chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unspecified number of patients of unknown age and gender. Information about patient's concurrent conditions and medical history was not reported. The physician reported that the patients were vaccinated with dose of improperly stored ROTATEQ (dose not reported, lot number L000425 with expiration date 21-JUN-2016, orally) on unspecified dates starting on or after 14-SEP-2015. No adverse effect was reported. This is one of several reports received from the same reporter (other linked case # 1510USA010197). Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unspecified number of patients of unknown age and gender. Information about patients' concurrent conditions and medical history was not reported. The physician reported that the patients were vaccinated with doses of improperly stored VAQTA (dose and route not reported, lot number reported as L023936 with expiration date 15-MAR-2017) on unspecified dates starting on or after 14-SEP-2015. No adverse effect was reported. This is one of several reports received from the same reporter (other linked case # 1510USA010113). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history of the patients were not reported. Between the dates of 01-SEP-2015 and 07-OCT-2015, the patients were inadvertently vaccinated with doses of improperly stored M-M-R II (lot # L005290, expiration date 17-FEB-2017 and lot # K018990, expiration date 15-OCT-2016, dose and route unspecified). Other suspect therapies were not reported. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a healthcare student referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. In approximately October 2014 (reported as a year ago), the immunocompetent patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot # were not reported). On an unknown date of 2015 (reported a few days ago). the patient inadvertently received a second dose of PNEUMOVAX 23 (dose, lot #, expiration date and route were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. There was no medical history or concurrent condition reported. On unknown dates since 25-SEP-2015, the unspecified patients were vaccinated with doses of improperly stored VARIVAX (Merck) (lot # L013827, expiration date 21-APR-20160 (dosage, strength and route were not reported). There was no concomitant medication reported. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse (L.P.N) via a telephone call, concerning a 12 month old male patient. No concurrent conditions or medical history were reported. On 11-JUN-2015, the patient was vaccinated with an improperly stored dose of (Oka-Merck) PROQUAD (Lot # K018142 Expiration date: 10-APR-2016) (dose, frequency and anatomical location of administration were not reported). No concomitant therapies or adverse experiences were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse (L.P.N) via a telephone call, concerning a 2 year old female patient. No concurrent conditions or medical history were reported. On 26-MAR-2015, the patient was vaccinated with an improperly stored dose of (Oka-Merck) PROQUAD (Lot # K018142 Expiration date: 10-APR-2016) (dose, frequency and anatomical location of administration were not reported). No concomitant therapies or adverse experiences were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse (L.P.N) via a telephone call, concerning a 4 year old male patient. No concurrent conditions or medical history were reported. On 22-APR-2015, the patient was vaccinated with an improperly stored dose of (Oka-Merck) PROQUAD (Lot # K018142 Expiration date: 10-APR-2016) (dose, frequency and anatomical location of administration were not reported). No concomitant therapies or adverse experiences were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse (L.P.N) via a telephone call, concerning a 12 month old female patient. No concurrent conditions or medical history were reported. On 18-JUN-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (Lot # K018142 Expiration date: 10-APR-2016) (dose, frequency and anatomical location of administration were not reported). No concomitant therapies or adverse experiences were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse (L.P.N) via a telephone call, concerning a 12 month old male patient. No concurrent conditions or medical history were reported. On 16-JUN-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (Lot # K018142 Expiration date: 10-APR-2016) (dose, frequency and anatomical location of administration were not reported). No concomitant therapies or adverse experiences were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse (L.P.N) via a telephone call, concerning a 4 year old female patient. No concurrent conditions or medical history were reported. On 08-MAY-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (Lot # K018142 Expiration date: 10-APR-2016) (dose, frequency and anatomical location of administration were not reported). No concomitant therapies or adverse experiences were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a patient's mother, referring to her 2 months old son. The patient's medical history and concurrent conditions were not reported. On 08-OCT-2015, the 2 months old patient was vaccinated intramuscularly with a dose of VAQTA PED 0.5 ml, one time dose (lot # and expiration date were not reported). No concomitant medications were reported. The patient did not receive any treatment. The reporter sought medical attention by contacting a physician. No adverse events were being reported. No product quality complaint was involved. Additional information is not expected as no reporter's contact details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site urticaria, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative regarding a 60 or 61 years old female patient. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On approximately September 2015 (reported as within the last week (date unspecified)), the patient was vaccinated with a dose of ZOSTAVAX, (dose, route, anatomical location, lot number and expiration date were not reported). There was no concomitant medication reported. In approximately September 2015 (reported as date unspecified), the pharmacist noted that the patient came to the pharmacy after receipt of the ZOSTAVAX with extensive bruising , and a large hot welt at the injection site of the ZOSTAVAX. The pharmacist suggested to the patient to seek medical attention to her physician. It was unspecified if treatment was given to the patient. At the time of the report, the outcome of the extensive bruising and a large hot welt at the injection site of the ZOSTAVAX was unknown. The relatedness between the events and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: This initial spontaneous report was received from an office manager referring to three patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On an unspecified date in approximately 2015, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (lot # L024129 with expiration date 21-JAN-2017; dose and route were not provided). The reporter stated that since 28-SEP-2015, the patients experienced adverse reaction to receiving a dose of the vaccine and reported severe swelling, redness, and warmth in the hand of the arm that received the PNEUMOVAX 23. The patients sought medical attention (called the physician office). Product quality complaint (PQC) was not involved. At the time of the report, the outcome of the events mentioned above was unknown. The relatedness between the events to PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician assistant referring to a 14 year old patient of unknown gender. Concurrent conditions, pertinent medical history or concomitant medications were not reported. On 02-JUN-2015, the patient received the first dose in the vaccine series of GARDASIL (also reported as GARDASIL 9) (lot# K001631, expiration date: 06-NOV-2016) (anatomical location, dose, route and frequency were unspecified). Then, on 15-JUN-2015, they received the second dose of GARDASIL (also reported as GARDASIL 9) (lot# K023432, expiration date: 18-JUN-2016) (anatomical location, dose, route and frequency were unspecified). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. The reporter stated that on multiple unspecified dates, the patients were administered improperly stored ZOSTAVAX injection (lot # L028282 with expiration date 28-OCT-2016 and lot # L024998 with expiration date 06-OCT-2016; dose, frequency and route were not provided). No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of 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 initial spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on multiple unspecified dates, the patients were administered improperly stored PROQUAD (Merck) injection (lot # L027634 with expiration date 21-JAN-2017, lot# L023112 with expiration date 24-DEC-2016 and lot# L023112 with expiration date 24-DEC-2016; dose, frequency and route were not provided). No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This initial spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on multiple unspecified date, the patients were administered improperly stored VARIVAX (Merck) injection (lot # L020000 with expiration date 02-JUN-2016, lot #L019126 with expiration date 27-MAY-2017, lot# L017142 with expiration date 13-MAY-2017 and lot # L015048 with expiration date 29-APR-2017; dose, frequency and route were not provided). No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse concerning multiple unspecified patients of unknown age. The nurse reported that on unknown date, multiple unspecified patients were vaccinated with improperly stored ROTATEQ, RECOMBIVAX HB, (1510USA003586), PNEUMOVAX 23, (MARRS# 1510USA010024) or M-M-R II (MARRS# 1510USA010025). No adverse effects were reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site extravasation
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history, drug reactions or allergie were not provided. On 15-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX (subcutaneously, dose, lot number and expiration date were not provided). Concomitant medications were not provided. On 15-OCT-2015, when the dose was administered, some of the volume of the dose leaked out of the injection site. Pharmacist was not aware of the patient's experiencing any adverse effects. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Malaise
Clinical narrative: This spontaneous report was received through a company representative from a physician who saw a media report on a TV channel about a month ago, referring to a female patient of unknown age. Concurrent conditions or pertinent medical history were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot#, anatomical location, dose and frequency were unspecified). Concomitant medications were not reported. On an unknown date, the patient experienced general malaise, dizziness and tiredness after receiving GARDASIL. No product quality complaint was involved. At the time of the report, the outcome of malaise, dizziness and fatigue was unknown. The relatedness of GARDASIL with the adverse events was not reported. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site pain, Peripheral swelling
Clinical narrative: This spontaneous report as received from a consumer concerning a 76 year old female patient with penicillin allergy, hypertension, and diabetes mellitus. On 05-OCT-2015 the patient was vaccinated with PNEUMOVAX 23, 0.5 ml, in her left arm. Concomitant therapies included influenza. On 05-OCT-2015, the patient reported that four hours after receiving PNEUMOVAX 23, she experienced her left arm started to swell and was very sore at the injection site. The patient also reported that the swelling and tenderness goes all the way to her left shoulder. The patient did notify the physician's office and received treatment with diphenhydramine (no further details). The patient reported this exact same adverse reactions, soreness and swelling had happened to her 40 years ago after receiving an unspecified pneumococcal vaccine. The outcome of injection site pain and peripheral swelling was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding an unspecified patient of unknown age and gender. The patient's medical history, drug reactions or allergies were not provided. On 15-OCT-2015, an unspecified nurse administered to the patient an expired dose of ZOSTAVAX (lot # K007985, expiration date 03-SEP-2015, dose and route were not provided). Concomitant medications were not provided. No adverse effects were reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: FLU3, HEP, HPV9, IPV, TD, VARCEL, FLU4, HEP, HPV9, IPV, TD, VARCEL
Symptoms: Dizziness, Tremor
Clinical narrative: Client was given vaccines and PPD.  HPV9 vaccine was given last at 10:45 am.  Client was already on exam table.  Complained of dizziness, remained responsive, no injury or fall observed.  Ice pack applied.  Pt said he didn't eat & afraid of needles. v/s @1050 AM 99 F, 60 [HR], 16 [respirations], 134/76. 0 pain. Color pink, not diaphoretic, but shaking. BP 140/90 @ 11 AM. Pt had warm water at 11:05 AM. Vitals @ 11:15 AM 140/80, 60 [HR], 18 [respirations], Temp 98.6. Still c/o shaking. 911 called, declined to go to ER. Pt stated feeling better, denied dizziness & shakiness when leaving the clinic, ambulating without difficulties.
Age: 17.0
Sex: M
Vaccine: FLU3, HEP, HPV9, IPV, TD, VARCEL, FLU4, HEP, HPV9, IPV, TD, VARCEL
Symptoms: Dizziness, Fear of injection, Tremor
Clinical narrative: Client was given vaccines and PPD.  HPV9 vaccine was given last at 10:45 am.  Client was already on exam table.  Complained of dizziness, remained responsive, no injury or fall observed.  Ice pack applied.  Pt said he didn't eat & afraid of needles. v/s @1050 AM 99 F, 60 [HR], 16 [respirations], 134/76. 0 pain. Color pink, not diaphoretic, but shaking. BP 140/90 @ 11 AM. Pt had warm water at 11:05 AM. Vitals @ 11:15 AM 140/80, 60 [HR], 18 [respirations], Temp 98.6. Still c/o shaking. 911 called, declined to go to ER. Pt stated feeling better, denied dizziness & shakiness when leaving the clinic, ambulating without difficulties.
Age: 21.0
Sex: F
Vaccine: FLUX, HEP, HPVX, FLU3, HEP, HPV9
Symptoms: Arthralgia, Dizziness, Immediate post-injection reaction, Pain, Syncope
Clinical narrative: I had administered 2 vaccines in her left deltoid (influenza trivalent and Hep B). Upon administering HPV vaccine, patient immediately stated that she felt weird. She subsequently developed some sweating on her upper lip and forehead. She continued feeling lightheaded and dizzy. From her seated position, I lowered her to the floor. I gave her cool compresses and water. After about 5 minutes she requested to lie down. Additionally, I had another emergency department provider to come and evaluate her. She never had full syncope, never lost consciousness. After about 15 minutes of lying down and another 10 minutes of sitting, she felt much improved. She recovered fully and left ambulatory.
Age: 21.0
Sex: F
Vaccine: FLUX, HEP, HPVX, FLU3, HEP, HPV9
Symptoms: Visual impairment
Clinical narrative: I had administered 2 vaccines in her left deltoid (influenza trivalent and Hep B). Upon administering HPV vaccine, patient immediately stated that she felt weird. She subsequently developed some sweating on her upper lip and forehead. She continued feeling lightheaded and dizzy. From her seated position, I lowered her to the floor. I gave her cool compresses and water. After about 5 minutes she requested to lie down. Additionally, I had another emergency department provider to come and evaluate her. She never had full syncope, never lost consciousness. After about 15 minutes of lying down and another 10 minutes of sitting, she felt much improved. She recovered fully and left ambulatory.
Age: 21.0
Sex: F
Vaccine: FLUX, HEP, HPVX, FLU3, HEP, HPV9
Symptoms: Dizziness, Feeling abnormal, Hyperhidrosis
Clinical narrative: I had administered 2 vaccines in her left deltoid (influenza trivalent and Hep B). Upon administering HPV vaccine, patient immediately stated that she felt weird. She subsequently developed some sweating on her upper lip and forehead. She continued feeling lightheaded and dizzy. From her seated position, I lowered her to the floor. I gave her cool compresses and water. After about 5 minutes she requested to lie down. Additionally, I had another emergency department provider to come and evaluate her. She never had full syncope, never lost consciousness. After about 15 minutes of lying down and another 10 minutes of sitting, she felt much improved. She recovered fully and left ambulatory.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Anaphylactic shock, Chest X-ray, Dyspnoea, Eye discharge, Eye pruritus
Clinical narrative: Caregiver reported pt had the following symptoms: Red itchy eyes with matter coming out. Sore throat. Runny nose. Loss of appetite. General discomfort.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Ocular hyperaemia, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Caregiver reported pt had the following symptoms: Red itchy eyes with matter coming out. Sore throat. Runny nose. Loss of appetite. General discomfort.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Decreased appetite, Discomfort, Eye discharge, Eye pruritus, Ocular hyperaemia
Clinical narrative: Caregiver reported pt had the following symptoms: Red itchy eyes with matter coming out. Sore throat. Runny nose. Loss of appetite. General discomfort.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Caregiver reported pt had the following symptoms: Red itchy eyes with matter coming out. Sore throat. Runny nose. Loss of appetite. General discomfort.
Age: 37.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Local swelling, Peripheral swelling, Rash generalised, Swelling
Clinical narrative: This spontaneous report was received from a pharmacist who refers to a 37 year old male patient with an allergy to penicillin and ciprofloxacin. No information about the patient's medical history or concomitant medication was provided. At 1:21 PM on 01-OCT-2015, the patient was vaccinated with a dose of PNEUMOVAX23 lot # L024129 (dose and expiration date were not reported) intramuscularly in the right arm. The patient did not receive any previous doses of PNEUMOVAX23 and at the time of vaccination he did not suffer from any illness. At 6;30 PM on 01-OCT-2015, the patient experienced swelling of head, neck and arm, full body rash, welts and red streaks. No relevant diagnostic test were performed. The patient was given BENADRYL 2 tablets twice a day for 4 days as a treatment of the events. Then, on an unspecified date approximately in October 2015, the symptoms resolved completely . The relatedness between the events and PNEUMOVAX23 was not reported. Additional information has been requested.
Age: 37.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist who refers to a 37 year old male patient with an allergy to penicillin and ciprofloxacin. No information about the patient's medical history or concomitant medication was provided. At 1:21 PM on 01-OCT-2015, the patient was vaccinated with a dose of PNEUMOVAX23 lot # L024129 (dose and expiration date were not reported) intramuscularly in the right arm. The patient did not receive any previous doses of PNEUMOVAX23 and at the time of vaccination he did not suffer from any illness. At 6;30 PM on 01-OCT-2015, the patient experienced swelling of head, neck and arm, full body rash, welts and red streaks. No relevant diagnostic test were performed. The patient was given BENADRYL 2 tablets twice a day for 4 days as a treatment of the events. Then, on an unspecified date approximately in October 2015, the symptoms resolved completely . The relatedness between the events and PNEUMOVAX23 was not reported. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Head injury, Loss of consciousness, Seizure
Clinical narrative: PATIENT REPORTED EXPERIENCING A SEIZURE WHILE AT WORK. PATIENT LOST CONSCIOUSNESS FOR UNDER A MINUTE AND WAS THEN TRANSPORTED TO THE ER. PATIENT REPORTS HITTING HEAD DURING THE SEIZURE.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Dysstasia, Joint swelling, Muscle spasms
Clinical narrative: Patient received ZOSTAVAX vaccine subq on 9/15/15. Twelve hours after receiving the vaccine he developed severe, debilitating lower back pain such that he had to lay on the floor, crawl and then pull himself up on furniture to stand to walk. He made an appointment with his chiropractor but his chiropractor did not find bone misalignment, only severe muscle cramping in the lower back region. This severe back pain did not begin to resolve until about 72 hours later at which time the intense, debilitating pain moved to his right knee and began to swell also causing intense calf pain and ankle swelling. Over the next 3 days, the back pain resolved but the knee pain persisted for 3 more days causing patient to have to use a cane to walk. One month later, the pain in his knee has almost resolved.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Walking aid user
Clinical narrative: Patient received ZOSTAVAX vaccine subq on 9/15/15. Twelve hours after receiving the vaccine he developed severe, debilitating lower back pain such that he had to lay on the floor, crawl and then pull himself up on furniture to stand to walk. He made an appointment with his chiropractor but his chiropractor did not find bone misalignment, only severe muscle cramping in the lower back region. This severe back pain did not begin to resolve until about 72 hours later at which time the intense, debilitating pain moved to his right knee and began to swell also causing intense calf pain and ankle swelling. Over the next 3 days, the back pain resolved but the knee pain persisted for 3 more days causing patient to have to use a cane to walk. One month later, the pain in his knee has almost resolved.
Age: 2.0
Sex: M
Vaccine: FLUX, MMR, VARCEL, FLU3, MMR, VARCEL, FLU3, MMR, VARCEL
Symptoms: Cardiac arrest, Death, Resuscitation
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to an approximately 2.5 year old male patient. The patient's medical history included "hyperplastic left heart" and multiple unspecified heart surgeries. There was no information about the patient's concurrent conditions or concomitant therapies provided. On 19-OCT-2015, at 12:30, the patient was vaccinated with a dose of M-M-R II, subcutaneously (lot # and expiration date were not reported), a dose of VARIVAX (Merck) (route of administration, lot # and expiration date were not reported) and a dose of an unspecified flu vaccine. On 19-OCT-2015, at 12:50, the patient was brought back to the provider's office, apparently in cardiac arrest. The reporter stated they began performing cardiopulmonary resuscitation (CPR) on the patient and called for an ambulance. The ambulance took the patient to an emergency room. The reporter stated they received a call from the coroner's office at 15:00, and was informed that the child died (on 19-OCT-2015). The event of cardiac arrest was reported as life threatening. The outcome of cardiac arrest was reported as fatal, however the cause of death was not provided. The relatedness between the adverse event and suspect therapies was not reported. Upon internal review, the event of cardiac arrest was considered to be medically significant. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: FLUX, MMR, VARCEL, FLU3, MMR, VARCEL, FLU3, MMR, VARCEL
Symptoms: Death, Resuscitation, Unresponsive to stimuli
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to an approximately 2.5 year old male patient. The patient's medical history included "hyperplastic left heart" and multiple unspecified heart surgeries. There was no information about the patient's concurrent conditions or concomitant therapies provided. On 19-OCT-2015, at 12:30, the patient was vaccinated with a dose of M-M-R II, subcutaneously (lot # and expiration date were not reported), a dose of VARIVAX (Merck) (route of administration, lot # and expiration date were not reported) and a dose of an unspecified flu vaccine. On 19-OCT-2015, at 12:50, the patient was brought back to the provider's office, apparently in cardiac arrest. The reporter stated they began performing cardiopulmonary resuscitation (CPR) on the patient and called for an ambulance. The ambulance took the patient to an emergency room. The reporter stated they received a call from the coroner's office at 15:00, and was informed that the child died (on 19-OCT-2015). The event of cardiac arrest was reported as life threatening. The outcome of cardiac arrest was reported as fatal, however the cause of death was not provided. The relatedness between the adverse event and suspect therapies was not reported. Upon internal review, the event of cardiac arrest was considered to be medically significant. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Pregnant Participant was administered a flu shot of Afluria. There was no adverse reaction to the injection.
Age: 1.45
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: Mom called into County Public Health Dept on 10/22/2015 at 8:45 am. She stated patient had approx. 10 bumps starting late Wednesday, 10/21/2015 from head to toe. Mom stated child has no fever, eating, drinking, and sleeping normally. Daycare sent child home. Instructed mom that a VAERS report would be done and to notify pediatrician. Noted chart.
Age: 1.31
Sex: F
Vaccine: DTAP, FLUX, HBHEPB, MMR
Symptoms: Rash
Clinical narrative: Developed a rash on her torso which then spread to her back, bum, arms and face. But cleared up within 2 days.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: Patient received the flu vaccination 9/29/15, states the vaccination caused no pain at the time of injection, but started having shoulder soreness the next day, which worsened over a couple days.  The pain lessened after a couple of days with applying a heating pack and taking Tylenol, but the pain has continued to constantly be a 5/10 aching throughout the month.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Abdominal pain upper, Cough, Diarrhoea, Lip pruritus, Oral mucosal erythema
Clinical narrative: The adverse event began with itchy lips and a red mark by his mouth. He began coughing a lot and the red rash spread around his mouth, nose, forehead, and ears and was accompanied by a severe itching. He began coughing a lot and complaining of stomach pains and a weird feeling in his mouth. The rash continued to spread throughout his entire body. He had a bout of diarrhea. Took him to the after hours medi-center and they gave him Benadryl and monitored his progress. The Benadryl relieved some of the itching and redness.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Pruritus, Rash erythematous, Rash generalised
Clinical narrative: The adverse event began with itchy lips and a red mark by his mouth. He began coughing a lot and the red rash spread around his mouth, nose, forehead, and ears and was accompanied by a severe itching. He began coughing a lot and complaining of stomach pains and a weird feeling in his mouth. The rash continued to spread throughout his entire body. He had a bout of diarrhea. Took him to the after hours medi-center and they gave him Benadryl and monitored his progress. The Benadryl relieved some of the itching and redness.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site infection, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Large red area where flu shot was given that was swollen, hot and itched.  Saw a doctor on Oct. 21, 2015 and was told it was infected and put on antibiotics for 7 days.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site scab, Injection site swelling
Clinical narrative: Not reported until 10/22 at 10:20am. Injection site tender to touch, red, raised and scabbed over.
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site infection, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: A large red area where the flu shot was given that was painful, swollen and hot to the touch.  Saw a Dr on 10/21/15 and was told it was infected and given a course of antibiotics to take.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Dehydration, Fall, Head injury, Hypotension, Syncope
Clinical narrative: SNYCOPE.. HIT HIS HEAD UPON FALL. VOMITED A COUPLE OF TIMES. EMTS WERE CALLED. PATIENT HAD LOW BLOOD PRESSURE. UPON FOLLOWING UP THE NEXT DAY, PATIENT HAD BEEN DIAGNOSED WITH LOW BLOOD PRESSURE AND DEHYDRATION DUE TO NOT EATING OR DRINKING ANYTHING ON 10/21/2015.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: SNYCOPE.. HIT HIS HEAD UPON FALL. VOMITED A COUPLE OF TIMES. EMTS WERE CALLED. PATIENT HAD LOW BLOOD PRESSURE. UPON FOLLOWING UP THE NEXT DAY, PATIENT HAD BEEN DIAGNOSED WITH LOW BLOOD PRESSURE AND DEHYDRATION DUE TO NOT EATING OR DRINKING ANYTHING ON 10/21/2015.
Sex: M
Vaccine: DTAP
Symptoms: Excessive eye blinking, Tic
Clinical narrative: Initial unsolicited report received from a consumer (patient's mother via social media) on 13 October 2015. This case is linked to 2015SA162207, 2015SA162201 (same reporter, different patients). This case involves a male patient (age not reported) who was vaccinated with a dose of DTaP (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. On an unspecified date following the vaccination, the patient developed a Tourette like effect with uncontrollable facial tics and rapid blinking. It was reported that the patient's healthy son was forced to undergo a DPT vaccine and he then developed events. Laboratory investigation and corrective treatment were not reported. The outcome of the events was not reported. Upon internal review, company assessed the event of Tourette like effect as serious and important medical event. List of documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Pain
Clinical narrative: Chills body aches, sob.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injected limb mobility decreased, Vaccination site pain
Clinical narrative: Pain in shoulder near placement of vaccine.  Pain worsened the next day and caused difficulty in range of movement of her arm.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Dyspnoea, Eye pruritus, Lacrimation increased, Pain
Clinical narrative: Trouble swollowing, itching and weeping eyes, vomiting, aching body, fever, difficult breathing. I considered going to Emergency, if breathing worsened I would have.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: Trouble swollowing, itching and weeping eyes, vomiting, aching body, fever, difficult breathing. I considered going to Emergency, if breathing worsened I would have.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Injection site reaction, Malaise, Muscle twitching
Clinical narrative: Dizzy, nauseous, heart racing and my left upper arm was twitching uncontrollably. Pounding headache, nauseous, dizzy, achy and malaise.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain, Palpitations
Clinical narrative: Dizzy, nauseous, heart racing and my left upper arm was twitching uncontrollably. Pounding headache, nauseous, dizzy, achy and malaise.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Pain, Rash, Swelling
Clinical narrative: Pain, swelling, raised rash, continued swelling and spreading of rash still as of the time of this report-10-22-2015, 10:40 am.
Age: 90.0
Sex: M
Vaccine: FLU3
Symptoms: Deafness unilateral, Sudden hearing loss
Clinical narrative: Sudden hearing loss in right ear upon awakening.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erosion
Clinical narrative: Patient developed bruising and had excoriated skin at the injection site.  She had gone to see her allergist for an unrelated matter. The allergist covered with dry sterile gauze and told her to keep the area covered until healed.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Eye movement disorder, Fall, Musculoskeletal stiffness, Opisthotonus
Clinical narrative: Patients eyes rolled in the back of her head. She fell backwards arched her back and went stiff as a board.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, Loss of consciousness
Clinical narrative: This spontaneous report was received from a consumer refers to her daughter, a 26 year old female patient with allergy to an unspecified antibiotics. The patients' medical history was not provided. On 17-JUL-2009, reported as "6 years ago on July 17", the patient was vaccinated with the first dose of GARDASIL, intramuscular injection, (anatomical location, lot number and expiration date were not reported). There were no concomitant medications provided. On an unspecified date, in September 2009, the patient started to loss of consciousness reported as "past out a lot". There was no product quality issue involved. The patient did not continue with the series of GARDASIL. The outcome of loss of consciousness was reported as recovered on an unspecified date. The reporter did not assess the relatedness of loss of consciousness with GARDASIL. Additional information is not expected since the reporter did not want to be contacted.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Erythema, Pain, Skin warm, Swelling
Clinical narrative: Patient presented with cellulitis like symptoms. Redness/swelling/warm to the touch/pain. Dr. placed on antibiotics.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Pneumovax 23 administered on 10/14/15. On approx. 6:00 AM on 10/15/15, rashed were noted on bilateral upper and lower extremities and lower abdomen area. No other complaints. Benadryl and Prednisone were prescribed by MD. Rash has resolved.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Patient returned 22 days post vaccine to report that his arm had been sore since the injection. No bruising, swelling, or redness. Stated that arm hurt and tingled. Advised him to contact physician.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Pt's arm that received vaccine swelled which sent her to her physician.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Oropharyngeal pain, Pain
Clinical narrative: Sore throat, Tired, Achy body.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Erythema, Pain in extremity
Clinical narrative: Pain in arm, extreme redness, joint pain.
Age: 6.0
Sex: M
Vaccine: FLUN4
Symptoms: Abdominal pain upper, Cough, Fatigue, Pneumonia, Pyrexia
Clinical narrative: Fever started on 10/17 along with stomachache, fatigue. 10/18 fever resolved but cough started.  Cough became worse overnext several days. Diagnosed with pneumonia on 10/22.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Ear discomfort
Clinical narrative: Left ear fullness and dizziness.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Left deltoid - inject site erythema, induration, mild pain. About 5 to 6 cm large, warm. No significant systemic reaction.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass
Clinical narrative: "Hard lump" at injection site and into "armpit" area. Feels this is some sort of "reaction". This was reported via telephone and area has not been visually assessed by us.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Patient reports that 2 to 3 hours after administration of vaccine he began having trouble breathing. He laid down and after resting symptoms resolved without further treatment.
Age: 55.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site reaction
Clinical narrative: Injection site reaction after receiving PREVNAR. Patinet also received FLUVIRIN in the opposit arm.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site exfoliation, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Arm at site of injection became swollen, hard, red and painful. The area that was swollen has peeled but continues to be red and painful.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Lethargy
Clinical narrative: Headache - severe started late pm 10-1-15 after receiving vaccine. Also c/o severe lethargy. Advised to see MD if worsens or continues past 48 hours on 10-2-15.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Blood test, Feeling abnormal, Immediate post-injection reaction, Nuclear magnetic resonance imaging
Clinical narrative: Immediately after administration, client stated that she felt strange with tingling sensation along left side of body. Blood pressure elevated at 5 and 15 min after injection. Client left clinic on own to go to urgent care and was directed to Emergency Room at medical ctr. Tingling in tongue still present on 10/21/15.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: Immediately after administration, client stated that she felt strange with tingling sensation along left side of body. Blood pressure elevated at 5 and 15 min after injection. Client left clinic on own to go to urgent care and was directed to Emergency Room at medical ctr. Tingling in tongue still present on 10/21/15.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Left arm in pain for past 11 days. Arm is numb/almost paralyzed.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site induration, Tenderness
Clinical narrative: Patient had redness and tenderness in arm of vaccination. "Hardness" at injection site. Visited health department and told to take ALEVE. No hives, rash, difficulty breathing reported. Still "hard" on day of reporting but not red.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Chills, Rash, Vomiting
Clinical narrative: Vomiting, shivering, rash.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Pallor
Clinical narrative: Dizziness and pale, no shortness of breath, no swollen tongue, no fever, no redness to site of injection.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Pruritus, Rash pruritic, Swelling
Clinical narrative: Hx of allergy to penicillin and TESSALON PERLES. Started itching, chills swelling one hr. after shot. Has itchy rash on arms and neck feels swollen.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Decreased eye contact, Dizziness, Feeling cold, Headache, Hyperhidrosis
Clinical narrative: At approximately 4:05pm, pt reported immediate dizziness after administration of flu vaccine. Reported name and DOB however unable to make eye contact. Pt advised to rest for 15 min. Mom present. Given H2O by RN and gummy candy by mom. Pt also reported sx of had HA and sweating. Cool to touch. After few min, pt report no HA, no dizziness, and feeling OK. Appeared in no distress. Pt left at approximately 4:45 pm with mother. Mom stated no previous reaction to flu shot.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction
Clinical narrative: At approximately 4:05pm, pt reported immediate dizziness after administration of flu vaccine. Reported name and DOB however unable to make eye contact. Pt advised to rest for 15 min. Mom present. Given H2O by RN and gummy candy by mom. Pt also reported sx of had HA and sweating. Cool to touch. After few min, pt report no HA, no dizziness, and feeling OK. Appeared in no distress. Pt left at approximately 4:45 pm with mother. Mom stated no previous reaction to flu shot.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Eye oedema, Laboratory test, VIIth nerve paralysis
Clinical narrative: (L) facial droop. (L) eye edema.
Age: 1.02
Sex: M
Vaccine: FLU3, HEPA, MMR
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Localized reaction to injection site right thigh. Localized reaction to left vastus lateralis injection site. BENADRYL 3/4 tsp given in office at 9:45AM.
Age: 13.0
Sex: M
Vaccine: FLU3, HPV9
Symptoms: Body temperature increased, Discomfort, Injection site discomfort, Injection site swelling, Local swelling
Clinical narrative: Slight swelling and discomfort at inj site and axilla (L) arm. Temp 99.7.
Age: 61.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Unevaluable event
Clinical narrative: THIS WILL BE SENT VIA EMAIL, BOX NOT ALLOWING COMMENT.
Age: 0.16
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Irritability, Neutrophil percentage decreased, Tremor, White blood cell count normal
Clinical narrative: Child had intermittent episodes of extreme irritability and shaking for several hours after the vaccine.
Age: 26.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Activities of daily living impaired, Insomnia, Mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: Shot in right arm for PPSV23. Pain in the right arm limiting movement and strength. Any use of the upper bicep or shoulder created intense pain leading to lack of sleep and lack of ability to complete daily routines requiring arm. Pain onset was a few hours after receiving shot, by evening it had intensified, and throughout the night because unbearable. In the morning pain was still present and limited mobility was still evident.
Age: 57.0
Sex: F
Vaccine: TD
Symptoms: Abdominal pain upper, Amnesia, Injection site pain, Pain in extremity, Weight decreased
Clinical narrative: The date and times listed above are estimates. I lost fifty (50) pounds by December 2013 but I started gaining some back in February 2014. Right arm sore at times also some stomach pain and legs pain at times. Memory Loss.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Swelling
Clinical narrative: Pain 4/10 & swelling increasing over last 2 hours.
Age: 50.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, tender to touch, warm, and itching at the injection site 3 hours after administration. Patient applied a cold compress to the area and we gave the patient diphenhydramine 50mg on 10/22/2015.