chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Accidental exposure to product, Delivery, Exposure during pregnancy
Clinical narrative: This spontaneous retrospective pregnancy report was received from an office manager concerning a 21 year old female patient. The patient did not have any known medical history, drug allergies/reactions or concomitant medications. In approximately June 2018, the subject became pregnant. The last menstrual period (LMP) was on 20-JUN-2017 and estimated date of delivery (EDD) was on 27-MAR-2018. On 02-JAN-2018, at 28 weeks of pregnancy, the patient was inadvertently accidentally vaccinated with a dose of VARIVAX indicated as prophylaxis (dose, route of administration, lot number and expiration date were not reported). At 37 weeks of gestation, the patient was admitted at an unspecified hospital to deliver the baby. There were no complications reported during delivery, no treatment was given for the adverse event and no laboratory studies were performed. At the time of reporting, the patient recovered from the adverse event. The causal relationship between deliver the baby and VARIVAX was not reported.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy skin, Herpes zoster, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of blister in a female patient who received SHINGRIX for prophylaxis. On 27th March 2018, the patient received SHINGRIX. On 28th March 2018, 1 days after receiving SHINGRIX, the patient experienced blister. On an unknown date, the patient experienced scar. On an unknown date, the outcome of the blister and scar were not reported. It was unknown if the reporter considered the blister and scar to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received shingles shot. The next day the patient had more baby blisters. In 2018, less than year after receiving SHINGRIX the patient arms were covered with scars from the shot.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Scar
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of blister in a female patient who received SHINGRIX for prophylaxis. On 27th March 2018, the patient received SHINGRIX. On 28th March 2018, 1 days after receiving SHINGRIX, the patient experienced blister. On an unknown date, the patient experienced scar. On an unknown date, the outcome of the blister and scar were not reported. It was unknown if the reporter considered the blister and scar to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received shingles shot. The next day the patient had more baby blisters. In 2018, less than year after receiving SHINGRIX the patient arms were covered with scars from the shot.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Injection site hypoaesthesia, Injection site pain, Injection site reaction, Muscular weakness
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of numbness of upper extremities in a 18-year-old male patient who received BEXSERO (batch number 16D501, expiry date 31st March 2019) for prophylaxis. Co-suspect products included BEXSERO for prophylaxis. On 2nd August 2018, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of BEXSERO. On 2nd August 2018, immediately after receiving BEXSERO and not applicable after receiving BEXSERO, the patient experienced numbness of upper extremities, pain in arm and weakness. On an unknown date, the patient experienced incomplete course of vaccination. On 6th August 2018, the outcome of the numbness of upper extremities, pain in arm and weakness were recovered/resolved. On an unknown date, the outcome of the incomplete course of vaccination was unknown. The reporter considered the numbness of upper extremities and pain in arm to be probably related to BEXSERO. It was unknown if the reporter considered the weakness to be related to BEXSERO. Additional details were provided as follows: The patient received a dose of BEXSERO into left deltoid. Immediately following administration of the vaccine, the patient experienced a sensation, further described as numbness and pain, in the bicep and upper arm area. The patient also experienced weakness, numbness, and pain in the left hand and arm. On 2nd August 2018, the patient also had venipuncture on the left arm, but the reporting physician noted that the symptoms were not in the antecubital region where the venipuncture was performed, and the patient reported feeling the sensation immediately following administration of BEXSERO, above the injection site. On day 2 the pain began to decrease and the numbness worsened. On day 3 the numbness began to improve. On 6th August 2018, the patient was seen by his primary physician and all symptoms were resolved. Till 6th September 2018, it was unable to clarify if patient received the second dose of BEXSERO, which led to inappropriate schedule of vaccine.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Asthenia, Hypoaesthesia, Immediate post-injection reaction, Incomplete course of vaccination, Pain in extremity
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of numbness of upper extremities in a 18-year-old male patient who received BEXSERO (batch number 16D501, expiry date 31st March 2019) for prophylaxis. Co-suspect products included BEXSERO for prophylaxis. On 2nd August 2018, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of BEXSERO. On 2nd August 2018, immediately after receiving BEXSERO and not applicable after receiving BEXSERO, the patient experienced numbness of upper extremities, pain in arm and weakness. On an unknown date, the patient experienced incomplete course of vaccination. On 6th August 2018, the outcome of the numbness of upper extremities, pain in arm and weakness were recovered/resolved. On an unknown date, the outcome of the incomplete course of vaccination was unknown. The reporter considered the numbness of upper extremities and pain in arm to be probably related to BEXSERO. It was unknown if the reporter considered the weakness to be related to BEXSERO. Additional details were provided as follows: The patient received a dose of BEXSERO into left deltoid. Immediately following administration of the vaccine, the patient experienced a sensation, further described as numbness and pain, in the bicep and upper arm area. The patient also experienced weakness, numbness, and pain in the left hand and arm. On 2nd August 2018, the patient also had venipuncture on the left arm, but the reporting physician noted that the symptoms were not in the antecubital region where the venipuncture was performed, and the patient reported feeling the sensation immediately following administration of BEXSERO, above the injection site. On day 2 the pain began to decrease and the numbness worsened. On day 3 the numbness began to improve. On 6th August 2018, the patient was seen by his primary physician and all symptoms were resolved. Till 6th September 2018, it was unable to clarify if patient received the second dose of BEXSERO, which led to inappropriate schedule of vaccine.
Age: 54.0
Sex: M
Vaccine: FLU4, PPV, PPV, UNK
Symptoms: Headache, Mobility decreased, Myalgia, Nausea
Clinical narrative: This spontaneous report was received from a consumer refers to her husband 54-year-old patient. Patient's concurrent condition, medical history, concomitant medications were not reported. On 11-SEP-2018, the patient was vaccinated with PNEUMOVAX 23 (unknown lot/exp date) and influenza virus vaccine (INFLUENZA VIRUS VACCINE (unknown manufacturer, unknown lot/expiry date)) in the left arm for prophylaxis. On the same day around 18:00, the patient experienced terrible headache. Around midnight on the same day of vaccination (approximated as 11-SEP-2018) the patient developed chills, pain in his arm around the injection site was unbearable to the point he could not move his arm nor could anyone touch his arm (injection site pain, pain in extremity), also developed a rash that went from his left shoulder to his elbow and across his chest to his heart, the rash was very hot to the touch (rash generalized). On 12-SEP-2018, the patient was hospitalized and treated with antibiotics and fluids overnight and discharged on 13-SEP-2018. The patient developed very bad cough, chocking, skin discolouration and asthenia at home after discharge. The outcome of the adverse events  terrible headache, chills, injection site pain, pain in extremity,rash generalized, bad cough, chocking, skin discolouration and asthenia were not recovered. The causality for the adverse events: terrible headache, chills, injection site pain, pain in extremity, rash generalized, bad cough, chocking, skin discolouration and asthenia was unknown. This is one of two reports received from a same reporter.
Age: 54.0
Sex: M
Vaccine: FLU4, PPV, PPV, UNK
Symptoms: Asthenia, Chills, Choking, Cough, Headache
Clinical narrative: This spontaneous report was received from a consumer refers to her husband 54-year-old patient. Patient's concurrent condition, medical history, concomitant medications were not reported. On 11-SEP-2018, the patient was vaccinated with PNEUMOVAX 23 (unknown lot/exp date) and influenza virus vaccine (INFLUENZA VIRUS VACCINE (unknown manufacturer, unknown lot/expiry date)) in the left arm for prophylaxis. On the same day around 18:00, the patient experienced terrible headache. Around midnight on the same day of vaccination (approximated as 11-SEP-2018) the patient developed chills, pain in his arm around the injection site was unbearable to the point he could not move his arm nor could anyone touch his arm (injection site pain, pain in extremity), also developed a rash that went from his left shoulder to his elbow and across his chest to his heart, the rash was very hot to the touch (rash generalized). On 12-SEP-2018, the patient was hospitalized and treated with antibiotics and fluids overnight and discharged on 13-SEP-2018. The patient developed very bad cough, chocking, skin discolouration and asthenia at home after discharge. The outcome of the adverse events  terrible headache, chills, injection site pain, pain in extremity,rash generalized, bad cough, chocking, skin discolouration and asthenia were not recovered. The causality for the adverse events: terrible headache, chills, injection site pain, pain in extremity, rash generalized, bad cough, chocking, skin discolouration and asthenia was unknown. This is one of two reports received from a same reporter.
Age: 54.0
Sex: M
Vaccine: FLU4, PPV, PPV, UNK
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site rash, Rash, Rash generalised
Clinical narrative: This spontaneous report was received from a consumer refers to her husband 54-year-old patient. Patient's concurrent condition, medical history, concomitant medications were not reported. On 11-SEP-2018, the patient was vaccinated with PNEUMOVAX 23 (unknown lot/exp date) and influenza virus vaccine (INFLUENZA VIRUS VACCINE (unknown manufacturer, unknown lot/expiry date)) in the left arm for prophylaxis. On the same day around 18:00, the patient experienced terrible headache. Around midnight on the same day of vaccination (approximated as 11-SEP-2018) the patient developed chills, pain in his arm around the injection site was unbearable to the point he could not move his arm nor could anyone touch his arm (injection site pain, pain in extremity), also developed a rash that went from his left shoulder to his elbow and across his chest to his heart, the rash was very hot to the touch (rash generalized). On 12-SEP-2018, the patient was hospitalized and treated with antibiotics and fluids overnight and discharged on 13-SEP-2018. The patient developed very bad cough, chocking, skin discolouration and asthenia at home after discharge. The outcome of the adverse events  terrible headache, chills, injection site pain, pain in extremity,rash generalized, bad cough, chocking, skin discolouration and asthenia were not recovered. The causality for the adverse events: terrible headache, chills, injection site pain, pain in extremity, rash generalized, bad cough, chocking, skin discolouration and asthenia was unknown. This is one of two reports received from a same reporter.
Age: 54.0
Sex: M
Vaccine: FLU4, PPV, PPV, UNK
Symptoms: Skin discolouration, Skin warm
Clinical narrative: This spontaneous report was received from a consumer refers to her husband 54-year-old patient. Patient's concurrent condition, medical history, concomitant medications were not reported. On 11-SEP-2018, the patient was vaccinated with PNEUMOVAX 23 (unknown lot/exp date) and influenza virus vaccine (INFLUENZA VIRUS VACCINE (unknown manufacturer, unknown lot/expiry date)) in the left arm for prophylaxis. On the same day around 18:00, the patient experienced terrible headache. Around midnight on the same day of vaccination (approximated as 11-SEP-2018) the patient developed chills, pain in his arm around the injection site was unbearable to the point he could not move his arm nor could anyone touch his arm (injection site pain, pain in extremity), also developed a rash that went from his left shoulder to his elbow and across his chest to his heart, the rash was very hot to the touch (rash generalized). On 12-SEP-2018, the patient was hospitalized and treated with antibiotics and fluids overnight and discharged on 13-SEP-2018. The patient developed very bad cough, chocking, skin discolouration and asthenia at home after discharge. The outcome of the adverse events  terrible headache, chills, injection site pain, pain in extremity,rash generalized, bad cough, chocking, skin discolouration and asthenia were not recovered. The causality for the adverse events: terrible headache, chills, injection site pain, pain in extremity, rash generalized, bad cough, chocking, skin discolouration and asthenia was unknown. This is one of two reports received from a same reporter.
Age: 27.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Erythema, Pyrexia
Clinical narrative: MILD FEVER.
Age: 27.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Pyrexia
Clinical narrative: MILD FEVER.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient received 4 vaccinations at approximately 3:55pm on 9/28/2018. Two immunizations were injected intramuscularly in the right detoid (SHINGRIX and FLUZONE-HD), while the other two immunizations were injected intramuscularly in the left deltoid (BOOSTRIX and PNEUMOVAX). Patient's husband called pharmacy around 10am on 9/30/2018 to notify of wife's swollen deltoid area of right arm; stated it was warm to touch, red, and painful. Other vaccines patient received that day were BOOSTRIX and PNEUMOVAX on her left arm (with no issues, no swelling, etc).
Age: 76.0
Sex: F
Vaccine: DTAP, FLU3, PPV
Symptoms: Chills, Neck pain, Pain, Pyrexia
Clinical narrative: Neck ache at first, chills, fever up to 104, aching all over, lasting 3 days.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age. Information about drug reactions/allergies, concomitant medication and medical history was not provided. On an unknown date the patient was administered an improperly stored dose of PEDVAXHIB (lot # N024571, expiration date 01-MAY-2020) intramuscularly for prophylaxis. No adverse effects reported. The outcome of the events was unknown.
Age: 46.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from an office manager and refers to a 46-year-old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 07-SEP-2018, the patient was vaccinated with PROQUAD, subcutaneously for prophylaxis (dose, lot #, expiration date and therapy type were not provided). Vaccine was reconstituted with sterile diluent. No adverse effect was reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information regarding medical history, concurrent conditions or concomitant medication was not provided. On 17-SEP-2018, the patient was vaccinated with improperly stored GARDASIL 9 lot # R011628, expiration date 11-DEC-2020, for prophylaxis (dosage information and route were not reported). No adverse effects reported. The temperature/time frame was below 0 degree C (-1.64 degree C) for 24 hours. There was no previous temperature excursion. A data logger was involved.
Sex: M
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a health care professional via a company representative and refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date (reported as "recently"), the patient was vaccinated with GARDASIL 9, 0.5 ml, once for prophylaxis (route of administration, dose #, lot # and expiration date were not provided). On unspecified date, the patient and had a raised red bump the size of a quarter at the injection site and that it was painful. The outcome of the events was not reported. The causality between the events and the GARDASIL 9 was not provided.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Vaccination site swelling
Clinical narrative: This spontaneous report has been received from a Medical Assistant concerning a 74 year old male patient. The patient's concurrent conditions included drug reaction/allergy to penicillin. The patient's concomitant therapies included unspecified blood pressure and cholesterol medications. It was reported that on an unknown date in 2016, the patient received PREVNAR 13. The patient had no pertinent medical history. On 02-JUL-2018, the patient was vaccinated with PNEUMOVAX 23 with lot number R009163 and expiration date on 06-JAN-2020, 0.5 ml once, administered intramuscularly in the left arm for prophylaxis (dose number was not provided). In July 2018 (reported as "within 12 hours of getting the PNEUMOVAX 23"), the patient's left arm was swelling around the vaccination site and spread to left hand. It was reported that the patient took BENADRYL and he recovered from the events in July 2018 (reported as "within three days after symptoms appeared"). No lab diagnostics or studies were performed. On 18-SEP-2018, the patient visited a physician. At the time of reporting, the causal relationship between PNEUMOVAX 23 and the events of vaccination site swelling and peripheral swelling was unknown.
Sex: U
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: This spontaneous report was received from a other health professional referring to an unspecified group of child patients. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On an unknown date, the patients' were vaccinated with M-M-R II (anatomical route of vaccination, lot # and expiration date were not provided) for prophylaxis. It was reported that, on an unknown date, an outbreak of mumps occurred at the school. It was unknown how many children were involved or if any children were vaccinated with M-M-R II. At the time of the report, the outcome of mumps and the causality between the reported event and vaccination with M-M-R II were unknown.
Age: 0.08
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse via company representative, referring to an approximately 4 weeks old patient of unknown gender and ethnicity. The patient's concurrent conditions, medical history and concomitant medications were not reported. The reported stated that on an unspecified date, an unspecified patient started ROTATEQ, oral (dose, frequency, lot/batch number and expiration date were not provided) series at 4 weeks of age instead of the recommended 6 weeks of age. (Inappropriate age at vaccine administration) for prophylaxis. No Adverse event was reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies and drug or allergy reactions were not provided. On 14-SEP-2018, the patient was vaccinated with a improperly stored dose of PNEUMOVAX 23 lot number R005345, expiration date 01-MAR-2020 (strength, dose, dose number and administration were not reported), for prophylaxis. The data logger registered a temperature excursion below 0 Celsius (C) for 41 hours and 0 C to 1 C for 49 hours. There was not previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA013661: US-009507513-1809USA013662: US-009507513-1809USA013663: US-009507513-1809USA013664: US-009507513-1809USA013665: US-009507513-1809USA013666: US-009507513-1809USA013667.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report was received from a health care professional, via the Agency and refers to an approximately 61 year old female patient. Information regarding the patient's pertinent medical history or concomitant medications was unknown by the reporter. The patient's previous drug reactions/allergies included sulfonamide and penicillin (reported as sulfa and pene). On 18-SEP-2018, the patient was vaccinated with PNEUMOVAX 23 1 dosage form (DF) for prophylaxis (dose number, anatomical site of administration, lot number and expiration date were unknown by the reporter). On an unknown date, following the vaccine administration, the patient experienced an unspecified serious reaction. No further information or clarifying details were reported. It was unknown by the reporter if the patient received any treatment; if any laboratory or any other diagnostic studies were performed to her, or if she sought for medical attention regarding the adverse event. The outcome of serious adverse reaction was unknown. The action taken with PNEUMOVAX 23 was not applicable.  The causal relationship between PNEUMOVAX 23 regarding unspecified serious reaction regarding was unknown by the reporter. Upon internal review unspecified serious reaction was medically significant.
Age: 4.0
Sex: F
Vaccine: HEPA, HEPA, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 4 year old female patient. Information on the patient's pertinent medical history was not reported. The patient had no known allergies. Concomitant therapies included PROQUAD. On 17-SEP-2018, the patient was inadvertently vaccinated with both VAQTA and HAVRIX for prophylaxis (dosing details, route, lot # and expiry date unknown). The patient sought medical attention at physician's office. No adverse event was reported. No product quality complaint was involved.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from registered nurse referring to a currently 11 year old male patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 21-SEP-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N026073, expiration date: 20-SEP-2019 (additional dosage regimen information was not provided) for prophylaxis. It could not be further clarified if sterile diluent was stored appropriately. No adverse event was reported. The vaccine was exposed to multiple temperature excursions to -12.4 Celsius degrees for a timeframe of 4 hours and 30 minutes. It was found because of a digital data logger.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
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 VARIVAX for prophylaxis. Other suspect therapies included PROQUAD. Concomitant therapies included sterile diluent. On an unknown date the patient experienced accidental overdose and no adverse event. The outcome of accidental overdose and no adverse event is unknown. The reporter considered no adverse event to be not assessed to PROQUAD and VARIVAX. The reporter considered accidental overdose to be not assessed to VARIVAX and PROQUAD. Lot Number R011008 has been verified not valid for VARIVAX.
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Immediate post-injection reaction
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a female patient of unknown age. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported) for prophylaxis and immediately experienced difficulty breathing. The patient was taken to the unspecified hospital (it was unknown if she was admitted). The outcome of the event was unknown. Causality assessment was not provided. The reporter considered the event to be life threatening.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On 24-SEP-2018, the patient was vaccinated with an expired dose of M-M-R II lot # M032157 with expiration date: 01-JUL-2018 (strength, dose, route and anatomical location were not provided) for prophylaxis. No adverse symptoms reported. The dose of M-M-R II did not have any temperature excursions prior to administration.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a non-pregnant 65 year old female patient with no pertinent medical history. Concomitant therapies included NORVASC, TOPROL XL, LIPITOR and ACCUPRIL. On 24-SEP-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly for prophylaxis (anatomical location, lot/batch # and expiration date were not reported). On the same date, she developed large swelling and redness from shoulder to elbow. It was reported that the patient received treatment (unspecified) for the events and not lab diagnostics were performed. The patient did not need hospitalization or intervention to prevent serious criteria, as did not present disability or a life threatening event. The outcome of peripheral swelling and erythema was reported as not resolved. The causality assessment between peripheral swelling and erythema with the therapy with PNEUMOVAX 23 was not reported.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 66 year old female patient. The patient had no pertinent medical history, drug reactions or allergies. On 21-SEP-2018, the patient was vaccinated with PNEUMOVAX 23 lot number: R000579, expiration date: 09-SEP-2019, intramuscularly, in the right arm, for prophylaxis (strength and dosage schedule were not reported). On the same day, the patient was vaccinated intramuscularly also in the right arm with an unspecified influenza virus vaccine (strength, dosage schedule, indication, lot number and expiration date were not reported).     Later on 21-SEP-2018 (a few hours later), the patient experienced injection site pain, swelling, erythema and developed a fever of 102 °F and the patient self-medicated with ice and diphenhydramine (BENEDRYL) without relief; therefore, the patient was examined at the hospital emergency room and was provided unspecified medical treatment, but no laboratory tests were carried out. On an unspecified day in September 2018, the patient was discharge to home on oral cephalexin (KEFLEX). The outcome of injection site pain, injection site erythema, injection site swelling and fever was reported as not recovered. The reporter did not assess the relatedness of the aforementioned adverse events with PNEUMOVAX 23 and the unspecified influenza virus vaccine .
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 19-SEP-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # N023828 with expiration date reported as 25-JUN-2020 (dose, frequency and route were not provided) for prophylaxis. No adverse effects reported. The vaccine was stored at a temperature of 47 Fahrenheit degree to 77 Fahrenheit degrees with a time frame of 1 hour and 10 minutes and previous temperature excursion of 47 Fahrenheit degree to 77 Fahrenheit degrees for 1 hour and 27 minutes and 47 Fahrenheit degree to 77 Fahrenheit degrees for 1 hour and 5 minutes. Digital Data logger was involved. This is one of eight reports received from the same reporter. Sender's Comments: US-009507513-1809USA013685: US-009507513-1809USA013686: US-009507513-1809USA013687: US-009507513-1809USA013684: US-009507513-1809USA013688: US-009507513-1809USA013682: US-009507513-1809USA013683.
Sex: M
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Oral administration complication, Vomiting
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to a 4 month old male patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. In July 2018 (reported as "about two months ago"), the patient was vaccinated with the first dose of ROTATEQ orally, and on 19-SEP-2018, he received the second dose of ROTATEQ orally, both for prevention of rotavirus (dose, lot number and expiration date were not reported). In July 2018, the patient vomited immediately after administration of the first dose of ROTATEQ, and then on 19-SEP-2018, he vomited immediately after a second dose of ROTATEQ. It was unknown if the patient received the full dose of ROTATEQ. The patient did not receive treatment for vomiting. The outcome of vomiting was unknown. The causal relationship between the vomiting and ROTATEQ was not reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse, concerning a 4 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant medications were not provided. On 26-SEP-2018, the patient was vaccinated with PROQUAD therapy type rHA, route intramuscularly instead of subcutaneously, lot # R006751 with expiration date 03-SEP-2019 (dose and frequency were not provided) for prophylaxis. No adverse effect reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, and refers to a patient of unknown age and gender. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 26-SEP-2018, the patient was vaccinated with an expired vaccine of VAQTA 50/1.0 U/ml, lot # N016805 with expiration date on 04-SEP-2018 (route of administration was not reported). However, no adverse event were reported.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 75 year old patient. The patient's concurrent conditions, medical history and concomitant medications were not provided. On an unspecified date in February 2018, the patient was vaccinated with the first dose of PNEUMOVAX 23 (strength, dose, route, frequency, lot # and expiration date were not provided) for prophylaxis. On an unspecified date in August 2018, the patient inadvertently received a second dose of PNEUMOVAX 23 (strength, dose, route, frequency, lot # and expiration date were not provided). No adverse effects reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. Concomitant therapies included sterile diluent. On 27-SEP-2018, the patient was vaccinated with improperly stored dose of VARIVAX (strength, dose, route of administration were unknown) with lot # R002507 and expiration date of 25-JAN-2020 for prophylaxis which was stored from 6 Fahrenheit degrees (°F) to 14 °F for 30 minutes and was determined due to a data logger. There was no previous temperature excursions. No adverse effects were reported. This is one of two cases from the same reporter. Sender's Comments: US-009507513-1809USA013459.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies and drug or allergy reactions were not provided. On 14-SEP-2018, the patient was vaccinated with a improperly stored dose of PNEUMOVAX 23 lot number R005345, expiration date 01-MAR-2020 (strength, dose, dose number and administration route were not reported), for prophylaxis. The data logger registered a temperature excursion below 0 Celsius (C) for 41 hours and 0 C to 1 C for 49 hours. There was not previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA009938.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies and drug or allergy reactions were not provided. On 17-SEP-2018, the patient was vaccinated with a improperly stored dose of PNEUMOVAX 23 lot number R005345, expiration date 01-MAR-2020 (strength, dose, dose number and administration route were not reported), for prophylaxis. The data logger registered a temperature excursion below 0 Celsius (C) for 41 hours and 0 C to 1 C for 49 hours. There was not previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA009938.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies and drug or allergy reactions were not provided. On 18-SEP-2018, the patient was vaccinated with a improperly stored dose of PNEUMOVAX 23 lot number R005345, expiration date 01-MAR-2020 (strength, dose, dose number and administration route were not reported), for prophylaxis. The data logger registered a temperature excursion below 0 Celsius (C) for 41 hours and 0 C to 1 C for 49 hours. There was not previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA009938.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 20-SEP-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # N023828 with expiration date reported as 25-JUN-2020 (dose, frequency and route were not provided) for prophylaxis. No adverse effects reported. The vaccine was stored at a temperature of 47 Fahrenheit degree to 77 Fahrenheit degrees with a time frame of 1 hour and 10 minutes and previous temperature excursion of 47 Fahrenheit degree to 77 Fahrenheit degrees for 1 hour and 27 minutes and 47 Fahrenheit degree to 77 Fahrenheit degrees for 1 hour and 5 minutes. Digital Data logger was involved. This is one of eight reports received from the same reporter. Sender's Comments: US-009507513-1809USA013685: US-009507513-1809USA013686: US-009507513-1809USA013687: US-009507513-1809USA013684: US-009507513-1809USA013688: US-009507513-1809USA012930: US-009507513-1809USA013683.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 20-SEP-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # N023828 with expiration date reported as 25-JUN-2020 (dose, frequency and route were not provided) for prophylaxis. No adverse effects reported. The vaccine was stored at a temperature of 47 Fahrenheit degree to 77 Fahrenheit degrees with a time frame of 1 hour and 10 minutes and previous temperature excursion of 47 Fahrenheit degree to 77 Fahrenheit degrees for 1 hour and 27 minutes and 47 Fahrenheit degree to 77 Fahrenheit degrees for 1 hour and 5 minutes. Digital Data logger was involved. This is one of eight reports received from the same reporter. Sender's Comments: US-009507513-1809USA013685: US-009507513-1809USA013686: US-009507513-1809USA013687: US-009507513-1809USA013684: US-009507513-1809USA013688: US-009507513-1809USA013682: US-009507513-1809USA012930.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 21-SEP-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # N023828 with expiration date reported as 25-JUN-2020 (dose, frequency and route were not provided) for prophylaxis. No adverse effects reported. The vaccine was stored at a temperature of 47 Fahrenheit degree to 77 Fahrenheit degrees with a time frame of 1 hour and 10 minutes and previous temperature excursion of 47 Fahrenheit degree to 77 Fahrenheit degrees for 1 hour and 27 minutes and 47 Fahrenheit degree to 77 Fahrenheit degrees for 1 hour and 5 minutes. Digital Data logger was involved. This is one of eight reports received from the same reporter.; Sender's Comments: US-009507513-1809USA013685: US-009507513-1809USA013686:  US-009507513-1809USA013687: US-009507513-1809USA012930: US-009507513-1809USA013688: US-009507513-1809USA013682: US-009507513-1809USA013683:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 21-SEP-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # N023828 with expiration date reported as 25-JUN-2020 (dose, frequency and route were not provided) for prophylaxis. No adverse effects reported. The vaccine was stored at a temperature of 47 Fahrenheit degree to 77 Fahrenheit degrees with a time frame of 1 hour and 10 minutes and previous temperature excursion of 47 Fahrenheit degree to 77 Fahrenheit degrees for 1 hour and 27 minutes and 47 Fahrenheit degree to 77 Fahrenheit degrees for 1 hour and 5 minutes. Digital Data logger was involved. This is one of eight reports received from the same reporter. Sender's Comments: US-009507513-1809USA012930: US-009507513-1809USA013686: US-009507513-1809USA013687: US-009507513-1809USA013684: US-009507513-1809USA013688: US-009507513-1809USA013682: US-009507513-1809USA013683.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 24-SEP-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # N023828 with expiration date reported as 25-JUN-2020 (dose, frequency and route were not provided) for prophylaxis. No adverse effects reported. The vaccine was stored at a temperature of 47 Fahrenheit degree to 77 Fahrenheit degrees with a time frame of 1 hour and 10 minutes and previous temperature excursion of 47 Fahrenheit degree to 77 Fahrenheit degrees for 1 hour and 27 minutes and 47 Fahrenheit degree to 77 Fahrenheit degrees for 1 hour and 5 minutes. Digital Data logger was involved. This is one of eight reports received from the same reporter. Sender's Comments: US-009507513-1809USA013685: US-009507513-1809USA012930: US-009507513-1809USA013687: US-009507513-1809USA013684: US-009507513-1809USA013688: US-009507513-1809USA013682: US-009507513-1809USA013683.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 24-SEP-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # N023828 with expiration date reported as 25-JUN-2020 (dose, frequency and route were not provided) for prophylaxis. No adverse effects reported. The vaccine was stored at a temperature of 47 Fahrenheit degree to 77 Fahrenheit degrees with a time frame of 1 hour and 10 minutes and previous temperature excursion of 47 Fahrenheit degree to 77 Fahrenheit degrees for 1 hour and 27 minutes and 47 Fahrenheit degree to 77 Fahrenheit degrees for 1 hour and 5 minutes. Digital Data logger was involved. This is one of eight reports received from the same reporter. Sender's Comments: US-009507513-1809USA013685: US-009507513-1809USA013686: US-009507513-1809USA012930: US-009507513-1809USA013684: US-009507513-1809USA013688: US-009507513-1809USA013682: US-009507513-1809USA013683.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 21-SEP-2018 the patient was vaccinated with improperly stored dose of M-M-R II lot # reported as N024150 with expiration date 24-AUG-2019 (dose, frequency and route were not provided) for prophylaxis which was reconstituted with a properly stored of sterile diluent. No adverse effects reported. The vaccine was stored at a temperature of 47 Fahrenheit degree to 77 Fahrenheit degrees with a time frame of 1 hour and 10 minutes and previous temperature excursion of 47 Fahrenheit degree to 77 Fahrenheit degrees for 1 hour and 27 minutes and 47 Fahrenheit degree to 77 Fahrenheit degrees for 1 hour and 5 minutes. Digital Data logger was involved. This is one of eight reports received from the same reporter. Sender's Comments: US-009507513-1809USA013685: US-009507513-1809USA013686: US-009507513-1809USA013687: US-009507513-1809USA013684: US-009507513-1809USA012930: US-009507513-1809USA013682: US-009507513-1809USA013683.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On 20th June 2018, the patient received the 1st dose of SHINGRIX. In July 2018, less than 2 months after receiving SHINGRIX, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles was recovering/resolving and the outcome of the rash was not reported. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were reported as follows: The age group was not reported but was selected as adult as per vaccine indication. The age at vaccination was not reported. The patient got rash in July 2018 after receiving SHINGRIX, but did not think it was shingles. The patient went to dermatologist in August 2018 and after testing, it was shown to be a shingles outbreak. Lab Comments: In August 2018, result of unspecified test shown a shingles outbreak.
Age: 58.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 58-year-old patient who received SHINGRIX (batch number DD43M, expiry date 15th September 2019) for prophylaxis. On 15th September 2018, the patient received SHINGRIX (subcutaneous). In September 2018, less than a week after receiving Shingrix, the patient experienced injection site pain and injection site swelling. On 15th September 2018, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site pain, injection site swelling and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site pain and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: At 2:30 pm, the patient received SHINGRIX in the right arm subcutaneously rather than intramuscular route in error, which led to incorrect route of vaccine administration. The patient complained of swelling and pain at the injection site. No additional details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced fever, pain and pain in arm. On an unknown date, the outcome of the fever, pain and pain in arm were unknown. It was unknown if the reporter considered the fever, pain and pain in arm to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The age group was not reported, but was captured as adult as per the vaccine indication. The patients had experienced fever, sore arm, aches and pain after vaccination with the 1st dose of SHINGRIX. The reporter would not provide any additional information in regards to the patients.