105, intramuscular for prophylaxis. On 22-AUG-2017, 1 day after onset of therapy, the patient experienced injection site erythema, injected limb mobility decreased, skin warm, injection site warmth and injection site swelling. The outcome of skin warm, injection site warmth, injection site swelling, injection site erythema and injected limb mobility decreased was reported as recovering/resolving.       Additional information has been requested.; Sender's Comments: US-009507513-1708USA013357:
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Injection site warmth, Skin warm
Clinical narrative: This spontaneous report as received from a other refers to a 61 year old female patient with hypothyroidism, blood cholesterol increased and drug hypersensitivity. On 29-AUG-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N010105, intramuscular for prophylaxis. Concomitant therapies included losartan potassium (COZAAR) and levothyroxine sodium (SYNTHROID). On 29-AUG-2017, 1 day after onset of therapy, the patient experienced injection site erythema, skin warm, injected limb mobility decreased, injection site warmth and injection site swelling.  The outcome of skin warm, injection site warmth, injection site swelling, injection site erythema and injected limb mobility decreased is unknown. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA013312:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician and refers to a multiple patient of unknown age and gender. Information on medical history, past drugs, concurrent conditions and concomitant medications were not provided. Physician reported that, on unspecified dates, multiple patients were vaccinated with improperly stored VARIVAX, (lot # N007930, Exp date: 08-MAR-2019), (dose, frequency were not provided) for prophylaxis and properly stored sterile diluent (dosage therapy not reported, (Lot # L025375, Exp Date: 14-MAR-2018). No adverse effects were reported. No additional information was provided. Product was stored at a temperature of 9 (degree Centigrade) °C to 8°C. Time frame was for 25 minutes. There was no previous temperature excursion. It was reported that call was because of a digital data logger.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX for prophylaxis. On an unknown date, the patient experienced injection site pain, injection site swelling and injection site erythema. The outcome of injection site pain, injection site swelling and injection site erythema was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: MENB
Symptoms: Vaccination complication
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A patient of unknown age, gender and race/ethnicity received 2 single doses of TRUMENBA on unspecified dates for immunization. Medical history and concomitant medications were not reported. The patient experienced an adverse reaction (local) to both doses. Outcome was not reported.
Age: 75.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Dysphagia, Extra dose administered, Eye pain, Feeding disorder, Feeling abnormal
Clinical narrative: Initial unsolicited report received from a consumer on 21-AUG-2017. This case involves a 75-year-old female patient who was vaccinated with an intramuscular second dose of (IMOVAX) in right deltoid and patient also received an intramuscular second dose of RABAVERT (manufacturer: GSK) in the left deltoid (for both the vaccines: batch number, expiry date, dose were not reported) on 03-AUG-2017. Patient's Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as none. Concomitant medications were not reported. On 03-AUG-2017, same day following the vaccination, the patient had headache which comes and goes like a shooting pain, muscle weakness, atrophy in muscles of arms and legs, losing weight, she is hungry but cannot eat, low BP, neck and shoulder stiffness, eye pain, brain feels foggy, weakness in legs, difficulty in swallowing and is uncertain if her throat is swollen, pain in her ribs. It was an actual medication error due to extra dose administered. No lab test was performed. Corrective treatment was not reported. The patient did not recovered from the events at the time of reporting (Patient states her symptoms are ongoing and not subsiding). List of documents held by sender: none. "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 and Module 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."
Age: 75.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Headache, Hunger, Hypotension, Muscle atrophy, Muscular weakness
Clinical narrative: Initial unsolicited report received from a consumer on 21-AUG-2017. This case involves a 75-year-old female patient who was vaccinated with an intramuscular second dose of (IMOVAX) in right deltoid and patient also received an intramuscular second dose of RABAVERT (manufacturer: GSK) in the left deltoid (for both the vaccines: batch number, expiry date, dose were not reported) on 03-AUG-2017. Patient's Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as none. Concomitant medications were not reported. On 03-AUG-2017, same day following the vaccination, the patient had headache which comes and goes like a shooting pain, muscle weakness, atrophy in muscles of arms and legs, losing weight, she is hungry but cannot eat, low BP, neck and shoulder stiffness, eye pain, brain feels foggy, weakness in legs, difficulty in swallowing and is uncertain if her throat is swollen, pain in her ribs. It was an actual medication error due to extra dose administered. No lab test was performed. Corrective treatment was not reported. The patient did not recovered from the events at the time of reporting (Patient states her symptoms are ongoing and not subsiding). List of documents held by sender: none. "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 and Module 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."
Age: 75.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Musculoskeletal chest pain, Musculoskeletal stiffness, Pain, Weight decreased
Clinical narrative: Initial unsolicited report received from a consumer on 21-AUG-2017. This case involves a 75-year-old female patient who was vaccinated with an intramuscular second dose of (IMOVAX) in right deltoid and patient also received an intramuscular second dose of RABAVERT (manufacturer: GSK) in the left deltoid (for both the vaccines: batch number, expiry date, dose were not reported) on 03-AUG-2017. Patient's Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as none. Concomitant medications were not reported. On 03-AUG-2017, same day following the vaccination, the patient had headache which comes and goes like a shooting pain, muscle weakness, atrophy in muscles of arms and legs, losing weight, she is hungry but cannot eat, low BP, neck and shoulder stiffness, eye pain, brain feels foggy, weakness in legs, difficulty in swallowing and is uncertain if her throat is swollen, pain in her ribs. It was an actual medication error due to extra dose administered. No lab test was performed. Corrective treatment was not reported. The patient did not recovered from the events at the time of reporting (Patient states her symptoms are ongoing and not subsiding). List of documents held by sender: none. "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 and Module 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."
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Crying, Dysphagia, Eye pruritus, Eye swelling, Lip swelling
Clinical narrative: Initial unsolicited case received from a health care professional (medical assistant) on 21 Aug 2017. This case involves four-year-old male patient who was vaccinated with a dose of QUADRACEL (Batch number: C5248AA, expiry date, dose, and dose in series were not reported) via intramuscular route in left thigh on 21 Aug 2017. The patient had no illness at the time of vaccination, and no pre-existing physician diagnosed allergies, birth defects, and medical conditions. Concomitant medications were not reported. On 21 Aug 2017, same day following the vaccination, the patient began crying and with his eyes feeling itchy, the patient also developed hives on his face and his eyes and lips became swollen. Benadryl (diphenhydramine hydrochloride) 10mg was given to the patient but then the patient could not swallow. MD administered an epi pen (epinephrine) and called 911, and by the time the ambulance arrived the patient was able to swallow, and he was taken to the ER. The patient relevant lab tests were unknown. Other corrective treatment was not reported. On an unknown date, the patient recovered from the event could not swallow, and the outcome of all the other events were unknown. Upon internal review the company decided to consider the case as serious due to important medical events Unable to swallow, Itchy eyes, hives broke out on his face, eyes swollen, and swollen lips. List of documents held by sender: none.; Sender's Comments: Patient experienced crying , itchy eyes, hives, eyes swollen, swollen lips, unable to swallow. Itchy eyes, hives, eyes swollen, swollen lips and unable to swallow are taken as listed under classic symptoms of anaphylactic reaction. Time to onset is compatible with the role of vaccine. Additional information including but not limited to confirmed diagnosis, the patient's immunization history (i.e., previous immunizations and any adverse events following immunization), allergic history, previous similar episodes as well as allergy testing to identify the culprit allergen are needed to further assess this case. Based on the information available, a role of the vaccine cannot be assessed.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Urticaria
Clinical narrative: Initial unsolicited case received from a health care professional (medical assistant) on 21 Aug 2017. This case involves four-year-old male patient who was vaccinated with a dose of QUADRACEL (Batch number: C5248AA, expiry date, dose, and dose in series were not reported) via intramuscular route in left thigh on 21 Aug 2017. The patient had no illness at the time of vaccination, and no pre-existing physician diagnosed allergies, birth defects, and medical conditions. Concomitant medications were not reported. On 21 Aug 2017, same day following the vaccination, the patient began crying and with his eyes feeling itchy, the patient also developed hives on his face and his eyes and lips became swollen. Benadryl (diphenhydramine hydrochloride) 10mg was given to the patient but then the patient could not swallow. MD administered an epi pen (epinephrine) and called 911, and by the time the ambulance arrived the patient was able to swallow, and he was taken to the ER. The patient relevant lab tests were unknown. Other corrective treatment was not reported. On an unknown date, the patient recovered from the event could not swallow, and the outcome of all the other events were unknown. Upon internal review the company decided to consider the case as serious due to important medical events Unable to swallow, Itchy eyes, hives broke out on his face, eyes swollen, and swollen lips. List of documents held by sender: none.; Sender's Comments: Patient experienced crying , itchy eyes, hives, eyes swollen, swollen lips, unable to swallow. Itchy eyes, hives, eyes swollen, swollen lips and unable to swallow are taken as listed under classic symptoms of anaphylactic reaction. Time to onset is compatible with the role of vaccine. Additional information including but not limited to confirmed diagnosis, the patient's immunization history (i.e., previous immunizations and any adverse events following immunization), allergic history, previous similar episodes as well as allergy testing to identify the culprit allergen are needed to further assess this case. Based on the information available, a role of the vaccine cannot be assessed.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Initial unsolicited case received from a consumer on 22-AUG-2017. This case involves a 38-year-old male patient who was vaccinated with 0.5 ml dose of ADACEL for Immunization (batch number: U1234AA, frequency: once, expiry date and dose in series were not reported) via intramuscularly in the left deltoid on 16-AUG-2017. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, patient developed pain in left arm, redness and swelling at injection site. Lab tests were not reported. As corrective treatment, patient was treated with steroid cream. Outcome of all events was reported as not recovered. List of documents held by sender: none.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Culture throat negative, Decreased appetite, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever 101-102, sore throat, headache, loss of appetite, and rash or hive on 08/31/2017 at night time.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Fever 101-102, sore throat, headache, loss of appetite, and rash or hive on 08/31/2017 at night time.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Peripheral swelling
Clinical narrative: Patient said arm swelled some and she couldnt move her arm up or down. She went to doctor.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient did not have adverse reaction. Administered the PENTACEL combination, forgot to add liquid to the HIB powder.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Irritability, Rash generalised, Rash macular, Scratch
Clinical narrative: At around 9:30 am on 9/1/2017 mother noted "red  blotches all over body  his body from head to toe. "States he was "alittle irritable." States the rash is "bad" on his stomach looks like big mosquito bites. Also states that he has scratches on his legs like he had been scratching.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Depressed level of consciousness, Electrocardiogram, Feeling abnormal, Feeling cold, Muscle twitching
Clinical narrative: After administering  the Hepatitis A vaccine and HPV vaccine, I was preparing to administer the MENVEO. But after administering the Hepatitis A and HPV vaccines client stated arm felt funny. Client then stated she needed to "throw up". Client vomited small amount in trash can. She then became very pale and began to lose consciousness. EMS was notified. She was moved onto the floor on her side to prevent aspiration. Vitals were taken. Blood pressure was 87/57, heart rate 74, SP02 98% room air. Pupils were dilated but when tested with pen light their response was equal and reactive to light. Client slowly became responsive. EMS took client's blood pressure while she was laying on the floor, sitting and then could not obtain one on her when she was standing. Client while sitting had twitches in lower extremities and stated she felt very cold. Client taken to hospital via EMS. MENVEO vaccine was wasted.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Mydriasis, Nausea, Pallor, Presyncope, Vomiting
Clinical narrative: After administering  the Hepatitis A vaccine and HPV vaccine, I was preparing to administer the MENVEO. But after administering the Hepatitis A and HPV vaccines client stated arm felt funny. Client then stated she needed to "throw up". Client vomited small amount in trash can. She then became very pale and began to lose consciousness. EMS was notified. She was moved onto the floor on her side to prevent aspiration. Vitals were taken. Blood pressure was 87/57, heart rate 74, SP02 98% room air. Pupils were dilated but when tested with pen light their response was equal and reactive to light. Client slowly became responsive. EMS took client's blood pressure while she was laying on the floor, sitting and then could not obtain one on her when she was standing. Client while sitting had twitches in lower extremities and stated she felt very cold. Client taken to hospital via EMS. MENVEO vaccine was wasted.
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Asthenia, Fatigue, Hyporesponsive to stimuli, Syncope
Clinical narrative: Child was given a Hepatitis A vaccine at 9:30 a.m. and then had a syncopal episode. Ammonia inhalant was administered and the child regained consciousness. Child was given juice box and a cold pack applied. Supervisor was called in to the room. Child was giving delayed responses to questions, was very fatigued and physically weak when asked to squeeze Nurse' hand. Vital signs taken at 9:45 a.m., blood pressure 110/72, pulse 60 bpm. At 9:45 blood pressure was 118/80, pulse 60. EMS was called at 10 a.m. EMS arrived at 10:10 a.m. and stated they would transport child to hospital. Child's mother was present and stated she would follow EMS to hospital. Medical director notified.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Erythema, Feeling cold, Nausea, Pain in extremity
Clinical narrative: 73 y/o female c/o severe pains, redness and swelling on the right arm after she had an Immunization of PCV 13 last week. She also had fever of 102, chills, feeling cold, +nausea but no vomiting, no shortness of breath, no throat tightening, no chest pains, no headaches, feels sleepy most of the time.  She has been taking Tylenol every 2 hours. Denies to have adverse reactions to immunizations in the past. Severe cellulitis of right arm. Post vaccination. Will send patient to ER for further evaluation.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Pyrexia, Somnolence
Clinical narrative: 73 y/o female c/o severe pains, redness and swelling on the right arm after she had an Immunization of PCV 13 last week. She also had fever of 102, chills, feeling cold, +nausea but no vomiting, no shortness of breath, no throat tightening, no chest pains, no headaches, feels sleepy most of the time.  She has been taking Tylenol every 2 hours. Denies to have adverse reactions to immunizations in the past. Severe cellulitis of right arm. Post vaccination. Will send patient to ER for further evaluation.
Age: 25.0
Sex: M
Vaccine: TYP
Symptoms: Bradycardia, Hyperhidrosis, Loss of consciousness, Neurological examination normal, Pallor
Clinical narrative: Brief 20 second loss of consciousness. Pale and diaphoretic. Placed recumbent. Vital signs with normal blood pressure but did have bradycardia at 50 BPM. Complete recovery in 3-5 minutes. Normal neuro exam and ambulatory. No respiratory abnormalities. BP 120/80 HR 66 RR 18 Pulse ox 98%.
Age: 23.0
Sex: F
Vaccine: FLU4, MMR
Symptoms: Nausea, Paraesthesia oral, Pharyngeal paraesthesia, Pruritus
Clinical narrative: Itching, throat and tongue and throat tingling, nauseous. No shortness of breath BENADRYL 50 mg taken. At time of completing this form, 10:45 am, she is still itching with tongue and throat tingling.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Cold sweat, Headache, Hepatitis B antibody positive, Vision blurred, Visual impairment
Clinical narrative: Headache, vision disturbances, blurry, continuous cold sweating from 1:25pm until 8:00pm the day the vaccine was given. No problems 7/29/2017.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient developed a half-dollar size red area at the injection site, the site was observed in the pharmacy 2 days after vaccination, patient stated it did not seem to be growing/getting worse, but was sore. Was given some hydrocortisone cream to help with the reaction.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Limb discomfort
Clinical narrative: The patient reported a reaction in the Left arm where she received her ZOSTAVAX. She said that it is about the size of an Egg (2" x 2"), slightly raised and red in color. It feels achy, and "heavy". The patient currently has the reaction area covered, and plan on trying BENADRYL. I recommended that she involve her PCP is symptoms persist or get worse.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to a patient of unknown age and gender, with no concurrent conditions and medical history reported. On 26-JUL-2017, the patient was vaccinated with improperly stored (18 hours in temperature -12 Celsius degrees) PROQUAD lot # M041083, therapy type RHA, expiration date 04-APR-2018 (route of administration was not reported), for prophylaxis. Other suspect therapy included sterile diluent lot # K019027, expiration date 07-AUG-2017 (dose, frequency and route of administration were not reported). No adverse effects were reported. This is one of four reports from the same reporter. Sender's Comments: US-009507513-1709USA000306: US-009507513-1709USA000305: US-009507513-1709USA000307.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age. From 21-JUL-2017 to 07-AUG-2017 the patients were vaccinated with improperly stored doses of VAQTA lot # N005796 for prophylaxis. Sender's Comments: US-009507513-1708USA012473.
Sex: F
Vaccine: MEA
Symptoms: Measles antibody negative, Psoriasis
Clinical narrative: This spontaneous report was received from a female patient of unknown age, who was also a physician, reporting on herself. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date in the 1960's, the patient was vaccinated with a measles vaccine (manufacturer unknown) injection (dose, route of administration, lot # and expiration date were not reported). However on an unknown date in 2017 (reported as presently), the physician revealed negative titers for the measles vaccine (manufacturer unknown). On an unknown date, the patient experienced psoriasis.  The outcome of the adverse events and the relatedness between the adverse events and measles vaccine (manufacturer unknown) were not reported.  Additional information is not expected as the reporter's contact details were not provided.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to an unknown number of patients of unknown demographics. Information regarding the patient's pertinent medical history and drug reactions or allergies were not provided. On an unknown date, an unknown number of patients were administered improperly stored doses of M-M-R II, therapy type rHA, lot # M048036, expiry date:08-DEC-2018 (dose, frequency and indication not provided). Concomitant therapies included sterile diluent (MERCK). The reporter could not provide the lot and expiration for the properly stored sterile diluent used to reconstitute the doses of M-M-R II. No adverse effects reported. The doses were stored at temperature of 47 degree F to 77 degree F (51.2 F) for 30 minutes. Data logger was involved. The outcome of incorrect product storage and no adverse event were unknown. No additional information provided. No product quality complaint was involved. Lot number M048036 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live. This case is cross-referenced with 1708USA011806 (same reporter). Sender's Comments: US-009507513-1708USA011806.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to an unknown number of patients of unknown demographics. Information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies were not provided. On an unknown date, an unknown number of patients were administered improperly stored doses of ROTATEQ lot # N009948, expiry date: 21-OCT-2018. No adverse effects reported. The doses were stored at temperature of 47 degree F to 77 degree F (51.2 F) for 30 minutes. Data logger was involved. The outcome of incorrect product storage and no adverse event were unknown. No additional information provided. No product quality complaint was involved. This case is cross-referenced with 1708USA011751 (same reporter). Sender's Comments: US-009507513-1708USA011751.