chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site reaction, Vaccination site scar, Vaccination site swelling
Clinical narrative: Reaction in the arm of the injection site; Red and bulge area form covering a pretty big area of upper arm; Red and bulge area form covering a pretty big area of upper arm; When it started to dry, it itched a lot; The mark is still visible; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on 21Aug2021 at 13:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and known allergies were reported as not applicable. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) and unspecified vitamins; both from unknown dates, for unknown indications and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 21Aug2021 at 22:00 the patient experienced reaction in the arm of the injection site. Red and bulge area form covering a pretty big area of her upper arm. The bulging went down first, then the redness. When it started to dry, it itched a lot. The mark was still visible in her arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events reaction in the arm of the injection site, red and bulge area form covering a pretty big area of her upper arm, when it started to dry, it itched a lot was resolved on an unknown date in 2021 and while that of the mark is still visible was not resolved. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the left arm on 11Sep2021 at 14:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Bad headache; This is a spontaneous report from a contactable consumer (patient herself).  A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 12Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE (age at vaccination was 78 years old) for COVID-19 immunization at Hospital Auxilio Mutuo. Medical history included blood pressure high ongoing. Concomitant medication(s) included losartan potassium (COZAAR) 50mg taken for hypertension, start and stop dates were not reported and clopidogrel bisulfate (PLAVIX) 50mg. Historical vaccine included bnt162b2, dose 1 via an unspecified route of administration on 22Jan2021 (Batch/Lot number was FL9261) as DOSE 1, SINGLE. On 19Feb2021, at 04:00 hrs the patient experienced bad headache. She stated that I got my second vaccine of Pfizer on Friday, February 12 and was speaking , on friday that's the second dose okay Vaccine number 2, is it possible that 8 days after that I can get the side effects, 8 days after the vaccine not on the day, not the day after but 8 days after because she having a bad headache since yesterday after 4 am in the morning I am taking Tylenol. Do you think it is possible that this headache could be a side effect of this vaccine after 8 days because I don't usually have headaches, I could say I rarely have headaches but this headache since yesterday worries me, I want to find out is this possible to have side effect from the second vaccine. When paraphrased the concern, consumer stated, correct, after 8 days. Consumer was informed about the role of Pfizer Drug safety and was also informed about Pfizer Medical Information department. When probed if County of Incidence was, consumer stated, yes (not appropriately paraphrased and clarified hence, captured). The patient stated, Expiration date I don't know, it says Pfizer 1st FL9261, the second dose says EN I think it looks like an N EN6200, it might be EN or EU, EU6200. Treatment received by the patient was acetacminophen, tylenol. The clinical outcome of the event headache was unknown.  Follow-up attempts completed. No further information expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram abnormal, Discomfort, Dysstasia, Gait inability, Hepatic steatosis
Clinical narrative: My symptoms onset right about the 24 hour mark. I thought I avoided all side affects other than a sore arm but I suddenly couldn?t walk. I couldn?t stand up straight. I screamed in pain trying to find a position to lay in. I could hardly hold my phone. My whole right side was affected from about mid rib cage to the knee area. My entire thigh and butt cheek was numb. I couldn?t use the restroom. It lasted exactly 7 days of which I was in fairly excruciating discomfort for at least 4 days. It was like I was being shocked in my back. I also had a CT scan which reflected  a fatty liver and spleen this scan was compared to a scan just two months earlier thats was unremarkable. I can?t say that was from the vaccine but I do find it odd that I would develop such condition. I do not drink alcohol at all.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Magnetic resonance imaging, Pain, Pain in extremity, Splenomegaly
Clinical narrative: My symptoms onset right about the 24 hour mark. I thought I avoided all side affects other than a sore arm but I suddenly couldn?t walk. I couldn?t stand up straight. I screamed in pain trying to find a position to lay in. I could hardly hold my phone. My whole right side was affected from about mid rib cage to the knee area. My entire thigh and butt cheek was numb. I couldn?t use the restroom. It lasted exactly 7 days of which I was in fairly excruciating discomfort for at least 4 days. It was like I was being shocked in my back. I also had a CT scan which reflected  a fatty liver and spleen this scan was compared to a scan just two months earlier thats was unremarkable. I can?t say that was from the vaccine but I do find it odd that I would develop such condition. I do not drink alcohol at all.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt received second dose of series 14 days early.   Pt has no symptoms at this time. Pt informed to monitor symptoms and to return to clinic if any concerns.   VAERS report line called.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia, Tremor
Clinical narrative: Severe chills, shaking, severe muscle aches, high fevers? despite around the clock ibuprofen and Tylenol
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dysarthria, Dysgeusia, Eye disorder, Facial paralysis
Clinical narrative: Facial Paresthesia, metal taste in mouth, LUQ pain and neck swelling/discomfort, left side facial droop, eyes close bilaterally, slurred speech.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Paraesthesia, Swelling
Clinical narrative: Facial Paresthesia, metal taste in mouth, LUQ pain and neck swelling/discomfort, left side facial droop, eyes close bilaterally, slurred speech.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site lymphadenopathy
Clinical narrative: Painful lump near collarbone/ swollen lymph node; Painful lump near collarbone/ whole area surrounding the lump was sore/pain near my collarbone; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Painful lump near collarbone/ swollen lymph node) and PAIN (Painful lump near collarbone/ whole area surrounding the lump was sore/pain near my collarbone) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Painful lump near collarbone/ swollen lymph node) and PAIN (Painful lump near collarbone/ whole area surrounding the lump was sore/pain near my collarbone). The patient was treated with IBUPROFEN from August 2021 to August 2021 for Swollen lymph nodes, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Painful lump near collarbone/ swollen lymph node) and PAIN (Painful lump near collarbone/ whole area surrounding the lump was sore/pain near my collarbone) had not resolved.            No concomitant medications were reported by the provider.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Hot flush
Clinical narrative: chills with hot flashes; chills with hot flashes; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (chills with hot flashes) and CHILLS (chills with hot flashes) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced HOT FLUSH (chills with hot flashes) and CHILLS (chills with hot flashes). At the time of the report, HOT FLUSH (chills with hot flashes) and CHILLS (chills with hot flashes) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment information were not provided by the reporter. Concomitant medications were not reported by reporter.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Cyclic vomiting syndrome, Muscle spasms, Nausea, Renal failure
Clinical narrative: Extreme nausea; cyclic vomiting; Muscular cramps in feet, legs, torso; Combination ofsweats and chills; Renal failure; This spontaneous case was reported by a consumer and describes the occurrence of RENAL FAILURE (Renal failure), NAUSEA (Extreme nausea), CYCLIC VOMITING SYNDROME (cyclic vomiting), MUSCLE SPASMS (Muscular cramps in feet, legs, torso) and COLD SWEAT (Combination ofsweats and chills) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cannabinoid hyperemesis syndrome.   On 27-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced RENAL FAILURE (Renal failure) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced NAUSEA (Extreme nausea) (seriousness criterion hospitalization), CYCLIC VOMITING SYNDROME (cyclic vomiting) (seriousness criterion hospitalization), MUSCLE SPASMS (Muscular cramps in feet, legs, torso) (seriousness criterion hospitalization) and COLD SWEAT (Combination ofsweats and chills) (seriousness criterion hospitalization). At the time of the report, RENAL FAILURE (Renal failure) was resolving and NAUSEA (Extreme nausea), CYCLIC VOMITING SYNDROME (cyclic vomiting), MUSCLE SPASMS (Muscular cramps in feet, legs, torso) and COLD SWEAT (Combination ofsweats and chills) outcome was unknown.            No concomitant medication details were reported. No treatment information was reported.  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscular weakness, Oropharyngeal pain
Clinical narrative: Weakness & inability to lift arm, fatigue, sore throat; Weakness & inability to lift arm, fatigue, sore throat; Weakness & inability to lift arm, fatigue, sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Weakness & inability to lift arm, fatigue, sore throat), MUSCULAR WEAKNESS (Weakness & inability to lift arm, fatigue, sore throat) and FATIGUE (Weakness & inability to lift arm, fatigue, sore throat) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced OROPHARYNGEAL PAIN (Weakness & inability to lift arm, fatigue, sore throat), MUSCULAR WEAKNESS (Weakness & inability to lift arm, fatigue, sore throat) and FATIGUE (Weakness & inability to lift arm, fatigue, sore throat). On 04-Sep-2021, OROPHARYNGEAL PAIN (Weakness & inability to lift arm, fatigue, sore throat), MUSCULAR WEAKNESS (Weakness & inability to lift arm, fatigue, sore throat) and FATIGUE (Weakness & inability to lift arm, fatigue, sore throat) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications and Treatment informations were not provided. My arm hurt badly enough that it was difficult to use and I could barely lift over my head
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Malaise, Pyrexia, Rash
Clinical narrative: malaise; dizziness; skin rash; Severe Vomiting; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise), DIZZINESS (dizziness), RASH (skin rash), VOMITING (Severe Vomiting) and PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis, Drug allergy (Multiple drug allergies), Insect sting allergy (severe reaction), Contrast media allergy (yellow dye 5) and Anaphylactic reaction. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), EZETIMIBE (ZETIA), UPADACITINIB (RINVOQ) and HYDROMORPHONE HYDROCHLORIDE (DILAUDID) for an unknown indication.   On 31-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, the patient experienced MALAISE (malaise), DIZZINESS (dizziness), RASH (skin rash), VOMITING (Severe Vomiting), PYREXIA (fever) and HEADACHE (headache). At the time of the report, MALAISE (malaise), DIZZINESS (dizziness), RASH (skin rash), VOMITING (Severe Vomiting), PYREXIA (fever) and HEADACHE (headache) was resolving.            No treatment medications were provided by reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: malaise; dizziness; skin rash; Severe Vomiting; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise), DIZZINESS (dizziness), RASH (skin rash), VOMITING (Severe Vomiting) and PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis, Drug allergy (Multiple drug allergies), Insect sting allergy (severe reaction), Contrast media allergy (yellow dye 5) and Anaphylactic reaction. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), EZETIMIBE (ZETIA), UPADACITINIB (RINVOQ) and HYDROMORPHONE HYDROCHLORIDE (DILAUDID) for an unknown indication.   On 31-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, the patient experienced MALAISE (malaise), DIZZINESS (dizziness), RASH (skin rash), VOMITING (Severe Vomiting), PYREXIA (fever) and HEADACHE (headache). At the time of the report, MALAISE (malaise), DIZZINESS (dizziness), RASH (skin rash), VOMITING (Severe Vomiting), PYREXIA (fever) and HEADACHE (headache) was resolving.            No treatment medications were provided by reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Back pain, Myalgia, Paraesthesia
Clinical narrative: pain from wrist to back/pain in the lumps when touched with hot or cold water; he has hard lumps in different spots on left side; it acts like nails in body like a nerve shock/tingling; tiny things under the skin; weakness; muscle pain; This spontaneous report was received from a consumer referring to himself, a male patient of unknown age. The patient's concurrent conditions included a heart condition and diabetes. The patient's concomitant medications included twelve unspecified medications (did not want to list them all). The patient had no drug reactions or allergies.   The patient stated that he was vaccinated with zoster vaccine live (ZOSTAVAX) from a pharmacy and had multiple side effects (he was unsure of what the name of the vaccine was and the pharmacy stated to him that "they think" it was manufactured by us). On an unknown date in September 2020, he had the first dose and had two doses total for prophylaxis (could not confirm when the second dose was given) (dose, vaccination scheme frequency, route of administration, lot # and expiration date not reported).   On an unknown date, the patient started having tiny things under the skin (skin disorder) and pain from wrist to back. He went to the endocrinologist and primary doctor where they confirmed it was a side effect of the vaccine. The patient said that now it was affecting his left side and he wanted to know what advice to do with side effects. He stated he had been suffering for eleven months with pain, he had hard lumps in different spots on left side (nodule), he had pain in the lumps when touched with hot or cold water, it acted like nails in body like a nerve shock, he had muscle pain (myalgia), he had weakness (asthenia), and he had tingling (paraesthesia). The patient's endocrinologist and primary care doctor provided no recommendations for the side effects. The outcome of the events was reported as not recovered.  The causal relationship between zoster vaccine live (ZOSTAVAX) and all the reported events was unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Skin disorder, Skin mass
Clinical narrative: pain from wrist to back/pain in the lumps when touched with hot or cold water; he has hard lumps in different spots on left side; it acts like nails in body like a nerve shock/tingling; tiny things under the skin; weakness; muscle pain; This spontaneous report was received from a consumer referring to himself, a male patient of unknown age. The patient's concurrent conditions included a heart condition and diabetes. The patient's concomitant medications included twelve unspecified medications (did not want to list them all). The patient had no drug reactions or allergies.   The patient stated that he was vaccinated with zoster vaccine live (ZOSTAVAX) from a pharmacy and had multiple side effects (he was unsure of what the name of the vaccine was and the pharmacy stated to him that "they think" it was manufactured by us). On an unknown date in September 2020, he had the first dose and had two doses total for prophylaxis (could not confirm when the second dose was given) (dose, vaccination scheme frequency, route of administration, lot # and expiration date not reported).   On an unknown date, the patient started having tiny things under the skin (skin disorder) and pain from wrist to back. He went to the endocrinologist and primary doctor where they confirmed it was a side effect of the vaccine. The patient said that now it was affecting his left side and he wanted to know what advice to do with side effects. He stated he had been suffering for eleven months with pain, he had hard lumps in different spots on left side (nodule), he had pain in the lumps when touched with hot or cold water, it acted like nails in body like a nerve shock, he had muscle pain (myalgia), he had weakness (asthenia), and he had tingling (paraesthesia). The patient's endocrinologist and primary care doctor provided no recommendations for the side effects. The outcome of the events was reported as not recovered.  The causal relationship between zoster vaccine live (ZOSTAVAX) and all the reported events was unknown.
Age: 38.0
Sex: F
Vaccine: HPV9
Symptoms: Human papilloma virus test positive
Clinical narrative: positive human papillomavims test; This spontaneous report was received from 39 years old female patient, referring to herself. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.   On 23-FEB-2021 and 24-MAR-2021, the patient was vaccinated with the first dose and the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, lot# and expiry date were not reported) respectively for prophylaxis.   On an unknown date in 2021, following the second dose, the patient was positive for the human papillomavims test. The outcome of positive for the human papillomavims test was unknown. The patient had not yet received a third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and expected to receive a third dose 24-AUG-2021.   Causality assessment was not provided.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional adverse events were reported; the consumer's son received a fourth dose of GARDASIL 9; This spontaneous report has been received from a consumer referring to a 25-year-old male patient. The patient's pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.  On 28-DEC-2015 and 15-FEB-2016, the patient was vaccinated with the first and second 0.5 milliliters (ml) doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) respectively (both with lot number L037339, which has been verified to be valid for syringe formulation, the expiration date was reported as "08-FEB-2018"; however, upon internal verification was established as 09-FEB-2018). On 29-JUL-2016, the patient received the third 0.5 ml dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number L019287 has been verified to be valid for syringe formulation, with an expiration date on 14-SEP-2017). The three doses of the vaccine were administered as prophylaxis (routes of administration and anatomical sites of vaccination were not provided).   On approximately 04-AUG-2021 (reported as "a few weeks ago, maybe the 4th (AUG2021)"), the patient was vaccinated with a 0.5 ml fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (extra dose administered) (formulation, route of administration, anatomical site of vaccination, lot number, and expiration date were not provided).   No additional adverse events were reported (no adverse event). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: L037339; expirationdate: 09-FEB-2018; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 7.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; Product administered to patient of inappropriate age; This spontaneous report as received from a health professional referring to a 7-year-old female patient. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.      On 19-AUG-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # T028583 that has been verified to be valid expiration date 04-MAR-2023, 0.5 milliliter for prophylaxis (frequency, strength, route of administration, were not reported) (product administered to patient of inappropriate age).  No adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: devicelotnumber: T028583; expirationdate: 04-MAR-2023; deviceage and unit: 0 ; operatorofdevice: Unknown; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 5.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was good to use. /No adverse event; temperature excursion occurred and that doses have been administered.; PROQUAD on 15-JUN-2021, VARIVAX on 26-JUL-2021; This spontaneous report was received from a Medical assistant concerning a 5-year-old female patient (birth weight 47LB). No concurrent condition, medical history, or concomitant therapy was reported.  On 15-JUN-2021, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose and route were unknown; lot # T021301 has been verified to be a valid lot number, expiration date reported and confirm upon internal validation as 19-DEC-2021) for prophylaxis. On 21-JUN-2021, there was a temperature excursion for varicella virus vaccine live (oka/merck)(VARIVAX). Temperature were 14.1 Fahrenheit (F). The time frame was reported as 1 hour 30 minutes. There was no previous temperature excursion. The temperature excursion occurred as a result of a reading from a Digital Data Logger. On 26-JUL-2021, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength and route were unknown; lot # T024285 has been verified to be a valid lot number, expiration date reported and confirm upon internal validation as 15-JUL-2022) 0.5 milliliter for prophylaxis (product storage error and inappropriate schedule of product administration). The operator was trained. The vaccines were used according to the instruction leaflet and were available for return/evaluation. The current location of the vaccines was laboratory. The vaccines were good to use. There was no adverse event.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA003384:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; incorrect product storage (temperature -8.66 C for 42 minutes); This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported.  On 19-AUG-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (dose, strength, route of administration and anatomical location were not provided) lot # T032315, expiry date: reported as 22-AUG-2022 however it was established as 22-SEP-2022; for prophylaxis. The vaccine underwent temperature excursion of -8.66 degree Celsius for 42 minutes. It was reported that there was also previous temperature excursion (-14.87 degree Celsius for 15 minutes). At the time of report, there was no adverse event (AE) reported.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2108USA005929: US-009507513-2108USA005928:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; incorrect product storage (temperature -8.66 C for 42 minutes); This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported.  On 19-AUG-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (dose, strength, route of administration and anatomical location were not provided) lot # T032315, expiry date: reported as 22-AUG-2022, however it was established as 22-SEP-2022, for prophylaxis. The vaccine underwent temperature excursion of -8.66 degree Celsius for 42 minutes. It was reported that there was also previous temperature excursion (-14.87 degree Celsius for 15 minutes). At the time of report, there was no adverse event (AE) reported.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2108USA005929: US-009507513-2108USA005796:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; incorrect product storage (temperature -8.66 C for 42 minutes); This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported.  On 19-AUG-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (dose, strength, route of administration and anatomical location were not provided) lot # T032315, expiry date: reported as 22-AUG-2022, however it was established as 22-SEP-2022; for prophylaxis. The vaccine underwent temperature excursion of -8.66 degree Celsius for 42 minutes. It was reported that there was also previous temperature excursion (-14.87 degree Celsius for 15 minutes). At the time of report, there was no adverse event (AE) reported.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2108USA005796: US-009507513-2108USA005928:
Age: 2.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no AE/PQC reported; temperature excursion/PROQUAD was Improperly stored and administered; This spontaneous report has been received from nurse referring to a 2 years old patient with unknown gender.  Information about concurrent condition, concomitant medication and medical history was not provided.  On 19-AUG-2021, the patient was vaccinated with a improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (recombinant Human albumin/rHA) (lot # T034824, expiration date reported as 01-APR-2022, but upon internal validation established as 11-APR-2022; dose detail and route of administration were not provided) for prophylaxis (product storage error). The vaccine was stored above -15 degree Celsius (-13) for 30 minutes. Previous temperature excursion was also reported. No adverse effects reported at this time.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details provided.; Improperly stored PROQUAD administered vaccine; This spontaneous report was received from a nurse, referring to a patient of unknown age and unknown gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.     On 30-JUL-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (Albumin status: rHA, lot # T021301,expiration date was reported and validated as 19-DEC-2021(also reported as 23-FEB-2022, conflicting information); dose, strength, route were not provided) for prophylaxis (product storage error). Temperature/Time frame: 9.6 degree Celsius for 80 minutes. There was no previous temperature excursion. No additional adverse event details provided.
Age: 8.0
Sex: M
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional information; Patient missed second dose of vaccine series for unspecified reason, will be receiving his second dose in the vaccine series late; This spontaneous report was received from a registered nurse and refers to an 8-year-old male (also reported gender: not applicable) patient. Patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapies were not reported.      On an unknown date the patient was vaccinated with a first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, lot #, expiration date, albumin status and route were not reported) for prophylaxis.  On unknown date in approximately 2021 (reported asprior to starting school this year), the patient was receiving second dose of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, lot #, expiration date, albumin status and route were not reported) for prophylaxis. The patient had missed the second scheduled dose years ago for unspecified reasons (inappropriate schedule of product administration).  The patient's family wanted to ensure that the child would not be putting at risk for shedding the virus to an immunocompromised family member after administration the vaccine. The family member was undergoing chemotherapy. No additional information was reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; lots that underwent temperature excursions were admnistered; This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 03-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number T017685, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 21-MAY-2022), for prophylaxis (dose, frequency, route of administration, anatomical location and vaccination scheme were not reported) (product storage error). The administered vaccine experienced a temperature excursion of 14 degrees Fahrenheit to 46 degrees Fahrenheit (24.8 degrees Fahrenheit) during a time frame of 30 minutes.   There were a previous temperature excursions n an unknown date: 6 to 14 degrees Fahrenheit (5.9 degrees Fahrenheit) during a time frame of 8 minutes, 6 to 14 degrees Fahrenheit (6.8 degrees Fahrenheit) during a time frame of 18 minutes and 6 to 14 degrees Fahrenheit (8.4 degrees Fahrenheit) during a time frame of 17 minutes.  No additional adverse events were reported.  This is one of ten reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA001125:AM US-009507513-2108USA001040:AL
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; lots that underwent temperature excursions were admnistered; This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 10-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number T017685, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 21-MAY-2022), for prophylaxis (dose, frequency, route of administration, anatomical location and vaccination scheme were not reported). The administered vaccine experienced a temperature excursion of 14 degrees Fahrenheit to 46 degrees Fahrenheit (24.8 degrees Fahrenheit) during a time frame of 30 minutes.   There were a previous temperature excursions n an unknown date: 6 to 14 degrees Fahrenheit (5.9 degrees Fahrenheit) during a time frame of 8 minutes, 6 to 14 degrees Fahrenheit (6.8 degrees Fahrenheit) during a time frame of 18 minutes and 6 to 14 degrees Fahrenheit (8.4 degrees Fahrenheit) during a time frame of 17 minutes.  No additional adverse events were reported.  This is one of ten reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA001125:AM US-009507513-2108USA001040:AL
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; VARIVAX expired on 8/18/2021 and was administered on 8/23/2021; This spontaneous report was received from a nurse, referring to a patient of unknown age and unknown gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 23-AUG-2021, the patient was vaccinated with expired varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S025612, expiration date 18-AUG-2021; dose, strength and route were not provided) for prophylaxis (expired product administered). No previous temperature excursion. No additional adverse event reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; one dose of VARlVAX was administered on 08/24/2021 following a temperature excursion; This spontaneous report was received from an office manager referring to a patient of unknown age and unknown gender. Information regarding the patient's pertinent medical history, current condition, previous drug reaction or allergy and concomitant medication was not reported.  On 24-AUG-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T027303, expiration date 12-AUG-2022, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported) for prophylaxis (product storage error ). The vaccine administered experienced temperature excursions of -10.7 degrees Celsius for 192 hours. No additional adverse event reported.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called in to report a temperature excursion; This spontaneous report has been received from a physician, referring to a 4-year-old female patient. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug and/or allergy reactions were not reported.  On 20-AUG-2021 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) (dose, vaccination scheme, route and anatomical location of administration were not reported; upon internal review, lot # T009932 has been verified as valid and expiration date  established as 16-SEP-2021) administered for prophylaxis (product storage error). The vaccine was improperly stored a temperature of 6.8 degrees Fahrenheit (°F), that was out of the recommended temperature frame of minus 58°F to 5°F, for a time frame of 30 minutes. No previous temperature excursion reported. It was not reported the use of a datalogger. No additionally adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; The vaccine was administered after a temperature excursion; This spontaneous report as received from an office manager, and refers a patient of unknown age and gender. No information was reported regarding the patient's medical history, concurrent conditions or concomitant medications.  On 27-AUG-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # T035393, expiration date 14-APR-2021, for prophylaxis.  On an unspecified date, the dose of measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live(PROQUAD) underwent a temperature excursion of 15 Fahrenheit degrees (°F) for 1 hour and 11 minutes. The vaccine had a previous temperature excursion on 21-JUL-2021, of 26°F for 2 hours and 45 minutes. No additional adverse events were reported.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/ PQC reported at this time; Physician reported PROQUAD (lot T009932 exp 16-SEP-2021) was administered to two patient who are sisters; This spontaneous report as received from a physician, and refers to a 12 month old female patient. No information has been reported regarding the patient's medical history, concurrent conditions or concomitant medications.  On 20-AUG-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) for prophylaxis. Lot number reported as T009932, expiration date: 16-SEP-2021. On an unspecified date, the dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) underwent a temperature excursion of -58 Fahrenheit degrees (°F) and 5°F (6.8°F) for 0 hours 30 minutes 0 seconds. No previous excursions were reported.   This is one of two reports received from the same source.; Sender's Comments:  US-009507513-2108USA007693:
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Loss of personal independence in daily activities, Pain in extremity, Paraesthesia
Clinical narrative: fingertips started tingling; it is hard to raise arm, it is hard to move her arm,; arm soreness; her arm feels weak; she feels really uncomfortable; This spontaneous report was received from a female patient of an unknown age, who reported on herself. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 28-JUL-2021, the patient was vaccinated with one dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (dose, lot #, expiration date, route and site of administration were not reported).  On the same day, she experienced arm soreness. The patient stated her arm was really sore. On 13-AUG-2021 (reported as two weeks ago) her fingertips started tingling and it was hard to raise and move her arm and it was persistent. On an unknown date in 2021, her arm was feeling weak even to wash dishes and she was feeling the tingling. On an unspecified date in 2021, she was feeling uncomfortable. It was reported that the patient called to her doctor and they tried to help her, they looked on Merck website but do not know how to help her and no treatment was given. The patient wanted to know how long to expect this to last. The outcome of the events was reported as not recovered.  The causality assessment between the events and the suspect vaccine was not provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; PROQUAD had a temperature excursion and was administered to a patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 28-AUG-2021, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (dosage regimen was not reported), lot # T036735 (rHA) and expiration date 28-APR-2022 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of -11.0 degree celsius (°C) for 2 hours and 5 minutes, and -7.5 °C for 71 hours on an unknown date; no previous temperature excursions were reported.  No adverse symptoms were reported
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE's; A caller stated that an expired dose of GARDASIL 9; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.    On 29-AUG-2021, the patient was vaccinated with a expired dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 1 time dose, expiry date 23-JUL-2021 for prophylaxis (strength, route of administration, and lot number,were not reported).  The vaccine did not experienced temperature excursion and no additional adverse events were reported.
Age: 11.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events or product quality complaints were reported; Temperature excursion for PROQUAD which has been administered; This spontaneous report was received from a nurse and refers to a 11-year-old female patient. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 27-AUG-2021, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dosage regimen was not reported), lot # U006313 (rHA) and expiration date 24-AUG-2022 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 38.8 degree fahrenheit (°F) for 8 hours on 26-AUG-2021; no previous temperature excursions were reported.  No adverse symptoms were reported. This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2108USA007980: US-009507513-2108USA008076:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse event; Improperly stored dose of VARIVAX and PROQUAD was administered to two patients; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 25-AUG-2021, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dosage regimen was not reported), lot # U009259 (rHA) and expiration date 19-SEP-2022 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of -13.5 degree celsius (°C) for 6 hours and 39 minutes on an unknown date; no previous temperature excursions were reported.  No adverse symptoms were reported. This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2108USA008014:02000587