chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Nasal congestion, Nausea, Ocular hyperaemia, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: Felt like lumps developed in throat that hurt, started wheezing, and slight nasal congestion.  2 hours after that my eyes swelled, had green discharge from them, throat continued to hurt and congestion worsened.  Felt extremely fatigues, went to bed and slept for 3 hours, woke up with eyes partially closed and red, sore throat went away and had slight congestion.  Went back to bed and slept for another 7 hours.  Got up and went to work.  Starting feeling dizzy, stomach got upset 2 hours afterwards, started vomiting.  There was only 1 incident of vomiting.  Drove back home and slept another 3 hours.  Felt queasy the rest of the day.  Went to bed and felt much better on Sunday morning as I'm typing this.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Sensation of foreign body, Vomiting, Wheezing
Clinical narrative: Felt like lumps developed in throat that hurt, started wheezing, and slight nasal congestion.  2 hours after that my eyes swelled, had green discharge from them, throat continued to hurt and congestion worsened.  Felt extremely fatigues, went to bed and slept for 3 hours, woke up with eyes partially closed and red, sore throat went away and had slight congestion.  Went back to bed and slept for another 7 hours.  Got up and went to work.  Starting feeling dizzy, stomach got upset 2 hours afterwards, started vomiting.  There was only 1 incident of vomiting.  Drove back home and slept another 3 hours.  Felt queasy the rest of the day.  Went to bed and felt much better on Sunday morning as I'm typing this.
Age: 49.0
Sex: F
Vaccine: FLUX, PER, TD
Symptoms: Asthenia, Chills, Cough, Dysphonia, Headache
Clinical narrative: Hoarseness, cough, systolic blood pressure went up from 102 to 147 in just 2.5 hrs, shiver with fever 103F, weakness, headache, muscle ache.
Age: 49.0
Sex: F
Vaccine: FLUX, PER, TD
Symptoms: Myalgia, Pyrexia
Clinical narrative: Hoarseness, cough, systolic blood pressure went up from 102 to 147 in just 2.5 hrs, shiver with fever 103F, weakness, headache, muscle ache.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Initially had redness, itching & soreness at injection site. About 24 hrs later had increased redness & swelling. Also had chills, felt achy & had a headache. These symptoms continued for about 48 hrs. Took Ibuprofen 600mg BID & topical Benadryl. Perspired last night, no headache or chills today. Arm at injection site less red but still sore to touch.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Initially had redness, itching & soreness at injection site. About 24 hrs later had increased redness & swelling. Also had chills, felt achy & had a headache. These symptoms continued for about 48 hrs. Took Ibuprofen 600mg BID & topical Benadryl. Perspired last night, no headache or chills today. Arm at injection site less red but still sore to touch.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Coordination abnormal, Gait disturbance, Hypoaesthesia
Clinical narrative: Child reported numbness in both feet that over time went up his legs.  After Dr apt in am he went back to school. He called from school reporting difficulty with coordination and walking. Took child to ER.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Extreme pain radiating down arm I to hand.  Pain conti use to date.  Injection was unusually painful during administration.  Injection was given very high  - on top on shoulder.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Oedema peripheral
Clinical narrative: Patient came back to pharmacy and claimed her left arm was swollen, then pulled up the sleeve on her blouse to show the swelling. Patient was directed to see a doctor due to severe erythema and edema in the extremity.  Pt had cellulitis.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Discomfort, Injection site pain, Myalgia, Paraesthesia
Clinical narrative: Unbearable left upper arm and shoulder muscle pain and shoulder joint pain. Inability to get comfortable, especially at night. Some tingling in thumb.  Have tried heat, ice packs, massage, alternating ibuprofen 800 and acetaminophen. Pain is going on 6th day and no signs of improvement.  Contacted administering pharmacist & primary physician on Day 4 who advised the above treatment and to 'wait'.  Will contact again on Day 8.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Nausea, Visual impairment
Clinical narrative: Patient reported onset of nausea near 5pm which got worse near 7pm, at which point she also reported seeing "white everywhere" (blank spots) and then she passed out for a VERY short time. She states she did not want to call 911 but she did take an aspirin around 8pm. She says since her condition did not improve, she went to bed and woke up at 7-7:30AM and felt fine.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Conjunctivitis, Cough, Dyspnoea, Pruritus
Clinical narrative: Conjunctivitis, difficulty in breathing with chest tightness and cough, itching.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Dizziness, Dry mouth, Headache, Hypertension
Clinical narrative: Anxiety; dry mouth; headache; light-headed; nausea; elevated blood pressure. Doctor visit, Atavan prescribed.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: Anxiety; dry mouth; headache; light-headed; nausea; elevated blood pressure. Doctor visit, Atavan prescribed.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching and hives on chest, stomach, back, upper arms and thighs.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Ultrasound scan normal, X-ray normal
Clinical narrative: Extreme pain in left shoulder where vaccination was administered. Limited mobility due to pain. Have been to oncology office, chiropractor and physical therapist and symptoms have not improved. Have been prescribed oxycodone for the pain. The pain continues.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Broke out in Hives next day.
Age: 16.0
Sex: F
Vaccine: HPVX
Symptoms: Asthenia, Dizziness, Headache, Pyrexia, Vomiting
Clinical narrative: Headache, vomiting, dizziness, fever 102, generalized weakness.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Chills, Feeling drunk, Gait disturbance, Nausea
Clinical narrative: Patient got home. Started to experience chills. The chills worsened to shuddering & felt like extremities drew in to body. Then felt nauseous. It subsided - so patient fell asleep and woke feeling like "drunk" - staggering & off balance. All symptoms subsided 24 hrs after vaccine. Physician seen day after vaccine 9:30am 10/12/12.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Patient got home. Started to experience chills. The chills worsened to shuddering & felt like extremities drew in to body. Then felt nauseous. It subsided - so patient fell asleep and woke feeling like "drunk" - staggering & off balance. All symptoms subsided 24 hrs after vaccine. Physician seen day after vaccine 9:30am 10/12/12.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Heart rate increased, Tachycardia
Clinical narrative: About 6 hrs after shot - temp 101.7 and 90 pulse - tachycardia. Pt went home - took Ibuprofen - woke up next morning - temp resolved - HR still elevated - rested several hrs later pt recovered.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Fatigue, Malaise, Oropharyngeal pain, Pyrexia
Clinical narrative: Administered flu shot 10/27/12 at 10 AM. After 20 mins, began to feel uneasy - at night felt increased fever - 100 degrees, tired, achy, sore throat, chills through night till about 10 AM 10/28/12 - still feel tired.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site swelling, Wheezing
Clinical narrative: Developed allergic reaction after receiving Flu vaccine at the site redness, swelling, itching. 85mm x 43mm LD. Mild wheezing.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 14 years old female patient. Pharmacist stated patient picked up GARDASIL (lot# was unknown) on 14-AUG-2012 and did not store it properly. Patient left the GARDASIL out at room temperature of 70F for more than 2 months. The patient was vaccinated with GARDASIL on 17-OCT-2012. That was the patient's first dose of GARDASIL. No adverse effects reported. Additional information is not expected.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Allergy to vaccine, Rash
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 18 years old male patient with no pertinent medical history. The patient was intramuscularly vaccinated with the second dose of 0.5 ml GARDASIL (lot # 671463/1359AA, Exp date 23-JUN-2014) in December 2011. There was no concomitant medications therapy. Then the patient developed a rash on an unknown date after his second dose and reported in July 2012 during his routine physical examination. Medical chart now noted "Allergic to GARDASIL". Reporter stated physician in the office did not intend to administer third dose. The patient did not sought medical attention. No lab diagnostics studies performed and no treatment was given for the event. The outcome was reported as recovered/resolved. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discolouration, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 58 years old female patient with hypertension, hypothyroid and drug allergy to penicillin. The patient was vaccinated with, 0.5 PNEUMOVAX 23 (lot # reported as 1947AA;exp 20-OCT-2013) intramuscular in left arm on 10-OCT-2012. No other co-suspects were reported. Concomitant medications included ergocalciferol, naproxen, VENTOLIN inhaler, levothyroxine sodium and omeprazole. The pharmacist reported client not had possible cellulitis. The injection site of left arm was black and swollen. Client was seen by her physician and treatment was sulfamethoxazole, BACTRIM. The patient had sought another medical attention by came into pharmacy yesterday (11-OCT-2012). Pharmacist stated they would be contacting client today (12-OCT-2012) to follow up with her. The outcome was reported as not recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, RV5
Symptoms: Constipation
Clinical narrative: Patient became chronically constipated. On the 2 next days after vaccination did 2 black bowel movements and nothing more for 10 subsequent days, until was given a suppository. Sometimes went 2 weeks without a bowel movement and only was able to have one after being inserted a suppository. The patient received the vaccines recommended at 4 months old (DTaP/DT/Td; Hib, IPV, PCV and Rotavirus) and is now 7 month old and keeps being constipated, only having a bowel movement after more than one week, and still needs to be helped with a suppository at times. Note it was a baby that was having numerous bowels movements per day until the date of vaccination.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, RV5
Symptoms: Abdominal X-ray, Abdominal distension, Constipation, Faeces discoloured, Ultrasound abdomen abnormal
Clinical narrative: Patient became chronically constipated. On the 2 next days after vaccination did 2 black bowel movements and nothing more for 10 subsequent days, until was given a suppository. Sometimes went 2 weeks without a bowel movement and only was able to have one after being inserted a suppository. The patient received the vaccines recommended at 4 months old (DTaP/DT/Td; Hib, IPV, PCV and Rotavirus) and is now 7 month old and keeps being constipated, only having a bowel movement after more than one week, and still needs to be helped with a suppository at times. Note it was a baby that was having numerous bowels movements per day until the date of vaccination.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, RV5
Symptoms: X-ray abnormal
Clinical narrative: Patient became chronically constipated. On the 2 next days after vaccination did 2 black bowel movements and nothing more for 10 subsequent days, until was given a suppository. Sometimes went 2 weeks without a bowel movement and only was able to have one after being inserted a suppository. The patient received the vaccines recommended at 4 months old (DTaP/DT/Td; Hib, IPV, PCV and Rotavirus) and is now 7 month old and keeps being constipated, only having a bowel movement after more than one week, and still needs to be helped with a suppository at times. Note it was a baby that was having numerous bowels movements per day until the date of vaccination.
Age: 13.0
Sex: F
Vaccine: DTAPH, VARCEL, VARCEL
Symptoms: Activities of daily living impaired, Injection site discomfort, Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: Information has been received from a mother of a 13 years old female with no reported medical history, who on 06-OCT-2012 received a dose of VARIVAX (Merck) (Lot H007704) in her arm (route and dose not specified). On 07-OCT-2012 the patient had developed and 5 inch by 3 inch wide welt on her arm at the injection site. She also developed a fever, felt dizzy and nauseous. The patient went to the emergency room but was not admitted. The patient also visited her physician twice. The patient was treated with antibiotics (not specified), BENADRYL and TYLENOL to treat her symptoms. The patient is recovering but continues to have a bump on her arm that feels like a rock. The reporter mentioned that the doctor "thinks this is a bad lot of VARIVAX (Merck)". The reporter states that she thinks the doctor has had other cases like the patients but did not have specifics. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: DTAPH, VARCEL, VARCEL
Symptoms: Injection site vesicles, Injection site warmth, Pyrexia, Urticaria
Clinical narrative: Information has been received from a mother of a 13 years old female with no reported medical history, who on 06-OCT-2012 received a dose of VARIVAX (Merck) (Lot H007704) in her arm (route and dose not specified). On 07-OCT-2012 the patient had developed and 5 inch by 3 inch wide welt on her arm at the injection site. She also developed a fever, felt dizzy and nauseous. The patient went to the emergency room but was not admitted. The patient also visited her physician twice. The patient was treated with antibiotics (not specified), BENADRYL and TYLENOL to treat her symptoms. The patient is recovering but continues to have a bump on her arm that feels like a rock. The reporter mentioned that the doctor "thinks this is a bad lot of VARIVAX (Merck)". The reporter states that she thinks the doctor has had other cases like the patients but did not have specifics. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: DTAPH, VARCEL, VARCEL
Symptoms: Dizziness, Induration, Injection site urticaria, Nausea, Pyrexia
Clinical narrative: Information has been received from a mother of a 13 years old female with no reported medical history, who on 06-OCT-2012 received a dose of VARIVAX (Merck) (Lot H007704) in her arm (route and dose not specified). On 07-OCT-2012 the patient had developed and 5 inch by 3 inch wide welt on her arm at the injection site. She also developed a fever, felt dizzy and nauseous. The patient went to the emergency room but was not admitted. The patient also visited her physician twice. The patient was treated with antibiotics (not specified), BENADRYL and TYLENOL to treat her symptoms. The patient is recovering but continues to have a bump on her arm that feels like a rock. The reporter mentioned that the doctor "thinks this is a bad lot of VARIVAX (Merck)". The reporter states that she thinks the doctor has had other cases like the patients but did not have specifics. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13, DTAPIPVHIB, MMR, PNC13, DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Aggression, Blood test normal, Computerised tomogram normal, Dyskinesia, Impulsive behaviour
Clinical narrative: This spontaneous report as received from a consumer refers to her 4 years old son. The patient was vaccinated with the first dose of VARIVAX (Merck) (lot number was unspecified) on 14-OCT-2008 and the second dose of VARIVAX (Merck) (lot number was unspecified, product circular number 9904705) on 26-SEP-2012. Secondary suspect therapy included MMR II (lot number 0218AE) on 26-SEP-2012. Concomitant therapy included PREVNAR 13 and PENTACEL on 26-SEP_2012. In the end of June or beginning of July 2010 the patient developed a case of chicken pox a day after his older brother received the second dose of VARIVAX (Merck). The case chicken pox the patient developed as a rash covering his body (head to toe) and the chicken pox rash was reported to be resolved after about 16 days (date unspecified). The consumer reported that she contacted the CDC about transmission (date of contact with the CDC was unspecified). The patient received four vaccinations on 26-SEP-2012, the second dose of VARIVAX (Merck) (lot number was unspecified, product circular number 9904705), MMR II (lot number 0218AE), PREVNAR 13) and PENTACEL. No concomitant medications were reported. Shortly after (time frame development unspecified) starting spitting, would blurt out "stop", developed weird leg movements, twitching and general weird abnormal behavior. On 09-OCT-2012 the patient was taken to the emergency room and was diagnosed with tics, a computerized axial tomography (CAT) scan was performed on 09-OCT-2012 which was negative. The reporter took the patient to physician's office on 11-OCT-2012 and the physician drew blood for an unspecified blood test. During the office visit on 11-OCT-2012 the physician diagnosed with tics that the patient had as petit mal seizures. The outcome of adverse events was reported as not recovered. Upon internal review, petit mal epilepsy was considered to be a medically significant event. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13, DTAPIPVHIB, MMR, PNC13, DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Obsessive-compulsive disorder, Posture abnormal, Throat irritation, Tic, Tourette's disorder
Clinical narrative: This spontaneous report as received from a consumer refers to her 4 years old son. The patient was vaccinated with the first dose of VARIVAX (Merck) (lot number was unspecified) on 14-OCT-2008 and the second dose of VARIVAX (Merck) (lot number was unspecified, product circular number 9904705) on 26-SEP-2012. Secondary suspect therapy included MMR II (lot number 0218AE) on 26-SEP-2012. Concomitant therapy included PREVNAR 13 and PENTACEL on 26-SEP_2012. In the end of June or beginning of July 2010 the patient developed a case of chicken pox a day after his older brother received the second dose of VARIVAX (Merck). The case chicken pox the patient developed as a rash covering his body (head to toe) and the chicken pox rash was reported to be resolved after about 16 days (date unspecified). The consumer reported that she contacted the CDC about transmission (date of contact with the CDC was unspecified). The patient received four vaccinations on 26-SEP-2012, the second dose of VARIVAX (Merck) (lot number was unspecified, product circular number 9904705), MMR II (lot number 0218AE), PREVNAR 13) and PENTACEL. No concomitant medications were reported. Shortly after (time frame development unspecified) starting spitting, would blurt out "stop", developed weird leg movements, twitching and general weird abnormal behavior. On 09-OCT-2012 the patient was taken to the emergency room and was diagnosed with tics, a computerized axial tomography (CAT) scan was performed on 09-OCT-2012 which was negative. The reporter took the patient to physician's office on 11-OCT-2012 and the physician drew blood for an unspecified blood test. During the office visit on 11-OCT-2012 the physician diagnosed with tics that the patient had as petit mal seizures. The outcome of adverse events was reported as not recovered. Upon internal review, petit mal epilepsy was considered to be a medically significant event. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13, DTAPIPVHIB, MMR, PNC13, DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Speech disorder, Tic, Tourette's disorder
Clinical narrative: This spontaneous report as received from a consumer refers to her 4 years old son. The patient was vaccinated with the first dose of VARIVAX (Merck) (lot number was unspecified) on 14-OCT-2008 and the second dose of VARIVAX (Merck) (lot number was unspecified, product circular number 9904705) on 26-SEP-2012. Secondary suspect therapy included MMR II (lot number 0218AE) on 26-SEP-2012. Concomitant therapy included PREVNAR 13 and PENTACEL on 26-SEP_2012. In the end of June or beginning of July 2010 the patient developed a case of chicken pox a day after his older brother received the second dose of VARIVAX (Merck). The case chicken pox the patient developed as a rash covering his body (head to toe) and the chicken pox rash was reported to be resolved after about 16 days (date unspecified). The consumer reported that she contacted the CDC about transmission (date of contact with the CDC was unspecified). The patient received four vaccinations on 26-SEP-2012, the second dose of VARIVAX (Merck) (lot number was unspecified, product circular number 9904705), MMR II (lot number 0218AE), PREVNAR 13) and PENTACEL. No concomitant medications were reported. Shortly after (time frame development unspecified) starting spitting, would blurt out "stop", developed weird leg movements, twitching and general weird abnormal behavior. On 09-OCT-2012 the patient was taken to the emergency room and was diagnosed with tics, a computerized axial tomography (CAT) scan was performed on 09-OCT-2012 which was negative. The reporter took the patient to physician's office on 11-OCT-2012 and the physician drew blood for an unspecified blood test. During the office visit on 11-OCT-2012 the physician diagnosed with tics that the patient had as petit mal seizures. The outcome of adverse events was reported as not recovered. Upon internal review, petit mal epilepsy was considered to be a medically significant event. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13, DTAPIPVHIB, MMR, PNC13, DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Abnormal behaviour, Blood test, Computerised tomogram normal, Dyskinesia, Muscle twitching
Clinical narrative: This spontaneous report as received from a consumer refers to her 4 years old son. The patient was vaccinated with the first dose of VARIVAX (Merck) (lot number was unspecified) on 14-OCT-2008 and the second dose of VARIVAX (Merck) (lot number was unspecified, product circular number 9904705) on 26-SEP-2012. Secondary suspect therapy included MMR II (lot number 0218AE) on 26-SEP-2012. Concomitant therapy included PREVNAR 13 and PENTACEL on 26-SEP_2012. In the end of June or beginning of July 2010 the patient developed a case of chicken pox a day after his older brother received the second dose of VARIVAX (Merck). The case chicken pox the patient developed as a rash covering his body (head to toe) and the chicken pox rash was reported to be resolved after about 16 days (date unspecified). The consumer reported that she contacted the CDC about transmission (date of contact with the CDC was unspecified). The patient received four vaccinations on 26-SEP-2012, the second dose of VARIVAX (Merck) (lot number was unspecified, product circular number 9904705), MMR II (lot number 0218AE), PREVNAR 13) and PENTACEL. No concomitant medications were reported. Shortly after (time frame development unspecified) starting spitting, would blurt out "stop", developed weird leg movements, twitching and general weird abnormal behavior. On 09-OCT-2012 the patient was taken to the emergency room and was diagnosed with tics, a computerized axial tomography (CAT) scan was performed on 09-OCT-2012 which was negative. The reporter took the patient to physician's office on 11-OCT-2012 and the physician drew blood for an unspecified blood test. During the office visit on 11-OCT-2012 the physician diagnosed with tics that the patient had as petit mal seizures. The outcome of adverse events was reported as not recovered. Upon internal review, petit mal epilepsy was considered to be a medically significant event. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13, DTAPIPVHIB, MMR, PNC13, DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Petit mal epilepsy, Rash generalised, Secondary transmission, Tic, Varicella
Clinical narrative: This spontaneous report as received from a consumer refers to her 4 years old son. The patient was vaccinated with the first dose of VARIVAX (Merck) (lot number was unspecified) on 14-OCT-2008 and the second dose of VARIVAX (Merck) (lot number was unspecified, product circular number 9904705) on 26-SEP-2012. Secondary suspect therapy included MMR II (lot number 0218AE) on 26-SEP-2012. Concomitant therapy included PREVNAR 13 and PENTACEL on 26-SEP_2012. In the end of June or beginning of July 2010 the patient developed a case of chicken pox a day after his older brother received the second dose of VARIVAX (Merck). The case chicken pox the patient developed as a rash covering his body (head to toe) and the chicken pox rash was reported to be resolved after about 16 days (date unspecified). The consumer reported that she contacted the CDC about transmission (date of contact with the CDC was unspecified). The patient received four vaccinations on 26-SEP-2012, the second dose of VARIVAX (Merck) (lot number was unspecified, product circular number 9904705), MMR II (lot number 0218AE), PREVNAR 13) and PENTACEL. No concomitant medications were reported. Shortly after (time frame development unspecified) starting spitting, would blurt out "stop", developed weird leg movements, twitching and general weird abnormal behavior. On 09-OCT-2012 the patient was taken to the emergency room and was diagnosed with tics, a computerized axial tomography (CAT) scan was performed on 09-OCT-2012 which was negative. The reporter took the patient to physician's office on 11-OCT-2012 and the physician drew blood for an unspecified blood test. During the office visit on 11-OCT-2012 the physician diagnosed with tics that the patient had as petit mal seizures. The outcome of adverse events was reported as not recovered. Upon internal review, petit mal epilepsy was considered to be a medically significant event. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Neuralgia, Pain in extremity, Paraesthesia, X-ray
Clinical narrative: Right arm (injection to right deltoid) started to hurt (pain 9/10) directly after injection for several hours. Continue to have numbness and sharp pains radiating from back of shoulder to thumb up until 10/23/12. Currently I have limited ROM and limited weight bearing in my right arm with sharp pain in my shoulder area.
Age: 27.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Joint range of motion decreased
Clinical narrative: Right arm (injection to right deltoid) started to hurt (pain 9/10) directly after injection for several hours. Continue to have numbness and sharp pains radiating from back of shoulder to thumb up until 10/23/12. Currently I have limited ROM and limited weight bearing in my right arm with sharp pain in my shoulder area.
Age: 27.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal pain, Pain in extremity, Weight bearing difficulty, X-ray
Clinical narrative: Right arm (injection to right deltoid) started to hurt (pain 9/10) directly after injection for several hours. Continue to have numbness and sharp pains radiating from back of shoulder to thumb up until 10/23/12. Currently I have limited ROM and limited weight bearing in my right arm with sharp pain in my shoulder area.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Activities of daily living impaired, Blood test, Culture, Herpes zoster, Rash
Clinical narrative: Patient called clinic to report rash on her forehead, after receiving Zostavax vaccine less than 24 hours prior. On-call doctor advised patient to come in for evaluation. Patient assessed by MD, who believed it was likely shingles. No blisters or pain at the site. MD noticed some rash at the base of her hairline also. Labs sent for IgM and pathology for swab of rash. Unfortunately, the MD did not specify which IGM she wanted. Result for IGM was 106. Swab was ordered incorrectly with the source as "stool". Lab did not call for clarification, although swab was sent. Result never sent to patient's chart. Patient seen on 10/22/12 by PCP for follow up. Rash improved.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous
Clinical narrative: Patient called clinic to report rash on her forehead, after receiving Zostavax vaccine less than 24 hours prior. On-call doctor advised patient to come in for evaluation. Patient assessed by MD, who believed it was likely shingles. No blisters or pain at the site. MD noticed some rash at the base of her hairline also. Labs sent for IgM and pathology for swab of rash. Unfortunately, the MD did not specify which IGM she wanted. Result for IGM was 106. Swab was ordered incorrectly with the source as "stool". Lab did not call for clarification, although swab was sent. Result never sent to patient's chart. Patient seen on 10/22/12 by PCP for follow up. Rash improved.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood immunoglobulin M, Culture, Herpes zoster, Rash
Clinical narrative: Patient called clinic to report rash on her forehead, after receiving Zostavax vaccine less than 24 hours prior. On-call doctor advised patient to come in for evaluation. Patient assessed by MD, who believed it was likely shingles. No blisters or pain at the site. MD noticed some rash at the base of her hairline also. Labs sent for IgM and pathology for swab of rash. Unfortunately, the MD did not specify which IGM she wanted. Result for IGM was 106. Swab was ordered incorrectly with the source as "stool". Lab did not call for clarification, although swab was sent. Result never sent to patient's chart. Patient seen on 10/22/12 by PCP for follow up. Rash improved.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Cellulitis, Erythema, Induration, Injection site erythema
Clinical narrative: Had a Zostavax vaccine SQ.  The site of injection developed into a large area of inflamation over the following 3 days.  The inflammation spread down to her elbow.  Patient went to her doctor's office following our advise to her.  The reaction measured 23 X 20 cm at its worst time.  She took Benadryl and ibuprofen but the reaction has started to resolve and does not need to take any more.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Jaundice, Swelling
Clinical narrative: Had a Zostavax vaccine SQ.  The site of injection developed into a large area of inflamation over the following 3 days.  The inflammation spread down to her elbow.  Patient went to her doctor's office following our advise to her.  The reaction measured 23 X 20 cm at its worst time.  She took Benadryl and ibuprofen but the reaction has started to resolve and does not need to take any more.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site inflammation
Clinical narrative: Had a Zostavax vaccine SQ.  The site of injection developed into a large area of inflamation over the following 3 days.  The inflammation spread down to her elbow.  Patient went to her doctor's office following our advise to her.  The reaction measured 23 X 20 cm at its worst time.  She took Benadryl and ibuprofen but the reaction has started to resolve and does not need to take any more.
Age: 57.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Abdominal distension, Hypoaesthesia, Hypoaesthesia oral, Pharyngeal oedema, Swelling
Clinical narrative: C/O tongue thickness sensation and intermittent numbness to forehead, hands, feet, starting approximately 4 hours after injection, all symptoms completely resolved within 24 hours per patient. No fever, no rash, no myalgias.
Age: 57.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Hypoaesthesia, Tongue disorder
Clinical narrative: C/O tongue thickness sensation and intermittent numbness to forehead, hands, feet, starting approximately 4 hours after injection, all symptoms completely resolved within 24 hours per patient. No fever, no rash, no myalgias.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Asthenia, Back pain, Chills, Dizziness
Clinical narrative: Extreme weakness, tiredness, fatigue, severe low back pain, fever, body aches, chills, headaches, lightheaded, near fainting, tachycardia, diaphoresis, tingling in feet, nausea. Symptoms began on Oct 5th and have been progressively worsened. Went to my PCP who ordered CBC, cmet, UA, sed rate and prescribed a Medrol dose pak and Levaquin prophylactically. All labs were normal. As of today I am still sick with all of the above symptoms despite finishing the medications. I have missed several days of work this past week due to nearly passing out at work from these symptoms.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Exercise test normal, Fatigue, Full blood count normal, Headache, Hyperhidrosis
Clinical narrative: Extreme weakness, tiredness, fatigue, severe low back pain, fever, body aches, chills, headaches, lightheaded, near fainting, tachycardia, diaphoresis, tingling in feet, nausea. Symptoms began on Oct 5th and have been progressively worsened. Went to my PCP who ordered CBC, cmet, UA, sed rate and prescribed a Medrol dose pak and Levaquin prophylactically. All labs were normal. As of today I am still sick with all of the above symptoms despite finishing the medications. I have missed several days of work this past week due to nearly passing out at work from these symptoms.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Nausea, Pain, Paraesthesia, Presyncope
Clinical narrative: Extreme weakness, tiredness, fatigue, severe low back pain, fever, body aches, chills, headaches, lightheaded, near fainting, tachycardia, diaphoresis, tingling in feet, nausea. Symptoms began on Oct 5th and have been progressively worsened. Went to my PCP who ordered CBC, cmet, UA, sed rate and prescribed a Medrol dose pak and Levaquin prophylactically. All labs were normal. As of today I am still sick with all of the above symptoms despite finishing the medications. I have missed several days of work this past week due to nearly passing out at work from these symptoms.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Pulmonary function challenge test normal, Pyrexia, Red blood cell sedimentation rate normal, Tachycardia, Urine analysis normal
Clinical narrative: Extreme weakness, tiredness, fatigue, severe low back pain, fever, body aches, chills, headaches, lightheaded, near fainting, tachycardia, diaphoresis, tingling in feet, nausea. Symptoms began on Oct 5th and have been progressively worsened. Went to my PCP who ordered CBC, cmet, UA, sed rate and prescribed a Medrol dose pak and Levaquin prophylactically. All labs were normal. As of today I am still sick with all of the above symptoms despite finishing the medications. I have missed several days of work this past week due to nearly passing out at work from these symptoms.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Malaise, Musculoskeletal pain, Nasal congestion, Pain
Clinical narrative: Shoulder aching, Became sick. Stuffy nose achy with chills.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Ligament sprain, Pain
Clinical narrative: Lower back Sprain. Rest for an hour. Pain subdued but still painfully until this time of reporting (1 and half day after onset). I can bend my back a little bit (40%). Took Tylenol.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills, fever, aches-lasted throughout the day and into that evening. Took ibuprofen all day long.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Burning sensation, Erythema, Feeling hot, Rash macular
Clinical narrative: This spontaneous report was received from a 67 years old female patient reporting on herself with high cholesterol and age-related macular degeneration (AMD), allergy to morphine, codeine and "many others" (unspecified) who on 01-OCT-2012 was vaccinated with a dose of AFLURIA under the skin in the upper left arm (dose and lot # not provided). Secondary suspect therapy included PNEUMOVAX23 (dose/frequency, route and lot # not provided). The patient stated that she might have also gotten the pneumonia vaccine at the same time but it was not sure. Concomitant medications included ALEVE, ibuprofen, ZETIA, xanthophyll and vitamins (unspecified, OTC). The patient stated that on 02-OCT-2012 "the day after she got her vaccine", her face was very red and blotchy and it felt hot and almost felt sun burnt although it was not sunburn. On 09-OCT-2012, the patient received a cortisone injection (unspecified) into the ankle. The patient also indicated that on 10-OCT-2012, she noticed a big black blotch on her left wrist extending about 6 inches up her arm. It began to appear as if it were clearing up until 22-OCT-2012 she stated the area was a raised red patch with smaller red areas within it. The patient claimed it might also have something to do with the cortisone injection she received in her ankle but did not know the brand of cortisone injectable she received either. Treatment given for the events included rubbed ice cubes on the area. No laboratory tests were performed. The patient did not seek medical attention. At the time of the report, the outcome of the event was unknown. The relatedness for the events was unknown for AFLURIA and PNEUMOVAX23. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Dyspnoea
Clinical narrative: Gave flu shot LD & ZOSTAVAX SQ LA on 10-24-12 at around 1630. Within 6-7 min, I received a call stating that she could hardly breathe. They were back in the parking lot & I ran down & gave EPI SQ & BENADRYL 50mg IM.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 years old female patient. The patient's medical history included bursitis in her elbow. The patient was vaccinated with a 0.5 ml dose of PNEUMOVAX23 (route, dose and lot # not reported) on 15-OCT-2012. No other co-suspects were reported. Concomitant medications included an unspecified tri-valent influenza virus vaccine in the opposite arm. Afterwards, the patient complained that she was unable to lift the arm that she had gotten the PNEUMOVAX23 in. The patient said it was similar to the bursitis she used to have in her elbow. The patient sought unspecified medical attention. There were no labs/diagnostics studies performed. Treatment with ice and heat was given for the events. The outcome of the events was reported as recovering. The relationship between the events and PNEUMOVAX23 was not reported. Additional information has been requested.
Age: 95.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Cardiac failure congestive, Condition aggravated, Nausea
Clinical narrative: Patient hospitalized 10/16-10/21 with CHF exacerbation and increased weakness. Assessment by HH 10/23/12 and vaccine given. Patient developed nausea later in the day. Called EMS morning of 10/24 and patient taken to E.R.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Mobility decreased, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age who was wheelchair bound due to a previous spinal injury. The patient was vaccinated with a first and second dose of PNEUMOVAX 23 (dose, route and lot number not provided) within 1 year respectively in January 2012 and on 19-OCT-2012, and received influenza virus vaccine (unspecified) (manufacture unknown) concomitantly in the same arm. No concomitant medications were reported. On 20-OCT-2012 ("about 24 hours after the vaccination) the patient developed fever of 100.3 F and unable to move his legs. The patient was hospitalized and subsequently discharged following a full recovery. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain of skin
Clinical narrative: Left palm, wrist and mid arm - skin very painful to touch. Felt like horrible sunburn. Within 24 hours the pain spread up to upper arm, shot site, left shoulder and lower left neck. Slightest touch was painful. Pain meds would only dull the feeling. 10/29/12 - pain has dulled and receeded back down to just mid arm.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Client claimed. No Objective data available. Client under PCP's care.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Oedema peripheral
Clinical narrative: Patient called our office on 10/26/12 to obtain the vaccine name and lot number to give to her physician. She reported having severe joint pain and swelling of the fingers.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Anti-cyclic citrullinated peptide antibody negative, Antinuclear antibody negative, Arthralgia, Arthritis, C-reactive protein normal
Clinical narrative: Patient called our office on 10/26/12 to obtain the vaccine name and lot number to give to her physician. She reported having severe joint pain and swelling of the fingers.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Full blood count normal, Headache, Laboratory test normal, Malaise, Parvovirus B19 test negative
Clinical narrative: Patient called our office on 10/26/12 to obtain the vaccine name and lot number to give to her physician. She reported having severe joint pain and swelling of the fingers.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Red blood cell sedimentation rate increased, Thyroid function test normal, Vitamin D
Clinical narrative: Patient called our office on 10/26/12 to obtain the vaccine name and lot number to give to her physician. She reported having severe joint pain and swelling of the fingers.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling, marked erythema at injection site.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Palpitations, Syncope
Clinical narrative: Heart palpitation followed by syncopal episode lasting about 15 minutes.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Acute polyneuropathy, Balance disorder, Fall, Grip strength decreased, Guillain-Barre syndrome
Clinical narrative: 34 yo comes in with a week of tingling that started in feet and hands after colonscopy on 10/10/12. Now having weakness in legs and hand grip. Has fallen a couple times the past couple days. Assessment - possible Guillain-Barre syndrome with upper and lower extremity  weakness/paresthesias. No evidence of respiratory compromise at this point. Assessment and Plan: 1) Numbness and Weakness of Upper and Lower Extremities. Given the patient's clinical history some concern for nerve compression or possible Guillain-Barre. Lumbar Puncture was performed, however the tap was traumatic and studies may need to be repeated. The patient has no signs or symptoms or respiratory depression, shortness of breath, or dysphagia at this time, therefore we will order Q4 Neurochecks, and well as negative inspiratory pressures, and will continue to monitor the patient overnight. We will also order an MRI of the lumbar sacral spine, and basic labs, as well as a neurology  consult. 2) Hypertension. Patient will be continued on Lisinopril, but his diltiazem will continue to be held as per outpatient management. 3) H. Pylori. Patient can be continued on triple therapy.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Lumbar puncture, Muscular weakness, Paraesthesia
Clinical narrative: 34 yo comes in with a week of tingling that started in feet and hands after colonscopy on 10/10/12. Now having weakness in legs and hand grip. Has fallen a couple times the past couple days. Assessment - possible Guillain-Barre syndrome with upper and lower extremity  weakness/paresthesias. No evidence of respiratory compromise at this point. Assessment and Plan: 1) Numbness and Weakness of Upper and Lower Extremities. Given the patient's clinical history some concern for nerve compression or possible Guillain-Barre. Lumbar Puncture was performed, however the tap was traumatic and studies may need to be repeated. The patient has no signs or symptoms or respiratory depression, shortness of breath, or dysphagia at this time, therefore we will order Q4 Neurochecks, and well as negative inspiratory pressures, and will continue to monitor the patient overnight. We will also order an MRI of the lumbar sacral spine, and basic labs, as well as a neurology  consult. 2) Hypertension. Patient will be continued on Lisinopril, but his diltiazem will continue to be held as per outpatient management. 3) H. Pylori. Patient can be continued on triple therapy.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain, Tremor
Clinical narrative: Had shaking chills and felt chilled for several hours; didn't check her temperature. Also noted body aches. Denied any other symptoms.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Chills, Fatigue, Feeling hot, Pyrexia
Clinical narrative: Later that afternoon, she felt like she was getting chills. By 10/06/2012 evening, her temperature was 100 degrees and she was having chills/hot feelings back and forth. Fever at 0100 10/07/2012 was 101.7 degrees and at 0400 10/07/2012 was 101.4 degrees. Fever lasted until mid-afternoon on 10/07/2012. She was very tired and pretty much slept on and off the entire time. Required her to call in sick from work on 10/07/2012.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Somnolence
Clinical narrative: Later that afternoon, she felt like she was getting chills. By 10/06/2012 evening, her temperature was 100 degrees and she was having chills/hot feelings back and forth. Fever at 0100 10/07/2012 was 101.7 degrees and at 0400 10/07/2012 was 101.4 degrees. Fever lasted until mid-afternoon on 10/07/2012. She was very tired and pretty much slept on and off the entire time. Required her to call in sick from work on 10/07/2012.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: 10/18/12 patient noticed her left upper arm being vey red, swollen and very painful.  Pt. states she had a lot of itching of the left arm.  Pt. came to the doctor on 10/19/12 and was instructed to use ice pack on the left arm and take Benadryl.  Patient states her arm remained that way until about 10/23/12.
Age: 0.83
Sex: M
Vaccine: DTAP, IPV, PNC13
Symptoms: Convulsion, Full blood count normal, Metabolic function test normal, Pyrexia
Clinical narrative: Fever initially, then generalized seizure about 1:30 am; went to ER, evaluated.
Age: 1.77
Sex: F
Vaccine: FLUX
Symptoms: Balance disorder, Convulsion, Fall, Gaze palsy, Musculoskeletal stiffness
Clinical narrative: Lost balance and fell three times. Upon final stumble, while lying on the ground, her right arm and leg stiffened straight out and her left side began convulsing (this lasted for about 10 seconds). I picked her up and noticed her eyes moving somewhat fast from side-to-side (this lasted for about 20 seconds). She DID NOT have a high temperature and she was back to her normal playful self immediately following this adverse event. Took her back to Clinic and we were told to wait and watch if it happened again. Setup appointment with a Neurologist.