chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown gender who would be 4 years old. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M023384 and expiration date on 20-JUL-2018 of lot # M033906 with expiration date on 06-JUN-2019 (dose and route of administration were not reported) for prophylaxis. The reporter could not provide details of which lot number the patient received. The doses of VARIVAX were exposed to a temperature excursion of 14.9 degrees Fahrenheit (°F) during a time frame of 11 hours, 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 source.; Sender's Comments: US-009507513-1710USA008686: US-009507513-1710USA008693: US-009507513-1710USA008688: US-009507513-1710USA008689: US-009507513-1710USA008690: US-009507513-1710USA001141: US-009507513-1710USA008692: US-009507513-1710USA008685: US-009507513-1710USA008684: US-009507513-1710USA008687:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown gender who would be 4 years old. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M023384 and expiration date on 20-JUL-2018 of lot # M033906 with expiration date on 06-JUN-2019 (dose and route of administration were not reported) for prophylaxis. The reporter could not provide details of which lot number the patient received. The doses of VARIVAX were exposed to a temperature excursion of 14.9 degrees Fahrenheit (°F) during a time frame of 11 hours, 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 source.; Sender's Comments:  US-009507513-1710USA008686: US-009507513-1710USA008693: US-009507513-1710USA008688: US-009507513-1710USA008689: US-009507513-1710USA008690: US-009507513-1710USA008691: US-009507513-1710USA001141: US-009507513-1710USA008685: US-009507513-1710USA008684: US-009507513-1710USA008687:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown gender who would be 17 months old. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M023384 and expiration date on 20-JUL-2018 of lot # M033906 with expiration date on 06-JUN-2019 (dose and route of administration were not reported) for prophylaxis. The reporter could not provide details of which lot number the patient received. The doses VARIVAX were exposed to a temperature excursion of 14.9 degrees Fahrenheit (°F) during a time frame of 11 hours, 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 source.; Sender's Comments: US-009507513-1710USA008686: US-009507513-1710USA001141: US-009507513-1710USA008688: US-009507513-1710USA008690: US-009507513-1710USA008691: US-009507513-1710USA008692: US-009507513-1710USA008685: US-009507513-1710USA008684: US-009507513-1710USA008687: US-009507513-1710USA008689:
Age: 0.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 6 day old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 23-AUG-2017, the patient was vaccinated with improperly stored VARIVAX injection, (lot # N007930 with expiration date on 08-MAR-2018, dose, anatomical location and route not reported) for prophylaxis (drug administered to patient of inappropriate age), reconstituted with properly stored sterile diluent (manufacturer unknown) (lot# N013282 with expiration date 23-AUG-2019). The administered vaccine experienced a temperature excursion of 6 degree Fahrenheit to 14 degree Fahrenheit for 18 hours. There was no previous temperature excursion and the call was not because of a data logger. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA001401: US-009507513-1710USA008702: US-009507513-1709USA000870:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 12 month old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 29-AUG-2017, the patient was vaccinated with improperly stored VARIVAX injection, (lot # N007930 with expiration date on 08-MAR-2018, dose, anatomical location and route) for prophylaxis, reconstituted with properly stored sterile diluent (manufacturer unknown) (lot# N013282 with expiration date 23-AUG-2019). The administered vaccine experienced a temperature excursion of 6 degree Fahrenheit to 14 degree Fahrenheit for 18 hours. There was no previous temperature excursion and the call was not because of a data logger. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA001401: US-009507513-1710USA008701: US-009507513-1709USA000870:
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Blood test normal, Chest X-ray, Joint swelling, Laboratory test
Clinical narrative: This is a spontaneous report from two contactable consumers (husband and daughter of the patient). A 65-years-old female patient received PREVNAR 13, via an unspecified route of administration in Jun2016 at single dose for immunization at physician office. Medical history included ongoing thyroid disorder. The patient previously received a pneumococcal vaccine on unknown date for immunisation. Concomitant medication included ongoing levothyroxine (unknown manufacturer) at 150mg once a day, for thyroid, taking for probably 20 years. The patient experienced swelling/everything swelling in her body/swelling in her upper extremities got so bad/body started swelling within 3 days of getting the shot/everything in her body was swelling, both hands, feet, knees, elbows on unspecified date in Jun2016 with outcome of not recovered; knees hurt on an unspecified date with outcome of unknown; hardly gets out of bed/can't get out of bed/ has to lie flat because otherwise her knees hurt on an unspecified date with outcome of unknown; still sick in bed on an unspecified date with outcome of not recovered; has residual pain/had all of this pain on an unspecified date with outcome of unknown; neck surgery to fused neck on an unspecified date with outcome of unknown. The patient have gone to the emergency room three times, not admitted to hospital. The daughter of the patient said that her mother got pneumococcal 13-val conj vac and her body has decompensated. The consumer said that this product poisoned her mom and her mother was still sick in bed. Her mother couldn't get out of bed and had residual pain with no identifiers. The daughter reported also that body started swelling within 3 days of getting the shot. Everything in her body was swelling. Both hands, feet, knees, elbows. It has been worse every day since then. She regularly was getting worse, it was still bad. Her swelling in her upper extremities got so bad and her mother had all of this pain. She said that they have done all kinds of tests, X-rays, and seen chiropractors, and no one has an answer. Have had lots of treatments, everything can think of she has had. First started given X-rays of neck, lungs, and had MRIs. Have had blood work checking kidneys, liver, heart, brain and for lupus, results were all good. Ended up having neck surgery to fused neck, thinking that was the problem, risked her life again with no affect. Seen two Rheumatologists, a Neurologist, Hematologist, and Allergist. She has gone through pain management, she was on Morphine from Mar2017 to Aug2017 and was trying to get off of that. Had knees x-rayed a week before, orthopedic surgeon reviewed them and showed swelling.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Malaise, Mobility decreased, Nuclear magnetic resonance imaging, Pain management, Peripheral swelling
Clinical narrative: This is a spontaneous report from two contactable consumers (husband and daughter of the patient). A 65-years-old female patient received PREVNAR 13, via an unspecified route of administration in Jun2016 at single dose for immunization at physician office. Medical history included ongoing thyroid disorder. The patient previously received a pneumococcal vaccine on unknown date for immunisation. Concomitant medication included ongoing levothyroxine (unknown manufacturer) at 150mg once a day, for thyroid, taking for probably 20 years. The patient experienced swelling/everything swelling in her body/swelling in her upper extremities got so bad/body started swelling within 3 days of getting the shot/everything in her body was swelling, both hands, feet, knees, elbows on unspecified date in Jun2016 with outcome of not recovered; knees hurt on an unspecified date with outcome of unknown; hardly gets out of bed/can't get out of bed/ has to lie flat because otherwise her knees hurt on an unspecified date with outcome of unknown; still sick in bed on an unspecified date with outcome of not recovered; has residual pain/had all of this pain on an unspecified date with outcome of unknown; neck surgery to fused neck on an unspecified date with outcome of unknown. The patient have gone to the emergency room three times, not admitted to hospital. The daughter of the patient said that her mother got pneumococcal 13-val conj vac and her body has decompensated. The consumer said that this product poisoned her mom and her mother was still sick in bed. Her mother couldn't get out of bed and had residual pain with no identifiers. The daughter reported also that body started swelling within 3 days of getting the shot. Everything in her body was swelling. Both hands, feet, knees, elbows. It has been worse every day since then. She regularly was getting worse, it was still bad. Her swelling in her upper extremities got so bad and her mother had all of this pain. She said that they have done all kinds of tests, X-rays, and seen chiropractors, and no one has an answer. Have had lots of treatments, everything can think of she has had. First started given X-rays of neck, lungs, and had MRIs. Have had blood work checking kidneys, liver, heart, brain and for lupus, results were all good. Ended up having neck surgery to fused neck, thinking that was the problem, risked her life again with no affect. Seen two Rheumatologists, a Neurologist, Hematologist, and Allergist. She has gone through pain management, she was on Morphine from Mar2017 to Aug2017 and was trying to get off of that. Had knees x-rayed a week before, orthopedic surgeon reviewed them and showed swelling.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Spinal X-ray, Spinal fusion surgery, Swelling, X-ray limb abnormal
Clinical narrative: This is a spontaneous report from two contactable consumers (husband and daughter of the patient). A 65-years-old female patient received PREVNAR 13, via an unspecified route of administration in Jun2016 at single dose for immunization at physician office. Medical history included ongoing thyroid disorder. The patient previously received a pneumococcal vaccine on unknown date for immunisation. Concomitant medication included ongoing levothyroxine (unknown manufacturer) at 150mg once a day, for thyroid, taking for probably 20 years. The patient experienced swelling/everything swelling in her body/swelling in her upper extremities got so bad/body started swelling within 3 days of getting the shot/everything in her body was swelling, both hands, feet, knees, elbows on unspecified date in Jun2016 with outcome of not recovered; knees hurt on an unspecified date with outcome of unknown; hardly gets out of bed/can't get out of bed/ has to lie flat because otherwise her knees hurt on an unspecified date with outcome of unknown; still sick in bed on an unspecified date with outcome of not recovered; has residual pain/had all of this pain on an unspecified date with outcome of unknown; neck surgery to fused neck on an unspecified date with outcome of unknown. The patient have gone to the emergency room three times, not admitted to hospital. The daughter of the patient said that her mother got pneumococcal 13-val conj vac and her body has decompensated. The consumer said that this product poisoned her mom and her mother was still sick in bed. Her mother couldn't get out of bed and had residual pain with no identifiers. The daughter reported also that body started swelling within 3 days of getting the shot. Everything in her body was swelling. Both hands, feet, knees, elbows. It has been worse every day since then. She regularly was getting worse, it was still bad. Her swelling in her upper extremities got so bad and her mother had all of this pain. She said that they have done all kinds of tests, X-rays, and seen chiropractors, and no one has an answer. Have had lots of treatments, everything can think of she has had. First started given X-rays of neck, lungs, and had MRIs. Have had blood work checking kidneys, liver, heart, brain and for lupus, results were all good. Ended up having neck surgery to fused neck, thinking that was the problem, risked her life again with no affect. Seen two Rheumatologists, a Neurologist, Hematologist, and Allergist. She has gone through pain management, she was on Morphine from Mar2017 to Aug2017 and was trying to get off of that. Had knees x-rayed a week before, orthopedic surgeon reviewed them and showed swelling.
Sex: U
Vaccine: HEP
Symptoms: Acute hepatitis B, Alanine aminotransferase normal, Hepatitis B core antibody positive
Clinical narrative: This case was reported in a literature article and described the occurrence of acute hepatitis B in a subject who received Hepatitis B vaccine. The subject's past medical history included hepatitis B exposure (after 1987). On an unknown date, unknown after receiving Hepatitis B vaccine and Hepatitis B vaccine, the subject developed acute hepatitis B. Serious criteria included GSK medically significant. The outcome of acute hepatitis B was unknown. The investigator considered that there was a reasonable possibility that the acute hepatitis B may have been caused by Hepatitis B vaccine and Hepatitis B vaccine. Relevant Tests: Lab tests performed on an unspecified date Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Alanine aminotransferase result was 30 u/L. On an unknown date, Hepatitis B core antibody result was anti-HBc IgM positive unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of possible acute hepatitis B virus infection in a patient of unspecified age and gender who was vaccinated with unspecified hepatitis B virus (HBV) vaccine (manufacturer unknown). The patient was part of the study that evaluated the Health System (HS) HBV vaccination program effectiveness at protecting against symptomatic illness among persons receiving equal to or more than 1 HBV vaccine dose during 1987-2011. In this study, among the 31 persons with acute HBV infection (27 confirmed and 4 possible), 20 were male. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On unspecified dates, the patient received 2 doses of unspecified HBV vaccine (administration site and route unspecified; batch number not provided). In 1984, HS began offering HBV vaccination to all infants starting at birth (99% 3 dose HBV coverage in children aged 19-35 months by 1998). The age of vaccination was not provided. On an unspecified date, an unknown period after the vaccination, the patient developed acute HBV infection. This case was considered as possible acute HBV infection. (In this study, possible acute HBV infection (symptomatic or subclinical) case was defined as persons lacking an alanine aminotransferase (ALT) less than or equal to 30 days from a positive anti-HBc IgM but with serologic evidence of exposure to HBV infection after 1987. The patient's laboratory investigation revealed ALT equal to 30 U/L at time of positive anti-HBc result. Treatment was unknown. The outcome of the event was not provided. The authors did not comment on the relationship between the event of possible acute hepatitis B virus infection and unspecified HBV vaccine. The authors concluded "The HS HBV vaccination program was highly effective because no confirmed acute symptomatic HBV infection cases were identified among specific persons followed through HS who received equal to or more than 1 HBV vaccine dose during the 25 year study period".
Age: 76.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Rash
Clinical narrative: Rash. Patient took Benadryl.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Musculoskeletal stiffness, Neck pain, Pain, Pain in extremity
Clinical narrative: Patient described fever, soreness, stiffness, and pain in arm, upper back, and into neck area.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Patient described fever, soreness, stiffness, and pain in arm, upper back, and into neck area.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus
Clinical narrative: Received vaccine on 09/29/17 at 1:32 pm. On 09/30/17 at 1:30 pm, employee developed a red itchy area the size of a softball.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Generalised erythema, Paraesthesia oral, Pruritus generalised, Rash
Clinical narrative: Slight rash, redness all over body, itching all over and lips tingled.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site pain, Malaise
Clinical narrative: Patient reported severe malaise, upper arm/shoulder pain that continued from the time of injection and began resolving on 10/08/17 when patient come in to report symptoms. Patient also mentioned joint pain but did not describe further and stated that that syptom had been resolving.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Administration site oedema, Administration site swelling
Clinical narrative: Patient has swelling and edema in the area of the administration. Area has been increasingly getting larger and moving down the arm. Cautioned patient about cellulitis (it is not warm to the touch or red but definitely extremely swollen) and recommended she go to MD. She was going to go after we spoke.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Flu vaccine given on 10/16/17 at approx 4 PM. She states she woke up at approximately 4 AM the next morning with hives over her whole body. She was rx with Medrol Pac. Symptoms resolved after treatment.
Age: 7.0
Sex: M
Vaccine: FLUC4
Symptoms: Erythema, Pain, Swelling, Vomiting
Clinical narrative: Pain, swelling, redness, vomiting.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Delivery, Exposure during pregnancy, Premature labour
Clinical narrative: 4 days after receiving the Tdap vaccination I began having pre-term contractions (28 weeks gestation). I was sent to the hospital at 5pm where I received medication to stop contractions and was sent home later that evening. The following morning around 6am the contractions started again and I went to the hospital where doctors were again able to control and cease contractions with medication. I was prescribed Nifedipine, taken orally every 4 hours to further control my contractions, which I was experiencing daily. I took Nifedipine from 28 weeks to 37 weeks gestation in order to control contractions and delay delivery of the baby. Up until the Tdap vaccination, my pregnancy was healthy and without complications. My actual delivery was a 8 lb. 15 oz. baby. This was my first pregnancy.
Age: 25.0
Sex: U
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patients arm swelled at injection site about the size of diameter of a tennis ball. Site was warm and tender/ painful to touch for 4 days. Arm returned to normal on 10/16/2017.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia oral, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient was given Flu shot by house supervisor, around 130 am while on -shift. At 0312 patient called reporting redness to site, swelling, itching at injection site and numbness to tip of tongue. Contacted Dr-ED provider, patient escorted to ED for evaluation. ZANTAC and Prednisone given.
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date in 2012 (reported as approximately 5 years ago), the patient was vaccinated with a dose of ZOSTAVAX (dose and route of administration were not reported) reconstituted with sterile diluent (MERCK STERILE DILUENT) for prophylaxis. There was no medication with vaccine given. On approximately 08-AUG-2017 (reported as approximately 6 weeks ago), the patient experienced shingles on his face and close to his eyes. The patient saw pharmacist. The patient was pretty uncomfortable because of the event. He began taking acyclovir 800 mg five times daily on an unspecified date in 2017 for a treatment of the shingles. The patient's shingles were getting worse even with the treatment with acyclovir. The outcome of the event was reported as not recovered. It was unknown if the patient was taking acyclovir at the time of the report. The relatedness between vaccination with ZOSTAVAX and the event was not reported.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an 18 year old male patient. The patient was a non-smoker. On 08-NOV-1998 (lot # 05571), 14-DEC-1998 (lot # 0650E) and on 09-SEP-1999, the patient was vaccinated with first, second and third doses of RECOMBIVAX (route: intramuscular) respectively (inappropriate schedule of vaccine administration). On 26-JUL-2017, the patient's anti Hbs titer was negative. On 27-JUL-2017, the patient has received the booster dose of RECOMBIVAX (lot # N0006321). The outcome and causality of the event were unknown. This is one of the two reports received from the same reporter.
Age: 34.0
Sex: F
Vaccine: FLUR4
Symptoms: Exposure during pregnancy, Foetal hypokinesia, Pruritus
Clinical narrative: Severe itching from neck to upper thigh x 2 days, plus decreased fetal movement x 2 days.  IVF pregnancy d/t endometriosis, EDD 2/7/18. No h/o any drug or food allergies. No problems with previous influenza immunizations.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Anal incontinence, Chills, Dyspnoea, Frequent bowel movements
Clinical narrative: Body aches from head to toe, chills, shortness of breath, rapid heartbeat, pain developed in upper stomach at sternum level, in my hiatal hernia region, nausea, uncontrollable bowls as if I had taken a 'bowl prep' such as for colonoscopy. 8 days after injection, still having pain in stomach, nausea, bowl movements not back to normal.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Heart rate increased, Nausea, Pain
Clinical narrative: Body aches from head to toe, chills, shortness of breath, rapid heartbeat, pain developed in upper stomach at sternum level, in my hiatal hernia region, nausea, uncontrollable bowls as if I had taken a 'bowl prep' such as for colonoscopy. 8 days after injection, still having pain in stomach, nausea, bowl movements not back to normal.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Headache, Lymph node pain, Myalgia
Clinical narrative: Sore glands in neck, headache, muscle aches, shortness of breath that started approximately 5 hours after injection. Symptoms subsided by this morning.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Pain, Skin warm, Swelling
Clinical narrative: Starting a few hours after injection, soreness, red and warm to touch began. Couldn't lift arm by bedtime. Still sore in the morning and still hot to touch, no redness still feels swollen. Told to put on ice on and keep muscles active to get serum out of muscles faster. He took a tramadol at bedtime the night before.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Hyperhidrosis, Injection site pain, Loss of consciousness, Malaise
Clinical narrative: Signs/Symptoms: sweaty, clammy, nauseas, tunnel vision. Patient was in classroom when she felt the symptoms. She went out to the hallway and blacked out. Ice was applied to her head. She was given Benadryl and Tylenol. Patient felt pain at injection site. She sat out in the hallway for 20-30 min, felt better, and went back inside the classroom. Patient felt symptoms again, went back out to hallway to rest, and then went back inside. Patient still felt sick on Thursday (day after vaccination) when she woke up and her arm was still hurting. Patient went to see a doctor on Thursday and was told that she was likely experiencing nerve pain due to vaccine possibly given at a higher injection site near the shoulder.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Neuralgia, Pain in extremity, Tunnel vision
Clinical narrative: Signs/Symptoms: sweaty, clammy, nauseas, tunnel vision. Patient was in classroom when she felt the symptoms. She went out to the hallway and blacked out. Ice was applied to her head. She was given Benadryl and Tylenol. Patient felt pain at injection site. She sat out in the hallway for 20-30 min, felt better, and went back inside the classroom. Patient felt symptoms again, went back out to hallway to rest, and then went back inside. Patient still felt sick on Thursday (day after vaccination) when she woke up and her arm was still hurting. Patient went to see a doctor on Thursday and was told that she was likely experiencing nerve pain due to vaccine possibly given at a higher injection site near the shoulder.
Age: 84.0
Sex: F
Vaccine: FLUA3
Symptoms: Dyspnoea, Middle insomnia
Clinical narrative: Patient describes waking in the middle of the night after receiving Fluad with shortness of breath lasting about 2 minutes.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at site. Tx with cephalexin.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Loss of consciousness, Skin discolouration
Clinical narrative: Child given flu shot and approx 15 sec later leaned back in assistants arms and passed out-eyes remained open. Pt quickly responded to stimulation, cold compress to head. Vital signs returned to normal. Pt taken to nurse's office where she rested until color was back to normal, vital signs stable for at least 20 min and tolerated apple juice. Child stated she had not felt good today. Child had runny nose. When mom phoned, she stated that she (mom) had also experienced passing out with injections and blood draws all her life. Pt did go home with mom with no further interventions or complications. Per school nurse, child returned to school and had no further events or reactions. Child was not evaluated by ER after event though it was offered. There were 4 nurses to evaluate pt during event.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Erythema, Injection site erythema, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Pain, swelling, redness both arms started in evening of same day given and continued swelling  for next 48hrs. Pressure to areas painful but able to move arms. No fever or rash or joint swelling. LD erythema 9x12cm and RD erythema 20x13cm. No distal swelling and not circumferential around arm, no numbness or tingling, intact distal pulses. Much better when called on am of 10/13/17 with ibuprofen.
Age: 46.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Fever, chills, pain and erythema around injection site.
Age: 1.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Diarrhoea, Diet refusal, Pyrexia, Vomiting
Clinical narrative: Health child (per doctor) had vaccine on 10/17/17 at 2:30pm. On 10/18/17 at 6:30am, child woke with fever, vomiting and diarrhea. Ibuprofen was offered and refused at 7am. Temperature was taken axillary and found to be 101 at 8:30. Child refused anything to drink or eat. An ounce of milk was ingested at 9am, but vomited up 10 minutes later.  Temp taken again at 9:25am axillary and found to be 99.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Facial asymmetry, Facial paresis, Immediate post-injection reaction, Motor developmental delay
Clinical narrative: Immediately after receiving vaccines went from being a baby who rarely cried to being inconsolable, developed golf ball size knot on left side of head, lost facial symmetry on left side of face and weakened muscles on left side also. Has been seen by multiple Dr's and has been declared to have motor development delay by his neurologist. Ongoing testing scheduled to determine if neurological damage was done.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Neurological examination abnormal, Nodule
Clinical narrative: Immediately after receiving vaccines went from being a baby who rarely cried to being inconsolable, developed golf ball size knot on left side of head, lost facial symmetry on left side of face and weakened muscles on left side also. Has been seen by multiple Dr's and has been declared to have motor development delay by his neurologist. Ongoing testing scheduled to determine if neurological damage was done.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erosion, Injection site erythema, Injection site induration, Injection site pain, Injection site reaction
Clinical narrative: Erythema, diffuse swelling and induration of upper arm from shoulder to above elbow. Started the day after the vaccine and spread to involve upper arm by 2 days after the vaccine. Mild splitting of the skin on upper outer arm, vs excoriations from scratching. Tenderness with moving the arm.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling, Pain, Skin disorder
Clinical narrative: Erythema, diffuse swelling and induration of upper arm from shoulder to above elbow. Started the day after the vaccine and spread to involve upper arm by 2 days after the vaccine. Mild splitting of the skin on upper outer arm, vs excoriations from scratching. Tenderness with moving the arm.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Redness under injection site.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nausea, Pain, Pyrexia, Urticaria
Clinical narrative: At 8pm on the day of vacicnation, hives on the inside of both arms, worse on the arm where the vaccination was administered. By 8am (24 hours after the shot), intense nausea, aches, pain, headache, low fever and vomiting. Symptoms persisted until 10/18/17 at 8am.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: At 8pm on the day of vacicnation, hives on the inside of both arms, worse on the arm where the vaccination was administered. By 8am (24 hours after the shot), intense nausea, aches, pain, headache, low fever and vomiting. Symptoms persisted until 10/18/17 at 8am.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Nausea, Pyrexia, Retching
Clinical narrative: Chills, 102.2 fever, nausea, dry heaves.
Age: 5.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Pain, Pyrexia
Clinical narrative: Local redness and a low grade fever, aches and pains.
Age: 86.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Day after adminstraion patinet concerned about redness on his arm where vaccine was given. Patient went to ER to check and they kept him for 2 days to treat his redness and monitored him. Called patient on sunday to check on him and spoke to his daugher and she told us that he was doing fine. It was not sore just redness at site of administration. Called patient again on sunday but no answer . Called again today 10/18 and he said he was fine. He said he came back home on monday and did need any help or assistance from us. We did report to standing order dr about this and they called back today to check on him.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Rt shoulder burning, aching and tender. Area warm and firm to touch, approx. 2x3 inch area. Sent to Occ Med for treatment. No treatment given. Told shot given "too high". Advised by provider will resolve in 7-10 days. Using Ibuprofen still on 10/16/17 and area of redness, aching and swelling improving.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth
Clinical narrative: Rt shoulder burning, aching and tender. Area warm and firm to touch, approx. 2x3 inch area. Sent to Occ Med for treatment. No treatment given. Told shot given "too high". Advised by provider will resolve in 7-10 days. Using Ibuprofen still on 10/16/17 and area of redness, aching and swelling improving.
Age: 55.0
Sex: F
Vaccine: FLUR4
Symptoms: Back pain, Facial pain, Oropharyngeal pain, Productive cough, Rhinalgia
Clinical narrative: Sore throat, facial pain, clogged sinus, coughing phylem yellow and nose, teeth hurt, sneezing, lower back pain.
Age: 55.0
Sex: F
Vaccine: FLUR4
Symptoms: Sinus congestion, Sneezing, Sputum discoloured, Toothache
Clinical narrative: Sore throat, facial pain, clogged sinus, coughing phylem yellow and nose, teeth hurt, sneezing, lower back pain.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Heart rate increased, Musculoskeletal disorder
Clinical narrative: I asked for regular dose and  not the high dose. I was given the high dose anyway. 30 minutes later I had rapid heart beat, light headed and my fingers wouldn't work right. I was OK after a few hours but the rapid heartbeat continued all day.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Peripheral swelling
Clinical narrative: Patient stated that arm is unevenly swollen. He stated it looked like he "worked out" with one arm.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Vaccine given 8/29/2017, patient still complains of arm/muscle pain near injection site-Left deltoid as of 10/14/2017.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Chest discomfort, Chills, Dysphagia, Dyspnoea
Clinical narrative: Vomiting, chest pressure, breathing shallow, trouble swallowing, tingling hands/feet, muscle twitching, muscle spasms, weakness, fatigue, woke up gasping for breath, chills, mental fog, shaky hands.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Feeling abnormal, Hypopnoea, Muscle spasms, Muscle twitching
Clinical narrative: Vomiting, chest pressure, breathing shallow, trouble swallowing, tingling hands/feet, muscle twitching, muscle spasms, weakness, fatigue, woke up gasping for breath, chills, mental fog, shaky hands.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Paraesthesia, Tremor, Vomiting
Clinical narrative: Vomiting, chest pressure, breathing shallow, trouble swallowing, tingling hands/feet, muscle twitching, muscle spasms, weakness, fatigue, woke up gasping for breath, chills, mental fog, shaky hands.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Fatigue, Feeling abnormal, Headache, Loss of consciousness, Loss of personal independence in daily activities
Clinical narrative: Short syncopal episode - on table, as laying down, passed out but came to almost immediately. Later in day - vomiting, 100.8 oral fever, headache, achy, fatigue next day. Out of school x 3 days, felt "out of it". Shot given Monday, returned to school Thursday.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Pain, Pyrexia, Syncope, Vomiting
Clinical narrative: Short syncopal episode - on table, as laying down, passed out but came to almost immediately. Later in day - vomiting, 100.8 oral fever, headache, achy, fatigue next day. Out of school x 3 days, felt "out of it". Shot given Monday, returned to school Thursday.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site urticaria
Clinical narrative: Patient's mom called pharmacy to report Hives breakout around injection site. Reported 2 days after shot.
Sex: U
Vaccine: HEP, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 31-AUG-2017, the patient was vaccinated with a dose of VARIVAX lot # M024702, expiry date 18-MAY-2018 (dose and route of administration were not reported). On 19-SEP-2017, the patient was vaccinated with a dose of ENGERIX-B (lot # GP7E7, expiry date 30-SEP-2017), and an expired dose of M-M-R II lot # M002418, expiry date 12-JAN-2017 (albumin status, dose and route of administration were not reported). No adverse effect was reported. No product quality complaint was involved.
Age: 1.08
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received on 29-SEP-2017 and 02-OCT-2017, from a registered nurse and a physician assistant referring to a 1 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On 29-SEP-2017, the patient was inadvertently vaccinated with a dose of GARDASIL 9 lot # N010497 and expiration date: 15-JAN-2020 (strength, route and anatomical location were not reported) for prophylaxis; instead of a LIQUID PEDVAXHIB, and in addition, it was unspecified how or why the error occured. No adverse effects were reported.
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Fatigue, Injection site pain, Myalgia, Oedema peripheral
Clinical narrative: This spontaneous report was received from a 36-year-old female, non-pregnant patient who was a company representative and was reporting on herself. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 19-SEP-2017 at 11:10, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) lot # N011867 for prophylaxis (dose, route of administration, expiration date were not reported). On the same day around 8:00 PM, the patient experienced sore throat, low degree fever, fatigue, severe injection site pain (upper deltoid area in right arm), muscle pain in right arm, right side armpit soreness/pain and swollen right side armpit. The patient received 1 tablet of ADVIL as a treatment however it was not helpful. At the reporting time, the patient not recovered from the events (all were ongoing). The relatedness between the events and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not reported.
Sex: F
Vaccine: PPV
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: This spontaneous report was received from a 36-year-old female, non-pregnant patient who was a company representative and was reporting on herself. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 19-SEP-2017 at 11:10, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) lot # N011867 for prophylaxis (dose, route of administration, expiration date were not reported). On the same day around 8:00 PM, the patient experienced sore throat, low degree fever, fatigue, severe injection site pain (upper deltoid area in right arm), muscle pain in right arm, right side armpit soreness/pain and swollen right side armpit. The patient received 1 tablet of ADVIL as a treatment however it was not helpful. At the reporting time, the patient not recovered from the events (all were ongoing). The relatedness between the events and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information was received on 13-OCT-2017 from  a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. It is complained and alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine (dose, route and lot # were not reported) on or about 30-AUG-2013 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. It was reported that the vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about  14-JAN-2016, the patient was treated at a Medical Center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles with residual post-herpetic neuropathic pain. The patient has been prescribed acyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a 4 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 11-OCT-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N014371, expiration date 09-MAY-2019 or lot# 019133, expiration date 22-JUN-2019 (dose was not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 6 and 14 degrees Fahrenheit for 1 hour and 45 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA009100: US-009507513-1710USA009099: US-009507513-1710USA009101: US-009507513-1710USA009098.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a 4 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 11-OCT-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N014371, expiration date 09-MAY-2019 or lot# 019133, expiration date 22-JUN-2019 (dose was not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 6 and 14 degrees Fahrenheit for 1 hour and 45 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA009100: US-009507513-1710USA009099: US-009507513-1710USA009101: US-009507513-1710USA009022.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a 4 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 05-OCT-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N014371, expiration date 09-MAY-2019 or lot# 019133, expiration date 22-JUN-2019 (dose was not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 6 and 14 degrees Fahrenheit for 1 hour and 45 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA009100: US-009507513-1710USA009098: US-009507513-1710USA009022: US-009507513-1710USA009101.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a 4 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 05-OCT-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N014371, expiration date 09-MAY-2019 or lot# 019133, expiration date 22-JUN-2019 (dose was not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 6 and 14 degrees Fahrenheit for 1hour and 45 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1710USA009022: US-009507513-1710USA009099: US-009507513-1710USA009101: US-009507513-1710USA009098:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a 4 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 29-SEP-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N014371, expiration date 09-MAY-2019 or lot# 019133, expiration date 22-JUN-2019 (dose was not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 6 and 14 degrees Fahrenheit for 1 hour and 45 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA009100: US-009507513-1710USA009099: US-009507513-1710USA009022: US-009507513-1710USA009098.