chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Nausea, Pain, Postural orthostatic tachycardia syndrome, Tilt table test positive, Ultrasound scan
Clinical narrative: Electrocardiogram; Tilt table test positive; Ultrasound scan; Nausea; Dizziness; Headache; Loss of personal independence in daily activities; Pain; Postural orthostatic tachycardia syndrome; Cardiac disorder; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 797712) and refers to a 13-year-old female patient. The patient's medical history was unknown. There were no current illness for the patient. The patient's other medication included multivitamin. On 18-AUG-2014, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose 2) (lot number: K001631) (needle and syringe (not specified further)) (dose, frequency and expiration date was unknown) on arm (unspecified) for prophylaxis.  On 26-OCT-2014, the patient had a lot of pain after hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) shot. On that day she started to get headaches and dizzy spells causing the patient to miss a lot of school (loss of personal independence in daily activities). On 29-OCT-2014, the patient was taken to see doctor, because she had been dizzy and nauseous for 3 days. The doctor referred the patient to an ear, nose, and throat (ENT) doctor.The ENT did a tilt table test and determined the patient's dizziness to be a cardiac issue (cardiac problem). On 31-OCT-2014, the doctor performed a thorough evaluation of the patient's heart and symptoms. The following tests were performed: electrocardiogram (EKG), ultrasound, tilt table test and thorough history for heart rate and blood pressure. On that day, the patient was diagnosed with Postural orthostatic tachycardia syndrome (POTS) by a pediatric cardiologist. The patient did not have problems like this before. She was an elite soccer player. The outcome of all the events was reported as not recovered at the reporting time. The causality assessment of the events to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported. The agency considered the events to be serious as it caused disability.  Lot number (K001631) is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast).  Follow-up information was received on 03-JUL-2019 from a consumer via the FDA under the Freedom of Information Act (VAERS # 797712) . The patient's details were updated. The patient's concurrent conditions included penicillin allergy. She had not any adverse events following any previous vaccines. Her concomitant therapies included vitamins (unspecified) (reported as multivitamin; previously reported as an other medication). She was not pregnant at the time of the vaccination.  Follow-up information was received from the registered nurse on 10-OCT-2019. The reporter was unable to assist. There were no patient identifiers on the original form. They were redacted. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Rash macular, Rash maculo-papular
Clinical narrative: generalized blotchy maculopapular rash; generalized blotchy maculopapular rash; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information (VAERS ID 804591) on 04-OCT-2019.   This spontaneous report was received from the healthcare professional and refers to 11-year-old male patient. The patient's concurrent conditions included autism. His medical history was not reported. Concomitant therapies included methylphenidate hydrochloride (CONCERTA) and montelukast sodium (SINGULAIR). He did not have any allergies to medications, food or other products.   On 07-MAR-2019 at 10:00, the patient was vaccinated with the first doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) into right arm intramuscularly, lot #R017457 (expiration date was not provided) for prophylaxis; diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL) into left arm intramuscularly, lot #U5798AB (expiration date was not provided) for prophylaxis; and meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) into left arm intramuscularly, lot #U6016AA (expiration date was not provided) for prophylaxis.  On the same day within a few minutes of injection at 10:02, the patient experienced generalized blotchy maculopapular rash. No other systemic reaction or findings were reported.  The outcome of was unknown. The relatedness between the events and the suspect therapies was not reported.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Rash, Rash macular, Rash maculo-papular
Clinical narrative: generalized blotchy maculopapular rash; generalized blotchy maculopapular rash; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information (VAERS ID 804591) on 04-OCT-2019.   This spontaneous report was received from the healthcare professional and refers to 11-year-old male patient. The patient's concurrent conditions included autism. His medical history was not reported. Concomitant therapies included methylphenidate hydrochloride (CONCERTA) and montelukast sodium (SINGULAIR). He did not have any allergies to medications, food or other products.   On 07-MAR-2019 at 10:00, the patient was vaccinated with the first doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) into right arm intramuscularly, lot #R017457 (expiration date was not provided) for prophylaxis; diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL) into left arm intramuscularly, lot #U5798AB (expiration date was not provided) for prophylaxis; and meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) into left arm intramuscularly, lot #U6016AA (expiration date was not provided) for prophylaxis.  On the same day within a few minutes of injection at 10:02, the patient experienced generalized blotchy maculopapular rash. No other systemic reaction or findings were reported.  The outcome of was unknown. The relatedness between the events and the suspect therapies was not reported.
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Erythema, Joint swelling, Pain in extremity, Rash, Skin warm
Clinical narrative: rash/ rash was from her elbow to just below the injection site on her arm; puffy and swollen; pain at the injection site; This spontaneous report as received from a pharmacist refers to a 71-year-old female patient. The patient had none pertinent medical history and none drug reactions or allergies.      On 27-SEP-2019, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # R012976, expiration date 25-JAN-2020) 0.5 milliliter dose, intramuscularly in an unspecified arm, as routine vaccination. Concomitant therapies included influenza virus split virion 3v vaccine inactivated (FLUZONE HIGH-DOSE VACCINE) administered on the same day, in a different arm.    On the same day in the evening, the patient started experiencing pain at the injection. When she woke up the next day, on 28-SEP-2019, she noticed rash from her elbow to just below the injection site on her arm. It was described as puffy and swollen. The patient sought medical attention and called a pharmacist. She was treated with diphenhydramine (BENEDRYL). None lab diagnostics or studies were performed. The events resolved within 3 days. The patient recovered from the pain at the injection site on 29-SEP-2019 and from puffy and swollen rash on 30-SEP-2019.  The relatedness between the events and the vaccination with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not provided.  This is one of the several reports from the same reporting source.; Sender's Comments:  US-009507513-1910USA002594: US-009507513-1910USA002780: US-009507513-1910USA002328:
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: rash/ rash was from her elbow to just below the injection site on her arm; puffy and swollen; pain at the injection site; This spontaneous report as received from a pharmacist refers to a 71-year-old female patient. The patient had none pertinent medical history and none drug reactions or allergies.      On 27-SEP-2019, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # R012976, expiration date 25-JAN-2020) 0.5 milliliter dose, intramuscularly in an unspecified arm, as routine vaccination. Concomitant therapies included influenza virus split virion 3v vaccine inactivated (FLUZONE HIGH-DOSE VACCINE) administered on the same day, in a different arm.    On the same day in the evening, the patient started experiencing pain at the injection. When she woke up the next day, on 28-SEP-2019, she noticed rash from her elbow to just below the injection site on her arm. It was described as puffy and swollen. The patient sought medical attention and called a pharmacist. She was treated with diphenhydramine (BENEDRYL). None lab diagnostics or studies were performed. The events resolved within 3 days. The patient recovered from the pain at the injection site on 29-SEP-2019 and from puffy and swollen rash on 30-SEP-2019.  The relatedness between the events and the vaccination with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not provided.  This is one of the several reports from the same reporting source.; Sender's Comments:  US-009507513-1910USA002594: US-009507513-1910USA002780: US-009507513-1910USA002328:
Age: 41.0
Sex: M
Vaccine: UNK, FLU4
Symptoms: Bursitis, Injection site pain
Clinical narrative: He stated he sought medical attention from the doctor at the wellness center and they prescribed Naproxen for the pain.  He stated he was unable to utilize that shoulder at this time.  I explained to him that he needed to follow the orders of the doctor at the wellness center at this time.  He could utilize heat at night if he it became painful to sleep.
Age: 41.0
Sex: M
Vaccine: UNK, FLU4
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: He stated he sought medical attention from the doctor at the wellness center and they prescribed Naproxen for the pain.  He stated he was unable to utilize that shoulder at this time.  I explained to him that he needed to follow the orders of the doctor at the wellness center at this time.  He could utilize heat at night if he it became painful to sleep.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Autoimmune thyroiditis, Fatigue, Laboratory test abnormal, Neck mass, Thyroidectomy
Clinical narrative: Hashimoto's disease; shingles; This initial spontaneous report was received from a lawyer and the patient regarding a case in litigation involving a female patient (pt) of unknown age. There was no information about the pt's concurrent conditions, concomitant therapies or medical history provided. In or around 06-JUL-2015, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (Herpes Zoster). A couple of months after being administered Defendants' Zostavax vaccine, the pt became increasingly severely fatigued and noticed a small midline anterior neck mass. She sought treatment with her primary care physician and following a multitude of laboratory tests was diagnosed with Hashimoto's disease, an autoimmune disorder believed to be triggered by a viral infection/response-including herpes zoster (shingles).  The pt underwent extensive medical treatment including thyroid lobectomy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of Zostavax, the pt sustained severe and permanent personal injuries. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event of Hashimoto's disease and shingles were considered as not recovered.   The reporter considered Hashimoto's disease and shingles to be related to Zoster Vaccine Live (ZOSTAVAX).   Upon internal review, the event of Hashimoto's disease was determined to be medically significant.  The reporters considered Hashimoto's disease and shingles to be disabling.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Autoimmune thyroiditis, Fatigue, Herpes zoster, Laboratory test, Neck mass
Clinical narrative: Hashimoto's disease; shingles; This initial spontaneous report was received from a lawyer and the patient regarding a case in litigation involving a female patient (pt) of unknown age. There was no information about the pt's concurrent conditions, concomitant therapies or medical history provided. In or around 06-JUL-2015, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (Herpes Zoster). A couple of months after being administered Defendants' Zostavax vaccine, the pt became increasingly severely fatigued and noticed a small midline anterior neck mass. She sought treatment with her primary care physician and following a multitude of laboratory tests was diagnosed with Hashimoto's disease, an autoimmune disorder believed to be triggered by a viral infection/response-including herpes zoster (shingles).  The pt underwent extensive medical treatment including thyroid lobectomy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of Zostavax, the pt sustained severe and permanent personal injuries. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event of Hashimoto's disease and shingles were considered as not recovered.   The reporter considered Hashimoto's disease and shingles to be related to Zoster Vaccine Live (ZOSTAVAX).   Upon internal review, the event of Hashimoto's disease was determined to be medically significant.  The reporters considered Hashimoto's disease and shingles to be disabling.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Thyroidectomy
Clinical narrative: Hashimoto's disease; shingles; This initial spontaneous report was received from a lawyer and the patient regarding a case in litigation involving a female patient (pt) of unknown age. There was no information about the pt's concurrent conditions, concomitant therapies or medical history provided. In or around 06-JUL-2015, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (Herpes Zoster). A couple of months after being administered Defendants' Zostavax vaccine, the pt became increasingly severely fatigued and noticed a small midline anterior neck mass. She sought treatment with her primary care physician and following a multitude of laboratory tests was diagnosed with Hashimoto's disease, an autoimmune disorder believed to be triggered by a viral infection/response-including herpes zoster (shingles).  The pt underwent extensive medical treatment including thyroid lobectomy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of Zostavax, the pt sustained severe and permanent personal injuries. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event of Hashimoto's disease and shingles were considered as not recovered.   The reporter considered Hashimoto's disease and shingles to be related to Zoster Vaccine Live (ZOSTAVAX).   Upon internal review, the event of Hashimoto's disease was determined to be medically significant.  The reporters considered Hashimoto's disease and shingles to be disabling.
Age: 58.0
Sex: F
Vaccine: PPV, FLUX, PPV, PPV, UNK
Symptoms: Erythema, Pain, Pruritus, Swelling, Ultrasound scan
Clinical narrative: the patient's "right arm  became red and swollen at the top which traveled down to her forearm/the patient went to unspecified emergency room and was diagnosed with cellulitis; This spontaneous report was received from a pharmacist, concerning a 58-years-old female patient. The patient's medical history was not reported. Her concurrent conditions included asthma and diabetes. The patient's drug reactions or allergies were unknown by the reporter. Her concomitant medications included fluticasone propionate (FLONASE), lorazepam and unspecified inhaler.    On 05-OCT-2019 (conflicting information, also reported as "05-AUG-2019"), the patient was vaccinated with  Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) intramuscularly, in the right arm, lot number S018140, expiration date 02-MAR-2021 for prophylaxis (strength and dose were not reported). On the same date, the patient additionally received a dose of influenza virus vaccine (unspecified) in the left arm, for prophylaxis (strength, dose, route of administration, lot number and expiration date were not reported).    On 07-OCT-2019, the patient's right arm became red and swollen at the top which traveled down to her forearm, therefore, the patient went to the unspecified emergency room and she was diagnosed with cellulitis. Subsequently, the patient took unspecified antibiotics to treat her cellulitis.    At the reporting time, the patient was recovering from the cellulitis.    The reporter did not assess the causal relationship between the suspect vaccines and the patient's cellulitis.    Upon internal review, the event of cellulitis was determined to be medically significant.
Age: 58.0
Sex: F
Vaccine: PPV, FLUX, PPV, PPV, UNK
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: the patient's "right arm  became red and swollen at the top which traveled down to her forearm/the patient went to unspecified emergency room and was diagnosed with cellulitis; This spontaneous report was received from a pharmacist, concerning a 58-years-old female patient. The patient's medical history was not reported. Her concurrent conditions included asthma and diabetes. The patient's drug reactions or allergies were unknown by the reporter. Her concomitant medications included fluticasone propionate (FLONASE), lorazepam and unspecified inhaler.    On 05-OCT-2019 (conflicting information, also reported as "05-AUG-2019"), the patient was vaccinated with  Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) intramuscularly, in the right arm, lot number S018140, expiration date 02-MAR-2021 for prophylaxis (strength and dose were not reported). On the same date, the patient additionally received a dose of influenza virus vaccine (unspecified) in the left arm, for prophylaxis (strength, dose, route of administration, lot number and expiration date were not reported).    On 07-OCT-2019, the patient's right arm became red and swollen at the top which traveled down to her forearm, therefore, the patient went to the unspecified emergency room and she was diagnosed with cellulitis. Subsequently, the patient took unspecified antibiotics to treat her cellulitis.    At the reporting time, the patient was recovering from the cellulitis.    The reporter did not assess the causal relationship between the suspect vaccines and the patient's cellulitis.    Upon internal review, the event of cellulitis was determined to be medically significant.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Decreased appetite, Fatigue, Fear of falling, Gait inability, Nausea
Clinical narrative: 1st vaccine in Late April 2019- mild flu symtoms lasting day or two - sore arm 2nd 9/25/19 - mild flu symptoms and some dizziness that evening - severe vertigo next few days - great difficulty walking - three weeks later still experiencing vertigo ranging from mild to occasionally very strong.  Also for three weeks have had cognitive fog and fatigue, off and on headaches, and a "slow motion " sensation when I walk.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccine positive rechallenge, Vertigo, Vomiting
Clinical narrative: 1st vaccine in Late April 2019- mild flu symtoms lasting day or two - sore arm 2nd 9/25/19 - mild flu symptoms and some dizziness that evening - severe vertigo next few days - great difficulty walking - three weeks later still experiencing vertigo ranging from mild to occasionally very strong.  Also for three weeks have had cognitive fog and fatigue, off and on headaches, and a "slow motion " sensation when I walk.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cognitive disorder, Dizziness, Fatigue, Feeling abnormal, Gait disturbance
Clinical narrative: 1st vaccine in Late April 2019- mild flu symtoms lasting day or two - sore arm 2nd 9/25/19 - mild flu symptoms and some dizziness that evening - severe vertigo next few days - great difficulty walking - three weeks later still experiencing vertigo ranging from mild to occasionally very strong.  Also for three weeks have had cognitive fog and fatigue, off and on headaches, and a "slow motion " sensation when I walk.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Influenza, Magnetic resonance imaging, Pain in extremity, Scan with contrast
Clinical narrative: 1st vaccine in Late April 2019- mild flu symtoms lasting day or two - sore arm 2nd 9/25/19 - mild flu symptoms and some dizziness that evening - severe vertigo next few days - great difficulty walking - three weeks later still experiencing vertigo ranging from mild to occasionally very strong.  Also for three weeks have had cognitive fog and fatigue, off and on headaches, and a "slow motion " sensation when I walk.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vertigo
Clinical narrative: 1st vaccine in Late April 2019- mild flu symtoms lasting day or two - sore arm 2nd 9/25/19 - mild flu symptoms and some dizziness that evening - severe vertigo next few days - great difficulty walking - three weeks later still experiencing vertigo ranging from mild to occasionally very strong.  Also for three weeks have had cognitive fog and fatigue, off and on headaches, and a "slow motion " sensation when I walk.
Age: 64.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Headache, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Facial droop; Facial Numbness; This case was reported by a pharmacist via call center representative and described the occurrence of facial droop in a 64-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 5MM97, expiry date 30th June 2020) for prophylaxis.   Previously administered products included Flu shot with an associated reaction of vision blurred (in 2017, the patient had flu shot and experienced blurred vision and headaches).   On 4th October 2019, the patient received Fluarix Quadrivalent 2019-2020 season. In October 2019, less than 2 weeks after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced facial droop (serious criteria GSK medically significant) and numbness facial. In October 2019, the outcome of the facial droop and numbness facial were recovered/resolved.   It was unknown if the reporter considered the facial droop and numbness facial to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: Pharmacist reports a patient experienced facial numbness and droop following a dose of Fluarix.  Facial numbness as extending near the eye and part of the bottom lip. The pharmacist described droop as little. The events lasted approximately two days with unknown outcome. The patient did not seek out treatment from a provider or the emergency department. The patient denied any symptoms to left arm. The reporter consented to follow up. This case is one of 2 cases reported by same reporter for same patient.
Age: 64.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Facial paralysis, Hypoaesthesia
Clinical narrative: Facial droop; Facial Numbness; This case was reported by a pharmacist via call center representative and described the occurrence of facial droop in a 64-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 5MM97, expiry date 30th June 2020) for prophylaxis.   Previously administered products included Flu shot with an associated reaction of vision blurred (in 2017, the patient had flu shot and experienced blurred vision and headaches).   On 4th October 2019, the patient received Fluarix Quadrivalent 2019-2020 season. In October 2019, less than 2 weeks after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced facial droop (serious criteria GSK medically significant) and numbness facial. In October 2019, the outcome of the facial droop and numbness facial were recovered/resolved.   It was unknown if the reporter considered the facial droop and numbness facial to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: Pharmacist reports a patient experienced facial numbness and droop following a dose of Fluarix.  Facial numbness as extending near the eye and part of the bottom lip. The pharmacist described droop as little. The events lasted approximately two days with unknown outcome. The patient did not seek out treatment from a provider or the emergency department. The patient denied any symptoms to left arm. The reporter consented to follow up. This case is one of 2 cases reported by same reporter for same patient.
Sex: M
Vaccine: HEP, HEP
Symptoms: Pyrexia, Septic screen, Serum sickness-like reaction, Urticaria
Clinical narrative: Urticarial rash and it is all over body; Fever; Apparent hypersensitivity syndrome; This case was reported by a physician via call center representative and described the occurrence of urticarial rash in a male patient who received HBV (Engerix B pediatric) for prophylaxis.   Concomitant products included HBV (Engerix B pediatric).   On 27th September 2019, the patient received the 2nd dose of Engerix B pediatric (intramuscular). On an unknown date, less than 2 weeks after receiving Engerix B pediatric, the patient experienced urticarial rash (serious criteria hospitalization), fever (serious criteria hospitalization) and hypersensitivity syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the urticarial rash and fever were not recovered/not resolved and the outcome of the hypersensitivity syndrome was unknown.   It was unknown if the reporter considered the urticarial rash, fever and hypersensitivity syndrome to be related to Engerix B pediatric.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of Engerix-B some time in August 2019 and received the 2nd dose of Engerix-B on 27th September 2019. The patient was admitted to the hospital after he developed a fever and rash. The reporter stated that it was a urticarial rash and it was all over his body. The reporter believed it may be apparent hypersensitivity syndrome. Emergency visit was required. The reporter did not have lot numbers or any additional information at the time of the call.
Sex: M
Vaccine: HEP, HEP
Symptoms: Drug reaction with eosinophilia and systemic symptoms, Pyrexia, Rash, Urticaria
Clinical narrative: Urticarial rash and it is all over body; Fever; Apparent hypersensitivity syndrome; This case was reported by a physician via call center representative and described the occurrence of urticarial rash in a male patient who received HBV (Engerix B pediatric) for prophylaxis.   Concomitant products included HBV (Engerix B pediatric).   On 27th September 2019, the patient received the 2nd dose of Engerix B pediatric (intramuscular). On an unknown date, less than 2 weeks after receiving Engerix B pediatric, the patient experienced urticarial rash (serious criteria hospitalization), fever (serious criteria hospitalization) and hypersensitivity syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the urticarial rash and fever were not recovered/not resolved and the outcome of the hypersensitivity syndrome was unknown.   It was unknown if the reporter considered the urticarial rash, fever and hypersensitivity syndrome to be related to Engerix B pediatric.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of Engerix-B some time in August 2019 and received the 2nd dose of Engerix-B on 27th September 2019. The patient was admitted to the hospital after he developed a fever and rash. The reporter stated that it was a urticarial rash and it was all over his body. The reporter believed it may be apparent hypersensitivity syndrome. Emergency visit was required. The reporter did not have lot numbers or any additional information at the time of the call.
Sex: U
Vaccine: FLUC4, FLUC4
Symptoms: Fatigue, Injection site erythema, Pharyngeal swelling, Swelling
Clinical narrative: Received the shot at approximately 1530 hours. By 1600 hours my neck on the side of the injection started going numb, went to my doctor. By the time he saw me at 1615 hours I was dizzy and my throat was tightening. He gave me a corizon shot and prescribed a medirol pack to take and had me take my Zyrtec. I remain very tired
Sex: U
Vaccine: FLUC4, FLUC4
Symptoms: Dizziness, Fatigue, Hypoaesthesia, Throat tightness
Clinical narrative: Received the shot at approximately 1530 hours. By 1600 hours my neck on the side of the injection started going numb, went to my doctor. By the time he saw me at 1615 hours I was dizzy and my throat was tightening. He gave me a corizon shot and prescribed a medirol pack to take and had me take my Zyrtec. I remain very tired
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Headache, Pain, Pyrexia
Clinical narrative: dizzy; high heartrate; nausea; body aches; fever; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 774SY, expiry date 2nd October 2021) for prophylaxis.   On 9th October 2019 10:00, the patient received the 1st dose of Shingrix (intramuscular). On 9th October 2019, less than a day after receiving Shingrix, the patient experienced nausea, general body pain and fever. On 9th October 2019 16:00, the patient experienced dizziness and heart rate high. On an unknown date, the outcome of the dizziness and heart rate high were not recovered/not resolved and the outcome of the nausea, general body pain and fever were recovered/resolved.   It was unknown if the reporter considered the dizziness, heart rate high, nausea, general body pain and fever to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient received the vaccine around 10 AM on Wednesday of 9th October 2019 and about 4 PM on the same day, 6 hours after vaccination, she started feeling very dizzy and her heart rate was elevated. On the same evening, the patient developed nausea, fever and body aches. Her heart rate was very elevated on 10th October 2019.  On the day of reporting, the patient no longer had a fever, but she still felt a little dizzy and her heart rate was higher than normal. The reporter did not consent to follow-up.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Heart rate increased, Nausea, Pain, Pyrexia
Clinical narrative: dizzy; high heartrate; nausea; body aches; fever; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 774SY, expiry date 2nd October 2021) for prophylaxis.   On 9th October 2019 10:00, the patient received the 1st dose of Shingrix (intramuscular). On 9th October 2019, less than a day after receiving Shingrix, the patient experienced nausea, general body pain and fever. On 9th October 2019 16:00, the patient experienced dizziness and heart rate high. On an unknown date, the outcome of the dizziness and heart rate high were not recovered/not resolved and the outcome of the nausea, general body pain and fever were recovered/resolved.   It was unknown if the reporter considered the dizziness, heart rate high, nausea, general body pain and fever to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The patient received the vaccine around 10 AM on Wednesday of 9th October 2019 and about 4 PM on the same day, 6 hours after vaccination, she started feeling very dizzy and her heart rate was elevated. On the same evening, the patient developed nausea, fever and body aches. Her heart rate was very elevated on 10th October 2019.  On the day of reporting, the patient no longer had a fever, but she still felt a little dizzy and her heart rate was higher than normal. The reporter did not consent to follow-up.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Joint stiffness
Clinical narrative: feeling tired, stiff jaw. patient went to urgent care and was told pt only needed over-the-counter ibuprofen.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Cardiac disorder, Investigation, Laboratory test normal, Lethargy, Loss of consciousness
Clinical narrative: patient felt lethargic the next afternoon at supper tablet. He continued to push through the next day and felt lethargic again the next evenng at supper and then pasted out. Wife is a nurse and she noted his pulse faint (cardiac event) and immediately took him to the ER. He was stabilized at the emergency room and attending physician could not explain what happened, tests showed nothing unusual. Cardiologist working his case said he has seen very infrequently a reaction like this with his Atenolol medication and the Quad flu shot. He was released out of hospital the next morning. All screenings/test done and only thing showed was early stages of double pneumonia. Patient wife came to mea with Levaquin 750mg prescription and told me about the incident that Saturday afternoon.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Pneumonia, Pulse abnormal
Clinical narrative: patient felt lethargic the next afternoon at supper tablet. He continued to push through the next day and felt lethargic again the next evenng at supper and then pasted out. Wife is a nurse and she noted his pulse faint (cardiac event) and immediately took him to the ER. He was stabilized at the emergency room and attending physician could not explain what happened, tests showed nothing unusual. Cardiologist working his case said he has seen very infrequently a reaction like this with his Atenolol medication and the Quad flu shot. He was released out of hospital the next morning. All screenings/test done and only thing showed was early stages of double pneumonia. Patient wife came to mea with Levaquin 750mg prescription and told me about the incident that Saturday afternoon.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Fatigue
Clinical narrative: 24 hours after receiving shot, spent the day in bed - very, very fatigued and tired.  1 week later had a day of significant stomach pains.  On the 2nd shot, within 12 hours of the shot became extremely fatigued, slept on/off for the next day, which is unusual for me.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Decreased appetite, Fatigue, Feeling cold, Headache
Clinical narrative: NEXT DAY:  woke up very sore, body aches, like tons of brick on me, headache, cold (needed a thick sweater and I am in specific area where it is a warm fall); also pain in both armpits (not sure if that's related, but I  have not had that pain before). couldn't get up so stayed in bed. Doctor husband gave me ibuprofen. Around 430pm - managed to will myself to get dress and go to church. Then at dinner forced myself to eat (no appetite).  2am woke up very itchy and noticed red rash on right torso just below right breast.  applied Triamcinolone cream.  DAY 2 - body aches less but headaches persisted and felt extremely tired. noticed rash on the left arm just below the injection site. several patches. itchy but not as itchy as the one on the torso.  DAY3 - drove mom to Dentist appt at 2pm. When I got back home at 6 - I was exhausted! and went to bed at 9 (I usually go to bed at midnight or a bit after).  I keep waking up at night with this severe itch. it's like having throbbing pain except it's throbbing itchiness. put warm towel on then dried then more triamcinolone. every few hours DAY 4 - just a small headache BUT STILL VERY ITCHY.  Triamcinolone doesnt seem to help. Then applied Desoximethasone 0.25% (Rx from last year's ezcema flare). that helped but still itchy. been applying it all day and it's less itchy as I write this report. I have photos too.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain, Pruritus, Rash erythematous
Clinical narrative: NEXT DAY:  woke up very sore, body aches, like tons of brick on me, headache, cold (needed a thick sweater and I am in specific area where it is a warm fall); also pain in both armpits (not sure if that's related, but I  have not had that pain before). couldn't get up so stayed in bed. Doctor husband gave me ibuprofen. Around 430pm - managed to will myself to get dress and go to church. Then at dinner forced myself to eat (no appetite).  2am woke up very itchy and noticed red rash on right torso just below right breast.  applied Triamcinolone cream.  DAY 2 - body aches less but headaches persisted and felt extremely tired. noticed rash on the left arm just below the injection site. several patches. itchy but not as itchy as the one on the torso.  DAY3 - drove mom to Dentist appt at 2pm. When I got back home at 6 - I was exhausted! and went to bed at 9 (I usually go to bed at midnight or a bit after).  I keep waking up at night with this severe itch. it's like having throbbing pain except it's throbbing itchiness. put warm towel on then dried then more triamcinolone. every few hours DAY 4 - just a small headache BUT STILL VERY ITCHY.  Triamcinolone doesnt seem to help. Then applied Desoximethasone 0.25% (Rx from last year's ezcema flare). that helped but still itchy. been applying it all day and it's less itchy as I write this report. I have photos too.
Age: 88.0
Sex: F
Vaccine: FLUX
Symptoms: Dehydration, Dry mouth, Gait inability, Incontinence, Loss of personal independence in daily activities
Clinical narrative: Nausea, muscle weakness, slight incontinence, babbling, dry mouth
Age: 88.0
Sex: F
Vaccine: FLUX
Symptoms: Muscular weakness, Nausea, Speech disorder
Clinical narrative: Nausea, muscle weakness, slight incontinence, babbling, dry mouth
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Muscle tightness, Neck pain
Clinical narrative: Patient stated after flu shot that his arm became tight and eventually had pain up his neck. Patient stated he visited E.R. and was later treated with medications listed in block 9. TX 4 Robaxin 500 mg Administered at 1430
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Rash
Clinical narrative: 1 day after vaccinations, pt starting to get swelling of injection site area and a rash started to develop. rash starting moving across the pt's arms.
Age: 5.0
Sex: M
Vaccine: FLUC4
Symptoms: Pyrexia
Clinical narrative: Flu shot(not sure which strand), -high fever, 102.9+ for 7 days no other symptoms.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Fatigue, Hypersensitivity, Inflammation, Malaise
Clinical narrative: Allergic reaction with localized swelling and inflammation left arm.  Arthralgia's multiple including both shoulders, neck, hips, ankles, wrists and fingers.  Fatigue and general malaise.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling
Clinical narrative: Allergic reaction with localized swelling and inflammation left arm.  Arthralgia's multiple including both shoulders, neck, hips, ankles, wrists and fingers.  Fatigue and general malaise.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Mobility decreased, Orthosis user, Pain, Paraesthesia
Clinical narrative: Patient stated she felt an electric shock like sensation with vaccination and developed pain immediately.    Pain got progressively worse over the week after the vaccine was given and patient could not move her arm much because of the pain.  She never developed swelling nor did she develop a rash.  Patient went to her primary care provider and was given steroids, ibuprofen,  and a sling for her arm. She was also told to use ice packs.  Patient initially was getting some improvement after starting steroids, but her pain level started to increase on day 3 of steroids so her primary care provider added ultram to her meds.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: cellulitis
Sex: M
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: no adverse effects; rubella titer was low; This spontaneous report was received from a currently 50-year-old male patient who is a pharmacist, referring to himself. The patient had no pertinent medical history, concomitant therapies or drug reactions and allergies. On an unknown date, when the patient was a child, he received two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (exact dose, injection site, route of administration, lot # and expiration date were not reported) as routine vaccination. On unknown date in 2019 (reported as earlier this year), the patient had titers drawn and the rubella titer was low. No adverse effects were reported. The outcome of event was unknown. There was no causality assessment provided by the reporter.
Sex: M
Vaccine: HPV9
Symptoms: Adverse event
Clinical narrative: her son had an adverse experience with HPV vaccine; This spontaneous report was received from the patient's mother referring to her son, a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      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) for prophylaxis.         On an unknown date, the patient had an unspecified adverse experience (adverse event) with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) ("HPV") vaccine.      At the reporting time, the outcome of adverse event was unknown. The causality assessment was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Herpes zoster, Malaise, Post herpetic neuralgia, Rash
Clinical narrative: Patient was diagnosed with herpes zoster; Patient was diagnosed with post herpetic neuralgia; Information has been received from a lawyer and the patient regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 29-SEP-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for routine health maintenance and for the prevention of shingles.   Shortly after vaccination, the patient suffered a painful rash in her right upper back, chest and underarm, she also experienced abdominal pain and malaise, therefore the patient was diagnosed with herpes zoster and post herpetic neuralgia. As a direct and proximate result of these malfunctions, the patient's symptoms had resulted  in physical limitations not present prior vaccination of zoster vaccine live (ZOSTAVAX). Additionally, the patient sustained severe, permanent, serious, progressive and incurable injuries. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The outcome of the events was not recovered. The reporter considered the events to be disabling.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported.; the patient was inadvertently administered a dose of GARDASIL 9; This spontaneous report has been received from a registered nurse concerning a patient of unknown age and gender.   On 08-OCT-2019, the patient was inadvertently vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) which had been improperly stored, with lot # S005524 and expiration date on 29-SEP-2021; administered for prophylaxis (dose, dose number, route of administration and anatomical location were not provided).  It was reported that on an unspecified date, the vaccine was exposed to a temperature of -6 degree Celsius for 14 hours. There was no previous temperature excursion. The call was not placed because of a Digital Data logger report. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; patient received improperly stored VARIVAX; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Information on pertinent medical history and drug reactions/allergies was not reported. Concomitant medications included properly stored sterile diluent.   On 12-SEP-2019, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, dose number, route of administration and location of administration were not reported) (lot # S005078, expiration date 19-FEB-2021 or lot # R019237, expiration date 04-JUL-2020 (the reporting nurse was unable to determine which lot was administered to the patient)), for prophylaxis.   The vaccine was exposed to a temperature range of -14 degree Celsius to -10 degree Celsius (-9.74 degree Celsius) for an unknown time frame as recorded by a digital data logger. There were no previous temperature excursions. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Nerve injury, Post herpetic neuralgia
Clinical narrative: shingles; postherpetic neuralgia; nerve damage; Information has been received from a lawyer and a consumer (reported as spouse) referring to a male patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  In or about November 2014, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for the prevention of shingles (herpes zoster) and routine health maintenance.  On an unknown date, the patient experienced shingles, nerve damage, and postherpetic neuralgia. The patient did not recover from the events. As per the reporter, the patient 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. The events were disabling.   The reporter considered the events were related to Zoster Vaccine Live (ZOSTAVAX).