chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9, HPV4
Symptoms: Blood test, Chest X-ray, Cyanosis, Electrocardiogram abnormal, Fall
Clinical narrative: My 14 year old daughter received an influenza vaccine and her 2nd HPV shot (Gardasil) at a Pharmacy. Within less than 2 minutes after receiving the shots, she fell face first into the ground. She was unconscious and not breathing when I (I'm the father) responded to her. When she started breathing and seemed  like she was coming back to awareness, I got her off her feet and tried to walk it off (by supporting her) and get her fresh air. Immediately, her face went dark blue and I gently put her back on the ground. As her head lay in my lap, I shouted for someone to call 911, and I pried her teeth open because it appeared like she was suffering a seizure. She was unconscious at this point for another minute or so. When the paramedics arrived, she was taken to a hospital where she had three EKGs, a chest xray, an ultrasound, and a liter of IV fluid. While at the hospital, her blood was drawn and her urine was sampled. Her first EKG was very irregular, but improved as she was given the IV. The doctor diagnosed her with premature atrial contraction and syncope.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9, HPV4
Symptoms: Loss of consciousness, Respiratory arrest, Supraventricular extrasystoles, Syncope, Ultrasound scan
Clinical narrative: My 14 year old daughter received an influenza vaccine and her 2nd HPV shot (Gardasil) at a Pharmacy. Within less than 2 minutes after receiving the shots, she fell face first into the ground. She was unconscious and not breathing when I (I'm the father) responded to her. When she started breathing and seemed  like she was coming back to awareness, I got her off her feet and tried to walk it off (by supporting her) and get her fresh air. Immediately, her face went dark blue and I gently put her back on the ground. As her head lay in my lap, I shouted for someone to call 911, and I pried her teeth open because it appeared like she was suffering a seizure. She was unconscious at this point for another minute or so. When the paramedics arrived, she was taken to a hospital where she had three EKGs, a chest xray, an ultrasound, and a liter of IV fluid. While at the hospital, her blood was drawn and her urine was sampled. Her first EKG was very irregular, but improved as she was given the IV. The doctor diagnosed her with premature atrial contraction and syncope.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9, HPV4
Symptoms: Urine analysis
Clinical narrative: My 14 year old daughter received an influenza vaccine and her 2nd HPV shot (Gardasil) at a Pharmacy. Within less than 2 minutes after receiving the shots, she fell face first into the ground. She was unconscious and not breathing when I (I'm the father) responded to her. When she started breathing and seemed  like she was coming back to awareness, I got her off her feet and tried to walk it off (by supporting her) and get her fresh air. Immediately, her face went dark blue and I gently put her back on the ground. As her head lay in my lap, I shouted for someone to call 911, and I pried her teeth open because it appeared like she was suffering a seizure. She was unconscious at this point for another minute or so. When the paramedics arrived, she was taken to a hospital where she had three EKGs, a chest xray, an ultrasound, and a liter of IV fluid. While at the hospital, her blood was drawn and her urine was sampled. Her first EKG was very irregular, but improved as she was given the IV. The doctor diagnosed her with premature atrial contraction and syncope.
Age: 66.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Amnesia, Anaemia, Blood lactic acid increased, Chills, Confusional state
Clinical narrative: PATIENT CAME TO THE OFFICE WITHOUT ANY SIGN OF ANY SYMPTOMS for flu vaccine(FLUCELVAX quadrivalent).After flucelvax vaccine was given with in 4 hours later patient husband called back reporting that her fever was 103.0,chills ,acute mental status change,pt was admitted to the local hospital, still under evaluation.
Age: 66.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Pyrexia
Clinical narrative: PATIENT CAME TO THE OFFICE WITHOUT ANY SIGN OF ANY SYMPTOMS for flu vaccine(FLUCELVAX quadrivalent).After flucelvax vaccine was given with in 4 hours later patient husband called back reporting that her fever was 103.0,chills ,acute mental status change,pt was admitted to the local hospital, still under evaluation.
Age: 66.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Chills, Mental status changes, Pyrexia
Clinical narrative: PATIENT CAME TO THE OFFICE WITHOUT ANY SIGN OF ANY SYMPTOMS for flu vaccine(FLUCELVAX quadrivalent).After flucelvax vaccine was given with in 4 hours later patient husband called back reporting that her fever was 103.0,chills ,acute mental status change,pt was admitted to the local hospital, still under evaluation.
Sex: F
Vaccine: FLU4, VARZOS, VARZOS, FLU4, VARZOS
Symptoms: Blister, Burning sensation, Contusion, Musculoskeletal pain, Pain
Clinical narrative: Received Shingles vaccine 8/19/20-4:30pm in left upper arm. The next day extreme deep pain in right buttock, also ran up back and down into thigh around 2 pm followed by rash on buttock and wrapping into crotch area on right side only. Woke up with blisters on labia and more blisters on front portion of underwear line. Contacted doctor who suspects a rare effect of the shot. Prescribed Valacyclovir, 2x/day for 5 days. Side note: My mother had an outbreak of Shingles around age 62 in the same area.
Sex: F
Vaccine: FLU4, VARZOS, VARZOS, FLU4, VARZOS
Symptoms: Rash
Clinical narrative: Received Shingles vaccine 8/19/20-4:30pm in left upper arm. The next day extreme deep pain in right buttock, also ran up back and down into thigh around 2 pm followed by rash on buttock and wrapping into crotch area on right side only. Woke up with blisters on labia and more blisters on front portion of underwear line. Contacted doctor who suspects a rare effect of the shot. Prescribed Valacyclovir, 2x/day for 5 days. Side note: My mother had an outbreak of Shingles around age 62 in the same area.
Sex: F
Vaccine: FLU4, VARZOS, VARZOS, FLU4, VARZOS
Symptoms: Genital blister, Genital rash, Musculoskeletal pain, Pain in extremity
Clinical narrative: Received Shingles vaccine 8/19/20-4:30pm in left upper arm. The next day extreme deep pain in right buttock, also ran up back and down into thigh around 2 pm followed by rash on buttock and wrapping into crotch area on right side only. Woke up with blisters on labia and more blisters on front portion of underwear line. Contacted doctor who suspects a rare effect of the shot. Prescribed Valacyclovir, 2x/day for 5 days. Side note: My mother had an outbreak of Shingles around age 62 in the same area.
Sex: F
Vaccine: FLU4, VARZOS, VARZOS, FLU4, VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Received Shingles vaccine 8/19/20-4:30pm in left upper arm. The next day extreme deep pain in right buttock, also ran up back and down into thigh around 2 pm followed by rash on buttock and wrapping into crotch area on right side only. Woke up with blisters on labia and more blisters on front portion of underwear line. Contacted doctor who suspects a rare effect of the shot. Prescribed Valacyclovir, 2x/day for 5 days. Side note: My mother had an outbreak of Shingles around age 62 in the same area.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Deafness
Clinical narrative: Claim patient lost hearing day after receiving Fluzone High dose Flu Vaccination, NDC: 49281-0120-65. Lot: UJ469AB EXP: 06/30/2021 Manufacturer: Sanofi Pasteur Patient said she had MRI, several hypobaric chamber treatments, injectable and oral steroid treatment, and had to have surgery to insert tubes. Met with ENT doctor who confirmed she has hearing loss and ear is dead static.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Deafness, Ear tube insertion, Hyperbaric oxygen therapy, Magnetic resonance imaging, Tinnitus
Clinical narrative: Claim patient lost hearing day after receiving Fluzone High dose Flu Vaccination, NDC: 49281-0120-65. Lot: UJ469AB EXP: 06/30/2021 Manufacturer: Sanofi Pasteur Patient said she had MRI, several hypobaric chamber treatments, injectable and oral steroid treatment, and had to have surgery to insert tubes. Met with ENT doctor who confirmed she has hearing loss and ear is dead static.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: Received the first of two Shingrix vaccines. Within a day and continuing to the present (9/19/2020), I have been experiencing headaches and fever. sometimes both, sometimes one or the other. fever never above 101.2F. Some nights I sweat during sleep, but the sweating is not always associated with a fever. No other symptoms or side effects. Headaches, when they occur, are located mostly in the rear and base of my skull. I've taken Tylenol or extra-strength Tylenol to treat the headaches and/or fever. That seems to work, but the length, i.e. duration of the reaction (my symptoms) seems longer than normal. I have taken a covid-19 test to make sure my reaction was not due to something else. that covid test came back negative. When I described my symptoms to my doctor via email before my covid results were known, he also surmised they were a reaction to the Shingrix vaccination, rather than covid.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Hyperhidrosis, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Received the first of two Shingrix vaccines. Within a day and continuing to the present (9/19/2020), I have been experiencing headaches and fever. sometimes both, sometimes one or the other. fever never above 101.2F. Some nights I sweat during sleep, but the sweating is not always associated with a fever. No other symptoms or side effects. Headaches, when they occur, are located mostly in the rear and base of my skull. I've taken Tylenol or extra-strength Tylenol to treat the headaches and/or fever. That seems to work, but the length, i.e. duration of the reaction (my symptoms) seems longer than normal. I have taken a covid-19 test to make sure my reaction was not due to something else. that covid test came back negative. When I described my symptoms to my doctor via email before my covid results were known, he also surmised they were a reaction to the Shingrix vaccination, rather than covid.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Night sweats, Pyrexia
Clinical narrative: Received the first of two Shingrix vaccines. Within a day and continuing to the present (9/19/2020), I have been experiencing headaches and fever. sometimes both, sometimes one or the other. fever never above 101.2F. Some nights I sweat during sleep, but the sweating is not always associated with a fever. No other symptoms or side effects. Headaches, when they occur, are located mostly in the rear and base of my skull. I've taken Tylenol or extra-strength Tylenol to treat the headaches and/or fever. That seems to work, but the length, i.e. duration of the reaction (my symptoms) seems longer than normal. I have taken a covid-19 test to make sure my reaction was not due to something else. that covid test came back negative. When I described my symptoms to my doctor via email before my covid results were known, he also surmised they were a reaction to the Shingrix vaccination, rather than covid.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: Received the first two Shingrix vaccines. Within a day and continuing to the present (9/19/2020), I have been experiencing headaches and fever. sometimes both, sometimes one or the other. fever never broke above 101.2F. Some nights I sweat during sleep, but the sweating is not always associated with a fever. No other symptoms or side effects. Headaches, when they occur, are located mostly in the rear and base of my skull. I've take Tylenol or extra-strength Tylenol to treat the headaches and/or fever. That seems to work, but the length, i.e. duration of the reaction (my symptoms) seems longer than normal. I have described my symptoms to my doctor via email before my covid results were known. he also surmised they were a reaction to the Shingrix vaccination, rather than covid.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Hyperhidrosis, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Received the first two Shingrix vaccines. Within a day and continuing to the present (9/19/2020), I have been experiencing headaches and fever. sometimes both, sometimes one or the other. fever never broke above 101.2F. Some nights I sweat during sleep, but the sweating is not always associated with a fever. No other symptoms or side effects. Headaches, when they occur, are located mostly in the rear and base of my skull. I've take Tylenol or extra-strength Tylenol to treat the headaches and/or fever. That seems to work, but the length, i.e. duration of the reaction (my symptoms) seems longer than normal. I have described my symptoms to my doctor via email before my covid results were known. he also surmised they were a reaction to the Shingrix vaccination, rather than covid.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Night sweats, Pyrexia
Clinical narrative: Received the first two Shingrix vaccines. Within a day and continuing to the present (9/19/2020), I have been experiencing headaches and fever. sometimes both, sometimes one or the other. fever never broke above 101.2F. Some nights I sweat during sleep, but the sweating is not always associated with a fever. No other symptoms or side effects. Headaches, when they occur, are located mostly in the rear and base of my skull. I've take Tylenol or extra-strength Tylenol to treat the headaches and/or fever. That seems to work, but the length, i.e. duration of the reaction (my symptoms) seems longer than normal. I have described my symptoms to my doctor via email before my covid results were known. he also surmised they were a reaction to the Shingrix vaccination, rather than covid.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Rash
Clinical narrative: Patient's arm became, red, swollen, itchy and she got a rash across her back and a smaller sized rash on her chest. Patient takes Cetirizine 10mg daily, so she did not take any antihistamine. She also applied OTC Hydrocortisone 1% to the rash. Everything has resolved by today.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus, Rash
Clinical narrative: Patient's arm became, red, swollen, itchy and she got a rash across her back and a smaller sized rash on her chest. Patient takes Cetirizine 10mg daily, so she did not take any antihistamine. She also applied OTC Hydrocortisone 1% to the rash. Everything has resolved by today.
Age: 76.0
Sex: F
Vaccine: FLUA4
Symptoms: Anxiety, Dizziness, Tinnitus
Clinical narrative: Patient reports mild tinnitus starting on 10/15/2020 and lasting through until 10/19/2020.  She also reports mild dizziness on 10/18/2020, which she was not sure due to anxiety or a side effect of the vaccine.
Age: 16.0
Sex: M
Vaccine: HPV9, JEV1, MNQ
Symptoms: Face injury, Immediate post-injection reaction, Loss of consciousness, Somnolence, Syncope
Clinical narrative: Pt received three vaccinations at time of visit. Immediately after receiving final vaccine, patient fainted from treatment bed. Patient lost consciousness and hit face on the floor knocking out two front right teeth. Patient took approximately 30 seconds to rouse but was still somnolent. Patient oriented to person, place, and time. Vital signs taken BP 130/76 HR 81 PaO2 100% on room air and 14 breathes/min. Rapid response called, ER arrived to evaluate patient. Pt escorted onto gurney and brought to ER to be further evaluated.
Age: 16.0
Sex: M
Vaccine: HPV9, JEV1, MNQ
Symptoms: Tooth loss
Clinical narrative: Pt received three vaccinations at time of visit. Immediately after receiving final vaccine, patient fainted from treatment bed. Patient lost consciousness and hit face on the floor knocking out two front right teeth. Patient took approximately 30 seconds to rouse but was still somnolent. Patient oriented to person, place, and time. Vital signs taken BP 130/76 HR 81 PaO2 100% on room air and 14 breathes/min. Rapid response called, ER arrived to evaluate patient. Pt escorted onto gurney and brought to ER to be further evaluated.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Electrocardiogram normal, Febrile convulsion
Clinical narrative: patient had 1 minute febrile seizure with full recovery over 15 minutes. Was taken via EMS to the pediatric emergency Department where he was seen to be back to normal and discharged with return precautions
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: The patient's arm has been sore for two months.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Rash, Urticaria
Clinical narrative: swollen left arm 3-4 inches around the injection site. hives rash from neck to waist started one and half days after administration lasted about 4-5 days. woke up one day and was gone. took benadryl second day but did not help resolve rash or anything. no fever chills.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine administration in reference to temperature excursion; Information has been received from a other referring to a currently 4 years old unknown gender patient. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD)(0.5 milliliter, lot # T005406, expiration date: 12-AUG-2021, frequency and route were not reported) for prophylaxis. The administered doses experienced a temperature excursion at  -9.5 C for 8 hours and 53 mins;  -10.1 C for 6 hours and 40 minutes. No previous temperature excursions. The temperature excursions were detected by a data logger (Product storage error).
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine administration in reference to temperature excursion; This spontaneous report was received from an unspecified reporter referring to a currently 1 year old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On an unknown date, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (0.5 milliliter (mL), lot # S038702, expiration date 01-DEC-2021; strength,  frequency and route of administration were not reported) for prophylaxis (product storage error). Current temperature excursion was -9.5 Celsius degrees for 8 hours and 53 minutes and -10.1 Celsius degrees for 6 hours and 40 minutes. There was no previous temperature excursion. Data logger was involved.
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: there was 1 dose of VARIVAX administered while it was out of recommended storage range; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On 26-SEP-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (0.5 milliliter (ml), lot # S032356, expiration date 14-OCT-2021; strength, frequency and route of administration were not reported) for prophylaxis, while it was out of recommended storage range (product storage error). Current temperature excursion was 6 Fahrenheit degrees to 14 Fahrenheit degrees for 1.5 hours and 15 Fahrenheit degrees to 46 Fahrenheit degrees for 20.5 hours. There was no previous temperature excursion. Data logger was involved.
Sex: U
Vaccine: HEPA, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO ADVERSE EFFECT; The patient was inadvertently administered a dose ofVAQTA which was expired; This spontaneous report was received from a Medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided. On 06-OCT-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) lot # S017739 with expiration date of 29-AUG-2020 for prophylaxis(strength, dose, frequency, route were not provided).No adverse effects reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S017739; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 1.17
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: Administered improperly stored MMR II.; This spontaneous report was received from a registered nurse, referring to a 14-months-old patient of unknown gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 13-OCT-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), administered at a dose of 0.5 milliliters (ml), as prophylaxis (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number 029454, which has been verified to be valid, expiration date reported and validated as 19-SEP-2021). The vaccine administered experienced a temperature excursion of -50 degrees Celsius (C) to +8C (14.58C), for a time frame of 11 hours and 45 minutes, as recorded by a data logger. There was no previous temperature excursion reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA004818:
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: HCP reported that ROTATEQ was expired on 16-SEP-2020 and was administered to a 2 month old baby on 06-OCT-2020; This spontaneous report was received from a physician concerning a 2-months-old female patient. The patient's concurrent conditions, medical history, drug reactions/allergies, historical drug and concomitant therapies were not provided.  On 06-OCT-2020, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) orally, lot number 1660148 expiration date 16-SEP-2020 (expired vaccine administered), for prophylaxis. The physician inquired if the patient need it a re-vaccination.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Syringe issue, Underdose
Clinical narrative: The plunger rod would not fully administer the complete dosage; The plunger rod felt stuck and would not advance anymore"/ "PQC: yes; This spontaneous report has been received from a registered nurse referring to a 12 year old female patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.      On an unknown date, during vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # S022599 with expiration date of 25-FEB-2020, 0.5 milliliter in the left deltoid for prophylaxis, the plunger rod did not fully administered the complete dosage (incorrect dose administered ), reported as the plunger rod felt stuck and did not advanced anymore; it was mentioned that when the needle was removed from the patient, the syringe appeared to have about half of the 0.5 ml dose left in it (syringe issue). 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: Merck Sharp & Dohme Corp.; devicelotnumber: S022599; expirationdate: 25-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: The patient experienced syncope associated with Gardasil 9 administration; This spontaneous report has been received from a physician assistant via company representative referring to a 13-year-old female patient. The information regarding the patient's concurrent conditions, concomitant therapies, historical drugs, drug reactions or allergies, or pertinent medical history was unknown by the reporter.  On an unspecified date, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection as prophylaxis (strength, dosage schedule, route of administration, anatomical site of vaccination, vaccination scheme frequency, lot number, and expiration date were not reported).   On an unknown date (conflicting information: also reported as 19-OCT-2018), the patient experienced syncope associated to the administration of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). The patient sought medical attentions and was treated for the event with a cold rag placed on her forehead and was instructed to lie down due to the symptoms experienced.   The outcome of the event was unknown at the reporting time. It was unknown by the reporter if any laboratory diagnostic or studies were performed.  The causal relationship between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the event occurrence was related.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 11-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # 1621929, expiration date: 06-DEC-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursion of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. 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: Merck Sharp & Dohme Corp.; devicelotnumber: 1621929; expirationdate: 06-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:same reporter
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 12-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # 1621929, expiration date: 06-DEC-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursion of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. 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: Merck Sharp & Dohme Corp.; devicelotnumber: 1621929; expirationdate: 06-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: HPV9
Symptoms: Chest pain, Heart rate decreased, Hypotension, Loss of consciousness
Clinical narrative: passed out; passed out; on an off chest pain; low blood pressure; Low heart rate; This spontaneous report as received from a physician via company representative refers to a 17-year-old female patient. No information on patient's pertinent medical history, drug reactions/ allergies and concomitant medications was provided.  On an unknown date, the patient was vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiration date, dose, route of administration and anatomical location were not reported) for prophylaxis.         Since receiving the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient experienced on and off chest pain, low heart rate, low blood pressure. On unknown dates, the patient passed out twice. The outcome of the events on and off chest pain, low heart rate and low blood pressure was reported as ongoing. The outcome of episodes of passing out was unknown.   The relatedness between the events and the vaccination with  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, the episodes of passing out were considered to be medically significant.
Sex: F
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: received GARDASIL 9 in the buttocks; no additional AE reported; This spontaneous report was received from an office manager who was a patient's mother via vaccine account representative and refers to a female patient of unknown age. No information on patient's pertinent medical history, drug reactions/ allergies and concomitant medications was provided.  On an unknown date, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiration date, dose, route of administration were not reported) in the buttocks for prophylaxis. No additional adverse events reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no side effects reported; administration of an expired VAQTA vaccine; This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's concurrent condition, concomitant medication and historical condition were not provided.  On 15-OCT-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # S024396, expiration date reported as 12-OCT-2020 (strengh, dose, route of administration and anatomical location of vaccine were not reported) for prophylaxis. No side effects were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S024396; expirationdate: 12-OCT-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No side effects experienced; Once every 3-4 years/once a year since 2011; This spontaneous report was received from a 69-year-old female patient referring to herself. No information about the patient's concurrent conditions, drug allergies and reactions were reported. The patient had a history of shingles rash while on prior vaccination with zoster vaccine live (ZOSTAVAX) (case #1805USA011374)  In 2011, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not reported) once a year (also reported as once every 3-4 years) (inappropriate schedule of product administration), without adverse reactions/side effects.; Sender's Comments:  US-009507513-1805USA011374:
Sex: F
Vaccine: FLUN4
Symptoms: Pain, Rotator cuff syndrome
Clinical narrative: HIT MY ROTATOR CUFF; STILL HAS PAIN; A spontaneous report has been received from a consumer. The report concerns a female patient of Unknown ethnic origin (age 49 years).    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    Concomitant medication included influenza vaccine.     The patient received Flumist Quadrivalent (influenza virus vaccine live, intranasal) (batch number Unknown), via nasal route, on an unknown date.     On an unknown date, the patient experienced hit my rotator cuff (preferred term: Rotator cuff syndrome). On an unknown date, the patient experienced still has pain (preferred term: Pain).     The patient recovered with sequelae from the event(s) of hit my rotator cuff on an unspecified date. At the time of reporting, the event of still has pain was ongoing.     The events were considered non-serious.     Minor correction on 19-Oct-2020: Form Completed date updated.Narrative updated.
Sex: F
Vaccine: VARZOS
Symptoms: Movement disorder, Paralysis, Urinary incontinence
Clinical narrative: had urinary incontinence; couldn't move from waist down; paralyzed for 10 hours; This case was reported by a consumer via other manufacturer and described the occurrence of paralysis in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included leg discomfort (Right leg not fully functioning all the time), constipation (had constipation), tuberculosis (had TB positive), cane user (had cane use) and multiple sclerosis (had MS(Multiple sclerosis)). Concurrent medical conditions included urinary tract infection. Concomitant products included ocrelizumab (Ocrevus), colecalciferol (Vitamin D3), Bone Strength, lactobacillus acidophilus (Acidophilus), magnesium + malic acid (Magnesium Malate) and dronabinol (Medical Marijuana).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced paralysis (serious criteria GSK medically significant), urinary incontinence and movement disorder. On an unknown date, the outcome of the paralysis, urinary incontinence and movement disorder were recovered/resolved.   It was unknown if the reporter considered the paralysis, urinary incontinence and movement disorder to be related to Shingrix.  Additional details were provided as foolows: The age at vaccination was not reported. The reporter stated that, after vaccination with Shingrix, in 2019 the patient experienced paralyzed for 10 hours, could not move from waist down, and also had urinary incontinence. The patient received Hyland's cough, Craneberry, Dulcolax and  Dramamine as a concomitant medication. The reporter stated that, patient recovered from paralysis, could not move from waist down and urinary incontinence.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a consumer and described the occurrence of shingles in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th September 2020, the patient received Shingrix. In September 2020, 8 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient herself. The age at vaccination was not reporter but patient could be 70 or 71 years old at time of vaccination. The patient received the Shingrix vaccine and 8 days later patient was diagnosed by physician with Shingles.  The patient's pharmacist suggested to her to  contact the manufacturer of vaccine.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Induration, Pruritus, Swelling
Clinical narrative: Localized reaction Induration 1.5"; localized reaction Itching; Localized reaction Swollen; Localized reaction Red; This case was reported by a nurse via call center representative and described the occurrence of induration in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA95AA, expiry date 28th February 2022) for prophylaxis.   On 10th September 2020, the patient received the 1st dose of Bexsero. On an unknown date, less than 2 months after receiving Bexsero, the patient experienced induration, localized itching, local swelling and localized erythema. On an unknown date, the outcome of the induration, localized itching, local swelling and localized erythema were recovered/resolved.   It was unknown if the reporter considered the induration, localized itching, local swelling and localized erythema to be related to Bexsero.  Additional details were reported as follows: The patient received dose of Bexsero and experienced localized reaction of induration 1.5 inch, itching, swollen and red which lasted for more than 3 weeks. No other information was available. The reporter did not consent to follow up. The batch number ADXA95AA, however captured as ABXA95AA as per sales sheet.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Myalgia
Clinical narrative: shingles; headache; muscle soreness; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 10th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 10th October 2020, 2 hrs after receiving Shingrix, the patient experienced muscle soreness. On 12th October 2020, the patient experienced shingles and headache. On an unknown date, the outcome of the shingles, muscle soreness and headache were recovered/resolved.   It was unknown if the reporter considered the shingles, muscle soreness and headache to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. The patient experienced muscle soreness all over the major muscle groups. The patient two days after receiving Shingrix experienced shingles and headache. The patient consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got shingles after the first dose of shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had shingles. The reporter did not consent to follow up. The reporter did not want to provide data because he said he had already reported it but no report was found.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: Shingles; received the 1st dose of Shingrix on 7Aug2020 / the 2nd dose on 29Sep2020; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 29th September 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 29th September 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. In October 2020, the patient experienced shingles. The patient was treated with antivirals nos. On an unknown date, the outcome of the shingles and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The patient received 2nd dose of vaccine and 1 week after developed shingles. The pharmacist told that the patient was currently taking antivirals. The patient received 2nd dose of shingrix earlier than the recommended interval, which led to shortening of vacination schdeule. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Rash
Clinical narrative: rash on her chest; Localized reaction; This case was reported by a nurse via call center representative and described the occurrence of rash in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash and local reaction. On an unknown date, the outcome of the rash and local reaction were unknown.   It was unknown if the reporter considered the rash and local reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had some localized reactions developed on her arm and after she experienced a rash on her chest.  The HCP did not had further details to provide. The reporter consented to follow up. No further clarifications performed by HCP.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles after 1st dose; Defused rash on left chest; This case was reported by a physician via sales rep and described the occurrence of shingles in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th September 2020, the patient received the 1st dose of Shingrix. On 2nd October 2020, 2 days after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: No Batch Number or Expiration Date was reported. The patient was vaccinated with dose of Shingrix. The 2 day after vaccination patient had a defused rash on the left chest. The patient also had Shingles. No further clarifications. The reporter consent to follow up.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 03-Oct-2020 regarding an unsolicited valid non-serious case received from a social media via consumer or non-healthcare professional.  This case involves male patient (age not reported) who experienced flu (influenza), while he received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for influenza.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: patient ended up with Guillian's Barre; Initial information received on 08-Oct-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional.  This case involves male patient of unknown demographics who had Guillain's Barre (Guillain-Barre syndrome), while he received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious "Guillain's Barre" (Guillain-Barre syndrome) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for the event Guillain-Barre syndrome.  There will be no information on the batch number to be requested.; Sender's Comments: This case concerns a male patient who presented with Guillain-Barre syndrome, after vaccination with INFLUENZA VACCINE from unknown manufacturer. The time to onset is unknown. Moreover, patient's medical condition at the time of vaccination and lab tests were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.