chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness
Clinical narrative: He felt very dizzy and extremely weak. He was afraid he could have fallen so he sat down for about 15 minutes till the feeling passed.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Asthenia, Dysstasia, Headache, Injection site pain, Muscular weakness
Clinical narrative: Initially, patient developed right arm pain at the injection site, then left arm pain. Pain began radiating across his back. He developed a severe headache and The next AM developed weakness. All symptoms worsened Through the day. Parent called at 6 pm on 11/23/2020 with concerns of all symptoms worsened and leg weakness, inability to stand. He was recommended to go to the nearest emergency department. He was told he had a reaction to the Bexsero vaccine and went home. He is reportedly feeling better today on 11/24/2020.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Pain
Clinical narrative: Initially, patient developed right arm pain at the injection site, then left arm pain. Pain began radiating across his back. He developed a severe headache and The next AM developed weakness. All symptoms worsened Through the day. Parent called at 6 pm on 11/23/2020 with concerns of all symptoms worsened and leg weakness, inability to stand. He was recommended to go to the nearest emergency department. He was told he had a reaction to the Bexsero vaccine and went home. He is reportedly feeling better today on 11/24/2020.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Accidental exposure to product, No adverse event, Underdose
Clinical narrative: Patient was administered full dose of oral rotavirus vaccine. She spit up vaccine and it splashed into her eye. Eye was washed out F/u call without mom showed no effect
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Rash, Skin warm
Clinical narrative: patient received pneumovax23 vaccination 10/13/2020 and presented in office on 10/14/2020 with a rash. The rash has taken up the upper part of her right arm. It is hard and warm to the touch. Patient also reported pain, swelling, and neck stiffness. Declined: SOB, wheezing, swelling of lips, tongue or throat. No recation was reported previously to the Prevnar13 vaccination.  Prescribed 50mg Benadryl q 6 hours and Medrol dose pack. Discussed signs of advancing recations and advised to go straight to ER if occurs.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Vasovagal syncope within 10 minutes of vaccine being given when walking out of office
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Rash
Clinical narrative: patient had rashes all over body since August, dry skin and patches
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Decreased appetite, Dysgraphia, Gait disturbance, Mobility decreased, Neuralgia
Clinical narrative: patient reported whole body severe nerve pain, loss of appetite, trouble walking and moving, trouble talking and writing
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Speech disorder
Clinical narrative: patient reported whole body severe nerve pain, loss of appetite, trouble walking and moving, trouble talking and writing
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, Injection site swelling, Wrong product administered
Clinical narrative: Patient was given GARDASIL 9 instead ofTDAP. Caller wants to know if there is any information about harm to the baby as she is in her 3rd trimester; Patient was given GARDASIL 9 instead ofTDAP; This spontaneous prospective pregnancy report was received from a consumer and refers to a female patient of an unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported.      On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, lot #, expiration date and location of administration were not reported) for prophylaxis instead of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (reported as "TDAP"). The reporter wanted to know it there was any information about harm to the baby as she was in 3rd trimester. At the reporting time, there was no additional adverse event (AE) information available at that time. The outcomes of events of wrong product administered and exposure during pregnancy and action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) were not reported   The causality between the events and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not reported.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given GARDASIL 9 instead ofTDAP. Caller wants to know if there is any information about harm to the baby as she is in her 3rd trimester; Patient was given GARDASIL 9 instead ofTDAP; This spontaneous prospective pregnancy report was received from a consumer and refers to a female patient of an unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported.      On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, lot #, expiration date and location of administration were not reported) for prophylaxis instead of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (reported as "TDAP"). The reporter wanted to know it there was any information about harm to the baby as she was in 3rd trimester. At the reporting time, there was no additional adverse event (AE) information available at that time. The outcomes of events of wrong product administered and exposure during pregnancy and action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) were not reported   The causality between the events and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not reported.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Altered state of consciousness, Chills, Delirium, Dysgeusia, Feeding disorder
Clinical narrative: Felt like she could not move; Delirious; Loss of awareness / could not take care of herself; Nausea; High fever; Her body hurt all over; Loss of dexterity in her hands; Sweating; Shuddering; Muscular pain; Skull splitting headache; She could barely walk last night; This case was reported by a consumer via call center representative and described the occurrence of movements reduced in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of heart rate increased (For the tolerability of 1st  dose, refer case US2020222236 reported for same patient).   On 17th November 2020, the patient received the 2nd dose of Shingrix (intramuscular). In November 2020, less than a day after receiving Shingrix, the patient experienced movements reduced (serious criteria GSK medically significant), delirium (serious criteria GSK medically significant), consciousness disturbed (serious criteria GSK medically significant), nausea, fever, general body pain, hands weakness of, sweating, tremor, muscle pain, headache and walking difficulty. On an unknown date, the outcome of the movements reduced, delirium, consciousness disturbed, nausea, fever, general body pain, hands weakness of, sweating, tremor, muscle pain, headache and walking difficulty were recovering/resolving.   It was unknown if the reporter considered the movements reduced, delirium, consciousness disturbed, nausea, fever, general body pain, hands weakness of, sweating, tremor, muscle pain, headache and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that patient received the 2nd dose of shingrix on 17th November 2020, and 7-8 hrs after the vaccination patient could not move, had nausea, was delirious, had a high fever, and her body hurt all over. The patient reported an overwhelming loss of awareness and could not take care of herself also patient reported loss of dexterity in her hands, sweating, shuddering, muscular pain, and a skull splitting headache.  The patient reported she could barely walk last night. The patient reported that she felt better now. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020222236:Same reporter. 1st dose.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Feeling cold, Headache, Heart rate increased, Myalgia, Nausea
Clinical narrative: Felt like she could not move; Delirious; Loss of awareness / could not take care of herself; Nausea; High fever; Her body hurt all over; Loss of dexterity in her hands; Sweating; Shuddering; Muscular pain; Skull splitting headache; She could barely walk last night; This case was reported by a consumer via call center representative and described the occurrence of movements reduced in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of heart rate increased (For the tolerability of 1st  dose, refer case US2020222236 reported for same patient).   On 17th November 2020, the patient received the 2nd dose of Shingrix (intramuscular). In November 2020, less than a day after receiving Shingrix, the patient experienced movements reduced (serious criteria GSK medically significant), delirium (serious criteria GSK medically significant), consciousness disturbed (serious criteria GSK medically significant), nausea, fever, general body pain, hands weakness of, sweating, tremor, muscle pain, headache and walking difficulty. On an unknown date, the outcome of the movements reduced, delirium, consciousness disturbed, nausea, fever, general body pain, hands weakness of, sweating, tremor, muscle pain, headache and walking difficulty were recovering/resolving.   It was unknown if the reporter considered the movements reduced, delirium, consciousness disturbed, nausea, fever, general body pain, hands weakness of, sweating, tremor, muscle pain, headache and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that patient received the 2nd dose of shingrix on 17th November 2020, and 7-8 hrs after the vaccination patient could not move, had nausea, was delirious, had a high fever, and her body hurt all over. The patient reported an overwhelming loss of awareness and could not take care of herself also patient reported loss of dexterity in her hands, sweating, shuddering, muscular pain, and a skull splitting headache.  The patient reported she could barely walk last night. The patient reported that she felt better now. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020222236:Same reporter. 1st dose.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: Felt like she could not move; Delirious; Loss of awareness / could not take care of herself; Nausea; High fever; Her body hurt all over; Loss of dexterity in her hands; Sweating; Shuddering; Muscular pain; Skull splitting headache; She could barely walk last night; This case was reported by a consumer via call center representative and described the occurrence of movements reduced in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of heart rate increased (For the tolerability of 1st  dose, refer case US2020222236 reported for same patient).   On 17th November 2020, the patient received the 2nd dose of Shingrix (intramuscular). In November 2020, less than a day after receiving Shingrix, the patient experienced movements reduced (serious criteria GSK medically significant), delirium (serious criteria GSK medically significant), consciousness disturbed (serious criteria GSK medically significant), nausea, fever, general body pain, hands weakness of, sweating, tremor, muscle pain, headache and walking difficulty. On an unknown date, the outcome of the movements reduced, delirium, consciousness disturbed, nausea, fever, general body pain, hands weakness of, sweating, tremor, muscle pain, headache and walking difficulty were recovering/resolving.   It was unknown if the reporter considered the movements reduced, delirium, consciousness disturbed, nausea, fever, general body pain, hands weakness of, sweating, tremor, muscle pain, headache and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that patient received the 2nd dose of shingrix on 17th November 2020, and 7-8 hrs after the vaccination patient could not move, had nausea, was delirious, had a high fever, and her body hurt all over. The patient reported an overwhelming loss of awareness and could not take care of herself also patient reported loss of dexterity in her hands, sweating, shuddering, muscular pain, and a skull splitting headache.  The patient reported she could barely walk last night. The patient reported that she felt better now. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020222236:Same reporter. 1st dose.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Altered state of consciousness, Delirium, Fine motor skill dysfunction, Gait disturbance, Headache
Clinical narrative: Felt like she could not move; Delirious; Loss of awareness / could not take care of herself; Nausea; High fever; Her body hurt all over; Loss of dexterity in her hands; Sweating; Shuddering; Muscular pain; Skull splitting headache; She could barely walk last night; This case was reported by a consumer via call center representative and described the occurrence of movements reduced in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of heart rate increased (For the tolerability of 1st  dose, refer case US2020222236 reported for same patient).   On 17th November 2020, the patient received the 2nd dose of Shingrix (intramuscular). In November 2020, less than a day after receiving Shingrix, the patient experienced movements reduced (serious criteria GSK medically significant), delirium (serious criteria GSK medically significant), consciousness disturbed (serious criteria GSK medically significant), nausea, fever, general body pain, hands weakness of, sweating, tremor, muscle pain, headache and walking difficulty. On an unknown date, the outcome of the movements reduced, delirium, consciousness disturbed, nausea, fever, general body pain, hands weakness of, sweating, tremor, muscle pain, headache and walking difficulty were recovering/resolving.   It was unknown if the reporter considered the movements reduced, delirium, consciousness disturbed, nausea, fever, general body pain, hands weakness of, sweating, tremor, muscle pain, headache and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that patient received the 2nd dose of shingrix on 17th November 2020, and 7-8 hrs after the vaccination patient could not move, had nausea, was delirious, had a high fever, and her body hurt all over. The patient reported an overwhelming loss of awareness and could not take care of herself also patient reported loss of dexterity in her hands, sweating, shuddering, muscular pain, and a skull splitting headache.  The patient reported she could barely walk last night. The patient reported that she felt better now. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020222236:Same reporter. 1st dose.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Hyperhidrosis, Hypokinesia, Loss of personal independence in daily activities, Muscular weakness, Myalgia
Clinical narrative: Felt like she could not move; Delirious; Loss of awareness / could not take care of herself; Nausea; High fever; Her body hurt all over; Loss of dexterity in her hands; Sweating; Shuddering; Muscular pain; Skull splitting headache; She could barely walk last night; This case was reported by a consumer via call center representative and described the occurrence of movements reduced in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of heart rate increased (For the tolerability of 1st  dose, refer case US2020222236 reported for same patient).   On 17th November 2020, the patient received the 2nd dose of Shingrix (intramuscular). In November 2020, less than a day after receiving Shingrix, the patient experienced movements reduced (serious criteria GSK medically significant), delirium (serious criteria GSK medically significant), consciousness disturbed (serious criteria GSK medically significant), nausea, fever, general body pain, hands weakness of, sweating, tremor, muscle pain, headache and walking difficulty. On an unknown date, the outcome of the movements reduced, delirium, consciousness disturbed, nausea, fever, general body pain, hands weakness of, sweating, tremor, muscle pain, headache and walking difficulty were recovering/resolving.   It was unknown if the reporter considered the movements reduced, delirium, consciousness disturbed, nausea, fever, general body pain, hands weakness of, sweating, tremor, muscle pain, headache and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that patient received the 2nd dose of shingrix on 17th November 2020, and 7-8 hrs after the vaccination patient could not move, had nausea, was delirious, had a high fever, and her body hurt all over. The patient reported an overwhelming loss of awareness and could not take care of herself also patient reported loss of dexterity in her hands, sweating, shuddering, muscular pain, and a skull splitting headache.  The patient reported she could barely walk last night. The patient reported that she felt better now. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020222236:Same reporter. 1st dose.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Nausea, Pain, Pyrexia, Tremor
Clinical narrative: Felt like she could not move; Delirious; Loss of awareness / could not take care of herself; Nausea; High fever; Her body hurt all over; Loss of dexterity in her hands; Sweating; Shuddering; Muscular pain; Skull splitting headache; She could barely walk last night; This case was reported by a consumer via call center representative and described the occurrence of movements reduced in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of heart rate increased (For the tolerability of 1st  dose, refer case US2020222236 reported for same patient).   On 17th November 2020, the patient received the 2nd dose of Shingrix (intramuscular). In November 2020, less than a day after receiving Shingrix, the patient experienced movements reduced (serious criteria GSK medically significant), delirium (serious criteria GSK medically significant), consciousness disturbed (serious criteria GSK medically significant), nausea, fever, general body pain, hands weakness of, sweating, tremor, muscle pain, headache and walking difficulty. On an unknown date, the outcome of the movements reduced, delirium, consciousness disturbed, nausea, fever, general body pain, hands weakness of, sweating, tremor, muscle pain, headache and walking difficulty were recovering/resolving.   It was unknown if the reporter considered the movements reduced, delirium, consciousness disturbed, nausea, fever, general body pain, hands weakness of, sweating, tremor, muscle pain, headache and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that patient received the 2nd dose of shingrix on 17th November 2020, and 7-8 hrs after the vaccination patient could not move, had nausea, was delirious, had a high fever, and her body hurt all over. The patient reported an overwhelming loss of awareness and could not take care of herself also patient reported loss of dexterity in her hands, sweating, shuddering, muscular pain, and a skull splitting headache.  The patient reported she could barely walk last night. The patient reported that she felt better now. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020222236:Same reporter. 1st dose.
Sex: F
Vaccine: VARCEL
Symptoms: Product dispensing error
Clinical narrative: An employee at the clinic accidentally got VARIVAX in her eye; An employee at the clinic accidentally got VARIVAX in her eye; This spontaneous report as received from a nurse practitioner referring to a female employee at the clinic of unknown age. The employee pertinent medical history, concomitant drugs and allergy to drugs were not reported.  On 29-OCT-2020, an employee at the clinic accidentally got varicella virus vaccine live (oka/merck) (VARIVAX) (dose, strength, route, lot number and expiration date were not reported) in her eye(exposure via eye contact,occupational exposure to product). It was unable to located information regarding topical or ocular exposure. The employee did flush out their eye. The caller was offered an escalation and they requested that this be listed as an urgent escalation as their clinic was unclear as to how severe a situation like this is as they have never had this occur.
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Axillary pain, Erythema, Feeling abnormal, Mobility decreased
Clinical narrative: Rash all over my arm and it's starting to spread/ red rash/ rash is itchy; pain is in my armpit; Rash all over my arm and it's starting to spread/ red rash/ rash is itchy; Pain in the knees/ paint in joints; The site became swollen and very painful; I was so scared; The site became swollen and very painful; skin was reddened on her upper arm and then the redness went down the arm; couldn't lift my arm for 4 days; even my nose felt strange; This spontaneous report, was received from a 73-year-old female patient referring to herself. The patient's concurrent conditions, concomitant medications, and drug allergies or reactions were not provided.  Historical vaccinations included pneumococcal 13v conj vaccine (CRM197) (PREVENAR 13) in 2019.   On 29-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as prophylaxis (strength, dose, administration route, lot number, and expiration date were not provided).         On the same day of vaccination, the injected site became swollen and very painful (vaccination site swelling and vaccination site pain). Also, she was very scared of the pain and felt that it was an inappropriate response (feeling abnormal).    On 31-OCT-2020 (reported as two days later), the patient reported to have a rash all over her arm, and it was starting to spread. Also the rash was reported as red and itchy (rash pruritic and rash erythematous).  The patient also experienced pain in her armpit, knees, fingers, and feet joints (arthralgia and axillary pain). That lasted for 2-3 days. The patient couldn't lift her arm due to the pain (application site joint movement impairment).       Additionally, on an unspecified day in 2020, the patient experienced erythema and nasal discomfort   The outcome of the events was not provided as well as the causal relationship between the events and the suspect vaccine.        .
Sex: F
Vaccine: PPV
Symptoms: Nasal discomfort, Pain in extremity, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Rash all over my arm and it's starting to spread/ red rash/ rash is itchy; pain is in my armpit; Rash all over my arm and it's starting to spread/ red rash/ rash is itchy; Pain in the knees/ paint in joints; The site became swollen and very painful; I was so scared; The site became swollen and very painful; skin was reddened on her upper arm and then the redness went down the arm; couldn't lift my arm for 4 days; even my nose felt strange; This spontaneous report, was received from a 73-year-old female patient referring to herself. The patient's concurrent conditions, concomitant medications, and drug allergies or reactions were not provided.  Historical vaccinations included pneumococcal 13v conj vaccine (CRM197) (PREVENAR 13) in 2019.   On 29-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as prophylaxis (strength, dose, administration route, lot number, and expiration date were not provided).         On the same day of vaccination, the injected site became swollen and very painful (vaccination site swelling and vaccination site pain). Also, she was very scared of the pain and felt that it was an inappropriate response (feeling abnormal).    On 31-OCT-2020 (reported as two days later), the patient reported to have a rash all over her arm, and it was starting to spread. Also the rash was reported as red and itchy (rash pruritic and rash erythematous).  The patient also experienced pain in her armpit, knees, fingers, and feet joints (arthralgia and axillary pain). That lasted for 2-3 days. The patient couldn't lift her arm due to the pain (application site joint movement impairment).       Additionally, on an unspecified day in 2020, the patient experienced erythema and nasal discomfort   The outcome of the events was not provided as well as the causal relationship between the events and the suspect vaccine.        .
Sex: F
Vaccine: PPV
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Rash all over my arm and it's starting to spread/ red rash/ rash is itchy; pain is in my armpit; Rash all over my arm and it's starting to spread/ red rash/ rash is itchy; Pain in the knees/ paint in joints; The site became swollen and very painful; I was so scared; The site became swollen and very painful; skin was reddened on her upper arm and then the redness went down the arm; couldn't lift my arm for 4 days; even my nose felt strange; This spontaneous report, was received from a 73-year-old female patient referring to herself. The patient's concurrent conditions, concomitant medications, and drug allergies or reactions were not provided.  Historical vaccinations included pneumococcal 13v conj vaccine (CRM197) (PREVENAR 13) in 2019.   On 29-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as prophylaxis (strength, dose, administration route, lot number, and expiration date were not provided).         On the same day of vaccination, the injected site became swollen and very painful (vaccination site swelling and vaccination site pain). Also, she was very scared of the pain and felt that it was an inappropriate response (feeling abnormal).    On 31-OCT-2020 (reported as two days later), the patient reported to have a rash all over her arm, and it was starting to spread. Also the rash was reported as red and itchy (rash pruritic and rash erythematous).  The patient also experienced pain in her armpit, knees, fingers, and feet joints (arthralgia and axillary pain). That lasted for 2-3 days. The patient couldn't lift her arm due to the pain (application site joint movement impairment).       Additionally, on an unspecified day in 2020, the patient experienced erythema and nasal discomfort   The outcome of the events was not provided as well as the causal relationship between the events and the suspect vaccine.        .
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: the patient was inadvertently administered a dose of VARIVAX which expired on 9/17/2020; no adverse effects reported; This spontaneous report was received from a pharmacy technician referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant drugs and allergy to drugs were not reported.  On 30-OCT-2020, the patient was inadvertently administered a expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number was R026548, expiration date was 17-SEP-2020, route and strength were not reported) for prophylaxis (Expired product administered). This was supported. No adverse effects reported.
Sex: U
Vaccine: HPV9, UNK
Symptoms: Product storage error
Clinical narrative: No additional AE/PQC reported; GARDASIL 9 that was administered after a temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 28-OCT-2020, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml, lot # S023475 with expiration date on 26-MAR-2022 (route of administration was not reported) for prophylaxis. No additional adverse event was reported. Administered dose of vaccine experienced the temperature excursion of 46.9 degrees Fahrenheit for 30 minutes twice, of 47.4 degrees Fahrenheit for 5 minutes and 46.2 degrees Fahrenheit for 1 hour 10 minutes. Digital data logger was involved and there was no previous temperature excursion. 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: S023475; expirationdate: 26-MAR-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Improperly Stored Vaccines Administered; This spontaneous report was received from an licensed practical nurse and refers to a 14-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 02-NOV-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # S017243 was verified to be valid with expiration date 01-DEC-2020, albumin status established as: rHa) in dose 0.5 ml (dose number, route of administration and anatomical location were not reported) for prophylaxis. The temperatures to which the vaccine was exposed were: -14 degrees of Celsius (C) to -10 C (-13.9C) the time frame was reported as 30 minutes; -14 C to -10 C (-14.2C) for 15 minutes; -14 C to -10 C (-14.7C) for 20 minutes; -14 C to -10 C (-14.6C) for 5 minutes. No previous temperature excursion was reported. A digital data logger was involved.
Age: 34.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: expired VAQTA vaccine used; This spontaneous report has been received from a health care professional regarding to a 34-year-old patient. The patient's concurrent conditions, medical history, concomitant therapies, drug allergies or reaction were not provided.   On 16-NOV-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) 1 mL (anatomical location of vaccine and route of administration were not reported), lot # S025258, expiration date reported 05-NOV-2020, for prophylaxis.    combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S025258; expirationdate: 05-NOV-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
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: no adverse reaction were noted; Expired VAQTA adminsitered; This spontaneous report has been received from a health care professional regarding to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies, drug allergies or reaction were not provided.   On 16-NOV-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) 1 mL (anatomical location of vaccine and route of administration were not reported), lot # S018772, expiration date reported 11-JUL-2020, but upon internal validation was established as 07-JUL-2020, for prophylaxis. No adverse reaction were noted to the patient. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S018772; expirationdate: 07-JUL-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
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: Caller is 28 weeks pregnant and was given GARDASIL 9 by mistake; Caller is 28 weeks pregnant and was given GARDASIL 9 by mistake, Caller stated the nurse was supposed to give her a flu shot; No additional AE/PQC was reported.; This spontaneous prospective pregnancy report was received from a unknown age female consumer referring to herself. The patient's pertinent concurrent conditions, medical history and concomitant medications were not provided.  On an unknown date in October 2020, the 28 weeks pregnant patient was mistakenly vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) as prophylaxis instead of influenza virus vaccine (unspecified)(reported as flu shot) (for both vaccines, concentrations number of administered dose, vaccination scheme frequencies, anatomical locations and routes of administration, lot numbers and expiration dates were not reported) (exposure during pregnancy and wrong product administered). No adverse events were reported. The patient's last menstrual period (LMP) was approximately on 23-MAR-2020 and the estimated due date (EDD) of 28-DEC-2020. The pregnancy outcome was pending.
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Loss of consciousness, Vomiting
Clinical narrative: Blacked out; Severe vomiting; Diarrhea; This case was reported by a consumer via interactive digital media and described the occurrence of blackout in a female patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, 2 hrs after receiving Hepatitis B vaccine, the patient experienced blackout (serious criteria GSK medically significant), vomiting and diarrhea. On an unknown date, the outcome of the blackout, vomiting and diarrhea were unknown.   The reporter considered the blackout, vomiting and diarrhea to be related to Hepatitis B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Hepatitis B vaccine and experienced blackout, severe vomiting, diarrhea. The patient visited to emergency room. The reporter asked was there any safe vaccine. The information regarding consent to follow up was not reported. No further information was available.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccine positive rechallenge
Clinical narrative: had flu; Initial information was received on 08-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves patient (unknown demography) who had flu (influenza), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(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, expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious had the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported that the patient got flu every time after the vaccination with influenza vaccine.  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.  Outcome of the event was unknown at the time of reporting.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Got the flu shot last year and still got a bad case of the flu, but not at the same time; Initial information was received on 08-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves a patient (unknown demography) who got the INFLUENZA VACCINE last year and still got a bad case of the flu, but not at the same time.  The patient's medical history, medical treatment(s), vaccination(s), 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 and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu shot last year and got a bad case of the flu, but not at the same time (influenza), unknown latency following the administration of INFLUENZA VACCINE.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome was unknown at the time of reporting.  There will be no information on the batch number for this cas
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: was ill; Initial information was received on 09-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves patient (unknown demography) who was ill (illness), while the patient received  INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(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, expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious was ill (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.  Outcome of the event was unknown at the time of reporting.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Vaccine positive rechallenge
Clinical narrative: have taken the shot every year and  had gotten the flu.; Initial information was received on 08-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves a female patient (unknown demography) who have taken the INFLUENZA VACCINE every year and got the flu (influenza).  The patient's medical history, medical treatment(s), vaccination(s), 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 and expiration date were not reported) via 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.  It was reported that she had to take the flu shot as she had work in a close environment of people.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome was unknown at the time of reporting.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: very very sick and was sick all day; Initial information received on 08-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves patient (unknown demographics) who got very very sick and was sick all day (illness), when 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 very very sick and was sick all day (illness) 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 illness.
Sex: F
Vaccine: FLUX
Symptoms: Pneumonia
Clinical narrative: Pneumonia; Initial information was received on 12-Nov-2020 regarding an unsolicited valid serious case received from a consumer/non-health care professional .  This case involves female patient (age not specified) who had pneumonia, while she received INFLUENZA VACCINE.  Medical history, medical treatment(s), past vaccination(s) 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 and expiry date were not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious pneumonia (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event.  Laboratory data was not provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting the outcome of event was unknown.  There will be no information available on batch number for this case.; Sender's Comments: This case concerns a female patient who had pneumonia after vaccination with INFLUENZA VACCINE. The time to onset is unknown. Additional information regarding patient's past medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies, information on causative organism would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient got flu; Initial information received on 15-Nov-2020 regarding an unsolicited valid non-serious case from social media via consumer or non-health care professional  This case involves patient of unknown demographics who got the flu (influenza), while patient received vaccine INFLUENZA VACCINE, [flu shot].  Medical history, 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 and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious patient got flu (influenza) 1 week following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 14-Nov-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional.  This case involves patient of unknown demographics who experienced flu, while patient received vaccine INFLUENZA VACCINE [Flu shot].  Medical history, 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 and expiry date not reported] via an unknown route at an unknown administration site prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  It was reported that, could not get the flu years ago patient never had another flu shot and have not had the flu since  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.   At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccine positive rechallenge
Clinical narrative: patient got the flu shot 20 years and got the flu; Initial information received on 14-Nov-2020 regarding an unsolicited valid non-serious case via consumer or non-health care professional.  This case involves patient of unknown demographics who got the flu shot 20 years and got the flu, while patient received vaccine INFLUENZA VACCINE [Flu shot].  Medical history, 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 and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious patient got the flu shot 20 years and got the, (influenza) unknown latency following the administration of INFLUENZA VACCINE.  It was reported that, patient got the flu, 4 years no flu shot and no flu.  Details of laboratory data not reported.      It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.