chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Blood test normal, Chills, Flushing, Pyrexia
Clinical narrative: A spontaneous report was received from a consumer whose 25 year old daughter was advised by her physician to receive GARDASIL injections. On 08MAY2013 the patient received her first GARDASIL injection. Shortly after administration the patient became flushed and broke out in a rash, which appeared on her face and arms and lasted a few hours. The physician reviewed the patient's condition, and they went home. Two weeks to a month later, the patient began to experience severe stomach pain, chills, shaking and fever. These symptoms have been experienced by the patient "three to five times per week." There have also been sporadic episodes of fainting. Subsequent dose (two and three) were not administered. The reported state "we tried eliminating certain foods, sulfites any suspect allergens, but nothing was shown." The patient was also tested for a urinary tract infection after a course of antibiotics. The patient was seen by another physician- "bloodwork showed no infection." The reporter considered GARDASIL to be the suspect. Patient is otherwise, and "has always been" healthy and active and in good physical condition, according to the reporter. The patient's present status is not recovered. No further information has been provided.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash, Syncope, Tremor, Urine analysis
Clinical narrative: A spontaneous report was received from a consumer whose 25 year old daughter was advised by her physician to receive GARDASIL injections. On 08MAY2013 the patient received her first GARDASIL injection. Shortly after administration the patient became flushed and broke out in a rash, which appeared on her face and arms and lasted a few hours. The physician reviewed the patient's condition, and they went home. Two weeks to a month later, the patient began to experience severe stomach pain, chills, shaking and fever. These symptoms have been experienced by the patient "three to five times per week." There have also been sporadic episodes of fainting. Subsequent dose (two and three) were not administered. The reported state "we tried eliminating certain foods, sulfites any suspect allergens, but nothing was shown." The patient was also tested for a urinary tract infection after a course of antibiotics. The patient was seen by another physician- "bloodwork showed no infection." The reporter considered GARDASIL to be the suspect. Patient is otherwise, and "has always been" healthy and active and in good physical condition, according to the reporter. The patient's present status is not recovered. No further information has been provided.
Age: 35.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Corneal reflex decreased, Dyskinesia, VIIth nerve paralysis
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of Bell's palsy (R) side in a 35-year-old male subject who was vaccinated with FLULAVAL TETRA (GlaxoSmithKline). On 1 November 2013 at 11:00 the subject received unspecified dose of FLULAVAL TETRA (.5 ml, unknown, left arm). On 1 November 2013, 30 minutes after vaccination with FLULAVAL TETRA, the subject experienced Bell's palsy (R) side, difficulty eating and drinking (swallowing) and paralysis. The subject experienced symptoms of Bell's Palsy 30 minutes following the vaccination with FLULAVAL TETRA. The right side of his face was affected. The subject was seen in the emergency room and was treated with steroids. The subject had difficulty eating and drinking due to the paralysis. This case was assessed as medically serious by GSK. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with FLULAVAL TETRA.
Age: 35.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Dysphagia, VIIth nerve paralysis
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of Bell's palsy (R) side in a 35-year-old male subject who was vaccinated with FLULAVAL TETRA (GlaxoSmithKline). On 1 November 2013 at 11:00 the subject received unspecified dose of FLULAVAL TETRA (.5 ml, unknown, left arm). On 1 November 2013, 30 minutes after vaccination with FLULAVAL TETRA, the subject experienced Bell's palsy (R) side, difficulty eating and drinking (swallowing) and paralysis. The subject experienced symptoms of Bell's Palsy 30 minutes following the vaccination with FLULAVAL TETRA. The right side of his face was affected. The subject was seen in the emergency room and was treated with steroids. The subject had difficulty eating and drinking due to the paralysis. This case was assessed as medically serious by GSK. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with FLULAVAL TETRA.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Hypoaesthesia, Injection site anaesthesia, Insomnia, Pain
Clinical narrative: My entire right arm (including my fingers) went numb on Tuesday night (10/29/2013) when I sat down to relax after a long and active day. Wednesday night (10/30/2013) my arm went numb again after I laid down to sleep for the night, although my fingers were not affected. In addition to the numbness, I experienced a dull, throbbing pain which started shortly after recieving the vaccine, has been present all week, and flared up again on 11/02/2013 around 1745, keeping me from sleeping before my 2345 shift that night. I developed a cough on 11/01/2013 which may also be related to recieving the vaccine. Like I said, this wouldn't concern me after only a day but these problems have persisted for four days after recieving my shot. The pain is pretty bad, but not enough for me to want to use medications at this time.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Abnormal behaviour, Aggression, Aphasia, Memory impairment
Clinical narrative: 10/16/13 -Patient left our house suddenly and without permission. Later he said he did not remember leaving.  As his awareness returned and he saw he was on his way to school, he just walked to school and was taken in by staff. 10-21-13 - 6 PM - Patient once again left our house and later he again said, he didn't remember leaving. He was found by police over a mile from home going through people's mailboxes looking for 'his catalog'. He said he was heading to his daycare facility which was over 2 miles and a major highway away.  The week of 10-21-13 - patient had great difficulty processing, unable to remember known words while reading, respond appropriately to daily directions and was constantly argumentative in every setting. None of these behaviors were typical during the given time. All behaviors have stopped by 10-28-13. Dr. has referred patient to a pediatric neurologist to investigate potential seizure activity caused by either vaccine or medication and/or the onset of other neurological disorders, impairments.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Gait disturbance, Neurological examination
Clinical narrative: Patient reporst several 20-30 second episodes of dizziness.  10-11 on the day of the vaccine, 5-6 the next day and 1 so far today.  No falls but has stumbled.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Injection site pain, Irritability
Clinical narrative: Child became very fussy and leg was tender to touch.  Parents able to console child.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Pruritus
Clinical narrative: Wife called about 4:15PM. States pt received flu vaccine this afternoon then about 45 minutes later he had redness and itching at the site of the vaccine then his fingers and hands developed redness and itching bilaterally with redness moving up above his wrists about 3 inches. He took BENADRYL 25 mgm and states he has improved. No shortness of breath or wheezing. I also spoke to patient at 6:00 PM and he stated he was fine at that time.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Blood test normal, Dizziness, Encephalitis viral, Pyrexia
Clinical narrative: Initial report received on 23-OCT-2013 from a healthcare professional: A 76-year-old male patient with a medical history of allergies to metronidazole and codeine and no reported concomitant medication had received an intramuscular dose of FLUZONE HD (Sanofi Pasteur Inc., batch number U4760AA, expiry date on 01-MAY-2014) in the left deltoid on 09-OCT-2013. On 11-OCT 2013, the patient was seen by the physician for fever, weakness, dizziness. The patient went to emergency room for blood work. It was stated that all blood work was negative. The patient continued to have symptoms and returned to the physician on 16-OCT-2013. The patient was admitted to the hospital on 16-OCT-2013 with diagnosis of encephalitis of viral cause. At the time of the report, the patient was still hospitalized. The patient had not recovered.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling, Laboratory test, Nephrotic syndrome, Periorbital oedema, Protein urine present
Clinical narrative: After 24 hours developed swelling of entire (L) upper arm. A week after Flu shot developed periorbital edema. Seen in office 10/14 (+) proteinuria. Sent to ER - admitted x 24 hours. Dx minimal change nephrotic syndrome. Rx Prednisone.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Proteinuria
Clinical narrative: After 24 hours developed swelling of entire (L) upper arm. A week after Flu shot developed periorbital edema. Seen in office 10/14 (+) proteinuria. Sent to ER - admitted x 24 hours. Dx minimal change nephrotic syndrome. Rx Prednisone.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Conjunctivitis, Erythema, Eye pain, Headache, Pain
Clinical narrative: Flu shot 10/3/2013, 1 week later mild URI with tender OD -> seen in office 10/17. Dx'd as conjunctivitis - felt viral, no meds. 10/22 - HA developed, (R) temple HA, OD - pain increased, increased erythema -> sent to eye doc 10/23.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Upper respiratory tract infection
Clinical narrative: Flu shot 10/3/2013, 1 week later mild URI with tender OD -> seen in office 10/17. Dx'd as conjunctivitis - felt viral, no meds. 10/22 - HA developed, (R) temple HA, OD - pain increased, increased erythema -> sent to eye doc 10/23.
Sex: F
Vaccine: FLUX
Symptoms: Influenza like illness, Vaccination complication
Clinical narrative: This case was reported by a consumer via Online and described the occurrence of possible pulmonary hypertension in a female patient who received VENTOLIN for an unknown drug indication. A physician or other health care professional has not verified this report. On an unknown date, the patient started salbutamol sulphate (unknown) at unknown dosing. At an unknown time after starting salbutamol sulphate, the patient saw a new pulmonologist, who told her she might have pulmonary hypertension. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unknown, and the patient was waiting for the completion of unspecified tests. Information was received on 15 February 2013 via monitoring of GSK website. The patient was taking VENTOLIN HFA but start date and dosing was not provided. She reported she "usually has mild side effects that go away with time." She had started a new medication really "did not realize that my labored breathing could have been from that medication. She just thought her COPD was just bad that day." COPD was concurrent medical condition. No other details provided. Follow-up information was received on 26 March 2013 via monitoring of GSK website. While on salbutamol sulphate, the patient experienced bloating, her stomach hurting and trouble breathing. She also reported having diverticulitis (onset date in relation to salbutamol sulphate use was not provided). The patient stated that her physician thought diverticulitis was the reason for the bloating and stomach pain. Follow-up information was received on 23 October 2013 from the patient via GSK Patient Market research Online Community (MROC). The patient was taking salbutamol sulphate for chronic obstructive pulmonary disease. The patient stated, "...while working around the house doing day to day chores I seemed to be having more and more trouble breathing (difficulty in breathing on exertion). At the time of reporting, the outcome of difficulty in breathing on exertion was unknown. Follow-up information was received on 22 October 2013 from the patient via GSK Patient Market Research Online Community (MROC). On an unspecified date in 2013 the subject received unspecified dose of influenza unspecified (unknown). Within months of vaccination with influenza unspecified, the subject experienced "some sort of reaction to my flu shot" (nonspecific reaction) and flu-like-illness. The subject stated "I have noticed this is the first year that I seemed to actually have some sort of reaction to my flu shot. I can only imagine if I had not got the shot how the flu would have knocked me out. I am so glad to get my shots and know that I will not get a full blown flu illness". At the time of reporting the outcome of the nonspecific reaction and flu-like-illness were unspecified.
Age: 48.0
Sex: U
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Eye discharge, Purulent discharge
Clinical narrative: Received Flu vaccine on site at place of employment (10/30/13 at 6 AM) 9 AM - onset of coughing and couldn't seem to stop. Shortly after chest felt tight and started getting stringy, yellowish-white drainage in both eyes. Thought might have rash on chest, but this wasn't clear. Denied difficulty swallowing or swelling of tongue. Still under Dr's care on prednisone and albuterol inhaler.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Computerised tomogram, Influenza like illness, Myelitis transverse, Pain
Clinical narrative: A few days after the shot I begin to feel like I had the flu. 8 days after the shot I went to primary phy. 20 days after that getting worse and aching more I went back to phy. Blood test, X-ray, CT due to tingling sensation in back and legs. 12-16-2012 admitted to hospital diagnosed with transverse myelitis. Hospital again 1-15-2013.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, X-ray
Clinical narrative: A few days after the shot I begin to feel like I had the flu. 8 days after the shot I went to primary phy. 20 days after that getting worse and aching more I went back to phy. Blood test, X-ray, CT due to tingling sensation in back and legs. 12-16-2012 admitted to hospital diagnosed with transverse myelitis. Hospital again 1-15-2013.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Full blood count, Herpes simplex serology, Hypoaesthesia oral, Nuclear magnetic resonance imaging, VIIth nerve paralysis
Clinical narrative: Numbness of tongue on 10/14/2013. On 10/17/2013 facial paralysis on the right side.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Inflammation, Injection site erythema, Injection site oedema
Clinical narrative: Local inflammatory reaction to MMRV: 5cm. Non-tender erythema and slight edema over left deltoid area.
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date the patient was vaccinated with dose 1 of ROTATEQ (oral, lot # was not reported). On an unknown date the patient experienced rotavirus infection. The patient sought medical attention and received an unspecified treatment. The outcome of rotavirus infection was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to multiple unspecified patients of unknown age. On an unknown date in 2013(reported as unspecified dates), the patients were vaccinated with a dose of VAQTA (lot # H012669, expiry date 17-APR-2015) which was exposed to 30F for 12 hours in 05-AUG-2013. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an unknown reporter refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of incorrect storage ZOSTAVAX lot # J000445, expiration date 11-APR-2014, dose and route unspecified. This is one of several reports received from same source. Additional information is not expected.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Nonspecific reaction
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to two patient of unknown age. On an unknown date the patients were vaccinated with PNEUMOVAX 23 (lot # 0653AE) (dose, route unknown). On the same day, both the patients received influenza virus vaccine (manufacturer unknown). On an unknown date both the patients experienced an unspecified reaction, after they received PNEUMOVAX 23 and influenza virus vaccine (manufacturer unknown). The outcome of the event was unknown. Additional information has been requested.
Age: 0.15
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: R thigh, Pentacel administered 10/30/13. Significant swelling (22 cm) warmth and erythremia at site. Very fussy all day. Seen back in office at 4:15 PM due to symptoms.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pharmacist reported that a patient received an expired dose of VARIVAX (Merck) (Lot# G008367, expiry date: 22-AUG-2013), (dose, route and location unspecified) on 20-OCT-2013. No adverse effect reported. Additional information has been requested.
Age: 1.02
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a 12 month old patient of unknown gender. On 14-OCT-2013 the patient received a dose of PROQUAD (Merck) 0.5 ml, subcutaneously (lot number reported as: J004161 exp date: 05-APR-2015) (site of administration was not reported) and a dose of VARIVAX (Merck), 0.5 ml, (lot number, dose, route and site of administration were not reported). No adverse effect was reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 12 month old male patient. There was no relevant medical history and no concomitant medication. In August 2013 the patient was vaccinated with M-M-R II dose 1. Lot number, dose, route and frequency were not provided. The patient was vaccinated at the age of 10 months. On an unknown date in 2013, reported as a week after the vaccination the patient experienced fever and rash. The patient was taken to his unspecified primary healthcare provider, on an unspecified date, in regards to the reaction. The outcome of fever and rash was reported as recovered/resolved a couple of days later. The reporter causality was unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 30-OCt-2013 the patient was vaccinated with the second dose of PNEUMOVAX 23 (lot # H010515, exp. 13-FEB-2014) intramuscular in her arm. On 31-OCT-2013, the patient developed redness and slight swelling on the inside of the arm in which PNEUMOVAX 23 was administered. The pharmacist stated that the redness and slight swelling extended from just below the site of injection to the wrist. The patient sought medical attention - visited the pharmacist. The outcome of redness and slight swelling on the inside of the arm was reported as not recovered/not resolved. The relatedness between redness and slight swelling on the inside of the arm and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Ultrasound scan normal, Vertigo, White blood cell count increased
Clinical narrative: This spontaneous report as received from a physician, via company representative, refers to a 61 year old female patient. The reporter stated that a patient experienced a severe allergic reaction on her arm at the injection site after receiving a dose of PNEUMOVAX 23 into arm, (dose, strength, route of administration not reported), on 27-AUG-2013. The patient has not fully recovered and continues to have unspecified issues with her arm. The patient was seen 3 different times in an unspecified emergency room for symptoms related to the injection site reaction. The first emergency room visit was on 01-SEP-2012. The dates of the other two visits were unknown. Besides the emergency room visits, the patient was also seen by two unspecified healthcare providers. It was reported that the patient had an elevated white blood cell count of 19,000 (units not provided) the date of this blood test was not specified. The patient also developed vertigo which started in November 2012. Due to the several and size of the injection site reaction, the patient had an ultra sound (date unspecified) of her arm to rule out cellulitis. Cellulitis was not detected on the ultra sound. The relatedness between PNEUMOVAX 23 and events was not reported. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Unevaluable event
Clinical narrative: None.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 05-NOV-2013 the patient was inadvertently vaccinated intramuscularly with a 0.5 ml expired dose of PNEUMOVAX23 (lot # 672781/1706AA, expiration date: 03-OCT-2013). No adverse effects were reported. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Joint injection, Mobility decreased
Clinical narrative: Shoulder was painful got worse until 10/31. Went to family doctor. Gave steroid shot in shoulder, mobility is getting better. MD thinks shot was given to high on shoulder.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: This spontaneous report was received from a registered nurse via company representative refers to two patients of unknown age. On an unknown date in OCT-2013, the patients were vaccinated with a dose of PNEUMOVAX23 ( lot # J010332, expiry date 04-JAN-2015). On an unknown date in OCT-2013, the patients experienced swelling, pain and stiffness at the injection site after administration of PNEUMOVAX23. There was no treatment rendered for the events. There was no lab tests performed. The outcome of the reported events were unknown. The patients sought medical attention. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: This spontaneous report was received from a registered nurse via company representative refers to a patient of unknown age. On an unknown date in OCT-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (lot # J004387, expiry date 04-JAN-2015). On an unknown date in OCT-2013, the patient experienced swelling, pain and stiffness at the injection site after administration of PNEUMOVAX23. There was no treatment rendered for the events. There was no lab tests performed. The outcome of the reported events were unknown. The patients sought medical attention. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Malaise, Myalgia, Nausea
Clinical narrative: Within 1 day of receiving flu vaccine, pt developed nausea, vomiting, myalgias, malaise, fatigue, chills. Tx ondansetron and supportive care.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Within 1 day of receiving flu vaccine, pt developed nausea, vomiting, myalgias, malaise, fatigue, chills. Tx ondansetron and supportive care.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a Registered Nurse refers to a 69 year old female patient. No medical history or drug reactions were reported. On 28-OCT-2013, the patient was vaccinated with PNEUMOVAX23 (lot # J006082, 12-APR-2014) 0.5 ml, intramuscular. Concomitant therapies included aspirin, anastrozole, CLARITIN, gabapentin, hydrochlorothiazide, lovastatin, metoprolol, venlafaxine hydrochloride and verapamil. On 29-OCT-2013, the patient developed a large red area at the injection site and the deltoid of the right arm, which was painful to the touch. Patient sought medical attention. The nurse stated the red area was "10 by 13 centimeters". The patient was seen in the office on 29-OCT-2013, and an unspecified physician instructed her to use a cold compress on the area. No laboratory tests were performed. The outcome of the deltoid of the right arm, which is painful to the touch and large red area at the injection site was reported as not recovered. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Skin lesion, Skin warm
Clinical narrative: 8cm round erythematous, warm lesion indurated, Tx with oral abx. Lesion one week old.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Local swelling
Clinical narrative: I woke up that morning and I was swollen and red and looked bruised almost my entire top arm.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Cough, Eye pruritus, Eyelid oedema, Hypoaesthesia oral
Clinical narrative: Sore throat, itchy eyes, arms, and legs, bloodshot/ puffy eyes, chills, cough, vomiting and nausea. Took Benadryl and itchiness/ nausea subsided. 11/7/13 tongue became numb.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Ocular hyperaemia, Oropharyngeal pain, Pruritus, Vomiting
Clinical narrative: Sore throat, itchy eyes, arms, and legs, bloodshot/ puffy eyes, chills, cough, vomiting and nausea. Took Benadryl and itchiness/ nausea subsided. 11/7/13 tongue became numb.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Headache, Lip swelling, Oropharyngeal pain, Pain
Clinical narrative: Woke up with sore, swollen throat and swollen upper lip; chest tightness, headache and general body aches.  She called in sick for that day's night shift.  No treatment.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema
Clinical narrative: Woke up with sore, swollen throat and swollen upper lip; chest tightness, headache and general body aches.  She called in sick for that day's night shift.  No treatment.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Lymph node pain, Lymphadenopathy, Vaccine positive rechallenge
Clinical narrative: Headache and large, painful lump under left clavicle. Headache relieved with Motrin, did not return. Lump still swollen and painful after 4 days. Previously experienced lump after flu shot in 2012. Previously diagnosed by MD as ganglion cyst.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Blood glucose normal, Cold sweat, Dizziness, Headache
Clinical narrative: Woke up several hours after vaccine, with severe shakes, cold sweats, back and head pain and presyncope.  Back to sleep, woke up again with same feeling of fainting. "Almost went to the ED."
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoglycaemia, Presyncope, Tremor
Clinical narrative: Woke up several hours after vaccine, with severe shakes, cold sweats, back and head pain and presyncope.  Back to sleep, woke up again with same feeling of fainting. "Almost went to the ED."
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Electromyogram, Exposure during pregnancy, Hypoaesthesia, Lumbar puncture
Clinical narrative: Tingling, numbness and loss of strength involving fingers and toes. Tremors around eyes.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Tremor
Clinical narrative: Tingling, numbness and loss of strength involving fingers and toes. Tremors around eyes.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Hyperhidrosis, Nausea, Throat tightness, Tremor
Clinical narrative: SOB, nausea, sweats, shakes, sensation of throat closing.  She came to the Employee Health office 90 mins after onset for evaluation; by this time she was almost completely normal.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Skin warm and red at site of administration. Approx. 3 inch site of redness and warmth noted. Teammate describes "burning" sensation at site. "I feel like the needle is still in there, stabbing me."
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Dizziness, Syncope, Vomiting
Clinical narrative: Fainting, vomiting, lightheaded, seizure.
Age: 40.0
Sex: F
Vaccine: FLUC3
Symptoms: Chills, Hyperhidrosis, Pyrexia
Clinical narrative: Severe chills, with fever. Lasted about 4 hours and broke with sweating.
Age: 56.0
Sex: M
Vaccine: FLUX
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: High fever 8 hours; low fever 22 hours; aches 30 hours; headache 30 hours; fatigue 36 hours.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Local swelling, Neck pain, Pain in extremity
Clinical narrative: Severe pain in L. arm, up to neck and shoulder with swelling, lasting two days.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from an unknown reporter, via company representative, refers to a two patients of unknown age and gender. On an unknown date the patients were vaccinated with a doses of ZOSTAVAX (dose, strength, route and sire of administration not reported). On an unknown date the patients developed rash after receiving the ZOSTAVAX. The outcome was unknown. The relatedness between ZOSTAVAX and rash was not reported. Additional information has been requested.
Age: 0.28
Sex: M
Vaccine: MMR, PPV, TDAP
Symptoms: Autism, Crying, Fine motor delay, Grunting, Pyrexia
Clinical narrative: Fever, grunting, rocking, loss of fine motor skills, inconsolable crying.
Age: 0.28
Sex: M
Vaccine: MMR, PPV, TDAP
Symptoms: Stereotypy
Clinical narrative: Fever, grunting, rocking, loss of fine motor skills, inconsolable crying.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Limb discomfort, Malaise
Clinical narrative: Prominent redness at injection site, itching and localized discomfort throughout RT upper extremity. Overall feeling of malaise with nausea and vomiting for four days.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: Prominent redness at injection site, itching and localized discomfort throughout RT upper extremity. Overall feeling of malaise with nausea and vomiting for four days.
Age: 1.89
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 23 month old patient of unknown gender. On 20-NOV-2011, the patient was vaccinated with the third dose of RECOMBIVAX HB (lot #, expiration date, dose, route and indication not reported). On 08-OCT-2013, the patient was vaccinated with the third dose of RECOMBIVAX HB (lot #, expiration date, route and indication not reported) 1.0 ml instead of the intended 0.5 ml dose. No adverse effect was reported. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an unknown reporter refers to a patient of unknown age. On an unknown date the patient was vaccinated with MMR II (lot # H018949, expiry date: 18-OCT-2014, therapy type, dose, route were unknown), which was improperly stored vaccine. The outcome of the event was unknown. This is one of several reports that received from the same source. Additional information is not expected.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Local reaction, Skin warm, Swelling, Tenderness
Clinical narrative: Client's wife (employee) reported today over 6 weeks after flu vaccine given, that he had developed local reaction of redness, swelling and tenderness - she reports that his arm was hot to touch. He had no fever or other systemic symptoms, fluid accumulated at the site even totally absorbed he had no treatment and did not see the dr about it - today he still has some redness and discomfort at the site.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient came back after a month stating the injection site arm is still painful and cannot lift it up as before. He states it has very limited movement.
Age: 1.73
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray normal, Crying, Febrile convulsion, Pyrexia, Rash
Clinical narrative: Febrile seizure and temp 105.9 10/31/13. Pt had fever x 3 days then rash ? roseola. 10-31-13 Mom calling states patient received flu shot yesterday around 12 noon. By 6 p.m. child had temp of 101.3 TYLENOL given, by 10 p.m. temp was 105.3 mom gave MOTRIN and tepid bath. Temp went down to 101. At 2 a.m. child woke crying and temp was 103, TYLENOL given. By 5:30 temp was 103.5, MOTRIN given and temp climbed to 105.9. At 9 a.m. temp still 104. Advised mom to give TYLENOL and another tepid bath. Per supervisor ok to put patient in this a.m. for appointment. 10:39 Mom calling from ambulance stated child had seizure and is on her way to the hospital so wont make appointment. Appointment canceled and mom given reassurance. Dr given information. 10-31-13 Mom calling back. The ER did CXR and UA both were normal. Sent her home on TYLENOL or MOTRIN. Mom informed dr would like to see for follow up next week and discuss maybe getting EEG for the seizures. Mom verbalized understanding back. 10-31-13 4:45 Mom questions doses and how to give the TYLENOL and MOTRIN. I had mom get a paper and write on it the time and the med. TYLENOL and MOTRIN to be alternated every 4 hours. To give tepid baths as needed and sips of cool fluids. Mom verbalized understanding. 11-1-13 Mom calling back with update after 10-31-13 ER visit for febrile seizure. States pt temp at 102.1 1hr after TYLENOL. Taking fluids, and playing. Mom states pt "never shows when she is sick". Taking >10oz fluids. Doing tepid baths, alternating TYLENOL/MOTRIN, and cool drinks. Mom states pt offered TYLENOL suppository at ER to try to bring fever down quicker. Questions if ok to try these instead of the oral? recs? F?U appointment scheduled with nurse in 11-4-13. Ok with suppository, fan, or popsicles, slushies, or ice cream. Left message to call back. Asked late night nurse to call and try to get ahold of mom regarding above. I tried both numbers given and had to leave a detailed message on one Advised if has more questions(since can't contact us) call the after hours service if needed.
Age: 1.73
Sex: F
Vaccine: FLU3
Symptoms: Urine analysis normal
Clinical narrative: Febrile seizure and temp 105.9 10/31/13. Pt had fever x 3 days then rash ? roseola. 10-31-13 Mom calling states patient received flu shot yesterday around 12 noon. By 6 p.m. child had temp of 101.3 TYLENOL given, by 10 p.m. temp was 105.3 mom gave MOTRIN and tepid bath. Temp went down to 101. At 2 a.m. child woke crying and temp was 103, TYLENOL given. By 5:30 temp was 103.5, MOTRIN given and temp climbed to 105.9. At 9 a.m. temp still 104. Advised mom to give TYLENOL and another tepid bath. Per supervisor ok to put patient in this a.m. for appointment. 10:39 Mom calling from ambulance stated child had seizure and is on her way to the hospital so wont make appointment. Appointment canceled and mom given reassurance. Dr given information. 10-31-13 Mom calling back. The ER did CXR and UA both were normal. Sent her home on TYLENOL or MOTRIN. Mom informed dr would like to see for follow up next week and discuss maybe getting EEG for the seizures. Mom verbalized understanding back. 10-31-13 4:45 Mom questions doses and how to give the TYLENOL and MOTRIN. I had mom get a paper and write on it the time and the med. TYLENOL and MOTRIN to be alternated every 4 hours. To give tepid baths as needed and sips of cool fluids. Mom verbalized understanding. 11-1-13 Mom calling back with update after 10-31-13 ER visit for febrile seizure. States pt temp at 102.1 1hr after TYLENOL. Taking fluids, and playing. Mom states pt "never shows when she is sick". Taking >10oz fluids. Doing tepid baths, alternating TYLENOL/MOTRIN, and cool drinks. Mom states pt offered TYLENOL suppository at ER to try to bring fever down quicker. Questions if ok to try these instead of the oral? recs? F?U appointment scheduled with nurse in 11-4-13. Ok with suppository, fan, or popsicles, slushies, or ice cream. Left message to call back. Asked late night nurse to call and try to get ahold of mom regarding above. I tried both numbers given and had to leave a detailed message on one Advised if has more questions(since can't contact us) call the after hours service if needed.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Mobility decreased, Oedema, Skin warm
Clinical narrative: Pt received PNA vaccine 11/05/13 at 5:20 pm. Two hours later developed swelling, redness and warmth. Presented to practice on 11/06/13 at 11 am with area 21 cm x 12 cm of erythema, edema and warmth. Unable to move arm. Initially started on abx for concern for cellulitis, but then discontinued on 11-07-13.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Swelling
Clinical narrative: Pt received PNA vaccine 11/05/13 at 5:20 pm. Two hours later developed swelling, redness and warmth. Presented to practice on 11/06/13 at 11 am with area 21 cm x 12 cm of erythema, edema and warmth. Unable to move arm. Initially started on abx for concern for cellulitis, but then discontinued on 11-07-13.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Productive cough, Pulmonary congestion, Sinus congestion
Clinical narrative: Developed a productive cough, chills (temp not taken but had what was described as severe chills; congestion - sinus - chest - took MUCINEX.
Age: 59.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 8 cm red, raised warm area at injection site.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site erythema, Injection site warmth, Wheezing
Clinical narrative: Redness and warmness on site of vaccination shape of fluoride 6-8 inches, tired, was lifting, and wheezing a lot after vaccination. Pt feeling better 11/7/13.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphonia, Throat irritation, Urticaria
Clinical narrative: Flu shot 10-31-13, woke next day with hives all over body. Scratchy throat, hoarse voice.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Vaccination site pain
Clinical narrative: Patient states right arm is painful to touch at vaccine site and has continued pain with movement of arm in any direction.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Patient reports headache, high fever, chills 4 days after vaccination. Resolved in 12 hrs. 4 days after 1st episode reported same symptoms with less severity.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Pt seemed Tdap, MCV4, Gardasil on 8/15/13. 1 week later pt developed urticaria. Seen for 2nd episode of urticaria on 9/1/13. treated with PO steroids.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from the consumers mother refers to a male patient of unknown age. Medical history and drug reactions allergies were not reported. On an unspecified date in 2011, the patient was vaccinated with GARDASIL, first dose (lot, dose and route not reported). In July 2012, the patient was vaccinated with GARDASIL, second dose (lot, dose and route not reported). Concomitant medication was not reported. No adverse effects reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, No adverse event
Clinical narrative: Information has been received from a physician for HPV, a Pregnancy Registry product, concerning a 15 year old female patient who on 08-JUL-2011 was vaccinated with a dose of HPV (Lot number 0886D) (not ad valid HPV vaccine lot number), when they did a urine pregnancy test which came back positive. It was reported that the patient last menstrual period (LMP) was last month in June 2011 so they determined that the patient was less than eight weeks pregnant. Her delivery date (EDD) was approximately on 07-MAR-2012. No adverse events were reported. Follow up information was received from the reporting physician. The physician stated that the patient was in a foster home and was unsure if she was going to keep the pregnancy. The patient then moved back with her mother but physician was unable to contact the patient after her move. The physician reported that this patient was lost to follow up. Additional information is not expected.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, redness, swelling at site of Influenza vaccine injection, pain 8/10 28 days after injection. Refer to PCP for followup.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold, Pain, Pyrexia
Clinical narrative: Received shot about 1:00 PM and by 3:00 PM started hurting all over and later started having fever and freezing. I was in horrible pain all over all night. Was better about 9:00 AM or so.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Pain, Pyrexia, Sinus congestion
Clinical narrative: Received vaccine 10/21/13 at 14:00 2:00 PM. 10/23/13 0200 AM, suddenly developed low grade fever, body aches, chest heaviness, head congestion. Symptoms gone after 24 hours.
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dry throat, Dyspnoea, Exposure during pregnancy, Foetal disorder
Clinical narrative: Initial report was received on 01October 2013 from a consumer who is also the patient. A pregnant female patient (date of birth not reported) with a history of allergies to penicillin, sulfa, shellfish and iodine had received at 10 AM on 01 October 2013 at 30 weeks gestation a dose of FLUZONE Quadrivalent (lot number, route and site of administration not reported) and after vaccination while driving to work at 1130 AM on 01 October 2013, experienced difficulty breathing, throat feeling dry and coughing. The reporter also stated that her baby's heart rate was elevated (captured in case 2013SA100444). The patient was treated in the emergency room with prednisone, BENADRYL and oxygen. The patient stated that about one hour later the symptoms cleared. The patient continued on prednisone and BENADRYL for three days. The outcome was reported as not recovered. Documents held by sender: none. After internal review on 04-NOV-2013, a significant corrective version with date of the previous version i.e. 02-OCT-2013 was created to change the suspect product from Influenza quadrival thiomersal free vaccine (manufacturer Sanofi Pasteur SA) to Influenza Quadrival A-B vaccine (manufacturer Sanofi Pasteur Inc.).
Age: 0.61
Sex: M
Vaccine: FLU3
Symptoms: C-reactive protein normal, Full blood count abnormal, Injection site movement impairment, Injection site pain, Injection site reaction
Clinical narrative: Patient developed pain in left leg and wouldn't move it on 10/28/13 (7 days after receiving flu vaccine in the left thigh). MRI showed diffuse myositis of the left quadriceps. Pt did have adenovirus diagnosed on 10/15/13 after febrile seizure 10/14/13 with full septic w/u.
Age: 0.61
Sex: M
Vaccine: FLU3
Symptoms: Myositis, Nuclear magnetic resonance imaging abnormal, White blood cell count increased, X-ray limb normal, X-ray normal
Clinical narrative: Patient developed pain in left leg and wouldn't move it on 10/28/13 (7 days after receiving flu vaccine in the left thigh). MRI showed diffuse myositis of the left quadriceps. Pt did have adenovirus diagnosed on 10/15/13 after febrile seizure 10/14/13 with full septic w/u.
Age: 12.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, warm to touch, hard (L) upper arm.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Feeling cold, Pyrexia, Tremor
Clinical narrative: Approximately 7 hours after vaccination, had uncontrollable shaking (cold), dizzy, weak, fever.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Pt. c/o lightheadedness 20 min after administration VS stable BP 108/72 HR 82. Pt instructed to drink H2O and eat food. No s/sx of anaphylaxis.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: When the patient woke up on Friday morning (10/25/13) she found her skin near the injection site reddish but not raised. It didn't hurt or itchy but she felt hot in that area. The patch was about 2.5 inch diameter to the left of the injection site (when facing patient) about an inch apart from the site.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Employee received flu vaccine on 10/8/13 about 3-4 PM into left deltoid and then that night began experiencing left deltoid muscle ache that traveled down to elbow anteriorly. ALEVE relieves discomfort. Hand grasps equal/strong - some limitation with range of motion but minimal.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling
Clinical narrative: Patient received FLUZONE HIGH DOSE 10/25/13 and came on 10/31/13 with complaints of itching around vaccination site and redness around site, slight swelling.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient experienced pain upon injection which got worse within few minutes of vaccine administration. Patient as to take Aleve as well use cold pack.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia, Tremor
Clinical narrative: Pt states, "within 20 min of vaccine, numbness and tingling in legs and arms. Uncontrollable shaking in arm and legs - worse in legs. Felt like she was going to fall. Sat down 15 min. Took a nap. When up 5-6 hrs after vaccine, sx decreases. Gone by next day."
Age: 61.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Face oedema, Oedema peripheral, Paraesthesia
Clinical narrative: Pt experiencing facial edema, hand edema, and "tingling" over body.
Age: 61.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Angioedema, Hypersensitivity, Urticaria
Clinical narrative: Pt experiencing facial edema, hand edema, and "tingling" over body.
Age: 0.38
Sex: F
Vaccine: DTAP, HIBV, PNC13, RV1
Symptoms: Incorrect route of drug administration
Clinical narrative: Medical assistant drew oral dose Rotarix up in a syringe. Administered vaccine IM injection Right thigh. When she started documenting vaccines, realized error and brought to attention of RN and MD. See #13, letter D.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain, Cough, Dyspnoea, Pharyngitis, Sneezing
Clinical narrative: Within 48 hrs of receiving vaccine child had abdominal pain. On 11-4-13 child had white pus in his throat and had problems breathing. Child has also been coughing and sneezing a lot.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction
Clinical narrative: Pt reports sharp pain on administration w/ no range of motion and continued pain since injection. No local site reaction. Two weeks and pain still constant. Claimed "tented skin" upon w/d of needle.