chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging normal, Pain in extremity, Paraesthesia, Viral test negative, Vision blurred
Clinical narrative: On January 7, 2017 (roughly two weeks after patient received the flu vaccine), I noticed patient was clenching his fists. Patient had never done this before. When I asked him why, he said it was because his hands were bothering him. I can send a timeline I have prepared, but over the next two weeks, the pain spread to his head (including at least two instances of blurry vision) and feet. We've had three blood tests since January 2017 (including one on January 21), an EMG and an MRI. The exams do not show a cause for his symptoms and patient continues to suffer from continuous hand and feet "tingling", as well as headaches. Medical Center Infectious Disease told us, there is "no way" his symptoms are caused by a bacteria or virus. At times, patient's symptoms become more painful. He has been seen by Medical Center Neurology, Infectious Disease and Immunology Departments. No definitive cause has been determined, but when I ask if it could be the flu vaccine, I have been told yes. Given that patient did not have a fever in December 2017 - April 2017 and his blood work does not show a bacterial or viral cause, the only cause my husband and I can think of is a potential adverse reaction to the flu vaccine. Medical journals note the flu vaccine may cause neurological issues and that such issues may present weeks after the vaccine. We have been told his symptoms may never go away. We are still seeking medical advice and will also visit the neurology department at another Hospital. I would be happy to submit copies of all medical exams done to date. Please note patient has no other developmental/emotional issues (no autism, disabilities, allergies).
Age: 53.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Injection site erythema
Clinical narrative: On 9/16/17 - patient went to a walk in medical complaining of reddening that had developed post injection and was spreading in the area where she had received the injection. She was prescribed an antibiotic (doxycyline 100mg tabs twice a day for 10 days). The next day the patient went to the emergency room (since she felt it was not improving and was given BACTRIM DS generic - one tablet every 12 hours for 10 days and BENADRYL OTC.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased, Irritability
Clinical narrative: Mom reports rectal temp of 101.2. She is more fussy than usual, no rash, no site discomfort or redness.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist via a company employee referring to a 42 year old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were reported as none. On 26-AUG-2017 the patient was vaccinated with PNEUMOVAX 23 lot # N014188, expiration date N014188, single 0.5 ml, intramuscular for prevention of Pneumococcal disease. On the same day, the patient experienced redness/swelling of skin and pain at injection site. The outcome of the events was reported as resolving. Unspecified treatment was given for the events.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a patient's mother, who was referring to her child of unknown age and gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions or allergies provided. On an unknown date, the patient was vaccinated with a fourth dose of GARDASIL 9 in injection for prophylaxis (lot number and expiration date were not reported). No adverse event was reported. No product quality complaint was involved.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to 4 different unspecified patients of unknown gender and age. Information about concurrent condition, drug reactions/allergies and medical history was unknown. Concomitant therapies included sterile diluent (manufacturer unknown). On 09-AUG-2017, 4 different unspecified patients were vaccinated with improperly stored PROQUAD (Lot# N002325, expiration date 19-JUL-2018) (strength, dose, and route unknown) for prophylaxis, the diluent (unspecified lot #'s and expiration dates) used to reconstitute the vaccine above was properly stored. The vaccine was stored at 6 to 14 degrees Fahrenheit for 15 hours and 45 minutes. There had not been a previous temperature excursion and the phone call was a result of the data logger. No adverse effects were reported. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-708USA007019: US-009507513-1709USA009153: US-009507513-1709USA009151: US-009507513-1709USA009152: US-009507513-1708USA008578: US-009507513-1709USA007605: US-009507513-1709USA007604: US-009507513-1709USA007603: US-009507513-1709USA007602: US-009507513-1709USA007601.
Age: 50.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Cellulitis, Chills, Erysipelas, Headache, Hyperhidrosis
Clinical narrative: At approximately 1600 on 9-16-17 patient reported experiencing a headache. On 9-16-17 at night time patient reported experiencing fever/chills/sweats. On 9-17-17 sweats continued. On 9-18-17 patient reported that when arrived to work her right arm was swollen and painful. On 9-18-17 patient left work at went to ER around 1200 where the MD diagnosed her with erysipelas/cellulitis and was given ibuprofen 800 mg and cephalexin 500 mg to be taken orally for 10 days. Outcome TBD.
Age: 50.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: At approximately 1600 on 9-16-17 patient reported experiencing a headache. On 9-16-17 at night time patient reported experiencing fever/chills/sweats. On 9-17-17 sweats continued. On 9-18-17 patient reported that when arrived to work her right arm was swollen and painful. On 9-18-17 patient left work at went to ER around 1200 where the MD diagnosed her with erysipelas/cellulitis and was given ibuprofen 800 mg and cephalexin 500 mg to be taken orally for 10 days. Outcome TBD.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Dyspnoea, Palpitations
Clinical narrative: HARD TO BREATH, FOREHEAD AND EARS WERE ON FIRE, HEART WAS POUNDING.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm, Urticaria
Clinical narrative: PATIENT REPORTED WARMNESS TO TOUCH AND A COUPLE BUMPS THAT APPEARED TO BE HIVES ABOUT 2 DAYS AFTER RECEIVING FLUZONE HD. PATIENT WENT TO URGENT CARE AND RECEIVED A STEROID INJECTION AND A STEROID PACK.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with an unspecified doses of improperly stored PEDVAXHIB lot # L042836 and expiration date 24-AUG-2018 (dose and frequency was not reported) for prophylaxis. No adverse effect reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA009980.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions and past drug reactions/allergies were not reported. The patient's concomitant medications included sterile diluent. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX 19400 PFU; lot # N016090 and expiration date: 23-AUG-2018 (dose, route and anatomical location were not reported) for prophylaxis. It was stated by the reporter that incorrect storage of ZOSTAVAX lasted 10 hours at 9° F; and the call was given because of a data logger. Previous temperature excursion had not occurred. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA008253.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 70 year old male patient. The patient's medical history were not reported. The patient's current condition included thyroid condition. On 06-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 (Dosing details not reported) (lot # N003997, expiry date 20-SEP-2018) intramuscularly for prophylaxis. Concomitant therapy included levothyroxine sodium (Manufacturer unknown). The patient reports that he had no lab work done. On the same day, he took TYLENOL and put ice on the injection site. On 08-SEP-2017, redness appeared higher on the arm. On 09-SEP-2017, the swelling first appeared on the arm and the pharmacist reports that the injection site is fine now and the arm is swollen and she compared the arm in which the injection was given to the arm that did not have the injection and she reports that the arm is quite swollen. The patient reports that he has not used any treatment for the Peripheral swelling and has not contacted his doctor. The outcome of erythema was reported as recovered and the outcome of peripheral swelling was reported as not recovered.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a 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 PEDVAXHIB lot # N008079, expiration date 02-DEC-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 0 degrees Celsius and 1 degrees Celsius (also reported as 0.7 degrees Celsius) for 5 hours. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Infantile spitting up
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to a 2 month old female patient with none pertinent medical history, drug reactions or allergies and none concomitant medication. On 13-SEP-2017, the patient was vaccinated with a dose of ROTATEQ orally, (dose, lot number and expiration date were not reported) as vaccine. On the same date maybe 20 or 30 minutes after vaccination, the patient spitted up while she was still in the office (infantile spitting up). None laboratory diagnostics were performed. No treatment was given for the event. At the time of the report, the patient recovered from the infantile spitting up on an unknown day in September 2017. The relatedness between the event and therapy with ROTATEQ was not reported.
Sex: U
Vaccine: MMR
Symptoms: Seizure
Clinical narrative: Information has been received from the authors of the published literature abstract. The objective of the authors was to address a methodological challenge for studies of the safety of concomitant vaccination. Baseline risk of adverse events (AE) in young children changes quickly with age. Timing of same versus separate day vaccination was also associated with age. The authors showed how this can create bias and how to adjust for it. They re-examined the known increase in risk of seizure and fever 710 days after MMR vaccination. They sought to identify whether other vaccines (1) independently increase the risk of either AE or (2) potentiate risk when given concomitantly with measles-mumps-rubella (MMR). The authors began with multivariable analysis including all concomitantly administered vaccines to screen for vaccines associated with AE after adjusting for all others. For identified vaccines, they used overall and age-stratified chi-square tests to evaluate whether risk in the 710 day window was different for MMR by itself vs. MMR with same day vaccination. They then used conditional logistic models that accounted for modification of MMR's effect on AE by age at vaccination and evaluated whether risk was different for MMR if identified vaccines were administered on the same versus separate days. Finally, they estimated attributable risk for same versus separate day vaccination. The authors identified seizures (N = 2,747) in children aged 1125 months. Initial analyses suggested DTaP had both an independent and potentiating effect of MMR on AEs. After accounting for age, there was no evidence for either independent or potentiating effect on risk of seizure with same day administration (p > 0.3). For fever, there was evidence for increased risk with same day DTaP and MMR in children over 18 months; X^2 = 11.1, p = 0.001, but not in younger children. The outcome of the seizures were unknown at the time of reporting. Upon internal review seizures were considered to be a medically significant event. This is one of two reports from the same literature source, linked to case # 1709USA009303. Sender's Comments: US-009507513-1709USA009303.
Sex: U
Vaccine: PPV
Symptoms: Seizure
Clinical narrative: This spontaneous report was received from a physician referring to an infant patient of unknown age. Information regarding pertinent medical history, drug reactions or allergies or concomitant medication was unknown. On an unknown date, the patient was vaccinated with an unspecified number of doses of PNEUMOVAX 23 for prophylaxis (route and lot number were not informed). On an unknown date, the patient developed seizures. The physician stated that "the defending plaintiff was saying that harm was done to an infant and it was initiated by phospholipids in the vaccine". At the time of reporting, the outcome of seizure was unknown. The reporter considered seizure to be related to PNEUMOVAX 23. Upon internal review the event seizure was determined to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an Immunization Coordinator 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 VARIVAX lot # M000757, expiration date 06-JAN-2018 (dose and route of administration were not reported). The vaccines were reconstituted with properly stored sterile diluents (manufacturer unknown). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9.5 degrees Fahrenheit for 36 hours. 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-009507513-1709USA009334.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown gender and age. Information about concurrent condition, drug reactions/allergies and medical history was unknown. Concomitant therapies included sterile diluent (manufacturer unknown). On 14-AUG-2017, 1 unspecified patient was vaccinated with improperly stored PROQUAD (Lot# N004631, expiration date 07-AUG-2018, strength, dose, and route unknown) for prophylaxis, the diluent (manufacturer unknown) used to reconstitute the vaccine above was properly stored. The vaccine was stored at 6 to 14 degrees Fahrenheit for 15 hours and 45 minutes. There had not been a previous temperature excursion and the phone call was a result of the data logger. No adverse effects were reported. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-708USA007019: US-009507513-1709USA009152: US-009507513-1709USA009150: US-009507513-1709USA009151: US-009507513-1708USA008578: US-009507513-1709USA007605: US-009507513-1709USA007604: US-009507513-1709USA007603: US-009507513-1709USA007602: US-009507513-1709USA007601.
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 a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL 9 injection (exact dose and route unknown) lot # M013636, expiry date 15-FEB-2018 for prophylaxis. The vaccine was stored between 47 degrees Fahrenheit (F) to 77F for 40 hours. No previous temperature excursions were detected. Data logger was involved. No adverse effects reported.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain, Injection site rash
Clinical narrative: This is a spontaneous report from a contactable nurse via a sales representative. This nurse reported similar events for four patients. This is the second of four reports. A patient of unspecified age, ethnicity, and gender received PREVNAR 13 (Lot number: S43277, Expiration date: Sep2018), via an unspecified route of administration on an unspecified date as a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced redness, swelling, and a hard knot at the injection site on an unspecified date lasting for several days. There were also bumps and immunization stinging. It was reported that the onset was within the last 2 weeks with the most recent lot number. The nurse also reported administering the product with possible quality issue to the patient. Outcome of the events was unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017400561 different patient; same product, similar events.
Sex: U
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse via a sales representative. This nurse reported similar events for four patients. This is the second of four reports. A patient of unspecified age, ethnicity, and gender received PREVNAR 13 (Lot number: S43277, Expiration date: Sep2018), via an unspecified route of administration on an unspecified date as a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced redness, swelling, and a hard knot at the injection site on an unspecified date lasting for several days. There were also bumps and immunization stinging. It was reported that the onset was within the last 2 weeks with the most recent lot number. The nurse also reported administering the product with possible quality issue to the patient. Outcome of the events was unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017400561 different patient; same product, similar events.
Age: 88.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling on left arm stopping at elbow from FLUAD.
Age: 37.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Drug administered at inappropriate site, Erythema, Injection site pain, Pain in extremity, Skin infection
Clinical narrative: The Pharmacist that gave me the shot injected my arm way lower that it should of been. Normally the flu shot is given in the upper arm, 3 fingers below the shoulder. I did notice that the Pharmacist wiped my upper arm with alcohol, then proceeded to give me the shot in the lower part of my arm. The injection itself was way more painful than it normally is, maybe because the site of injection was completely wrong. The next day my arm was really sore and a little red but, I didn't think too much of it. That Monday (2 days later) my arm was extremely sore, and very hot to touch. I called the Pharmacy and they said they would like me to come in so, they can see. I went straight from work to the Pharmacy to show the Pharmacist Manager what the injection site looked like, she was very alarmed and thought the site could be "Mersa" and advised me to go to a Emergency Facility immediately to rule out.  The Dr at urgent care prescribed me Antibiotics and Pain Meds (Sulfameth & Naproxen) to start ASAP as he said I have a skin infection.
Age: 37.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Skin warm
Clinical narrative: The Pharmacist that gave me the shot injected my arm way lower that it should of been. Normally the flu shot is given in the upper arm, 3 fingers below the shoulder. I did notice that the Pharmacist wiped my upper arm with alcohol, then proceeded to give me the shot in the lower part of my arm. The injection itself was way more painful than it normally is, maybe because the site of injection was completely wrong. The next day my arm was really sore and a little red but, I didn't think too much of it. That Monday (2 days later) my arm was extremely sore, and very hot to touch. I called the Pharmacy and they said they would like me to come in so, they can see. I went straight from work to the Pharmacy to show the Pharmacist Manager what the injection site looked like, she was very alarmed and thought the site could be "Mersa" and advised me to go to a Emergency Facility immediately to rule out.  The Dr at urgent care prescribed me Antibiotics and Pain Meds (Sulfameth & Naproxen) to start ASAP as he said I have a skin infection.
Age: 37.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Cellulitis, Drug administered at inappropriate site, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: The Pharmacist that gave me the shot injected my arm way lower that it should of been. Normally the flu shot is given in the upper arm, 3 fingers below the shoulder. I did notice that the Pharmacist wiped my upper arm with alcohol, then proceeded to give me the shot in the lower part of my arm. The injection itself was way more painful than it normally is, maybe because the site of injection was completely wrong. The next day my arm was really sore and a little red but, I didn't think too much of it. That Monday (2 days later) my arm was extremely sore, and very hot to touch. I called the Pharmacy and they said they would like me to come in so, they can see. I went straight from work to the Pharmacy to show the Pharmacist Manager what the injection site looked like, she was very alarmed and thought the site could be "Mersa" and advised me to go to a Emergency Facility immediately to rule out.  The Dr at urgent care prescribed me Antibiotics and Pain Meds (Sulfameth & Naproxen) to start ASAP as he said I have a skin infection.
Age: 37.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Injection site warmth
Clinical narrative: The Pharmacist that gave me the shot injected my arm way lower that it should of been. Normally the flu shot is given in the upper arm, 3 fingers below the shoulder. I did notice that the Pharmacist wiped my upper arm with alcohol, then proceeded to give me the shot in the lower part of my arm. The injection itself was way more painful than it normally is, maybe because the site of injection was completely wrong. The next day my arm was really sore and a little red but, I didn't think too much of it. That Monday (2 days later) my arm was extremely sore, and very hot to touch. I called the Pharmacy and they said they would like me to come in so, they can see. I went straight from work to the Pharmacy to show the Pharmacist Manager what the injection site looked like, she was very alarmed and thought the site could be "Mersa" and advised me to go to a Emergency Facility immediately to rule out.  The Dr at urgent care prescribed me Antibiotics and Pain Meds (Sulfameth & Naproxen) to start ASAP as he said I have a skin infection.
Age: 68.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient received shot on Monday and her arm started to get warm and red on Friday morning. Pt said that it got worse overnight and came in pharmacy on Saturday. Her arm was slightly swollen and red. We told her to put some ice pack and gave her 3 BENADRYL to take every night for next 3 nights. And if symptoms get worse then go see MD.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient called on 9/17/17 and said their arm is red and warm from the injection site to their elbow. They are following up with their family doctor but wanted to let us know about the reaction.
Age: 80.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: PATIENT PRESENTED TO PHARMACY 9/19/17 WITH RED, ITCHY RASH ON LEFT ARM JUST BELOW SITE OF PREVNAR IMMUNIZATION INJECTION SITE. PATIENT STATED THAT RASH FIRST APPEARED 9/18/17. RASH IS CIRCULAR IN SHAPE, APPOXIMATELY 2-3 INCHES IN DIAMETER.  PATIENT WAS COUNSELED BY PHARMACIST TO TREAT WITH OTC HYDROCORTISONE 1% CREAM AND FOLLOW UP WITH MD IF SYMPTOMS WORSEN OR NO IMPROVEVENT.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Confusional state, Disorientation, Dizziness, Gait disturbance, Heart rate decreased
Clinical narrative: Client left clinic about 1032 and mother stated he was confused, dizzy, and having trouble walking. The RN brought him back to exam room. VS: 50, 98%, 118/48. EMS called because of low heart rate. Client was diaphoretic, dizzy, disoriented, and stated he didn't feel well. Was having trouble seeing because of the dizziness. Client's pulse stayed in low 50s for about 5-7 minutes. Pulse started to rise to 70s when EMS arrived at 1041. Mother decided to take child to doctor to get checked out herself. Client's vitals totally stable-98 and 99% and oriented at 1055 upon discharge by mother's choice.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Hyperhidrosis, Malaise, Visual impairment
Clinical narrative: Client left clinic about 1032 and mother stated he was confused, dizzy, and having trouble walking. The RN brought him back to exam room. VS: 50, 98%, 118/48. EMS called because of low heart rate. Client was diaphoretic, dizzy, disoriented, and stated he didn't feel well. Was having trouble seeing because of the dizziness. Client's pulse stayed in low 50s for about 5-7 minutes. Pulse started to rise to 70s when EMS arrived at 1041. Mother decided to take child to doctor to get checked out herself. Client's vitals totally stable-98 and 99% and oriented at 1055 upon discharge by mother's choice.
Age: 25.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Neck pain, Pyrexia
Clinical narrative: Patient had neck pain and fever. She went to urgent care. I have not received a return phone call or any information on treatment.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: PATIENT COMPLAINED OF PAIN, ERYTHEMA, AND SWELLING IN THE RIGHT ARM. ADMINISTERED 2 VACCINES 1 IN SAME ARM ABOUT 5 INCHES APART.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Borrelia test negative, CSF culture negative, CSF glucose normal, CSF protein normal, CSF red blood cell count positive
Clinical narrative: Paralysis of his upper and lower extremities. This occurred just a few hours after vaccination. MRI spine, CT head, and results of lumbar puncture were unremarkable. He was treated with IV and oral steroids and discharged to home on 9/17/17.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: CSF white blood cell count negative, Computerised tomogram head abnormal, Diplegia, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal
Clinical narrative: Paralysis of his upper and lower extremities. This occurred just a few hours after vaccination. MRI spine, CT head, and results of lumbar puncture were unremarkable. He was treated with IV and oral steroids and discharged to home on 9/17/17.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Sinusitis
Clinical narrative: Paralysis of his upper and lower extremities. This occurred just a few hours after vaccination. MRI spine, CT head, and results of lumbar puncture were unremarkable. He was treated with IV and oral steroids and discharged to home on 9/17/17.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Patient complains of pain, redness and swelling in his entire left arm the vaccination.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Patient complains of pain, redness and swelling in his entire left arm the vaccination.
Age: 0.42
Sex: M
Vaccine: DTAPIPV
Symptoms: Wrong drug administered
Clinical narrative: Gave KINRIX instead of PEDIARIX.
Age: 51.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Neck pain
Clinical narrative: The patient had neck pain. I have not heard back on treatment or outcome.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: Large red swelling around injection sight, hard, hot, growing, fever, irritability, obvious pain.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Pain, Pyrexia
Clinical narrative: Large red swelling around injection sight, hard, hot, growing, fever, irritability, obvious pain.
Age: 63.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Symptoms include redness, swelling and pain at injection site, and mild shortness of breath. Home treatment included ibuprofen only. Pharmacist recommended BENADRYL, however patient was on the way to Dr's office and wanted to wait.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient said the arm was red and hot under the injection site. Patient did not seek medical attention. She came to pharmacy on 9-19 to report the reaction. Her arm is getting better per patient.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Mobility decreased, Musculoskeletal stiffness, Pain
Clinical narrative: VERY STIFF NECK. DIFFICULTY RAISING HEAD UP AND DOWN. SHOOTING PAIN TO TOP OF HEAD.  PATIENT CONTACTED DR. ABOUT ADVERSE EVENTS.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Received vaccines on 9-15-2017. On 9-16-17 mother noticed right upper thigh was red and inflamed. Inflammation increased during the day and into the next. Redness also increased and area became very warm to touch. On the evening of 9-17-2017 parents took child to the emergency room and child was diagnosed with Cellulitis. Antibiotics prescribed. On 9-19-17 child came to this office for follow up where diagnosis was confirmed.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 78 years old patient of unknown gender. The patient's concurrent conditions included diabetes. The patient's medical history, drug an allergy history were not reported. It was reported that before the patient was 65 years old, the patient received the first dose of PNEUMOVAX intramuscular injection, 0.5 ml (lot # and expiration date were not reported) for prophylaxis; In 2009, the patient received the second dose of PNEUMOVAX and the third dose of PNEUMOVAX intramuscular injection, 0.5 ml (lot # N010109 and expiration date on 20-NOV-2018) was administered on 08-SEP-2017 (inappropriate schedule of drug administration). The patient's concomitant therapy was not reported. No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: This spontaneous report has been received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 18-SEP-2017, the patient was vaccinated with an expired dose of M-M-R II lot # L009544, expiration date 19-MAR-2017 (dose and route of administration were not reported). No adverse effects were reported. No product quality complaint has been filled.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a multiple 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 VAQTA lot # M039202 with expiration date on 11-APR-2018 and lot # N005796 with expiration date on 26-MAY-2018 (dose and route of administration were not provided) for prophylaxis. The doses of VAQTA were exposed to a temperature excursion of 9 degrees Celsius (°C) to 25°C (13.5°C), during a time frame of 5 hours 47 minutes, which was detected by the data logger. There was no prior temperature excursion and no adverse events were reported. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1709USA009398: US-009507513-1709USA009399.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Monocyte count increased, Neutrophil count increased, Peripheral swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a registered Nurse refers to a 71 year old male patient with diabetes mellitus. The patient's medical history was not provided. Concomitant therapies included metformin. On 30-AUG-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 0.5 ml, with lot # N011491 and expiration date of 04-NOV-2018, intramuscularly in the left arm for prevention against pneumonia. On an unspecified date in 2017, a complete blood count (CBC) and basic metabolic panel (BMP) were performed and the results showed neutrophils high, monocyte absolute was high and white blood cell count was 16.2 (units not provided). On approximately 01-SEP-2017, 48 hours later of vaccination, the patient developed swelling of the left arm and both legs, unspecified fever and unspecified joint pain. The nurse stated that the patient was seen in the office on the following dates: 05-SEP-2017 and 07-SEP-2017. On 07-SEP-2017, the nurse also stated that the patient was seen in an unspecified emergency room for the events but the patient was not admitted. The patient was seen in the office also on 08-SEP-2017 and 18-SEP-2017. The nurse stated that the patient was treated with unspecified antibiotics and unspecified steroids on unspecified dates for the events. At the time of reporting, the patient was not recovered from the events. The causality between PNEUMOVAX 23 and the events was not provided.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: This spontaneous report as received from a registered Nurse refers to a 71 year old male patient with diabetes mellitus. The patient's medical history was not provided. Concomitant therapies included metformin. On 30-AUG-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 0.5 ml, with lot # N011491 and expiration date of 04-NOV-2018, intramuscularly in the left arm for prevention against pneumonia. On an unspecified date in 2017, a complete blood count (CBC) and basic metabolic panel (BMP) were performed and the results showed neutrophils high, monocyte absolute was high and white blood cell count was 16.2 (units not provided). On approximately 01-SEP-2017, 48 hours later of vaccination, the patient developed swelling of the left arm and both legs, unspecified fever and unspecified joint pain. The nurse stated that the patient was seen in the office on the following dates: 05-SEP-2017 and 07-SEP-2017. On 07-SEP-2017, the nurse also stated that the patient was seen in an unspecified emergency room for the events but the patient was not admitted. The patient was seen in the office also on 08-SEP-2017 and 18-SEP-2017. The nurse stated that the patient was treated with unspecified antibiotics and unspecified steroids on unspecified dates for the events. At the time of reporting, the patient was not recovered from the events. The causality between PNEUMOVAX 23 and the events was not provided.
Sex: U
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Information has been received from the authors of the published literature abstract title as stated below. The objective of the authors was to address a methodological challenge for studies of the safety of concomitant vaccination. Baseline risk of adverse events (AE) in young children changes quickly with age. Timing of same versus separate day vaccination was also associated with age. The authors showed how this can create bias and how to adjust for it. They re-examined the known increase in risk of seizure and fever 710 days after measles-mumps-rubella (MMR) vaccination. They sought to identify whether other vaccines (1) independently increase the risk of either AE or (2) potentiate risk when given concomitantly with measles-mumps-rubella (MMR). The authors began with multivariable analysis including all concomitantly administered vaccines to screen for vaccines associated with AE after adjusting for all others. For identified vaccines, they used overall and age-stratified chi-square tests to evaluate whether risk in the 710 day window was different for measles-mumps-rubella (MMR) by itself vs. measles-mumps-rubella (MMR) with same day vaccination. They then used conditional logistic models that accounted for modification of MMR's effect on AE by age at vaccination and evaluated whether risk was different for measles-mumps-rubella (MMR) if identified vaccines were administered on the same versus separate days. Finally, they estimated attributable risk for same versus separate day vaccination. The authors identified fevers (N = 23,309) in children aged 1125 months. Initial analyses suggested DTaP had both an independent and potentiating effect of measles-mumps-rubella (MMR) on AEs. After accounting for age, there was no evidence for either independent or potentiating effect on risk of seizure with same day administration (p > 0.3). For fever, there was evidence for increased risk with same day DTaP and measles-mumps-rubella (MMR) in children over 18 months; X^2 = 11.1, p = 0.001, but not in younger children. The outcome of the fevers were unknown at the time of reporting. This is one of two reports from the same literature source, linked to case # 1709USA007329. Sender's Comments: US-009507513-1709USA007329.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Insomnia, Pain
Clinical narrative: Yesterday, September 18, 2017, on the advice of my doctors, I had a PNEUMOVAX 23 injection in my left (non-dominant) arm. I was told there could be some discomfort for several days, and, in fact, the person who gave me the injection said he had been in pain for 2 weeks. I have a very high pain threshold and rarely take any type of painkiller. However, I was totally unprepared for how painful and disabling this injection would be. By the evening, I could barely use my arm. I had to take painkillers to sleep at all, and by six this morning, I was wide awake because of the pain. If this vaccine is going to stay on the market, I think it should be accompanied by a warning that the patient may be disabled for several days after the injection. My experience is not at all unique. The internet has a site for evaluating drugs like PNEUMOVAX, and all of the comments mentioned severe injection site pain lasting at least several days.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Pain
Clinical narrative: PT EXPERIENCED SORENESS, REDNESS, SWELLING AND ERYTHEMA AROUND THE INJECTION SITE AND SOME RASH AROUND HER ELBOW AT THE BEGINNING. PT TOOK BENADRYL AND SOME OTC FOR PAIN WHICH WAS HELPFUL AND GOT BETTER. SHE CAME 3 DAYS LATER WHEN HER ARM WAS BETTER. SHE WAS EXPERIENCING ITCHING AND SOME SORENESS.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pruritus
Clinical narrative: PT EXPERIENCED SORENESS, REDNESS, SWELLING AND ERYTHEMA AROUND THE INJECTION SITE AND SOME RASH AROUND HER ELBOW AT THE BEGINNING. PT TOOK BENADRYL AND SOME OTC FOR PAIN WHICH WAS HELPFUL AND GOT BETTER. SHE CAME 3 DAYS LATER WHEN HER ARM WAS BETTER. SHE WAS EXPERIENCING ITCHING AND SOME SORENESS.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation
Clinical narrative: Patient presented to me a red, inflamed area on her left arm 2-3 inches in diameter. She indicated that it neither itched nor was warm to the touch. She indicated that a friend pointed it out to her, so she turned her arm in order to observe it for herself. I recommended acetaminophen or another anti inflammatory if needed. I also recommended an ice pack if it got worse and advised diphenhydramine if it began to itch.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest discomfort, Dyspnoea, Erythema, Immediate post-injection reaction, Swelling face
Clinical narrative: Almost immediately after giving second vaccine (FLUZONE HD) patient felt pressure on her chest and difficulty breathing. Patient became visibly red and face appeared swollen. Epinephrine 0.3 mg was administered by auto-injector and 50 mg diphenhydramine given orally at pharmacy while EMS was summoned. Patient quickly recovered after administration of epinephrine and diphenhydramine. Pt was lucid, conversational, and cracking jokes while EMS was on the way. PT left with EMS en route to hospital. Reaction occured immediately following flu vaccine. Patient received PNEUMOVAX 23 about 30 seconds prior.
Age: 53.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site mass, Pain, Tenderness
Clinical narrative: Patient called the pharmacy and said she had a lump at the injection site that was inflamed and red. She mentioned that touching underneath the arm pit was tender. She is taking ibuprofen for the pain and inflammation and an antihistamine.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Eczema, Erythema, Pruritus, Rash
Clinical narrative: The night of the injection, patient started itching in the creases of each arm, bumps appeared. The scratching led to rash/eczema flare up. Patient used triamcinolone cream and shea butter to decrease the itching. Patient is still experiencing itching/redness from the day of the immunization.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Pyrexia, Rash erythematous, Skin warm
Clinical narrative: Red Rash bump and warm to the touch. Fever at night.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Injection site erythema, Injection site swelling
Clinical narrative: Patient received PNEUMOVAX 23 and FLUZONE HD at around 2PM on 09/18. Patient came back to the pharmacy at around 10AM on 09/19. They stated they had an injection site reaction (redness, swelling, spreading erythema) and trouble breathing at 2AM. They sought medical attention and were subsequently given a dose of BENADRYL injection. Upon return to pharmacy, patient was counseled to take BENADRYL, Ibuprofen and apply a cold compress and to report any additional adverse reactions.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: Patient reports similar event of patient given same shot with same lot number. Patient reports itching in the creases of each arm, on the top with minimal itching in other areas. Patient has been itching since the day of injection and gave.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Local arm swelling and redness.
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Inflammation, Injection site inflammation, Injection site pruritus, Injection site rash, Rash
Clinical narrative: It was a Tdap but I wasn't sure which one (there were multiple options to choose from). I broke out in a rash that worsened over the next 2 days. The rash was all over my upper arms (tricep/bicep area) and all over my thighs (front and back), hips and butt. It was swollen/inflammed and a bit itchy.
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Rash pruritic, Swelling
Clinical narrative: It was a Tdap but I wasn't sure which one (there were multiple options to choose from). I broke out in a rash that worsened over the next 2 days. The rash was all over my upper arms (tricep/bicep area) and all over my thighs (front and back), hips and butt. It was swollen/inflammed and a bit itchy.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to an unknown number of patients of unknown gender and age. The patients' concurrent condition and medical history were not reported. On unknown dates, an unknown number of patients were vaccinated with improperly stored ZOSTAVAX (dose, route unknown, lot# M034765 and expiration date 26-OCT-2017) for prophylaxis (Incorrect product storage). It was unknown if the sterile diluent (manufacturer unknown) used to reconstitute the vaccine was properly stored. The vaccine was improperly stored at 6 to 14 degrees Fahrenheit for 51 minutes. The vaccine also had a previous temperature excursion at 15 to 46 degrees Fahrenheit for 3 hours. The phone call was a result of the data logger.  No adverse effects were reported. This is one of three reports received from the same reporter.; Sender's Comments: US-009507513-1709USA009051: US-009507513-1709USA009052:
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a registered nurse and referred to a 28-year-old female patient. No information regarding the patient's medical history, concomitant therapies and concurrent conditions was provided. On an unknown date in 2013, the patient was vaccinated with GARDASIL (dose, frequency, route of administration, lot # and expiration date were not reported). The following day (on an unknown date in 2013), the patient experienced a fever. The outcome of fever was reported as recovered (date unspecified). The causality assessment between the event of fever and GARDASIL was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 12-SEP-2017, the patient was vaccinated with ZOSTAVAX subcutaneously (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. The vaccine was reconstituted with expired sterile diluent (lot# was not reported), expiration date: 06-SEP-2017. No adverse effect was reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 12-SEP-2017, the patient was vaccinated with one improperly stored dose of ZOSTAVAX (lot #: N013274, expiration date 04-JUL-2018; dose and route of administration were not reported) for prophylaxis. The sterile diluent (lot # M006117 and expiration date: 24-AUG-2018) used did not undergo a temperature excursion. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 hour. Data logger was involved. There were no previous excursions reported.