chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: ? PATIENT CALLED PHARMACY AT 10:55 AM ON 2/22/2020 and stated, "she wanted to know if she should be concerned about the reaction she is having to her Shingles vaccine administered on 02/18/2020" ? She reported classic signs of an injection site reaction: localized itching, redness, sore arm, skin felt feverish/warm to the touch. only at the site of the injections. ? I informed patient that reactions is common for this vaccination, and gave her information on how to care for the reactions and possibles signs of concern when she might need to escalate care. ? Event: Injection-site reaction ? Symptoms: Soreness of injection site, Inflammation, Itching/Swelling ? Pharmacist Response: Apply a cold compress to the site for approximately 15 minutes if the patient has any inflammation/swelling/or soreness. Recommend an analgesic such as acetaminophen or non-steroid anti-inflammatory drug. An anti-histamine can be used for any swelling make sure to observe and discuss with the patient signs of generalized anaphylaxis. ? Informed patient we would follow up on Monday to check on the status of the reaction. Cont... 02/23/2020 - Patient came to pharmacy to show me the reactions. - The reaction was consistent with anaphylaxis "serious allergy" - The patient presented with generalized itching and erythema to the full upper right portion of the left arm. - No signs of Hives, shortness of breath, or cardiovascular issues were present. - Patient stated she would see treatment with an Urgent Care Provider. Event Details
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: ? PATIENT CALLED PHARMACY AT 10:55 AM ON 2/22/2020 and stated, "she wanted to know if she should be concerned about the reaction she is having to her Shingles vaccine administered on 02/18/2020" ? She reported classic signs of an injection site reaction: localized itching, redness, sore arm, skin felt feverish/warm to the touch. only at the site of the injections. ? I informed patient that reactions is common for this vaccination, and gave her information on how to care for the reactions and possibles signs of concern when she might need to escalate care. ? Event: Injection-site reaction ? Symptoms: Soreness of injection site, Inflammation, Itching/Swelling ? Pharmacist Response: Apply a cold compress to the site for approximately 15 minutes if the patient has any inflammation/swelling/or soreness. Recommend an analgesic such as acetaminophen or non-steroid anti-inflammatory drug. An anti-histamine can be used for any swelling make sure to observe and discuss with the patient signs of generalized anaphylaxis. ? Informed patient we would follow up on Monday to check on the status of the reaction. Cont... 02/23/2020 - Patient came to pharmacy to show me the reactions. - The reaction was consistent with anaphylaxis "serious allergy" - The patient presented with generalized itching and erythema to the full upper right portion of the left arm. - No signs of Hives, shortness of breath, or cardiovascular issues were present. - Patient stated she would see treatment with an Urgent Care Provider. Event Details
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Soreness at injection site Tiredness, Fever, Muscle Soreness, Headache
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Mobility decreased, Nerve injury
Clinical narrative: Pain at injection site has been constant since injection received.  I have limited motion in my left arm. I notified my primary care physician on the Portal about two months after receiving the injection.  When I saw my physician for my annual check up on 01/22/2020, he told me the Pharmacist had hit a nerve when he gave me the shot. He told me the pain could last for a year.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Deep vein thrombosis, Malaise, Myocardial strain, Pain in extremity, Pneumonia
Clinical narrative: Patient started having right calf pain on February 13 while walking his daily 2 miles. On the 17th of February he started feeling ill and went to the doctor where he was diagnosed with pneumonia and put on an antibiotic. He ended up collapsing on the 22nd at home where he was transported to the hospital and diagnosed with a large pulmonary embolism causing right sided heart strain/failure and a right leg deep vein thrombosis
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pulmonary embolism, Right ventricular failure, Syncope
Clinical narrative: Patient started having right calf pain on February 13 while walking his daily 2 miles. On the 17th of February he started feeling ill and went to the doctor where he was diagnosed with pneumonia and put on an antibiotic. He ended up collapsing on the 22nd at home where he was transported to the hospital and diagnosed with a large pulmonary embolism causing right sided heart strain/failure and a right leg deep vein thrombosis
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Head injury, Pyrexia, Syncope
Clinical narrative: Patient called the pharmacy about 1pm on 02/04/2020 and stated that she had felt tired and had a slight fever the night of having the vaccine (02/0/3/2020). After she woke up about 4:45AM on 02/04/2020, she fainted and hit her head. Her husband called for an ambulance that took her to the hospital.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia, Rash
Clinical narrative: Fever, chills, aches, for 24 hours starting day after shot. I think it was about 3 days later that I broke out in a rash that started on my chest, spread to stomach,  legs, face, very close to my eye.  Went to Dr. got an ointment for rash, did not seem to work. Went to ER, they gave me a steroid injection and put me on prednisone for I think 1 week. Rash lasted for about a month.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Lethargy, Rash pruritic
Clinical narrative: Itchy bumps; "feeling out of sort and felt like lying down" (lethargy?); feeling out of sort and felt like lying down; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Shingles vaccine (received 1 year after having shingles). Concurrent medical conditions included immunocompromised.   On 5th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 6th August 2019, 1 days after receiving Shingrix, the patient experienced lethargy and feeling abnormal. On an unknown date, the patient experienced itchy rash. The patient was treated with steroids nos (Steroids). Shingrix was discontinued. On an unknown date, the outcome of the itchy rash was recovering/resolving and the outcome of the lethargy was resolved with sequelae and the outcome of the feeling abnormal was recovered/resolved.   It was unknown if the reporter considered the itchy rash, lethargy and feeling abnormal to be related to Shingrix.  Additional details were received as follows: The patient after vaccination felt out of sort and felt like lying down. The patient developed a rash that started off as small, itchy bumps that became larger. Physician gave a steroid shot that relieved it for approximately 2 to 3 weeks and then reappeared. The reporter stated that the dermatologist advised consumer not to receive 2nd dose Shingrix. The patient consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Alopecia
Clinical narrative: First dose of SHINGRIX vaccine received 01/03/2020. Hairdresser noted 9 bald spots on scalp 01/20/2020. Significant numbers of easily epilated hair noticed 01/27/2020 along with enlargement of bald spots. Diagnosed with extensive alopecia areata by board certified dermatologist 02/04/2020.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Alopecia, Alopecia areata, Blood iron normal, Blood thyroid stimulating hormone decreased, Full blood count normal
Clinical narrative: First dose of SHINGRIX vaccine received 01/03/2020. Hairdresser noted 9 bald spots on scalp 01/20/2020. Significant numbers of easily epilated hair noticed 01/27/2020 along with enlargement of bald spots. Diagnosed with extensive alopecia areata by board certified dermatologist 02/04/2020.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Iron binding capacity total normal, Liver function test normal, Platelet count normal, Serum ferritin normal, Transferrin saturation
Clinical narrative: First dose of SHINGRIX vaccine received 01/03/2020. Hairdresser noted 9 bald spots on scalp 01/20/2020. Significant numbers of easily epilated hair noticed 01/27/2020 along with enlargement of bald spots. Diagnosed with extensive alopecia areata by board certified dermatologist 02/04/2020.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Vaccine positive rechallenge
Clinical narrative: Patient to ask what he should do about a side effect he has from getting a Shingrix Vaccine. He said that he was concerned because the side effects has persisted for 5 months.  The symptoms were soreness at the site of injection and were intermittent and sometimes painful.  I gave him the customer service contact ( Telephone # ) for the manufacturer Glaxo Smith Kline-GSK.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient to ask what he should do about a side effect he has from getting a Shingrix Vaccine. He said that he was concerned because the side effects has persisted for 5 months.  The symptoms were soreness at the site of injection and were intermittent and sometimes painful.  I gave him the customer service contact ( Telephone # ) for the manufacturer Glaxo Smith Kline-GSK.
Age: 61.0
Sex: M
Vaccine: FLU4, FLUX, FLU4
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture abnormal
Clinical narrative: Guillain Barre; This case was reported by a pharmacist via call center representative and described the occurrence of guillain barre syndrome in a 61-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number K3593, expiry date 30th June 2020) for prophylaxis.   On 25th January 2020, the patient received Fluarix Quadrivalent 2019-2020 season. On 17th February 2020, 23 days after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was not recovered/not resolved.   The reporter considered the guillain barre syndrome to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The physician reported that, the patient patient experienced guillain barre syndrome due to Fluarix Quadrivalent 2019-2020 season. Till the time of reporting, the patient released from hospital but was in rehab facility. The symptoms were about 90 percent resolved.
Age: 61.0
Sex: M
Vaccine: FLU4, FLUX, FLU4
Symptoms: Guillain-Barre syndrome, Laboratory test, Lumbar puncture, Musculoskeletal disorder
Clinical narrative: Guillain Barre; This case was reported by a pharmacist via call center representative and described the occurrence of guillain barre syndrome in a 61-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number K3593, expiry date 30th June 2020) for prophylaxis.   On 25th January 2020, the patient received Fluarix Quadrivalent 2019-2020 season. On 17th February 2020, 23 days after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was not recovered/not resolved.   The reporter considered the guillain barre syndrome to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The physician reported that, the patient patient experienced guillain barre syndrome due to Fluarix Quadrivalent 2019-2020 season. Till the time of reporting, the patient released from hospital but was in rehab facility. The symptoms were about 90 percent resolved.
Age: 61.0
Sex: M
Vaccine: FLU4, FLUX, FLU4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre; This case was reported by a pharmacist via call center representative and described the occurrence of guillain barre syndrome in a 61-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number K3593, expiry date 30th June 2020) for prophylaxis.   On 25th January 2020, the patient received Fluarix Quadrivalent 2019-2020 season. On 17th February 2020, 23 days after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was not recovered/not resolved.   The reporter considered the guillain barre syndrome to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The physician reported that, the patient patient experienced guillain barre syndrome due to Fluarix Quadrivalent 2019-2020 season. Till the time of reporting, the patient released from hospital but was in rehab facility. The symptoms were about 90 percent resolved.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effects were reported in the patient; a expired dose of Proquad was administered to a patient; This spontaneous report was received from a certified medical assistant and was referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, or concomitant therapies were not reported.   On 24-JAN-2020, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), lot # R020678, expiration date 15-JAN-2020, (strength, frequency, route, and anatomical location were not reported), for prophylaxis (Expirred vaccine used).   No additional adverse effects were reported in the patient.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Headache, Hypoaesthesia, Syncope
Clinical narrative: Shortly after receiving ZOSTAVAX, the patient suffered left sided numbness, weakness, dizziness, headaches and sings of syncope. The patient was diagnoses with transient cerebral ischemic attack; This initial spontaneous report was received from a lawyer on 13-FEB-2020, regarding a case in litigation and refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 02-FEB-2018, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the routine health maintenance and for its intended purpose: the prevention of shingles (the dosage regimen information was not reported). Then, on an unspecified date, (reported as "shortly"), the patient suffered left sided numbness, weakness, dizziness, headaches and sings of syncope. The patient was diagnosed with transient cerebral ischemic attack. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the patient's symptoms had resulted in physical limitations not present prior to using this vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX) vaccination, the patient sustained severe and permanent personal injuries, serious, progressive, 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 zoster vaccine live (ZOSTAVAX) vaccination, the patient had suffered and incurred damages, including medical expenses, the loss of accumulations and other economic and non-economic damages. At the time of the report, the outcome of transient ischemic attack was not recovered. Upon internal review, transient ischemic attack was considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Transient ischaemic attack
Clinical narrative: Shortly after receiving ZOSTAVAX, the patient suffered left sided numbness, weakness, dizziness, headaches and sings of syncope. The patient was diagnoses with transient cerebral ischemic attack; This initial spontaneous report was received from a lawyer on 13-FEB-2020, regarding a case in litigation and refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 02-FEB-2018, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the routine health maintenance and for its intended purpose: the prevention of shingles (the dosage regimen information was not reported). Then, on an unspecified date, (reported as "shortly"), the patient suffered left sided numbness, weakness, dizziness, headaches and sings of syncope. The patient was diagnosed with transient cerebral ischemic attack. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the patient's symptoms had resulted in physical limitations not present prior to using this vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX) vaccination, the patient sustained severe and permanent personal injuries, serious, progressive, 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 zoster vaccine live (ZOSTAVAX) vaccination, the patient had suffered and incurred damages, including medical expenses, the loss of accumulations and other economic and non-economic damages. At the time of the report, the outcome of transient ischemic attack was not recovered. Upon internal review, transient ischemic attack was considered to be medically significant.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: arm swelling/real puffy like it was so swollen; it may itch if irritated; Information has been received from an 82-year-old female patient with breast cancer, reporting on herself. The patient's medical history included breast operation. Concomitant therapies included atorvastatin, levothyroxine sodium, losartan potassium (manufacturer unknown) and venlafaxine hydrochloride.  The patient's drug reactions/allergies were not provided.   On 09-AUG-2019, the patient was vaccinated a with a dose of zoster vaccine live (ZOSTAVAX) (dosage, route, lot # and expiration date were not provided) in the left arm for prophylaxis.   The patient stated that right after the vaccination, her arm started to become swollen and then "it just kept going and was quite swollen" (peripheral swelling). It was reported that her arm got just a little better but then once a while it got worse. The patient explained that "after an airplane ride it got worse" and the swelling "went way down to her fingers". The patient also explained "sometimes it just happens during the day", it maybe twice a wee it gets worse and then just a little better. She has not had any pain, but the arm "may itch if irritated". Her left arm was "real puffy like it was so swollen". As a treatment, the patient took "TUMERX" (therapy unspecified) for a month or two, but she did not really notice any difference. At the time of the report, the patient had not recovered form peripheral swelling and pruritus. The causality assessment between the events and suspect therapy was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Dizziness, Dyspnoea, Pneumonia
Clinical narrative: Pneumonia, shortness of breath, cough; dizziness; Information has been received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided. In or around 31-AUG-2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) vaccine for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccination, on an unspecified date, pt suffered shortness of breath, cough, dizziness and was diagnosed with pneumonia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, pt's symptoms had resulted in physical limitations not present prior to using the product. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. Additionally, pt sustained severe and permanent personal injuries, 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. Finally, pt had suffered and incurred damages, including medical expenses; the loss of accumulations and other economic and non-economic damages. At the reporting time, the pt was not recovered from the events and they were considered to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, pneumonia was considered to be a medically significant event.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Nurse reported a patient received a dose of PREVNAR 13 on 12/31/2018 and a dose of PNEUMOV AX 23 on 7/5/2019; Nurse reported a patient received a dose of PREVNAR 13 on 12/31/2018 and a dose of PNEUMOV AX 23 on 7/5/2019; This spontaneous report was received from a nurse referring to a 66-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not provided.  On 05-JUL-2019, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) for prophylaxis (concentration, frequency, vaccination scheme, route and anatomical location of vaccination were not reported). Lot Number R033080 has been verified to be a valid lot number for pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) expiration date reported and validated as 06-JUN-2020).  The nurse reported that before the vaccination with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23), the patient had been vaccinated with pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR), which occurred on 31-DEC-2018 (inappropriate schedule of product administration and interchange of vaccine products).   No additional information was provided.
Sex: F
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: unspecified adverse reaction; This spontaneous report has been received from a physician via company representative and refers to the physician's mother-in-law, a female patient of unknown age.      The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On an unknown date (reported as years ago), the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, frequency, route of administration, lot number, and expiration date were not reported) as prophylaxis.         On an unknown date (reported as years ago), the patient had an unspecified adverse reaction. At the reporting time, the outcome of the adverse reaction was unknown.    The causal relationship between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the event was not reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2002USA008023:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient was administered an improperly stored dose of M-M-R II; This spontaneous report was received from the Immunization official who was also a nurse concerning a 4-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concomitant medications or drug reactions/allergies was not provided.  On 11-NOV-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), lot number S004118, expiration date 11-FEB-2021 for prophylaxis (dosage schedule, anatomical location and route of administration were not reported) (product storage error). The vaccine was reconstituted with sterile diluent (lot number and expiration date were not reported).  The administered dose of the vaccine experienced a temperature excursion above 9°C: 10.9 C for 8 hours and 15 minutes, as recorded by a data logger. There was no adverse effect reported.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE; the patient was inadvertently administered a dose of VARIVAX by intramuscular injection instead of subcutaneous injection; Information has been received from an office manager referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 19-FEB-2020, the patient was inadvertently administered a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose detail and frequency were not reported) (lot # S010298, expiration date 03-APR-2021) with sterile diluent (STERILE DILUENT) by intramuscular injection instead of subcutaneous injection for prophylaxis (incorrect route of product administration). No additional adverse event was reported.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Pain in extremity, Peripheral swelling
Clinical narrative: my arm is still hot; my arm is still swollen; my arm is still red; my arm is still hurts; This case was reported by a consumer via call center representative and described the occurrence of feeling hot in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th February 2020, the patient received Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced feeling hot, swelling arm, erythema of extremities and pain in arm. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the feeling hot, swelling arm, erythema of extremities and pain in arm were unknown.   It was unknown if the reporter considered the feeling hot, swelling arm, erythema of extremities and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and arm was still hot, red and swollen and hurts. The reporter asked how long would this last.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash
Clinical narrative: developed rash on both thighs; sore arm from injection site; This case was reported by a consumer via sales rep and described the occurrence of rash in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 13th February 2020, 4 days after receiving Shingrix, the patient experienced rash. In February 2020, the patient experienced pain in arm. On an unknown date, the outcome of the rash and pain in arm were unknown.   It was unknown if the reporter considered the rash and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced sore arm from injection site and developed rash on both thighs. The reporter consented to follow up. The patient agreed to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: fever; shivering; This case was reported by a consumer via call center representative and described the occurrence of fever in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and shivering. On an unknown date, the outcome of the fever and shivering were recovered/resolved.   It was unknown if the reporter considered the fever and shivering to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced fever and shivering and that these had resolved. The reporter did not consent to follow up. This case linked with US2020026930, reported for patient's wife.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site bruising, Platelet count decreased
Clinical narrative: fatigue; low platelet count down from 124K to 99K; bruise at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site bruising in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced injection site bruising, fatigue and platelet count low. On an unknown date, the outcome of the injection site bruising, fatigue and platelet count low were unknown.   It was unknown if the reporter considered the injection site bruising, fatigue and platelet count low to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced fatigue and bruise at injection site.  The bruise lasted for about 5 weeks.  The patient also has experienced low platelet count down from 124K to 99K.. The reporter did not consent to follow up. This case was linked with the US2020026929, reported for patient's husband.      Lab Comments: lab test performed om unknown date
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: flu-like symptoms a couple of days; redness at injection site; pain after injection and still a little painful today; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number P9733, expiry date 8th February 2021) for prophylaxis.   On 8th February 2020, the patient received the 1st dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms, injection site erythema and injection site pain. In February 2020, the outcome of the influenza-like symptoms was recovered/resolved. On an unknown date, the outcome of the injection site erythema and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced flu-like symptoms for a couple of days, redness at injection site, pain after injection and still a little painful today. The reporter did not consent to follow-up.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia
Clinical narrative: Post-herpetic neuralgia; This case was reported by a nurse via call center representative and described the occurrence of post herpetic neuralgia in a 85-year-old female patient who received Herpes zoster (Shingrix) (batch number HE2P5, expiry date 22nd February 2020) for prophylaxis.   On 30th November 2019, the patient received Shingrix. On an unknown date, 6 weeks after receiving Shingrix, the patient experienced post herpetic neuralgia. On an unknown date, the outcome of the post herpetic neuralgia was unknown.   It was unknown if the reporter considered the post herpetic neuralgia to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and 6 weeks after experienced Post-herpetic neuralgia. Reporter did not consent to follow-up.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Colonoscopy, Ileostomy, Incomplete course of vaccination, Large intestinal obstruction, Surgery
Clinical narrative: went in for a colonoscopy in July 2019, but it was cancelled when it was found she had a blockage; This case was reported by a consumer via call center representative and described the occurrence of colon obstruction in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included renal neoplasm (diagnosed on 16th January 2019) and tumor ablation (ablation on 11th February 2019). Concurrent medical conditions included heart disorder (subsequent to ablation on kidney tumor).   On 15th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced colon obstruction (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the colon obstruction was recovered/resolved.   It was unknown if the reporter considered the colon obstruction to be related to Shingrix.  Additional case details were reported as follows: In July 2019, the patient went in for a colonoscopy but it was cancelled when it was found she had a blockage.  On 29th July 2019, the patient had surgery to put in an ileostomy bag. She then spent a lot of time in and out of the hospital. On 7th October 2019, ileostomy bag was finally removed. Due to the frequent hospitalizations, the patient was unable to get the 2nd dose of Shingrix.  The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph node on the right side of her neck; This case was reported by a other health professional via call center representative and described the occurrence of lymphadenopathy cervical in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number L9F99, expiry date 10th May 2022) for prophylaxis.   On 2nd January 2020, the patient received Shingrix (intramuscular). On 24th January 2020, 22 days after receiving Shingrix, the patient experienced lymphadenopathy cervical. On an unknown date, the outcome of the lymphadenopathy cervical was recovered/resolved.   It was unknown if the reporter considered the lymphadenopathy cervical to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm and had a swollen lymph node on the right side of her neck.   The swollen lymph node has since resolved. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: cellulitis at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site cellulitis in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 453S4, expiry date 19th March 2022) for prophylaxis.   On 12th February 2020, the patient received the 1st dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced injection site cellulitis. The patient was treated with antibiotics nos. On an unknown date, the outcome of the injection site cellulitis was unknown.   It was unknown if the reporter considered the injection site cellulitis to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and developed cellulitis at the injection site.  As a measure, this patient visited the emergency room where antibiotics were prescribed.  The outcome of this event was unknown. The reporter consented to follow up.
Age: 27.0
Sex: M
Vaccine: FLU4, HEPAB, MMR, MNQ, VARCEL
Symptoms: Papule, Pruritus, Rash vesicular, Scab, Varicella virus test positive
Clinical narrative: Nine days after vaccination patient developed a vesicular rash and papules that crusted over after opening and experienced intense pruritus.   Patinet's symptoms resolved 23 February 2020.
Age: 1.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Hyperhidrosis, Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: 2/12/20 visit: On her right thigh there is a 1 inch red Firm patch.No warmth.She does have about 10 red spots on her abdomen and chest that ranged from 2 mm to 10 mm also several on her back they are nontender.  Discussed lukewarm baths Aquaphor. She does have a local reaction on her thigh from the immunizations she could use a little hydrocortisone 1% over-the-counter for this. 2/14/20 Visit: Patient is here today with mom and dad with a rash. She saw healthcare provider on 02/12/2020 and was told to use hydrocortisone with aquaphor. The rash has spread since and has not gotten any better. She's been sweating a lot but she also has a tooth coming in. Given timing and nature of rash likely varicella vaccine reaction. Rash appears similar to varicella without vesicle formation, discussed with parents this may occur. Also on differential is viral xanthem however currently patient has had rash x 1 week and is afebrile with no other associated symptoms. Also has local site reaction on R thigh with erythema. Discussed with parents. Presenting for re-check rash. Discontinued antibiotics still with diffuse papular rash. Had received varicella injection 01/31/2020 and started having symptoms on 2/2/2020 with papular rash which started near injection site with localized erythema and spread down leg and to body. No associated fever, parents have notice some itching of lesions.
Age: 1.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Local reaction, Pruritus, Rash, Rash papular, Rash vesicular
Clinical narrative: 2/12/20 visit: On her right thigh there is a 1 inch red Firm patch.No warmth.She does have about 10 red spots on her abdomen and chest that ranged from 2 mm to 10 mm also several on her back they are nontender.  Discussed lukewarm baths Aquaphor. She does have a local reaction on her thigh from the immunizations she could use a little hydrocortisone 1% over-the-counter for this. 2/14/20 Visit: Patient is here today with mom and dad with a rash. She saw healthcare provider on 02/12/2020 and was told to use hydrocortisone with aquaphor. The rash has spread since and has not gotten any better. She's been sweating a lot but she also has a tooth coming in. Given timing and nature of rash likely varicella vaccine reaction. Rash appears similar to varicella without vesicle formation, discussed with parents this may occur. Also on differential is viral xanthem however currently patient has had rash x 1 week and is afebrile with no other associated symptoms. Also has local site reaction on R thigh with erythema. Discussed with parents. Presenting for re-check rash. Discontinued antibiotics still with diffuse papular rash. Had received varicella injection 01/31/2020 and started having symptoms on 2/2/2020 with papular rash which started near injection site with localized erythema and spread down leg and to body. No associated fever, parents have notice some itching of lesions.
Age: 1.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Teething, Vaccination complication
Clinical narrative: 2/12/20 visit: On her right thigh there is a 1 inch red Firm patch.No warmth.She does have about 10 red spots on her abdomen and chest that ranged from 2 mm to 10 mm also several on her back they are nontender.  Discussed lukewarm baths Aquaphor. She does have a local reaction on her thigh from the immunizations she could use a little hydrocortisone 1% over-the-counter for this. 2/14/20 Visit: Patient is here today with mom and dad with a rash. She saw healthcare provider on 02/12/2020 and was told to use hydrocortisone with aquaphor. The rash has spread since and has not gotten any better. She's been sweating a lot but she also has a tooth coming in. Given timing and nature of rash likely varicella vaccine reaction. Rash appears similar to varicella without vesicle formation, discussed with parents this may occur. Also on differential is viral xanthem however currently patient has had rash x 1 week and is afebrile with no other associated symptoms. Also has local site reaction on R thigh with erythema. Discussed with parents. Presenting for re-check rash. Discontinued antibiotics still with diffuse papular rash. Had received varicella injection 01/31/2020 and started having symptoms on 2/2/2020 with papular rash which started near injection site with localized erythema and spread down leg and to body. No associated fever, parents have notice some itching of lesions.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: the patient is experiencing headache, muscle aches and tiredness; the patient is experiencing headache, muscle aches and tiredness; the patient is experiencing headache, muscle aches and tiredness; This spontaneous report was received from a consumer and refers to a 61-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 07-FEB-2020, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not reported), for prophylaxis   On 08-FEB-2020, the patient experienced headache, muscle aches and tiredness. There was no information if the patient received any treatment. The outcome of the events was reported as not recovered/not resolved.   The causality assessment between the events and the suspect vaccine was not reported.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Adverse event
Clinical narrative: kid is having a reaction; This spontaneous report as received from a registered nurse refers to a 12 month old patient of unknown gender. No information regarding the patient's medical history, concomitant medications and concurrent conditions was provided.  On an unknown date (reported as: "recently"), the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)(strength, dosing schedule, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the patient was having a reaction, no other specified. The outcome of adverse event was unknown. The causality assessment between the suspect therapy and the event was not reported.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Injection site pain, Pain, Vomiting
Clinical narrative: her arm was sore at the injection site; had body aches; have bouts of vomiting; began to have bouts of diarrhea; she is tired from having to get up during the night to handle these symptoms; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd February 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 3rd February 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, general body pain, vomiting, diarrhea and tiredness. On 5th February 2020, the outcome of the vomiting was recovered/resolved. On an unknown date, the outcome of the injection site pain and diarrhea were not recovered/not resolved and the outcome of the general body pain and tiredness were unknown.   It was unknown if the reporter considered the injection site pain, general body pain, vomiting, diarrhea and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of the Shingrix Monday in the afternoon.   On 3rd February 2020, same evening her arm was sore at the injection site and she had body aches.  During the night she had bouts of vomiting and diarrhea. This had continued.   On 5th February 2020, she still had the diarrhea.   The patient was tired from having to get up during the night to handle these symptoms. The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Decreased appetite, Fatigue, Headache, Injection site pain, Pain
Clinical narrative: Very sore right shoulder. Tired. Achy. Loss of appetite. Slight headache.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Neck pain
Clinical narrative: Pain, redness and swelling at injection site, still unresolved 3 days post injection. Neck pain, resolved 2 days post injection (note, same reaction with first dose of this vaccine)
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Pruritus
Clinical narrative: EXTREME DRY AND ITCHY SKIN
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Patient received the vaccine in office and was later evaluated the same day by urgent care for rash, pain, swelling, redness and itching at the injection site. Patient was prescribed hydroxyzine and prednisone.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pustule
Clinical narrative: When patient came in on 12/17/2019 to receive Shingrix #2, patient told the nurse that was administering the shot that he had an adverse reaction after the first shot.  Patient stated that about a week and half after he got the first vaccine of Shingrix, he got shingles on his back, spine and around his side.  He said he had pustules, but that he didn't have any pain.  They stayed for a few days and then went away.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Diarrhoea, Hyperhidrosis, Pyrexia, Skin warm
Clinical narrative: Mother called reporting child developed "fevers" 2/21/20. Unsure of time as patient was with grandmother. Grandmother does not have thermometer, but states patient his warm to the touch, sweaty, and developed diarrhea later in the evening. Symptoms continued into 2/22/20. Patient was given children's Tylenol and children's ibuprofen at approx. 2:30AM Sunday which helped reduce "fever" but returned later 2/23/20.  Mother advised to bring patient to be evaluated by PCP or walk in provider.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: site is red/ swollen/ warm to touch /traveling inward from injections
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Mass, Pain in extremity, Skin warm
Clinical narrative: EDD-3/13/20 Painful arm, lump under the skin, red and hot to touch.