chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: Arm itched; Rash up and down my arm; Could not sleep; Arm became swollen; Arm hot to the touch; This case was reported by a consumer and described the occurrence of swelling arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix. On an unknown date, between 2 and 3 months after receiving Shingrix, the patient experienced swelling arm, extremities hot feeling of, itchy upper limbs, rash and insomnia. On an unknown date, the outcome of the swelling arm, extremities hot feeling of, rash and insomnia were recovered/resolved and the outcome of the itchy upper limbs was not recovered/not resolved.   It was unknown if the reporter considered the swelling arm, extremities hot feeling of, itchy upper limbs, rash and insomnia to be related to Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported. The patient stated, she had a terrible reaction which included her arm became swollen, it became hot to the touch, was itched and she had a rash up and down her arm.  She could not sleep.  After 9 days the symptoms abated, but her arm still itched. The patient stated, she had recently been informed that the vaccine was back in stock and that she should return for 2nd Shingrix shot but she was afraid.  She asked questions like if she forgot the 2nd shot, would she have limited protection from the 1st Shingrix shot and for how long period. Also, whether these reactions to the 1st shot were common because she had read the literature and since she was not prone to allergic reactions to many things, this episode was alarming to her.  Also she stated, if the 1st shot and the reaction to it was a warning to not to receive 2nd shot.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling hot, Insomnia, Peripheral swelling, Pruritus, Rash
Clinical narrative: Arm itched; Rash up and down my arm; Could not sleep; Arm became swollen; Arm hot to the touch; This case was reported by a consumer and described the occurrence of swelling arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix. On an unknown date, between 2 and 3 months after receiving Shingrix, the patient experienced swelling arm, extremities hot feeling of, itchy upper limbs, rash and insomnia. On an unknown date, the outcome of the swelling arm, extremities hot feeling of, rash and insomnia were recovered/resolved and the outcome of the itchy upper limbs was not recovered/not resolved.   It was unknown if the reporter considered the swelling arm, extremities hot feeling of, itchy upper limbs, rash and insomnia to be related to Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported. The patient stated, she had a terrible reaction which included her arm became swollen, it became hot to the touch, was itched and she had a rash up and down her arm.  She could not sleep.  After 9 days the symptoms abated, but her arm still itched. The patient stated, she had recently been informed that the vaccine was back in stock and that she should return for 2nd Shingrix shot but she was afraid.  She asked questions like if she forgot the 2nd shot, would she have limited protection from the 1st Shingrix shot and for how long period. Also, whether these reactions to the 1st shot were common because she had read the literature and since she was not prone to allergic reactions to many things, this episode was alarming to her.  Also she stated, if the 1st shot and the reaction to it was a warning to not to receive 2nd shot.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Facial pain
Clinical narrative: after she got the shot, she developed cellulitis and wasn't able to lift up her arm as much
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Fatigue, Fine motor skill dysfunction, Headache, Hyperhidrosis, Hypoaesthesia
Clinical narrative: after she got the shot, she developed cellulitis and wasn't able to lift up her arm as much
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site cellulitis, Mental impairment, Middle insomnia, Migraine
Clinical narrative: after she got the shot, she developed cellulitis and wasn't able to lift up her arm as much
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Nasal congestion, Nausea, Pain in extremity, Paraesthesia, Speech disorder
Clinical narrative: after she got the shot, she developed cellulitis and wasn't able to lift up her arm as much
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Mobility decreased
Clinical narrative: after she got the shot, she developed cellulitis and wasn't able to lift up her arm as much
Age: 62.0
Sex: U
Vaccine: VARZOS, UNK, VARZOS
Symptoms: Axillary pain, Chills, Decreased appetite, Fatigue, Heart rate increased
Clinical narrative: Underarm is sore; Underarm is swollen; This case was reported by a consumer and described the occurrence of pain in arm in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   On 26th September 2019, the patient received Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. On 30th September 2019, 4 days after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced pain in arm and local swelling. On an unknown date, the outcome of the pain in arm and local swelling were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and local swelling to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional case details were provided as follows: On the last Thursday (before the reporting date), the patient received Shingrix vaccine and at the same time had a flu vaccine.  The patient's underarm was still sore and swollen.  The patient asked whether it was a normal side affect. The GlaxoSmithKline representative suggested the patient should visit to doctor, pharmacist or nurse. The patient then stated that, they received vaccine at work clinic but the information regarding side affects was not provided to the patient.
Age: 62.0
Sex: U
Vaccine: VARZOS, UNK, VARZOS
Symptoms: Injection site pain, Injection site swelling, Malaise, Pain in extremity, Peripheral swelling
Clinical narrative: Underarm is sore; Underarm is swollen; This case was reported by a consumer and described the occurrence of pain in arm in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   On 26th September 2019, the patient received Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. On 30th September 2019, 4 days after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced pain in arm and local swelling. On an unknown date, the outcome of the pain in arm and local swelling were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and local swelling to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional case details were provided as follows: On the last Thursday (before the reporting date), the patient received Shingrix vaccine and at the same time had a flu vaccine.  The patient's underarm was still sore and swollen.  The patient asked whether it was a normal side affect. The GlaxoSmithKline representative suggested the patient should visit to doctor, pharmacist or nurse. The patient then stated that, they received vaccine at work clinic but the information regarding side affects was not provided to the patient.
Age: 62.0
Sex: U
Vaccine: VARZOS, UNK, VARZOS
Symptoms: Swelling, Thirst
Clinical narrative: Underarm is sore; Underarm is swollen; This case was reported by a consumer and described the occurrence of pain in arm in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   On 26th September 2019, the patient received Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. On 30th September 2019, 4 days after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced pain in arm and local swelling. On an unknown date, the outcome of the pain in arm and local swelling were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and local swelling to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional case details were provided as follows: On the last Thursday (before the reporting date), the patient received Shingrix vaccine and at the same time had a flu vaccine.  The patient's underarm was still sore and swollen.  The patient asked whether it was a normal side affect. The GlaxoSmithKline representative suggested the patient should visit to doctor, pharmacist or nurse. The patient then stated that, they received vaccine at work clinic but the information regarding side affects was not provided to the patient.
Age: 62.0
Sex: U
Vaccine: VARZOS, UNK, VARZOS
Symptoms: Pain in extremity, Swelling
Clinical narrative: Underarm is sore; Underarm is swollen; This case was reported by a consumer and described the occurrence of pain in arm in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   On 26th September 2019, the patient received Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. On 30th September 2019, 4 days after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced pain in arm and local swelling. On an unknown date, the outcome of the pain in arm and local swelling were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and local swelling to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional case details were provided as follows: On the last Thursday (before the reporting date), the patient received Shingrix vaccine and at the same time had a flu vaccine.  The patient's underarm was still sore and swollen.  The patient asked whether it was a normal side affect. The GlaxoSmithKline representative suggested the patient should visit to doctor, pharmacist or nurse. The patient then stated that, they received vaccine at work clinic but the information regarding side affects was not provided to the patient.
Age: 61.0
Sex: F
Vaccine: FLUC4, PPV, FLUC3, PPV, PPV
Symptoms: Erythema, Headache, Lymphadenopathy, Peripheral swelling, Pyrexia
Clinical narrative: pain behind her left ear; injection site was red and swollen; injection site was red and swollen; swelling extended down to the patient's elbow, armpit and lymph gland in her left arm were swollen; vomited several times; cellulitis; This spontaneous report was received from a pharmacist referring to a 61 year old female patient. The patient's medical history included pneumonia and hospitalization. The patient's concurrent conditions were not reported. The patient's concomitant therapies were not reported. On 27-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, frequency were not reported) lot # R012976 and expiry date 25-JAN-2020 via intramuscular route on left arm for vaccination against pneumonia. Other suspect therapies included: On 27-SEP-2019, the patient was vaccinated with influenza virus sag 4v vaccine inactivated (mdck cell) (FLUCELVAX QUADRIVALENT) (dose, route, frequency, lot number and expiry date were not reported) on left arm for prophylaxis. On 28-SEP-2019, (reported as 24 hours after receiving pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23)) the patient experienced headache (reported as migraine like) with pain behind her left ear and fever (ear pain). The patient's injection site was red and swollen in a 2 inch circle around the injection site (injection site erythema, injection site swelling). The patient's armpit and lymph gland in her left arm were swollen in an area described as "2 inches by 4 inches" (lymphadenopathy). It was reported that fever lasted all over the week and on 29-SEP-2019, the fever was 102°F. On 29-SEP-2019, the swelling extended down to the patient's elbow. On 29-SEP-2019, the patient felt so sleepy and stayed in bed most of the day. On an unknown date in September 2019, the patient took an unspecified dose of over the counter ibuprofen and also reported that she vomited several times. On an unknown date in 2019, the patient visited the physician and was diagnosed with cellulitis and was prescribed with an unspecified antibiotic. It was reported that the patient has a mild fever today (01-OCT-2019). The patient sought medical attention. No PQC was reported. The outcome of the events was reported as not recovered. Causal relationship between the events and the suspect therapy was unknown by the reporter.  Upon internal review the event cellulitis was determined to be medically significant.  This is one of the several reports from the same reporter.; Sender's Comments:  US-009507513-1910USA002780: US-009507513-1910USA002818: US-009507513-1910USA002328:
Age: 61.0
Sex: F
Vaccine: FLUC4, PPV, FLUC3, PPV, PPV
Symptoms: Somnolence, Vomiting
Clinical narrative: pain behind her left ear; injection site was red and swollen; injection site was red and swollen; swelling extended down to the patient's elbow, armpit and lymph gland in her left arm were swollen; vomited several times; cellulitis; This spontaneous report was received from a pharmacist referring to a 61 year old female patient. The patient's medical history included pneumonia and hospitalization. The patient's concurrent conditions were not reported. The patient's concomitant therapies were not reported. On 27-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, frequency were not reported) lot # R012976 and expiry date 25-JAN-2020 via intramuscular route on left arm for vaccination against pneumonia. Other suspect therapies included: On 27-SEP-2019, the patient was vaccinated with influenza virus sag 4v vaccine inactivated (mdck cell) (FLUCELVAX QUADRIVALENT) (dose, route, frequency, lot number and expiry date were not reported) on left arm for prophylaxis. On 28-SEP-2019, (reported as 24 hours after receiving pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23)) the patient experienced headache (reported as migraine like) with pain behind her left ear and fever (ear pain). The patient's injection site was red and swollen in a 2 inch circle around the injection site (injection site erythema, injection site swelling). The patient's armpit and lymph gland in her left arm were swollen in an area described as "2 inches by 4 inches" (lymphadenopathy). It was reported that fever lasted all over the week and on 29-SEP-2019, the fever was 102°F. On 29-SEP-2019, the swelling extended down to the patient's elbow. On 29-SEP-2019, the patient felt so sleepy and stayed in bed most of the day. On an unknown date in September 2019, the patient took an unspecified dose of over the counter ibuprofen and also reported that she vomited several times. On an unknown date in 2019, the patient visited the physician and was diagnosed with cellulitis and was prescribed with an unspecified antibiotic. It was reported that the patient has a mild fever today (01-OCT-2019). The patient sought medical attention. No PQC was reported. The outcome of the events was reported as not recovered. Causal relationship between the events and the suspect therapy was unknown by the reporter.  Upon internal review the event cellulitis was determined to be medically significant.  This is one of the several reports from the same reporter.; Sender's Comments:  US-009507513-1910USA002780: US-009507513-1910USA002818: US-009507513-1910USA002328:
Age: 61.0
Sex: F
Vaccine: FLUC4, PPV, FLUC3, PPV, PPV
Symptoms: Cellulitis, Ear pain, Headache, Injection site erythema, Injection site swelling
Clinical narrative: pain behind her left ear; injection site was red and swollen; injection site was red and swollen; swelling extended down to the patient's elbow, armpit and lymph gland in her left arm were swollen; vomited several times; cellulitis; This spontaneous report was received from a pharmacist referring to a 61 year old female patient. The patient's medical history included pneumonia and hospitalization. The patient's concurrent conditions were not reported. The patient's concomitant therapies were not reported. On 27-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, frequency were not reported) lot # R012976 and expiry date 25-JAN-2020 via intramuscular route on left arm for vaccination against pneumonia. Other suspect therapies included: On 27-SEP-2019, the patient was vaccinated with influenza virus sag 4v vaccine inactivated (mdck cell) (FLUCELVAX QUADRIVALENT) (dose, route, frequency, lot number and expiry date were not reported) on left arm for prophylaxis. On 28-SEP-2019, (reported as 24 hours after receiving pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23)) the patient experienced headache (reported as migraine like) with pain behind her left ear and fever (ear pain). The patient's injection site was red and swollen in a 2 inch circle around the injection site (injection site erythema, injection site swelling). The patient's armpit and lymph gland in her left arm were swollen in an area described as "2 inches by 4 inches" (lymphadenopathy). It was reported that fever lasted all over the week and on 29-SEP-2019, the fever was 102°F. On 29-SEP-2019, the swelling extended down to the patient's elbow. On 29-SEP-2019, the patient felt so sleepy and stayed in bed most of the day. On an unknown date in September 2019, the patient took an unspecified dose of over the counter ibuprofen and also reported that she vomited several times. On an unknown date in 2019, the patient visited the physician and was diagnosed with cellulitis and was prescribed with an unspecified antibiotic. It was reported that the patient has a mild fever today (01-OCT-2019). The patient sought medical attention. No PQC was reported. The outcome of the events was reported as not recovered. Causal relationship between the events and the suspect therapy was unknown by the reporter.  Upon internal review the event cellulitis was determined to be medically significant.  This is one of the several reports from the same reporter.; Sender's Comments:  US-009507513-1910USA002780: US-009507513-1910USA002818: US-009507513-1910USA002328:
Age: 61.0
Sex: F
Vaccine: FLUC4, PPV, FLUC3, PPV, PPV
Symptoms: Lymphadenopathy, Pyrexia, Somnolence, Vomiting
Clinical narrative: pain behind her left ear; injection site was red and swollen; injection site was red and swollen; swelling extended down to the patient's elbow, armpit and lymph gland in her left arm were swollen; vomited several times; cellulitis; This spontaneous report was received from a pharmacist referring to a 61 year old female patient. The patient's medical history included pneumonia and hospitalization. The patient's concurrent conditions were not reported. The patient's concomitant therapies were not reported. On 27-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, frequency were not reported) lot # R012976 and expiry date 25-JAN-2020 via intramuscular route on left arm for vaccination against pneumonia. Other suspect therapies included: On 27-SEP-2019, the patient was vaccinated with influenza virus sag 4v vaccine inactivated (mdck cell) (FLUCELVAX QUADRIVALENT) (dose, route, frequency, lot number and expiry date were not reported) on left arm for prophylaxis. On 28-SEP-2019, (reported as 24 hours after receiving pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23)) the patient experienced headache (reported as migraine like) with pain behind her left ear and fever (ear pain). The patient's injection site was red and swollen in a 2 inch circle around the injection site (injection site erythema, injection site swelling). The patient's armpit and lymph gland in her left arm were swollen in an area described as "2 inches by 4 inches" (lymphadenopathy). It was reported that fever lasted all over the week and on 29-SEP-2019, the fever was 102°F. On 29-SEP-2019, the swelling extended down to the patient's elbow. On 29-SEP-2019, the patient felt so sleepy and stayed in bed most of the day. On an unknown date in September 2019, the patient took an unspecified dose of over the counter ibuprofen and also reported that she vomited several times. On an unknown date in 2019, the patient visited the physician and was diagnosed with cellulitis and was prescribed with an unspecified antibiotic. It was reported that the patient has a mild fever today (01-OCT-2019). The patient sought medical attention. No PQC was reported. The outcome of the events was reported as not recovered. Causal relationship between the events and the suspect therapy was unknown by the reporter.  Upon internal review the event cellulitis was determined to be medically significant.  This is one of the several reports from the same reporter.; Sender's Comments:  US-009507513-1910USA002780: US-009507513-1910USA002818: US-009507513-1910USA002328:
Age: 61.0
Sex: F
Vaccine: FLUC4, PPV, FLUC3, PPV, PPV
Symptoms: Body temperature increased, Cellulitis, Erythema, Fatigue, Headache
Clinical narrative: pain behind her left ear; injection site was red and swollen; injection site was red and swollen; swelling extended down to the patient's elbow, armpit and lymph gland in her left arm were swollen; vomited several times; cellulitis; This spontaneous report was received from a pharmacist referring to a 61 year old female patient. The patient's medical history included pneumonia and hospitalization. The patient's concurrent conditions were not reported. The patient's concomitant therapies were not reported. On 27-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, frequency were not reported) lot # R012976 and expiry date 25-JAN-2020 via intramuscular route on left arm for vaccination against pneumonia. Other suspect therapies included: On 27-SEP-2019, the patient was vaccinated with influenza virus sag 4v vaccine inactivated (mdck cell) (FLUCELVAX QUADRIVALENT) (dose, route, frequency, lot number and expiry date were not reported) on left arm for prophylaxis. On 28-SEP-2019, (reported as 24 hours after receiving pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23)) the patient experienced headache (reported as migraine like) with pain behind her left ear and fever (ear pain). The patient's injection site was red and swollen in a 2 inch circle around the injection site (injection site erythema, injection site swelling). The patient's armpit and lymph gland in her left arm were swollen in an area described as "2 inches by 4 inches" (lymphadenopathy). It was reported that fever lasted all over the week and on 29-SEP-2019, the fever was 102°F. On 29-SEP-2019, the swelling extended down to the patient's elbow. On 29-SEP-2019, the patient felt so sleepy and stayed in bed most of the day. On an unknown date in September 2019, the patient took an unspecified dose of over the counter ibuprofen and also reported that she vomited several times. On an unknown date in 2019, the patient visited the physician and was diagnosed with cellulitis and was prescribed with an unspecified antibiotic. It was reported that the patient has a mild fever today (01-OCT-2019). The patient sought medical attention. No PQC was reported. The outcome of the events was reported as not recovered. Causal relationship between the events and the suspect therapy was unknown by the reporter.  Upon internal review the event cellulitis was determined to be medically significant.  This is one of the several reports from the same reporter.; Sender's Comments:  US-009507513-1910USA002780: US-009507513-1910USA002818: US-009507513-1910USA002328:
Age: 61.0
Sex: F
Vaccine: FLUC4, PPV, FLUC3, PPV, PPV
Symptoms: Pain, Pain in extremity, Peripheral swelling, Vomiting
Clinical narrative: pain behind her left ear; injection site was red and swollen; injection site was red and swollen; swelling extended down to the patient's elbow, armpit and lymph gland in her left arm were swollen; vomited several times; cellulitis; This spontaneous report was received from a pharmacist referring to a 61 year old female patient. The patient's medical history included pneumonia and hospitalization. The patient's concurrent conditions were not reported. The patient's concomitant therapies were not reported. On 27-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, frequency were not reported) lot # R012976 and expiry date 25-JAN-2020 via intramuscular route on left arm for vaccination against pneumonia. Other suspect therapies included: On 27-SEP-2019, the patient was vaccinated with influenza virus sag 4v vaccine inactivated (mdck cell) (FLUCELVAX QUADRIVALENT) (dose, route, frequency, lot number and expiry date were not reported) on left arm for prophylaxis. On 28-SEP-2019, (reported as 24 hours after receiving pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23)) the patient experienced headache (reported as migraine like) with pain behind her left ear and fever (ear pain). The patient's injection site was red and swollen in a 2 inch circle around the injection site (injection site erythema, injection site swelling). The patient's armpit and lymph gland in her left arm were swollen in an area described as "2 inches by 4 inches" (lymphadenopathy). It was reported that fever lasted all over the week and on 29-SEP-2019, the fever was 102°F. On 29-SEP-2019, the swelling extended down to the patient's elbow. On 29-SEP-2019, the patient felt so sleepy and stayed in bed most of the day. On an unknown date in September 2019, the patient took an unspecified dose of over the counter ibuprofen and also reported that she vomited several times. On an unknown date in 2019, the patient visited the physician and was diagnosed with cellulitis and was prescribed with an unspecified antibiotic. It was reported that the patient has a mild fever today (01-OCT-2019). The patient sought medical attention. No PQC was reported. The outcome of the events was reported as not recovered. Causal relationship between the events and the suspect therapy was unknown by the reporter.  Upon internal review the event cellulitis was determined to be medically significant.  This is one of the several reports from the same reporter.; Sender's Comments:  US-009507513-1910USA002780: US-009507513-1910USA002818: US-009507513-1910USA002328:
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Rash, Rash erythematous
Clinical narrative: Large red hot itchy circular rash appeared 21 hours after initial shot.  Large red 14" x 8" red rash appeared 3 days after shot with blisters appearing.  Blister continued to enlarge at the bottom into one large lesion.  Rash is large, hot red, itchy and almost bruised or burned at the top and  at the bottom (where the blister appeared.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: Large red hot itchy circular rash appeared 21 hours after initial shot.  Large red 14" x 8" red rash appeared 3 days after shot with blisters appearing.  Blister continued to enlarge at the bottom into one large lesion.  Rash is large, hot red, itchy and almost bruised or burned at the top and  at the bottom (where the blister appeared.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Altered state of consciousness, Arthralgia, Chills, Dizziness
Clinical narrative: Patient has muscle aches, nausea, cramps, and metal taste in mouth.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Hyperhidrosis, Malaise, Nausea, Pain
Clinical narrative: Patient has muscle aches, nausea, cramps, and metal taste in mouth.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient has muscle aches, nausea, cramps, and metal taste in mouth.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dysgeusia, Muscle spasms, Myalgia, Nausea
Clinical narrative: Patient has muscle aches, nausea, cramps, and metal taste in mouth.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Fatigue, body aches, headaches, chills, left arm soreness, low grade fever the day after vaccine administration. Symptoms lasted one day
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fatigue, body aches, headaches, chills, left arm soreness, low grade fever the day after vaccine administration. Symptoms lasted one day
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Feeling hot, Pain
Clinical narrative: Temperature of 102, aches and pains, chills lasting from 7 pm through night.  Upon waking, some better but still hot.  Haven't taken temperature yet this morning, but can feel fever.  Aches and pains gone.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site joint pain, Injection site swelling
Clinical narrative: Redness and swelling larger then an inch from injection site, on day three swelling is down to elbow and causing joint pain.  monitor site and take pain meds as needed
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain, Pain in extremity, Skin warm
Clinical narrative: Patient reported pain radiating down to elbow and up to shoulder, was originally warm to the touch. At time of report on 10/4/19 no longer warm, not red, not swollen
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; Inadvertently administered a dose of rotateq, that was delivered late and deemed not viable by the wholesaler; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 20-SEP-2019, the patient was inadvertently vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 1 dosage form via oral route(defaulted route) (lot number S006159 with expiry date of 10-NOV-2010) for prophylaxis, which was delivered late and deemed not viable by the wholesaler (poor quality product administered). No adverse effect was reported. No information regarding temperature, time frame, previous temperature excursion and data logger were provided by the reporter. No product quality complaint was filed by the reporter.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: an improperly stored dose of GARDASIL9 was administered to lhe patient on an unknown date; no adverse effects; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided.      On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # N022952 with an expiration date in 14-JUN-2020), for prophylaxis (strength, dose and route were not provided), that underwent a temperature excursion from 36 degrees Fahrenheit to 32.1 degrees Fahrenheit, during a time frame of 8 hours. Digital data logger was involved, however no previous temperature excursion was reported. No adverse effects.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Improperly stored dose of GARDASIL 9; no adverse effects; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # N022952, expiration date 14-JUN-2020 for prophylaxis (strength, dose, route, anatomical site and frequency were not reported), that had a temperature excursion of 32.1 F for 8 hours which was detected by a data logger. The reporter stated that the vaccine had no previous temperature excursion and that the patient had no adverse effects.
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Malaise
Clinical narrative: patient became sick; This spontaneous report as received from a physician refers to a patient of unknown age. The patient's concurrent conditions included auto-immunity illness. Thepatient's medical history and concomitant medications were not provided.  On an unknown date the patient was vaccinated with an unidentified Merck hpv vaccine (name and lot number not provided). On an unknown date, after the vaccination, the patient became sick.    The outcome of malaise, the action taken with the vaccines and the causality assessment were not provided.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: patient called medical practice reporting a "rash and swelling at the injection site"; patient called medical practice reporting a "rash and swelling at the injection site"; This spontaneous report was received from an office manager, referring to a 43-year-old female patient. The patient's pertinent medical history, concomitant medication, concurrent conditions, previous drug reactions or allergies were unknown by the reporter.  On 25-SEP-2019, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection for immunization, lot # S013490 expiration date not reported but upon internal validation established as 06-MAR-2021 (strength, frequency and route of administration were unknown by the reporter; anatomical injection site was not reported).   Afterwards, on an unspecified date in September 2019, the patient experienced rash and swelling at the injection site (injection site rash and injection site swelling). The patient sought medical attention, and an unspecified physician prescribed antibiotic cream (unspecified) and loratadine (CLARITIN) as treatment. It was unknown by the reporter if any laboratory diagnostics or studies were performed to the patient.   At the time of this report, the outcome of injection site rash and injection site swelling was unknown.  The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events was not provided.
Age: 1.25
Sex: U
Vaccine: MMR, UNK
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: a patient was administered the first dose of MMRII at 12 months old and was administered a second dose of MMRII at 15 months old; No adverse effects were reported; This spontaneous report was received a licensed practical nurse referring to a 15 month old patient of an unknown gender. No information was provided regarding the patient's medical history, current conditions, concomitant medications, drug reactions and allergies.   On an unknown date, at 12 months old, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (dose, route of administration and anatomical injection site were not reported). At 15 months old, the patient received the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (dose, route of administration and anatomical injection site were not reported) (inappropriate schedule of product administration). Both vaccines were reconstituted using an sterile diluent (dose, route of administration, anatomical injection site, lot number and expiration date were not reported). No adverse effects were reported.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; one male infant received improperly stored ROTATEQ; This spontaneous report was received from a physician, referring to a 10 weeks old male patient. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 12-SEP-2019, the patient was vaccinated with an improperly stored dose of  Rotavirus Vaccine, Live, Oral, Pentavalent  (ROTATEQ) orally, lot # R002805, expiration date 23-SEP-2019 , for prophylaxis (strength, dose and frequency were not reported).   The temperature excursion was above 9 Centigrade degrees (°C) (17.4°C) during 24 hours, below 36°F / 2°C (-0.3, multiple) for 11 hours and 17 minutes, 2°C to 8°C (1.6°C) for 2 hours and 52 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. The physician stated that no doses of Rotavirus Vaccine, Live, Oral, Pentavalent  (ROTATEQ) were administered since 12-SEP-2019 through 02-OCT-2019. Expired vaccines were taken out of the formulary.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: persistent strain of herpes zoster/severe herpes zoster; did not prevent shingles as intended; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of an unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2017, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, dose number, route and site of administration, lot# and expiration date were not reported) for routine adult health maintenance and for the prevention of shingles at a physician office. On an unknown date, the vaccine did not prevent shingles as intended and the pt subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date, the pt was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. As a direct and proximate result of  zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving  zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles, the pt suffered painful injuries and damages and required extensive medical care and treatment. As a direct and proximate result of these malfunctions the pt suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result the pt had suffered and would continue to suffer significant medical expenses, and pain and suffering and other damages. The outcome of events was not provided. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Heart rate irregular, Visual impairment
Clinical narrative: chest pains; irregular heartbeat; difficulties with her vision; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, frequency, route, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After injection, the patient suffered chest pains, irregular heartbeat and difficulties with her vision (onset dates unknown). As a result of her symptoms, the patient presented to a medical provider in her state. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), her symptoms had resulted in physical limitations not present prior to using the product. 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), 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 had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.    Chest pains, irregular heartbeat and difficulties with her vision were considered to be disabling.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date in 2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, frequency, route, lot number and expiration date were not reported) by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to her zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider for shingles (onset date unknown). As a direct and proximate result of her use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date in 2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, frequency, route, lot number and expiration date were not reported) at a medical office by a physician for the long-term prevention of shingles and zoster-related conditions. Subsequent to her zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by the physician for shingles (date unknown). As a direct and proximate result of her use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was not reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; A patient was administered 1 dose of improperly stored ROTATEQ; This spontaneous report was received from a nurse concerning a 4 month old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions or drug reactions/allergies.    On 02-OCT-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), 1 dose, orally, lot number R015435, expiration date 17-APR-2020  to prevent rotavirus gastroenteritis (prophylaxis) (product storage error). The administered dose of the vaccine experienced a temperature excursion of 9.1C for 19 minutes, as recorded by a data logger. There was no adverse effect reported.
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Sore Arm; Swollen arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced pain in arm and swelling arm. On an unknown date, the outcome of the pain in arm and swelling arm were unknown.   It was unknown if the reporter considered the pain in arm and swelling arm to be related to Flu vaccine.  Additional information received were as follows: The age at vaccination was not reported. The patient stated she experiences slight sore and swollen arm when received flu shot. For tolerance of Shingrix, refer case US2019146715. This case has been linked with US2019AMR147479, reported by the same reporter.
Age: 55.0
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Decreased appetite, Fatigue, Headache
Clinical narrative: Headache; Tiredness; Upset stomach; No appetite; This case was reported by a consumer and described the occurrence of headache in a 55-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced headache, tiredness, upset stomach and appetite absent. On an unknown date, the outcome of the headache, tiredness, upset stomach and appetite absent were unknown.   It was unknown if the reporter considered the headache, tiredness, upset stomach and appetite absent to be related to Shingrix.  Additional information received were as follows: On Saturday, the patient received Shingrix. The patient experienced headache, tiredness and upset stomach and no appetite. The patient had no elevated temp since the first 48 hours. The patient experienced events beyond 3 days but it appeared for some individuals had experienced side effects a bit longer. The patient appreciate the information and was grateful for this new vaccine and the patient would certainly get the second dose at the appropriate 2 to 6 months window. This case has been linked with US2019AMR173523, reported by the same reporter.