chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: calling for temperature evaluation for VARIVAX and notifed it was administered to multiple patients; This spontaneous report as received from a registered nurse 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 15-APR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX)(strength, dosing schedule, lot#, expiration date and route of administration were not provided) for prophylaxis. Administered dose of vaccine was exposed to the temperature from -14 Celsius degrees to -10 Celsius degrees for 4 hours 15 minutes. There was a previous temperature excursion noted: from -9 Celsius degrees to 8 Celsius degrees for 2 hours 21 minutes, as recorded by a digital data logger.  This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2007USA003458: US-009507513-2007USA004416:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: calling for temperature evaluation for VARIVAX and notifed it was administered to multiple patients; This spontaneous report as received from a registered nurse 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-APR-2020, the patient was vaccinated with an improperly stored dose of  varicella virus vaccine live (oka/merck)(VARIVAX)(strength, dosing schedule, lot#, expiration date and route of administration were not provided)  for prophylaxis. Administered dose of vaccine was exposed to the temperature from -14 Celsius degrees to -10 Celsius degrees for 4 hours 15 minutes. There was a previous temperature excursion noted: from -9 Celsius degrees to 8 Celsius degrees for 2 hours 21 minutes, as recorded by a digital data logger.          This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2007USA003458: US-009507513-2007USA004416:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: calling for temperature evaluation for VARIVAX and notifed it was administered to multiple patients; This spontaneous report as received from a registered nurse 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 29-APR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX)(strength, dosing schedule, lot#, expiration date and route of administration were not provided) for prophylaxis. Administered dose of vaccine was exposed to the temperature from -14 Celsius degrees to -10 Celsius degrees for 4 hours 15 minutes. There was a previous temperature excursion noted: from -9 Celsius degrees to 8 Celsius degrees for 2 hours 21 minutes, as recorded by a digital data logger.  This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2007USA003458: US-009507513-2007USA004416:
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received Shingrix and experinced fever.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient asked how long and how high can a fever last with the Shingrix vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: side effects; This case was reported by a consumer via interactive digital media and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (Trelegy Ellipta).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after starting Trelegy Ellipta, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patent was asking that, how long the side effects of shingles vaccine last.
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: temperature excursion of 49.7 degrees F for  11 hours 30 minutes due to refrigerator door left open, no AE; Initial information received on 13-Jul-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves Adult female patient which was DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6273AA ,U6217AA and expiry date: 24-Apr-2021, 21-Mar-2021) temperature excursion of 49.7 degrees for 11 hours 30 minutes due to refrigerator door left open (product storage error).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medication was not reported.   This was potential medication error case due to incorrect product storage.   At the time of reporting, it was not reported if the vaccine was not administered or not  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pain of skin
Clinical narrative: Moderately severe muscle aches, fatigue and scalp tenderness gradually starting to improve after eight days
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue
Clinical narrative: Tiredness; Stomach Upset; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th June 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced tiredness and upset stomach. On an unknown date, the outcome of the tiredness and upset stomach were not recovered/not resolved.   It was unknown if the reporter considered the tiredness and upset stomach to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's husband. The reporter stated that, the patient experienced feeling of tiredness and an upset stomach after vaccination with dose of Shingrix. The reporter wanted to know how long these side effects last. The reporter did not consent to follow up. This case was 1 of 2 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020121803:original: HUSBAND´S CASE
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Electrocardiogram T wave inversion, Headache, Injection site erythema, Injection site swelling, Paraesthesia
Clinical narrative: Patient reported back with adverse reactions due to second Shingirx vaccine. Patient reports to have had raised swelling and redness at site of injection for two days after immunization was given, headaches for two days, and left-sided tingles leading to her toes for two days. Patient is feeling normal now and did not use any treatments to alleviate symptoms.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Body temperature increased, C-reactive protein increased, Vomiting, White blood cell count increased
Clinical narrative: Mom reported later in the evening around 10pm on 07/08/20 her son vomited X 3 episodes and had an elevated temperature of 102F.  Mom stated she rotated between Tylenol and Motrin which seemed to lower temp, but the next day son had a temperature of 106.4.  She stated she took son to pediatrician when temp remained elevated.  Mom stated she took son to Hospital for lab work.  She reported WBC count "over 20,000" and CRP "34."  Mom denied son had diarrhea, cough, seizure.   She was referred to a rheumatologist for possible "periodic fever syndrome...familial mediterranean fever syndrome."
Sex: F
Vaccine: VARZOS
Symptoms: Bacterial infection, Cardiac failure congestive, Herpes zoster, Myocardial infarction, Neuralgia
Clinical narrative: post herpetic neuralgia; issues with her vision; congestive heart failure; heart attack; bacterial infection; herpes zoster; Information has been received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions and concomitant medications. On or about 30-AUG-2017, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered from a painful blistering rash, which recurred multiple times; herpes zoster; post herpetic neuralgia; issues with her vision; nerve pain; congestive heart failure; heart attack; and bacterial infection. As a result of these symptoms, the pt was seen and treated by medical providers. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt's symptoms resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. As a result of the vaccination, the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the vaccination, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the vaccination, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of post herpetic neuralgia, abnormal vision, cardiac failure congestive, heart attack, bacterial infection and herpes zoster was not recovered. The reporter considered post herpetic neuralgia, abnormal vision, cardiac failure congestive, heart attack, bacterial infection and herpes zoster to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the events of cardiac failure congestive and heart attack were determined to be medically significant.  The reporter considered post herpetic neuralgia, abnormal vision, cardiac failure congestive, heart attack, bacterial infection and herpes zoster to be disabling.
Sex: F
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia, Rash, Rash vesicular, Visual impairment
Clinical narrative: post herpetic neuralgia; issues with her vision; congestive heart failure; heart attack; bacterial infection; herpes zoster; Information has been received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions and concomitant medications. On or about 30-AUG-2017, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered from a painful blistering rash, which recurred multiple times; herpes zoster; post herpetic neuralgia; issues with her vision; nerve pain; congestive heart failure; heart attack; and bacterial infection. As a result of these symptoms, the pt was seen and treated by medical providers. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt's symptoms resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. As a result of the vaccination, the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the vaccination, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the vaccination, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of post herpetic neuralgia, abnormal vision, cardiac failure congestive, heart attack, bacterial infection and herpes zoster was not recovered. The reporter considered post herpetic neuralgia, abnormal vision, cardiac failure congestive, heart attack, bacterial infection and herpes zoster to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the events of cardiac failure congestive and heart attack were determined to be medically significant.  The reporter considered post herpetic neuralgia, abnormal vision, cardiac failure congestive, heart attack, bacterial infection and herpes zoster to be disabling.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: calling for temperature evaluation for VARIVAX and notifed it was administered to multiple patients; This spontaneous report as received from a registered nurse 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 02-APR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX)(strength, dosing schedule, lot#, expiration date and route of administration were not provided) for prophylaxis. Administered dose of vaccine was exposed to the temperature from -14 Celsius degrees to -10 Celsius degrees for 4 hours 15 minutes. There was a previous temperature excursion noted: from -9 Celsius degrees to 8 Celsius degrees for 2 hours 21 minutes, as recorded by a digital data logger.  This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2007USA003458: US-009507513-2007USA004416:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: calling for temperature evaluation for VARIVAX and notifed it was administered to multiple patients; This spontaneous report as received from a registered nurse 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 20-MAY-2020, the patient was vaccinated with an improperly stored dose of  varicella virus vaccine live (oka/merck)(VARIVAX)(strength, dosing schedule, lot#, expiration date and route of administration were not provided)  for prophylaxis. Administered dose of vaccine was exposed to the temperature from -14 Celsius degrees to -10 Celsius degrees for 4 hours 15 minutes. There was a previous temperature excursion noted: from -9 Celsius degrees to 8 Celsius degrees for 2 hours 21 minutes, as recorded by a digital data logger.          This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2007USA003458: US-009507513-2007USA004416:
Sex: M
Vaccine: RV1
Symptoms: Intussusception
Clinical narrative: intususception; This case was reported by a other health professional via sales rep and described the occurrence of intussusception in a infant male patient who received Rota (Rotarix oral suspension) (batch number F5L35, expiry date unknown) for prophylaxis.   On an unknown date, the patient received the 1st dose of Rotarix oral suspension (oral). On an unknown date, 3 days after receiving Rotarix oral suspension, the patient experienced intussusception (serious criteria GSK medically significant). On an unknown date, the outcome of the intussusception was unknown.   It was unknown if the reporter considered the intussusception to be related to Rotarix oral suspension.  Additional information was provided as follows: The age at vaccination was not reported, but could be less than 5 months. The patient developed intussuscpetion, it was diagnosed after 3 days. The reporter consented to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site reaction
Clinical narrative: Allergic Reaction close to injection site; This case was reported by a physician via call center representative and described the occurrence of allergic reaction in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional details were provided as follows: In july 2020, after receiving 1st dose of Shingrix, the patient developed some allergic reactions, but not sure what they were. One of them was close to the injection site. The reporter was consented to follow up. No further details were reported.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Cancer surgery, Condition aggravated, Herpes zoster, Neoplasm malignant, Stent placement
Clinical narrative: Carcinoma cancers removed from her face; Shingles outbreaks are worse; Shingles outbreaks are worse; This case was reported by a consumer via call center representative and described the occurrence of carcinoma in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles, open heart surgery, cancer and stent placement. Concomitant products included acyclovir and valaciclovir hydrochloride (Valacyclovir).   On 23rd October 2019, the patient received the 1st dose of Shingrix. On 27th February 2020, the dose was an unknown dose. In November 2019, 2 weeks after receiving Shingrix, the patient experienced shingles and condition aggravated. On an unknown date, the patient experienced carcinoma (serious criteria GSK medically significant). On an unknown date, the outcome of the carcinoma, shingles and condition aggravated were unknown.   It was unknown if the reporter considered the carcinoma, shingles and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The patient received the vaccine in the top part of her arm.  The patient had a history of shingles but she claimed that her shingles outbreaks were worse after getting both doses of the Shingrix.  The shingles were on her behind.  After getting the 1st dose of Shingrix, two weeks later, the patient got shingles again and she had a shingles outbreak about 5 times since and they were worse than before.  The patient reported that, she would have gotten the second dose closer to the first dose but she had four carcinoma cancers removed from her face in December 2019. The patient also reported that, she had a stent put in on 04th November 2019 after having open heart surgery in 2017.  At the time of reporting, the patient was taking Acyclovir each night and used the Zovirax cream.  The reporter was consented to follow up. For the tolerance of 2nd dose, refer the linked case US2020AMR127486.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR127486:same patient
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: Carcinoma cancers removed from her face; Shingles outbreaks are worse; Shingles outbreaks are worse; This case was reported by a consumer via call center representative and described the occurrence of carcinoma in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles, open heart surgery, cancer and stent placement. Concomitant products included acyclovir and valaciclovir hydrochloride (Valacyclovir).   On 23rd October 2019, the patient received the 1st dose of Shingrix. On 27th February 2020, the dose was an unknown dose. In November 2019, 2 weeks after receiving Shingrix, the patient experienced shingles and condition aggravated. On an unknown date, the patient experienced carcinoma (serious criteria GSK medically significant). On an unknown date, the outcome of the carcinoma, shingles and condition aggravated were unknown.   It was unknown if the reporter considered the carcinoma, shingles and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The patient received the vaccine in the top part of her arm.  The patient had a history of shingles but she claimed that her shingles outbreaks were worse after getting both doses of the Shingrix.  The shingles were on her behind.  After getting the 1st dose of Shingrix, two weeks later, the patient got shingles again and she had a shingles outbreak about 5 times since and they were worse than before.  The patient reported that, she would have gotten the second dose closer to the first dose but she had four carcinoma cancers removed from her face in December 2019. The patient also reported that, she had a stent put in on 04th November 2019 after having open heart surgery in 2017.  At the time of reporting, the patient was taking Acyclovir each night and used the Zovirax cream.  The reporter was consented to follow up. For the tolerance of 2nd dose, refer the linked case US2020AMR127486.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR127486:same patient
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Felt tired; Soreness; Fever; This case was reported by a pharmacist via call center representative and described the occurrence of tiredness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tiredness, pain and fever. On an unknown date, the outcome of the tiredness, pain and fever were unknown.   It was unknown if the reporter considered the tiredness, pain and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable. The patient received Shingrix and experienced fever, soreness, felt tired.  No specific patient The reporter did not consent to follow up.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on arms and legs
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Extra dose administered
Clinical narrative: Pt already had Menactra and HPV that was unknown to us at the time.  Pt got duplicate vaccines
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Muscle contractions involuntary, Postictal state, Somnolence, Tonic convulsion
Clinical narrative: 5-10  minutes after vaccine administration patient had a 1-2 minute tonic seizure with loss of posture, urinary incontinence.  Both arms tonic flexed elbows, clenched inverted hands.  Lowered to the floor.  Post-ictal for 20-30 minutes, briefly fell asleep.  Vomited x 2 after seizure was over.  No memory of seizure.  Spontaneous resolution of seizure.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Urinary incontinence, Vomiting
Clinical narrative: 5-10  minutes after vaccine administration patient had a 1-2 minute tonic seizure with loss of posture, urinary incontinence.  Both arms tonic flexed elbows, clenched inverted hands.  Lowered to the floor.  Post-ictal for 20-30 minutes, briefly fell asleep.  Vomited x 2 after seizure was over.  No memory of seizure.  Spontaneous resolution of seizure.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling, Skin warm, Tenderness
Clinical narrative: PT is experiencing warmth, swollen and tenderness in the arm.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Inflammation, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: it looks like cellulitis or something from the shot; arm got really sore and it was pretty painful/inflammation/not the injection site, behind his arm and elbow/ It was really red and swollen.; he can hardly move his arm; he touches the inflamed area it turns white; allergic reaction; This spontaneous report was received from a 49-year-old male consumer, who was also a patient, via Pfizer (Mfr Control No 2020263644). The patient's medical history included right arm surgery (on 10-JUN-2020). Concomitant therapies included acetaminophen (TYLENOL) for pain due to the surgery.  On 06-JUL-2020 at 07.30 in the morning, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) prefilled syringe, in the left arm, between the shoulder and elbow, (strength, dose, route of administration, lot number and expiry date were not provided) for vaccination.  On 06-JUL-2020, as the day progressed, the patient's arm got really sore and it was pretty painful. The patient could hardly move his arm and due to the event he could not get out of bed on 07-JUL-2020 (however, he also stated the vaccine was given in his good arm and he could not use the other arm, because of the surgery he had on it before vaccination - discrepant information). He was taking acetaminophen (TYLENOL) to help with inflammation. He stated the inflammation was not at the injection site, but behind his arm and elbow. On 08-JUL-2020, it was really red and swollen. The patient was icing it to get the swelling to go down. Moreover, he stated it looked like cellulitis "or something" from the shot. On an unknown date in July 2020, when he touched the inflamed area, it turned white. Additionally, he thought he might have an allergic reaction. He also asked if he should go to the emergency room. He stated he did not think "he was going to die or anything" and that he was not trying to complain; he was just trying to get information about side effects. The outcome of the event of "the patient could hardly move his arm" was reported as recovering/resolving. The outcome of the other events was unknown (however it was also reported as ongoing and as recovering - discrepant information).  The reporter considered the event of cellulitis to be related to the suspect vaccine (reported as "from the shot"). The causal relationship between other events and the suspect vaccine was not reported.  Upon internal review, the event of cellulitis was determined to be medically significant. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Skin discolouration
Clinical narrative: it looks like cellulitis or something from the shot; arm got really sore and it was pretty painful/inflammation/not the injection site, behind his arm and elbow/ It was really red and swollen.; he can hardly move his arm; he touches the inflamed area it turns white; allergic reaction; This spontaneous report was received from a 49-year-old male consumer, who was also a patient, via Pfizer (Mfr Control No 2020263644). The patient's medical history included right arm surgery (on 10-JUN-2020). Concomitant therapies included acetaminophen (TYLENOL) for pain due to the surgery.  On 06-JUL-2020 at 07.30 in the morning, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) prefilled syringe, in the left arm, between the shoulder and elbow, (strength, dose, route of administration, lot number and expiry date were not provided) for vaccination.  On 06-JUL-2020, as the day progressed, the patient's arm got really sore and it was pretty painful. The patient could hardly move his arm and due to the event he could not get out of bed on 07-JUL-2020 (however, he also stated the vaccine was given in his good arm and he could not use the other arm, because of the surgery he had on it before vaccination - discrepant information). He was taking acetaminophen (TYLENOL) to help with inflammation. He stated the inflammation was not at the injection site, but behind his arm and elbow. On 08-JUL-2020, it was really red and swollen. The patient was icing it to get the swelling to go down. Moreover, he stated it looked like cellulitis "or something" from the shot. On an unknown date in July 2020, when he touched the inflamed area, it turned white. Additionally, he thought he might have an allergic reaction. He also asked if he should go to the emergency room. He stated he did not think "he was going to die or anything" and that he was not trying to complain; he was just trying to get information about side effects. The outcome of the event of "the patient could hardly move his arm" was reported as recovering/resolving. The outcome of the other events was unknown (however it was also reported as ongoing and as recovering - discrepant information).  The reporter considered the event of cellulitis to be related to the suspect vaccine (reported as "from the shot"). The causal relationship between other events and the suspect vaccine was not reported.  Upon internal review, the event of cellulitis was determined to be medically significant. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: M
Vaccine: CHOL, HEPA, TTOX, TYP
Symptoms: Oral administration complication, Vomiting
Clinical narrative: THREW UP THE DOSE 15 TO 20 MIN AFTER INGESTING; This spontaneous case report (PVX2019-1958) was received from a nurse on 29-Jul-2019. It described a 29-year-old adult male consumer who "threw up the dose 15 to 20 min after ingesting" (PT: Vomiting), after the administration of Vaxchora, Hepatitis A, Tetanus and Typhoid VI vaccines for unknown indications.  Case report: The consumer took Vaxchora on 29-Jul-2019 and threw up it 15 to 20 minutes after ingesting it. She stated that after administering Vaxchora, the patient also received Hepatitis A, Tetanus and Typhoid VI vaccines prior to throwing up. She stated they were injectable and not oral.  Action taken with Vaxchora, Hepatitis A, Tetanus and Typhoid VI was unknown.  The clinical outcome of the event was unknown.  Company's Comment: In this case, a male consumer "threw up the dose 15 to 20 min after ingesting", after the administration of Vaxchora, Hepatitis A, Tetanus and Typhoid VI. There seems to be a temporal association between the intake of Vaxchora and the event. Hence, the causality of the events with Vivotif was assessed as possible. Additionally, co-administration of multiple vaccines also provides an alternative explanation for the reported event.; Sender's Comments: Company's Comment: In this case, a male consumer "threw up the dose 15 to 20 min after ingesting", after the administration of Vaxchora, Hepatitis A, Tetanus and Typhoid VI. There seems to be a temporal association between the intake of Vaxchora and the event. Hence, the causality of the events with Vivotif was assessed as possible. Additionally, co-administration of multiple vaccines also provides an alternative explanation for the reported event.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Itchy rash on her left arm at the injection site; Itchy rash on her left arm at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th June 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced injection site rash and injection site itching. On an unknown date, the outcome of the injection site rash was not recovered/not resolved and the outcome of the injection site itching was unknown.   It was unknown if the reporter considered the injection site rash and injection site itching to be related to Shingrix.  Additional details were provided as follows: After receiving 1st dose, the patient had three inch itchy rash on her left arm at the injection site. The reporter stated she wanted more information concerning the 2nd injection and her healthcare professional told her to call GlaxoSmithKline.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood pressure decreased, Cold sweat, Dizziness, Heart rate decreased, Nausea
Clinical narrative: Pt experienced dizziness 5 min post receiving Tdap/Menveo/HPV-9- pt became clammy and nauseous- BP and P monitored - low. Pt kept X 20 min- sucker and juice given prior to vaccines- finished both.  Put cool pack on head- 20 min post vaccines pt felt much better- BP and P back to normal. Left with mom after being checked by Dr. No injury.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Fatigue, Feeling hot, Injection site warmth, Muscle spasms
Clinical narrative: Vaccine was administered in left deltoid at 10:40, reaction began at 10:45. Pt initially had no concerns, then felt a rush of warmth from left shoulder across chest. The warmth across her chest made her cough, denied SOB and chest pain. She then began having spasms down spine and into lower back. This continued for approximately 10 min. Pt then was transported to a lying position on an exam table. Spasms were alleviated. After another 15 minutes or so pt was re-evaluated by doctor (neuro, lung, and heart exams clear), and vitals obtained. Pt stated she felt 100% better and left facility. I called pt at her home two hours later, she stated she felt well, but tired.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: on 7/15/2020, his right arm, where the Kinrix vaccine  and the proquad vaccine were given, got red, warm  and swollen approximately 7 1/2 in x 7 in wide/long
Age: 21.0
Sex: F
Vaccine: MENB, TD
Symptoms: Concussion, Hypoaesthesia, Injection site pain, Syncope
Clinical narrative: 5/13/20 - woke up with (R) shoulder pain with syncope episode. Went to ER 5/14/20 - Follow from ER (R) shoulder pain + concussion. 5/19/20 Telemedicine visit, followup with improvent. 5/28/20 ortho visit - follow up on numbness + (R) shoulder pain. Gabapentin started 5/19/20 with Relief.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Rash, Vomiting
Clinical narrative: SkinRash & Nausea Vomiting
Age: 46.0
Sex: M
Vaccine: FLUX
Symptoms: Localised oedema
Clinical narrative: & LOCALIZED EDEMA
Age: 54.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Urticaria
Clinical narrative: UrticariaPruritus
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: & Redness and warmth to injection site
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash & UrticariaPruritus TREATMENT: METHYLPREDNISOLONE, DIPHENHYDRAMINE, RANITIDINE
Age: 54.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Chills, Hyperhidrosis, Injection site erythema, Injection site pain
Clinical narrative: Rash & cellulitis CEFTRIAXONE 1 GM ONCE ,LIDOCAINE 2.1 ML ONCE
Age: 54.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pyrexia, Rash
Clinical narrative: Rash & cellulitis CEFTRIAXONE 1 GM ONCE ,LIDOCAINE 2.1 ML ONCE
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Urticaria
Clinical narrative: Acute urticaria all over the body swollen 4" round shot site swollen, red, tender Allegra 180 mg PO QD Zyrtec 10mg one PO QD Medrol DosPak
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Redness, knot at injection sight Tuesday night, Wednesday redness, warmth to injection sight. Thursday 7-16-20 redness, swelling, knot at sight. Redness spreading, warmth across thigh area
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. Pt's pertinent medical history, concurrent conditions and concomitant medications were not provided. On an unspecified date in 2011, pt was inoculated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to this inoculation, on an unknown date, pt was treated by a healthcare provider at a local medical office for shingles (herpes zoster). As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. At reporting time, pt was not recovered from herpes zoster and it was related to zoster vaccine live (ZOSTAVAX).
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Patient was only given the Hib portion of Pentacel vaccine mixed with alternate diluent from MMR and the diluent was not given/No AE; Initial information was received on 14-Jul-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a four years old female patient who was vaccinated with only Hib portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] vaccine which was mixed with alternate diluent from MMR and the diluent was not given (product preparation issue)  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diluent portion of MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) (lot U6622AA) via intramuscular route in the right arm for prophylactic vaccination.  On 08-Jul-2020, the patient received a 0.5 mL fourth dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ187AA and expiry date 16-Feb-2021) via intramuscular route in the right arm for prophylactic vaccination.  Case details: the reported stated that dose of Pentacel was administered to the patient and only the Hib portion was given reconstituted with diluent from MMR vaccine, diluent (DTap-IPV) was not administered.   It was an actual medication error case due to Inappropriate reconstitution technique.  It was unknown whether the patient had any adverse reactions.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: temperature excursion Menactra Vial that was left out overnight at room temp of 72 degree F, no AE; Initial information received on 14-Jul-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves Adult female patient which was MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6575AA and expiry date: 08-May-2020) temperature excursion menactra vial that was left out overnight at room temp of 72 degree (product storage error).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medication was not reported.   This was potential medication error case due to incorrect product storage. It was reported that Menactra Vial that was left out overnight at room temp of 72 degree this was considered a Human error.  At the time of reporting, it was not reported if the vaccine was not administered or not  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Menactra vaccine was administered to the patient / No AE; Initial information received on 14-Jul-2020 regarding an unsolicited valid non-serious case from a health care professional.  This case involves a patient (with unknown demographics) who received a dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number not reported and Expiry date 25-May-2020) via unknown route in unknown administration site for prophylactic vaccination on 14-Jul-2020 (expired product administered).  The patient's medical history, past medical treatment, vaccination, family history and concomitant medications were not provided.  It was an actual medication error case due to expired vaccine used.  Reporter wanted to know if this was okay as the vaccine was used within 60 days of expiration.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling at injection site on day after immunizations given. No fever or discomfort. Area is hard and warm to touch. Area is the size of a silver dollar.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Local reaction
Clinical narrative: Local reaction about 8 days later
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Contusion, Pain in extremity, Peripheral swelling, Ultrasound scan
Clinical narrative: right arm pain, swelling, bruising consistent for 6 months
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cough, Dyspnoea, Flushing, Nasal congestion, Sneezing
Clinical narrative: After receiving her shots. I went out to get her sister's immunization record then returned with it and let them go. At this point she was doing fine. They got to check out and while waiting there for their appointments she started sneezing, coughing and her face became flush. The receptionist called for me to come up there . I immediately went up there and upon seeing her I also saw and heard her gasping. I brought her straight back and got the doctor out of the office and he came and examined her and ordered 25mg  IM of Benadryl. I gave it and just within about three minutes her breathing had already calmed down but she still was rubbing her nose and was stopped up. We ended up giving her a breathing treatment and she seemed much better after that. We observed her for about 1 hour and 40 minutes and let her go. I called two days in a row and was unable to reach the mom but on the third day was able to reach her and she said that she done great after leaving the office and that she was at the allergist office right at that time.
Age: 18.0
Sex: F
Vaccine: ADEN_4_7, IPV
Symptoms: Adverse drug reaction, Asthenia, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: Patient received immunizations on 1Jul 2020. developed o rash on her foot on 6 Jul. Seen in podiatry on 7 Jul and was given atarax. States the Atarax made her nauseous. 8 Jul she awoke with paresthesia's  bilater lower extremities. Exam demonstrated hypoesthesia bilat lower legs and decreased strength on left.  Concerned for Guillian-Barre Syndrome, she was sent to ER, subsequently admitted. Neuro consult confirmed GBS, and was managed with IV Ig.
Age: 18.0
Sex: F
Vaccine: ADEN_4_7, IPV
Symptoms: Nausea, Paraesthesia, Rash
Clinical narrative: Patient received immunizations on 1Jul 2020. developed o rash on her foot on 6 Jul. Seen in podiatry on 7 Jul and was given atarax. States the Atarax made her nauseous. 8 Jul she awoke with paresthesia's  bilater lower extremities. Exam demonstrated hypoesthesia bilat lower legs and decreased strength on left.  Concerned for Guillian-Barre Syndrome, she was sent to ER, subsequently admitted. Neuro consult confirmed GBS, and was managed with IV Ig.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site pain, Vaccination site swelling
Clinical narrative: patient called 07/16 - had vaccine on 07/13 - has redness, swelling, tenderness, itching at the vaccine site for 3 days - has not improved with advil or tylenol,
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: Fever to 105 that same evening