chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant regarding a patient of unknown age and gender. Information on the concurrent conditions and medical history of the patient was not reported. On 29-MAR-2016, the patient was vaccinated with unspecified doses of improperly stored GARDASIL lot #, expiry date dose, units, frequency, route and anatomical location were not specified). Concomitant medication were not reported. There were no adverse effects reported. There was no Product Quality Complaint (PQC) involved. Temperature and time frame at which the product was exposed was 33 degree Fahrenheit for 72 hours. Temperature and time frame at which the product was exposed previously: 34 degree Fahrenheit for 72 hours and 47 degree Fahrenheit for 12 hours. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse regarding a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 25-MAY-2016, the patient was vaccinated with an expired 0.5 mL dose of PROQUAD (lot # K021548; expiration date: 06-MAY-2016), intramuscularly. Concomitant therapies were not reported.  No adverse effects were reported. Additional information is not expected as reporter did not want to be contacted for follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX injection (strength, dose, route and site of administration were unspecified). It was reported that, on an unknown date, the patient "still ended up getting shingles". The outcome of the events was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information had been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Immediate post-injection reaction, Injection site rash, Injection site urticaria, Rash, Urticaria
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of rash in a 4-year-old male patient who received KINRIX (batch number GM7X3, expiry date 13th November 2017). Concomitant products included PROQUAD. On 1st June 2016, the patient received the 1st dose of KINRIX. On 1st June 2016, immediately after receiving KINRIX, the patient experienced rash and hives. The patient was treated with BENADRYL. On 1st June 2016, the outcome of the rash and hives were recovered/resolved. It was unknown if the reporter considered the rash and hives to be related to KINRIX. Additional details were provided as follows: The patient received the 1st dose of KINRIX concomitantly with PROQUAD and immediately after receiving both vaccines, the patient experienced a rash and hives beginning on his abdomen, and then it got spread to both arms, growing area, face and jaw. The patient was treated with Benadryl and was monitored in the office. The patient would follow up with an allergist. The reported batch number of KINRIX (UM7X3) did not exist and was updated to GM7X3 as per sales database.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of rash in a 4-year-old male patient who received KINRIX (batch number GM7X3, expiry date 13th November 2017). Concomitant products included PROQUAD. On 1st June 2016, the patient received the 1st dose of KINRIX. On 1st June 2016, immediately after receiving KINRIX, the patient experienced rash and hives. The patient was treated with BENADRYL. On 1st June 2016, the outcome of the rash and hives were recovered/resolved. It was unknown if the reporter considered the rash and hives to be related to KINRIX. Additional details were provided as follows: The patient received the 1st dose of KINRIX concomitantly with PROQUAD and immediately after receiving both vaccines, the patient experienced a rash and hives beginning on his abdomen, and then it got spread to both arms, growing area, face and jaw. The patient was treated with Benadryl and was monitored in the office. The patient would follow up with an allergist. The reported batch number of KINRIX (UM7X3) did not exist and was updated to GM7X3 as per sales database.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Immediate post-injection reaction, Injection site rash, Injection site urticaria, Rash, Urticaria
Clinical narrative: Hives abdomen area, arms near elbows, groin area. Face: one small by (R) jaw. No respiratory symptoms.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: Hives abdomen area, arms near elbows, groin area. Face: one small by (R) jaw. No respiratory symptoms.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 year old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were unspecified. The pharmacist stated that, the patient on 23 MAY-2016 (reported as yesterday), was administered ZOSTAVAX vial (strength, dose number, lot#/expiration date, dose, frequency and route unspecified), was experiencing unspecified symptoms approximately on 23-MAY-2016 (reported as starting on an unspecified date). So that on 23-MAY-2016 (reported as today), her physician prescribed her a MEDROL dose pack and ZITHROMAX. The pharmacist did not have information as to why the physician ordered these medications. Therapy with ZOSTAVAX was not discontinued. Outcome of the event was unknown. Product quality complaint (PQC) was not involved. Causality assessment was not provided. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to eight unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 01-JUN-2016, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # reported as L048680, expiration date June 2017; exact doses and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccines were exposed to temperature of 51.3 degree Fahrenheit for 4.5 hours and 31.2 degree Fahrenheit for 1 hour 10 minutes (1 cycle) before administration to the patients. No previous temperature excursion was reported. No adverse effects were reported. Additional information has not been provided.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Seizure
Clinical narrative: Initial unsolicited report received from a nurse on 01 June 2016. This case involves 4-year-old male patient who was vaccinated with a dose of DTAP (batch number was reported as unknown, route and site of administration not reported) on an unspecified date. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had experienced seizure and unable to relate any information on the seizure including if he was febrile at the time. It was told by pediatrician never to take pertussis vaccine again. The patient required ER/doctor visit. Laboratory data was reported as none. The patient's corrective treatment was not reported. On an unspecified date, the patient was recovered from event. Upon internal review the case was considered as serious because of important medical event seizure. List of documents held by sender: none. Sender's Comments: This is a poorly documented case. Time to onset is unknown. Additional information on the patient's medical history and immunization history, vaccination details, complementary investigation results ruling out a concurrent infection and exploration of alternate etiologies is needed to further assess this case. Based on the available information, the role of the vaccine cannot be evaluated.
Age: 15.0
Sex: M
Vaccine: IPV, MMRV
Symptoms: Injection site erythema, Injection site warmth, Peripheral swelling
Clinical narrative: Swelling of left upper arm. Received IVP and MMRV on 06/16/2016 at 4:26PM and noticed swelling since then Reports Erythema and warmth in area. Denies fever.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Anaphylactic reaction, Hypersensitivity, Respiratory distress, Urticaria
Clinical narrative: Pt had an anaphylactic reaction 40min after immz where administered. Pt presented with hives all over body and was in moderate resp distress. Pt was immediately give Epi Jr and shortly after symptoms began to subside, 911 was called and pt was transported to the hospital for further care.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Dysstasia, Electromyogram abnormal, Guillain-Barre syndrome, Hypoaesthesia, Laboratory test normal
Clinical narrative: Lower extremity weakness. Physical and occupational therapy. Dx: Guillain-Barre. Electrodiagnostic Study consistent with GBS. 78yo active male with PMHx of HTN presenting with BL LE weakness that started this AM. He was in his usual state of health yesterday and walked 2 miles without problems. Today he awoke without issues and ate a grapefruit for breakfast. Shortly after he was walking around his house and his legs felt weak like his knees were going to buckle. He sat in his chair and watched some football and when he tried to get out of his chair he couldn't get up. His legs felt like they just couldn't support him. He is no longer able to stand. He has some mild toe numbness but nothing significant. He is able to lift BL LE off of the bed during eval. He denies inciting event or back pain. No sciatica symptoms. No problems with bladder/bowel issues, no saddle anesthesia, no fevers, rash, change in medications, or trauma. Labs at the local ER were essential normal. Neurology asked me to evaluate and admit for them tonight. He denies chest pain or shortness of breath. He did receive pneumococcal vaccine about 1.5 weeks ago.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Muscular weakness, Weight bearing difficulty
Clinical narrative: Lower extremity weakness. Physical and occupational therapy. Dx: Guillain-Barre. Electrodiagnostic Study consistent with GBS. 78yo active male with PMHx of HTN presenting with BL LE weakness that started this AM. He was in his usual state of health yesterday and walked 2 miles without problems. Today he awoke without issues and ate a grapefruit for breakfast. Shortly after he was walking around his house and his legs felt weak like his knees were going to buckle. He sat in his chair and watched some football and when he tried to get out of his chair he couldn't get up. His legs felt like they just couldn't support him. He is no longer able to stand. He has some mild toe numbness but nothing significant. He is able to lift BL LE off of the bed during eval. He denies inciting event or back pain. No sciatica symptoms. No problems with bladder/bowel issues, no saddle anesthesia, no fevers, rash, change in medications, or trauma. Labs at the local ER were essential normal. Neurology asked me to evaluate and admit for them tonight. He denies chest pain or shortness of breath. He did receive pneumococcal vaccine about 1.5 weeks ago.
Age: 3.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Gait disturbance, Injection site erythema, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: 3 year 9 month old male presents to clinic with c/o temp around 100 since recieving vaccine yesterday but temp spike to 103 Oral and pt is not standing or walking on right leg. Pt with tenderness around injection site to right upper leg from vaccinations on 6/7. Minimal erythema, the right upper leg is slightly edematous. Pt will not bear any weight on the right leg. Mom reports pt was acting normal all yesterday afternoon after vaccinations. She reports he was running around and helped build a fort at home without any complaints. Mom reports about 2300 pt was laying in bed and requested assistance up to go to the bathroom as well as reported pain to his right upper leg. Mom reports pt has had a fever today, highest of 100.7. She reports pt has not ambulated at all today and has required assistance to use the restroom as he will not stand alone on his left leg. Follow up tomorrow, 6/9 even if improvement. Discussed exam findings with patient/parent, mom reports she wants to hold off on lab draw (CBC & Sed rate) and will continue to monitor pt's status. She reports she will more diligently alternate IBU/APAP as well as apply cool compresses to the leg. She verbalized her understanding of if patient status worsens to seek treatment at the ER. IBU administered orally while pt in clinic.
Age: 3.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Weight bearing difficulty, X-ray limb
Clinical narrative: 3 year 9 month old male presents to clinic with c/o temp around 100 since recieving vaccine yesterday but temp spike to 103 Oral and pt is not standing or walking on right leg. Pt with tenderness around injection site to right upper leg from vaccinations on 6/7. Minimal erythema, the right upper leg is slightly edematous. Pt will not bear any weight on the right leg. Mom reports pt was acting normal all yesterday afternoon after vaccinations. She reports he was running around and helped build a fort at home without any complaints. Mom reports about 2300 pt was laying in bed and requested assistance up to go to the bathroom as well as reported pain to his right upper leg. Mom reports pt has had a fever today, highest of 100.7. She reports pt has not ambulated at all today and has required assistance to use the restroom as he will not stand alone on his left leg. Follow up tomorrow, 6/9 even if improvement. Discussed exam findings with patient/parent, mom reports she wants to hold off on lab draw (CBC & Sed rate) and will continue to monitor pt's status. She reports she will more diligently alternate IBU/APAP as well as apply cool compresses to the leg. She verbalized her understanding of if patient status worsens to seek treatment at the ER. IBU administered orally while pt in clinic.
Sex: F
Vaccine: FLUX(H1N1), HEP
Symptoms: Sleep apnoea syndrome, Sleep study abnormal, Somnolence, Surgery
Clinical narrative: This case was reported by a consumer and described the occurrence of narcolepsy in a adult female patient who received Hepatitis B vaccine. Co-suspect products included H1N1 vaccine. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose and H1N1 vaccine at an unknown dose. On an unknown date, an unknown time after receiving Hepatitis B vaccine and H1N1 vaccine, the patient experienced narcolepsy (serious criteria GSK medically significant), sleep apnea, daytime sleepiness, muscle weakness, fatigue and nightmare. On an unknown date, the outcome of the narcolepsy, sleep apnea, daytime sleepiness, muscle weakness, fatigue and nightmare were not recovered/not resolved. It was unknown if the reporter considered the narcolepsy, sleep apnea, daytime sleepiness, muscle weakness, fatigue and nightmare to be related to Hepatitis B vaccine. Additional details were provided as follows: The patient had worked in the healthcare industry from 2007-2010. The patient received Hepatitis B and influenza with H1N1 vaccines. Since 2009, the patient always had sleep apnea and have worn a continuous positive airway pressure (CPAP), due to this she had struggled over time with daytime sleepiness. Things changed and the daytime sleepiness progressively worsened. The patient's regular physician sent her to an ENT and she had surgery to help her apnea. Her severe apnea improved between the surgery and the CPAP, but the daytime sleepiness turned scary, she fell asleep while driving daily, muscle weakness and fatigue took over her body and nothing was helping. The ENT sent the patient to a specialist with a sleep disorder degree. He suspected narcolepsy. The patient had to take a stimulant to keep her awake to function, since she was a mother and had a career too. With the help of a stimulant, she can stay awake long enough to get her through the day, but every 2 hours she was hit with this overwhelming exhaustion. Sometimes it was so bad that she went into automatic behavior, felt like sleeping with eyes open. The patient's sleep study showed that she entered REM (Rapid eye movement) within 5 minutes of sleep and did not come out of it. She struggled daily to get out of bed and with each day it as a guess on how she would feel. The patient's blood test showed low levels of hypocretin. Her thin frame was now considered obese. The patient experienced terrifying nightmare, where she screamed out and jump in her sleep and was classic narcolepsy. The patient knew and remembered the narcolepsy cases in another country in 2009. She inquired about how many cases had been reported after H1N1 in this country. She had taken shots since 2003, with her current symptoms and asked should she not receive the vaccines and if she did would it worsen her current symptoms. She inquired about her low levels of hypocretin could be genetic and should she not allow her children to be vaccinated with the H1N1 to be safe. Currently they had also received H1N1 vaccines since 2003 and she was worried about seeing the same symptoms in them.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Headache, Herpes zoster, Malaise
Clinical narrative: This spontaneous report was received from a 71 year old male patient, community health educator with no know allergies. The patient's medical history included hypertension. The patient's concurrent conditions were not provided. On an unspecified date in 2014 (reported as 2 years ago), the patient was vaccinated with a dose of ZOSTAVAX, dose of 0.65 ml, subcutaneously (dose number, frequency, concentration, lot number and expiration date were not reported). There were no concomitant medications reported. On 12-APR-2016 the patient experienced pain in his toes, right knee and back, for which he went to an urgent care on an unspecified date and as a result, on 17-APR-2016, the patient was diagnosed with "shingles" and was prescribed with Acyclovir for 10 days. On an unspecified date in 2016, the patient sought medical attention. On an unknown date the patient experienced headache and general malaise. It was also reported that there was no intervention to prevent serious criteria; significant disability or hospitalization and it was not considered to be life threatening. There was no product quality complaint (PQC) involved. At the time of reporting, the outcome of herpes zoster, headache and malaise was reported as recovering. The primary reporter did not provide the causal relationship between ZOSTAVAX and the events. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report was received from a 71 year old male patient, community health educator with no know allergies. The patient's medical history included hypertension. The patient's concurrent conditions were not provided. On an unspecified date in 2014 (reported as 2 years ago), the patient was vaccinated with a dose of ZOSTAVAX, dose of 0.65 ml, subcutaneously (dose number, frequency, concentration, lot number and expiration date were not reported). There were no concomitant medications reported. On 12-APR-2016 the patient experienced pain in his toes, right knee and back, for which he went to an urgent care on an unspecified date and as a result, on 17-APR-2016, the patient was diagnosed with "shingles" and was prescribed with Acyclovir for 10 days. On an unspecified date in 2016, the patient sought medical attention. On an unknown date the patient experienced headache and general malaise. It was also reported that there was no intervention to prevent serious criteria; significant disability or hospitalization and it was not considered to be life threatening. There was no product quality complaint (PQC) involved. At the time of reporting, the outcome of herpes zoster, headache and malaise was reported as recovering. The primary reporter did not provide the causal relationship between ZOSTAVAX and the events. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 18-MAY-2016, the patient was vaccinated with improperly stored (temperature: -11 Celsius for 216 hours) ZOSTAVAX vial 19400 plaque forming units (PFU) lot # L037791 (expiry date: 30-DEC-2016) (dosage not reported). No previous temperature excursion reported. No adverse symptoms 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 refers to a multiple, unspecified patients of an unknown age and gender. The patients relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the multiple unspecified patients were vaccinated with improperly stored doses (temperature 15F for 3 hours) of ZOSTAVAX lot# L012477 (expiry date: 10-JUL-2016); lot# L000461 (expiry date: 18-MAR-2016) (dosage not reported). No adverse effects reported. The multiple, unspecified patients were exposed to previous temperature excursion: a high temperature of 21F for 14 hours. The cumulative time out of range was 17 hours, including this excursion. The temperature was back in range. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a multiple, unspecified patients of an unknown age and gender. The patients relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the multiple unspecified patients were vaccinated with improperly stored doses (temperature 15F for 3 hours) of VARIVAX lot# L008273 (expiry date: 11-MAR-2017), lot# L005298 (expiry date: 17-FEB-2017) (dosage not reported). No adverse effects reported. The multiple, unspecified patients were exposed to previous temperature excursion: a high temperature of 21F for 14 hours. The cumulative time out of range was 17 hours, including this excursion. The temperature was back in range. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Blister, Injection site vesicles
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 5 year and 2 months old male patient. The patient medical history and concurrent conditions were not reported. On 17-SEP-2012, the patient was vaccinated with a dose of M-M-R II (route of administration, dose, lot number and expiry date were not reported) and VARIVAX (route of administration, dose, lot number and expiry date were not reported). Subsequently, on 06-MAY-2016, the patient was vaccinated with a dose of PROQUAD (subcutaneously, dose, lot number and expiry date were not reported). On an unknown date in May 2016, a couple of days ago, the patient developed vesicles on his legs, arms, chest, back and face. The patient sought medical attention, presented to the reporting nurse at the office. No treatment was given for the adverse event and no laboratory test diagnostic was performed. At the time of the report, the patient did not recover from vesicles on his legs, arms, chest, back and face. The relatedness between the adverse event of vesicles on his legs, arms, chest, back and face and vaccination with M-M-R II , VARIVAX and PROQUAD was not reported. Additional information has been requested.
Age: 35.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 35 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-MAR-2016, the patient was vaccinated with the improperly stored dose of RECOMBIVAX HB (1 ml, in left deltoid, lot # reported as 042846 (verified to be non valid), expiration date 15-SEP-2017; route was not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected as all the correspondence was returned by the post office.
Age: 39.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 39 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-MAR-2016, the patient was vaccinated with the improperly stored dose of RECOMBIVAX HB (1 ml, intramuscularly in left deltoid, lot # reported as 042846 (verified to be non-valid), expiration date 15-SEP-2017). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected as all the correspondence was returned by the post office.
Age: 51.0
Sex: F
Vaccine: HEP, MMR, TDAP, HEP, MMR, TDAP
Symptoms: Arthralgia, Burning sensation, Chest pain, Chills, Decreased appetite
Clinical narrative: Excruciating headache, fever, chills, high blood pressure, chest pain, heart rate 100-124, general discomfort. General decay, joint pain, loss of appetite.  By the second week, swelling of the lymph nodes in the neck, swollen tongue and extreme dryness of the mouth and throat.  The arms don't respond to reflexes, severe burning on the mediastinum. Lasting to today, disoriented, dizziness, nausea and others.
Age: 51.0
Sex: F
Vaccine: HEP, MMR, TDAP, HEP, MMR, TDAP
Symptoms: Discomfort, Disorientation, Dizziness, Dry mouth, Dry throat
Clinical narrative: Excruciating headache, fever, chills, high blood pressure, chest pain, heart rate 100-124, general discomfort. General decay, joint pain, loss of appetite.  By the second week, swelling of the lymph nodes in the neck, swollen tongue and extreme dryness of the mouth and throat.  The arms don't respond to reflexes, severe burning on the mediastinum. Lasting to today, disoriented, dizziness, nausea and others.
Age: 51.0
Sex: F
Vaccine: HEP, MMR, TDAP, HEP, MMR, TDAP
Symptoms: General physical health deterioration, Headache, Hypertension, Lymphadenopathy, Nausea
Clinical narrative: Excruciating headache, fever, chills, high blood pressure, chest pain, heart rate 100-124, general discomfort. General decay, joint pain, loss of appetite.  By the second week, swelling of the lymph nodes in the neck, swollen tongue and extreme dryness of the mouth and throat.  The arms don't respond to reflexes, severe burning on the mediastinum. Lasting to today, disoriented, dizziness, nausea and others.
Age: 51.0
Sex: F
Vaccine: HEP, MMR, TDAP, HEP, MMR, TDAP
Symptoms: Pyrexia, Reflexes abnormal, Swollen tongue
Clinical narrative: Excruciating headache, fever, chills, high blood pressure, chest pain, heart rate 100-124, general discomfort. General decay, joint pain, loss of appetite.  By the second week, swelling of the lymph nodes in the neck, swollen tongue and extreme dryness of the mouth and throat.  The arms don't respond to reflexes, severe burning on the mediastinum. Lasting to today, disoriented, dizziness, nausea and others.
Age: 51.0
Sex: F
Vaccine: HEP, MMR, TDAP, HEP, MMR, TDAP
Symptoms: Amenorrhoea, Arthralgia, Blood potassium decreased, Chest pain, Diarrhoea
Clinical narrative: Excruciating headache, fever, chills, high blood pressure, chest pain, heart rate 100-124, general discomfort. General decay, joint pain, loss of appetite.  By the second week, swelling of the lymph nodes in the neck, swollen tongue and extreme dryness of the mouth and throat.  The arms don't respond to reflexes, severe burning on the mediastinum. Lasting to today, disoriented, dizziness, nausea and others.
Age: 51.0
Sex: F
Vaccine: HEP, MMR, TDAP, HEP, MMR, TDAP
Symptoms: Dizziness, Fatigue, Headache, Hypertension, Lymphadenopathy
Clinical narrative: Excruciating headache, fever, chills, high blood pressure, chest pain, heart rate 100-124, general discomfort. General decay, joint pain, loss of appetite.  By the second week, swelling of the lymph nodes in the neck, swollen tongue and extreme dryness of the mouth and throat.  The arms don't respond to reflexes, severe burning on the mediastinum. Lasting to today, disoriented, dizziness, nausea and others.
Age: 51.0
Sex: F
Vaccine: HEP, MMR, TDAP, HEP, MMR, TDAP
Symptoms: Mobility decreased, Nausea, Pain, Pain in extremity, Sensitivity of teeth
Clinical narrative: Excruciating headache, fever, chills, high blood pressure, chest pain, heart rate 100-124, general discomfort. General decay, joint pain, loss of appetite.  By the second week, swelling of the lymph nodes in the neck, swollen tongue and extreme dryness of the mouth and throat.  The arms don't respond to reflexes, severe burning on the mediastinum. Lasting to today, disoriented, dizziness, nausea and others.
Age: 51.0
Sex: F
Vaccine: HEP, MMR, TDAP, HEP, MMR, TDAP
Symptoms: Swollen tongue, Tachycardia, Vomiting
Clinical narrative: Excruciating headache, fever, chills, high blood pressure, chest pain, heart rate 100-124, general discomfort. General decay, joint pain, loss of appetite.  By the second week, swelling of the lymph nodes in the neck, swollen tongue and extreme dryness of the mouth and throat.  The arms don't respond to reflexes, severe burning on the mediastinum. Lasting to today, disoriented, dizziness, nausea and others.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Abdominal pain upper, Headache, Nausea
Clinical narrative: Child awoke with headache, stomach ache. Nausea.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Decreased appetite, Fatigue, Hypophagia, Injection site erythema
Clinical narrative: Chills, fatigue that same day (Thurs); Day 2 had chills, fatigue, no appetite, no food, stayed in bed (Fri); Day 3 no improvement, fatigue, no appetite, no food, stayed in bed;  Day 4 some improvement, had broth to eat, was up for a time (Sun);  Day 5 - finally, up and functioning, appetite returning. AT SITE of INJECTION, on Sunday, itching and redness with heat, and inflammation about 3" x 7" area near injection site.  Still exists today, 6/9/2016.  not yet recovered one week later.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site inflammation, Injection site pruritus, Injection site warmth
Clinical narrative: Chills, fatigue that same day (Thurs); Day 2 had chills, fatigue, no appetite, no food, stayed in bed (Fri); Day 3 no improvement, fatigue, no appetite, no food, stayed in bed;  Day 4 some improvement, had broth to eat, was up for a time (Sun);  Day 5 - finally, up and functioning, appetite returning. AT SITE of INJECTION, on Sunday, itching and redness with heat, and inflammation about 3" x 7" area near injection site.  Still exists today, 6/9/2016.  not yet recovered one week later.
Age: 58.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 58 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-MAR-2016, the patient was vaccinated with the improperly stored dose of RECOMBIVAX HB (1 ml, intramuscularly in left deltoid, lot # reported as 042846 (verified to be non-valid), expiration date 15-SEP-2017). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected as all the correspondence was returned by the post office.
Age: 33.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a back office lead and refers to a 33 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 26-MAR-2016, the patient was vaccinated with the improperly stored dose of RECOMBIVAX HB (1 ml, intramuscularly in right deltoid, lot # reported as L042856 (verified to be non-valid), expiration date 15-SEP-2017). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected as all the correspondence was returned by the post office.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Eyelid rash, Herpes zoster, Pain, Pruritus
Clinical narrative: This spontaneous report as received from a 70 year female patient, who was reporting on herself. None pertinent medical history, drug reaction/allergies and concomitant medications was reported. On an unspecified day in April 2015, the patient was vaccinated with ZOSTAVAX (lot number, expiration date, dose and route of administration were not reported). On 23-MAY-2016, the patient developed shingles. The first symptom was a clear bump with a hole in it on her left eyelid. More of the same bumps developed in the left eyebrow area. She also had shooting pains in the left eye area. She took TYLENOL but sent a photo of the bumps to her unspecified physician, who diagnosed her from the photo as having shingles. No labs performed. He prescribed an antiviral and and antifungal that she was taking along with an over the counter probiotic. It was reported that the patient was treated with doxycycline and valacyclovir. She also was using Res-Q by the itchy areas. the bumps were almost gone. One had some redness around it and fluid. The patient was recovering from the event. There was no product quality complaint. The relatedness between the event and ZOSTAVAX was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 1.04
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number, expiration date, dose and route of administration were not reported). On an unknown date, the patient developed shingles. The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Peripheral swelling, Swelling
Clinical narrative: Given on 6/4/16. Side effects started 6/4 (evening) - red. On 6/5 (morning) - aching and swollen, continued to swell (hurting from shoulder to finger tips).
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician and refers to a 22 year old female patient. The patient did not have any pertinent medical history, drug reactions, allergies and concomitant therapies. On 18-MAY-2016, the patient, who was at four to six weeks of gestation, was inadvertently vaccinated with M-M-R II (lot #, expiration date, exact dose and route of administration were not reported). No adverse effects were reported. The patient sought medical attention and was seen in the physician's office. No lab diagnostic studies were performed. The last menstrual period (LMP) and estimated delivery date (EDD) were not specified. The pregnancy outcome was pending. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema
Clinical narrative: Redness on del (Rt) going up to shoulder
Age: 56.0
Sex: F
Vaccine: TD
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: c/o severe pain in arm, generalized body aches, fever chills started on day of Td vaccine 5/2/16, lasted 3-4 days and then resolved.
Age: 0.48
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Decreased appetite, Pyrexia, Urine output decreased
Clinical narrative: Fever x 3 days, decreased appetite, decrease urine output. Denies localized pain, diarrhea or vomiting.
Sex: F
Vaccine: MMR
Symptoms: Hypotonia, Loss of consciousness
Clinical narrative: This report is received from a consumer (patient's mother), as part of a marketing research program, refers to a female patient of unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date, the subject was vaccinated with a dose of MMR (manufacturer unknown) (lot #, expiration date, dose, route and site of vaccination were not reported). Concomitant medications were not reported. On an unknown date (few days after vaccination), the subject had a reaction and she passed out playing in the car. The reporter's husband ran her limp daughter to a doctor. The patient was fine but the final outcome of the events of passed out and unspecified reaction was not reported. The relatedness between the events and MMR (manufacturer unknown) was not reported. Additional information is not expected as there was no consent for further contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On an unknown date, the patient was vaccinated with 1 dose of improperly stored VARIVAX from either Lot # reported as L050560, expiry date: 14-DEC-2017, Lot # L044525, expiry date: 9-NOV-2017, Lot # reported as M002063, expiry date: 12-JAN-2018, Lot # L050956, expiry date: 17-DEC-2017 or Lot # L044524, expiry date: 09-NOV-2017 (dose, frequency and route of administration were not reported). Nurse was unable to confirm which lot the dose was administered from. No adverse effects reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site inflammation, Injection site urticaria
Clinical narrative: Vaccine given 6/7/16. Pt came to office today 6/9/16 with guardian. Pt has 8 mm wheal and 10 cm flare on R lateral thigh and has enlarged by 2 cm since onset 6/8/16. No complaint of pain. MD recommended ice and BENADRYL.
Age: 5.0
Sex: F
Vaccine: UNK
Symptoms: Gait disturbance, Local swelling, Tenderness
Clinical narrative: Localized swelling 1 cm, firm, tender, mobile. Walks with slight limp.
Age: 10.0
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Administered adult dose of hep A.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown gender and age, who on unspecified dates received an improperly stored dose of PEDVAXHIB, intramuscular injection, lot number L042257, expiration date 17-AUG-2018 and another lot number reported as L042259, expiration date 18-AUG-2018 (dose, route and anatomical location were not reported). No adverse effects were reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Administered adult dose of hep A
Age: 14.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, Syringe issue, Underdose
Clinical narrative: Administered incorrect dose of hep A - and there was a syringe failure - so only half dose was administered (disconnected at hub).
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of allergic reaction in a 67-year-old female patient who received Seasonal Influenza vaccine. Concurrent medical conditions included drug allergy (Gabapentin, NEURONTIN, COMPAZINE). On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to Seasonal Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. It was reported that, the patient was also taking some prescription and over the counter medications like, Acetylsalicylic acid, Valsartan, Metoprolol, Repaglinide, Mepyramine, LYRICA, Tramadol, Stool softener, PRILOSEC, Duloxetine.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Diarrhoea, Headache, Pyrexia
Clinical narrative: PT EXPERIENCE HEADACHE, CHILLS, SLIGHT FEVER, AND DIARRHEA AFTER RECEIVING BOOSTRIX SHOT.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 6/3-6/4: Patient complained of sore legs and felt sick. 6/5-6/6: Patient legs felt better but new complaint of localized swelling, "hotness", and "redness" at site of injection (left deltoid) with itching and light pain. 6/7: Patient went to see MD and was prescribed levocetirizine and prednisone. When inquired, per husband, pt feels a little better. Pharmacist suggested could ice along with medications prescribed.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Local swelling, Malaise, Pain in extremity
Clinical narrative: 6/3-6/4: Patient complained of sore legs and felt sick. 6/5-6/6: Patient legs felt better but new complaint of localized swelling, "hotness", and "redness" at site of injection (left deltoid) with itching and light pain. 6/7: Patient went to see MD and was prescribed levocetirizine and prednisone. When inquired, per husband, pt feels a little better. Pharmacist suggested could ice along with medications prescribed.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Peripheral swelling
Clinical narrative: REDNESS AROUND THE AREA OF ADMINISTRATION. SWELLING SPREAD FROM ELBOW TO SHOULDER.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Mass, Pruritus
Clinical narrative: Started itching the night on the day the vaccine was administered, but didn't notice lump until the next day.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: On 06/09/2016 at 2:00PM.  Patient came into the pharmacy reported Adverse reaction occured the day after pt being vaccinated.  Patient stated redness, harden to touch, fluid pocket away from the injection side towards innard arm.  No chills, no fever.  The adverse reactions went away after 6 days report per patient.  Patient did not call to report the adverse reaction during that 6 days period. She did not report to doctor's office either.  Patient stated that the injection site and her arm went back to normal after 6 days. Pharmacist looked at patient's arm and the injection site on 06/09/2016 - no adveres reaction noted at this time.
Age: 44.0
Sex: F
Vaccine: HEPAB, RAB, TDAP
Symptoms: Cough, Decreased appetite, Headache, Injection site pain, Lethargy
Clinical narrative: On Thursday, 6/2/2016 pt received the following vaccines: Boostrix, Twinrix #2 and Imovax #3. That night, pt experienced "extremely sore / painfully achy arms from shoulders to hands" that improved over the course of the night. On Sunday, 6/5/2016, pt experienced the following symptoms: body aches in the upper legs/thighs, feet, back and buttox. These were temporarily relieved with a hot shower and tub soak. She also had a sore throat, swollen glands, light cough, nausea, lethargy, thirst, low appetite and a light headache. She felt much improved Monday 6/6/2016 and most of her symptoms had either completely resolved or diminished, although her sore throat and cough continued through 6/8/2016.
Age: 44.0
Sex: F
Vaccine: HEPAB, RAB, TDAP
Symptoms: Lymphadenopathy, Nausea, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: On Thursday, 6/2/2016 pt received the following vaccines: Boostrix, Twinrix #2 and Imovax #3. That night, pt experienced "extremely sore / painfully achy arms from shoulders to hands" that improved over the course of the night. On Sunday, 6/5/2016, pt experienced the following symptoms: body aches in the upper legs/thighs, feet, back and buttox. These were temporarily relieved with a hot shower and tub soak. She also had a sore throat, swollen glands, light cough, nausea, lethargy, thirst, low appetite and a light headache. She felt much improved Monday 6/6/2016 and most of her symptoms had either completely resolved or diminished, although her sore throat and cough continued through 6/8/2016.
Age: 44.0
Sex: F
Vaccine: HEPAB, RAB, TDAP
Symptoms: Thirst
Clinical narrative: On Thursday, 6/2/2016 pt received the following vaccines: Boostrix, Twinrix #2 and Imovax #3. That night, pt experienced "extremely sore / painfully achy arms from shoulders to hands" that improved over the course of the night. On Sunday, 6/5/2016, pt experienced the following symptoms: body aches in the upper legs/thighs, feet, back and buttox. These were temporarily relieved with a hot shower and tub soak. She also had a sore throat, swollen glands, light cough, nausea, lethargy, thirst, low appetite and a light headache. She felt much improved Monday 6/6/2016 and most of her symptoms had either completely resolved or diminished, although her sore throat and cough continued through 6/8/2016.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, RV5
Symptoms: Aphasia, Decreased eye contact, Developmental delay, Eczema, Emotional distress
Clinical narrative: Lethargy and excessive sleepiness for at least 72 hours; high pitched inconsolable screaming on day three for at least three hours, followed by loss of speech, loss of eye contact, development of sensory processing dysfunction, plateau in development, eczema and new food sensitivities.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, RV5
Symptoms: Food allergy, Gene mutation identification test positive, Lethargy, Methylenetetrahydrofolate reductase gene mutation, Screaming
Clinical narrative: Lethargy and excessive sleepiness for at least 72 hours; high pitched inconsolable screaming on day three for at least three hours, followed by loss of speech, loss of eye contact, development of sensory processing dysfunction, plateau in development, eczema and new food sensitivities.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, RV5
Symptoms: Sensory processing disorder, Somnolence
Clinical narrative: Lethargy and excessive sleepiness for at least 72 hours; high pitched inconsolable screaming on day three for at least three hours, followed by loss of speech, loss of eye contact, development of sensory processing dysfunction, plateau in development, eczema and new food sensitivities.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: After injection upper arm extremely sore, 4-5 hrs later unable to raise arm without intense pain in shoulder and upper arm area. After several days with no improvement contacted PCP. RX Oral Prednisone. Still no improvement, PCP made referral to Orthopedic Surgeon who administered an injection to the site. Within 48 hrs the pain was gone. Approx. 5 months later the pain returned.