chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site vesicles, Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: Diarrhea, blister at the injection site, severe shoulder pain, headache, swelling at the site, shivering, fever, stomach pain, severe soreness in arm, severe muscle soreness, tiredness.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Diarrhea, blister at the injection site, severe shoulder pain, headache, swelling at the site, shivering, fever, stomach pain, severe soreness in arm, severe muscle soreness, tiredness.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Feeling abnormal, Hypersomnia, Influenza like illness, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 64-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX. On 14th September 2018, the patient received the 1st dose of SHINGRIX. On 14th September 2018, less than a day after receiving SHINGRIX, the patient experienced general body pain, feeling miserable, fever, fatigue, somnolence, nausea and injection site pain. On 15th September 2018, the patient experienced influenza like illness and muscle pain. On 17th September 2018, the outcome of the general body pain, feeling miserable, influenza like illness, fever, fatigue, somnolence, nausea, injection site pain and muscle pain were recovered/resolved. It was unknown if the reporter considered the general body pain, feeling miserable, influenza like illness, fever, fatigue, somnolence, nausea, injection site pain and muscle pain to be related to SHINGRIX. Additional details were reported as follows: The patient received 1st dose of SHINGRIX and the patient experienced a pretty miserable 48 hour thereafter. The patient's symptoms could best be described as flu like, total body aches, fever, extreme fatigue (patient probably slept 15 hours, on and off) and nausea. The patient was pretty much back to normal the day of reporting. The patient asked was this typical. The patient asked can he expect this again after his 2nd shot. The patient got the shot at the pharmacy upon recommendation by his general practitioner. His office had not received their supply yet. He stated his symptoms started the day he received the injection and that Saturday he felt terrible, felt like he had the flu, muscle aches. The day before reporting, he felt slightly better. The patient received vaccine on right arm (shoulder area) and that hurt the day before reporting. He said it did not hurt during the injection itself but afterwards. He said the arm pain had the same onset and duration as his other symptoms. (He plans on completing the 2 shot series).
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 64-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX. On 14th September 2018, the patient received the 1st dose of SHINGRIX. On 14th September 2018, less than a day after receiving SHINGRIX, the patient experienced general body pain, feeling miserable, fever, fatigue, somnolence, nausea and injection site pain. On 15th September 2018, the patient experienced influenza like illness and muscle pain. On 17th September 2018, the outcome of the general body pain, feeling miserable, influenza like illness, fever, fatigue, somnolence, nausea, injection site pain and muscle pain were recovered/resolved. It was unknown if the reporter considered the general body pain, feeling miserable, influenza like illness, fever, fatigue, somnolence, nausea, injection site pain and muscle pain to be related to SHINGRIX. Additional details were reported as follows: The patient received 1st dose of SHINGRIX and the patient experienced a pretty miserable 48 hour thereafter. The patient's symptoms could best be described as flu like, total body aches, fever, extreme fatigue (patient probably slept 15 hours, on and off) and nausea. The patient was pretty much back to normal the day of reporting. The patient asked was this typical. The patient asked can he expect this again after his 2nd shot. The patient got the shot at the pharmacy upon recommendation by his general practitioner. His office had not received their supply yet. He stated his symptoms started the day he received the injection and that Saturday he felt terrible, felt like he had the flu, muscle aches. The day before reporting, he felt slightly better. The patient received vaccine on right arm (shoulder area) and that hurt the day before reporting. He said it did not hurt during the injection itself but afterwards. He said the arm pain had the same onset and duration as his other symptoms. (He plans on completing the 2 shot series).
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 64-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX. On 14th September 2018, the patient received the 1st dose of SHINGRIX. On 14th September 2018, less than a day after receiving SHINGRIX, the patient experienced general body pain, feeling miserable, fever, fatigue, somnolence, nausea and injection site pain. On 15th September 2018, the patient experienced influenza like illness and muscle pain. On 17th September 2018, the outcome of the general body pain, feeling miserable, influenza like illness, fever, fatigue, somnolence, nausea, injection site pain and muscle pain were recovered/resolved. It was unknown if the reporter considered the general body pain, feeling miserable, influenza like illness, fever, fatigue, somnolence, nausea, injection site pain and muscle pain to be related to SHINGRIX. Additional details were reported as follows: The patient received 1st dose of SHINGRIX and the patient experienced a pretty miserable 48 hour thereafter. The patient's symptoms could best be described as flu like, total body aches, fever, extreme fatigue (patient probably slept 15 hours, on and off) and nausea. The patient was pretty much back to normal the day of reporting. The patient asked was this typical. The patient asked can he expect this again after his 2nd shot. The patient got the shot at the pharmacy upon recommendation by his general practitioner. His office had not received their supply yet. He stated his symptoms started the day he received the injection and that Saturday he felt terrible, felt like he had the flu, muscle aches. The day before reporting, he felt slightly better. The patient received vaccine on right arm (shoulder area) and that hurt the day before reporting. He said it did not hurt during the injection itself but afterwards. He said the arm pain had the same onset and duration as his other symptoms. (He plans on completing the 2 shot series).
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 64-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX. On 14th September 2018, the patient received the 1st dose of SHINGRIX. On 14th September 2018, less than a day after receiving SHINGRIX, the patient experienced general body pain, feeling miserable, fever, fatigue, somnolence, nausea and injection site pain. On 15th September 2018, the patient experienced influenza like illness and muscle pain. On 17th September 2018, the outcome of the general body pain, feeling miserable, influenza like illness, fever, fatigue, somnolence, nausea, injection site pain and muscle pain were recovered/resolved. It was unknown if the reporter considered the general body pain, feeling miserable, influenza like illness, fever, fatigue, somnolence, nausea, injection site pain and muscle pain to be related to SHINGRIX. Additional details were reported as follows: The patient received 1st dose of SHINGRIX and the patient experienced a pretty miserable 48 hour thereafter. The patient's symptoms could best be described as flu like, total body aches, fever, extreme fatigue (patient probably slept 15 hours, on and off) and nausea. The patient was pretty much back to normal the day of reporting. The patient asked was this typical. The patient asked can he expect this again after his 2nd shot. The patient got the shot at the pharmacy upon recommendation by his general practitioner. His office had not received their supply yet. He stated his symptoms started the day he received the injection and that Saturday he felt terrible, felt like he had the flu, muscle aches. The day before reporting, he felt slightly better. The patient received vaccine on right arm (shoulder area) and that hurt the day before reporting. He said it did not hurt during the injection itself but afterwards. He said the arm pain had the same onset and duration as his other symptoms. (He plans on completing the 2 shot series).
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13, FLU4, PNC13
Symptoms: Pruritus, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer. A 68-year-old female patient received PREVNAR 13; NCD number: 00005-1971-01, lot number: T94428 and expiration date: Apr2020) in the right deltoid for pneumococcal vaccination and FLUZONE in the left deltoid for flu vaccination; both intramuscular on 18Sep2018 at 0.5 ml, single. Medical history included hypercholesterolemia, hypertension and rheumatoid arthritis. There were no concomitant medications. The patient received FLUZONE for the past 3 years with no reactions and also received REMICADE in 2017, last year, isn't sure if that has anything to do with the patient's reaction. It was reported that the patient received the vaccines on 18Sep2018 at a pharmacy and reported that she had an allergic reaction as hives to the vaccine. The patient stated that her ankles began itching on the evening of 18Sep2018 then she woke up with hives on 19Sep2018. Reporter stated that the hives are mild but widespread on her back, legs, trunk, arms, waist, buttocks, abdomen, and chest. The patient was treated with Diphenhydramine and Prednisone dose pack. The patient also went to the Urgent Care where she received Triamcinolone 0.05% cream, a MEDROL dose pack, and CALADRYL 1-8%. The patient will be following up with her physician. Outcome of the events was unknown.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13, FLU4, PNC13
Symptoms: Hypersensitivity, Pruritus, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer. A 68-year-old female patient received PREVNAR 13; NCD number: 00005-1971-01, lot number: T94428 and expiration date: Apr2020) in the right deltoid for pneumococcal vaccination and FLUZONE in the left deltoid for flu vaccination; both intramuscular on 18Sep2018 at 0.5 ml, single. Medical history included hypercholesterolemia, hypertension and rheumatoid arthritis. There were no concomitant medications. The patient received FLUZONE for the past 3 years with no reactions and also received REMICADE in 2017, last year, isn't sure if that has anything to do with the patient's reaction. It was reported that the patient received the vaccines on 18Sep2018 at a pharmacy and reported that she had an allergic reaction as hives to the vaccine. The patient stated that her ankles began itching on the evening of 18Sep2018 then she woke up with hives on 19Sep2018. Reporter stated that the hives are mild but widespread on her back, legs, trunk, arms, waist, buttocks, abdomen, and chest. The patient was treated with Diphenhydramine and Prednisone dose pack. The patient also went to the Urgent Care where she received Triamcinolone 0.05% cream, a MEDROL dose pack, and CALADRYL 1-8%. The patient will be following up with her physician. Outcome of the events was unknown.
Age: 56.0
Sex: F
Vaccine: RV1
Symptoms: Discomfort, Headache, Lethargy, Middle insomnia, Pain
Clinical narrative: I woke up in the middle of the night several times very uncomfortable with aches and pains. Aching, low grade fever, headache and very lethargic.
Age: 56.0
Sex: F
Vaccine: RV1
Symptoms: Pyrexia
Clinical narrative: I woke up in the middle of the night several times very uncomfortable with aches and pains. Aching, low grade fever, headache and very lethargic.
Age: 30.0
Sex: F
Vaccine: FLUR4
Symptoms: Dry mouth, Injection site pain, Pruritus
Clinical narrative: Prior to injection patient reported she sometimes gets itching from getting vaccines and it occurred last year a few hours after. She was counseled to stay in the area for observation after. She states about 10 minutes after the injection she was feeling itchy on both arms and her hands. She denies other symptoms, other than a dry mouth, but that was present before the injection. She asked if we had BENADRYL, which we did not. She did not exhibit other symptoms warranting an anaphylactic reaction or need for Epinephrine. She remained in the area another 10 minutes and no other symptoms progressed other than feeling pain in the area of the injection and neck. After further discussion encouraged patient to be evaluated at the employee health office instead of using over the counter BENADRYL. Patient was escorted to the clinic at work.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Pain at injection site, fatigue, muscle pain, fever.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Soreness on the injected arm, swelling, redness, not at the injected site but around the arm.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown ages and genders. No information was provided regarding the patients' historical conditions, concurrent conditions, drug reactions, allergies or concomitant medications. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (dose and route of administration unknown) lot # N035937 with expiration date 18-DEC-2019 and lot #N024568 with expiration date 07-SEP-2019, for prophylaxis. All lots of VARIVAX were reconstituted with properly stored sterile diluent (MERCK). The vaccines were stored at a temperature below of -3.1C for the time frame of 1 hour and 28 minutes. There were multiple previous temperature excursions going from -9C to 8C with a duration of 53 hours and 11 minutes. The call was because of a data logger. No adverse event reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about the patient's medical history, concomitant medications and drug reactions/allergies was not provided. On 06-SEP-2018, the patient was inadvertently administered improperly stored PROQUAD (lot # R002934, expired date29-JUL-2019) for prophylaxis (Incorrect product storage), which was reconstituted with properly stored sterile diluent (MERCK). The vaccine was exposed to temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 hour and 46 minutes. Data logger was involved. The vaccine was previously exposed to temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 28 hours and 24 minutes and 15 degrees Fahrenheit to 46 degrees Fahrenheit for 35 hours and 21 minutes. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1809USA011721.
Sex: F
Vaccine: HEPA
Symptoms: Skin laceration, Syringe issue
Clinical narrative: This spontaneous report was received from a female registered nurse of unknown age, regarding herself. The patient's concurrent conditions and medical history were not reported. On 10-SEP-2018, the reporter was administering a dose of VAQTA lot # R011952, expiration date 27-MAY-2019, to a patient, via intramuscular route, for prophylaxis; however, during the administration, the finger flange broke off of one side of the VAQTA prefilled syringe and the nurse cut her middle finger of her right hand on the broken finger flange. It was also mentioned that the patient received the full dose of VAQTA and no adverse events were experienced by the patient. A product quality complaint (PQC) was filled. At the reporting time, the outcome of laceration and product quality issue were not reported. The reporter  did not provide a causality assessment between the events and VAQTA.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to a patient of unknown age and gender. On 13-SEP-2018, the patient might have received an improperly stored dose of VARIVAX (lot # N029628, expired date 23-NOV-2019) subcutaneously for prophylaxis. The temperature excursion in the range of 6 Fahrenheit (F) to 14 F for 21 minutes and in range of 15 F to 46 F for 3 hours and 25 minutes. There was previous temperature excursion of total time in the range of 6 F to 14 F for 34 hours and 57 minutes and in the range 15 F to 46 F for 36 hours and 32 minutes. Data logger involved. No adverse effect was reported. It was unknown if sterile diluent was improperly stored.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, Injection site bruising, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist, via a company representative, referring to a 56 year old male patient with unspecified chronic medical condition. The patient's pertinent medical history was not provided. The reporter did not know the patient's concomitant medications neither his drug reactions/allergies. On an unspecified date in 2017, the patient received his first vaccination with PNEUMOVAX 23 0.5 ml, for unspecified chronic medical condition (strength, route of administration, lot # and expiration date were not reported). Due to the patient chronic condition, he required to get vaccinated annually. Thus, on 16-SEP-2018, reported as "yesterday", the patient was vaccinated with a PNEUMOVAX 23 0.5 ml for unspecified chronic medical condition (strength, route of administration, lot # and expiration date were not reported). One day after, on 17-SEP-2018, the patient called the pharmacy and said he was experiencing, since on an unknown date, pain, bruising and itchiness at the injection site. Also, he was experiencing swelling and as the patient explained it to the pharmacist, the swelling had gone beyond the injection site. All previous information was given to the pharmacist over the phone and the pharmacist did not known if the patient received any treatment for the adverse experiences, if any laboratory study was performed or if the patient sought medical attention. At the reporting time, the patient was not recovered from injection site pain, swelling, injection site pruritus and injection site bruising (outcome also reported as unknown). The causality assessment between the aforementioned adverse events and PNEUMOVAX 23 was not provided.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: This spontaneous report was received from a pharmacist, via a company representative, referring to a 56 year old male patient with unspecified chronic medical condition. The patient's pertinent medical history was not provided. The reporter did not know the patient's concomitant medications neither his drug reactions/allergies. On an unspecified date in 2017, the patient received his first vaccination with PNEUMOVAX 23 0.5 ml, for unspecified chronic medical condition (strength, route of administration, lot # and expiration date were not reported). Due to the patient chronic condition, he required to get vaccinated annually. Thus, on 16-SEP-2018, reported as "yesterday", the patient was vaccinated with a PNEUMOVAX 23 0.5 ml for unspecified chronic medical condition (strength, route of administration, lot # and expiration date were not reported). One day after, on 17-SEP-2018, the patient called the pharmacy and said he was experiencing, since on an unknown date, pain, bruising and itchiness at the injection site. Also, he was experiencing swelling and as the patient explained it to the pharmacist, the swelling had gone beyond the injection site. All previous information was given to the pharmacist over the phone and the pharmacist did not known if the patient received any treatment for the adverse experiences, if any laboratory study was performed or if the patient sought medical attention. At the reporting time, the patient was not recovered from injection site pain, swelling, injection site pruritus and injection site bruising (outcome also reported as unknown). The causality assessment between the aforementioned adverse events and PNEUMOVAX 23 was not provided.
Age: 1.83
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Product appearance confusion, Wrong product administered
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning a 22 months old patient of unknown gender. The patient's historical conditions, concurrent conditions, concomitant therapies, historical drugs or allergies were not reported. On an unspecified date, the patient was inadvertently vaccinated with a dose of PROQUAD reported lot number R002932, expiry date 29-JUL-2019 (strength, dose and frequency were not reported) and VARIVAX (strength, dose, route, frequency, lo number and expiration date were not reported) both vaccines for prophylaxis (Accidental overdose). It was also reported that the patient's sibling was vaccinated on the same date with the same vaccines (refer to case 1809USA008265). The nurse practitioner reported that it was a medication error as well as a product confusion (Product appearance confusion). She stated that the PROQUAD was confused with M-M-R II, and that "the nurse who administered these vaccines did not realize that the PROQUAD (MMRV) was not M-M-R II, as the PROQUAD also contained measles mumps and rubella" (Wrong drug administered ). It was unknown which dose in the measles mumps rubella and varicella vaccination series the dose of PROQUAD or VARIVAX was. No adverse effects were reported. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1809USA008265: Patient's sibling.
Age: 4.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Product appearance confusion, Wrong product administered
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning a 4-years-old patient of unknown gender. The patient's historical conditions, concurrent conditions, concomitant therapies, historical drugs or allergies were not reported. On an unspecified date, the patient was inadvertently vaccinated with a dose of PROQUAD subcutaneously, reported lot number R002932, expiry date 29-JUL-2019 (strength, dose and frequency were not reported) and VARIVAX (strength, dose, route, frequency, lot number and expiration date were not reported) both vaccines for prophylaxis. It was also reported, that the patient's sibling was vaccinated on the same date with the same vaccines (refer to case 1809USA008251). The nurse practitioner reported that it was a medication error as well as a product confusion. She stated that the PROQUAD was confused with M-M-R II, and that "the nurse who administered these vaccines did not realize the PROQUAD was not M-M-R II, as the PROQUAD also contained measles mumps and rubella". It was unspecified which dose in the measles mumps rubella and varicella vaccination series the dose of PROQUAD or VARIVAX were. No adverse effects were reported. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1809USA008251: Patient's sibling.
Sex: U
Vaccine: HIBV, HPV9, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report had been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. It was reported that on unspecified dates, multiple unspecified patients could have inadvertently received improperly stored unspecified doses of ROTATEQ orally for prophylaxis, lot numbers: N030152 (expiration date: 01-SEP-2019), N034400 (expiration date: 10-MAY-2019) and N013989 (expiration date: 30-JAN-2019); (dosage schedule, route and anatomical location  were not reported); GARDASIL 9 for prophylaxis Lot number: N032284 (expiration date: 22-SEP-2020) (dosage schedule was not reported); and PEDVAXHIB for prophylaxis lot number: R000875 (expiration date: 26-SEP-2020) (dosage schedule, route and  anatomical location  were not reported). The temperature was from 9 Celsius (C) to 25 C for a timeframe of 96 hours. There was no previous temperature excursion. The call was because a data logger. No adverse effects were reporter. No further information was provided.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9, MNQ
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse, referring to a 17 year old female patient with a well controlled asthma. Concomitant therapies included unspecified prenatal vitamins and VENTOLIN as rescue inhaler. It was reported none concomitant drug reactions or allergies. In 2015, the patient received a dose of GARDASIL (strength, dose, dose number, administration route, lot number and expiration date were not reported), for prophylaxis Approximately on 07-AUG-2018, the patient became pregnant with Last Menstrual Period (LMP) of 24-JUL-2018 and Estimated Date of Delivery (EDD) of 30-APR-2019. On 22-AUG-2018 at her family physician, without knowing about the pregnancy, she was vaccinated with GARDASIL 9 intramuscularly (strength, dose and dose number were not reported), lot number N035957, expiration date on 10-OCT-2020, for prophylaxis. On 05-SEP-2018, it was determined after a pregnancy test that the patient was pregnant. It was reported that the patient was doing fine and any treatment was not given. At the reporting time the patient had 8 weeks and 1 day of gestation. Initial exposure to GARDASIL 9 was at 4 weeks. The pregnancy outcome was pending.  No adverse effects were reported.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9, MNQ
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse, referring to a 17 year old female patient with a well controlled asthma. Concomitant therapies included unspecified prenatal vitamins and VENTOLIN as rescue inhaler. It was reported none concomitant drug reactions or allergies. In 2015, the patient received a dose of GARDASIL (strength, dose, dose number, administration route, lot number and expiration date were not reported), for prophylaxis Approximately on 07-AUG-2018, the patient became pregnant with Last Menstrual Period (LMP) of 24-JUL-2018 and Estimated Date of Delivery (EDD) of 30-APR-2019. On 22-AUG-2018 at her family physician, without knowing about the pregnancy, she was vaccinated with GARDASIL 9 intramuscularly (strength, dose and dose number were not reported), lot number N035957, expiration date on 10-OCT-2020, for prophylaxis. On 05-SEP-2018, it was determined after a pregnancy test that the patient was pregnant. It was reported that the patient was doing fine and any treatment was not given. At the reporting time the patient had 8 weeks and 1 day of gestation. Initial exposure to GARDASIL 9 was at 4 weeks. The pregnancy outcome was pending.  No adverse effects were reported.
Sex: F
Vaccine: PPV
Symptoms: Chills, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a currently 68 year old female patient, regarding herself. The patient had no pertinent medical history and drug reactions/allergies. The patient's concomitant medication included unspecified blood pressure medications. On an unknown date (reported as: years back), the patient was vaccinated with first dose of PNEUMOVAX 23 (dose, frequency, lot #, expiry date and route were not reported) for prophylaxis. On 17-SEP-2018, the patient was vaccinated with second dose of PNEUMOVAX 23 injection (0.5 ml) (lot # and expiry date were not reported) for prevention of pneumococcal disease. About an hour later, the patient experienced pain, warmth, and swelling at the injection site and redness on her arm below the injection site. The patient also stated that she experienced chills and fever after receiving the vaccine. The patient experienced pain at the injection site extended to the back of shoulder. On 18-SEP-2018 (reported as: as of yesterday) the patient was unable to lift the arm, but today she can lift it a little higher. The patient received unspecified treatment for the events. Lab diagnostics/studies was not performed. The patient sought medical attention for the event (called doctor's office). No product quality complaint was involved. The outcome of events was reported as recovering/resolving. The relationship between the events and PNEUMOVAX 23 was not provided.
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: This spontaneous report as received from a currently 68 year old female patient, regarding herself. The patient had no pertinent medical history and drug reactions/allergies. The patient's concomitant medication included unspecified blood pressure medications. On an unknown date (reported as: years back), the patient was vaccinated with first dose of PNEUMOVAX 23 (dose, frequency, lot #, expiry date and route were not reported) for prophylaxis. On 17-SEP-2018, the patient was vaccinated with second dose of PNEUMOVAX 23 injection (0.5 ml) (lot # and expiry date were not reported) for prevention of pneumococcal disease. About an hour later, the patient experienced pain, warmth, and swelling at the injection site and redness on her arm below the injection site. The patient also stated that she experienced chills and fever after receiving the vaccine. The patient experienced pain at the injection site extended to the back of shoulder. On 18-SEP-2018 (reported as: as of yesterday) the patient was unable to lift the arm, but today she can lift it a little higher. The patient received unspecified treatment for the events. Lab diagnostics/studies was not performed. The patient sought medical attention for the event (called doctor's office). No product quality complaint was involved. The outcome of events was reported as recovering/resolving. The relationship between the events and PNEUMOVAX 23 was not provided.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to a 5 year old female patient. The patient's medical history, concurrent conditions and concomitant therapy were not provided. On 29-AUG-2018, the patient was vaccinated with the first dose of Oka-Merck PROQUAD per subcutaneous route (dose, lot# and expiration date were not provided) for prophylaxis, and on 12-SEP-2018, a second dose was inadvertently administered (dose unspecified) per subcutaneous route, lot # R011801 for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and drug reactions or allergies were not provided. On 18-SEP-2018, the patient inadvertently received an expired dose of PROQUAD injection, lot # M044719 with expiration date on 07-MAY-2018 (dose and route of administration were not reported). Concomitant therapies included sterile diluent (lot# and expiration date were unknown). No adverse effects were reported.
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 14 year old patient (gender unknown). No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 14-SEP-2018, the patient was vaccinated with a dose of PROQUAD lot#R011802, expiration date 21-OCT-2019 (dose, route of administration were not reported) for prophylaxis. Other suspect therapies included sterile diluent (manufacturer unknown) (dose, route of administration, lot# and expiration date were not reported). No adverse effects were reported.
Age: 24.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a 24 year old patient. The patient's medical history, concurrent conditions, concomitant therapies and drug or allergy reactions were not provided. On 22-SEP-2018 the patient was vaccinated with M-M-R II (strength, dose and dose number were not reported) lot number N019126 (recombinant human albumin (rHA)), expiration date on 22-JUN-2019, for prophylaxis, intramuscularly rather than the recommended subcutaneous route. Concomitant therapies included sterile diluent (MERCK) (lot number N028090, expiration date on 13-FEB-2020). No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a physician referring to a patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, drug, allergy history or concomitant medications. On 17-APR-2018, the patient was vaccinated with improperly stored doses of M-M-R II intramuscularly, lot # N020927, expiration date 01-AUG-2019, (strength, dose and frequency were not provided) for prophylaxis. The M-M-R II was reconstituted with properly stored sterile diluent (MRK). The doses of M-M-R II were exposed to a temperature excursion of 47 degree Fahrenheit (°F) to 77°F (53°F) during a time frame of 5 hours. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: 1805USA001303: Original Case: 1805USA001303; 1809USA011187: Original Case: 1809USA010671; 1809USA011188: Original Case: 1809USA010671; 1809USA010671: Original Case: 1809USA010671; 1809USA011186: Original Case: 1809USA010671; 1809USA011190: Original Case: 1809USA010671; 1809USA011184: Original Case: 1809USA010671; 1809USA011185: Original Case: 1809USA010671.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a physician referring to a patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, drug, allergy history or concomitant medications. On 24-APR-2018, the patient was vaccinated with improperly stored doses of M-M-R II, intramuscularly, lot # N020927, expiration date 01-AUG-2019, (strength, dose and frequency were not provided) for prophylaxis. The M-M-R II was reconstituted with properly stored MRK Sterile Diluent. The doses of M-M-R II were exposed to a temperature excursion of 47 degree Fahrenheit (degrees F) to 77 degrees F (53 degrees F) during a time frame of 5 hours. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA001303: Original Case: 1805USA001303; US-009507513-1809USA011187: Original Case: 1809USA010671; US-009507513-1809USA011188: Original Case: 1809USA010671; US-009507513-1809USA011189: Original Case: 1809USA010671; US-009507513-1809USA011186: Original Case: 1809USA010671; US-009507513-1809USA010671: Original Case: 1809USA010671; US-009507513-1809USA011184: Original Case: 1809USA010671; US-009507513-1809USA011185: Original Case: 1809USA010671.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 04-SEP-2018, the patient received one dose of improperly stored (-9 Celsius (C) degree to 8 C degree for 68 minutes; previous temperature excursion: -9 C degree to 8 C degree for 76 minutes) VARIVAX (lot # N029634, expiration date 23-OCT-2019; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (as reported lot# R002715, expiration date 20-FEB-2020). No adverse effects reported. The reporter called because of a data logger. Sender's Comments: US-009507513-1809USA005628: US-009507513-1809USA011283: US-009507513-1809USA011743: US-009507513-1809USA011744: US-009507513-1809USA011745: US-009507513-1809USA011746: US-009507513-1809USA011747: US-009507513-1809USA011748: US-009507513-1809USA011749: US-009507513-1809USA011750: US-009507513-1809USA011751: US-009507513-1809USA011752: US-009507513-1809USA011753: US-009507513-1809USA011754: US-009507513-1809USA011756: US-009507513-1809USA011757: US-009507513-1809USA011758: US-009507513-1809USA011759.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 07-SEP-2018, the patient received one dose of improperly stored (-9 Celsius (C) degree to 8 C degree for 68 minutes; previous temperature excursion: -9 C degree to 8 C degree for 76 minutes) VARIVAX (lot # N029634, expiration date 23-OCT-2019; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (as reported lot# R002715, expiration date 20-FEB-2020). No adverse effects reported. The reporter called because of a data logger. Sender's Comments: US-009507513-1809USA005628: US-009507513-1809USA011283: US-009507513-1809USA011743: US-009507513-1809USA011744: US-009507513-1809USA011745: US-009507513-1809USA011746: US-009507513-1809USA011747: US-009507513-1809USA011748: US-009507513-1809USA011749: US-009507513-1809USA011750: US-009507513-1809USA011751: US-009507513-1809USA011752: US-009507513-1809USA011753: US-009507513-1809USA011754: US-009507513-1809USA011755: US-009507513-1809USA011757: US-009507513-1809USA011758: US-009507513-1809USA011759.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 11-SEP-2018, the patient received one dose of improperly stored (-9 Celsius (C) degree to 8 C degree for 68 minutes; previous temperature excursion: -9 C degree to 8 C degree for 76 minutes) VARIVAX (lot # N029634, expiration date 23-OCT-2019; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (as reported lot# R002715, expiration date 20-FEB-2020). No adverse effects reported. The reporter called because of a data logger. Sender's Comments: US-009507513-1809USA005628: US-009507513-1809USA011283: US-009507513-1809USA011743: US-009507513-1809USA011744: US-009507513-1809USA011745: US-009507513-1809USA011746: US-009507513-1809USA011747: US-009507513-1809USA011748: US-009507513-1809USA011749: US-009507513-1809USA011750: US-009507513-1809USA011751: US-009507513-1809USA011752: US-009507513-1809USA011753: US-009507513-1809USA011754: US-009507513-1809USA011755: US-009507513-1809USA011756: US-009507513-1809USA011758: US-009507513-1809USA011759.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 11-SEP-2018, the patient received one dose of improperly stored (-9 Celsius (C) degree to 8 C degree for 68 minutes; previous temperature excursion: -9 C degree to 8 C degree for 76 minutes) VARIVAX (lot # N029634, expiration date 23-OCT-2019; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (as reported lot# R002715, expiration date 20-FEB-2020). No adverse effects reported. The reporter called because of a data logger. Sender's Comments: US-009507513-1809USA005628: US-009507513-1809USA011283: US-009507513-1809USA011743: US-009507513-1809USA011744: US-009507513-1809USA011745: US-009507513-1809USA011746: US-009507513-1809USA011747: US-009507513-1809USA011748: US-009507513-1809USA011749: US-009507513-1809USA011750: US-009507513-1809USA011751: US-009507513-1809USA011752: US-009507513-1809USA011753: US-009507513-1809USA011754: US-009507513-1809USA011755: US-009507513-1809USA011756: US-009507513-1809USA011757: US-009507513-1809USA011759.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 11-SEP-2018, the patient received one dose of improperly stored (-9 Celsius (C) degree to 8 C degree for 68 minutes; previous temperature excursion: -9 C degree to 8 C degree for 76 minutes Oka/Merck VARIVAX (lot # R008393, expiration date 20-MAR-2020; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (as reported lot# M040792, expiration date 29-MAY-2019). No adverse effects reported. The reporter called because of a data logger. Sender's Comments: US-009507513-1809USA005628: US-009507513-1809USA011283: US-009507513-1809USA011743: US-009507513-1809USA011744: US-009507513-1809USA011745: US-009507513-1809USA011746: US-009507513-1809USA011747: US-009507513-1809USA011748: US-009507513-1809USA011749: US-009507513-1809USA011750: US-009507513-1809USA011751: US-009507513-1809USA011752: US-009507513-1809USA011753: US-009507513-1809USA011754: US-009507513-1809USA011755: US-009507513-1809USA011756: US-009507513-1809USA011757: US-009507513-1809USA011758.
Age: 2.0
Sex: F
Vaccine: MMR, PNC13
Symptoms: Body temperature increased, Monocyte count increased, Mononucleosis heterophile test, White blood cell count increased
Clinical narrative: This is a spontaneous report from a contactable physician via a sales representative. A 2-year-old female patient received the third dose PREVNAR 13 at a single dose and the first dose of MMR at an unspecified dose; both via an unspecified route of administration on 10Sep2018 for immunization. The patient's medical history and concomitant medications were not reported. The patient received the first and second dose of PREVNAR 13 on an unspecified dates. The patient's mother reported that the patient's temperature was 105, they went to the ER to evaluate her temperature and was then documented as 102. Labs drawn in ER showed elevated WBC, so the second panel was ordered by primary physician which showed elevated monocytes, mono spot was currently pending at the time of report. Outcome of the events was unknown.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Injection site warmth, Mobility decreased
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received PREVNAR 13 (lot number and expiration date were unknown), via an unspecified route of administration on 12Feb2018 15:30 at a single dose for immunisation. The patient's medical history included chronic obstructive pulmonary disease (COPD) from 2017 and ongoing, and ongoing allergies that the patient has had for a long time. The patient's concomitant medications were not reported. On an unspecified date in 2018, the patient experienced weight gain. On 13Feb2018, the patient experienced muscle spasms/contracting, redness at injection site, swelling at injection site, fever and hot at injection site, joint pain, and could not move and couldn't get out bed. The patient reported that she has been having symptoms since receiving pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) vaccine. She added that she has been in therapy since Mar2018; she had to go to physical therapy after receiving vaccine since Mar2018. The patient also reported that she has also gained weight since getting the shot. She usually weighed 155 to 160 lbs. Currently (2018), her weight is 180 lbs. The patient also reported that she received the vaccine at a clinic, received the shot at 3:30 pm on 12Feb2018. The next morning (13Feb2018) when she got up at 7:00 am, she could not move and couldn't get out bed. She stated that she has taken the other kind of pneumonia shot before and it did not affect her. She has had x-rays (2018). The therapist said she was still having muscle contractions and spasms. She was told by the therapist to call and report symptoms. The outcome of the events weight gain, muscle spasms/contracting, and joint pain was not recovered. Outcome of the events redness at injection site, swelling at injection site, fever and hot at injection site was recovered on Feb2018. And outcome of the event "could not move and couldn't get out bed" was unknown. Information on the batch/lot number has been requested.