chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Contusion, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to an 84 year old female patient. No concurrent or historical conditions were reported. It was reported that the patient received the last year a dose of PREVNAR vaccine. On 24-SEP-2015, the patient was vaccinated with a booster dose of PNEUMOVAX 23 (lot # K009874, expiration date 19-MAR-2016), unknown dose, intramuscular on unspecified arm. The same day, the patient received as well an unspecified flu vaccine which was given in the same arm as the PNEUMOVAX 23. Concomitant medication included Simvastatin (manufacturer unknown) and "Lodapine". On 24-SEP-2015, the patient developed the initial reaction of bruising and swelling in her arm she received PNEUMOVAX 23, later the patient went to the pharmacy on 29-SEP-2015, with the swelling in the lower part of her arm showing some improvement. The patient sought medical attention with her sister who is a Nurse practitioner, she was treated with BENADRYL, TYLENOL and ice on the area. The outcome of bruising in her arm was reported as recovering/resolving. The reporter considered bruising and swelling in her arm was related to PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to a newborn (numbered 132). Background: Since June 2015, there had been 1645 times (30 minutes each time = 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time = 72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 26-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 2 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 27-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 11 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 28-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.9
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 10 month old patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On an unknown date the patient was vaccinated with a dose of VAQTA (lot #, expiration date, dose and route not provided). No adverse effects were reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: The teacher returned to the room where vaccines were being administered with the child complaining of itching. There was obvious hives present on child's face and arms. I administered an EPIPEN and ambulance was called. EMT arrived with parent consent took child to ER at hosp.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 2 newborns (numbered 146 and 147). Background: Since June 2015, there had been 1645 times (30 minutes each time = 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time = 72 hours)) that temperature was 32F, the lowest being 29/7F. On 04-JUL-2015, there was a low temperature of 30/2F. On 29-AUG-2015 the patient were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 4 newborns (numbered 148, 149, 150 and 151). Background: Since June 2015, there had been 1645 times (30 minutes each time = 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time = 72 hours) that temperature was 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 30-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0/5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 4 newborns (numbered 152, 153, 154 and 155). Background: Since June 2015, there had been 1645 times (30 minutes each time = 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time = 72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30/2F. On 31-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 2 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature  of 30.2F. On 01-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported0. There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 3 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 02-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was not product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown demographics. There was no medical history or drug reaction/allergies reported. On 08-OCT-2015, the patients were vaccinated with doses of improperly stored VARIVAX (lot # L007224 with expired date 03-MAR-2017, dose and route were unknown). No concomitant medication was provided. No adverse effect were reported. This is one of two reports received from the same reporter (1510USA005107). Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown demographics. There was no medical history or drug reaction/allergies reported. On 08-OCT-2015, the patients were vaccinated with doses of improperly stored (Merck) PROQUAD (lot # K008355 with expired date 11-SEP-2016, dose and route were unknown). No concomitant medication was provided. No adverse effects were reported. This is one of two reports received from the same reporter (1510USA005951). Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to unspecified multiple patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored (Merck) PROQUAD (lot # L023112, expiration date 24-DEC-2016; lot # L027634, expiration date 21-JAN-2017) (dose and route were not reported). The defrost cycles of vaccine temperature of -14 Celsius degrees occurred 6 days in October 2015, and -13 degrees Celsius for 5 days in September 2015. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to unspecified multiple patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored VARIVAX (lot # L001333, expiration date 13-JAN-2017; lot # L011085, expiration date 01-APR-2017; lot # L020003, expiration date 02-JUN-2017) (dose and route were not reported). The defrost cycles of vaccine temperature of -14 Celsius degrees occurred 6 days in October 2015, and -13 degrees Celsius for 5 days in September 2015. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to unspecified multiple patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored ZOSTAVAX (lot # L006381, expiration date 25-MAY-2016) (dose and route were not reported). The defrost cycles of vaccine temperature of -14 Celsius degrees occurred 6 days in October 2015, and -13 degrees Celsius for 5 days in September 2015. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Insomnia, Musculoskeletal pain, Musculoskeletal stiffness, Restlessness
Clinical narrative: Hard time sleeping, restlessness, sore shoulder and stiff neck. Weakness, sluggishness.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Sluggishness
Clinical narrative: Hard time sleeping, restlessness, sore shoulder and stiff neck. Weakness, sluggishness.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Death, Malaise
Clinical narrative: Patient died within 48 hours. He went home, took a nap because he did not feel well, and never got up.
Age: 50.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: VIIth nerve paralysis
Clinical narrative: Case number PHEH2015US019819 is an initial spontaneous report received from a health care professional on 05 Oct 2015. This report refers to a 50 year old female patient. Past medical history included Bell's Palsy (diagnosed in emergency room) which resolved on treatment with steroids. Her concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: 174084, expiry date: May 2016) intramuscularly in the left arm on 22 Sep 2015. When she woke up on 23 Sep 2015 morning, her face drooped on left side (Bell's Palsy). The events outcome was reported as condition improving. The event was assessed as medically significant. The causality of the event was not reported. The reporter did not provide contact information for follow up contact and denied consent for contact. The case was considered as lost to follow up at initial.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Axillary pain, Breast pain, Lymphadenopathy, Rash
Clinical narrative: Pain in armpit, progressing down arm, around back, across breast. Diagnosed as Shingles.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Axillary pain, Back pain, Breast pain, Herpes zoster, Pain in extremity
Clinical narrative: Pain in armpit, progressing down arm, around back, across breast. Diagnosed as Shingles.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash
Clinical narrative: PATIENT HAS A RASH IN THE AREA OF SHOT. ABOUT 3 INCHES LONG GOING DOWN ARM, LIKE A BAND.
Age: 0.53
Sex: M
Vaccine: DTAP, HIBV, IPV, RVX
Symptoms: Crying, Screaming, Vaccine positive rechallenge
Clinical narrative: 1.5 hour of intense screaming and crying, this baby doesnt cry. Same reaction with 2 and 4 month shots. He appears to have recovered and is now sleeping.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Rhinorrhoea, Wheezing
Clinical narrative: Runny nose, wheezing, cough. Administered Xopenex nebulizer treatment.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 72 year old female patient and refers to herself. The patient was diabetic and had allergy to sulfur. On an unknown date in 2013 (reported as "about two years ago"), the patient was vaccinated with a dose of ZOSTAVAX, (strength, dose, route of administration, lot # and expiration date were not provided). The patient did not take concomitant medication. On 30-SEP-2015, the patient got shingles. She sought medical attention. On an unknown date in 2015, the patient was hospitalized. The patient had no lab diagnostics studies performed. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected as no contact details were provided.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Multiple sclerosis
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 16 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 28-AUG-2013, the patient received his first dose of GARDASIL 9 (route of administration, lot # and expiration date were not reported). The patient received his second dose of GARDASIL 9 on 30-OCT-2013 and the third dose on 06-MAR-2014. On an unknown date, the patient experienced multiple sclerosis. The outcome of multiple sclerosis and the relatedness between the adverse event and GARDASIL 9 were not reported. Upon internal review, the event of multiple sclerosis was considered to be medically significant. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Insomnia, Pain in extremity
Clinical narrative: As usual, my arm was sore and hurt after the shot. It felt this way for several days. I noticed a redness in the shot area. After a while, the symptoms went away, but now it's a week later and my arm is hurting so much that I had trouble sleeping. The pain is where I got the shot & is radiating down the arm. I plan to call the doctor today.
Age: 32.0
Sex: M
Vaccine: FLUN4
Symptoms: Wrong drug administered
Clinical narrative: Patient given LAIV instead of IM injection due to clerical error.  Patient made aware and given educational material by Dr.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: The area of injection presented redness and was itchy.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: A lot of swelling at the site of injection and it felt hot to the touch.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site of injection was red, highly swollen and painful.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Contusion, Erythema
Clinical narrative: IT BURNED LAST EVENING AFTER SHE GOT THE SHOT, WHEN SHE TOOK OFF THE BANDAID IT WAS RED. TODAY THERE IS A RED SPOT WITH MINOR BRUISING.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Back pain, Burning sensation, Chest pain, Dermatitis allergic
Clinical narrative: Hypersensitive skin on back and underside of arm. Clothes and goosebumps feel mildly painful. Persistent dull pain in arm, armpit, shoulder blade, and chest. Intense pain on left side of arm and left side of arm pit when touched. Intermittent stabbing pain in underside of arm and shoulder. Pain from armpit radiates down into chest. Pain from shoulder radiates across back and up the neck. Occasional burning sensation in shoulder blade and up neck.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Neck pain, Pain, Pain in extremity, Piloerection
Clinical narrative: Hypersensitive skin on back and underside of arm. Clothes and goosebumps feel mildly painful. Persistent dull pain in arm, armpit, shoulder blade, and chest. Intense pain on left side of arm and left side of arm pit when touched. Intermittent stabbing pain in underside of arm and shoulder. Pain from armpit radiates down into chest. Pain from shoulder radiates across back and up the neck. Occasional burning sensation in shoulder blade and up neck.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Dizziness, Syncope, Tremor
Clinical narrative: Mom stated that child felt dizzy, got the shakes and eventually fainted.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Hallucination, Injection site pain, Injection site rash
Clinical narrative: PT COMPLAINED OF HALLUCINATING. COMPLAINED OF PAIN AT INJECTION SITE, SHE DIDN'T KNOW WHERE SHE WAS OR WHO SHE WAS WITH, SHE FELT TIRED, TALKING OUT OF HEAD, HAD RASH AROUND INJECTION SITE.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Erythema, Flushing, Heart rate increased, Immediate post-injection reaction
Clinical narrative: Vaccine given then immediately reported to mom he didn't feel well. HE began to turn red and became flushed. Developed facial hives, nausea and moderate SOB. HR increased to 140, Biox 96%, pt remained alert and responsive. Lungs clear. Pulses normal but tachy. Given 1/2 L O2, albuterol treatment, BENADRYL 10 ml, Prelone. After 10-15 min symptoms improved significantly. Skin still itchy but less flushed. HR decreased to 110, Biox 99%.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Malaise, Nausea, Pruritus, Urticaria
Clinical narrative: Vaccine given then immediately reported to mom he didn't feel well. HE began to turn red and became flushed. Developed facial hives, nausea and moderate SOB. HR increased to 140, Biox 96%, pt remained alert and responsive. Lungs clear. Pulses normal but tachy. Given 1/2 L O2, albuterol treatment, BENADRYL 10 ml, Prelone. After 10-15 min symptoms improved significantly. Skin still itchy but less flushed. HR decreased to 110, Biox 99%.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Feeling cold, Hypersomnia, Impaired work ability, Pain
Clinical narrative: Severe body and joint aches to the point I thought I might need to go to the emergency room. Very cold unable to get warm even with numerous blankets, also vertigo, and vomiting.  No other signs of illness (e.g., sore throat, headache or congestion).  Missed work the following day and slept the entire day.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Vertigo, Vomiting
Clinical narrative: Severe body and joint aches to the point I thought I might need to go to the emergency room. Very cold unable to get warm even with numerous blankets, also vertigo, and vomiting.  No other signs of illness (e.g., sore throat, headache or congestion).  Missed work the following day and slept the entire day.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: LEFT ARM WITH REDNESS AND SWELLING.  HARDNESS THE SIZE OF A "TENNIS BALL" ACCORDING TO SCHOOL NURSE.  CALLED LHD AT 9 AM ON 10/14/2015.  NO FEVER.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient's caregiver complained of redness and swelling around injection site, about the size of 2 fists.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Syncope
Clinical narrative: Patient received her vaccine around 12:30 pm and reported no adverse events at that time. When her shift at work ended she went home. After she arrived at home, she ate some food because she said she had not eaten anything all day. Shortly after eating (around 1:50 pm), she reportedly fainted. The patient said she came to on her floor and assumed she must have fainted. She said she doesn't believe she hit her head, but may have landed on her shoulder because that hurt a little bit.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site rash, Injection site warmth
Clinical narrative: Rash-looking area with redness, warmness, and inflammation at subcutaneous injection site.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient received FLUZONE on 10/9/15 at approx. 11 a.m. then 6 hours later woke up from nap with itching and hives over neck, arms, which then spread to trunk, legs. Went to urgent care given DEXPAK and advised BENADRYL prn.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site
Clinical narrative: Employee is an RN, and feels Inactivate Flu vaccine was given accidentally into her left shoulder joint - not in the deltoid like it is supposed to be given.
Age: 54.0
Sex: U
Vaccine: FLUC3
Symptoms: Fatigue, Lethargy, Pruritus
Clinical narrative: Developed itching evening of vaccine continues to feel tired and lethargic.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: After the vaccine was given, it was discovered that the high dose vaccine was administered not the preservative free vaccine that was registered.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Erythema, Feeling hot, Headache
Clinical narrative: Cough, tightness in chest, headache, fever, itchy, profused generalized rash. (Took TYLENOL, BENADRYL, albuterol Inh). Was given flu shot at 10/08/2015 5:00 PM. On 10/9/15 I had a cough, headache and started to feel achy, tired around 5:00 PM. I noticed the area of IM site was swollen, sore with red area where Band Aid was. I took a shower for aches and noticed the back of my arms were bright red and faint rash on abd, back. I felt hot, itching. My cough became tight/hacking and I felt tightness in my chest. I took TYLENOL, BENADRYL, albuterol Inh and felt better by 1:00 AM. Woke at 4:15 with fever, itchy prickly rash and swollen joints (wrist). Took another TYLENOL, BENADRYL and woke at 10:00 AM better.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Joint swelling, Pain
Clinical narrative: Cough, tightness in chest, headache, fever, itchy, profused generalized rash. (Took TYLENOL, BENADRYL, albuterol Inh). Was given flu shot at 10/08/2015 5:00 PM. On 10/9/15 I had a cough, headache and started to feel achy, tired around 5:00 PM. I noticed the area of IM site was swollen, sore with red area where Band Aid was. I took a shower for aches and noticed the back of my arms were bright red and faint rash on abd, back. I felt hot, itching. My cough became tight/hacking and I felt tightness in my chest. I took TYLENOL, BENADRYL, albuterol Inh and felt better by 1:00 AM. Woke at 4:15 with fever, itchy prickly rash and swollen joints (wrist). Took another TYLENOL, BENADRYL and woke at 10:00 AM better.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Pyrexia, Rash generalised, Rash pruritic
Clinical narrative: Cough, tightness in chest, headache, fever, itchy, profused generalized rash. (Took TYLENOL, BENADRYL, albuterol Inh). Was given flu shot at 10/08/2015 5:00 PM. On 10/9/15 I had a cough, headache and started to feel achy, tired around 5:00 PM. I noticed the area of IM site was swollen, sore with red area where Band Aid was. I took a shower for aches and noticed the back of my arms were bright red and faint rash on abd, back. I felt hot, itching. My cough became tight/hacking and I felt tightness in my chest. I took TYLENOL, BENADRYL, albuterol Inh and felt better by 1:00 AM. Woke at 4:15 with fever, itchy prickly rash and swollen joints (wrist). Took another TYLENOL, BENADRYL and woke at 10:00 AM better.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Eye discharge, Impaired work ability, Nasopharyngitis
Clinical narrative: Patient received the vacccine on Friday (9/11). Patient said that "cold-like symptoms" began on Saturday (day after vaccination), with "drainage and weakness" beginning on Monday. The patient said she had to call off work due to the severity of her symptoms. By Friday (one week later), she felt better. The patient noted that her other family members were sick with similar symptoms before her symptoms began, so it was likely a coincidence that she experienced these symptoms after receiving her flu shot.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Cough, Pyrexia
Clinical narrative: Fever, cough and weakness.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, FLU4, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Very large localized erythema on right thigh causing pain.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Cough, Dizziness, Myalgia, Oropharyngeal pain
Clinical narrative: High Fever (102) Muscle aches & pains, sore throat, cough, weakness, light-headed, treatment - Tylenol. As of 10/14/2015 - still experiencing symptoms.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: High Fever (102) Muscle aches & pains, sore throat, cough, weakness, light-headed, treatment - Tylenol. As of 10/14/2015 - still experiencing symptoms.
Age: 9.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Pyrexia, Vomiting
Clinical narrative: Fever 101+, dizziness & vomiting.
Age: 1.0
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Crying, Dyskinesia, Emotional distress, Hyperhidrosis, Muscle contractions involuntary
Clinical narrative: Sweating profusely, screaming/crying- initially unconsolable, body jerks/involuntary limb twitching and muscle contractions, staring of into space, was able to call him down while muscles continued to twitch after 1.5 hours. 48 Hours later, hives broken out all over legs and arms, raised and purple in places. Muscles still twitching when he falling asleep, seeking neurologist appt and allergist appt.
Age: 1.0
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Muscle twitching, Screaming, Staring
Clinical narrative: Sweating profusely, screaming/crying- initially unconsolable, body jerks/involuntary limb twitching and muscle contractions, staring of into space, was able to call him down while muscles continued to twitch after 1.5 hours. 48 Hours later, hives broken out all over legs and arms, raised and purple in places. Muscles still twitching when he falling asleep, seeking neurologist appt and allergist appt.
Sex: M
Vaccine: FLU4
Symptoms: Abasia, Arthralgia, Impaired work ability
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of unable to walk in a adult male patient who received FLULAVAL QUADRIVALENT (batch number H33J2, expiry date unknown). On 2nd October 2015, the patient received FLULAVAL QUADRIVALENT. On 4th October 2015, 2 days after receiving FLULAVAL QUADRIVALENT, the patient experienced unable to walk (serious criteria disability and GSK medically significant) and generalized joint pain (serious criteria disability). On an unknown date, the outcome of the unable to walk and generalized joint pain were unknown. It was unknown if the reporter considered the unable to walk and generalized joint pain to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: Two days after vaccination the patient was unable to walk and had overall joint pain and was unable to go to work on 5th October 2015 and worked only a half day on 6th October. It was unknown if he required a doctor's care or if he received any treatment. He was not hospitalized. This case was linked to 6 cases reported by the same reporter.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 79.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Ataxia, Balance disorder, Bradycardia, Fall
Clinical narrative: Patient is a 79-year-old male, who was admitted to this hospital initially on 03/06, with history of ataxia and multiple falls, which apparently started following a pneumonia that he (and flu shot) supposedly had in January. He was extensively evaluated during his hospitalization between 03/06 and 03/14, including Neurology, Neurosurgery, physical therapist, and eventually was felt to have some possible form of Guillain-Barre syndrome. He was then transferred to rehabilitation where he is progressing slowly. He still has problems with his balance but states that he has improved. On his examination today, Dr. found a bradycardia in the 40s, reason why he cut down his LOPRESSOR and asked for a cardiology consultation.
Age: 83.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pain from injection site to elbow as well as redness. Referred to PCP. (Left arm).
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Per patient few days after receiving Flu vaccine her arm was red and itchy surrounding the site of injection. Pt seen in our office 10/08 Dr prescribed topical steroid cream (WESTCORT) and ZYRTEC.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Soreness, redness, some swelling shot was given. The day (after), could not raise arm w/ shot and once my head or from left to right w/ pain (2) days. Also fatigue. On and off w/ hot and cold packs.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Soreness, redness, some swelling shot was given. The day (after), could not raise arm w/ shot and once my head or from left to right w/ pain (2) days. Also fatigue. On and off w/ hot and cold packs.
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Feeling abnormal, Influenza like illness, Rhinorrhoea
Clinical narrative: Pt experienced flu like symptoms for at least 2 days I know of. I believe it started a day or two after the PREVNAR 13 was given. On 10/2 and 10/4 she was not feeling good, nose drips, exhausted, flu-like symptoms.
Age: 66.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient c/o swelling/redness of left arm started a few days after receiving influenza and PCV13 vaccines. Treated with topical steroid/ZYRTEC and BENADRYL
Age: 59.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash, Injection site swelling, Injection site vesicles, Varicella virus test
Clinical narrative: Blisters and rash at injection site of varicella vaccine. Swelling to arm surrounding site.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Injection site bruising, Injection site swelling, Injection site warmth
Clinical narrative: Raised area further out than where shot was given. Continues to get larger. Very bruised area. Warm to touch.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Neuralgia, Paraesthesia
Clinical narrative: Patient reported 2 days after vaccine that her arm began to tingle from the shoulder to the tips of fingers. She stated it was painful nerve pain that was not relieved by OTC medication or muscle rubs.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Patient presented with swelling at injection site 10 minutes after injection. Site was slightly firm to the touch - ice applied. Pt instructed to take TYLENOL/MOTRIN and BENADRYL as needed.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: Right after giving injections, but before pulling out needle, I noticed area right around injection site swelling. Pt said it did not hurt. I also had other pharmacist on duty look at it. We called the local urgent care they recommended ice and BENADRYL. Pt stayed in pharmacy waiting room about 20 minutes - swelling reduced considerably.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Nasopharyngitis
Clinical narrative: Had cold symptoms. Sharp pain in left shoulder periodically after shot given. Had pain during 1st week after shot.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal pain, Enema administration, Intussusception, Ultrasound abdomen
Clinical narrative: Abdominal pain 1 day after ROTATEQ. 5 days later, extreme abdominal pain dx with intussusception. 1 day hospital stay.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient complains of pain in arm after receiving shot and has persisted to present.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Approximately, 30 minutes after injection, employee experienced redness and warmth at injection site.  Some induration of about 3-4cm has begun.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives all over body 1 hour after vaccine administration. No anaphylaxis.  Tx: oral loratadine.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Dizziness, Heart rate increased, Pyrexia
Clinical narrative: Fever, rapid heart rate, dizzy, weakness.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: HOT TO TOUCH, SWOLLEN UNDER INJECTION SITE AND RED.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Headache, Nausea
Clinical narrative: Daily headaches and nausea.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Generalised tonic-clonic seizure, Postictal state, Seizure
Clinical narrative: Patient had a generalized tonic clonic seizure lasting 2 min with post ictal 5 minutes and a second facial generalized sz in ED at 750 also lasting 2 min with no post ictal.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Injection site pain, Pain in extremity, Skin tightness
Clinical narrative: FROM DAY OF INJECTION UNTIL NOW LEFT SHOULDER DOWN TO FINGERS CONTINUES TO FEEL SORE. ARM FEELS LIKE I SLEPT ON IT AND PERSISTS, TIGHTNESS AND A LITTLE NUMBING AT TIMES.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Swelling
Clinical narrative: Left axillary pain and swelling.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain lower, Back pain, Nausea, Vomiting
Clinical narrative: Extreme pain in lower left back which migrated, over the next 36 hours to the middle lower abdomen. Accompanied by nausea, vomiting, and inability to consume even water without vomiting.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Erythema, Injection site pain, Injection site warmth, Local reaction
Clinical narrative: Received flu vaccine from pharmacy pharmacist. Injection given wrong site, (R) mid upper arm.  Local reaction of erythema 7.5 cm x 8.5 cm - irregular shape, increased warm at site and painful.
Age: 61.0
Sex: F
Vaccine: FLUC3
Symptoms: Musculoskeletal stiffness
Clinical narrative: Developed stiff neck evening after receiving vaccine.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Disorientation, Dizziness, Headache, Hyperventilation, Pain in extremity
Clinical narrative: Per mom sore arm x 2 days - had flu vaccine 10/6/15 - started running low grade fever 10/11/15, vomited, headache, dizzy, disoriented. On the 13th breathing fast and heavy - called 911. EMS came, checked her out and appeared to be ok. Still running low grade fever. Seems to be feeling better. Mom just wanted us to know - states was wondering if anyone else called with those complaints - states she may just have virus. Advised to see PMD for further eval.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Respiratory rate increased, Vomiting
Clinical narrative: Per mom sore arm x 2 days - had flu vaccine 10/6/15 - started running low grade fever 10/11/15, vomited, headache, dizzy, disoriented. On the 13th breathing fast and heavy - called 911. EMS came, checked her out and appeared to be ok. Still running low grade fever. Seems to be feeling better. Mom just wanted us to know - states was wondering if anyone else called with those complaints - states she may just have virus. Advised to see PMD for further eval.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal stiffness, Nerve injury
Clinical narrative: Fine 1st day. Went to doctor had pain in left deltoid. Dr. felt nerve was hit when given shot.  Still have pain and stiffness.
Age: 80.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Differential white blood cell count, Erythema, Full blood count, Injection site rash, LDL/HDL ratio
Clinical narrative: This spontaneous report was received from a consumer referring to an 80 year old male patient with Parkinson's disease, and pituitary tumour. On 01-OCT-2015, the patient was vaccinated with a dose of PNEUMOVAX (manufacturer unknown) (lot # and expiry date not reported). On the same day the patient was vaccinated with a dose of influenza virus vaccine. Concomitant therapies included ramipril, 5 mg once a day, simvastatin (manufacturer unknown), 20 mg once a day, metoprolol succinate extended release, 50 mg once a day, and aspirin, 81 mg once a day. On 01-OCT-2015, the patient underwent blood work before the vaccinations doses were given to him, but he was not having the results. He had CBC with differential platelet, lipid panel with HDL:LDL ratio, and comprehensive metabolic panel 14. On 02-OCT-2015, the patient experienced at the arm with PNEUMOVAX (manufacturer unknown) shot had a bad reaction to it, it was all red, swollen and spots all over his shoulder on his arm, and he did not feel well. The outcome of limb discomfort, malaise, rash macular, peripheral swelling and erythema was unknown. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Limb discomfort, Malaise, Metabolic function test, Peripheral swelling, Rash
Clinical narrative: This spontaneous report was received from a consumer referring to an 80 year old male patient with Parkinson's disease, and pituitary tumour. On 01-OCT-2015, the patient was vaccinated with a dose of PNEUMOVAX (manufacturer unknown) (lot # and expiry date not reported). On the same day the patient was vaccinated with a dose of influenza virus vaccine. Concomitant therapies included ramipril, 5 mg once a day, simvastatin (manufacturer unknown), 20 mg once a day, metoprolol succinate extended release, 50 mg once a day, and aspirin, 81 mg once a day. On 01-OCT-2015, the patient underwent blood work before the vaccinations doses were given to him, but he was not having the results. He had CBC with differential platelet, lipid panel with HDL:LDL ratio, and comprehensive metabolic panel 14. On 02-OCT-2015, the patient experienced at the arm with PNEUMOVAX (manufacturer unknown) shot had a bad reaction to it, it was all red, swollen and spots all over his shoulder on his arm, and he did not feel well. The outcome of limb discomfort, malaise, rash macular, peripheral swelling and erythema was unknown. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Rash macular
Clinical narrative: This spontaneous report was received from a consumer referring to an 80 year old male patient with Parkinson's disease, and pituitary tumour. On 01-OCT-2015, the patient was vaccinated with a dose of PNEUMOVAX (manufacturer unknown) (lot # and expiry date not reported). On the same day the patient was vaccinated with a dose of influenza virus vaccine. Concomitant therapies included ramipril, 5 mg once a day, simvastatin (manufacturer unknown), 20 mg once a day, metoprolol succinate extended release, 50 mg once a day, and aspirin, 81 mg once a day. On 01-OCT-2015, the patient underwent blood work before the vaccinations doses were given to him, but he was not having the results. He had CBC with differential platelet, lipid panel with HDL:LDL ratio, and comprehensive metabolic panel 14. On 02-OCT-2015, the patient experienced at the arm with PNEUMOVAX (manufacturer unknown) shot had a bad reaction to it, it was all red, swollen and spots all over his shoulder on his arm, and he did not feel well. The outcome of limb discomfort, malaise, rash macular, peripheral swelling and erythema was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Diarrhoea, Gait disturbance, Pain, Swelling
Clinical narrative: SEVERE GENERALIZED PAIN, DIFFICULTY WALKING DUE TO SEVERE PAIN AND SWELLING, UNCONTROLLABLE DIARRHEA, WEAKNESS.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Abasia, Asthenia, CSF protein increased, CSF white blood cell count negative, Cervical spinal stenosis
Clinical narrative: Patient presented with bilateral lower extremity pain and edema. Patient says that the pain started in the morning while she was getting ready for work. She had just gone to the bathroom and she bent over to get some of the lint off of her pants and then got up. The pain came on all of a sudden. It is described as a burning and throbbing pain that she rates as a 10/10 when it first started. At exam she stated it is 8/10 since she had been given some medicine. She was unable to walk and had numbness in her toes and was unable to move them. She stated that she was able to move them earlier. She had some nausea and vomiting and with the vomiting she did have some incontinence. She had never had this pain before and she is a foster child and does not know her family history. She is a nonsmoker and denies any illegal drug use. She does not drink either. She denies any injury or trauma.  Patient was subsequently admitted to Hospital. She underwent an urgent MRI on admission which showed no evidence for acute fracture. No cord impingement or abnormal cord signal. There was spinal stenosis at cervical levels related to a combination of disc degenerative change at C3-C4 and C5-C6 superimposed upon a low normal caliber spinal canal. Cord impingement, but no myelomalacia. Neurology was consulted as patient was experiencing paralysis of her lower extremities and numbness, along with pain upon urination. Neurology completed a lumbar puncture which was positive for protein but negative for white cells. Also completed EMG/NCS of the left limbs which revealed very early neuropathy with primarily motor findings. Neurology diagnosed the patient with Guillain Barre Syndrome, likely related to administration of the flu vaccine. Patient was treated with 0.4g/kg of IVIG x 5 doses. After treatment she has considerably less tingling but unchanged weakness. She is being discharged to a rehab facility.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Diplegia, Dysuria, Electromyogram abnormal, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Patient presented with bilateral lower extremity pain and edema. Patient says that the pain started in the morning while she was getting ready for work. She had just gone to the bathroom and she bent over to get some of the lint off of her pants and then got up. The pain came on all of a sudden. It is described as a burning and throbbing pain that she rates as a 10/10 when it first started. At exam she stated it is 8/10 since she had been given some medicine. She was unable to walk and had numbness in her toes and was unable to move them. She stated that she was able to move them earlier. She had some nausea and vomiting and with the vomiting she did have some incontinence. She had never had this pain before and she is a foster child and does not know her family history. She is a nonsmoker and denies any illegal drug use. She does not drink either. She denies any injury or trauma.  Patient was subsequently admitted to Hospital. She underwent an urgent MRI on admission which showed no evidence for acute fracture. No cord impingement or abnormal cord signal. There was spinal stenosis at cervical levels related to a combination of disc degenerative change at C3-C4 and C5-C6 superimposed upon a low normal caliber spinal canal. Cord impingement, but no myelomalacia. Neurology was consulted as patient was experiencing paralysis of her lower extremities and numbness, along with pain upon urination. Neurology completed a lumbar puncture which was positive for protein but negative for white cells. Also completed EMG/NCS of the left limbs which revealed very early neuropathy with primarily motor findings. Neurology diagnosed the patient with Guillain Barre Syndrome, likely related to administration of the flu vaccine. Patient was treated with 0.4g/kg of IVIG x 5 doses. After treatment she has considerably less tingling but unchanged weakness. She is being discharged to a rehab facility.