chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PNC13, PPV
Symptoms: Anger, Emotional distress, Pneumonia
Clinical narrative: a year later on an unspecified date was vaccinated with PNEUMOVAX 23 and "still got pneumonia"; a year later on an unspecified date was vaccinated with PNEUMOVAX 23 and "still got pneumonia"; the patient got really mad and was very upset that she was vaccinated and still got pneumonia; the patient got really mad and was very upset that she was vaccinated and still got pneumonia; This spontaneous report was received from a pharmacist via a field representative referring to a female patient of over 65 years old. Information about medical history, concurrent conditions, drug reactions/allergies and concomitant therapies was unknown.  On an unknown date, the patient was vaccinated with pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) for prophylaxis. On an unknown date (reported as a year after vaccination), the patient was vaccinated pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (vaccine dosage detail, route of administration, lot# and expiration date were not reported). And on an unknown date the patient still got pneumonia. The patient sought medical attention, and spent some time in an unspecified hospital on unspecified dates for pneumonia. The patient got really mad and was very upset that she was vaccinated and still got pneumonia. It was unknown if any intervention to prevent serious criteria or lab diagnostics/studies were performed for the event. The outcome of pneumonia was unknown. The causality between the event of pneumonia and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.  Upon internal review, pneumonia was determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: Guillain Barre syndrome; Information has been received from a lawyer referring to a male patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 22-FEB-2018, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) (date not reported), the patient suffered right upper weakness, tingling, numbness and dizziness and was diagnosed with Guillain Barre Syndrome. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences 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 zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), 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. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event Guillain Barre Syndrome was not recovered and causal relationship was assessed as related.   The lawyer considered the event Guillain Barre Syndrome to be disability.   Upon internal review, the event Guillain Barre Syndrome was determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Herpes zoster, Myocardial reperfusion injury, Ophthalmic herpes zoster, Rash
Clinical narrative: acute myocardial injury; herpes zoster of the left upper face, eye; herpes zoster of the left upper face, eye; rash on the legs and arms; Information has been received from a lawyer referring to a male patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 03-AUG-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) (date not reported), the patient suffered acute chest pain located over the left chest and neck. The patient also had a rash on the legs and arms. The patient was diagnosed with having an acute myocardial injury. A few months later the patient suffered from a rash over the left side of his face. The patient was diagnosed with herpes zoster of the left upper face, eye. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences 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 zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), 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. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events rash on the legs and arms, acute myocardial injury and herpes zoster of the left upper face, eye was not recovered and causal relationship was assessed as related.   The lawyer considered the events rash on the legs and arms, acute myocardial injury and herpes zoster of the left upper face, eye to be disability.   Upon internal review the events acute myocardial injury and herpes zoster of the eye were determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Pneumothorax, Pneumothorax spontaneous, Respiratory failure
Clinical narrative: spontaneous pneumothorax; Information has been received from a lawyer referring to a male patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 01-AUG-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On 06-AUG-2017, reported as approximately five days after receiving zoster vaccine live (ZOSTAVAX), the patient suffered acute shortness of breath, collapsed lungs and respiratory failure. The patient was diagnosed with spontaneous pneumothorax. The patient's injuries resulted in prolonged hospitalizations As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences 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 zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), 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. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event spontaneous pneumothorax was not recovered and causal relationship was assessed as related.   The lawyer considered the event spontaneous pneumothorax to be disability.   Upon internal review the event spontaneous pneumothorax were determined to be medically significant.
Sex: U
Vaccine: PNC13, PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Inappropriate schedule of vaccine administered; no adverse events were reported; This spontaneous report was received from a pharmacist, concerning an elderly patient of unknown age. The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications were unknown by the reporter  On an unknown date, the patient was vaccinated before he was 65-years-old with a series of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) and pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported), both for prophylaxis.   It was also reported that on unknown date, the patient was vaccinated with another series of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) and pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13)  at age 66-year-old (inappropriate schedule of product administration) and then, he was vaccinated once again when he was in early 70s with another series of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) and pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) No adverse events were reported.
Sex: U
Vaccine: PNC13, PPV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: patient was administered a second dose of PREVNAR 13 instead of PNEUMOVAX 23; No adverse effects were reported; This spontaneous report was received from a pharmacist regarding a 69-year-old patient of unknown gender. There was no information reported about the patient's concomitant medications, pertinent medical history and drug reactions or allergies.   On an unspecified date, when the patient was 69 years old, received a dose of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13). Then, on an unspecified date, at age 70, received a second dose of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) instead of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) (strengths, doses, routes of administration, lot numbers and expiration dates were not provided). No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: the patient received improperly stored vaccine; 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.   On 30-SEP-2019, the patient was vaccinated with an improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally, (dose and dose number were not reported) (lot # S004251, expiration date 22-SEP-2020), administered for prophylaxis.   The vaccine was exposed to a temperature of 1.4 degree Celsius multiple times for a time frame of 20 minutes as recorded by a digital data logger. Previous temperature excursions included 10.5 degree Celsius for 56 minutes.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Arm soreness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2019, the patient received the 1st dose of Shingrix. On 6th August 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 15th October 2019, the outcome of the injection site pain was resolved with sequelae.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient stated that she had her first injection and only experienced arm soreness. The patient consented to follow up. This case is 1 of the 2 linked cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Rash on back; This case was reported by a non-health professional via sales rep and described the occurrence of red rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced red rash. The patient was treated with antihistamine and topical steroid nos (Steroid Cream). On an unknown date, the outcome of the red rash was unknown.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient had a rash on her back after vaccination. The reporter stated that her physician said she did not have shingles. The physician gave her an antihistamine and a steroid cream.
Sex: U
Vaccine: RAB
Symptoms: Musculoskeletal pain
Clinical narrative: Shoulder pain; This case was reported by a pharmacist via call center representative and described the occurrence of shoulder pain in a patient who received Rabies NVS (RabAvert) for prophylaxis.   On an unknown date, the patient received the 1st dose of RabAvert. On an unknown date, unknown after receiving RabAvert, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was unknown.   It was unknown if the reporter considered the shoulder pain to be related to RabAvert.  Additional details were provided as follows: The age at vaccination was not reported. The patient's demographic details were not provided. The pharmacist reported that, the patient experienced shoulder pain after receiving RabAvert for post exposure prophylaxis. The reporter was reluctant to provide more information. The reporter did not consent to follow up.
Age: 40.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Fatigue, Muscular weakness, Pain, Pyrexia
Clinical narrative: fever; bilateral lower extremity and left arm weakness; body aches; fatigue; This case was reported by a other health professional via call center representative and described the occurrence of fever in a 40-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2019-2020 season) (batch number T9N35, expiry date 30th June 2020) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 16th October 2019, the patient received Fluarix Tetra 2019-2020 season (intramuscular) .5 ml and Boostrix (intramuscular) .5 ml. On 16th October 2019, 6 hrs after receiving Fluarix Tetra 2019-2020 season and Boostrix, the patient experienced fever, weakness in extremity, general body pain and fatigue. On an unknown date, the outcome of the fever and weakness in extremity were recovered/resolved and the outcome of the general body pain and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the fever, weakness in extremity, general body pain and fatigue to be related to Fluarix Tetra 2019-2020 season and Boostrix.  Additional details were provided as follows: The patient received dose of Fluarix Tetra 2019-2020 season in the left deltoid. After vaccination with dose of Fluarix Tetra 2019-2020 season and Boostrix, the patient had fever of 102 degree F. The patient stated that, till the time of reporting, recovered with fever and weakness but still had aches and fatigue. The reporter consented to follow up. There was discrepancy in outcome reported for adverse events in data base and in source document.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Influenza like illness, Pain, Tenderness
Clinical narrative: inappropriate schedule of vaccine; flu like symptoms; body aches / felt achy; painful to the touch; This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 17th January 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 18th January 2019, 1 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced general body pain. On an unknown date, the patient experienced influenza-like symptoms, tenderness and incomplete course of vaccination. On an unknown date, the outcome of the influenza-like symptoms, general body pain and tenderness were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the influenza-like symptoms, general body pain and tenderness to be related to Shingrix.  Additional details were provided as follows: The caller was a pharmacy intern calling on behalf of a patient. The patient experienced flu like symptoms, body aches and her entire body was painful to the touch. These symptoms lasted for approximately 8 hours. The day after receiving the vaccine, the patient felt achy. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Muscular weakness
Clinical narrative: Arm muscle weakness; Difficulty raising the left arm; Redness at injection site; Soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th October 2019, the patient received the 2nd dose of Shingrix (intramuscular). In October 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site pain. On 21st October 2019, the patient experienced muscle weakness upper limb and injected limb mobility decreased. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site erythema and injection site pain were recovered/resolved and the outcome of the muscle weakness upper limb and injected limb mobility decreased were unknown.   It was unknown if the reporter considered the injection site erythema, injection site pain, muscle weakness upper limb and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. After vaccination, the patient had usual soreness and redness at the injection site and that has cleared up. 3 days after vaccination, the patient had arm muscle weakness in that had difficulty raising the left arm. The reporter did not consent to follow up. The reporter decline to provide full demographics details and further follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Erythema around injection site; Blistering around injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema and injection site blisters. On an unknown date, the outcome of the injection site erythema and injection site blisters were unknown.   It was unknown if the reporter considered the injection site erythema and injection site blisters to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient experienced erythema and blistering around injection site. No demographic details were provided. No lot number or expiration dates were provided. No additional details provided. The healthcare professional did not wish to file adverse event. This case has been linked with cases US2019193803 and US2019AMR196379, reported by the same reporter.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site cellulitis
Clinical narrative: cellulitis at the injection sight spreading around to the medial part of his arm
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: Patient stated  has had chronic shoulder pain  over the last few months.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling hot, Hyperhidrosis, Malaise, Nausea, Swelling face
Clinical narrative: patient states that the evening after receiving the shot (received at about 10:00am), she began to feel sweaty and hot and her face began to swell up, also felt nauseated and some malaise.  She states that she took some acetaminophen.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Heart rate increased
Clinical narrative: pt states started feeling dizzy and had rapid heart beat starting a few days after receiving vaccine
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Chest pain, Dyspnoea exertional, Myocarditis, Troponin increased
Clinical narrative: MYOCARDITIS, EXERTIONAL CHEST PAIN AND DYSPNEA, TROPONIN 18.0, ADMITTED TO THE HOSPITAL
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Injection site reaction
Clinical narrative: yes circle around injection site
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Alopecia, Alopecia areata, Blood iron normal, Blood thyroid stimulating hormone normal, Full blood count normal
Clinical narrative: In 2012 patient experience spotty hair loss almost immediately after vaccines.  End of August/first of September patient's hair began to fall out again - he presented with alopecia areata By October the hair loss has worsened.  Since this is patient's second reaction after some form of Tdap I wanted to report. The hair loss may be due to vitamin deficiency, but time relationship to vaccines is questionable.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Serum ferritin normal, Vitamin D deficiency
Clinical narrative: In 2012 patient experience spotty hair loss almost immediately after vaccines.  End of August/first of September patient's hair began to fall out again - he presented with alopecia areata By October the hair loss has worsened.  Since this is patient's second reaction after some form of Tdap I wanted to report. The hair loss may be due to vitamin deficiency, but time relationship to vaccines is questionable.
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Dermatitis
Clinical narrative: & DERMATITIS
Age: 29.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Hyperhidrosis, Hypotension
Clinical narrative: Hypotension & Diaphoretic. Patient has tolerated flu shot in the past
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea
Clinical narrative: Dyspnea
Age: 42.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Fever & redness/swelling injection site
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash & UrticariaPruritus
Age: 76.0
Sex: F
Vaccine: FLUA3, VARZOS, FLUA3, VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Feeling abnormal, Injection site pain, Insomnia
Clinical narrative: Had these symptoms that night such as sleeplessness, pain at injection site, upset stomach, diarrhea in the morning and felt lousy all next day, Oct 29.  Symptoms were much improved by evening but noticed that blotches were starting on my face and being my ears.They became redder, raised and itchy as the day went by.  Called the tech at the Pharmacy who gave me the shots.  He told me he had not seen the red raised splotches  as a complication but I should call my family  Dr to report this. I did so on Wednesday, Oct 30th and have not heard back. Not using anything different on my face or eating anything different. Took a benadryl last night and splotches look muchbetter this morning.
Age: 76.0
Sex: F
Vaccine: FLUA3, VARZOS, FLUA3, VARZOS
Symptoms: Rash erythematous, Rash macular, Rash papular, Rash pruritic
Clinical narrative: Had these symptoms that night such as sleeplessness, pain at injection site, upset stomach, diarrhea in the morning and felt lousy all next day, Oct 29.  Symptoms were much improved by evening but noticed that blotches were starting on my face and being my ears.They became redder, raised and itchy as the day went by.  Called the tech at the Pharmacy who gave me the shots.  He told me he had not seen the red raised splotches  as a complication but I should call my family  Dr to report this. I did so on Wednesday, Oct 30th and have not heard back. Not using anything different on my face or eating anything different. Took a benadryl last night and splotches look muchbetter this morning.
Age: 76.0
Sex: F
Vaccine: FLUA3, VARZOS, FLUA3, VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Headache, Injection site pain, Insomnia
Clinical narrative: Had these symptoms that night such as sleeplessness, pain at injection site, upset stomach, diarrhea in the morning and felt lousy all next day, Oct 29.  Symptoms were much improved by evening but noticed that blotches were starting on my face and being my ears.They became redder, raised and itchy as the day went by.  Called the tech at the Pharmacy who gave me the shots.  He told me he had not seen the red raised splotches  as a complication but I should call my family  Dr to report this. I did so on Wednesday, Oct 30th and have not heard back. Not using anything different on my face or eating anything different. Took a benadryl last night and splotches look muchbetter this morning.
Age: 76.0
Sex: F
Vaccine: FLUA3, VARZOS, FLUA3, VARZOS
Symptoms: Pruritus, Rash, Rash macular
Clinical narrative: Had these symptoms that night such as sleeplessness, pain at injection site, upset stomach, diarrhea in the morning and felt lousy all next day, Oct 29.  Symptoms were much improved by evening but noticed that blotches were starting on my face and being my ears.They became redder, raised and itchy as the day went by.  Called the tech at the Pharmacy who gave me the shots.  He told me he had not seen the red raised splotches  as a complication but I should call my family  Dr to report this. I did so on Wednesday, Oct 30th and have not heard back. Not using anything different on my face or eating anything different. Took a benadryl last night and splotches look muchbetter this morning.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 8.5 CM IN DIAMETER RED, RAISED ERYTHEMATOUS AREA ON PTS LEFT DELTIOD. LOCATION IS ITCHY AND TENDER TO THE TOUCH.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: hives mostly upper body , improved after Benadryl, steroids and Pepcid no tongue swelling or edema
Age: 76.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left Arm redness and swelling near injection site 4 day post administration
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: First symptom felt like something was caught in throat, then nausea and profuse sweating, exhaustion, headache, slight fever, lasted from 10:00 p.m. 10/28 to 10/30, a.m.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Sensation of foreign body
Clinical narrative: First symptom felt like something was caught in throat, then nausea and profuse sweating, exhaustion, headache, slight fever, lasted from 10:00 p.m. 10/28 to 10/30, a.m.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Within 36 hours of injection, developed an itchy rash all over his body.  Lasted for about 36 hours. Rash resolved except for his back.  The rash became red painful rash on his back - not vesicular by report.  Lasted 10 days. Used topical cortisol cream and ice.  All symptoms have resolved.  This was a phoned in report.  the patient declined to come to be seen, but wanted this information reported.  Past injections with quadrivalent flu vaccines uneventful.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Dyspnoea exertional, Troponin increased
Clinical narrative: Pt states he received a smallpox vaccination prior to his symptoms, but I cannot find specific data to this effect.  Pt presented to the ED c/o chest pain and dyspnea on exertion, worsening over 3 days.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Electrocardiogram normal, Fatigue, Full blood count normal
Clinical narrative: pt seen on 10/2/19 with right sided neck pain headache fatigue weakness dizziness
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Metabolic function test normal, Neck pain
Clinical narrative: pt seen on 10/2/19 with right sided neck pain headache fatigue weakness dizziness
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Injection site mass, Injection site vesicles, Myalgia
Clinical narrative: He received the 2nd dose of Shingrix vaccine on 10/25/2019 at 0848. Later that evening he developed a fever, chills, sweats and myalgia. He also reported that he had a lump and two blisters  at the injection site about the size of a dime. The blisters popped in the shower the next morning.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: He received the 2nd dose of Shingrix vaccine on 10/25/2019 at 0848. Later that evening he developed a fever, chills, sweats and myalgia. He also reported that he had a lump and two blisters  at the injection site about the size of a dime. The blisters popped in the shower the next morning.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Cellulitis, Erythema, Injection site pain, Peripheral swelling, Skin warm
Clinical narrative: Patients left arm became red, swollen and warm to the touch. Diagnosed with Cellulitis. Treated with Sulfamethoxazole-Trimethoprim 800-160 mg.  Returned to clinic on 10/31/19 with intermittent left arm pain around the injection site.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Administration site cellulitis
Clinical narrative: cellulitis around administration site
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Loss of personal independence in daily activities, Nausea
Clinical narrative: Completely incapable of doing normal activities. Chills, fever, nausea, weakness, headache.  Could barely sit up all
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Posture abnormal, Pyrexia
Clinical narrative: Completely incapable of doing normal activities. Chills, fever, nausea, weakness, headache.  Could barely sit up all
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pain
Clinical narrative: Everything hurts. Headache. Muscle aches. Everything. This is probably the worst reaction I have ever had.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Dizziness, Grip strength decreased, Muscular weakness
Clinical narrative: Muscle pain in left arm, left back, and left breast. Has left hand weakness, runny nose, dizziness, weakness, and drop things from left hand.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Rhinorrhoea
Clinical narrative: Muscle pain in left arm, left back, and left breast. Has left hand weakness, runny nose, dizziness, weakness, and drop things from left hand.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Incorrect dose administered
Clinical narrative: Patient received adult Hep A instead of Pedi hep a
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Ear discomfort, Tinnitus, Vertigo
Clinical narrative: vertigo, ringing in ears, plugged ears.  Same thing happened happened last year with fluzone.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient did not report any adverse events. She did received an immunization not indicated for her age.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient was given shingles vaccine ON 5/21/2019 and developed a rash that started in his lower back at the beginning of July. It began as an erythematous rash and was itchy. It then spread becoming generalized and pruritic. Patient contacted provider on 8/30 via phone and was advised to take Benadryl. Patient was contacted again for follow up on 9/3 and rash did not improve. Provider prescribed methylprednisolone and triamcinolone and rash has since resolved. No additional therapy was required.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: & Urtucaria
Age: 90.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Skin warm, Swelling
Clinical narrative: & baseball size red, warth, little swellen local reaction.
Age: 16.0
Sex: U
Vaccine: FLU4, MENB, MNQ
Symptoms: Injection site erythema
Clinical narrative: 2x3 cm area of erythema on left upper arm
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Bursitis, Injected limb mobility decreased, Injection site pain, Injection site reaction, Product administered at inappropriate site
Clinical narrative: 2 weeks ago (10/14/19) was given flu vaccine right dominant upper arm. Employee is CRNA: felt injection was given "too high" Now having right shoulder bursitis (decreased ROM 5 pain) 0 lymphadenopathy or erythema. Prednisone 50mg PO x 7 days given. Improvement noter after 2 days
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Cough, Lower respiratory tract infection, Nasopharyngitis
Clinical narrative: Head & chest cold, bad cough Lasted 2 weeks
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Drooling, Dysarthria, Facial paralysis, Pyrexia
Clinical narrative: Drooling, dysarthria, fever to 103 x 3 days, right facial droop with resolution of everything except the dysarthria.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood culture, Blood lactic acid, Chest X-ray, Decreased appetite, Diarrhoea
Clinical narrative: lethargic, slept for 13 hours first night, 11 hours second night.  No appetite, diarrhea and nauseated.  low grade fever.  Needed 1 1/2 bags of IV.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Full blood count, Hypersomnia, Lethargy, Metabolic function test, Nausea
Clinical narrative: lethargic, slept for 13 hours first night, 11 hours second night.  No appetite, diarrhea and nauseated.  low grade fever.  Needed 1 1/2 bags of IV.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Urine analysis
Clinical narrative: lethargic, slept for 13 hours first night, 11 hours second night.  No appetite, diarrhea and nauseated.  low grade fever.  Needed 1 1/2 bags of IV.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Decreased appetite, Irritability, Pyrexia, Urticaria
Clinical narrative: Baby started with a fever later that afternoon and has continued with fever through to today.  Temp max 103 - does respond to tylenol but comes straight back when tylenol wears off.  Hives covering the whole body.  baby irritable and fussy - reduced appetite.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, RV5
Symptoms: Diarrhoea, Feeling abnormal, Mucous stools, Nasopharyngitis
Clinical narrative: PATIENT STARTED WITH DIARRHEA ON THE DAY OF THE VACCINE ADMINISTRATION AND THIS DIARRHEA CONTINUED MORE THAN 5 TIMES A DAY FOR A MINIMUM OF 2 WEEKS. SHE ALSO HAD COLD SYMPTOMS WHICH I DO NOT REPORT AS AN ADVERSE EVENT, BUT THE DIARRHEA FOR > 2 WEEKS AFTER THE THIRD ROTA WAS REPORTABLE IN MY OPINION. PARENT REPORTED CHILD WAS "NOT HERSELF" FOR THE MONTH, BUT MAINLY DUE TO LIQUIDY STOOLS AND SOME WERE MUCOUSY AND EXPLOSIVE IN NATURE.
Age: 29.0
Sex: F
Vaccine: FLUR4
Symptoms: Pruritus
Clinical narrative: pt developed a generalized pruritic  eruption
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site pain, Insomnia, Pain
Clinical narrative: Arm pain in R side (where HPV was received) persistent beyond typical time frame. Was seen in clinic on 10/31 for this continued pain. Causing difficulty sleeping on R side. Difficulty with playing at recess (football). Other injection site pain on L arm resolved weeks ago. No redness/swelling/cyst noted to R arm. Full range of motion. Pain at it's worst when arms extended overhead. Pain with palpation of deltoid muscle, about 4-5 inches below acromion process
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Herpes zoster, Rash
Clinical narrative: THE DAY AFTER THE VACCINE ADMINISTRATION PATIENT STARTED WITH A RASH THAT SPREAD AND PROGRESSED AND WAS DETERMINED BY MYSELF ON 10/21/2019 TO BE A CASE OF HERPES ZOSTER (SHINGLES).
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Aggression, Dyskinesia, Irritability, Selective eating disorder, Staring
Clinical narrative: Child cranky, flailing arms & legs - tantrums NOT eating well Frequent staring episodes. Referred to Neurology
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient mentioned ongoing soreness in right arm on 10/27/2019 (7 days after vaccination), but did not mention seeking medical treatment for soreness at that time.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects reported; patient inadvertently received an expired dose of MMR II on 02.10.19; This spontaneous report was received from a medical lab technician (who is also office manager) and refers to a patient of unknown age. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not reported.  On 02-OCT-2019, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) recombinant human albumin (rHA), lot # N023150, expiration date 24-AUG-2019 (exact dose, route and site of administration were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent. No adverse effects were reported.
Age: 0.5
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Interchange of vaccine products/ administered gardasil 9 instead of PREVNAR 13; This spontaneous report was received from other health professional (nurse) refers to a 6 month old infant of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and history of drug reactions/allergies were not reported.  On 28-OCT-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route were not reported, lot # 1602281 has been verified to be a valid lot number for (hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)) expiration date reported as 21-JUL-2021) for prophylaxis instead of pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) (interchange of vaccine products). The nurse reported that the patient slept well last night with no adverse effect (no adverse event) reported. It was reported that pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) was not administered during this well visit. No product quality complaint was reported. The outcome of interchange of vaccine products and no adverse event was unknown.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache, Injection site pain
Clinical narrative: Soreness at injection site; Tired; Dizzy; Chills; Headache; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On 14th October 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 14th October 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, tiredness, dizziness, chills and headache. On 15th October 2019, the outcome of the injection site pain, tiredness, dizziness, chills and headache were recovered/resolved.   It was unknown if the reporter considered the injection site pain, tiredness, dizziness, chills and headache to be related to Shingrix.  Additional details were provided as follows: This case was reported by the wife of the patient. The reporter reported that she did not know when patient received his 1st dose. The patient received Shingrix and had injection site pain, tiredness, dizziness, chills and headache. The reporter consented to follow up. This case is 2 of 2 cases, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Palpitations
Clinical narrative: Palpitations; Feeling weak; Headache; This case was reported by a consumer and described the occurrence of palpitation in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced palpitation, feelings of weakness and headache. On an unknown date, the outcome of the palpitation, feelings of weakness and headache were unknown.   It was unknown if the reporter considered the palpitation, feelings of weakness and headache to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced palpitations, headache and was feeling weak. The patient asked whether the palpations and headache and feeling weak a reaction from the shot.
Sex: M
Vaccine: RAB
Symptoms: Exposure via skin contact, Immediate post-injection reaction, Occupational exposure to product, Skin laceration
Clinical narrative: cut finger; Accidental Exposure; Exposure via skin contact; This case was reported by a nurse via call center representative and described the occurrence of laceration of finger in a male who was preparing Rabies NVS (RabAvert) (batch number unknown, expiry date 31st July 2022) for administration in other patient for prophylaxis.  On 10th October 2019, the patient received RabAvert. On 10th October 2019, immediately after receiving RabAvert, the patient experienced laceration of finger, occupational exposure while administering product and exposure via skin contact. On an unknown date, the outcome of the laceration of finger, occupational exposure while administering product and exposure via skin contact were unknown.   It was unknown if the reporter considered the laceration of finger to be related to RabAvert.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The batch number was not reported. The nurse was giving a pre-exposure dose of Rabavert to a patient and accidentally broke the vial and cut himself, 1 to 2 drops of the vaccine went into the cut, which led to laceration of finger, occupational exposure while administering product and exposure via skin contact. No symptoms were reported.  The reporter consented to follow up. This case linked with US2019186971, reported by same reporter for same patient.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache, Injection site pain
Clinical narrative: Soreness at injection site; tired; dizzy; chills; headache; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of pain in extremity (received 1st dose on 6th August 2019, refer case US2019AMR191400).   On 14th October 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 14th October 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, tiredness, dizziness, chills and headache. Rechallenge with Shingrix was positive. On 15th October 2019, the outcome of the injection site pain, tiredness, dizziness, chills and headache were recovered/resolved.   It was unknown if the reporter considered the injection site pain, tiredness, dizziness, chills and headache to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experience arm soreness on left arm and also had injection site pain, tiredness, dizziness, chills and headache. The reporter consented to follow up. This case linked with US2019190817, reported by same reporter.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: Soreness at injection site; tired; dizzy; chills; headache; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of pain in extremity (received 1st dose on 6th August 2019, refer case US2019AMR191400).   On 14th October 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 14th October 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, tiredness, dizziness, chills and headache. Rechallenge with Shingrix was positive. On 15th October 2019, the outcome of the injection site pain, tiredness, dizziness, chills and headache were recovered/resolved.   It was unknown if the reporter considered the injection site pain, tiredness, dizziness, chills and headache to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experience arm soreness on left arm and also had injection site pain, tiredness, dizziness, chills and headache. The reporter consented to follow up. This case linked with US2019190817, reported by same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Broken out in hives; This case was reported by a other health professional via call center representative and described the occurrence of hives in a 17-year-old patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number J9F97, expiry date 30th June 2020) for prophylaxis.   In October 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On an unknown date, less than an hour after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient received Fluarix within the last week of reporting. The patient broken out in hives within 15 minutes after getting the vaccine and needed to go to the emergency room. The reporter also reported adverse event attributed to the quality defect of Fluarix vaccine. As per the reporter, syringe was affected which was purchased from wholesaler. The sample was not available for return for the investigation. The reporter consented to follow up. This is one of 3 cases, reported by the same reporter.
Age: 70.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Fatigue, Nausea, Pain in extremity
Clinical narrative: right arm pain; tiredness; nausea; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix and PNEUMONIA VACCINE. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm, tiredness and nausea. On an unknown date, the outcome of the pain in arm, tiredness and nausea were recovered/resolved.   It was unknown if the reporter considered the pain in arm, tiredness and nausea to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on the right arm. On the same day, the patient received Pneumonia vaccine on the left arm. The patient stated that she had right arm pain with nausea and tiredness which lasted for 4 to 5 days. These symptoms had completely resolved at the time of reporting. The reporter consented to follow up.