chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site hypersensitivity, Injection site pain, Injection site swelling
Clinical narrative: Patient received flu vaccine on 9/26/17 has swelling, redness, pain on the left thigh after the shot. Was seen in our office yesterday 9/27/17 and had benadryl po for allergic reaction at the shot site.  Seen again on 9/28/17 lesion getting worse with increase redness, warmth, and tenderness , no fever. Dr. has placed patient on Cephalexin and ibuprofen. Patient has a recheck appointment scheduled for 9/29/17. Will continue to observe and treat accordingly.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Skin lesion, Skin warm, Tenderness
Clinical narrative: Patient received flu vaccine on 9/26/17 has swelling, redness, pain on the left thigh after the shot. Was seen in our office yesterday 9/27/17 and had benadryl po for allergic reaction at the shot site.  Seen again on 9/28/17 lesion getting worse with increase redness, warmth, and tenderness , no fever. Dr. has placed patient on Cephalexin and ibuprofen. Patient has a recheck appointment scheduled for 9/29/17. Will continue to observe and treat accordingly.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient received the PNEUMOVAX 23 vaccine on 9/24/17 administered by certified technician. She said she felt a sting as the vaccine went in on the same day. On 9/27/17 she noticed a red band slightly above her elbow on the right arm which was the same one she received the vaccine in. She called and reported to us on 9/27/17, and we advised her to follow up with her primary care provider.
Age: 76.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Blood glucose increased
Clinical narrative: The patient experienced an increase in her blood sugar the following morning after receiving these vaccines. She said it started at about 180 mg/dL and steadily increased to about 300 mg/dL.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with GARDASIL 9 injection, lot # M011840 with expiry date 01-FEB-2018, lot # N003703 with expiry date 29-OCT-2019 and lot # M034780 with expiry date 15-APR-2019 (dose, route of administration and vaccination site were not specified) for prophylaxis. Administered doses of GARDASIL 9 underwent a temperature excursion between 32 Fahrenheit degrees and Fahrenheit degrees for 10 days. There was no previous temperature excursion. Data Logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA013078: US-009507513-1709USA013077: US-009507513-1709USA013075: US-009507513-1709USA007903.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with PNEUMOVAX 23 injection, lot # M029681 with expiry date 08-NOV-2018 and lot # M029681 with expiry date 22-JAN-2018 (dose, route of administration and vaccination site were not specified) for prophylaxis. Administered doses of PNEUMOVAX 23 underwent a temperature excursion between 32 Fahrenheit degrees and Fahrenheit degrees for 10 days. There was no previous temperature excursion. Data Logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA013078: US-009507513-1709USA007903: US-009507513-1709USA013075: US-009507513-1709USA013076.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patient's medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ oral liquid, lot # M025572 with expiry date 20-JAN-2018, lot # M046008 with expiry date 29-JUN-2018 and lot # M033337 with expiry date 14-APR-2018 (dose was not specified) for prophylaxis. Administered doses of ROTATEQ underwent temperature excursion between 32 Fahrenheit degrees and 35 Fahrenheit degrees for 10 days. Data Logger was involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007903: US-009507513-1709USA013077: US-009507513-1709USA013075: US-009507513-1709USA013076.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Alopecia, Burning sensation, Circadian rhythm sleep disorder, Eye discharge, Eyelid margin crusting
Clinical narrative: This is a spontaneous report from a contactable consumer. A 72-year-old female patient received PREVNAR 13, via an unspecified route of administration in 2016 as a single dose as a pneumonia shot. The patient had unspecified medical conditions and concomitant medications. The consumer stated that she got the shot last year in March or April and she broke out all over; itching and stuff and scratching the blood out of herself and she was messed up. Her hair came out and her eyes were stuck and she broke out all over. She had to pull layers of skin off and she wanted to know who she could talk to about it. The consumer stated that this got her eyes "running" and she would wake up and they will be stuck together. She also stated that she broke all over and she got "Jet leg"; they were sun spots, she got light spots and it's from her feet to all way up to her head which broke out all over. She received the shot around 5-6 of March last year in the hospital and two days later, she broke out ever since. The consumer further stated that as soon as she got the shot, she started to hurt the next day and the next day it swelled all over and then she got the breaking out turning all over the stuff; rashes all over her, all over her head; took her hair off. The consumer mentioned that she had consulted with a physician and they have been treating it ever since last year but they did not get rid of it. It had not improved and were not getting any better. She stated that she got to try to get these people because somebody got to help her as it broke her out; itching, scratching, burn all the time, and her eyes were messed up. Outcome of the event "Had to pull layers of skin off" was unknown; while for the rest of the events was not recovered.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Haemorrhage, Pruritus, Rash generalised, Scratch, Skin exfoliation
Clinical narrative: This is a spontaneous report from a contactable consumer. A 72-year-old female patient received PREVNAR 13, via an unspecified route of administration in 2016 as a single dose as a pneumonia shot. The patient had unspecified medical conditions and concomitant medications. The consumer stated that she got the shot last year in March or April and she broke out all over; itching and stuff and scratching the blood out of herself and she was messed up. Her hair came out and her eyes were stuck and she broke out all over. She had to pull layers of skin off and she wanted to know who she could talk to about it. The consumer stated that this got her eyes "running" and she would wake up and they will be stuck together. She also stated that she broke all over and she got "Jet leg"; they were sun spots, she got light spots and it's from her feet to all way up to her head which broke out all over. She received the shot around 5-6 of March last year in the hospital and two days later, she broke out ever since. The consumer further stated that as soon as she got the shot, she started to hurt the next day and the next day it swelled all over and then she got the breaking out turning all over the stuff; rashes all over her, all over her head; took her hair off. The consumer mentioned that she had consulted with a physician and they have been treating it ever since last year but they did not get rid of it. It had not improved and were not getting any better. She stated that she got to try to get these people because somebody got to help her as it broke her out; itching, scratching, burn all the time, and her eyes were messed up. Outcome of the event "Had to pull layers of skin off" was unknown; while for the rest of the events was not recovered.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Solar lentigo
Clinical narrative: This is a spontaneous report from a contactable consumer. A 72-year-old female patient received PREVNAR 13, via an unspecified route of administration in 2016 as a single dose as a pneumonia shot. The patient had unspecified medical conditions and concomitant medications. The consumer stated that she got the shot last year in March or April and she broke out all over; itching and stuff and scratching the blood out of herself and she was messed up. Her hair came out and her eyes were stuck and she broke out all over. She had to pull layers of skin off and she wanted to know who she could talk to about it. The consumer stated that this got her eyes "running" and she would wake up and they will be stuck together. She also stated that she broke all over and she got "Jet leg"; they were sun spots, she got light spots and it's from her feet to all way up to her head which broke out all over. She received the shot around 5-6 of March last year in the hospital and two days later, she broke out ever since. The consumer further stated that as soon as she got the shot, she started to hurt the next day and the next day it swelled all over and then she got the breaking out turning all over the stuff; rashes all over her, all over her head; took her hair off. The consumer mentioned that she had consulted with a physician and they have been treating it ever since last year but they did not get rid of it. It had not improved and were not getting any better. She stated that she got to try to get these people because somebody got to help her as it broke her out; itching, scratching, burn all the time, and her eyes were messed up. Outcome of the event "Had to pull layers of skin off" was unknown; while for the rest of the events was not recovered.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Dysgeusia, Erythema, Eye swelling, Flushing, Lip swelling
Clinical narrative: "MEDICINE TASTE IN MOUTH", FACIAL FLUSHING (RED), FACIAL SWELLING (CHEEKS/EYES/LIPS).
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: "MEDICINE TASTE IN MOUTH", FACIAL FLUSHING (RED), FACIAL SWELLING (CHEEKS/EYES/LIPS).
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Injection site pruritus, Injection site swelling
Clinical narrative: Localized swelling and itching at injection site - 3"x5" - resolved fully in 3 days. Pt also had asthma symptoms. Pt used albuterol inhaler and took benadryl.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Herpes virus infection, Rash, Skin warm, Swelling
Clinical narrative: Swelling, rash, warmth to touch that progressively worsened x 3 days. Currently diagnosed as Herpes without complication and cellulitis. Treatment - Amoxicillin-Pot.Claulanate 875-125mg PO BID X 10 days, Valacyclovir HCL 1g PO TID X 7days.
Age: 89.0
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient is experiencing no adverse affects at this time.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Facial paralysis, Injection site erythema, Pain
Clinical narrative: Pain, redness injection up radiating up neck. Presented to ER on 8-30-17 (PM). Admitted, discharged 9-1-17 9PM-"Bell's Palsy" on discharge papers.
Age: 69.0
Sex: F
Vaccine: HEPAB
Symptoms: Cardiac arrest, Chest X-ray normal, Hyperhidrosis, Myocardial necrosis marker normal, Nausea
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of cardiac arrest in a 69-year-old female patient who received TWINRIX (batch number NZ3TA, expiry date 12th November 2018). On an unknown date, the patient received TWINRIX. On an unknown date, less than a minute after receiving TWINRIX, the patient experienced cardiac arrest (serious criteria GSK medically significant), respiratory arrest (serious criteria GSK medically significant), seizure (serious criteria GSK medically significant), nausea, diaphoresis and syncope. On an unknown date, the outcome of the cardiac arrest, respiratory arrest, nausea, diaphoresis and syncope were unknown and the outcome of the seizure was recovered/resolved. It was unknown if the reporter considered the cardiac arrest, respiratory arrest, seizure, nausea, diaphoresis and syncope to be related to TWINRIX. Additional details were provided as follows: Within a 1 minute after receiving TWINRIX, the patient became nauseous and diaphoretic followed by syncope. Within a few seconds, the patient went into respiratory and cardiac arrest. The cardiopulmonary resuscitation (CPR) was initiated, but only a few compressions were delivered before the patient had a seizure. The seizure lasted approximately 30 seconds. The patient was stabilized before emergency medical services (EMS) arrived. The patient transferred to the emergency room (ER) where the cardiac enzymes and chest X-ray (CXR) were found to be normal. The patient discharged to home from the emergency room.
Age: 69.0
Sex: F
Vaccine: HEPAB
Symptoms: Respiratory arrest, Resuscitation, Seizure, Syncope
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of cardiac arrest in a 69-year-old female patient who received TWINRIX (batch number NZ3TA, expiry date 12th November 2018). On an unknown date, the patient received TWINRIX. On an unknown date, less than a minute after receiving TWINRIX, the patient experienced cardiac arrest (serious criteria GSK medically significant), respiratory arrest (serious criteria GSK medically significant), seizure (serious criteria GSK medically significant), nausea, diaphoresis and syncope. On an unknown date, the outcome of the cardiac arrest, respiratory arrest, nausea, diaphoresis and syncope were unknown and the outcome of the seizure was recovered/resolved. It was unknown if the reporter considered the cardiac arrest, respiratory arrest, seizure, nausea, diaphoresis and syncope to be related to TWINRIX. Additional details were provided as follows: Within a 1 minute after receiving TWINRIX, the patient became nauseous and diaphoretic followed by syncope. Within a few seconds, the patient went into respiratory and cardiac arrest. The cardiopulmonary resuscitation (CPR) was initiated, but only a few compressions were delivered before the patient had a seizure. The seizure lasted approximately 30 seconds. The patient was stabilized before emergency medical services (EMS) arrived. The patient transferred to the emergency room (ER) where the cardiac enzymes and chest X-ray (CXR) were found to be normal. The patient discharged to home from the emergency room.
Age: 1.25
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Abnormal behaviour, Acute disseminated encephalomyelitis, Central venous catheterisation, Computerised tomogram head, Encephalitis
Clinical narrative: Patient noted the day following vaccines to be stumbling and not acting right. Seen at urgent care on 6-17-17, returned to ER and had head CT on 6-18-17 and admitted to hospital 6-19-17 with abnormal head MRI with evidence of encephalitis, underwent lumbar puncture and then in ICU for 10 days. Dx of post-infectious ADEM [G04.01] as well as Go4.90 and R26.81. Underwent plasmapheresis while admitted
Age: 1.25
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Gait disturbance, Intensive care, Lumbar puncture, Nuclear magnetic resonance imaging brain abnormal, Plasmapheresis
Clinical narrative: Patient noted the day following vaccines to be stumbling and not acting right. Seen at urgent care on 6-17-17, returned to ER and had head CT on 6-18-17 and admitted to hospital 6-19-17 with abnormal head MRI with evidence of encephalitis, underwent lumbar puncture and then in ICU for 10 days. Dx of post-infectious ADEM [G04.01] as well as Go4.90 and R26.81. Underwent plasmapheresis while admitted
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: Extreme pain and stiffness in shoulder and upper arm where needle was administered. Not responsive to heat treatments or anti inflammatory drugs.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Itching began sacral area and back of legs, extending over few days to front of thighs, mid-back, and arms. No hives, no redness, tiny pale to red bumps only, non draining, no scabs. No change in diet, laundry, personal care items. no UTI or yeast, no bug bites, OTC remedies minimal help.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Injection site erythema, Injection site urticaria, Pain in extremity, Peripheral swelling
Clinical narrative: Extreme arm pain x3d, large red hives covering upper (L) arm x3d, large amt of swelling in left arm and face x2d, arm and face warm to touch x3d, scratchy throat x2d - determined to be an anaphylactic reaction.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm, Swelling face, Throat irritation
Clinical narrative: Extreme arm pain x3d, large red hives covering upper (L) arm x3d, large amt of swelling in left arm and face x2d, arm and face warm to touch x3d, scratchy throat x2d - determined to be an anaphylactic reaction.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness, warm to touch, painful to touch at injection site.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Headache, Hypoaesthesia, Hypoaesthesia oral, Injection site pain
Clinical narrative: 0910 - Patient was given Flucelvax to right arm, Patient initially stated 'it hurt more than usual'. 0925 - Patient started complaining of headache and nausea. 0945 - patient started complaining of tingling around her lips and dizziness. Provided was then notified. Patient was placed laid on exam table with feet elevated. 0953 - IV was started by provider to patient's right hand and provider gave patient Benadryl and solu-medrol. Patient started on 500ml of Normal Saline. VS BP 139/94 P 83 RR 20 T 97.7, patient complaining of dizziness and numbness/tingling to around lips. Denies pain. 1007 - VS BP 149/106 P 90 RR 20. Patient denied dizziness. Does report numbness to right hand. Patient is shaking, but states she does not feel cold and denies a blanket. Provider informed. 1019 - Normal saline completed. Patient ambulated to bathroom. Not complaining of dizziness or numbness. Denies pain. Ambulated with assistance. No concerns. 1025 - Returned from bathroom with no concerns. No dizziness. No numbness/tingling. 2nd bag of 500ml Normal Saline started. 1032 - VS BP 138/96 P 73 RR 18. Denies dizziness. Denies numbness/tingling. Denies pain. 1045 - Patient resting comfortably. 1100 - VS BP 130/80 P 69 . IV Discontinued. Patient released from clinic with assistance.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Nausea, Paraesthesia oral, Tremor
Clinical narrative: 0910 - Patient was given Flucelvax to right arm, Patient initially stated 'it hurt more than usual'. 0925 - Patient started complaining of headache and nausea. 0945 - patient started complaining of tingling around her lips and dizziness. Provided was then notified. Patient was placed laid on exam table with feet elevated. 0953 - IV was started by provider to patient's right hand and provider gave patient Benadryl and solu-medrol. Patient started on 500ml of Normal Saline. VS BP 139/94 P 83 RR 20 T 97.7, patient complaining of dizziness and numbness/tingling to around lips. Denies pain. 1007 - VS BP 149/106 P 90 RR 20. Patient denied dizziness. Does report numbness to right hand. Patient is shaking, but states she does not feel cold and denies a blanket. Provider informed. 1019 - Normal saline completed. Patient ambulated to bathroom. Not complaining of dizziness or numbness. Denies pain. Ambulated with assistance. No concerns. 1025 - Returned from bathroom with no concerns. No dizziness. No numbness/tingling. 2nd bag of 500ml Normal Saline started. 1032 - VS BP 138/96 P 73 RR 18. Denies dizziness. Denies numbness/tingling. Denies pain. 1045 - Patient resting comfortably. 1100 - VS BP 130/80 P 69 . IV Discontinued. Patient released from clinic with assistance.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: RASH DEVELOPED AFTER ABOUT 24 HOURS. WAS RED AND TURNED DARKER. SPOKE WITH PATIENT ON 9-27 AND IT WAS BETTER THAN THE DAY BEFORE.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Headache, Hypotension, Nausea, Somnolence
Clinical narrative: Morning after vaccination given patient started feeling nausea, headache, low blood pressure, sleepyness, dizzyness.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Body temperature increased, Chest X-ray, Eye movement disorder
Clinical narrative: Caregiver called Health Dept on 9-28-17 and reported that on 9-27-17 at approx. 5:30 PM the infants "eyes rolled back in her head" and she called 911. Infant was taken to ER and seen. At the ER, she reports they checked her temp (she does not know the amount of temp), did a CXR, gave her TYLENOL and sent her home. She reports they told her if was a delayed reaction from her shots. She stated that earlier in the day of the 27th, she had checked the temp and it was only 99.6.
Age: 76.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Headache, Injection site erythema, Vomiting
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 76 year old female patient. The patient did not have any pertinent medical history and drug allergies or reactions. The patient's concomitant therapies included apixaban (ELIQUIS), atenolol, rosuvastatin calcium (CRESTOR) and amlodipine. On 30-AUG-2017, the patient was vaccinated with PNEUMOVAX 23 intramuscularly, lot # N013521 and expiration date: 23-JAN-2019 (dose was not reported) as "routine vaccine" and a dose of unspecified flu vaccine. In August 2017, within 12 hours of receiving the vaccines, the patient developed a severe headache and vomiting and 14 hours after receiving the vaccines she developed erythema at the PNEUMOVAX 23 injection site that was 4 inches. The outcome of headache and vomiting was reported as resolved on an unknown date in 2017. The outcome of the erythema was reported as not recovered. The relatedness between the events and PNEUMOVAX 23 was not reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unspecified gender and age. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On unknown dates, the unspecified number of improperly stored doses of GARDASIL 9 lot# reported as M004798, expiration date 31-OCT-2019 (dose, route of administration and anatomical location were not reported) were administered to the patients. The doses were stored in temperatures from 32 degrees Fahrenheit  to 25  degrees Fahrenheit  for 240 hours. No adverse effects have been reported. Data logger was not involved. There was no previous excursion reported. Product quality complaint was not involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. The patients' concurrent conditions and pertinent medical history were not reported.     On an unknown date, the patients were vaccinated with an improperly stored doses of VARIVAX (lot # N008077, expiration date 09-MAR-2019) (dose and route were not reported) for prophylaxis. Concomitant therapies included sterile diluent. The vaccine was exposed from -14 degree Celsius (°C) to -10 degree Celsius (°C) for 4 hours and 45 minutes. There was previous temperature excursion from -9°C to 8°C for 6 hours and 26 minutes. The call was made because there was a "data logger". No adverse effects reported. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1709USA008769:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician refers to 200 patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with an improperly stored doses of M-M-R II (lot # M032486, expiration date: 06-JUL-2018) (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion from 9 to 25 degrees Celsius for 5.5 hours. Data logger was not involved. There were no previous excursions reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M046373, expiration date 04-NOV-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 49 degrees Fahrenheit to for 12 hours. Data logger was involved. There were some previous temperature excursion of 57 degrees Fahrenheit to for 4 hours. This is one of two reports received from the same reporter. ; Sender's Comments: US-009507513-1709USA014163:
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injected limb mobility decreased, Skin warm
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 67 year old female patient. The patient had none concomitant medication, pertinent medical history or drug reactions or allergies. On 19-SEP-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot# reported as: N016106, expiration date reported as: 16-NOV-2018), intramuscularly (frequency was unspecified) for prophylaxis. On that same date at night, the inside of her injected arm was red, warm, and tight. The patient did not receive any treatment for her conditions. It was reported that no laboratory diagnostics were performed, that the patient sought for medical attention with the reporting pharmacist, that intervention to prevent serious criteria was not necessary, that the patient was not hospitalized and that the patient's conditions were not life threatening. No product quality complaint was involved. At the time of the report, the outcome of injection site movement impairment, injection site warmth and injection site erythema was reported as not recovered. The relatedness assessment between PNEUMOVAX 23 and the aforementioned adverse events was not provided. Lot# N016106 was verified to be an invalid lot number for PNEUMOVAX 23.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist referring to multiple unspecified patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications. On unknown dates the patients were vaccinated with improperly stored ZOSTAVAX 19400 plaque-forming unit (PFU), lot # M037655 and expiration date on 29-NOV-2017 (dose and route of administration were not reported) for prophylaxis; which was reconstituted with properly stored sterile diluent (DILUENT MRK). The doses of stored zoster vaccine live (ZOSTAVAX) were exposed to a temperature excursion of 15 degrees Fahrenheit (°F) to 46°F during a time frame of 17 hours, which was detected by the data logger. Previous temperature excursion was reported as 6°F to 14°F for 7 hours 30 minutes. No adverse events were reported and no product quality complaints were present.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Aplastic anaemia, Inappropriate schedule of drug administration, Incomplete course of vaccination
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a 19 years old female patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported. The patient did not have drug reactions or allergies. It was reported that on an unspecified date in 2015 (reported as between July 2015 and August 2015), the patient was vaccinated with a first dose of GARDASIL 9 (strength, route, dose, anatomical location, lot number and expiration date were not reported) for prevention of human papillomavirus (HPV). The patient did not complete this schedule. On an unspecified date in 2016, the patient restarted the vaccination schedule and received two doses "(these two doses were actually the second and third)". It was also mentioned that the patient did not receive the third dose of the 2016 revaccination schedule of GARDASIL 9. On an unspecified date approximately in December 2016, the patient developed aplastic anemia. It was not known if laboratory test were performed. At the reporting time the patient's outcome and the causality assessment between therapy with GARDASIL 9 and the event was not reported. Upon internal review the event of aplastic anemia was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Infection, Injection site erythema, Injection site pain, Product preparation error
Clinical narrative: This spontaneous report was received from a 70-year-old female patient who refers to herself. The patient's medical history was not reported. The patient's concurrent conditions included high blood pressure, thyroid issues and allergy to codeine, morphine and TYLOX. The patient's concomitant therapies included unspecified high blood pressure and thyroid medications. On an unknown date in 2015 (reported as "about 2 years ago" and "on an unspecified date 2 years ago") at around 2-3 pm., the patient was vaccinated with 1 dose of ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported), reconstituted with sterile diluent, for prevention of shingles. On an unknown date in 2015 (reported as "later that night"), the patient developed a burning sensation at the injection site with a little red round circle ("about the size of a half dollar") that was dark in the middle and then became lighter on the outside. The patient stated that she iced the area and went to sleep. The following morning, the circle developed into a 4 inch round circle and was still burning. The patient went to her pharmacist, who stated that she developed shingles. The pharmacist then talked with the patient's physician to ask the physician to prescribe an unspecified pain medication. The physician refused to prescribe any medication until he had seen the patient. When the patient went to her physician, the physician stated that it was not shingles, but an infection. The physician further stated that the ZOSTAVAX "was not mixed enough" and that the powder was "underneath her skin instead of having been mixed properly with the diluent". The patient was prescribed an unspecified antibiotic and had recovered about a "week, or week and half" after starting the antibiotic. Product quality complaint was involved. The relatedness between the events and ZOSTAVAX was not reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, with lot# M044395, expiration date 31-MAY-2018 and with lot# M042821, expiration date 14-JUN-2018 and with lot# M044397, expiration date 20-JUN-2018 and with lot# M042822, expiration date 19-JUN-2018, and with lot N003980, expiration date 12-NOV-2018 (dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of -1.5 degrees Celsius for 20 hours and 5 minutes and between 0 degrees Celsius and 1 degree Celsius for 154 hours. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 27-SEP-2017, the patient was administered one dose of expired RECOMBIVAX HB injection, lot # M023892, expiration date: 15-SEP-2017, intramuscularly, (dose, dose number and injection site were not provided) for prophylaxis. There were no concomitant medications reported. No adverse effects were reported. Additional information is not expected because the reporter did not wish to be contacted.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On 20-SEP-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # M017983, expiry date 20-MAY-2018 (exact dose and route of administration were not reported) for prophylaxis. The dose of vaccine was stored in temperature -17 degrees Celsius (C) for 1 hour. No previous temperature excursions were detected. Digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # N005605, expiration date 08-APR-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 49 degrees Fahrenheit to for 12 hours. Data logger was involved. There were some previous temperature excursion reported, of 57 degrees Fahrenheit to for 4 hours. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA009147.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Seriousness criteria: Important medical Event. Initial unsolicited case received from a consumer (patient herself) on 19 Sep 2017. This case involves 67-year-old female patient who was vaccinated with 0.5 ml one dose of FLUZONE HIGH-DOSE (Batch number: UI845AA, expiry date and dose in series not reported) via intramuscular route in left deltoid on 15 Sep 2017 for immunization. The patient medical history was not reported. It was reported as the patient was previously diagnosed with cellulitis based on a similar reaction to another manufacturer's vaccine in past based on overt symptoms and not a confirmed culture. The patient was not ill at the time of vaccination. Concomitant medications were not reported. On 16 Sep 2017, one day after the vaccination, the patient developed progressing site reaction of warmth, hardness at the injection site with redness that was 6 inches long and 4 inches wide across her arm. On an unknown date, the patient was self-diagnosed with cellulitis. It was reported as the patient was not evaluated or treated by her physician because she stated it was not as big as her other reaction in the past. Relevant lab tests were not reported. The patient was recommended to take BENADRYL by the pharmacist. It was reported that as of 18 Sep 2017, the patient was recovering from her symptoms. Upon internal review the company decided to consider the case as serious, due to important medical event cellulitis. List of documents held by sender: none. Sender's Comments: Patient experienced cellulitis after vaccination. Time to onset is compatible with the role of vaccine. Further information on confirmed diagnosis, medical history, immune status at the time of vaccination, laboratory investigations excluding alternative etiologies would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed due to insufficient information.
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Headache, Malaise, Myalgia, Neck pain, Pain
Clinical narrative: 1 hour later severe headache, neck pain and total body pain, severe muscle pain. I was sick for 13 days and still have leg pain; both legs and had a fever of 99.1. I was not asked by the pharmacist if I was allergic to latex or asked if I wanted the Senior dose! I had an allergic reaction to the latex from the needle and a reaction to the Senior dose because it was too strong for me. I was sick for 13 days and in severe muscle pain. Still having leg pain in both legs. Ran a fever of 99.1.
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: 1 hour later severe headache, neck pain and total body pain, severe muscle pain. I was sick for 13 days and still have leg pain; both legs and had a fever of 99.1. I was not asked by the pharmacist if I was allergic to latex or asked if I wanted the Senior dose! I had an allergic reaction to the latex from the needle and a reaction to the Senior dose because it was too strong for me. I was sick for 13 days and in severe muscle pain. Still having leg pain in both legs. Ran a fever of 99.1.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Left arm soreness. Left arm redness and swelling - around arm. Arm warm to touch. Treating for cellulitis.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Bruising on arm above elbow but below injection site 1/2 way down arm.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt came in to pharmacy on 9/27/17. He said his arm is a bit itchy and red around injection site. I saw it was red and a bit (raised). I asked if he had taken anything, he said no. I advised him to put ice and if it gets worst to see MD or go to hospital.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Limb discomfort, Peripheral swelling
Clinical narrative: Here because of swelling right arm. Patient was here yesterday on nurse appointment for vaccines, received influenza vaccine left upper arm, BEXSERO Men B vaccine right upper arm about 420 pm. 4 hours later she developed marked swelling and pain/burning sensation in her right upper arm. Had difficulty moving arm and was unable to sleep because of discomfort. Did not want to take any medication. Applied ice. Swelling a little less today but still present along with discomfort. Able to move arm more. Denies redness of arm, numbness or tingling of hand/fingers. Did not have hives or difficulty breathing. No problem with first dose BEXSERO last month.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Burning sensation, Erythema, Injection site rash, Injection site urticaria, Peripheral swelling
Clinical narrative: Bilateral hand and feet redness and itching, bilateral hand warm with burning sensation, rash/hives at injection site (right upper arm), face redness, bilateral hand swelling.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Skin warm
Clinical narrative: Bilateral hand and feet redness and itching, bilateral hand warm with burning sensation, rash/hives at injection site (right upper arm), face redness, bilateral hand swelling.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Large area of Pain, redness & swelling at the injection site. Pain experienced in the entire left arm. Treated with Tylenol & Benadryl with improved symptoms in 24 hours but not complete resolution.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site papule, Injection site swelling, Injection site warmth
Clinical narrative: Child awoke this morning complaining with Rt arm. Mom brought him into the office with upper arm red, swollen and warm to the touch. Physician assessed area and also viewed a small papule. So, Child was treated for ? infection vs localized reaction. Parent was also instructed to apply cool compresses, along with giving either BENADRYL or Cetirizine and to follow up if not improved.
Age: 70.0
Sex: M
Vaccine: FLUA3
Symptoms: Chest pain, Cough, Epistaxis, Headache, Lacrimation increased
Clinical narrative: Sore throat, cold, nasal condition, wet eyes, headaches, heave cough, congestion in lunch, chest pain, during cough, 1. Nose bleed morning, getting better now, day 8. Still hanging on as a cough , and light nasal drip.
Age: 70.0
Sex: M
Vaccine: FLUA3
Symptoms: Nasal disorder, Nasopharyngitis, Oropharyngeal pain, Pulmonary congestion, Retching
Clinical narrative: Sore throat, cold, nasal condition, wet eyes, headaches, heave cough, congestion in lunch, chest pain, during cough, 1. Nose bleed morning, getting better now, day 8. Still hanging on as a cough , and light nasal drip.
Age: 70.0
Sex: M
Vaccine: FLUA3
Symptoms: Upper-airway cough syndrome
Clinical narrative: Sore throat, cold, nasal condition, wet eyes, headaches, heave cough, congestion in lunch, chest pain, during cough, 1. Nose bleed morning, getting better now, day 8. Still hanging on as a cough , and light nasal drip.
Age: 36.0
Sex: M
Vaccine: UNK
Symptoms: Lymphadenopathy, Tenderness
Clinical narrative: Tender axillary lymphadenopathy starting one day after vaccination, increasing in tenderness on day two. No other recent injury to the R arm. No other symptoms.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Chills, Pain, Pyrexia, Somnolence
Clinical narrative: Patient reported being really drowsy a few hours after administration. Patient went to sleep and woke up around 4am with really bad stomach pain, body aches and chills. Patient went to the urgent care and stated that she had a fever when she arrived. The doctors told her it was a reaction to the flu shot.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: Patient reported being really drowsy a few hours after administration. Patient went to sleep and woke up around 4am with really bad stomach pain, body aches and chills. Patient went to the urgent care and stated that she had a fever when she arrived. The doctors told her it was a reaction to the flu shot.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Blister, Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling increase warmth and blisters in the center. 9 cm by 11cm  Central blister area was 4x3cm.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Joint range of motion decreased, Neck pain, Pain in extremity
Clinical narrative: One half hour after administration had soreness in L arm that gradually moved to the L neck. Subsequently with decreased range of motion in both the arm and the neck with 7/10 pain.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: C/O reaction to Pneumonia vaccine, site area is swelling and has hives around it.
Age: 62.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Abdominal pain upper, Bacterial test negative, Blood magnesium normal, Culture stool negative, Diarrhoea
Clinical narrative: Traveler complained that after completing the final oral dose of typhoid he fell violently ill with stomach pain, fevers, diarrhea and night sweats. He said this went on for over a month and included oral thrush. He saw his PCP multiple times for these symptoms and was given multiple antibiotics and nystatin. Labs and stool studies were all negative. This was all prior to his travel.
Age: 62.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Full blood count normal, HIV test negative, Hepatitis C antibody negative, Lipids normal, Malaise
Clinical narrative: Traveler complained that after completing the final oral dose of typhoid he fell violently ill with stomach pain, fevers, diarrhea and night sweats. He said this went on for over a month and included oral thrush. He saw his PCP multiple times for these symptoms and was given multiple antibiotics and nystatin. Labs and stool studies were all negative. This was all prior to his travel.
Age: 62.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Metabolic function test normal, Night sweats, Oral candidiasis, Pyrexia, Serum ferritin normal
Clinical narrative: Traveler complained that after completing the final oral dose of typhoid he fell violently ill with stomach pain, fevers, diarrhea and night sweats. He said this went on for over a month and included oral thrush. He saw his PCP multiple times for these symptoms and was given multiple antibiotics and nystatin. Labs and stool studies were all negative. This was all prior to his travel.
Age: 1.92
Sex: M
Vaccine: FLU4
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: Cellulitis of right thigh, give Keflex. Vaccination site was red, no fever.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Erythema and swelling- likely cellulitis. Appeared 2 days after the injection.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Adverse event: redness (about the size of a baseball), swelling near injection site, warm to touch. Doesn't really bother the patient, just wanted to let us know. Suggested the patient apply ice and take ibuprofen or tylenol for pain. Follow up with us or her physician if symptoms worsen.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Influenza, Malaise, Pain in extremity
Clinical narrative: 4 hours after vaccination patient reported signs and symptoms of the flu. Extreme arm pain, chills, and malaise.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Erythema and induration of entire thigh - improved after 24 hrs.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Injection site warmth, Rash, Rash erythematous
Clinical narrative: A red rash going down from the sight of injection. Started sometime on the 27th and she called pharmacy on the 28th. Patient said rash was hot and sore but getting better.
Age: 51.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Swelling
Clinical narrative: SWELLING AND REDNESS.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Fall, Injection site erythema, Pyrexia
Clinical narrative: Patient received immunizations on 9/25/17 and on 9/26/17 called pharmacy to report fever and redness at injection site. Pharmacist advised patient to contact her doctor for fever and that redness upon injection site is normal site reaction. Patient reported on 9/28/17 to pharmacist that she did go to her doctors office 9/26/17 and while there she fell, and was transported to hospital for fall.  Patient is now at hospital being treated for cellulitis.