chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Initial unsolicited report received from a non-health care professional on 19 January 2016. This case involves a male patient (age unknown) who was vaccinated with a dose of Influenza vaccine (batch number, expiry date, route and site of administration were not reported) on an unspecified date (reported that he received the vaccine "this year"). Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient experienced flu A. It was reported that the patient saw the doctor. Laboratory investigation and corrective treatment were not reported. The outcome of event was not reported. Upon internal review, the company decided to consider the event serious because of important medical event: Flu A. List of documents held by sender: none.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered medical assistant refers to multiple patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant medications were not reported. On unknown dates, the multiple unspecified patients received doses of improperly stored VAQTA (dose, route and site of administration were not reported) lot# K012457, expiry date 04-JUN-2017. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to multiple unspecified patients of unknown age and gender. There was no concurrent condition, medical history or concomitant medication reported for the patients. On unknown dates, improperly stored doses of GARDASIL lot # K011562, expiration date 08-APR-2017, (dose, frequency and route were not reported) were administered to an unspecified number of patients. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 4 year old patient of unknown gender. The patient's concurrent conditions, past medical history were not reported. On 03-DEC-2015, the patient was vaccinated with an improperly stored M-M-R II (lot # K021151, expiry date 02-NOV-2016, dose, strength, vaccination site, dose number unspecified). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint (PQC) was not reported. On 26-JAN-2016, a phone call was placed to the physician. The physician was unavailable at the time of call. The phone call was transferred to the Certified Medical Assistant (CMA). The C.M.A. was unable to place specific lot numbers for each of the reported vaccines that experienced a temperature excursion; M-M-R II, ROTATEQ and VAQTA, with the information already supplied for patient identifiers, date of birth and date of vaccination, at this time. The C.M.A. will need to review the records. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.42
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 5 months old patient of unknown gender. The patient's concurrent conditions, past medical history were not reported. On 28-DEC-2015, the patient was vaccinated with improperly stored oral, ROTATEQ (lot # K014826, expiry date 28-MAY-2016, dose, strength, vaccination site, dose number unspecified). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint (PQC) was not reported. On 26-JAN-2016, a phone call was placed to the physician. The physician was unavailable at the time of call. The phone call was transferred to the Certified Medical Assistant (CMA). The C.M.A was unable to place specific lot numbers for each of the reported vaccines that experienced a temperature excursion; M-M-R II, ROTATEQ and VAQTA, with the information already supplied for patient identifiers, date of birth and date of vaccination, at this time. The C.M.A will need to review the records. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Detoxification, Headache, Lethargy
Clinical narrative: My daughter was very lethargic, headache, weak, could not stay up at all. Absolutely no energy. Onset was within 36 hour of vaccine. She did not get better until I start flushing her system of lemon water and detox diet food to promote flushing of metal posing and detox. Epson and ginger baths. It took a good week or two till it occurred to me that she had the shot at that it could be a correlation. That's when I began the detox.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On an unknown date, multiple unspecified patients were administered with improperly stored doses of VARIVAX (Merck) (lot # L017997, expiry date 19-MAY-2017 and lot # L027288, expiry date 12-JUL-2017) dose, route unknown. Concomitant medications were not reported. During the storage the vaccine was exposed to temperature of 70 degrees for a time frame of 60 hours and later the storage temperature was back in range. It was reported there was previous temperature excursion where the same vaccine was exposed to -11.9 degrees C for 44 hours on 14-DEC-2015. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the three reports received from the same reporter. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Preterm premature rupture of membranes
Clinical narrative: Vaccine given 45 minutes after began to leak fluid pregnant due date was 9/19/15. Water broke membranes. Was sent from hospital to medical. Was (31 w 3 days).
Sex: U
Vaccine: RV5
Symptoms: Faeces discoloured
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding a child of unknown age and gender. Information on the concurrent conditions, medical history and drug allergies of the patient were not reported. Illness of the patient/siblings at the time of/prior vaccination were not reported. On an unknown date the patient was vaccinated with ROTATEQ (lot, expiry date, dose number and anatomical location were not specified) orally. Concomitant medication were not reported. On an unknown date (after receiving ROTATEQ), it was reported that the unspecified parents of the unspecified child reported, during a routine follow-up visit that the child had experienced "black stools" for an unspecified length of time. The patient had sought medical attention by going for a routine follow-up visit. Lab diagnostics studies were not performed. No treatment was given for adverse event. Outcome of faeces discolored was unknown at the time of reporting. There was no Product Quality Complaint (PQC) filed. Reporter did not provide the causal relationship for faeces discolored with ROTATEQ. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On an unknown date the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # L032402, expiry date: 26-NOV-2016). Temperature excursion details of the vaccine included: temperature 29 degree F, time frame 7 hours 15 minutes, which came back in range. No adverse effects were reported. Additional information has been requested.
Age: 0.51
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 6 months old patient of unknown gender. The patient's concurrent conditions, past medical history were not reported. On 07-DEC-2015, the patient was vaccinated with an improperly stored ROTATEQ (lot # K014826, expiry date 28-MAY-2016, dose, strength, vaccination site, dose number unspecified). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint (PQC) was not reported. On 26-JAN-2016, a phone call was placed to the physician. The physician was unavailable at the time of call. The phone call was transferred to the Certified Medical Assistant (CMA). The C.M.A. was unable to place specific lot numbers for each of the reported vaccines that experienced a temperature excursion; M-M-R II, ROTATEQ and VAQTA, with the information already supplied for patient identifiers, date of birth and date of vaccination, at this time. The C.M.A. will need to review the records. This is one of the several reports received from the same reporter. 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 healthcare worker regarding unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On an unknown date, multiple unspecified patients were administered with improperly stored doses of PROQUAD (Merck) (lot # L023113, expiry date 24-DEC-2016 and lot # K020748, expiry date 30-APR-2016) dose, route unknown. Concomitant medications were not reported. During the storage the vaccine was exposed to temperature of 70 degrees F for a time frame of 60 hours and later the storage temperature was back in range. It was reported there was previous temperature excursion where the same vaccine was exposed to -11.9 degrees C for 44 hours on 14-DEC-2015. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the three reports received from the same reporter. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a female patient of unknown age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. The healthcare worker stated that the patient received her first dose of GARDASIL 9 on 05-AUG-2015, second dose on 07-OCT-2015 and third dose on 11-DEC-2015. The patient received her third dose too early (inappropriate schedule of drug administration). No adverse effects were not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On an unknown date, multiple unspecified patients were administered with improperly stored doses of ZOSTAVAX (lot # L032402, expiry date 26-NOV-2016 and lot # L031273, expiry date 19-NOV-2016) dose, route unknown. Concomitant medications were not reported. During the storage the vaccine was exposed to temperature of 70 degrees F for a time frame of 60 hours and later the storage temperature was back in range. It was reported there was previous temperature excursion where the same vaccine was exposed to -11.9 degrees C for 44 hours on 14-DEC-2015. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the three reports received from the same reporter. Additional information has been requested.
Age: 0.39
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 4 months old patient of unknown gender. The patient's concurrent conditions, past medical history were not reported. On 08-DEC-2015, the patient was vaccinated with an improperly stored ROTATEQ (lot # K014826, expiry date 28-MAY-2016, dose, strength, vaccination site, dose number unspecified). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint (PQC) was not reported. On 26-JAN-2016, a phone call was placed to the physician. The physician was unavailable at the time of call. The phone call was transferred to the Certified Medical Assistant (CMA). The C.M.A. was unable to place specific lot numbers for each of the reported vaccines that experienced a temperature excursion; M-M-R II, ROTATEQ and VAQTA, with the information already supplied for patient identifiers, date of birth and date of vaccination, at this time. The C.M.A. will need to review the records. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Biopsy, Cerebellar ataxia, Encephalitis, Endoscopy, Immunoglobulin therapy
Clinical narrative: Encephalitis, cerebellar ataxia, liver damage, psychiatric symptoms et al.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Liver injury, Psychiatric symptom, Ultrasound liver
Clinical narrative: Encephalitis, cerebellar ataxia, liver damage, psychiatric symptoms et al.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to multiple unspecified patients of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were unknown. It was reported that doses of ROTATEQ Lot # K004432, expiry date 27-JAN-2016; lot # L000434, expiry date 10-JUL-2016; lot # L006184, expiry date 13-DEC-2016, lot # L020859, expiry date 19-JAN-2017; lot # K004922, 26-FEB-2016; (dose was not reported) that were exposed for 2 hours at 34.4 F and then back in the range, were given to unspecified patients on unspecified dates. It was also confirmed that the vaccine had no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. It was unknown if the patients sought medical attention. This is one of several reports received from the same source. Lot number K004922 has been verified to be a valid lot number for Rotavirus vaccine, live, oral, Pentavalent. Additional information has been requested.
Age: 91.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Cellulitis, Decreased appetite, Erythema, Injection site erythema
Clinical narrative: Extreme swelling - redness - sore.  On Sep 5th went to Dr. Several days concerned about cellulitis. 5 days of clindamycin 75 mg. Loss of appetite - lost 8 lbs. Weak feeling, red streaks from shot area to elbow. Saw Dr.
Age: 91.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site streaking, Pain, Swelling, Weight decreased
Clinical narrative: Extreme swelling - redness - sore.  On Sep 5th went to Dr. Several days concerned about cellulitis. 5 days of clindamycin 75 mg. Loss of appetite - lost 8 lbs. Weak feeling, red streaks from shot area to elbow. Saw Dr.
Age: 5.0
Sex: M
Vaccine: DT, IPV, MMR
Symptoms: Blood test, Dysphemia, Immunoglobulin therapy, Learning disability, Mental disorder
Clinical narrative: P.A.N.D.A.S. - crazy psychiatric behavior, terrible tics, stutter, out of school for one year - learning disabilities - weight loss, impossible situation.
Age: 5.0
Sex: M
Vaccine: DT, IPV, MMR
Symptoms: Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection, Tic, Weight decreased
Clinical narrative: P.A.N.D.A.S. - crazy psychiatric behavior, terrible tics, stutter, out of school for one year - learning disabilities - weight loss, impossible situation.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: The right shoulder is observed a little bit red, swollen and a little bit hot to the touch. The child was evaluated by a physician on the 01/15/16 and had treatment and a prescription.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Arthritis, Back pain, Fatigue, Headache, Injection site erythema
Clinical narrative: I'm going to take you back to 2006 when my MD, at that time, gave me a pneumonia and tetanus shot in the upper section of my left arm. There was no pain; needle marks; redness; or after affects. I have not had a cold in nine (9) years. Now, I have been cursed!! When I asked for a pneumonia shot, my MD was not the person who administered the shot; who, at no time, explained in full detail what the consequences of the strength of this pneumonia shot would be. The shot was given as follows: The needle was inserted into top of my left shoulder, and it stung. Then, it turned red! When I arrived home, the upper section of my left arm turned RED! It hurt, and there was pain. I put alcohol on the area. In a few days the redness evaporated, but the arm was achy, ad then there was pain. I did contact the doctor's office when the arm turned red, and was told to call back if it became worse. It did get worse. I spoke to Dr., and told him there was pain and severe headaches. He also stated to call him back, if it got worse. I asked him if I could get a stroke or heart attack. He stated: "No." The third call I made was to schedule an appointment with Dr. He suggested an x-ray of my left arm. The results were: beginning of arthritis!! He did mention to take ADVIL twice a day and some light exercise. This is what I eventually took to relieve the pressure and pain: ADVIL or TYLENOL light exercise heating pad. The existing conditions to this day are: Sniffles, runny nose, sneezing, achiness: Joint and muscle, Stiffness: neck; Shoulder, Back, Pain: neck; shoulder arm, headaches, tiredness. On Wednesday, 6 January 2016, a blood red spot appeared on the left side of my left eye. in four (4) days it disappeared. My other medical conditions are; High blood pressure, High cholesterol, Sinus condition, Arthritis. I am allergic to: Penicillin, aspirin, SUDAFED, Lisinopril, Lovastatin, PREVNAR 13. I did report this mele of circumstances to Health Plan, but was told that I only up to 60 days to report any backlash from P-13. I am still experiencing all the conditions listed in this letter. If I had bee given a clearer insight into P-13's shot, I would not have taken it. all medical personnel should thoroughly advise and give a better interpretation of what this pneumonia shot is capable of to all recipients. I am a senior who thought I was going into never-never land!! On Wednesday, 13 January 2016, I contacted Dr's office to have lab work done. The person I spoke with stated she would call me back. She did not. On Friday, 15 January 2016, I call again. She denied talking to me on the 13th. I stated again, about lab work, and she stated in April, I don't trust her. I hope Dr was contacted.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Joint stiffness, Musculoskeletal pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: I'm going to take you back to 2006 when my MD, at that time, gave me a pneumonia and tetanus shot in the upper section of my left arm. There was no pain; needle marks; redness; or after affects. I have not had a cold in nine (9) years. Now, I have been cursed!! When I asked for a pneumonia shot, my MD was not the person who administered the shot; who, at no time, explained in full detail what the consequences of the strength of this pneumonia shot would be. The shot was given as follows: The needle was inserted into top of my left shoulder, and it stung. Then, it turned red! When I arrived home, the upper section of my left arm turned RED! It hurt, and there was pain. I put alcohol on the area. In a few days the redness evaporated, but the arm was achy, ad then there was pain. I did contact the doctor's office when the arm turned red, and was told to call back if it became worse. It did get worse. I spoke to Dr., and told him there was pain and severe headaches. He also stated to call him back, if it got worse. I asked him if I could get a stroke or heart attack. He stated: "No." The third call I made was to schedule an appointment with Dr. He suggested an x-ray of my left arm. The results were: beginning of arthritis!! He did mention to take ADVIL twice a day and some light exercise. This is what I eventually took to relieve the pressure and pain: ADVIL or TYLENOL light exercise heating pad. The existing conditions to this day are: Sniffles, runny nose, sneezing, achiness: Joint and muscle, Stiffness: neck; Shoulder, Back, Pain: neck; shoulder arm, headaches, tiredness. On Wednesday, 6 January 2016, a blood red spot appeared on the left side of my left eye. in four (4) days it disappeared. My other medical conditions are; High blood pressure, High cholesterol, Sinus condition, Arthritis. I am allergic to: Penicillin, aspirin, SUDAFED, Lisinopril, Lovastatin, PREVNAR 13. I did report this mele of circumstances to Health Plan, but was told that I only up to 60 days to report any backlash from P-13. I am still experiencing all the conditions listed in this letter. If I had bee given a clearer insight into P-13's shot, I would not have taken it. all medical personnel should thoroughly advise and give a better interpretation of what this pneumonia shot is capable of to all recipients. I am a senior who thought I was going into never-never land!! On Wednesday, 13 January 2016, I contacted Dr's office to have lab work done. The person I spoke with stated she would call me back. She did not. On Friday, 15 January 2016, I call again. She denied talking to me on the 13th. I stated again, about lab work, and she stated in April, I don't trust her. I hope Dr was contacted.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Ocular hyperaemia, Pain, Pain in extremity, Rhinorrhoea, Sneezing
Clinical narrative: I'm going to take you back to 2006 when my MD, at that time, gave me a pneumonia and tetanus shot in the upper section of my left arm. There was no pain; needle marks; redness; or after affects. I have not had a cold in nine (9) years. Now, I have been cursed!! When I asked for a pneumonia shot, my MD was not the person who administered the shot; who, at no time, explained in full detail what the consequences of the strength of this pneumonia shot would be. The shot was given as follows: The needle was inserted into top of my left shoulder, and it stung. Then, it turned red! When I arrived home, the upper section of my left arm turned RED! It hurt, and there was pain. I put alcohol on the area. In a few days the redness evaporated, but the arm was achy, ad then there was pain. I did contact the doctor's office when the arm turned red, and was told to call back if it became worse. It did get worse. I spoke to Dr., and told him there was pain and severe headaches. He also stated to call him back, if it got worse. I asked him if I could get a stroke or heart attack. He stated: "No." The third call I made was to schedule an appointment with Dr. He suggested an x-ray of my left arm. The results were: beginning of arthritis!! He did mention to take ADVIL twice a day and some light exercise. This is what I eventually took to relieve the pressure and pain: ADVIL or TYLENOL light exercise heating pad. The existing conditions to this day are: Sniffles, runny nose, sneezing, achiness: Joint and muscle, Stiffness: neck; Shoulder, Back, Pain: neck; shoulder arm, headaches, tiredness. On Wednesday, 6 January 2016, a blood red spot appeared on the left side of my left eye. in four (4) days it disappeared. My other medical conditions are; High blood pressure, High cholesterol, Sinus condition, Arthritis. I am allergic to: Penicillin, aspirin, SUDAFED, Lisinopril, Lovastatin, PREVNAR 13. I did report this mele of circumstances to Health Plan, but was told that I only up to 60 days to report any backlash from P-13. I am still experiencing all the conditions listed in this letter. If I had bee given a clearer insight into P-13's shot, I would not have taken it. all medical personnel should thoroughly advise and give a better interpretation of what this pneumonia shot is capable of to all recipients. I am a senior who thought I was going into never-never land!! On Wednesday, 13 January 2016, I contacted Dr's office to have lab work done. The person I spoke with stated she would call me back. She did not. On Friday, 15 January 2016, I call again. She denied talking to me on the 13th. I stated again, about lab work, and she stated in April, I don't trust her. I hope Dr was contacted.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: X-ray limb abnormal
Clinical narrative: I'm going to take you back to 2006 when my MD, at that time, gave me a pneumonia and tetanus shot in the upper section of my left arm. There was no pain; needle marks; redness; or after affects. I have not had a cold in nine (9) years. Now, I have been cursed!! When I asked for a pneumonia shot, my MD was not the person who administered the shot; who, at no time, explained in full detail what the consequences of the strength of this pneumonia shot would be. The shot was given as follows: The needle was inserted into top of my left shoulder, and it stung. Then, it turned red! When I arrived home, the upper section of my left arm turned RED! It hurt, and there was pain. I put alcohol on the area. In a few days the redness evaporated, but the arm was achy, ad then there was pain. I did contact the doctor's office when the arm turned red, and was told to call back if it became worse. It did get worse. I spoke to Dr., and told him there was pain and severe headaches. He also stated to call him back, if it got worse. I asked him if I could get a stroke or heart attack. He stated: "No." The third call I made was to schedule an appointment with Dr. He suggested an x-ray of my left arm. The results were: beginning of arthritis!! He did mention to take ADVIL twice a day and some light exercise. This is what I eventually took to relieve the pressure and pain: ADVIL or TYLENOL light exercise heating pad. The existing conditions to this day are: Sniffles, runny nose, sneezing, achiness: Joint and muscle, Stiffness: neck; Shoulder, Back, Pain: neck; shoulder arm, headaches, tiredness. On Wednesday, 6 January 2016, a blood red spot appeared on the left side of my left eye. in four (4) days it disappeared. My other medical conditions are; High blood pressure, High cholesterol, Sinus condition, Arthritis. I am allergic to: Penicillin, aspirin, SUDAFED, Lisinopril, Lovastatin, PREVNAR 13. I did report this mele of circumstances to Health Plan, but was told that I only up to 60 days to report any backlash from P-13. I am still experiencing all the conditions listed in this letter. If I had bee given a clearer insight into P-13's shot, I would not have taken it. all medical personnel should thoroughly advise and give a better interpretation of what this pneumonia shot is capable of to all recipients. I am a senior who thought I was going into never-never land!! On Wednesday, 13 January 2016, I contacted Dr's office to have lab work done. The person I spoke with stated she would call me back. She did not. On Friday, 15 January 2016, I call again. She denied talking to me on the 13th. I stated again, about lab work, and she stated in April, I don't trust her. I hope Dr was contacted.
Age: 20.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Mucosal dryness, Syncope, Vomiting
Clinical narrative: Syncope, vomiting - dry to mucous (all approximately within 1/2 hr to 45 minutes). Treatment: rehydration.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling about 6 inches x 3 inches (L) upper arm at injection site.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Diarrhoea, Local reaction, Malaise, Muscular weakness
Clinical narrative: Within hours - became ill with temp of 101, body aches - local reaction, diarrhea - still having problems with muscle pain and weakness - taking ALEVE since 9/30.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pain
Clinical narrative: Within hours - became ill with temp of 101, body aches - local reaction, diarrhea - still having problems with muscle pain and weakness - taking ALEVE since 9/30.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, FLU3, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth, Oedema
Clinical narrative: Developed edema (pitting 2+), erythema, warmth and pain in left deltoid area (3 in x 3 in).
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, FLU3, MNQ
Symptoms: Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Developed edema (pitting 2+), erythema, warmth and pain in left deltoid area (3 in x 3 in).
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, warmth, erythema at injection site. Unsure if allergic reaction or cellulitis. Given hx of cellulitis (recent), we will treat as cellulitis.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster, Pain in extremity
Clinical narrative: Received flu shot 9/28/15 (L) arm very sore 2 days Oct 7, 2015 broke out in shingles on my face knew of other people 42-70 who had the same experience - took the flu shot then in a few weeks got shingles {Received FLUZONE HIGH DOSE 0.5 mL.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Dyspnoea, Fatigue, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: 1 day after receiving vaccine patient developed flu-like symptoms, shortness of breath, fatigue, muscle aches and redness/swelling at the site of injection.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Myalgia
Clinical narrative: 1 day after receiving vaccine patient developed flu-like symptoms, shortness of breath, fatigue, muscle aches and redness/swelling at the site of injection.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Headache, Injection site erythema, Injection site streaking, Pain in extremity
Clinical narrative: Patient reports a sore right arm. "Streaking redness" on right deltoid, dizziness and headaches.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Anxiety, Asthenia, Delusion, Diarrhoea, Dizziness
Clinical narrative: On Friday, 1/8/16 he was delusional, weak, some diarrhea, heart palpitation and did not feel well. Was sent home from school. Slept a few hours then felt better. On Saturday 1/9/16 he had rapid heartbeats at about 6:15 pm was dizzy, had headache, anxious, nervous felt weak, had to walk to get heart rate back to normal. Took him to the Emergency room at hospital. They monitored him there.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          On Friday, 1/8/6 8:10 AM he was delusional, weak, some diarrhea, heart palpitation, and did not feel well. Was sent home from school. Slept a few hours then felt better. On Saturday, 1/9/16 he had rapid heart beats at about 6:15 pm was dizzy, had headache, anxious, nervous felt weak, had to walk to get heart rate back to normal. (Took him to the Emergency Room at hospital, monitored him there.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Electrocardiogram, Headache, Heart rate increased, Malaise, Nervousness
Clinical narrative: On Friday, 1/8/16 he was delusional, weak, some diarrhea, heart palpitation and did not feel well. Was sent home from school. Slept a few hours then felt better. On Saturday 1/9/16 he had rapid heartbeats at about 6:15 pm was dizzy, had headache, anxious, nervous felt weak, had to walk to get heart rate back to normal. Took him to the Emergency room at hospital. They monitored him there.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          On Friday, 1/8/6 8:10 AM he was delusional, weak, some diarrhea, heart palpitation, and did not feel well. Was sent home from school. Slept a few hours then felt better. On Saturday, 1/9/16 he had rapid heart beats at about 6:15 pm was dizzy, had headache, anxious, nervous felt weak, had to walk to get heart rate back to normal. (Took him to the Emergency Room at hospital, monitored him there.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Palpitations
Clinical narrative: On Friday, 1/8/16 he was delusional, weak, some diarrhea, heart palpitation and did not feel well. Was sent home from school. Slept a few hours then felt better. On Saturday 1/9/16 he had rapid heartbeats at about 6:15 pm was dizzy, had headache, anxious, nervous felt weak, had to walk to get heart rate back to normal. Took him to the Emergency room at hospital. They monitored him there.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          On Friday, 1/8/6 8:10 AM he was delusional, weak, some diarrhea, heart palpitation, and did not feel well. Was sent home from school. Slept a few hours then felt better. On Saturday, 1/9/16 he had rapid heart beats at about 6:15 pm was dizzy, had headache, anxious, nervous felt weak, had to walk to get heart rate back to normal. (Took him to the Emergency Room at hospital, monitored him there.
Age: 84.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Blood test, Myalgia, X-ray
Clinical narrative: 8/27/2015 received flu and pneumonia injections. Pain in muscles in both upper arms, and upper muscles in both legs. Dr. took blood tests, orthopedic took x-ray, neurologist tested and Hospital tested.
Age: 1.05
Sex: M
Vaccine: FLU4, HEPA, MMRV, VARCEL
Symptoms: Abnormal behaviour, Gait disturbance, Hypersomnia, Psychomotor hyperactivity, Toe walking
Clinical narrative: Parents had concerns for behavior - very active, racing around, then tipping, "bumping into walls", sleeping a lot, low normal temps in 48-72 hours after vaccines. Pt examined on 1/8, 1/10, 1/13 with normal exams - full PE exam and fully normal coordination, gait, engagement. No studies. No intervention without discussion with immunization dept and reassurance and anticipatory guidance.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Dizziness, Dysphonia, Fatigue, Headache
Clinical narrative: 1st day headache. 2nd day headache, sore throat, hoarseness. 3rd day muscle aches, fatigue. 4 day dizziness, aches. 5 diarrhea, dizziness. Lasted 5 to 6 days. Didn't feel better for 2 weeks. Different symptoms every 24 hours.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Oropharyngeal pain, Pain
Clinical narrative: 1st day headache. 2nd day headache, sore throat, hoarseness. 3rd day muscle aches, fatigue. 4 day dizziness, aches. 5 diarrhea, dizziness. Lasted 5 to 6 days. Didn't feel better for 2 weeks. Different symptoms every 24 hours.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient complains of soreness and pain in arm at injection site.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: Patient received FLUZONE 0.5mL in the (L) arm. Has egg allergy but has received flu vaccine in the past with no reaction. Vaccine administered 11/11/15, presented on 11/13/15 small bruise at injection site, below injection site red and warm for 4", no pain, patient reports itching.
Age: 1.07
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Crying, Epistaxis, Initial insomnia, Middle insomnia, Pyrexia
Clinical narrative: Bloody nose (only one he has ever had) started shortly after vaccination.  It was a slow oozing that took an hour to stop. He has also spiked to mild fevers (101 degrees F), had long fits of inconsolable crying and had disrupted sleep (difficulty falling to sleep and then waking through the night). This is all very out of character.  There have been no other changes to his health or environment during this time.
Age: 1.07
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Sleep disorder
Clinical narrative: Bloody nose (only one he has ever had) started shortly after vaccination.  It was a slow oozing that took an hour to stop. He has also spiked to mild fevers (101 degrees F), had long fits of inconsolable crying and had disrupted sleep (difficulty falling to sleep and then waking through the night). This is all very out of character.  There have been no other changes to his health or environment during this time.
Age: 2.0
Sex: M
Vaccine: HEP
Symptoms: Decreased appetite, Pyrexia, Vomiting
Clinical narrative: Loss of appetite, vomited once, mild fever (100.2).
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Allodynia, Alopecia, Antinuclear antibody negative, Anxiety
Clinical narrative: Pt has a hx of: Bullseye Rash as a child; Mononucleosis at age 5; hemiplegic migraine at age 8, well controlled, medicated ages 8-11. No sx after mediation d/c'd. At age 12, had 3 does of HPV-4 Gardasil (11/2012, 2/2013, 7/2013). Began having increased asthma attacks, dizziness and anxiety in October, 2013. October, 2014 developed weakness of left arm, left leg. Tingling in face. December 2014- ER admission for severe hypokalemia, hypomagnesemia, tachycardia, prolonged QT interval. Sx include: Muscle weakness, Migraines, Seizure-like activity, Hypokalemia, Fatigue, Pruritis, Shortness of breath with simple activity, Alopecia, Neuropathy, Allodynia, Nystagmus, Nausea/vomiting, Periodic Paralysis, Left arm severe pain with episodes of paralysis, Brain fog, Inability to write or perform ADLs, Needed walker or wheelchair for mobility, Difficulty breathing during attacks, On home-bound schooling. Diagnosed with Hypokalemic Periodic Paralysis in 11/2015.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Asthma, Blood potassium decreased, Borrelia test negative, Condition aggravated, Dizziness
Clinical narrative: Pt has a hx of: Bullseye Rash as a child; Mononucleosis at age 5; hemiplegic migraine at age 8, well controlled, medicated ages 8-11. No sx after mediation d/c'd. At age 12, had 3 does of HPV-4 Gardasil (11/2012, 2/2013, 7/2013). Began having increased asthma attacks, dizziness and anxiety in October, 2013. October, 2014 developed weakness of left arm, left leg. Tingling in face. December 2014- ER admission for severe hypokalemia, hypomagnesemia, tachycardia, prolonged QT interval. Sx include: Muscle weakness, Migraines, Seizure-like activity, Hypokalemia, Fatigue, Pruritis, Shortness of breath with simple activity, Alopecia, Neuropathy, Allodynia, Nystagmus, Nausea/vomiting, Periodic Paralysis, Left arm severe pain with episodes of paralysis, Brain fog, Inability to write or perform ADLs, Needed walker or wheelchair for mobility, Difficulty breathing during attacks, On home-bound schooling. Diagnosed with Hypokalemic Periodic Paralysis in 11/2015.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dysgraphia, Dyspnoea, Electrocardiogram QT prolonged, Electromyogram abnormal, Familial periodic paralysis
Clinical narrative: Pt has a hx of: Bullseye Rash as a child; Mononucleosis at age 5; hemiplegic migraine at age 8, well controlled, medicated ages 8-11. No sx after mediation d/c'd. At age 12, had 3 does of HPV-4 Gardasil (11/2012, 2/2013, 7/2013). Began having increased asthma attacks, dizziness and anxiety in October, 2013. October, 2014 developed weakness of left arm, left leg. Tingling in face. December 2014- ER admission for severe hypokalemia, hypomagnesemia, tachycardia, prolonged QT interval. Sx include: Muscle weakness, Migraines, Seizure-like activity, Hypokalemia, Fatigue, Pruritis, Shortness of breath with simple activity, Alopecia, Neuropathy, Allodynia, Nystagmus, Nausea/vomiting, Periodic Paralysis, Left arm severe pain with episodes of paralysis, Brain fog, Inability to write or perform ADLs, Needed walker or wheelchair for mobility, Difficulty breathing during attacks, On home-bound schooling. Diagnosed with Hypokalemic Periodic Paralysis in 11/2015.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Feeling abnormal, Hypokalaemia, Hypomagnesaemia, Migraine
Clinical narrative: Pt has a hx of: Bullseye Rash as a child; Mononucleosis at age 5; hemiplegic migraine at age 8, well controlled, medicated ages 8-11. No sx after mediation d/c'd. At age 12, had 3 does of HPV-4 Gardasil (11/2012, 2/2013, 7/2013). Began having increased asthma attacks, dizziness and anxiety in October, 2013. October, 2014 developed weakness of left arm, left leg. Tingling in face. December 2014- ER admission for severe hypokalemia, hypomagnesemia, tachycardia, prolonged QT interval. Sx include: Muscle weakness, Migraines, Seizure-like activity, Hypokalemia, Fatigue, Pruritis, Shortness of breath with simple activity, Alopecia, Neuropathy, Allodynia, Nystagmus, Nausea/vomiting, Periodic Paralysis, Left arm severe pain with episodes of paralysis, Brain fog, Inability to write or perform ADLs, Needed walker or wheelchair for mobility, Difficulty breathing during attacks, On home-bound schooling. Diagnosed with Hypokalemic Periodic Paralysis in 11/2015.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Monoplegia, Muscular weakness, Nausea, Neuropathy peripheral, Nystagmus
Clinical narrative: Pt has a hx of: Bullseye Rash as a child; Mononucleosis at age 5; hemiplegic migraine at age 8, well controlled, medicated ages 8-11. No sx after mediation d/c'd. At age 12, had 3 does of HPV-4 Gardasil (11/2012, 2/2013, 7/2013). Began having increased asthma attacks, dizziness and anxiety in October, 2013. October, 2014 developed weakness of left arm, left leg. Tingling in face. December 2014- ER admission for severe hypokalemia, hypomagnesemia, tachycardia, prolonged QT interval. Sx include: Muscle weakness, Migraines, Seizure-like activity, Hypokalemia, Fatigue, Pruritis, Shortness of breath with simple activity, Alopecia, Neuropathy, Allodynia, Nystagmus, Nausea/vomiting, Periodic Paralysis, Left arm severe pain with episodes of paralysis, Brain fog, Inability to write or perform ADLs, Needed walker or wheelchair for mobility, Difficulty breathing during attacks, On home-bound schooling. Diagnosed with Hypokalemic Periodic Paralysis in 11/2015.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Paraesthesia, Pruritus, Psychiatric evaluation normal, Seizure like phenomena
Clinical narrative: Pt has a hx of: Bullseye Rash as a child; Mononucleosis at age 5; hemiplegic migraine at age 8, well controlled, medicated ages 8-11. No sx after mediation d/c'd. At age 12, had 3 does of HPV-4 Gardasil (11/2012, 2/2013, 7/2013). Began having increased asthma attacks, dizziness and anxiety in October, 2013. October, 2014 developed weakness of left arm, left leg. Tingling in face. December 2014- ER admission for severe hypokalemia, hypomagnesemia, tachycardia, prolonged QT interval. Sx include: Muscle weakness, Migraines, Seizure-like activity, Hypokalemia, Fatigue, Pruritis, Shortness of breath with simple activity, Alopecia, Neuropathy, Allodynia, Nystagmus, Nausea/vomiting, Periodic Paralysis, Left arm severe pain with episodes of paralysis, Brain fog, Inability to write or perform ADLs, Needed walker or wheelchair for mobility, Difficulty breathing during attacks, On home-bound schooling. Diagnosed with Hypokalemic Periodic Paralysis in 11/2015.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Tachycardia, Thyroid function test normal, Vomiting, Walking aid user, Wheelchair user
Clinical narrative: Pt has a hx of: Bullseye Rash as a child; Mononucleosis at age 5; hemiplegic migraine at age 8, well controlled, medicated ages 8-11. No sx after mediation d/c'd. At age 12, had 3 does of HPV-4 Gardasil (11/2012, 2/2013, 7/2013). Began having increased asthma attacks, dizziness and anxiety in October, 2013. October, 2014 developed weakness of left arm, left leg. Tingling in face. December 2014- ER admission for severe hypokalemia, hypomagnesemia, tachycardia, prolonged QT interval. Sx include: Muscle weakness, Migraines, Seizure-like activity, Hypokalemia, Fatigue, Pruritis, Shortness of breath with simple activity, Alopecia, Neuropathy, Allodynia, Nystagmus, Nausea/vomiting, Periodic Paralysis, Left arm severe pain with episodes of paralysis, Brain fog, Inability to write or perform ADLs, Needed walker or wheelchair for mobility, Difficulty breathing during attacks, On home-bound schooling. Diagnosed with Hypokalemic Periodic Paralysis in 11/2015.
Age: 0.98
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to 11 months old patient of unknown gender. The patient's concurrent conditions, past medical history were not reported. On 10-DEC-2015, the patient was vaccinated with an improperly stored ROTATEQ (lot # K014826, expiry date 28-MAY-2016, dose, strength, vaccination site, dose number unspecified). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint (PQC) was not reported. On 26-JAN-2016, a phone call was placed to the physician. The physician was unavailable at the time of call. The pone call was transferred to the Certified Medical Assistant (CMA). The C.M.A was unable to place specific lot numbers for each of the reported vaccines that experienced a temperature excursion; M-M-R II, ROTATEQ and VAQTA, with the information already supplied for patient identifiers, date of birth and date of vaccination, at this time. The C.M.A will need to review the records. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Asthenia, Dizziness, Headache
Clinical narrative: Pt states she had a headache and felt dizzy, two hours after the vaccine. Pt reports then feeling weak and went to sleep early. Pt woke this morning with the same symptoms.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Urticaria
Clinical narrative: Generalized hives (urticaria) after 1 hr-1 1/2 hr vaccination. No systemic symptoms. Resolved by 3 doses of BENADRYL (oral).