chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.02
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: Information has been received from the healthcare worker who reported that on 06-MAY-2014, a 12 month old patient of unspecified gender was vaccinated with a single dose (was exposed to 47 F for 4 hours) reported as 0,5 (units not provided) of MMR II (lot# J003790, expiration date: 28-MAR-2015) (dose number and route were not provided). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: FLUX
Symptoms: Pruritus
Clinical narrative: This case was reported by a consumer (subject) and described the occurrence of itching in a 66 or 67-year-old female subject who was vaccinated with Influenza vaccine (unspecified) (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to neomycin, codeine allergy, nickel allergy and shellfish allergy. On an unspecified date "4 to 5 years ago" in October, the subject received a dose of Influenza vaccine (unspecified) (unknown details, left arm). On an unknown date, less than one month after vaccination with Influenza vaccine (unspecified), the subject experienced itching. The subject stated that "this was the only time she had a reaction to a flu shot." The reporter did consult a healthcare professional regarding the event and that medical attention was not required. The reporter stated that she was "going into doctor's office for another reason and mentioned the reaction to the flu vaccine to her healthcare professional." At the time of reporting the event was resolved. The subject said it resolved in a "couple of weeks".
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site haemorrhage
Clinical narrative: This case was reported by a pharmacist and described the occurrence of bruise injection site in a 53-year-old female subject who was vaccinated with FLUARIX quadrivalent (GlaxoSmithKline). On 10 December 2013 the subject received 1st dose of FLUARIX quadrivalent (unknown, right arm). On 10 December 2013, less than one day after vaccination with FLUARIX quadrivalent, the subject experienced injection site bleeding. On 11 December 2013, one day after vaccination with FLUARIX quadrivalent, the subject experienced bruise injection site, described as bruising "half-dollar size". At the time of reporting the bruise injection site improved; the injection site bleeding resolved on 10 December 2013. The lot number was reported as "5K4TZ" from the reporter; however, based on a safety lot number review, the lot number was updated to 5K4TL.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient with no pertinent medica history or drug reactions/allergies. On 16-JUN-2014 the patient was vaccinated with a dose of ZOSTAVAX lot # J011335, expiration date 13-DEC-2014, 0.65 ml, subcutaneously for preventing shingles. On 17-JUN-2014 the patient developed redness, inflammation, and warm to touch at the injection site after receiving ZOSTAVAX. The injection site was "a little more painful" a "day or two later" after receiving the ZOSTAVAX. The patient also stated that it felt like a "burn wound" at the injection site and that the injection site was red and swollen. The patient said that it felt like there was a "breast under her arm". The patient called and spoke with the pharmacist The outcome of the events was reported as not recovered. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient with no pertinent medica history or drug reactions/allergies. On 16-JUN-2014 the patient was vaccinated with a dose of ZOSTAVAX lot # J011335, expiration date 13-DEC-2014, 0.65 ml, subcutaneously for preventing shingles. On 17-JUN-2014 the patient developed redness, inflammation, and warm to touch at the injection site after receiving ZOSTAVAX. The injection site was "a little more painful" a "day or two later" after receiving the ZOSTAVAX. The patient also stated that it felt like a "burn wound" at the injection site and that the injection site was red and swollen. The patient said that it felt like there was a "breast under her arm". The patient called and spoke with the pharmacist The outcome of the events was reported as not recovered. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Feeling cold, Hypoaesthesia, Paraesthesia, Somnolence
Clinical narrative: This case was reported by a pharmacist (also subject) and described the occurrence of arm numbness in a 43-year-old female subject who was vaccinated with FLUARIX quadrivalent (GlaxoSmithKline). Concurrent medications included SYNTHROID. On 8 January 2014 at 16:00 the subject received a dose of FLUARIX quadrivalent (.5 ml, unknown route, right arm). On 8 January 2014, 15 minutes after vaccination with FLUARIX quadrivalent, the subject experienced arm numbness, tingling in cheek, feeling sleepiness, felt cold and shivering. On 8 January 2014, the events were resolved. The subject reported that she "had to lay down and her symptoms resolved approximately 3 hours after administration" of FLUARIX quadrivalent.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Joint swelling
Clinical narrative: This case was reported by a pharmacy via a pharmacy claims management company and described the occurrence of joint swelling in a female subject of unspecified age who was vaccinated with FLUARIX quadrivalent (GlaxoSmithKline). On 27 November 2013 the subject received a dose of FLUARIX quadrivalent (unknown). On an unspecified date, within months of vaccination with FLUARIX quadrivalent, the subject experienced swelling to her joints. No other information was provided. At the time of reporting the outcome of the joint swelling was unspecified. Follow-up information received on 19 February 2014 via pharmacy who reported the subject was an adult in his 40's. The outcome of the joint swelling was unknown. No other information was provided.
Sex: U
Vaccine: HEPA, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Patient's medical history was not reported. On 24-JUN-2014 the patient was inadvertently vaccinated with VAQTA (strength, dose number, lot# and expiry date unknown) 1 ml, intramuscularly for vaccine prophylaxis that had been improperly stored. No concomitant medications were administered. No adverse effect was reported. The outcome of patient was inadvertently administered VAQTA on 24-JUN-2014 that had been improperly stored and no adverse effect was unknown. No further information provided. Additional information has been requested.
Sex: U
Vaccine: HEPA, HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Patient's medical history was not reported. On 24-JUN-2014 the patient was inadvertently vaccinated with VAQTA (strength, dose number, lot# and expiry date unknown) 1 ml, intramuscularly for vaccine prophylaxis that had been improperly stored. No concomitant medications were administered. No adverse effect was reported. The outcome of patient was inadvertently administered VAQTA on 24-JUN-2014 that had been improperly stored and no adverse effect was unknown. No further information provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and a licensed nurse practitioner refers to a patient of unspecified age and gender. On 17-APR-2014, the patient was vaccinated with a dose of improperly stored PROQUAD (lot # reported as K002999, exp date: 27-AUG-2015, 0.5 milliliters (ml), subcutaneous) (strength and indication not reported). The PROQUAD had been stored at -10 C (celcius) (above recommended temperature range in product information) since July 2013. No adverse effects was reported for the patient. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 92.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: This spontaneous report as received from a consumer reporting on himself: a 92 years old male patient. The patient's medical history included shingles outbreak, from which he recovered approximately in June 2013. He had no concomitant medications and no drug reactions/allergies. On an unspecified date in December 2013 (reported as 6 months ago), 6 months after recovering from shingles outbreak, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously, injection site, lot#, expiration date not reported. On an unspecified date in approximately December 2013 (reported as "3-4 days after getting the vaccine") the patient started experiencing continuous itching sensations in his upper back area across the upper 3rd of his back from side to side. The reported explained that the area was red but did not look like a rash and mildly painful. The patient stated that his adverse effect reaction was much milder than what he had expected with his previous shingles breakout. The patient did not seek medical attention but reportedly was treated with OTC (over the counter) creams that have not been effective and "countless other medicines". No lab diagnostic studies were performed. The outcome of the adverse effects was reported as not recovered/not resolved. Relatedness between use of ZOSTAVAX and the reported adverse effects was unknown Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 22-JUN-2014 the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (strength reported as 2.5/0.5, lot#, dose, route, indication not reported). Concomitant therapy was not reported. No Adverse symptoms were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 23-JUN-2014 the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (strength reported as 2.5/0.5, lot#, dose, route, indication not reported). Concomitant therapy was not reported. No Adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and a licensed nurse practitioner refers to a patient of unspecified age and gender. On 09-APR-2014, the patient was vaccinated with a dose of improperly stored VARIVAX (lot# J003532, expiration date: 25-MAR-2015, 0.5 milliliters (ml), subcutaneous) (strength and indication not reported). The VARIVAX has been stored at -10 C (Celsius) above recommended temperature range in product information) since July 2013. No adverse effects reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and a licensed nurse practitioner refers to a patient of unspecified age and gender. On 07-MAR-2014, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # J002618, exp date: 01-MAR-2015, 0.5 milliliter (ml), subcutaneous) (strength and indication not reported). The (Oka/Merck) VARIVAX had been stored at -10 C (celcius) (above recommended temperature range in product information) since July 2013. No adverse effects reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and a licensed nurse practitioner refers to a patient of unspecified age and gender. On 07-MAR-2014, the patient was vaccinated with a dose of improperly stored VARIVAX (lot# J002618, expiration date: 01-MAR-2015, 0.5 milliliters (ml), subcutaneous) (strength and indication not reported). The VARIVAX has been stored at -10 C (Celsius) above recommended temperature range in product information) since July 2013. No adverse effects reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and a licensed nurse practitioner refers to a patient (patient ID # 2082736) of unspecified age and gender. On 08-AUG-2013, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # J002618, exp date: 01-MAR-2014, 0.5 milliliter (ml) subcutaneous (strength and indication not reported). The (Oka/Merck) VARIVAX had been stored at -10C (acelius) (above recommended temperature range in product information) since July 2013. No adverse effects reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and licensed nurse practitioner refers to a patient (patient ID # 1677710) of unspecified age and gender. On 20-AUG-2013, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # J002618, exp date: 01-MAR-2015, 0.5 milliliter (ml), subcutaneous) (strength and indication not reported). The (Oka/Merck) VARIVAX had been stored at -10 C (celsius) (above recommended temperature range in product information) since July 2013. No adverse effect reported. It was unspecified if the patient sought medication attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and a licensed nurse practitioner refers to a patient  (patient ID # 3479995) of unspecified age and gender. On 15-MAY-2014, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # J002618, exp date: 01-MAR-2015) 0.5 milliliter (ml) subcutaneous (strength and indication not reported). The (Oka/Merck) VARIVAX had been stored at -10C (celsius) (above mentioned temperature range in product information) since July 2013. No adverse effects reported. It was unspecified if the patient sought medical attention. Thi sis one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and a licensed nurse practitioner refers to a patient  (patient ID # 1709295) of unspecified age and gender. On 12-MAY-2013, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # J002618, exp date: 01-MAR-2015) 0.5 milliliter (ml) subcutaneous (strength and indication not reported). The (Oka/Merck) VARIVAX had been stored at -10C (celsius) (above mentioned temperature range in product information) since July 2013. No adverse effects reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and a licensed nurse practitioner refers to a patient  (patient ID # 1650790) of unspecified age and gender. On 07-AUG-2013, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # J002618, exp date: 01-MAR-2015) 0.5 milliliter (ml) subcutaneous (strength and indication not reported). The (Oka/Merck) VARIVAX had been stored at -10C (celsius) (above mentioned temperature range in product information) since July 2013. No adverse effects reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Abnormal behaviour, Blood test, Computerised tomogram, Constipation, Fatigue
Clinical narrative: On Sunday, June 1, he had a fever of about 100.5, but I thought nothing of it.  Gave him over the counter medicine for the fever.  Early morning Monday at 3am he woke up with a fever still and complained that his "legs hurt."  I gave him over the counter medicine for the fever.  Monday morning he slept very late, and woke up without a fever but feeling very tired and not himself.  He started to throw up around 2:30, and had several heaves over the course of a few minutes.  The last heave was a large amount of blood.  I called the pediatrician and they told me to take him to the ER.  He threw up one more time, bloody, on the way to the hospital.  Hospital admitted him and did xray to check for blockage since he had been constipated on Saturday.  He had a high fever.  Blood work showed platelets were low, and doctor said that since his platelets were low he probably tore his esophagus when he threw up which caused the blood.  Tuesday morning he started to develop a rash at the hospital.  The rash spread to his entire body, was circular and blotchy.  He continued to have very high fevers and low platelets at the hospital.  His lymph nodes near his appendix were also enlarged.  Hospital discharged him Friday, June 6 when his platelets started to increase and his fevers were low and controllable.  The hospital tested for many different viruses, and all came back negative.  I told the hospital and his pediatrician that I was researching and found a similar rash on children who had a reaction to the MMR vaccine.  Plus, if this were a virus why did no one else in the family show signs of this virus?  The hospital and pediatrician kept dismissing my thoughts that this was caused to the vaccine, and kept trying to point the cause elsewhere.  Doctor did repeat Parvo virus testing on Monday, June 16 along with CBC.  Repeat Parvo testing again came back negative and the CBC results were finally back to normal.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Feeling abnormal, Full blood count abnormal, Haematemesis, Lymphadenopathy, Oesophageal rupture
Clinical narrative: On Sunday, June 1, he had a fever of about 100.5, but I thought nothing of it.  Gave him over the counter medicine for the fever.  Early morning Monday at 3am he woke up with a fever still and complained that his "legs hurt."  I gave him over the counter medicine for the fever.  Monday morning he slept very late, and woke up without a fever but feeling very tired and not himself.  He started to throw up around 2:30, and had several heaves over the course of a few minutes.  The last heave was a large amount of blood.  I called the pediatrician and they told me to take him to the ER.  He threw up one more time, bloody, on the way to the hospital.  Hospital admitted him and did xray to check for blockage since he had been constipated on Saturday.  He had a high fever.  Blood work showed platelets were low, and doctor said that since his platelets were low he probably tore his esophagus when he threw up which caused the blood.  Tuesday morning he started to develop a rash at the hospital.  The rash spread to his entire body, was circular and blotchy.  He continued to have very high fevers and low platelets at the hospital.  His lymph nodes near his appendix were also enlarged.  Hospital discharged him Friday, June 6 when his platelets started to increase and his fevers were low and controllable.  The hospital tested for many different viruses, and all came back negative.  I told the hospital and his pediatrician that I was researching and found a similar rash on children who had a reaction to the MMR vaccine.  Plus, if this were a virus why did no one else in the family show signs of this virus?  The hospital and pediatrician kept dismissing my thoughts that this was caused to the vaccine, and kept trying to point the cause elsewhere.  Doctor did repeat Parvo virus testing on Monday, June 16 along with CBC.  Repeat Parvo testing again came back negative and the CBC results were finally back to normal.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Pain in extremity, Parvovirus B19 test negative, Platelet count decreased, Pyrexia, Rash generalised
Clinical narrative: On Sunday, June 1, he had a fever of about 100.5, but I thought nothing of it.  Gave him over the counter medicine for the fever.  Early morning Monday at 3am he woke up with a fever still and complained that his "legs hurt."  I gave him over the counter medicine for the fever.  Monday morning he slept very late, and woke up without a fever but feeling very tired and not himself.  He started to throw up around 2:30, and had several heaves over the course of a few minutes.  The last heave was a large amount of blood.  I called the pediatrician and they told me to take him to the ER.  He threw up one more time, bloody, on the way to the hospital.  Hospital admitted him and did xray to check for blockage since he had been constipated on Saturday.  He had a high fever.  Blood work showed platelets were low, and doctor said that since his platelets were low he probably tore his esophagus when he threw up which caused the blood.  Tuesday morning he started to develop a rash at the hospital.  The rash spread to his entire body, was circular and blotchy.  He continued to have very high fevers and low platelets at the hospital.  His lymph nodes near his appendix were also enlarged.  Hospital discharged him Friday, June 6 when his platelets started to increase and his fevers were low and controllable.  The hospital tested for many different viruses, and all came back negative.  I told the hospital and his pediatrician that I was researching and found a similar rash on children who had a reaction to the MMR vaccine.  Plus, if this were a virus why did no one else in the family show signs of this virus?  The hospital and pediatrician kept dismissing my thoughts that this was caused to the vaccine, and kept trying to point the cause elsewhere.  Doctor did repeat Parvo virus testing on Monday, June 16 along with CBC.  Repeat Parvo testing again came back negative and the CBC results were finally back to normal.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Rash macular, Retching, Ultrasound scan, Viral test negative, Vomiting
Clinical narrative: On Sunday, June 1, he had a fever of about 100.5, but I thought nothing of it.  Gave him over the counter medicine for the fever.  Early morning Monday at 3am he woke up with a fever still and complained that his "legs hurt."  I gave him over the counter medicine for the fever.  Monday morning he slept very late, and woke up without a fever but feeling very tired and not himself.  He started to throw up around 2:30, and had several heaves over the course of a few minutes.  The last heave was a large amount of blood.  I called the pediatrician and they told me to take him to the ER.  He threw up one more time, bloody, on the way to the hospital.  Hospital admitted him and did xray to check for blockage since he had been constipated on Saturday.  He had a high fever.  Blood work showed platelets were low, and doctor said that since his platelets were low he probably tore his esophagus when he threw up which caused the blood.  Tuesday morning he started to develop a rash at the hospital.  The rash spread to his entire body, was circular and blotchy.  He continued to have very high fevers and low platelets at the hospital.  His lymph nodes near his appendix were also enlarged.  Hospital discharged him Friday, June 6 when his platelets started to increase and his fevers were low and controllable.  The hospital tested for many different viruses, and all came back negative.  I told the hospital and his pediatrician that I was researching and found a similar rash on children who had a reaction to the MMR vaccine.  Plus, if this were a virus why did no one else in the family show signs of this virus?  The hospital and pediatrician kept dismissing my thoughts that this was caused to the vaccine, and kept trying to point the cause elsewhere.  Doctor did repeat Parvo virus testing on Monday, June 16 along with CBC.  Repeat Parvo testing again came back negative and the CBC results were finally back to normal.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: X-ray
Clinical narrative: On Sunday, June 1, he had a fever of about 100.5, but I thought nothing of it.  Gave him over the counter medicine for the fever.  Early morning Monday at 3am he woke up with a fever still and complained that his "legs hurt."  I gave him over the counter medicine for the fever.  Monday morning he slept very late, and woke up without a fever but feeling very tired and not himself.  He started to throw up around 2:30, and had several heaves over the course of a few minutes.  The last heave was a large amount of blood.  I called the pediatrician and they told me to take him to the ER.  He threw up one more time, bloody, on the way to the hospital.  Hospital admitted him and did xray to check for blockage since he had been constipated on Saturday.  He had a high fever.  Blood work showed platelets were low, and doctor said that since his platelets were low he probably tore his esophagus when he threw up which caused the blood.  Tuesday morning he started to develop a rash at the hospital.  The rash spread to his entire body, was circular and blotchy.  He continued to have very high fevers and low platelets at the hospital.  His lymph nodes near his appendix were also enlarged.  Hospital discharged him Friday, June 6 when his platelets started to increase and his fevers were low and controllable.  The hospital tested for many different viruses, and all came back negative.  I told the hospital and his pediatrician that I was researching and found a similar rash on children who had a reaction to the MMR vaccine.  Plus, if this were a virus why did no one else in the family show signs of this virus?  The hospital and pediatrician kept dismissing my thoughts that this was caused to the vaccine, and kept trying to point the cause elsewhere.  Doctor did repeat Parvo virus testing on Monday, June 16 along with CBC.  Repeat Parvo testing again came back negative and the CBC results were finally back to normal.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Pruritus, Rash erythematous, Skin warm
Clinical narrative: Red worm-like rash radiating from injection site around back of arm and slightly underneath arm about 3-4 inches. Warm and slightly itchy.  Gradually disappeared but took about 10 days.
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Itching and red swollen area at injection site in left back of upper arm.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blister, Ear swelling, Erythema, Inflammation, Lip swelling
Clinical narrative: Spotted rash began on face the morning of 6/20/2014.  Took her to doctors in which she confirmed it seems like the measles rash.  3 swollen lymph nodes in neck.  Next day fever of 100 going up to 101 x 3 days.  Rash became severe all over body by day 2 in which the rash on her face became so inflamed her lips and ears were swollen.  The rash on her face became one big red blister on both cheeks by day 3.  Severe itching for 5 days.  Severe congestion and "cold like symptoms" through the duration.  Rash and fever finally started to subside by day 5.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Lymphadenopathy, Nasopharyngitis, Pruritus, Pyrexia, Rash
Clinical narrative: Spotted rash began on face the morning of 6/20/2014.  Took her to doctors in which she confirmed it seems like the measles rash.  3 swollen lymph nodes in neck.  Next day fever of 100 going up to 101 x 3 days.  Rash became severe all over body by day 2 in which the rash on her face became so inflamed her lips and ears were swollen.  The rash on her face became one big red blister on both cheeks by day 3.  Severe itching for 5 days.  Severe congestion and "cold like symptoms" through the duration.  Rash and fever finally started to subside by day 5.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash generalised, Rash morbilliform, Respiratory tract congestion
Clinical narrative: Spotted rash began on face the morning of 6/20/2014.  Took her to doctors in which she confirmed it seems like the measles rash.  3 swollen lymph nodes in neck.  Next day fever of 100 going up to 101 x 3 days.  Rash became severe all over body by day 2 in which the rash on her face became so inflamed her lips and ears were swollen.  The rash on her face became one big red blister on both cheeks by day 3.  Severe itching for 5 days.  Severe congestion and "cold like symptoms" through the duration.  Rash and fever finally started to subside by day 5.
Age: 45.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Itchy, red, swollen area warm to the touch at injection sight.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Chills, Decreased appetite, Fatigue
Clinical narrative: Aching joints, muscle aches, hot flashes, shivering, migraines, no appetite, weak, tired, continuing thru Friday morning.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Hot flush, Migraine, Myalgia
Clinical narrative: Aching joints, muscle aches, hot flashes, shivering, migraines, no appetite, weak, tired, continuing thru Friday morning.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Abnormal behaviour, Dizziness, Mental impairment
Clinical narrative: Per Mother: Dizziness, Behavioral Changes (Giggling, Laughing), inability to comprehend basic math function.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Blister, Herpes zoster, Pain
Clinical narrative: Outbreak of shingles.  Blisters on right side of torso, tremendous pain, went to our gent care and given Valtrex, which did not relieve symptons.  Subside over next eight weeks.  Three recurrences since. Not as severe as first outbreak.
Age: 68.0
Sex: M
Vaccine: HEPA
Symptoms: Asthenia, Decreased appetite, Dizziness, Somnolence, Vertigo
Clinical narrative: Dizziness, vertigo, loss of appitite, drowsiness, weakness.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Pruritus
Clinical narrative: Onset of itching 24 hours after varicella immunization, redness, inflammation, swelling at injection site next day. Patient provided with antibiotics.
Age: 33.0
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea, Headache, Nausea, Vomiting
Clinical narrative: Pt had nausea, vomit x2, diarrhea x2 and headache (HA) but went away after vomit.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site vesicles
Clinical narrative: After shingles vaccine got a rash with blisters and pain in arm where injection was given. Took vaccine at pharmacy.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Arrhythmia, Arteriogram coronary normal, Blood pressure, Blood pressure abnormal, Blood pressure increased
Clinical narrative: This case was reported by a consumer (patient) via a program and described the occurrence of elevated blood pressure in a currently 65-year-old female patient who received generic carvedilol for hypertension. A physician or other health care professional has not verified this report. The subject's medical history included appendectomy, coronary angiography, deep vein thrombosis, hospitalization for chest pain, malignant hypertension, migraine headache, Prinzmetal's angina, protein S deficiency, pulmonary embolism, stent, subtotal hysterectomy and transient ischemic attack. Concurrent medical conditions included allergy to TALWIN, chronic back pain, codeine allergy, coronary artery disease, degenerative disc disease, dyslipidemia, fibromyalgia, hypercholesterolemia, hypercoagulability, hypertension, peripheral arterial occlusive disease and peripheral vascular disease. Co-suspect vaccination included influenza vaccine. Co-suspect medication included COREG CR and ketorolac tromethamine. Concurrent medications included clonidine, CYMBALTA, EPIPEN, FUROSEMIDE; LIPITOR, minoxidil, MS CONTIN, NEXIUM, nitroglycerin, NITROSTAT, PHENERGAN, potassium, warfarin and ZANAFLEX. On an unknown date, the patient started generic carvedilol (unknown) (unknown manufacturer), unknown dosing. At an unknown time after starting carvedilol, the patient experienced elevated blood pressure, lack of effect, chronic headaches, concussion and hit head in fall. The patient reported that "generic COREG does not control my blood pressure/hypertension" and she is unable to take it as her blood pressure stays above 140/90. The patient also stated COREG (brand name) works for her as she is intolerant to many blood pressure medications. Since her last physician's visit the patient's blood pressure has been "slightly elevated" and the patient feels it is because she had a chronic headache caused by a concussion that occurred after a fall in which she hit her head on an end table. The patient denied any symptoms associated with elevated blood pressure. On an unknown date the patient started treatment with ketorolac trometamol (unknown), unknown dosing. The patient reported experiencing arrhythmia, bradycardia and dyspnea from ketorolac trometamol. The patient also reported receiving the flu vaccine (unknown) on an unspecified date and experienced rash and throat pain. Details regarding the vaccination and events were provided. At the time of reporting, the outcome of the events was unknown.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Bradycardia, Cardiac enzymes normal, Computerised tomogram thorax normal, Concussion, Dyspnoea
Clinical narrative: This case was reported by a consumer (patient) via a program and described the occurrence of elevated blood pressure in a currently 65-year-old female patient who received generic carvedilol for hypertension. A physician or other health care professional has not verified this report. The subject's medical history included appendectomy, coronary angiography, deep vein thrombosis, hospitalization for chest pain, malignant hypertension, migraine headache, Prinzmetal's angina, protein S deficiency, pulmonary embolism, stent, subtotal hysterectomy and transient ischemic attack. Concurrent medical conditions included allergy to TALWIN, chronic back pain, codeine allergy, coronary artery disease, degenerative disc disease, dyslipidemia, fibromyalgia, hypercholesterolemia, hypercoagulability, hypertension, peripheral arterial occlusive disease and peripheral vascular disease. Co-suspect vaccination included influenza vaccine. Co-suspect medication included COREG CR and ketorolac tromethamine. Concurrent medications included clonidine, CYMBALTA, EPIPEN, FUROSEMIDE; LIPITOR, minoxidil, MS CONTIN, NEXIUM, nitroglycerin, NITROSTAT, PHENERGAN, potassium, warfarin and ZANAFLEX. On an unknown date, the patient started generic carvedilol (unknown) (unknown manufacturer), unknown dosing. At an unknown time after starting carvedilol, the patient experienced elevated blood pressure, lack of effect, chronic headaches, concussion and hit head in fall. The patient reported that "generic COREG does not control my blood pressure/hypertension" and she is unable to take it as her blood pressure stays above 140/90. The patient also stated COREG (brand name) works for her as she is intolerant to many blood pressure medications. Since her last physician's visit the patient's blood pressure has been "slightly elevated" and the patient feels it is because she had a chronic headache caused by a concussion that occurred after a fall in which she hit her head on an end table. The patient denied any symptoms associated with elevated blood pressure. On an unknown date the patient started treatment with ketorolac trometamol (unknown), unknown dosing. The patient reported experiencing arrhythmia, bradycardia and dyspnea from ketorolac trometamol. The patient also reported receiving the flu vaccine (unknown) on an unspecified date and experienced rash and throat pain. Details regarding the vaccination and events were provided. At the time of reporting, the outcome of the events was unknown.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Echocardiogram, Echocardiogram normal, Fall, Headache, Oropharyngeal pain
Clinical narrative: This case was reported by a consumer (patient) via a program and described the occurrence of elevated blood pressure in a currently 65-year-old female patient who received generic carvedilol for hypertension. A physician or other health care professional has not verified this report. The subject's medical history included appendectomy, coronary angiography, deep vein thrombosis, hospitalization for chest pain, malignant hypertension, migraine headache, Prinzmetal's angina, protein S deficiency, pulmonary embolism, stent, subtotal hysterectomy and transient ischemic attack. Concurrent medical conditions included allergy to TALWIN, chronic back pain, codeine allergy, coronary artery disease, degenerative disc disease, dyslipidemia, fibromyalgia, hypercholesterolemia, hypercoagulability, hypertension, peripheral arterial occlusive disease and peripheral vascular disease. Co-suspect vaccination included influenza vaccine. Co-suspect medication included COREG CR and ketorolac tromethamine. Concurrent medications included clonidine, CYMBALTA, EPIPEN, FUROSEMIDE; LIPITOR, minoxidil, MS CONTIN, NEXIUM, nitroglycerin, NITROSTAT, PHENERGAN, potassium, warfarin and ZANAFLEX. On an unknown date, the patient started generic carvedilol (unknown) (unknown manufacturer), unknown dosing. At an unknown time after starting carvedilol, the patient experienced elevated blood pressure, lack of effect, chronic headaches, concussion and hit head in fall. The patient reported that "generic COREG does not control my blood pressure/hypertension" and she is unable to take it as her blood pressure stays above 140/90. The patient also stated COREG (brand name) works for her as she is intolerant to many blood pressure medications. Since her last physician's visit the patient's blood pressure has been "slightly elevated" and the patient feels it is because she had a chronic headache caused by a concussion that occurred after a fall in which she hit her head on an end table. The patient denied any symptoms associated with elevated blood pressure. On an unknown date the patient started treatment with ketorolac trometamol (unknown), unknown dosing. The patient reported experiencing arrhythmia, bradycardia and dyspnea from ketorolac trometamol. The patient also reported receiving the flu vaccine (unknown) on an unspecified date and experienced rash and throat pain. Details regarding the vaccination and events were provided. At the time of reporting, the outcome of the events was unknown.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: This case was reported by a consumer (patient) via a program and described the occurrence of elevated blood pressure in a currently 65-year-old female patient who received generic carvedilol for hypertension. A physician or other health care professional has not verified this report. The subject's medical history included appendectomy, coronary angiography, deep vein thrombosis, hospitalization for chest pain, malignant hypertension, migraine headache, Prinzmetal's angina, protein S deficiency, pulmonary embolism, stent, subtotal hysterectomy and transient ischemic attack. Concurrent medical conditions included allergy to TALWIN, chronic back pain, codeine allergy, coronary artery disease, degenerative disc disease, dyslipidemia, fibromyalgia, hypercholesterolemia, hypercoagulability, hypertension, peripheral arterial occlusive disease and peripheral vascular disease. Co-suspect vaccination included influenza vaccine. Co-suspect medication included COREG CR and ketorolac tromethamine. Concurrent medications included clonidine, CYMBALTA, EPIPEN, FUROSEMIDE; LIPITOR, minoxidil, MS CONTIN, NEXIUM, nitroglycerin, NITROSTAT, PHENERGAN, potassium, warfarin and ZANAFLEX. On an unknown date, the patient started generic carvedilol (unknown) (unknown manufacturer), unknown dosing. At an unknown time after starting carvedilol, the patient experienced elevated blood pressure, lack of effect, chronic headaches, concussion and hit head in fall. The patient reported that "generic COREG does not control my blood pressure/hypertension" and she is unable to take it as her blood pressure stays above 140/90. The patient also stated COREG (brand name) works for her as she is intolerant to many blood pressure medications. Since her last physician's visit the patient's blood pressure has been "slightly elevated" and the patient feels it is because she had a chronic headache caused by a concussion that occurred after a fall in which she hit her head on an end table. The patient denied any symptoms associated with elevated blood pressure. On an unknown date the patient started treatment with ketorolac trometamol (unknown), unknown dosing. The patient reported experiencing arrhythmia, bradycardia and dyspnea from ketorolac trometamol. The patient also reported receiving the flu vaccine (unknown) on an unspecified date and experienced rash and throat pain. Details regarding the vaccination and events were provided. At the time of reporting, the outcome of the events was unknown.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This case was reported by a consumer and described the occurrence of influenza in a male subject aged between 30 and 39 years old who was vaccinated with influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to pet dander, dust mites allergy, gluten intolerance, grass allergy, lactose intolerance, latex allergy, migraine, penicillin allergy, pollen allergy, seasonal allergy, soy intolerance and tree allergy. Historic vaccination included tetanus vaccine (non-gsk); non-GSK manufacturer; unknown given in 2008. On an unspecified date in 2009 the subject received a dose of influenza vaccine unspecified (unknown). In 2009, 2 days after vaccination with influenza vaccine unspecified, the subject experienced influenza. The subject reported at least five years ago (2009) he got a flu vaccine and two days later he had the flu. He stated the flu vaccine gave him the flu (flu vaccine and manufacturer were unknown). At the time of reporting the outcome of the event was unspecified. The subject experienced adverse events with BOOSTRIX vaccine, for that case please see A1062563A and with HepB vaccine, for that case please see A1062563B.
Sex: M
Vaccine: FLU3
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a pharmacist via a pharmacy via a pharmacy claims management company and described the occurrence of adverse reaction in a male subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On 2 December 2013 the subject received a dose of FLUARIX (unknown details). On 2 December 2013, less than one month after vaccination with FLUARIX, the subject experienced adverse reaction. At the time of reporting the outcome of the event was unspecified.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a consumer via sales representative and described the occurrence of vaccination failure in a female subject aged between 30 and 39 years old who was vaccinated with FLUARIX (manufacturer unspecified). A physician or other health care professional has not verified this report.  On an unspecified date the subject received a dose of influenza vaccine (unknown details). The specified date of vaccination was not reported; however, based on the date of the report, it was assumed that the vaccination was of the current influenza season. On 18 January 2014, less than one year after vaccination with influenza vaccine, the subject experienced vaccination failure and influenza infection. The subject wished to remain anonymous. At the time of reporting the outcome of the events were unspecified.
Sex: F
Vaccine: FLU3
Symptoms: Injection site nodule
Clinical narrative: This case was reported by a healthcare professional (nurse and co-worker to subject) and described the occurrence of nodule injection site in a female subject of unspecified age who was vaccinated with influenza vaccine (GlaxoSmithKline). On an unspecified date the subject received a dose of influenza vaccine unspecified (unknown details). The reporter stated that the subject received "a GSK flu vaccination given several years ago." At an unspecified time after vaccination with influenza vaccine unspecified, the subject experienced nodule injection site (described as "a severe apple sized reaction"). The reporter refused to provide additional details regarding the event at the time of reporting. It was unclear from the report what location on the body the "apple sized reaction" occurred or where the vaccination was administered. At the time of reporting the outcome of the event was unspecified.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via sales representative and described the occurrence of adverse reaction in a currently 38-year-old female subject who was vaccinated with influenza vaccine (unspecified) (manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date the subject received a dose of influenza vaccine (unspecified) (unknown details). At an unspecified time after vaccination with influenza vaccine (unspecified), the subject experienced adverse reaction. Per the reporter, she "had an adverse reaction to the flu vaccine years ago." No other details were provided. At the time of reporting the outcome of the event was unspecified.
Sex: M
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: This case was reported by a consumer and described the occurrence of reaction to vaccination in a male subject of unspecified age who was vaccinated with influenza vaccine, (manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of influenza vaccine (unspecified) (unknown details). At an unspecified time after vaccination with influenza vaccine (unspecified), the subject experienced reaction to vaccination (described as "caused me damage"). The subject reported that the "flu shot caused me damage." No further details were provided. At the time of reporting the outcome of the event was unspecified.