chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to 18-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 30-MAY-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # N005274 and expiration date 03-APR-2018; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 25-APR-2017 until 07-SEP-2017, the vaccine was exposed to various temperature excursions ranging from 32 degrees Fahrenheit (F) to 54F for the period of up to 70 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter.; Sender's Comments: US-009507513-1709USA012768:
Age: 7.0
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to 7-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 03-JUN-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # N005274 and expiration date 03-APR-2018; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 25-APR-2017 until 07-SEP-2017, the vaccine was exposed to various temperature excursions ranging from 32 degrees Fahrenheit (F) to 54F for the period of up to 70 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter.; Sender's Comments: US-009507513-1709USA012768:
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 14-year-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 17-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M043731, expiration date 22-JUN-2019 (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 11-year-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 23-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M043731, expiration date 22-JUN-2019 (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32 degrees Fahrenheit (F) and the higher was 54 (F) for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to an 14 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 17-JUL-2017, the patient was vaccinated with an improperly stored GARDASIL 9 lot # M043731, expiry date 22-JUN-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 11-year-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 21-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M043731, expiration date 22-JUN-2019 (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 17-year-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 23-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M043731, expiration date 22-JUN-2019 (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to an 12 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 12-JUL-2017, the patient was vaccinated with an improperly stored GARDASIL 9 lot # M043731, expiry date 22-JUN-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to an 13 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 18-JUL-2017, the patient was vaccinated with an improperly stored GARDASIL 9 lot # M043731, expiry date 22-JUN-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766.
Sex: F
Vaccine: HEP, HEPA, PPV
Symptoms: Chemotherapy, Liver transplant, Lymphoma
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 70 year old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient completed series of vaccinations with PNEUMOVAX23, VAQTA and RECOMBIVAX HB (dose, concentration, route of administration, lot# and expiration date were not reported for any of the vaccines). On an unknown date in 2002 (reported as 15 years ago), the patient received a liver transplant. On an unknown date, the patient was diagnosed with lymphoma and was treated with an unspecified chemotherapy regimen for an unspecified duration by an unspecified physician. The outcome of liver transplant and lymphoma was reported as recovered (dates of recovery not specified). The causality assessment was not provided. Upon internal review, the events of lymphoma and liver transplant were considered to be medically significant.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site abscess, Injection site cellulitis, Injection site induration, Injection site mass, Rash
Clinical narrative: This is a spontaneous report from a contactable other Healthcare professional (physician assistant) via a Pfizer sales representative. A 64-year-old female patient received on 23Oct2017 PREVNAR 13 at 0.5 ml single in the left arm as routine vaccination. Medical history included diabetes, hypothyroid, gout, hypertension and hyperlipidemia, all ongoing. Concomitant medications included allopurinol, bumetanide, clonidine, levothyroxine, losartan, lovastatin, metformin, metoprolol, pantoprazole and venlafaxine, all ongoing. In Oct2017 the patient experienced cellulitis and abscess with outcome of recovering. Course of the event was reported as follows: Patient received the injection at a local pharmacy. She went to the ER on 26Oct2017, 3 days after the injection and it was found she had left upper arm cellulitis and an abscess. Treatment included oral clindamycin. Then, on 06Nov2017, patient was seen again by primary physician and at that time cellulitis and abscess have improved. It was also noticed that the patient had a pretty hard lump on the left upper arm. On 06Nov2017 patient was visited because she developed a rash under breast, inguinal folds and under her left arm, possible due to clindamycin. She was started on MEDROL for the rash. Sender's Comments: A possible contributory role of the suspect product cannot be excluded for the reported events cellulitis and abscess as it is possible to be from injection. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Age: 44.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site urticaria, Pain in extremity
Clinical narrative: Red hives on left upper arm, treated with benadryl through 11/13/17 more soreness in arm than in past.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Haemorrhage, Hypoaesthesia, Immediate post-injection reaction, Injection site induration
Clinical narrative: Bleeding immediately following flu shot. Visible bruising for 2 weeks. Firm area noted in right deltoid for 4.5 weeks. Soreness/pain in right arm/shoulder s/p shot and persisted for 5 weeks. Numbness & tingling developed 3.5 weeks after shot and persists in thumb as of now. Sought massage and chiro care to help with pain and numbness/tingling.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Musculoskeletal pain, Paraesthesia
Clinical narrative: Bleeding immediately following flu shot. Visible bruising for 2 weeks. Firm area noted in right deltoid for 4.5 weeks. Soreness/pain in right arm/shoulder s/p shot and persisted for 5 weeks. Numbness & tingling developed 3.5 weeks after shot and persists in thumb as of now. Sought massage and chiro care to help with pain and numbness/tingling.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Immunisation, Incorrect route of drug administration, No adverse event
Clinical narrative: ROTAVIRUS IMMUNIZATION WAS GIVEN INTRAMUSCULAR BY STAFF AND SHOULD HAVE BEEN GIVEN ORALLY. PATIENT WAS BROUGHT BACK TO CLINIC AND GIVEN DOSE ORALLY AS WELL AS INJECTION SITE OBSERVED BY M.D. NO ADVERSE REACTION WAS SEEN. PATIENT RETURNED TO CLINIC AFTER 7 DAYS FOR INSPECTION OF INJECTION SITE. NO ADVERSE REACTION NOTED.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Arrhythmia, Asthenia, Dizziness, Dyspnoea, Malaise
Clinical narrative: Patient was driving from our clinic up into another state. While he was driving, he began to experience shortness of breath, malaise, lightheadedness, tachycardia, weakness, vision changes, and drowsiness. Patient pulled his car over to the side of the road and called 911. Patient was transported to Hospital ER, where he was stabilized. He was then transferred to another Medical Center, where he was hospitalized for 2 days. Patient states that he was found to have cardiac arrhythmias while inpatient.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Somnolence, Tachycardia, Visual impairment
Clinical narrative: Patient was driving from our clinic up into another state. While he was driving, he began to experience shortness of breath, malaise, lightheadedness, tachycardia, weakness, vision changes, and drowsiness. Patient pulled his car over to the side of the road and called 911. Patient was transported to Hospital ER, where he was stabilized. He was then transferred to another Medical Center, where he was hospitalized for 2 days. Patient states that he was found to have cardiac arrhythmias while inpatient.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: I don't know which vaccine was given at pharmacy. You will need to follow up with them. Chills started around 3 AM accompanied by nausea. Vomiting occurred around 5 AM. Fever spiked at 102 and broke 24 hours later. I am still achy but recovering.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out after vaccine.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out shortly after vaccine.
Age: 59.0
Sex: F
Vaccine: TD
Symptoms: Back pain, Biopsy skin normal, Burning sensation, Chills, Decreased appetite
Clinical narrative: Received a TDAP vaccination on 9/11/2017 and been fighting bad side effects ever since. Beginning on 9/13/2017 - low-grade fever (about 99.5-101 F), severe uncontrollable shaking and shivering of entire body (even when not cold), severe mid-to-lower back pain, extreme tinnitus in left ear and itchy neuralgia in and around left eye, weight loss (7 pounds in one week), fast heart rate (95-110), severe headache and extreme fatigue. Went to emergency room, allergy and asthma and primary doctor but to no avail. Symptoms continued to worsen and on 9/28/2017, also developed burning rash on upper back and neck. Was in so much pain and discomfort from back pain. rash and "sick feeling" that I could not sleep even with pain medicine. Since mid-October shaking and heart rate have subsided but continue to experience intermittent low-grade fever, chronic severe back pain, intermittent rashes, hives and EXTREMELY itchy below waistline, chronic fatigue, headaches and lack of appetite. These are the exact same symptoms that I have experienced after the flu shot the past three years (2014-2016) including development of burning rash after about 2 weeks. At the time (2014-2016), my rash was (in hindsight) erroneously diagnosed as Shingles so everything subsequent was blamed on that. However, when rash kept reoccurring for several months, my dermatologist did a biopsy that ruled out a viral origin (as well as bacterial and other). Exact cause was never diagnosed and rash eventually subsided in about May/ June of each year but then reappeared (along with all other symptoms) after receiving subsequent annual flu and then TDAP vaccinations in the Fall of subsequent year(s). If this replicates the previous three years, I will continue to be "sick" with above referenced symptoms for 5-6 months. As my health records will indicate, I've been in and out of Emergency Rooms and Urgent Care centers for several months following each vaccination. Had to figure this out on my own ... and through the help of a local television news station featuring other patients who also had problems following vaccinations. I am very, very concerned about these vaccinations and permanent damage to my body. Would very much like a response from FDA on what type of doctor I should see to resolve these concerns. Not getting anywhere with primary Internist. I've been told that I technically don't have any "allergies" but rather, an intolerance and that there are no doctors for intolerances so left on my own to manage. Please contact me with recommendation for what type of doctor to see. Thank you!
Age: 59.0
Sex: F
Vaccine: TD
Symptoms: Discomfort, Fatigue, Headache, Heart rate increased, Insomnia
Clinical narrative: Received a TDAP vaccination on 9/11/2017 and been fighting bad side effects ever since. Beginning on 9/13/2017 - low-grade fever (about 99.5-101 F), severe uncontrollable shaking and shivering of entire body (even when not cold), severe mid-to-lower back pain, extreme tinnitus in left ear and itchy neuralgia in and around left eye, weight loss (7 pounds in one week), fast heart rate (95-110), severe headache and extreme fatigue. Went to emergency room, allergy and asthma and primary doctor but to no avail. Symptoms continued to worsen and on 9/28/2017, also developed burning rash on upper back and neck. Was in so much pain and discomfort from back pain. rash and "sick feeling" that I could not sleep even with pain medicine. Since mid-October shaking and heart rate have subsided but continue to experience intermittent low-grade fever, chronic severe back pain, intermittent rashes, hives and EXTREMELY itchy below waistline, chronic fatigue, headaches and lack of appetite. These are the exact same symptoms that I have experienced after the flu shot the past three years (2014-2016) including development of burning rash after about 2 weeks. At the time (2014-2016), my rash was (in hindsight) erroneously diagnosed as Shingles so everything subsequent was blamed on that. However, when rash kept reoccurring for several months, my dermatologist did a biopsy that ruled out a viral origin (as well as bacterial and other). Exact cause was never diagnosed and rash eventually subsided in about May/ June of each year but then reappeared (along with all other symptoms) after receiving subsequent annual flu and then TDAP vaccinations in the Fall of subsequent year(s). If this replicates the previous three years, I will continue to be "sick" with above referenced symptoms for 5-6 months. As my health records will indicate, I've been in and out of Emergency Rooms and Urgent Care centers for several months following each vaccination. Had to figure this out on my own ... and through the help of a local television news station featuring other patients who also had problems following vaccinations. I am very, very concerned about these vaccinations and permanent damage to my body. Would very much like a response from FDA on what type of doctor I should see to resolve these concerns. Not getting anywhere with primary Internist. I've been told that I technically don't have any "allergies" but rather, an intolerance and that there are no doctors for intolerances so left on my own to manage. Please contact me with recommendation for what type of doctor to see. Thank you!
Age: 59.0
Sex: F
Vaccine: TD
Symptoms: Laboratory test normal, Malaise, Metabolic function test normal, Neuralgia, Pain
Clinical narrative: Received a TDAP vaccination on 9/11/2017 and been fighting bad side effects ever since. Beginning on 9/13/2017 - low-grade fever (about 99.5-101 F), severe uncontrollable shaking and shivering of entire body (even when not cold), severe mid-to-lower back pain, extreme tinnitus in left ear and itchy neuralgia in and around left eye, weight loss (7 pounds in one week), fast heart rate (95-110), severe headache and extreme fatigue. Went to emergency room, allergy and asthma and primary doctor but to no avail. Symptoms continued to worsen and on 9/28/2017, also developed burning rash on upper back and neck. Was in so much pain and discomfort from back pain. rash and "sick feeling" that I could not sleep even with pain medicine. Since mid-October shaking and heart rate have subsided but continue to experience intermittent low-grade fever, chronic severe back pain, intermittent rashes, hives and EXTREMELY itchy below waistline, chronic fatigue, headaches and lack of appetite. These are the exact same symptoms that I have experienced after the flu shot the past three years (2014-2016) including development of burning rash after about 2 weeks. At the time (2014-2016), my rash was (in hindsight) erroneously diagnosed as Shingles so everything subsequent was blamed on that. However, when rash kept reoccurring for several months, my dermatologist did a biopsy that ruled out a viral origin (as well as bacterial and other). Exact cause was never diagnosed and rash eventually subsided in about May/ June of each year but then reappeared (along with all other symptoms) after receiving subsequent annual flu and then TDAP vaccinations in the Fall of subsequent year(s). If this replicates the previous three years, I will continue to be "sick" with above referenced symptoms for 5-6 months. As my health records will indicate, I've been in and out of Emergency Rooms and Urgent Care centers for several months following each vaccination. Had to figure this out on my own ... and through the help of a local television news station featuring other patients who also had problems following vaccinations. I am very, very concerned about these vaccinations and permanent damage to my body. Would very much like a response from FDA on what type of doctor I should see to resolve these concerns. Not getting anywhere with primary Internist. I've been told that I technically don't have any "allergies" but rather, an intolerance and that there are no doctors for intolerances so left on my own to manage. Please contact me with recommendation for what type of doctor to see. Thank you!
Age: 59.0
Sex: F
Vaccine: TD
Symptoms: Pruritus, Pyrexia, Rash, Skin burning sensation, Tinnitus
Clinical narrative: Received a TDAP vaccination on 9/11/2017 and been fighting bad side effects ever since. Beginning on 9/13/2017 - low-grade fever (about 99.5-101 F), severe uncontrollable shaking and shivering of entire body (even when not cold), severe mid-to-lower back pain, extreme tinnitus in left ear and itchy neuralgia in and around left eye, weight loss (7 pounds in one week), fast heart rate (95-110), severe headache and extreme fatigue. Went to emergency room, allergy and asthma and primary doctor but to no avail. Symptoms continued to worsen and on 9/28/2017, also developed burning rash on upper back and neck. Was in so much pain and discomfort from back pain. rash and "sick feeling" that I could not sleep even with pain medicine. Since mid-October shaking and heart rate have subsided but continue to experience intermittent low-grade fever, chronic severe back pain, intermittent rashes, hives and EXTREMELY itchy below waistline, chronic fatigue, headaches and lack of appetite. These are the exact same symptoms that I have experienced after the flu shot the past three years (2014-2016) including development of burning rash after about 2 weeks. At the time (2014-2016), my rash was (in hindsight) erroneously diagnosed as Shingles so everything subsequent was blamed on that. However, when rash kept reoccurring for several months, my dermatologist did a biopsy that ruled out a viral origin (as well as bacterial and other). Exact cause was never diagnosed and rash eventually subsided in about May/ June of each year but then reappeared (along with all other symptoms) after receiving subsequent annual flu and then TDAP vaccinations in the Fall of subsequent year(s). If this replicates the previous three years, I will continue to be "sick" with above referenced symptoms for 5-6 months. As my health records will indicate, I've been in and out of Emergency Rooms and Urgent Care centers for several months following each vaccination. Had to figure this out on my own ... and through the help of a local television news station featuring other patients who also had problems following vaccinations. I am very, very concerned about these vaccinations and permanent damage to my body. Would very much like a response from FDA on what type of doctor I should see to resolve these concerns. Not getting anywhere with primary Internist. I've been told that I technically don't have any "allergies" but rather, an intolerance and that there are no doctors for intolerances so left on my own to manage. Please contact me with recommendation for what type of doctor to see. Thank you!
Age: 59.0
Sex: F
Vaccine: TD
Symptoms: Tremor, Tryptase, Urine analysis normal, Urticaria, Vaccination complication
Clinical narrative: Received a TDAP vaccination on 9/11/2017 and been fighting bad side effects ever since. Beginning on 9/13/2017 - low-grade fever (about 99.5-101 F), severe uncontrollable shaking and shivering of entire body (even when not cold), severe mid-to-lower back pain, extreme tinnitus in left ear and itchy neuralgia in and around left eye, weight loss (7 pounds in one week), fast heart rate (95-110), severe headache and extreme fatigue. Went to emergency room, allergy and asthma and primary doctor but to no avail. Symptoms continued to worsen and on 9/28/2017, also developed burning rash on upper back and neck. Was in so much pain and discomfort from back pain. rash and "sick feeling" that I could not sleep even with pain medicine. Since mid-October shaking and heart rate have subsided but continue to experience intermittent low-grade fever, chronic severe back pain, intermittent rashes, hives and EXTREMELY itchy below waistline, chronic fatigue, headaches and lack of appetite. These are the exact same symptoms that I have experienced after the flu shot the past three years (2014-2016) including development of burning rash after about 2 weeks. At the time (2014-2016), my rash was (in hindsight) erroneously diagnosed as Shingles so everything subsequent was blamed on that. However, when rash kept reoccurring for several months, my dermatologist did a biopsy that ruled out a viral origin (as well as bacterial and other). Exact cause was never diagnosed and rash eventually subsided in about May/ June of each year but then reappeared (along with all other symptoms) after receiving subsequent annual flu and then TDAP vaccinations in the Fall of subsequent year(s). If this replicates the previous three years, I will continue to be "sick" with above referenced symptoms for 5-6 months. As my health records will indicate, I've been in and out of Emergency Rooms and Urgent Care centers for several months following each vaccination. Had to figure this out on my own ... and through the help of a local television news station featuring other patients who also had problems following vaccinations. I am very, very concerned about these vaccinations and permanent damage to my body. Would very much like a response from FDA on what type of doctor I should see to resolve these concerns. Not getting anywhere with primary Internist. I've been told that I technically don't have any "allergies" but rather, an intolerance and that there are no doctors for intolerances so left on my own to manage. Please contact me with recommendation for what type of doctor to see. Thank you!
Age: 59.0
Sex: F
Vaccine: TD
Symptoms: Weight decreased
Clinical narrative: Received a TDAP vaccination on 9/11/2017 and been fighting bad side effects ever since. Beginning on 9/13/2017 - low-grade fever (about 99.5-101 F), severe uncontrollable shaking and shivering of entire body (even when not cold), severe mid-to-lower back pain, extreme tinnitus in left ear and itchy neuralgia in and around left eye, weight loss (7 pounds in one week), fast heart rate (95-110), severe headache and extreme fatigue. Went to emergency room, allergy and asthma and primary doctor but to no avail. Symptoms continued to worsen and on 9/28/2017, also developed burning rash on upper back and neck. Was in so much pain and discomfort from back pain. rash and "sick feeling" that I could not sleep even with pain medicine. Since mid-October shaking and heart rate have subsided but continue to experience intermittent low-grade fever, chronic severe back pain, intermittent rashes, hives and EXTREMELY itchy below waistline, chronic fatigue, headaches and lack of appetite. These are the exact same symptoms that I have experienced after the flu shot the past three years (2014-2016) including development of burning rash after about 2 weeks. At the time (2014-2016), my rash was (in hindsight) erroneously diagnosed as Shingles so everything subsequent was blamed on that. However, when rash kept reoccurring for several months, my dermatologist did a biopsy that ruled out a viral origin (as well as bacterial and other). Exact cause was never diagnosed and rash eventually subsided in about May/ June of each year but then reappeared (along with all other symptoms) after receiving subsequent annual flu and then TDAP vaccinations in the Fall of subsequent year(s). If this replicates the previous three years, I will continue to be "sick" with above referenced symptoms for 5-6 months. As my health records will indicate, I've been in and out of Emergency Rooms and Urgent Care centers for several months following each vaccination. Had to figure this out on my own ... and through the help of a local television news station featuring other patients who also had problems following vaccinations. I am very, very concerned about these vaccinations and permanent damage to my body. Would very much like a response from FDA on what type of doctor I should see to resolve these concerns. Not getting anywhere with primary Internist. I've been told that I technically don't have any "allergies" but rather, an intolerance and that there are no doctors for intolerances so left on my own to manage. Please contact me with recommendation for what type of doctor to see. Thank you!
Age: 1.08
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13
Symptoms: Electroencephalogram, Fatigue, Generalised tonic-clonic seizure, Nuclear magnetic resonance imaging, Petit mal epilepsy
Clinical narrative: My daughter was given her year old vaccinations late in the day on 9/6/13. She'd been fatigued all day 9/7, then around 11 pm 9/7/13 we found her having a grand mal seizure in her crib. I called the pediatrician at home, who said go to ER. She was evaluated at ER until well after midnight, she was NOT running a fever, not a febrile seizure. She was sent home. We followed up with PCP on 9/9/13. She had following multiple tests including EEG, ambulatory 24 hour EEG, and MRI. Pediatrician states that it was a reaction to the vaccination, to never give her pertussis again. She has developed petit mal seizures from the time of this vaccine forward. Prior to 9/6/13 she had never had any signs or symptoms of seizure like activity. Fast forward to her 5 year old vaccinations, on 8/8/17 the nurse erroneously gave her the pertussis vaccine again - even though it was clearly marked in the chart for her, as well as discussed in detail between myself (mother) and the pediatrician as well as the nursing staff twice - during this visit and during her physical on 8/3/17 where they specifically ordered pertussis free vaccine JUST for patient. Her reaction this time was a high fever lasting 4 days. Per Dr we had to do TYLENOL/ibuprofen alternating and BENADRYL for 72 hours. Dr states that he consulted with pediatric specialists in hospital for a treatment plan. We watched her around the clock for the 72 hours, and her fever even with the TYLENOL/ibuprofen was in the 99-100 range. I documented hourly how she was reacting, and we called Dr routinely to discuss the situation. The office claims that the incident was reported to the nursing board, but both of the nurses are still employed there. The nurse tried to claim she didn't know there was a reaction, but it was clearly listed in the chart under both allergies and under every single office note from the original incident, as well as having been discussed in detail the week before. As well as the fever, she has had an increase in absence seizures and seizure activity, and the seizures have become noticeably more frequent and more lengthy. She went from having them a few times a month to a few times a week after the August incident.
Age: 1.08
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13
Symptoms: Pyrexia, Seizure, Vaccination complication
Clinical narrative: My daughter was given her year old vaccinations late in the day on 9/6/13. She'd been fatigued all day 9/7, then around 11 pm 9/7/13 we found her having a grand mal seizure in her crib. I called the pediatrician at home, who said go to ER. She was evaluated at ER until well after midnight, she was NOT running a fever, not a febrile seizure. She was sent home. We followed up with PCP on 9/9/13. She had following multiple tests including EEG, ambulatory 24 hour EEG, and MRI. Pediatrician states that it was a reaction to the vaccination, to never give her pertussis again. She has developed petit mal seizures from the time of this vaccine forward. Prior to 9/6/13 she had never had any signs or symptoms of seizure like activity. Fast forward to her 5 year old vaccinations, on 8/8/17 the nurse erroneously gave her the pertussis vaccine again - even though it was clearly marked in the chart for her, as well as discussed in detail between myself (mother) and the pediatrician as well as the nursing staff twice - during this visit and during her physical on 8/3/17 where they specifically ordered pertussis free vaccine JUST for patient. Her reaction this time was a high fever lasting 4 days. Per Dr we had to do TYLENOL/ibuprofen alternating and BENADRYL for 72 hours. Dr states that he consulted with pediatric specialists in hospital for a treatment plan. We watched her around the clock for the 72 hours, and her fever even with the TYLENOL/ibuprofen was in the 99-100 range. I documented hourly how she was reacting, and we called Dr routinely to discuss the situation. The office claims that the incident was reported to the nursing board, but both of the nurses are still employed there. The nurse tried to claim she didn't know there was a reaction, but it was clearly listed in the chart under both allergies and under every single office note from the original incident, as well as having been discussed in detail the week before. As well as the fever, she has had an increase in absence seizures and seizure activity, and the seizures have become noticeably more frequent and more lengthy. She went from having them a few times a month to a few times a week after the August incident.
Sex: F
Vaccine: FLUX
Symptoms: Erythema multiforme, Pruritus, Rash
Clinical narrative: I received the flu shot on 10/13/2017, and by the end of the day on 10/14/17, I developed a rash on my hands and feet with severe itching. It did not respond to typical over the counter hydrocortisone and diphenhydramine creams/ointments. I went to the dermatologist a week later because it had not resolved. He began a course of high dose oral prednisone and also diagnosed it as erythema multiforme. I am a healthcare provider myself. The rash resolved approximately 14 days after the initial injection. I have never had a reaction to any type of influenza vaccine and not allergic to eggs.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of personal independence in daily activities, Nausea, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Patient reported normal arm soreness the immediate days following vaccination. However the soreness developed into sharp pains when moving her arm. She gets a nauseating feeling during the pain. The pain is so bad that she has a hard time sleep on that arm during the night for it wakes her up. This developed within a week of getting the shot and has not abated. The patient does state it is starting to interfere with daily life. Patient does plan on following up this week with her primary care doctor.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Arthralgia, Erythema, Joint range of motion decreased, Peripheral swelling
Clinical narrative: Arm swelling to forearm, elbow pain, redness, limited range of motion of arm due to pain and swelling. Symptoms/swelling resolved spontaneously and was resolved 11/14 when seen in clinic.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Injection site pain, Neuralgia, Pain in extremity, Peripheral swelling
Clinical narrative: Arm swelling to forearm, elbow pain, redness, limited range of motion of arm due to pain and swelling. Symptoms/swelling resolved spontaneously and was resolved 11/14 when seen in clinic.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever of 102, fussy.
Age: 1.08
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to 13-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 07-JUN-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # N005274 and expiration date 03-APR-2018; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 25-APR-2017 until 07-SEP-2017, the vaccine was exposed to various temperature excursions ranging from 32 degrees Fahrenheit (F) to 54F for the period of up to 70 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter.; Sender's Comments: US-009507513-1709USA012768:
Age: 1.58
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to 19-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 07-JUN-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # N005274 and expiration date 03-APR-2018; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 25-APR-2017 until 07-SEP-2017, the vaccine was exposed to various temperature excursions ranging from 32 degrees Fahrenheit (F) to 54F for the period of up to 70 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter.; Sender's Comments:  US-009507513-1709USA012768:
Age: 1.58
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to 19-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 10-JUN-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # N005274 and expiration date 03-APR-2018; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 25-APR-2017 until 07-SEP-2017, the vaccine was exposed to various temperature excursions ranging from 32 degrees Fahrenheit (F) to 54F for the period of up to 70 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter.; Sender's Comments:  US-009507513-1709USA012768:
Age: 1.08
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to 13-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions or allergies was provided. On 07-JUN-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # N005274 and expiration date 03-APR-2018; dose and route of administration were not reported) for prophylaxis. It was reported, that on several dates between 25-APR-2017 until 07-SEP-2017, the vaccine was exposed to various temperature excursions ranging from 32 degrees Fahrenheit (F) to 54F for the period of up to 70 hours at a time. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter.; Sender's Comments:  US-009507513-1709USA012768:
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Angiogram, Borrelia test, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging normal, Papilloedema
Clinical narrative: Teen C/O black spots in (L) eye and trouble seeing from eye. Seen at optometrist 8/21 and was Dx'd w/swollen optic nerve (L) eye. Seen again 8/25 no change in swelling.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Visual impairment
Clinical narrative: Teen C/O black spots in (L) eye and trouble seeing from eye. Seen at optometrist 8/21 and was Dx'd w/swollen optic nerve (L) eye. Seen again 8/25 no change in swelling.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Acute kidney injury, Body temperature increased, Chills, Feeling cold, Incoherent
Clinical narrative: Patient felt terrible pain in arm after shot on 9/22/17. After going home she had chills and could not get warm. Patient's son reported inability to understand patient on phone. Went to hospital on Friday evening 9/22 and was admitted to ICU. Temp 104 degrees F, BP 82/66. Diagnosed acute kidney failure. Released 9/25/17.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Intensive care, Pain in extremity
Clinical narrative: Patient felt terrible pain in arm after shot on 9/22/17. After going home she had chills and could not get warm. Patient's son reported inability to understand patient on phone. Went to hospital on Friday evening 9/22 and was admitted to ICU. Temp 104 degrees F, BP 82/66. Diagnosed acute kidney failure. Released 9/25/17.
Age: 53.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Dyspnoea, Flushing, Pain
Clinical narrative: Faintness, dizziness, shortness of breath, pain, flushness.
Sex: U
Vaccine: DTAPIPV
Symptoms: Local reaction
Clinical narrative: Severe local reaction.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test normal, Electromyogram normal, Hypoaesthesia, Inflammatory marker test, Injection site erythema
Clinical narrative: On 10/26/2017, I received employee vaccine in clinic conference room. Right arm was sore; and became increasingly painful over next few days. On 10/31/2017, notified my manager of sharp, radiating pain in my right arm that was bringing me close to tears. Area where shot was given in arm was swollen, hot & red. Recommended to see nurse, who examined and recommended seeing provider right away. Saw Dr. late afternoon in Urgent Care, was prescribed TYLENOL and 800mg ibuprofen, and something to prevent stomach from reacting to ibuprofen (Don't have with me, not remembering name) and icing area. Next day, 11/1/2017, in morning realized my right side of face had some numb areas, (right eyebrow to cheek bone) which seemed to progress to more areas on right side of face as the morning went on. Let my manager know I was having some additional symptoms, discussed with nurse as well; went to Clinic at 1pm to see Dr. to let her know of new symptoms and persisting pain & weakness in arm. Was admitted into hospital observation that afternoon. Dr stopped in to evaluate, said most likely combination of needle too close to nerve & chemical reaction to vaccine. 11/2/2017 MRI to brain & cervical area was done, results good, was released to go home. Given pain meds to take when needed; 11/6/17 Returned to work for couple hours, but experienced numbness in shoulder/forearm while typing/using mouse. Saw Dr. for after hospital check. Lab work to check inflammation. Prescribed muscle relaxer and I went home. Physical therapy also prescribed. 11/7/17 Saw Dr. at clinic; had EMG with good results, no long term nerve damage; anticipates 4-6 weeks to recover/heal. Follow up with physical therapy. 11/13/2017 Physical therapy appt at 4:15pm. Overall improving, still have arm discomfort / tenseness / weakness in arm.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site warmth, Limb discomfort, Muscular weakness, Nuclear magnetic resonance imaging brain normal
Clinical narrative: On 10/26/2017, I received employee vaccine in clinic conference room. Right arm was sore; and became increasingly painful over next few days. On 10/31/2017, notified my manager of sharp, radiating pain in my right arm that was bringing me close to tears. Area where shot was given in arm was swollen, hot & red. Recommended to see nurse, who examined and recommended seeing provider right away. Saw Dr. late afternoon in Urgent Care, was prescribed TYLENOL and 800mg ibuprofen, and something to prevent stomach from reacting to ibuprofen (Don't have with me, not remembering name) and icing area. Next day, 11/1/2017, in morning realized my right side of face had some numb areas, (right eyebrow to cheek bone) which seemed to progress to more areas on right side of face as the morning went on. Let my manager know I was having some additional symptoms, discussed with nurse as well; went to Clinic at 1pm to see Dr. to let her know of new symptoms and persisting pain & weakness in arm. Was admitted into hospital observation that afternoon. Dr stopped in to evaluate, said most likely combination of needle too close to nerve & chemical reaction to vaccine. 11/2/2017 MRI to brain & cervical area was done, results good, was released to go home. Given pain meds to take when needed; 11/6/17 Returned to work for couple hours, but experienced numbness in shoulder/forearm while typing/using mouse. Saw Dr. for after hospital check. Lab work to check inflammation. Prescribed muscle relaxer and I went home. Physical therapy also prescribed. 11/7/17 Saw Dr. at clinic; had EMG with good results, no long term nerve damage; anticipates 4-6 weeks to recover/heal. Follow up with physical therapy. 11/13/2017 Physical therapy appt at 4:15pm. Overall improving, still have arm discomfort / tenseness / weakness in arm.