chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Pyrexia, Skin warm
Clinical narrative: This spontaneous report was received from a female patient of unknown age, who was reporting on herself. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unspecified Friday in 2017, the patient was vaccinated with a dose of PNEUMOVAX 23 injection, in right arm, lot # N013541with expiry date on 28-MAY-2017 (dose, route of administration and expiration date were not reported). On the same day in the evening, the patient's arm became bright red and she could not move it. On the next day, the patient could not move and her arm became "even redder". On the second day after the vaccination (reported as "on the following day"), the patient experienced flu-like symptoms and her right arm was extremely painful and became swollen by that night (reported as 3 times the size of her left arm). On the third day (reported as "the next day") after the vaccination, the patient visited an emergency room for medical attention. The symptoms were diagnosed as either allergic reaction to PNEUMOVAX 23 or cellulitis. The patient also requested an investigation into the lot # N013541. The outcome of the events was unknown. The event of allergic reaction was considered to be related to PNEUMOVAX 23. The relatedness between the remaining events and PNEUMOVAX 23 was not reported. Upon internal review, the event of cellulitis was considered to be medically significant.
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Cellulitis, Erythema, Hypersensitivity, Influenza like illness, Mobility decreased
Clinical narrative: This spontaneous report was received from a female patient of unknown age, who was reporting on herself. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unspecified Friday in 2017, the patient was vaccinated with a dose of PNEUMOVAX 23 injection, in right arm, lot # N013541with expiry date on 28-MAY-2017 (dose, route of administration and expiration date were not reported). On the same day in the evening, the patient's arm became bright red and she could not move it. On the next day, the patient could not move and her arm became "even redder". On the second day after the vaccination (reported as "on the following day"), the patient experienced flu-like symptoms and her right arm was extremely painful and became swollen by that night (reported as 3 times the size of her left arm). On the third day (reported as "the next day") after the vaccination, the patient visited an emergency room for medical attention. The symptoms were diagnosed as either allergic reaction to PNEUMOVAX 23 or cellulitis. The patient also requested an investigation into the lot # N013541. The outcome of the events was unknown. The event of allergic reaction was considered to be related to PNEUMOVAX 23. The relatedness between the remaining events and PNEUMOVAX 23 was not reported. Upon internal review, the event of cellulitis was considered to be medically significant.
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a female patient of unknown age, who was reporting on herself. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unspecified Friday in 2017, the patient was vaccinated with a dose of PNEUMOVAX 23 injection, in right arm, lot # N013541with expiry date on 28-MAY-2017 (dose, route of administration and expiration date were not reported). On the same day in the evening, the patient's arm became bright red and she could not move it. On the next day, the patient could not move and her arm became "even redder". On the second day after the vaccination (reported as "on the following day"), the patient experienced flu-like symptoms and her right arm was extremely painful and became swollen by that night (reported as 3 times the size of her left arm). On the third day (reported as "the next day") after the vaccination, the patient visited an emergency room for medical attention. The symptoms were diagnosed as either allergic reaction to PNEUMOVAX 23 or cellulitis. The patient also requested an investigation into the lot # N013541. The outcome of the events was unknown. The event of allergic reaction was considered to be related to PNEUMOVAX 23. The relatedness between the remaining events and PNEUMOVAX 23 was not reported. Upon internal review, the event of cellulitis was considered to be medically significant.
Age: 42.0
Sex: M
Vaccine: MMR
Symptoms: Computerised tomogram, Hypoaesthesia, Libido decreased, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Paralysis and numbness in lower body, numbness in arms, decreased sex drive.
Age: 42.0
Sex: M
Vaccine: MMR
Symptoms: Paralysis
Clinical narrative: Paralysis and numbness in lower body, numbness in arms, decreased sex drive.
Sex: M
Vaccine: PPV
Symptoms: Full blood count, Mobility decreased, Pain in extremity, Pyrexia, Tenderness
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 57 year old male patient with coronary artery disease, diabetes mellitus, hypertension, high cholesterol and allergy to DEMEROL. The patient's concomitant therapies were not reported. On 20-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N004564 and expiration date on 22-OCT-2018 (dose and route of administration were not provided) for pneumonia prevention. On the same day, after receiving the vaccine, the patient began experiencing tenderness, pain in his right arm and was unable to move it. It was additionally reported that, on 21-SEP-2017, in the morning, the patient had an unspecified fever; therefore, he was seen at physician's office on the same day in the afternoon, where he was found to have a fever of 102.7 degrees Fahrenheit (°F), the patient was prescribed ADVIL as fever treatment and he was also performed a complete blood count (unspecified results). No product quality complaints were reported. At the reporting time the patient had not recovered from fever, tenderness, pain in his right arm and was unable to move it and the and the causality assessment between PNEUMOVAX 23 and the events was unknown.
Age: 34.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician and refers to a 34 year old pregnant female patient. The patient had no concomitant medication, pertinent medical history, drug reactions or allergies. On 20-SEP-2017 (at which time she was 7 weeks pregnant) the patient was vaccinated with GARDASIL 9, (lot # N012093, expiration date: 13-JAN-2020), (dose, route of administration were not provided). The patient Last Menstrual Period (LMP) was estimated as 02-AUG-2017 (calculated using gestation period at the time of vaccination), estimated Date of Conception: 16-SEP-2017 and estimated Date of Delivery (EDD) was 09-MAY-2018. The exposure to GARDASIL 9 occurred in the first trimester of patient's pregnancy. The pregnancy outcome was pending at the time of the report and the fetal outcome was unknown.
Age: 34.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician and refers to a 34 year old pregnant female patient. The patient had no concomitant medication, pertinent medical history, drug reactions or allergies. On 20-SEP-2017 (at which time she was 7 weeks pregnant) the patient was vaccinated with GARDASIL 9, (lot # N012093, expiration date: 13-JAN-2020), (dose, route of administration were not provided). The patient Last Menstrual Period (LMP) was estimated as 02-AUG-2017 (calculated using gestation period at the time of vaccination), estimated Date of Conception: 16-SEP-2017 and estimated Date of Delivery (EDD) was 09-MAY-2018. The exposure to GARDASIL 9 occurred in the first trimester of patient's pregnancy. The pregnancy outcome was pending at the time of the report and the fetal outcome was unknown.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Injected limb mobility decreased, Limb mass, Pain in extremity
Clinical narrative: This spontaneous report was received from the patient's mother concerning her 15 year old son. Patient's current conditions included seasonal allergies, and his concomitant medications included unspecified vitamins and ZYRTEC. The consumer reported that her son was vaccinated on 18-SEP-2017 with the first dose of GARDASIL 9 intramuscular route, (strength, dose, lot number and expiration date were not reported) for prophylaxis. On 18-SEP-2017, after vaccination, the patient experienced typical arm pain, it began that evening and lasted for about a day and then the patient got better. The consumer reported also that on 24-SEP-2017, the pain reappeared and the patient presented a lump and he was unable to lift his arm. The consumer stated that the health care provider was informed on an unspecified date and the physician said that it was unusual that the pain reappeared after a week. There were no diagnostic laboratory tests performed. At the time of this report, the outcome of pain in extremity was recovered on 19-SEP-2017 (Reported as "lasted about a day"), and of pain in extremity (24-SEP-2017), limb mass, and injected limb mobility decreased was not reported. The causal relationship between the vaccination with GARDASIL 9 and the events, was not reported. There was no PQC involved.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 12-year-old patient of unknown gender. On 07-AUG-2017, the patient was vaccinated with an improperly stored doses of GARDASIL 9 lot # M041990 and expiration date 28-JUN-2019 (dose and route of administration were not reported) for prophylaxis. There were no adverse symptoms reported. Administered dose of vaccine experienced the temperature excursion from 9 to 25 degrees Celsius (11.1 C) for 1 hour and 31 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA008849.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an 11-year-old patient of unknown gender. On 07-AUG-2017, the patient was vaccinated with an improperly stored doses of GARDASIL 9 lot # M041990 and expiration date 28-JUN-2019 (dose and route of administration were not reported) for prophylaxis. There were no adverse symptoms reported. Administered dose of vaccine experienced the temperature excursion from 9 to 25 degrees Celsius (11.1 C) for 1 hour and 31 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA008849.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given the adult dose of  0.5ml of flu vaccine instead of the pediatric dose of 0.25.
Age: 47.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Erythema, Musculoskeletal pain, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling and pain of the full L arm and shoulder. Redness as well. Occurred about 10 hours after vaccination.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chills, Mobility decreased, Nausea, Vertigo
Clinical narrative: Patient states that about 5 hours after she received the Flu vaccine, she had uncontrollable shivers, the room started to spin, nausea and vomiting, weakness, unable to get up on her own. States that by next day she was better. Patient did not go to see MD for this until her follow appointment on 10/2/17 when she reported this to our office.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Patient states that about 5 hours after she received the Flu vaccine, she had uncontrollable shivers, the room started to spin, nausea and vomiting, weakness, unable to get up on her own. States that by next day she was better. Patient did not go to see MD for this until her follow appointment on 10/2/17 when she reported this to our office.
Age: 25.0
Sex: M
Vaccine: HPV9
Symptoms: Dysphagia, Glossodynia, Swollen tongue
Clinical narrative: Patient presented to the local emergency room complaining of difficulty swallowing and a sore and swollen tongue.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, FLU4, PNC13, RV5
Symptoms: Eye swelling, Oral mucosal eruption, Rash, Rash erythematous
Clinical narrative: About 20 minutes after immunizations given and topical fluoride applied to teeth, patient developed erythematous rash around eyes, mouth and arm; as well as swelling of his eyes. Benadryl with given, with resolution of swelling and near resolution of rash over course of 45 minutes. No stridor, no vomiting, no change in mental status.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster
Clinical narrative: Shingles. Pain meds and anti-viral med.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Fatigue, Heart rate increased, Pharyngeal oedema
Clinical narrative: SWELLING OF THROAT, FAST HEARTBEAT, WEAKNESS, FATIGUE. BEGAN 4 HOURS AFTER SHOT.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site vesicles
Clinical narrative: The patient's left arm is red and has blisters at the site of injection. The patient also stated that the injection site it itching. The patient received her vaccine on Friday 9/29/2017 and symptoms began on Sunday 10/1/2017. The patient visited her physician on Monday 10/2/2017 to let her check her injection site. The patient stated that her physician said her injection may have activated her shingles. She had a case of shingles about 10 years ago.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: I received flu shot on my left upper arm on 10/2/17 and later that evening noticed site is reddened, raised, hardened with a bleb wheel and painful to touch. I am not allergic to eggs, fish or latex.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Eosinophilic cellulitis
Clinical narrative: Diagnosed with Wells Syndrome, took days to resolve, had never had a bad reaction to vaccine before.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Haematochezia, Occult blood positive
Clinical narrative: MOC states pt had blood in stool starting day after Rota given at 2 month and 4 month visit.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash, Rash vesicular, Scab, Scar
Clinical narrative: Shot on Thursday, by Friday I started to notice bumps & itching on my chest area, the issue continued  through today 10/3/17 and spread to the upper breast, neck and upper arms. The itching became intense over the first week and I applied itch medications daily, the bumps scabbed over and started to scar on about 10/1/17 while I continue to use itch cream on the newer bumps.  Appears remarkably similar to chicken pox, which I've had twice as a child.
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative
Clinical narrative: This spontaneous report has been received from a nurse and refers to a 31-year-old female patient. The patient's concomitant therapies included methotrexate (manufacturer unknown) and concurrent conditions included arthritis. The patient did not have any known drug reactions or allergies. On 21-MAY-1987, the patient was vaccinated with measles virus vaccine, live (enders-edmonston) (manufacturer unknown) (dose, route of administration, lot # and expiration date were not reported) and on 08-OCT-1997 with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (unknown if these were monovalent components or a combination vaccine) (dose, route of administration, lot # and expiration date were not reported). On 21-JUL-2017, the patient had negative measles and mumps titers and on 01-AUG-2017, the patient was vaccinated with M-M-R II. The treatment was given for the adverse events. The lab diagnostic studies included blood work. The patient sought medical attention by visiting the office. No product quality complaint was involved. The outcome of the events and the relatedness between the events and suspect therapies were not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, Hypoaesthesia, Paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No information regarding the patient's pertinent medial history, concomitant medications, drug reactions, or allergies was provided. On 16-SEP-2017, the patient was vaccinated with an expired dose of ZOSTAVAX (dose, route of administration, lot# and expiration date were not provided). On an unknown date in September 2017, the patient experienced numbness and tingling on the right side of her face. The pharmacist did not know if the dose of ZOSTAVAX had any previous temperature excursions prior to administration. The outcome of numbness and tingling on the right side of her face was not reported. The relatedness between the adverse events and ZOSTAVAX was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, Hypoaesthesia, Paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to an almost 65-year-old female patient. The patient's pertinent medical history included diabetes. No information regarding the patient's drug reactions or allergies was provided. On 16-SEP-2017, the patient was vaccinated with an expired dose of ZOSTAVAX 19400 plaque-forming units (PFU) (0.65 ml in the right arm; lot # L007222, expiration date: June 2016) for a doctor recommendations. Concomitantly she took unspecified diabetes medications. On an unknown date in September 2017, an unspecified amount of hours after the vaccination, the patient experienced numbness and tingling on the right side of her head. The patient sought a medical attention and talk with the pharmacist on the phone about the event. No treatment was given for the adverse events and no laboratory diagnostic studies were performed. The numbness and tingling on the right side of her head was unknown. The relatedness between the adverse events and ZOSTAVAX was not provided.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unspecified gender and age. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On 21-SEP-2017, an improperly stored dose of VAQTA 2 ml, once, lot#N017094, expiration date 31-AUG-2018 (route of administration and anatomical location were not reported) was administered to the patient. The dose was stored in temperature 33.8 degrees Fahrenheit for 20 minutes and in temperature 35.8 degrees Fahrenheit for 2 minutes. No previous temperature excursions were reported. No adverse effects have been reported. Data logger was involved. Product quality complaint was not involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA012899: US-009507513-1709USA011805: US-009507513-1709USA011805: US-009507513-1709USA012897.
Sex: F
Vaccine: PPV
Symptoms: Adverse drug reaction, Dysphonia, Staphylococcal infection
Clinical narrative: This spontaneous report was received from a female patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 injection in arm (route of administration, dose, lot number and expiration date were not reported) for prophylaxis. Concomitant vaccinations included an unspecified influenza virus vaccine. On an unknown date, the patient experienced staphylococcal infection which she described as "horrible". The patient stated she did not think she would survive the infection. She was rushed to an Urgent Care where she was treated with cephalexin to which she had an unspecified reaction and was still "raspy" at the time of the report. It was not specified if the patient was also admitted to a hospital. The patient wanted to be compensated for pain and suffering. The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and the PNEUMOVAX 23 was not reported. Upon internal review, the event of Staphylococcus infection was considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Medical history or concurrent conditions were not provided. Concomitant therapies included sterile diluent lot number: M044953 (expiration date: 17-JAN-2019). On 26-SEP-2017 the patient was vaccinated with an improperly stored ZOSTAVAX (19400 plaque forming units) lot number: N013289 (expiration date: 04-JUL-2018) for prophylaxis (route, dose or units were not provided) witch was reconstituted with a properly stored sterile diluent. The storage characteristics for ZOSTAVAX were the following: - Temperature: 47°F to 77°F - Time frame: 24 hours - Previous temperature excursion: No - Was call because of a "data logger": No. No adverse effects were reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients. On unspecified dates multiple unspecified patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L045117, expiration date 06-OCT-2018; lot # M010212, expiration date 21-JAN-2019). RECOMBIVAX HB (lot # L045117, expiration date 06-OCT-2018) was stored in temperature: 31°F or colder (30 F) for 46 hours 30 minutes and 47°F to 77°F (75 F) for 15 hours 30 minutes. No temperature timeframe was reported for RECOMBIVAX HB (lot # M010212, expiration date 21-JAN-2019). Digital Data Logger was involved. No adverse events were reported. The outcome of the events was unknown. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA011056.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patients were vaccinated with and incorrect stored dose of RECOMBIVAX HB lot # M022077 with expiration date on 10-MAR-2019 (strength and route were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccines were exposed to temperature of 47 Fahrenheit grades range for a time frame of 1 hours and 15 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patients were vaccinated with and incorrect stored dose of M-M-R II lot # N001532 with expiration date on 13-JAN-2019 (strength and route were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccines were exposed to temperature of 47 Fahrenheit grades range for a time frame of 1 hour and 15 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter.
Age: 0.33
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Patient given expired HIB by mistake, patient has been contacted.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Patient given expired vaccine by mistake.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: At present time, there are no reported adverse event. PENTACEL was inadvertently given to patient instead of the ordered HIB. Guardian was contacted, reported no fever or change in behavior or level of consciousness. Guardian will continue to monitor and report any adverse effect to MD. It has been more than 24 hours since injection and patient is reported to be doing well as per guardian.
Age: 0.42
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Patient given expired vaccine by mistake.
Age: 17.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Fall, Hypotonia, Unresponsive to stimuli
Clinical narrative: Patient sitting on exam table after MA administered vaccines, slumped over and fell next to exam table, limp and unresponsive. Helped up to exam table and immediately came back. Laid there for 5 minutes, then sat for 5 minutes. No c/o of head pain, alert and responsive. V.S. O2 sat 100% BP 124/70 p88 R22.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Patient reported getting 2-3 dime-sized blisters on arm near injection site 24 hours after vaccination. Patient reported the blisters going away 24 hours after that with no intervention needed. Indicated to patient to continue to monitor the area, but most likely an acute reaction.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Altered state of consciousness, Asthenia, Back pain, Blood pressure decreased, Body temperature increased
Clinical narrative: Received my vaccination 2 pm. Left my office about 6. I was feeling very weak and lightheaded. My neck hurt and my back hurt. I live close, so it only took me 15 min to get home. By 6:30 I was very lightheaded and felt as if I were going to pass out. I have a BP cuff at home. My BP was 88/54. It?s been running 140-150 over 80s. My HR was 110. By 7 pm I was having hard chills. By 8 pm my temp was 102.7. Took Tylenol and hydrated. It slowly passed. By midnight temp was down to 99.5. This morning everything is normal.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Dizziness, Neck pain
Clinical narrative: Received my vaccination 2 pm. Left my office about 6. I was feeling very weak and lightheaded. My neck hurt and my back hurt. I live close, so it only took me 15 min to get home. By 6:30 I was very lightheaded and felt as if I were going to pass out. I have a BP cuff at home. My BP was 88/54. It?s been running 140-150 over 80s. My HR was 110. By 7 pm I was having hard chills. By 8 pm my temp was 102.7. Took Tylenol and hydrated. It slowly passed. By midnight temp was down to 99.5. This morning everything is normal.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site infection, Pain, Swelling
Clinical narrative: Sudden painful swelling, red, 2-3".
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash, Rash erythematous
Clinical narrative: On 09/30/17, mom called MD pt started with fever and rash, red pinpoint rash on face and trunk. No distress. Not itchy.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Malaise, Nausea, Vertigo, Vomiting
Clinical narrative: Malaise, vertigo, nausea, vomiting, aching knee and hip joints bilaterally until noon September 30th, 2017.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Influenza, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: PATIENT EXPERIENCED FLU SYMPTOMS STARTING 3 HOURS AFTER RECEIVING VACCINATION (SORE ARM, CHILLS, FEVER, VOMITTING, ETC). SYMPTOMS LASTED APPROXIMATELY 5 DAYS.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Back pain, Blood test, Bundle branch block, Chest pain, Gait inability
Clinical narrative: Patient, a healthy 15 yr. old HS football player received an intramuscular injection in the left shoulder (2nd dose). One and one-half hours later patient was unable to walk on his own, had severe pain in his chest, back, general thoracic area, and legs, and had to be helped to bed. Mother called the doctor's office, was connected to the Hospital. RN stated to immediately call the rescue squad and have them assess patient. Rescue squad arrived, assessed patient, found the above mentioned medical ailments, plus a problem with patients heart (bundle branch anomaly). Was transported via ambulance to Hospital, then later sent home. Following morning, patient still had pain in all previous mentioned areas, plus some nausea.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Nausea, Pain in extremity
Clinical narrative: Patient, a healthy 15 yr. old HS football player received an intramuscular injection in the left shoulder (2nd dose). One and one-half hours later patient was unable to walk on his own, had severe pain in his chest, back, general thoracic area, and legs, and had to be helped to bed. Mother called the doctor's office, was connected to the Hospital. RN stated to immediately call the rescue squad and have them assess patient. Rescue squad arrived, assessed patient, found the above mentioned medical ailments, plus a problem with patients heart (bundle branch anomaly). Was transported via ambulance to Hospital, then later sent home. Following morning, patient still had pain in all previous mentioned areas, plus some nausea.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patients were vaccinated with and incorrect stored dose of VAQTA lot # N005274 with expiration date on 03-APR-2018 (strength and route were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccines were exposed to temperature of 47 Fahrenheit grades range for a time frame of 1 hour and 15 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Streptococcal infection
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently (at the reporting time) 60 years old female patient with no pertinent medical history, drug reactions or allergies. The patient did not take any concomitant medication. On an unknown date the patient was vaccinated with ZOSTAVAX (lot # M042504, expiration date: 30-NOV-2017, dose and route were not provided) for prevention of shingles. The vaccine was reconstituted with sterile diluent (STERILE DILUENT) (lot #, expiration date, dose and route of administration were not reported). On an unknown date, one day after the vaccination, the patient developed redness and itching at the injection site. The itching and redness continued to worsen by day 3 and she sought medical attention. Her practitioner diagnosed her with Streptococcal infection. The patient was treated with amoxicillin + clavulanate potassium (AUGMENTIN) for 7 days and oral diphenhydramine (BENEDRYL)(duration of treatment not provided). She did not have any laboratory test performed. The outcome of streptococcal infection, injection site redness and itching was reported as not recovered. Relatedness between the events and ZOSTAVAX, sterile diluent (STERILE DILUENT) was not reported. The patient did seek medical attention.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse via a company representative and refers to a male patient of unknown age. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with ZOSTAVAX injection (dose, route of administration, vaccination site, lot # and expiry date were not specified) for prophylaxis. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT). On an unknown date, after receiving ZOSTAVAX, the patient developed shingles. The outcome of the event was unknown. The reporter did not provide the causality assessment between the events and ZOSTAVAX.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist, concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not provided. On an unknown date in December 2016, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route of administration and expiration date were not provided) and then was vaccinated again with a second dose of ZOSTAVAX Lot number M041087  and expiration date 30-JAN-2018 which were reconstitued with an unspecified sterile diluent (manufacturer unknown). No adverse effects reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patients were vaccinated with and incorrect stored dose of ROTATEQ lot # M043669 with expiration date on 15-JUN-2018 (strength and route were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccines were exposed to temperature of 47 Fahrenheit grades range for a time frame of 1 hour and 15 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patients were vaccinated with an incorrect stored dose of GARDASIL 9 lot # M034780 with expiration date on 15-APR-2019 (strength and route were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccines were exposed to temperature of 47 Fahrenheit grades range for a time frame of 1 hour and 15 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: Around 6:30 PM patient complained his legs where itchy, upon inspection we discovered hives and took him to ER.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oral mucosal eruption, Tongue eruption
Clinical narrative: PATIENT REPORTED REACTION AS DEVELOPEMENT OF RASH IN MOUTH, UPPER PALATE AND TONGUE, PATIENT WAS ABLE SWALLOW AND NORMAL BREATHING AT  TIME OF REPORTING, HAD 2 TABELT OF BENADRYL 25 MG WAS TAKEN, AND WAS KEPT HERE UNDER SUPERVISION OF DAUGHTER AND DIRECTED TO SSEEK MEDICAL ADVICE BUT DENIED AND KEEP WATCHING.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Headache, Hypoaesthesia oral, Pain, Paraesthesia
Clinical narrative: h/a, bone and body pain, fever, Numbness tongue , pins and needles in rt arm.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: h/a, bone and body pain, fever, Numbness tongue , pins and needles in rt arm.
Age: 5.0
Sex: M
Vaccine: FLU4, MMR, MNQ
Symptoms: Injection site oedema, Injection site pain, Pain in extremity
Clinical narrative: INITIALLY RIGHT ARM PAIN AND RIGHT DELTOID EDEMA WHICH PROGRESSED TO RIGHT FOREARM AND RIGHT HAND PAIN OVER THE 24 HOURS FOLLOWING ADMINISTRATION OF VACCINES.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Severe shoulder pain, resulting in immobility lasting from time of injection until present (currently at 12 days and still with severe mobility limitation).
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Rash, Vaccination complication
Clinical narrative: Redness/Rash on arm that vaccines were given in appeared the day after vaccination. Hard to tell for sure which vaccine caused reaction. Patient was seen by physician and he told her he did think it was a reaction to vaccine that would clear up on it's own with no needed treatment.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Nausea, Pyrexia, Vaccination site swelling
Clinical narrative: Patient received vaccinations on Sunday Oct 1st, 2017. Patient came to pharmacy this morning & said that when he was in the shower that he noticed the swelling & redness on his arm where he received the vaccinations. He presented with at least a 6 inch red band on his left arm around injection area with oval swelling towards inner arm about 3 inches long & about 1 inch wide in the center. He said that he had been nauseated since he received the vaccines & had had some fever since Sunday as well. Recommended patient get Benadryl & if not getting better in 24-48 hours or if symptoms worsen he should go to MD and may possible need a steroid of some sort.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Erythema, Malaise, Pain in extremity, Peripheral swelling
Clinical narrative: Woke up with sore, red, swollen and hot arm. Patient also complained of general malaise and dizziness. Patient reported to the pharmacy on 10-2-17 around 5:30pm and arm was still red and swollen to the elbow.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Woke up with sore, red, swollen and hot arm. Patient also complained of general malaise and dizziness. Patient reported to the pharmacy on 10-2-17 around 5:30pm and arm was still red and swollen to the elbow.
Age: 25.0
Sex: M
Vaccine: FLU4
Symptoms: Flushing, Hyperhidrosis, Paraesthesia
Clinical narrative: TINGLING IN THE FACE, ARMS AND HANDS. SWEATY PALMS AND FLUSHED FACE.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13
Symptoms: Rash erythematous
Clinical narrative: Patient had rash red and elevated. Cleared mostly within 1 hour. Didn't seem to be itchy. No new foods. No cold or cough.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient had rash red and elevated. Cleared mostly within 1 hour. Didn't seem to be itchy. No new foods. No cold or cough.
Age: 6.0
Sex: M
Vaccine: PNC13
Symptoms: Wrong drug administered
Clinical narrative: NURSE PHN RN MISTAKENLY INJECTED PCV13 INSTEAD OF PPV23. CLIENT WAS RECOMMENDED BY MD TO HAVE PPV23 PRIOR TO HIS COCHLEAR IMPLANT PROCEDURE.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Pain, Pain in extremity
Clinical narrative: Severe pain in clavicle/chest region, and shooting pains down left arm to wrist. Treated with OTC pain relievers, and heat. Pain is a little lessened, but still persists to present (12 days post injection).
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain
Clinical narrative: Patient was given PNEUMOVAX and FLUZONE HD at the same time and in the same arm in close proximity (less than 1 inch apart). Patient has soreness of the right arm where the medication was given. She went to the emergency room and she was given a rx for Ibuprofen.
Age: 79.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, swelling with warm touch- Radius 4 inches started on 9/5 and still have reaction until 9/15/17 with redness, swelling went down to 3 inches radius. Recommend to put ice on injection site and take Tylenol.
Age: 34.0
Sex: M
Vaccine: TD
Symptoms: Injection site haematoma, Injection site swelling, Injection site warmth
Clinical narrative: Patient came back in to office 4 days after receiving TD vaccine. The area was slightly swollen, slightly warm, may have been a hematoma. No fever or any other reaction, no redness. Ibuprofen suggested as well as ice/heat.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Dyskinesia, Eyelid function disorder, Facial paralysis, Vision blurred
Clinical narrative: Around 9/26/17 at 8pm I noticed subtle changes in my smile (the left side of my mouth wasn't raised as high as my right side). The next morning on 9/27/17 my smile remained the same as previous night but I also noticed I wasn't able to close my left eyes all the way (when I washed my face water would get into my left eye because I wasn't able to shut it tightly). As a result of my eyes not shutting all the way I developed blurry vision in my left eye. I also had some difficulty swishing water in my mouth when brushing my teeth and spitting the water out. When I try to raise my eyebrows my left eyebrows wouldn't raise as high as my right eyebrow. I did not have any weakness on my limbs/extremities, no headache, no confusion/change in mental state, no pain, no difficulty swallowing or eating. I went to urgent care on 9/28/17 and they diagnosed me with Bell's Palsy and gave me steroids (prednisone taper starting at 60mg per day and tapered over a ten day period) and Valtrex (1000 mg once daily for 5 days). So far my symptoms reached its peak on 9/29/17 and as of today (10/3/17) symptoms have remained the same although vision feels a bit blurrier. I am using artificial tears every hour and wearing an eye patch at night.  I have follow up appointment with neurology specialist on 11/9/17.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Computerised tomogram head, Crying, Headache
Clinical narrative: Patient sister contact our office 1.5 hours later stating the patient was complaining of severe Headache and Crying. Patient was advised to go to the ER. CT of the head was completed and meds administered for comfort.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Intensive care, Muscular weakness, Paraesthesia
Clinical narrative: Received vaccine 9/22/17. Reported upper respiratory tract infection "1-2 days prior to the onset of his symptoms", no additional description offered. Developed bilateral lower extremity tingling and some weakness 9/25/17 morning, progressing to hand and shoulder. On 9/26/17 reported to PCP muscles of chest abdomen somewhat weaker. Admitted 9/26/17 with diagnosis Guillain-Barre syndrome following vaccination and ascending paralysis. Transferred to ICU 9/27/17 to closely monitor respiratory status and negative inspiratory force. Completed 5 day course IVIG, improved, transferred to intermediate care 9/30/17. Planned transfer to Inpatient Rehab Unit 10/2/17.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Upper respiratory tract infection
Clinical narrative: Received vaccine 9/22/17. Reported upper respiratory tract infection "1-2 days prior to the onset of his symptoms", no additional description offered. Developed bilateral lower extremity tingling and some weakness 9/25/17 morning, progressing to hand and shoulder. On 9/26/17 reported to PCP muscles of chest abdomen somewhat weaker. Admitted 9/26/17 with diagnosis Guillain-Barre syndrome following vaccination and ascending paralysis. Transferred to ICU 9/27/17 to closely monitor respiratory status and negative inspiratory force. Completed 5 day course IVIG, improved, transferred to intermediate care 9/30/17. Planned transfer to Inpatient Rehab Unit 10/2/17.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Eye swelling, Hypersensitivity, Rash, Rash papular, Swelling face
Clinical narrative: Pt received the FLUARIX QUADRIVALENT influenza vaccine at a flu clinic held at the same location as his provider on Sat 9/30/2017. (Note: He did receive a FLUARIX QUADRIVALENT influenza vaccine last year, 10/15/2016, with mild arm swellling). On Sunday evening, mother noted pink papular rash on torso, head, neck, face, as well as facial swelling. No shortness of breath or difficulty breathing. Presenting to the clinic 10/3/2017 with symptoms still present.
Age: 14.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chest discomfort, Fatigue, Nausea, Streptococcus test negative, Throat tightness
Clinical narrative: Patient woke up on the morning of 08/03/17 complaining of fatigue, throat tightness, chest heaviness, and nausea. The symptoms persisted and patient was seen in the office and examined by MD around 12PM.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Shoulder and arm pain after injection. Patient seen by provider and prescribed OTC Advil.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose increased, Pain, Pain in extremity
Clinical narrative: Patient called the pharmacy to complain of Right arm soreness and full body aches. Patient also mentioned that his blood sugar was to high to be measured with his meter. Upon recheck it was in the 400s. He took his insulin and was instructed to seek medical attention if his blood sugar did not come down. Checking with patient the next morning he stated his blood sugar had returned to what had normally been running, but was still suffering from body aches.
Age: 61.0
Sex: M
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: VARIVAX was accidently given instead of ZOSTAVAX to 61 year old patient. Manufacturer said to revaccinate with ZOSTAVAX in 28 days.
Age: 9.0
Sex: F
Vaccine: FLU4, HEP, PPV
Symptoms: Seizure
Clinical narrative: New-onset seizure.
Age: 52.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Nausea, Pain in extremity
Clinical narrative: PATIENT CALLED YESTERDAY COMPLAINING ABOUT SORENESS OF ARM AND WAS TOLD THAT IT DOES CAUSE SOME SORENESS AND USUALLY GOES AWAY AFTER 3 DAYS. SHE SAID AT THE TIME OF THE SHOT SHE FEEL THE SORENESS AND TODAY TUESDAY 10/3/17 SHE CAME TO THE PHARMACY AND SHOWED THE RPH THAT HER ARM ARE STILL SORE AND COMPLAINING ABOUT FEELING NAUSEATED. PER PATIENT SHE CALLED HER DR AND WILL BE SEEN BY DR TOMORROW 10/4/17.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Dizziness, Vomiting
Clinical narrative: SAYS HE WOKE UP THE NEXT MORNING FEELING DIZZY AND HE EXPERIENCED SOME VOMITING.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Adverse Reaction - Redness and warmth noted at injection site. As reported in chart.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: Rash developed below the injection site at elbow and above for about 6 inches.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: No treatment, MD told the patient not to get the high dose next year because the patient stated that she had a reaction last year as well. And to call back if it got worse.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site rash
Clinical narrative: PT REPORTED WITH LOCALIZED RASH, APPROXIMATELY 3 INCHES IN DIAMETER, AROUND INJECTION SITE. ALSO EXPERIENCED HEADACHE BEGINNING AT MIDNIGHT THE NIGHT AFTER INJECTION THAT CONTINUED FOR ABOUT 12 HOURS. NO TREATMENT WAS GIVEN, PT WAS INSTRUCTED TO MONITOR RASH FOR ANY SIGNS OF WORSENING.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Pain
Clinical narrative: WOKE UP SHIVERING AND ACHING OVER ENTIRE BODY.