chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: RAB
Symptoms: Allergy to chemicals, Autoimmune disorder, Back pain, Condition aggravated, Fatigue
Clinical narrative: This case was upgraded to serious on 13 March 2015 due to new serious events reported. Initial report received from consumer (the patient) on 18 August 2014. A 62-year-old female patient, whose medical history and concomitant medications were not reported, had received a third dose of IMOVAX (batch number were not reported) intramuscularly in right arm on 05 August 2014. It was reported that an unspecified date the patient received Immunoglobulin for rabies (unknown which product). 06 August 2014 the patient experienced fatigue and muscle pain at injection site in right arm with pain shooting in neck and back. Also had experienced some soreness in left arm. The patient had required ER/doctor visit. The corrective treatments and laboratory investigations were not reported. At the time of this report the outcome of event was unknown. Follow-up information was received for this unsolicited case on 13 March 2015 from a consumer, which upgraded the case to serious. The patient received Rabies vaccine, a "series of 5 shots in arms (same reaction) and two in upper thighs (immunoglobulin)" and experienced increased pain, soreness and lameness. The patient reported that since the vaccine her health has been poor with increased inflammation, increased autoimmune reaction and hypersensitivity to everything (chemicals, food, touch, exercise etc). The date of vaccination on 05 August 2014 was reported as "1st (two out of five)". Pre-existing medical conditions were reported as chemical sensitivities, autoimmune Hashimoto, fibromyalgia, chronic post-Lyme disease, allergy to dyes and preservatives, aluminum, formaldehyde and mercury. The patient was vaccinated at a public health clinic/hospital. It was reported that rabies immunoglobulin was given the same day as "1st two rabies vaccine." It took almost one month to recover from the pain. Since the incident, the patient reported that her immune system has been compromised with increased sympathetic overdrive causing pain, inflammation, chemical sensitivity, skin disorders etc, for the past six months. The patient believed that she was given a standard size needle verses a smaller one and that may have impacted pain. The patient reported that she is thin with very little upper arm fat and should have been given a pediatric needle. The patient's biggest concern is that since she already had an autoimmune disease she believes her central nervous system was disrupted and over stimulated. She experienced a severe sympathetic overdrive and increased sensitivity for six months since the vaccine. She has been housebound for months due to a weakened immune system, increased skin inflammation, increased allergies, increased muscle weakness and increased reactions to common allergies and chemicals. The patient recovered on an unreported date. Documents held by sender: none.
Age: 62.0
Sex: F
Vaccine: RAB
Symptoms: Gait disturbance, General physical health deterioration, Hypersensitivity, Inflammation, Injection site reaction
Clinical narrative: This case was upgraded to serious on 13 March 2015 due to new serious events reported. Initial report received from consumer (the patient) on 18 August 2014. A 62-year-old female patient, whose medical history and concomitant medications were not reported, had received a third dose of IMOVAX (batch number were not reported) intramuscularly in right arm on 05 August 2014. It was reported that an unspecified date the patient received Immunoglobulin for rabies (unknown which product). 06 August 2014 the patient experienced fatigue and muscle pain at injection site in right arm with pain shooting in neck and back. Also had experienced some soreness in left arm. The patient had required ER/doctor visit. The corrective treatments and laboratory investigations were not reported. At the time of this report the outcome of event was unknown. Follow-up information was received for this unsolicited case on 13 March 2015 from a consumer, which upgraded the case to serious. The patient received Rabies vaccine, a "series of 5 shots in arms (same reaction) and two in upper thighs (immunoglobulin)" and experienced increased pain, soreness and lameness. The patient reported that since the vaccine her health has been poor with increased inflammation, increased autoimmune reaction and hypersensitivity to everything (chemicals, food, touch, exercise etc). The date of vaccination on 05 August 2014 was reported as "1st (two out of five)". Pre-existing medical conditions were reported as chemical sensitivities, autoimmune Hashimoto, fibromyalgia, chronic post-Lyme disease, allergy to dyes and preservatives, aluminum, formaldehyde and mercury. The patient was vaccinated at a public health clinic/hospital. It was reported that rabies immunoglobulin was given the same day as "1st two rabies vaccine." It took almost one month to recover from the pain. Since the incident, the patient reported that her immune system has been compromised with increased sympathetic overdrive causing pain, inflammation, chemical sensitivity, skin disorders etc, for the past six months. The patient believed that she was given a standard size needle verses a smaller one and that may have impacted pain. The patient reported that she is thin with very little upper arm fat and should have been given a pediatric needle. The patient's biggest concern is that since she already had an autoimmune disease she believes her central nervous system was disrupted and over stimulated. She experienced a severe sympathetic overdrive and increased sensitivity for six months since the vaccine. She has been housebound for months due to a weakened immune system, increased skin inflammation, increased allergies, increased muscle weakness and increased reactions to common allergies and chemicals. The patient recovered on an unreported date. Documents held by sender: none.
Age: 62.0
Sex: F
Vaccine: RAB
Symptoms: Muscular weakness, Myalgia, Neck pain, Pain, Pain in extremity
Clinical narrative: This case was upgraded to serious on 13 March 2015 due to new serious events reported. Initial report received from consumer (the patient) on 18 August 2014. A 62-year-old female patient, whose medical history and concomitant medications were not reported, had received a third dose of IMOVAX (batch number were not reported) intramuscularly in right arm on 05 August 2014. It was reported that an unspecified date the patient received Immunoglobulin for rabies (unknown which product). 06 August 2014 the patient experienced fatigue and muscle pain at injection site in right arm with pain shooting in neck and back. Also had experienced some soreness in left arm. The patient had required ER/doctor visit. The corrective treatments and laboratory investigations were not reported. At the time of this report the outcome of event was unknown. Follow-up information was received for this unsolicited case on 13 March 2015 from a consumer, which upgraded the case to serious. The patient received Rabies vaccine, a "series of 5 shots in arms (same reaction) and two in upper thighs (immunoglobulin)" and experienced increased pain, soreness and lameness. The patient reported that since the vaccine her health has been poor with increased inflammation, increased autoimmune reaction and hypersensitivity to everything (chemicals, food, touch, exercise etc). The date of vaccination on 05 August 2014 was reported as "1st (two out of five)". Pre-existing medical conditions were reported as chemical sensitivities, autoimmune Hashimoto, fibromyalgia, chronic post-Lyme disease, allergy to dyes and preservatives, aluminum, formaldehyde and mercury. The patient was vaccinated at a public health clinic/hospital. It was reported that rabies immunoglobulin was given the same day as "1st two rabies vaccine." It took almost one month to recover from the pain. Since the incident, the patient reported that her immune system has been compromised with increased sympathetic overdrive causing pain, inflammation, chemical sensitivity, skin disorders etc, for the past six months. The patient believed that she was given a standard size needle verses a smaller one and that may have impacted pain. The patient reported that she is thin with very little upper arm fat and should have been given a pediatric needle. The patient's biggest concern is that since she already had an autoimmune disease she believes her central nervous system was disrupted and over stimulated. She experienced a severe sympathetic overdrive and increased sensitivity for six months since the vaccine. She has been housebound for months due to a weakened immune system, increased skin inflammation, increased allergies, increased muscle weakness and increased reactions to common allergies and chemicals. The patient recovered on an unreported date. Documents held by sender: none.
Age: 62.0
Sex: F
Vaccine: RAB
Symptoms: Skin disorder
Clinical narrative: This case was upgraded to serious on 13 March 2015 due to new serious events reported. Initial report received from consumer (the patient) on 18 August 2014. A 62-year-old female patient, whose medical history and concomitant medications were not reported, had received a third dose of IMOVAX (batch number were not reported) intramuscularly in right arm on 05 August 2014. It was reported that an unspecified date the patient received Immunoglobulin for rabies (unknown which product). 06 August 2014 the patient experienced fatigue and muscle pain at injection site in right arm with pain shooting in neck and back. Also had experienced some soreness in left arm. The patient had required ER/doctor visit. The corrective treatments and laboratory investigations were not reported. At the time of this report the outcome of event was unknown. Follow-up information was received for this unsolicited case on 13 March 2015 from a consumer, which upgraded the case to serious. The patient received Rabies vaccine, a "series of 5 shots in arms (same reaction) and two in upper thighs (immunoglobulin)" and experienced increased pain, soreness and lameness. The patient reported that since the vaccine her health has been poor with increased inflammation, increased autoimmune reaction and hypersensitivity to everything (chemicals, food, touch, exercise etc). The date of vaccination on 05 August 2014 was reported as "1st (two out of five)". Pre-existing medical conditions were reported as chemical sensitivities, autoimmune Hashimoto, fibromyalgia, chronic post-Lyme disease, allergy to dyes and preservatives, aluminum, formaldehyde and mercury. The patient was vaccinated at a public health clinic/hospital. It was reported that rabies immunoglobulin was given the same day as "1st two rabies vaccine." It took almost one month to recover from the pain. Since the incident, the patient reported that her immune system has been compromised with increased sympathetic overdrive causing pain, inflammation, chemical sensitivity, skin disorders etc, for the past six months. The patient believed that she was given a standard size needle verses a smaller one and that may have impacted pain. The patient reported that she is thin with very little upper arm fat and should have been given a pediatric needle. The patient's biggest concern is that since she already had an autoimmune disease she believes her central nervous system was disrupted and over stimulated. She experienced a severe sympathetic overdrive and increased sensitivity for six months since the vaccine. She has been housebound for months due to a weakened immune system, increased skin inflammation, increased allergies, increased muscle weakness and increased reactions to common allergies and chemicals. The patient recovered on an unreported date. Documents held by sender: none.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Joint injury, Mobility decreased, Nerve injury, Neuralgia
Clinical narrative: Initial unsolicited report was received on 09 March 2015 from a consumer from a media report on the internet. The reporter also reported another event which is captured in case number 2015SA031445. A male patient, age and date of birth not reported was vaccinated on an unreported date with Influenza Vaccine, manufacturer, batch, site and route not reported. On an unreported date he suffered from a shoulder injury, had painful nerve damage into his left arm, can't raise his left arm and takes powerful medications. The patient "thought he actually stuck it into my bone." The patient's medical history, concomitant medications and laboratory tests were not reported. The patient outcome is not recovered. No further details were available at the time of this report. Documents held by sender.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Joint injury, Mobility decreased, Nerve injury, Skeletal injury
Clinical narrative: Initial unsolicited report was received on 09 March 2015 from a consumer from a media report on the internet. The reporter also reported another event which is captured in case number 2015SA031445. A male patient, age and date of birth not reported was vaccinated on an unreported date with Influenza Vaccine, manufacturer, batch, site and route not reported. On an unreported date he suffered from a shoulder injury, had painful nerve damage into his left arm, can't raise his left arm and takes powerful medications. The patient "thought he actually stuck it into my bone." The patient's medical history, concomitant medications and laboratory tests were not reported. The patient outcome is not recovered. No further details were available at the time of this report. Documents held by sender.
Age: 30.0
Sex: F
Vaccine: RAB
Symptoms: Back pain, Chills, Constipation, Cough, Diarrhoea
Clinical narrative: Initial unsolicited report received from a healthcare professional on 26 February 2015. It is one of a cluster of three patients who experienced similar events after vaccination with IMOVAX Rabies; the other two cases are captured in 2014SA120847 and 2015SA026062. A 30-year-old female patient, with a history of penicillin allergy and kidney stones, received three doses of IMOVAX Rabies on the following dates as part of an pre-exposure employment requirement: dose 1 (lot number not reported) on 06 March 2014; dose 2 (lot number not reported) on 13 March 2014; and dose 3 (lot number K1057-2) on 27 March 2014. Concomitant medications included AMBIEN and KLONOPIN. On 28 March 2014, i.e. 1 day after her last dose of vaccine, the patient presented to her physician with the following complaints: rash "all over", felt sore skin on trunk area, fever of 101 degrees, cough, runny nose, sneezing, headache, chills, body aches, nausea, and diarrhea. An exam revealed faint papules on the abdomen. Weight was 122 lb, temperature in the office 97.9 F, and blood pressure 116/70 mmHg. She was diagnosed with an allergic reaction, and treated with PHENERGAN and ATARAX. On 31 March 2014 she presented to her physician again with ongoing fatigue, muscle aches, and a sore and stiff neck. She was diagnosed with muscle spasms and treated with SKELAXIN. At a visit 03 April 2014 she reported feeling "a lot better" but still had nausea and muscle aches in the neck. On 11 April 2014 she was again seen by a physician, and at that time complained of blood in the stool, which she attributed to constipation secondary to pain medication. She also complained of a sore throat with sores on her tongue, and low back pain with urinary urgency. An exam revealed mild internal hemorrhoids, and a mildly swollen tongue. Diagnoses at that time included allergic reaction, myalgia, stomatitis, back pain, and rectal bleeding. The physician ordered a screen for strep throat, and a urinalysis; results were not reported. New treatment included Proctocream twice daily to the rectum, and the patient was referred for PT. She was to follow-up in 2 weeks. Outcome was not reported. Of note, the patient was 29 years old when she received doses 1 and 2 of the vaccine; she turned 30 prior to the third dose. Documents held by sender: Doctor visit notes.
Age: 30.0
Sex: F
Vaccine: RAB
Symptoms: Fatigue, Haematochezia, Haemorrhoids, Headache, Hypersensitivity
Clinical narrative: Initial unsolicited report received from a healthcare professional on 26 February 2015. It is one of a cluster of three patients who experienced similar events after vaccination with IMOVAX Rabies; the other two cases are captured in 2014SA120847 and 2015SA026062. A 30-year-old female patient, with a history of penicillin allergy and kidney stones, received three doses of IMOVAX Rabies on the following dates as part of an pre-exposure employment requirement: dose 1 (lot number not reported) on 06 March 2014; dose 2 (lot number not reported) on 13 March 2014; and dose 3 (lot number K1057-2) on 27 March 2014. Concomitant medications included AMBIEN and KLONOPIN. On 28 March 2014, i.e. 1 day after her last dose of vaccine, the patient presented to her physician with the following complaints: rash "all over", felt sore skin on trunk area, fever of 101 degrees, cough, runny nose, sneezing, headache, chills, body aches, nausea, and diarrhea. An exam revealed faint papules on the abdomen. Weight was 122 lb, temperature in the office 97.9 F, and blood pressure 116/70 mmHg. She was diagnosed with an allergic reaction, and treated with PHENERGAN and ATARAX. On 31 March 2014 she presented to her physician again with ongoing fatigue, muscle aches, and a sore and stiff neck. She was diagnosed with muscle spasms and treated with SKELAXIN. At a visit 03 April 2014 she reported feeling "a lot better" but still had nausea and muscle aches in the neck. On 11 April 2014 she was again seen by a physician, and at that time complained of blood in the stool, which she attributed to constipation secondary to pain medication. She also complained of a sore throat with sores on her tongue, and low back pain with urinary urgency. An exam revealed mild internal hemorrhoids, and a mildly swollen tongue. Diagnoses at that time included allergic reaction, myalgia, stomatitis, back pain, and rectal bleeding. The physician ordered a screen for strep throat, and a urinalysis; results were not reported. New treatment included Proctocream twice daily to the rectum, and the patient was referred for PT. She was to follow-up in 2 weeks. Outcome was not reported. Of note, the patient was 29 years old when she received doses 1 and 2 of the vaccine; she turned 30 prior to the third dose. Documents held by sender: Doctor visit notes.
Age: 30.0
Sex: F
Vaccine: RAB
Symptoms: Micturition urgency, Muscle spasms, Musculoskeletal stiffness, Myalgia, Nausea
Clinical narrative: Initial unsolicited report received from a healthcare professional on 26 February 2015. It is one of a cluster of three patients who experienced similar events after vaccination with IMOVAX Rabies; the other two cases are captured in 2014SA120847 and 2015SA026062. A 30-year-old female patient, with a history of penicillin allergy and kidney stones, received three doses of IMOVAX Rabies on the following dates as part of an pre-exposure employment requirement: dose 1 (lot number not reported) on 06 March 2014; dose 2 (lot number not reported) on 13 March 2014; and dose 3 (lot number K1057-2) on 27 March 2014. Concomitant medications included AMBIEN and KLONOPIN. On 28 March 2014, i.e. 1 day after her last dose of vaccine, the patient presented to her physician with the following complaints: rash "all over", felt sore skin on trunk area, fever of 101 degrees, cough, runny nose, sneezing, headache, chills, body aches, nausea, and diarrhea. An exam revealed faint papules on the abdomen. Weight was 122 lb, temperature in the office 97.9 F, and blood pressure 116/70 mmHg. She was diagnosed with an allergic reaction, and treated with PHENERGAN and ATARAX. On 31 March 2014 she presented to her physician again with ongoing fatigue, muscle aches, and a sore and stiff neck. She was diagnosed with muscle spasms and treated with SKELAXIN. At a visit 03 April 2014 she reported feeling "a lot better" but still had nausea and muscle aches in the neck. On 11 April 2014 she was again seen by a physician, and at that time complained of blood in the stool, which she attributed to constipation secondary to pain medication. She also complained of a sore throat with sores on her tongue, and low back pain with urinary urgency. An exam revealed mild internal hemorrhoids, and a mildly swollen tongue. Diagnoses at that time included allergic reaction, myalgia, stomatitis, back pain, and rectal bleeding. The physician ordered a screen for strep throat, and a urinalysis; results were not reported. New treatment included Proctocream twice daily to the rectum, and the patient was referred for PT. She was to follow-up in 2 weeks. Outcome was not reported. Of note, the patient was 29 years old when she received doses 1 and 2 of the vaccine; she turned 30 prior to the third dose. Documents held by sender: Doctor visit notes.
Age: 30.0
Sex: F
Vaccine: RAB
Symptoms: Neck pain, Oropharyngeal pain, Pain, Pain of skin, Papule
Clinical narrative: Initial unsolicited report received from a healthcare professional on 26 February 2015. It is one of a cluster of three patients who experienced similar events after vaccination with IMOVAX Rabies; the other two cases are captured in 2014SA120847 and 2015SA026062. A 30-year-old female patient, with a history of penicillin allergy and kidney stones, received three doses of IMOVAX Rabies on the following dates as part of an pre-exposure employment requirement: dose 1 (lot number not reported) on 06 March 2014; dose 2 (lot number not reported) on 13 March 2014; and dose 3 (lot number K1057-2) on 27 March 2014. Concomitant medications included AMBIEN and KLONOPIN. On 28 March 2014, i.e. 1 day after her last dose of vaccine, the patient presented to her physician with the following complaints: rash "all over", felt sore skin on trunk area, fever of 101 degrees, cough, runny nose, sneezing, headache, chills, body aches, nausea, and diarrhea. An exam revealed faint papules on the abdomen. Weight was 122 lb, temperature in the office 97.9 F, and blood pressure 116/70 mmHg. She was diagnosed with an allergic reaction, and treated with PHENERGAN and ATARAX. On 31 March 2014 she presented to her physician again with ongoing fatigue, muscle aches, and a sore and stiff neck. She was diagnosed with muscle spasms and treated with SKELAXIN. At a visit 03 April 2014 she reported feeling "a lot better" but still had nausea and muscle aches in the neck. On 11 April 2014 she was again seen by a physician, and at that time complained of blood in the stool, which she attributed to constipation secondary to pain medication. She also complained of a sore throat with sores on her tongue, and low back pain with urinary urgency. An exam revealed mild internal hemorrhoids, and a mildly swollen tongue. Diagnoses at that time included allergic reaction, myalgia, stomatitis, back pain, and rectal bleeding. The physician ordered a screen for strep throat, and a urinalysis; results were not reported. New treatment included Proctocream twice daily to the rectum, and the patient was referred for PT. She was to follow-up in 2 weeks. Outcome was not reported. Of note, the patient was 29 years old when she received doses 1 and 2 of the vaccine; she turned 30 prior to the third dose. Documents held by sender: Doctor visit notes.
Age: 30.0
Sex: F
Vaccine: RAB
Symptoms: Pyrexia, Rash generalised, Rectal haemorrhage, Rhinorrhoea, Sneezing
Clinical narrative: Initial unsolicited report received from a healthcare professional on 26 February 2015. It is one of a cluster of three patients who experienced similar events after vaccination with IMOVAX Rabies; the other two cases are captured in 2014SA120847 and 2015SA026062. A 30-year-old female patient, with a history of penicillin allergy and kidney stones, received three doses of IMOVAX Rabies on the following dates as part of an pre-exposure employment requirement: dose 1 (lot number not reported) on 06 March 2014; dose 2 (lot number not reported) on 13 March 2014; and dose 3 (lot number K1057-2) on 27 March 2014. Concomitant medications included AMBIEN and KLONOPIN. On 28 March 2014, i.e. 1 day after her last dose of vaccine, the patient presented to her physician with the following complaints: rash "all over", felt sore skin on trunk area, fever of 101 degrees, cough, runny nose, sneezing, headache, chills, body aches, nausea, and diarrhea. An exam revealed faint papules on the abdomen. Weight was 122 lb, temperature in the office 97.9 F, and blood pressure 116/70 mmHg. She was diagnosed with an allergic reaction, and treated with PHENERGAN and ATARAX. On 31 March 2014 she presented to her physician again with ongoing fatigue, muscle aches, and a sore and stiff neck. She was diagnosed with muscle spasms and treated with SKELAXIN. At a visit 03 April 2014 she reported feeling "a lot better" but still had nausea and muscle aches in the neck. On 11 April 2014 she was again seen by a physician, and at that time complained of blood in the stool, which she attributed to constipation secondary to pain medication. She also complained of a sore throat with sores on her tongue, and low back pain with urinary urgency. An exam revealed mild internal hemorrhoids, and a mildly swollen tongue. Diagnoses at that time included allergic reaction, myalgia, stomatitis, back pain, and rectal bleeding. The physician ordered a screen for strep throat, and a urinalysis; results were not reported. New treatment included Proctocream twice daily to the rectum, and the patient was referred for PT. She was to follow-up in 2 weeks. Outcome was not reported. Of note, the patient was 29 years old when she received doses 1 and 2 of the vaccine; she turned 30 prior to the third dose. Documents held by sender: Doctor visit notes.
Age: 30.0
Sex: F
Vaccine: RAB
Symptoms: Stomatitis, Streptococcus test negative, Swollen tongue, Tongue ulceration, Urine analysis
Clinical narrative: Initial unsolicited report received from a healthcare professional on 26 February 2015. It is one of a cluster of three patients who experienced similar events after vaccination with IMOVAX Rabies; the other two cases are captured in 2014SA120847 and 2015SA026062. A 30-year-old female patient, with a history of penicillin allergy and kidney stones, received three doses of IMOVAX Rabies on the following dates as part of an pre-exposure employment requirement: dose 1 (lot number not reported) on 06 March 2014; dose 2 (lot number not reported) on 13 March 2014; and dose 3 (lot number K1057-2) on 27 March 2014. Concomitant medications included AMBIEN and KLONOPIN. On 28 March 2014, i.e. 1 day after her last dose of vaccine, the patient presented to her physician with the following complaints: rash "all over", felt sore skin on trunk area, fever of 101 degrees, cough, runny nose, sneezing, headache, chills, body aches, nausea, and diarrhea. An exam revealed faint papules on the abdomen. Weight was 122 lb, temperature in the office 97.9 F, and blood pressure 116/70 mmHg. She was diagnosed with an allergic reaction, and treated with PHENERGAN and ATARAX. On 31 March 2014 she presented to her physician again with ongoing fatigue, muscle aches, and a sore and stiff neck. She was diagnosed with muscle spasms and treated with SKELAXIN. At a visit 03 April 2014 she reported feeling "a lot better" but still had nausea and muscle aches in the neck. On 11 April 2014 she was again seen by a physician, and at that time complained of blood in the stool, which she attributed to constipation secondary to pain medication. She also complained of a sore throat with sores on her tongue, and low back pain with urinary urgency. An exam revealed mild internal hemorrhoids, and a mildly swollen tongue. Diagnoses at that time included allergic reaction, myalgia, stomatitis, back pain, and rectal bleeding. The physician ordered a screen for strep throat, and a urinalysis; results were not reported. New treatment included Proctocream twice daily to the rectum, and the patient was referred for PT. She was to follow-up in 2 weeks. Outcome was not reported. Of note, the patient was 29 years old when she received doses 1 and 2 of the vaccine; she turned 30 prior to the third dose. Documents held by sender: Doctor visit notes.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, HEPA
Symptoms: Expired product administered
Clinical narrative: Expired MMRV given to pt.
Age: 39.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Dizziness, Pallor
Clinical narrative: Pt show a fainting look after I gave her FLULAVAL vaccine. Prior to that, I gave her BOOSTRIX vaccine, 5 minutes prior, she start looking pale, so I call for help, and have her sips of water.
Age: 16.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Dizziness, Face injury, Fall, Feeling abnormal, Head injury
Clinical narrative: Patient after receiving vaccination went out to waiting area. Felt lightheaded and passed out. Pt came to a few moments later. Administered 1st aid called EMS and he was taken to Med Center.
Age: 16.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Lip injury, Loss of consciousness, Muscle rigidity
Clinical narrative: Patient after receiving vaccination went out to waiting area. Felt lightheaded and passed out. Pt came to a few moments later. Administered 1st aid called EMS and he was taken to Med Center.
Age: 16.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient after receiving vaccination went out to waiting area. Felt lightheaded and passed out. Pt came to a few moments later. Administered 1st aid called EMS and he was taken to Med Center.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Axillary pain, Infection, Injection site erythema, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report as received from a 65 year old female consumer reporting on herself with allergies to multiple unspecified medications. On 02-MAR-2015, the patient was vaccinated with a dose of PNEUMOVAX23 in the left deltoid, lot # K016294, expiry date 28-APR-2016 (dose and route were not reported). Concomitant therapies included nabumetone. The patient experienced an adverse reaction starting on 03-MAR-2015 as follows: pain under left deltoid (pain in extremity) with 2 pink lines going from injection site and wrapping around the front of her arm and under her armpit (injection site erythema). It was also stated, that the consumer made a physician's appointment on 04-MAR-2015 to look at her arm, was diagnosed with infection, and was prescribed cefadroxil 500 mg capsules as a treatment. The outcome of infection, injection site erythema and pain in extremity was reported as resolved on 08-MAR-2015. Relatedness between the therapy with PNEUMOVAX23 and the events: infection, injection site erythema and pain in extremity was not reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Infection, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a 65 year old female consumer reporting on herself with allergies to multiple unspecified medications. On 02-MAR-2015, the patient was vaccinated with a dose of PNEUMOVAX23 in the left deltoid, lot # K016294, expiry date 28-APR-2016 (dose and route were not reported). Concomitant therapies included nabumetone. The patient experienced an adverse reaction starting on 03-MAR-2015 as follows: pain under left deltoid (pain in extremity) with 2 pink lines going from injection site and wrapping around the front of her arm and under her armpit (injection site erythema). It was also stated, that the consumer made a physician's appointment on 04-MAR-2015 to look at her arm, was diagnosed with infection, and was prescribed cefadroxil 500 mg capsules as a treatment. The outcome of infection, injection site erythema and pain in extremity was reported as resolved on 08-MAR-2015. Relatedness between the therapy with PNEUMOVAX23 and the events: infection, injection site erythema and pain in extremity was not reported. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: (L) arm swelling, redness, onset same day, body aches 2 days later seen at ED Rx with abx and steroid. Continued Prednisone ? serum sickness.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers an unspecified number of patients of unknown age and gender. On an unspecified dates since 21-Feb-2015, the patients were vaccinated with an improperly stored doses of VAQTA (dose, route, lot # and expiration date were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers an unspecified number of patients of unknown age and gender. On an unspecified dates since 21-FEB-2015, the patients were vaccinated with a dose of improperly stored RECOMBIVAX HB (dose, route, lot #, therapy type and expiration date were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a clinical medical assistant referring to patient of unknown age and gender. On 26-JAN-2015 the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX lot K005180, expiration date 10-APR-2016, (dose, frequency, therapy route unspecified). No adverse effects were reported. The outcomes of events reported were unknown. No product complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date in 2015, since 26-FEB-2015, the patients were vaccinated with improperly stored GARDASIL (dose, route, lot number and expiration date were not reported). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 27.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On an unknown dates, the patient was vaccinated with first two doses of GARDASIL. On an unknown date, the patient turned 27 years old. On 16-MAR-2015, the patient presented to the office for third dose of GARDASIL (Inappropriate schedule of drug administration). No adverse effects were reported. No product quality complaint was reported for GARDASIL. Additional information is not expected as the reporter did not wish to contact.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to four unspecified patients of unknown age and gender. On an unknown dates since 21-FEB-2015, the patients were vaccinated with an improperly stored doses of M-M-R II (lot # K005109, expiration date 04-APR-2016, therapy type, dose and route were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Tenderness
Clinical narrative: This spontaneous report as received from a physician via the field employee refers to a female patient of unknown age. No medical history, drug allergies and concurrent conditions were reported. On an unknown date in 2014, the patient was vaccinated with ZOSTAVAX (strength, dose, route and lot number were unspecified). No concomitant medications were reported. Approximately six months ago in September 2014, 2 weeks after received the zoster vaccine live, the patient developed shingles. The patient was tender in an unspecified area for 2 weeks after that. Patient sought medical attention and treatment was given for the event with acyclovir. No product quality complaint (PQC) involved. The outcome of events was reported as recovered on an unspecified date. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling (R) leg increased 13mm to 16.5mm
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Asthenia, Full blood count, Headache, Nausea
Clinical narrative: HA, nausea, feels weak, vomiting, stomach ache, fever up to 100 degrees. Started after she had her GARDASIL shot yesterday 3/11/15.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Vomiting
Clinical narrative: HA, nausea, feels weak, vomiting, stomach ache, fever up to 100 degrees. Started after she had her GARDASIL shot yesterday 3/11/15.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown demographics. The pertinent medical history was not reported. The nurse reported that since an unknown date in February 2015, the patients were vaccinated with PNEUMOVAX 23, intramuscular which underwent a supported temperature excursion. The concomitant medications were not reported. No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza virus test negative, Injection site warmth, Pain, Pyrexia
Clinical narrative: Fever 102F, localized warmth at injection site (without) erythema), body aches.
Age: 38.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse event.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a clinical medical assistant referring to patient of unknown age and gender. On 20-JAN-2015 the patient was vaccinated with improperly stored VARIVAX (Merck) lot K005180, expiration date 10-APR-2016, (dose, frequency, therapy route unspecified). No adverse effects were reported. The outcomes of events reported were unknown. No product quality complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal discomfort, Ageusia, Arthralgia, Diarrhoea, Feeling abnormal
Clinical narrative: Intense stomach distress; pain and diarrhea x 6 days. Intense itching-arms, abdomen, neck, back, legs, headache x 6 days. Joint pain-increased loss of sense of taste-lasting 12 days. Swollen cervical lymph nodes-bilateral-still generally felt awful-fluish x 6 days.
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Headache, Lymphadenopathy, Pain, Pruritus
Clinical narrative: Intense stomach distress; pain and diarrhea x 6 days. Intense itching-arms, abdomen, neck, back, legs, headache x 6 days. Joint pain-increased loss of sense of taste-lasting 12 days. Swollen cervical lymph nodes-bilateral-still generally felt awful-fluish x 6 days.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: Redness on arm, warm when she lays on it. Pt refused to answer report questions. Pt was advised to seek medical attention.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 12-FEB-2015, the patient was vaccinated with an expired dose of M-M-R II (dose 0.5 ml, subcutaneous, lot # J000202, expiration date 09-JAN-2015). No adverse effects were reported. Product quality complain (PQC) was not involved. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Pt noticed tenderness in (R) deltoid 3/19/15 in the AM. He has approx 4x8 in area which is red, warm to touch, swollen and very tender.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Blood culture, Chest X-ray, Fatigue, Full blood count, Headache
Clinical narrative: Fever x now it 13 days. Myalgias, HA, rash, fatigue.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Myalgia, Pyrexia, Rash
Clinical narrative: Fever x now it 13 days. Myalgias, HA, rash, fatigue.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pyrexia, Vomiting, Wheezing
Clinical narrative: Pt came into office 3 days after vaccine administered wheezing. Wheezing subjective fever and vomiting started the evening after the HPV vaccine.
Age: 1.49
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Cough, Pyrexia
Clinical narrative: Fever 102.2 (Ax) started day of vaccine 3/16/15. Slightly barky cough 2 days after vaccine 3/18/15. Tx- ibuprofen PRN fever, push fluids.
Age: 34.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Ultrasound antenatal screen
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 34 year old female patient. The patient's medical history included abortion spontaneous. The patient became pregnant with last menstrual period (LMP) of 24-AUG-2014 and estimated date of conception (EDC) of 06-SEP-2014. On 10-NOV-2014, an ultrasound test was performed and the result was reported as 10-6. On 09-MAR-2015, the patient was vaccinated with first dose of GARDASIL (lot number: K006117 with unknown expiry date). Other suspect therapies included levothyroxine sodium (manufacturer unknown) (strength: 25 microgram, frequency: once a day) for hypothyroidism. Concomitant medications were not reported. Initial exposure to GARDASIL was at 28 weeks. The estimated date of delivery (EDD) was reported as 31-MAY-2015. Action taken with levothyroxine sodium was unknown. The pregnancy outcome was outcome pending. The outcome of exposure during pregnancy was unknown. The causality of the event with suspect therapies was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown demographics. On 17-MAR-2015 the patient was vaccinated with PROQUAD (Merck), that was improperly stored. No adverse effects were reported. Outcome of the event was unknown. No product quality complaint (PQC) was involved. Reporter considered the event to be not relate to PROQUAD (Merck). Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date in 2015, since 26-FEB-2015, the patients were vaccinated with improperly stored PEDVAXHIB (dose, route, lot number and expiration date were not reported). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date in 2015, since 26-FEB-2015, the patients were vaccinated with improperly stored RECOMBIVAXH B oral (dose, lot number and expiration date were not reported). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient given PREVNAR 13 and PREVNAR 13 was given 2/11/15. Patient did not have any reaction.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown demographics. On 16-MAR-2015 the patient was vaccinated with an expired dose of ZOSTAVAX, .65 ml, once, subcutaneous, which expired on 06-MAR-2015. No adverse events were reported. Outcome of the event was unknown. No product quality complaint (PQC) was involved. Reporting pharmacist considered the event to be related to ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date in 2015, since 26-FEB-2015, the patients were vaccinated with improperly stored VAQTA (dose, route, lot number and expiration date were not reported). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Nausea, Pallor, Syncope, Vomiting
Clinical narrative: APN states that pt fainted as soon as vaccine was administered. Pt states she had not eaten all day and denied ever fainting with shots or vaccines and for any other reason. Pale, clammy skin- nausea vomiting.
Age: 61.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Left deltoid is swollen and red, pt advised to use warm compresses, prescribed sulfamethoxazole.
Age: 61.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Laboratory test abnormal
Clinical narrative: Left deltoid is swollen and red, pt advised to use warm compresses, prescribed sulfamethoxazole.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Cough, Wheezing
Clinical narrative: Develop a cough with wheezing hours after receiving vaccine. 3/18 Rx's antibiotics and steroids.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Skin mass
Clinical narrative: Swelling at injection site - no redness. Large knot like formation under skin.
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 52-year-old male patient who received ENGERIX B adult (batch number AHBVC189AA, expiry date 23rd January 2015). On an unknown date, the patient received ENGERIX B adult. On an unknown date, an unknown time after receiving ENGERIX B adult, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information: The office inadvertently administered a dose of ENGERIX-B to an adult that was expired.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: Circular red, itchy, rash on arm of administration. Warm to touch and appears to be decreasing. Advised to use cold packs, antihistamines and pain relievers and report to MD.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient developed raised red area surrounding injection site shortly after administration. Patient has taken BENADRYL to treat. Site is warm to touch and extends from deltoid to about 3 inches above elbow. It persists 6 days after injection but had lightened in color.