chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Aspiration joint, Blood uric acid decreased, Joint fluid drainage, Joint swelling
Clinical narrative: Could not determine site of injection; was not noted right or left arm on medication administration record.  However, peripheral line was inserted in right arm same day as administration of vaccine. 6/19/12 @8:30 -> swollen and tenderness in right arm, edema noted. Pain noted 9/10. Warm blanket wrapped around area and elevated.  6/19/12: peripheral line switched from right to left arm due to swelling. 6/19/12 @15:40 -> arm remains swollen, ice pack applied. 6/19/12 @1915 -> 1 tab percocet for 8/10 elbow pain.  6/20/12 @7:45 -> right arm pain, swelling to right elbow. 6/20/12 @1205 needle aspiration performed. 6/20/12 @1920 -> pain noted 3/10. 6/21/12: right elbow remains swollen, site drained.  6/21/12 @1530 -> pt denies pain.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Oedema, Oedema peripheral, Pain, Pain in extremity, Synovial fluid analysis normal
Clinical narrative: Could not determine site of injection; was not noted right or left arm on medication administration record.  However, peripheral line was inserted in right arm same day as administration of vaccine. 6/19/12 @8:30 -> swollen and tenderness in right arm, edema noted. Pain noted 9/10. Warm blanket wrapped around area and elevated.  6/19/12: peripheral line switched from right to left arm due to swelling. 6/19/12 @15:40 -> arm remains swollen, ice pack applied. 6/19/12 @1915 -> 1 tab percocet for 8/10 elbow pain.  6/20/12 @7:45 -> right arm pain, swelling to right elbow. 6/20/12 @1205 needle aspiration performed. 6/20/12 @1920 -> pain noted 3/10. 6/21/12: right elbow remains swollen, site drained.  6/21/12 @1530 -> pt denies pain.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Could not determine site of injection; was not noted right or left arm on medication administration record.  However, peripheral line was inserted in right arm same day as administration of vaccine. 6/19/12 @8:30 -> swollen and tenderness in right arm, edema noted. Pain noted 9/10. Warm blanket wrapped around area and elevated.  6/19/12: peripheral line switched from right to left arm due to swelling. 6/19/12 @15:40 -> arm remains swollen, ice pack applied. 6/19/12 @1915 -> 1 tab percocet for 8/10 elbow pain.  6/20/12 @7:45 -> right arm pain, swelling to right elbow. 6/20/12 @1205 needle aspiration performed. 6/20/12 @1920 -> pain noted 3/10. 6/21/12: right elbow remains swollen, site drained.  6/21/12 @1530 -> pt denies pain.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC13
Symptoms: Body temperature increased
Clinical narrative: 103.0 temp
Age: 56.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Incontinence, Loss of consciousness, Malaise
Clinical narrative: Pt given Hepatitis A #2 & Hepatitis B #3 in arm immediately after c/o not feeling well, ashen color unconscious w/o closing eyes, did not respond to voices lasted a few seconds responded for a few minutes then lapsed into unconsciousness again became rigid & incontinent. 911 called. Pulse assessed - 50, BP 90/50, diaphoretic. EMT's arrived assessed pt now conscious and responding BP 90/50, pulse ox 96, pulse 74 - BS 141 - alert & oriented x 4 - did not go to ER. Followed up with Primary Care Physician.
Age: 56.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Muscle rigidity, Pallor, Unresponsive to stimuli
Clinical narrative: Pt given Hepatitis A #2 & Hepatitis B #3 in arm immediately after c/o not feeling well, ashen color unconscious w/o closing eyes, did not respond to voices lasted a few seconds responded for a few minutes then lapsed into unconsciousness again became rigid & incontinent. 911 called. Pulse assessed - 50, BP 90/50, diaphoretic. EMT's arrived assessed pt now conscious and responding BP 90/50, pulse ox 96, pulse 74 - BS 141 - alert & oriented x 4 - did not go to ER. Followed up with Primary Care Physician.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: Information has been received from a pharmacy student concerning a 15 month old female patient with allergy to sesame oil who on 06-MAR-2012, was vaccinated with a dose of VARIVAX (Merck) (dose and route not provided) (lot# 671130/1220AA). There was no concomitant medication. On 21-MAR-2012, the patient developed varicella like rash all over the body along with febrile illness after receiving VARIVAX (Merck). No laboratory tests were performed. The patient was treated with acyclovir. The patient sought medical attention, went to the clinic. At the time of the report, the patient's outcome was unknown. A lot check has been initiated. This is one of several reports received from the same source. A preliminary lot check investigation was performed. To date our investigation has found that this lot 671130/1220AA conformed to quality release parameters and the manufacturing was typical of a lot of VARIVAX (Merck). Additional information will be provided upon finalization of this manufacturing investigation. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cough, Malaise, Respiratory tract congestion
Clinical narrative: This spontaneous report was received from a female consumer reporting on herself who on an unknown date was vaccinated with a dose of pneumococcal vaccine (manufacturer unknown) (dose, route and lot # not provided). On an unknown date, the patient became very sick 48 hours after receiving the pneumonia vaccine. The consumer stated that she had both coughing and congestion. No Product Quality Complaint was reported. On an unknown date, the patient recovered from the events. The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist concerning an unknown number of unspecified patients who on unknown dates were vaccinated with a dose of ZOSTAVAX (dose, route and lot # not provided). The registered pharmacist stated that the patients had developed swelling at the injection site after vaccination with ZOSTAVAX. At the time of the report, the patient outcomes were unknown. It was unknown if the patients sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 02-JUL-2012, was vaccinated SQ with an expired 0.65 ml dose of ZOSTAVAX (Merck) (lot# 669538/1390Z, exp date 19-JAN-2012). No adverse effects were reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Urticaria
Clinical narrative: One to two hours after injection had a single large hive right arm. Redness measured 60 mm L by 30 mm W and induration at 10 mm L by 5 mm W. Stable vital signs. Released from office 20-30 mins after.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Atrophy, Erythema, Pain
Clinical narrative: Indentation or atrophy, redness and pain 30 days after vaccine administered. She was given Ibuprofen and CEPHALEXA for 10 days.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness, tenderness, & warmth at injection site.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Abasia, Arthralgia, Myalgia
Clinical narrative: Information has been received from a physician concerning his 11 year old son who on 16-MAR-2012, was vaccinated with a first dose of GARDASIL (lot number 671994/1537AA, expiration date 21-JUN-2014) (dose, route not reported). There was no concomitant medication. On 18-MAR-2012, the patient experienced "joint pain in both knees and both ankles". At the time of the report the patient's outcome was not recovered. The patient sought medical attention, the patient was the physician's son. Follow up information has been received from a Certificate Medical Assistant concerning an 11 year old male with intermittent mild asthma and no illness at the time of vaccination who on 16-MAR-2012, 2:33 PM, was vaccinated with the third dose of GARDASIL (lot number 671994/1537AA, expiration date 21-JUN-2014) IM in the left deltoid. On 16-MAR-2012 the patient experienced transient myalgia in ankles/thigh and knee, initially could not walk, the patient was improved with time, heat, NSAIDS (nonsteroidal antiinflammatory drug). On 22-MAR-2012, the patient was recovered. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness and warmth at injection site with mild swelling.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Patient developed a rash and swelling in (L) arm.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Fatigue, Herpes zoster, Pain, Pain in extremity
Clinical narrative: Information has been received from a registered pharmacist concerning a 77 year old female patient with no pertinent medical history and no drug reactions or allergies, who on 28-APR-2012 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot # not reported) SQ. There was no concomitant medication. The pharmacist reported that the patient developed shingles after being administered ZOSTAVAX (Merck). The pharmacist also reported that the patient was tired and achy after receiving the vaccine. The patient contacted the pharmacist and was treated with acyclovir 400 mg and ZOVIRAX cream. There were no Lab diagnosis/studies performed. At the time of the report, the patient had not recovered. Follow up information has been received from a health care professional via herpes zoster questionnaire concerning the patient with a history of chickenpox as child, who on 28-APR-2012 (also reported as around 08-MAY-2012) was vaccinated with ZOSTAVAX (Merck). The health care professional reported that 1-2 weeks after vaccination, on approximately 05-MAY-2012, the patient went with shingles. On 22-MAY-2012 a sample of a vesicle scab from left arm in the deltoid area was obtained. VZV DNA was amplified and identification showed a wild type strain. It was reported that the patient did not have recent exposure to chickenpox or shingles. At the time of the report, the patient had not recovered, still had fatigue and arm pain. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Scab, Varicella virus test positive
Clinical narrative: Information has been received from a registered pharmacist concerning a 77 year old female patient with no pertinent medical history and no drug reactions or allergies, who on 28-APR-2012 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot # not reported) SQ. There was no concomitant medication. The pharmacist reported that the patient developed shingles after being administered ZOSTAVAX (Merck). The pharmacist also reported that the patient was tired and achy after receiving the vaccine. The patient contacted the pharmacist and was treated with acyclovir 400 mg and ZOVIRAX cream. There were no Lab diagnosis/studies performed. At the time of the report, the patient had not recovered. Follow up information has been received from a health care professional via herpes zoster questionnaire concerning the patient with a history of chickenpox as child, who on 28-APR-2012 (also reported as around 08-MAY-2012) was vaccinated with ZOSTAVAX (Merck). The health care professional reported that 1-2 weeks after vaccination, on approximately 05-MAY-2012, the patient went with shingles. On 22-MAY-2012 a sample of a vesicle scab from left arm in the deltoid area was obtained. VZV DNA was amplified and identification showed a wild type strain. It was reported that the patient did not have recent exposure to chickenpox or shingles. At the time of the report, the patient had not recovered, still had fatigue and arm pain. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Cold sweat, Depressed level of consciousness, Headache, Nausea, Pallor
Clinical narrative: Within 60 sec of completing vaccination pt. became pale with decreased LOC. Skin moist. C/o nausea. Difficulty focusing eyes. Pt later states 1hr 30 min after vaccination with c/o headache and slight visual disturbance.
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Vision blurred, Visual impairment
Clinical narrative: Within 60 sec of completing vaccination pt. became pale with decreased LOC. Skin moist. C/o nausea. Difficulty focusing eyes. Pt later states 1hr 30 min after vaccination with c/o headache and slight visual disturbance.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Robust 8X10cm erythema, swelling, warm reaction at R deltoid - shot.
Age: 39.0
Sex: M
Vaccine: HEPAB
Symptoms: Fall, Loss of consciousness, Thirst
Clinical narrative: Received TWINRIX at about 8:40 A.M. Seemed fine. Talking not dizzy and walked out to waiting rm. Felt thirsty. Was directed to water fountain by CSR. Passed out, hit the wall and slid down about 9:00 A.M. Came to right away. Alert. No problems.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Patient reported swollen at site of injection and rash and itchiness 2 days after vaccine was administered. Went to her physician he reported to her that she is allergic to the vaccine. He also gave her an antibiotic treatment.
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Eye pain, Myalgia, Pain, Rash
Clinical narrative: Employee reported on 7/10/2012 onset of symptoms on 7/7/2012 of pain in eyes and with motion, myalgia, and observed rash on 7/9/2012 on trunk and extremities. Received MMR 12 days before symptom onset.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient had rash at site of injection. She was seen by her physician & taking treatment.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site erythema
Clinical narrative: Patient had rash at site of injection. She was seen by her physician & taking treatment.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (R) thigh, hot, swelling, redness 7/9/12.
Age: 0.41
Sex: F
Vaccine: DTAPHEPBIP, DTAPIPV, PNC, RV1
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Infant was to receive PEDIARIX, HIB, PREVNAR and ROTARIX. Received PEDIARIX, KINRIX, PREVNAR and ROTARIX - no immed. problems. Parents notified mistake and Immunization Quality also notified. Parents to seek immed. attention if any problems noticed.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest pain, Diarrhoea, Dizziness, Erythema, Induration
Clinical narrative: Shot given 7-7-12. Within 12 hours redness a 1 1/2" deep hard lump that extended about 6" x 5:". Nausea and diarrhea within 12 hours. Chest pain within 24 hours intermittent light headed.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea
Clinical narrative: Shot given 7-7-12. Within 12 hours redness a 1 1/2" deep hard lump that extended about 6" x 5:". Nausea and diarrhea within 12 hours. Chest pain within 24 hours intermittent light headed.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest pain, Diarrhoea, Dizziness, Injection site induration, Injection site mass
Clinical narrative: Shot given 7-7-12. Within 12 hours redness a 1 1/2" deep hard lump that extended about 6" x 5:". Nausea and diarrhea within 12 hours. Chest pain within 24 hours intermittent light headed.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site pruritus, Nausea, Pyrexia, Rhinorrhoea
Clinical narrative: Shot given 7-7-12. Within 12 hours redness a 1 1/2" deep hard lump that extended about 6" x 5:". Nausea and diarrhea within 12 hours. Chest pain within 24 hours intermittent light headed.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Confusional state, Electroencephalogram, Muscle rigidity, Postictal state
Clinical narrative: Pt fainted after vaccination, was found lying on floor, supine rigid w/tonic-clonic movements, eyes closed approx 15 sec. postictal confusion. Pt has history of fainting with sight of blood.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Tonic clonic movements
Clinical narrative: Pt fainted after vaccination, was found lying on floor, supine rigid w/tonic-clonic movements, eyes closed approx 15 sec. postictal confusion. Pt has history of fainting with sight of blood.
Age: 10.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Pt awake on 7-9-12 with quarter sized raised reddened area on back of (R) A hot to touch, painful itching within 1 hour nausea & vomiting developed. Child was taken to hospital where she was given BENADRYL.
Age: 10.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Vomiting
Clinical narrative: Pt awake on 7-9-12 with quarter sized raised reddened area on back of (R) A hot to touch, painful itching within 1 hour nausea & vomiting developed. Child was taken to hospital where she was given BENADRYL.
Age: 1.05
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Fever on Saturday 7/7/2012 only rash of red small bumps on chest, back, face and legs. Patients mother discussed with triage nurse - home care measures reviewed.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: After the shot patient complained of pain at the site, redness, swelling & warmth. Treatment AUGMENTIN oral tab 875 mg BID two days after injection when seen again in office.
Age: 33.0
Sex: F
Vaccine: HEPAB
Symptoms: Grand mal convulsion
Clinical narrative: Grand mal seizure 2 min length. O2 per mask.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Fall, Gait disturbance, Joint injury, Limb injury
Clinical narrative: Pt. began to wobble while walking and slowly crumpled to the floor off to her right, leg came in contact with scale and shoulder came in contact with room divider, head did not hit floor. Pts. eyes were open. RN picked child up, placed on exam table, assessed resp/pulse/BP every 5 minutes, lying, sitting, standing, cold compresses to forehead and back of neck. Sips of water. Occurred at about 0933/0935. Left at 0950. Pt. recovered well.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Excessive sleepiness, vomiting, headache, hot itchy painful rash at injection site and surrounding tissue traveling up to shoulder and down to arm.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence, Vomiting
Clinical narrative: Excessive sleepiness, vomiting, headache, hot itchy painful rash at injection site and surrounding tissue traveling up to shoulder and down to arm.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Expired drug administered, Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 22-JUN-2012 was inadvertently vaccinated with a dose of improperly stored MMR II (lot# 670621/0568AA, expired on 15-APR-2012). No adverse effect reported. It was unknown if the patient had sought medical attention. This was one of the several reports received from the same source. Additional information has been requested.
Age: 87.0
Sex: M
Vaccine: PPV
Symptoms: Cough
Clinical narrative: Information has been received from a licensed practical nurse concerning an 87 year old male patient with chronic obstructive pulmonary disease (COPD), asthma, melanoma and leukaemia who on approximately 20-JUN-2012 was vaccinated IM with a 0.5 ml of a single dose of PNEUMOVAX 23 (lot # 672673/0492AE; Exp date: 22-AUG-2013). On approximately 20-JUN-2012, within the last week, the patient experienced cough after vaccination. The patient went to emergency room (ER), given an unspecified antibiotic and discharged. Subsequently, on an unspecified date, the patient recovered from cough after vaccination. This is one of several reports received from the same source. Additional information has been requested.
Age: 47.0
Sex: M
Vaccine: PPV
Symptoms: Cough
Clinical narrative: Information has been received from a licensed practical nurse concerning a 47 year old male patient who approximately 20-JUN-2012 was vaccinated IM with a 0.5 ml of a single dose of PNEUMOVAX 23 (lot # 672673/0492AE; Exp date: 22-AUG-2013). The patient was taking unspecified medications for pain and stomach acid as well as muscle relaxers. On approximately 20-JUN-2012, within the last week, the patient experienced cough after vaccination. It was unknown if the patient sought medical attention. Subsequently, on an unspecified date, the patient recovered from cough after vaccination. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: TDAP
Symptoms: Axillary pain, Injection site pruritus, Injection site swelling, Injection site warmth, Lymphadenopathy
Clinical narrative: Initial and follow up information received from a healthcare professional on 06 May 2012 and 15 May 2012. This case was cluster of 8 patients those experiencing adverse events after receiving ADACEL vaccine lot number C4051BA on same center and reported by same reporter. The 8 patient received ADACEL vaccine (Lot number C4051BA, exp. June 20, 2014), who have complained of swelling at the site of injection, swollen lymph nodes, sore armpits, nausea, aching, and site warm to touch and itching, the vaccines were given on 2 May 2012 (route and site of administration was not reported). A few members were sent to a local MTF, one member was given a course of antibiotics, and two were told to follow up at this week. This appears to be a high number of members having the same symptoms in such a short period of time. A total of 10 received the vaccine on this day, and 8 have reported two or more of the above symptoms. The next day 3 returned to clinic. Two patients complained of pain, heat, swelling and redness at the site along with swelling of an axillary node. They were sent to Sick Call. One was given antibiotics, both were much better in 2-3 days. The third patient complained of flu like symptoms with fever and sweats along with the large, local reaction symptoms. He was better systemically in a couple of days and by 2 weeks he had a small knot left at the site. They called the remaining 6 patient's who were there on 5/2. 5 of them reported more swelling, pain and redness than they usually got with Td. The 6th had nothing to report. Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Nausea, Pain
Clinical narrative: Initial and follow up information received from a healthcare professional on 06 May 2012 and 15 May 2012. This case was cluster of 8 patients those experiencing adverse events after receiving ADACEL vaccine lot number C4051BA on same center and reported by same reporter. The 8 patient received ADACEL vaccine (Lot number C4051BA, exp. June 20, 2014), who have complained of swelling at the site of injection, swollen lymph nodes, sore armpits, nausea, aching, and site warm to touch and itching, the vaccines were given on 2 May 2012 (route and site of administration was not reported). A few members were sent to a local MTF, one member was given a course of antibiotics, and two were told to follow up at this week. This appears to be a high number of members having the same symptoms in such a short period of time. A total of 10 received the vaccine on this day, and 8 have reported two or more of the above symptoms. The next day 3 returned to clinic. Two patients complained of pain, heat, swelling and redness at the site along with swelling of an axillary node. They were sent to Sick Call. One was given antibiotics, both were much better in 2-3 days. The third patient complained of flu like symptoms with fever and sweats along with the large, local reaction symptoms. He was better systemically in a couple of days and by 2 weeks he had a small knot left at the site. They called the remaining 6 patient's who were there on 5/2. 5 of them reported more swelling, pain and redness than they usually got with Td. The 6th had nothing to report. Documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Feeling abnormal, Injection site discolouration, Injection site erythema
Clinical narrative: Initial report received from office staff of health care on 18 May 2012. Number: 12-0292. A female patient, whose age, medical history and concomitant medication were not reported, had received a dose of ADACEL on an unspecified date (lot number, route and site of administration was not reported). It was reported that on an unspecified date the patient experienced a dollar sized red mark at the injection site with a white ring around the mark and had temperature (100) for 2 days the patient also reported that she felt horrible for 3 days. The outcome of the adverse reaction was not reported. The complimentary investigations and corrective treatments were not reported. List of documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Ear pain, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Initial report received from a patient/consumer via healthcare professional on 07 May 2012. 12-0273. A 66-year-old female patient, whose medical history included thyroid, osteoporosis, HBP (high blood pressure), GERD, Arthritis and Pinched nerve and concomitant medications were not reported, had received a intramuscular dose of ADACEL vaccine in right deltoid (lot number U4046AA) on 26 March 2012. On 26 March 2012, the patient developed left arm was tender right after the injection. Bruising occurred and lasted 1 to 1.5 weeks. Lumps developed on the left side of her head. The patient had ear and throat pain. The visited to the physician and physician examined the patient and made diagnosis of clusters of lymph nodes on the left side. The patient also had complaint of headaches, a throbbing pain, which occur only left side of head. Patient also felt tired much of the time. The patient laboratory data included: none. The outcome of the events was reported as not recovered. Documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Oropharyngeal pain, Pain, Swelling, Tenderness
Clinical narrative: Initial report received from a patient/consumer via healthcare professional on 07 May 2012. 12-0273. A 66-year-old female patient, whose medical history included thyroid, osteoporosis, HBP (high blood pressure), GERD, Arthritis and Pinched nerve and concomitant medications were not reported, had received a intramuscular dose of ADACEL vaccine in right deltoid (lot number U4046AA) on 26 March 2012. On 26 March 2012, the patient developed left arm was tender right after the injection. Bruising occurred and lasted 1 to 1.5 weeks. Lumps developed on the left side of her head. The patient had ear and throat pain. The visited to the physician and physician examined the patient and made diagnosis of clusters of lymph nodes on the left side. The patient also had complaint of headaches, a throbbing pain, which occur only left side of head. Patient also felt tired much of the time. The patient laboratory data included: none. The outcome of the events was reported as not recovered. Documents held by sender: none.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pyrexia
Clinical narrative: Initial report received from a health care professional on 04 May 2012 via MIS/VIS call. MIS/VIS reference number: 12-0271. A 38- year-old female patient whose medical history and concomitant medications not reported, received an intramuscular dose of ADACEL (batch number U4325AA) in her left deltoid on 02 May 2012. The patient was presented with induration, mild erythema and swelling at injection site which measured 4 inches. Patient also reported mild fever (100.8 degree C) this morning. The patient was being treated symptomatically for site reactions while low grade fever was reported to have subsided on the morning of report. At the time of report all events were reported as recovered. Documents held by sender: None.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation
Clinical narrative: A 51-year-old female patient, whose medical history and concomitant medications were not reported, had received intramuscular second dose of ADACEL in right deltoid (lot number U4305AA) on 01 May 2012. The patient had received first dose of ADACEL on 18 September 2011. On 23 April 2012, the patient had complaint that her titanium knee replacement feel as if they were on fire. She was unable to get relief from any medications. It was reported that, the patient inadvertently received a second dose of ADACEL seven months after the first dose. The outcome of events was reported as not recovered. Documents held by sender: none.
Age: 45.0
Sex: U
Vaccine: TDAP
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Initial report was received from a healthcare professional on 20 January 2012. A patient (age and gender not reported) had received an Intramuscular (IM) injection of ADACEL; sanofi pasteur lot number C4023AA in left deltoid on 16 January 2011. On an unspecified date, the patient left axilla became swollen and tender; with five to ten pain levels. No further information was available at the time of this report. The patient outcome was reported as not recovered/not resolved. Documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: This case is a cluster of 2 patients who experienced adverse events following administration of ADACEL; lot number C4023AA. The events for the other patient was captured in case number 2012-00780. Initial report was received from a healthcare professional on 20 January 2012. A female patient (age not reported) had received an injection of ADACEL; sanofi pasteur Ltd. lot number C4023AA. On an unspecified date following vaccination, the patient developed redness, swelling and pain in arm. It is unknown if the patient received any corrective treatment. No further information was available at the time of this report. The patient outcome was not reported.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Condition aggravated, Haemangioma of skin, Injection site erythema, Injection site reaction
Clinical narrative: Initial report was received on 24 February 2012 from a health care professional. An 11-year-old male patient, with no concurrent illness, had received an intramuscular injection of ADACEL, lot number C1008AA and MENACTRA, lot number U4074BA on 20 February 2012 (sites of administration not reported). The patient had a history of a peanut allergy, asthma and capillary hemangioma that was present on the left deltoid since birth. According to the reporter, the capillary hemangioma "went down" over time. On 23 February 2012, three days post vaccination, the patient's parents called the office to report that the hemangioma developed again, describing it as bulbous, raised and red on the left deltoid where vaccine was administered: the vaccine administered at this site was not specified). Laboratory or diagnostic testing was not performed, and the event did not require a doctor's visit. It was unknown if the patient had experienced and adverse events following prior vaccinations. Outcome was not recovered. Documents held by sender: None. The follow-up information was received on 07 May 2012: The patient mother stated that the prior to immunization Hemangioma was faint ashen in color and flat followed the immunization area become bulbous, dark red, purple which laste for one week. Hemangioma had returned to pre immunization state in color and size.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Chest pain, Erythema, Incorrect route of drug administration, Local swelling
Clinical narrative: Initial report was received from a health care professional on 24 February 2012, which also involved a case of misuse (wrong route of administration). A 53-year-old male patient had received a subcutaneous injection in the right arm below the right deltoid of ADACEL, sanofi pasteur Ltd. C4063 (sanofi pasteur Inc. lot number U4308AA) on 20 February 2012. On 21 February 2012, the patient experienced redness and swelling of an area of 3"x4" on the right arm and pain down the right side and across the chest. The patient had no illness at the time of vaccination, no medical history, took no concomitant medications and received no other vaccinations within four weeks of ADACEL. It was unknown if the patient had any adverse events to prior vaccinations. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: None. Follow up information received on 4 May 2012: Illness at the time of vaccination: None. The patient recovered on 26 February 2012 and was reported that he was doing well.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Ear discomfort, Fatigue, Nuclear magnetic resonance imaging normal
Clinical narrative: Initial case received from a healthcare professional on 13 February 2012. A 28-year-old female patient received a left deltoid intramuscular injection of ADACEL, sanofi pasteur Ltd. lot number not reported, on 19 January 2012. The patient had no medical history and had no illnesses at the time of vaccination. Adverse event following prior vaccination in patient was unknown. The patient took concomitant medications: TREXIMET and XANAX. One week after vaccination, the patient was seen in the office for symptoms of ear pressure, fatigue and intermittent dizziness. The patient had an Magnetic Resonance Imaging (MRI), which was reported as negative. The patient's outcome was not recovered. Follow-up information was received from a health care professional on 15 March 2012. The sanofi pasteur Ltd. lot number of ADACEL was C4063 (sanofi pasteur Inc. lot number U4308BA). No treatment was prescribed. No other additional information was available at the time of the report. The patient's outcome remained not recovered. Documents held by sender: None.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Drug hypersensitivity, Flushing, Injection site erythema, Injection site swelling
Clinical narrative: Initial report was received from a health care professional on 06 April 2012. The reporter also reported two other adverse events for two other patients which were captured in case numbers 2012-03759 and 2012-037. A 12-year-old female patient had received an intramuscular injection in the left deltoid of ADACEL, sanofi pasteur Ltd. lot number C3940 (sanofi pasteur Inc. lot number U4046AA) on 04 April 2012, the patient experienced a site reaction that included redness, swelling and a red ring around the injection site. The patient also experienced nausea, abdominal pain and flushing of the skin. The patient's parent stated the patient was showing signs of increased sensitivity to medications. The patient was prescribed ice packs and TYLENOL. The patient had a history of multiple allergies, a latex allergy and is underweight. The patient's last Dtap was seven years ago. The patient's concomitant medication included BENADRYL as needed. The site reaction was improving per patient. The patient's outcome was unknown. Documents held by sender: None.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea
Clinical narrative: Initial report was received from a health care professional on 06 April 2012. The reporter also reported two other adverse events for two other patients which were captured in case numbers 2012-03759 and 2012-037. A 12-year-old female patient had received an intramuscular injection in the left deltoid of ADACEL, sanofi pasteur Ltd. lot number C3940 (sanofi pasteur Inc. lot number U4046AA) on 04 April 2012, the patient experienced a site reaction that included redness, swelling and a red ring around the injection site. The patient also experienced nausea, abdominal pain and flushing of the skin. The patient's parent stated the patient was showing signs of increased sensitivity to medications. The patient was prescribed ice packs and TYLENOL. The patient had a history of multiple allergies, a latex allergy and is underweight. The patient's last Dtap was seven years ago. The patient's concomitant medication included BENADRYL as needed. The site reaction was improving per patient. The patient's outcome was unknown. Documents held by sender: None.
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Skin warm
Clinical narrative: This case involves a cluster of three patients who experienced adverse events after receiving ADACEL. The other two patients are captured in cases 2012-02772 and 2012-02773. Initial report was received from a health care professional on 09 March 2012. A female patient (age and date of birth not reported) had received an injection of ADACEL, sanofi pasteur Ltd., lot number C3990 (sanofi pasteur Inc. lot number U4137AA) (route, site and date of administration not reported) and an unspecified amount of time later developed redness and swelling at the injection site, hot ears and itchy hands. No illness at the time of vaccination was reported. The patient's past medical history and concomitant medications were unknown. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: None.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Myalgia
Clinical narrative: Initial report was received from a health care professional on 03 April 2012. A 57-year-old male patient had received an injection of ADACEL, sanofi pasteur Ltd. lot number C3962 (sanofi pasteur Inc. lot number U4104AA) on 23 August 2011 and at the time of the report continued to have a sore, achy deltoid. The patient had no illness at the time of vaccination and had no known drug allergies. The patient's outcome was not recovered. Documents held by sender: None.
Sex: F
Vaccine: TDAP
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: This case involves a cluster of three unidentified patients who experienced "reactions" after administration of ADACEL lot number C4063 (U4308BA). Initial report was received from a health care professional on 12 March 2012. Three unidentified patient's (gender, age and date of birth not reported) received an injection of ADACEL, Sanofi Pasture Ltd, lot number C4063 (Sanofi Pasteur Inc. lot number U4308BA) (date, route and site not reported) and an unspecified amount of time later experienced "reactions." No further information was available at the time of the report. The patient's outcomes were no reported. Follow-up information was received from a health care professional on 20 March 2012. The three patient's were identified as female and developed reaction following vaccination. Two of the patient's experienced hives and itching all over. The patients outcomes were not reported. This reporter also reported other adverse events, which captured in case number 2012-03160 and 2012-03162. Documents held by sender: None.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Axillary mass, Headache, Influenza like illness, Mammogram abnormal
Clinical narrative: Initial report was received on 12 March 2012 from a health care professional. A 58 year-old female (date of birth not reported) with a history of "Thyroid", arthritis, increased cholesterol and Sjogren's syndrome had received on 03 March 2012 an intramuscular left arm injection of ADACEL (lot number not reported). On 06 March 2012, the patient reported a lump under her left armpit, achy joints, flu like symptoms and a headache. The patient had an ultrasound and a mammography with showed "lymph nodes noted". The patient was evaluated by a physician. Treatments were not reported. Concomitant medications included: CRESTOR, Glucosamine, OSCAL, Folic acid, NORVASC and SYNTHROID. The patient's outcome was recovered (date not reported). Documents held by sender: none.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Ultrasound scan abnormal
Clinical narrative: Initial report was received on 12 March 2012 from a health care professional. A 58 year-old female (date of birth not reported) with a history of "Thyroid", arthritis, increased cholesterol and Sjogren's syndrome had received on 03 March 2012 an intramuscular left arm injection of ADACEL (lot number not reported). On 06 March 2012, the patient reported a lump under her left armpit, achy joints, flu like symptoms and a headache. The patient had an ultrasound and a mammography with showed "lymph nodes noted". The patient was evaluated by a physician. Treatments were not reported. Concomitant medications included: CRESTOR, Glucosamine, OSCAL, Folic acid, NORVASC and SYNTHROID. The patient's outcome was recovered (date not reported). Documents held by sender: none.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site abscess sterile, Injection site discolouration, Injection site swelling, Injection site warmth
Clinical narrative: Initial report was received from a healthcare professional on 17 November 2011. A 45-year-old female patients had received an intramuscular (IM) injection of ADACEL; lot number U4090BA (sanofi pasteur Ltd. lot number C3961) in the right deltoid on 17 November 2011. On the same day of the injection, the patient developed a "7x6 cm" dark (pigmented skin), swollen and warm distal from the injection site (10 cm below the injection site). The reporter stated that it looks like a sterile abscess. No further information was available at the time of the report. The patient outcome was reported as not recovered/not resolved. Follow-up information was received from a health care professional on 22 March 2012. The patient was vaccinated on 17 November 2011 and on 21 November 2011 she was re-examined. The patient had noted swelling about 8 hours after immunization. On 20 February 2012, the patient noted no residual pain and no scarring. The injection reaction resolved over a 3 weeks period. No antibiotics were needed. The patient's outcome was recovered. Documents held by sender: None.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in jaw, Toothache, Wisdom teeth removal
Clinical narrative: Initial report was received from a healthcare professional on 19 November 2011. A 37-year-old male patient had received an Intramuscular (IM) injection of ADACEL (sanofi pasteur Ltd. lot number C3961) in left deltoid on 18 November 2011. On the same day of the injection two hours post vaccination, the patient developed severe pain in right jaw area and back molars. The physician ruled out parotid stone. The patient received corrective treatment with hydrocodone and KEFLEX. No further informational was available at the time of the report. The patient outcome was reported as unknown. Follow-up information was received from a healthcare professional on 05 March 2012. The patient was seen by his dentist and had an impacted wisdom tooth which was removed. No further follow-up needed. The patient outcome was reported as recovered/resolved after tooth was removed. Documents held by sender: none.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain
Clinical narrative: Initial report was received from a healthcare professional on 03 November 2011. A 31-year-old female patient had received an Intramuscular (IM) injection of ADACEL (sanofi pasteur Ltd. lot number C3947BA) in left deltoid on 18 October 2011. On the same day of the injection, the patient developed pain at the injection site. The pain was so severe that she was unable to move her arm without experiencing pain. As of 03 November 2011, the pain persisted. The patient received corrective treatment with TYLENOL and warm compresses. No further information was available at the time of the report. The patient outcome was reported as unknown. Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site vesicles, Injection site warmth
Clinical narrative: Initial report was received from a healthcare professional on 26 October 2011. A patient had received an injection of ADACEL (lot number, route and site of administration not reported). On an unspecified date, the patient developed a large reddened area, hot to the touch at the injection site and a blister at the center of area. The reported was only calling for a treatment plan and refused to provide further information. No further information was available at the time of the report. The patient outcome was not reported. Documents held by sender: None.
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: This case is a cluster of 2 patients who experienced adverse events following administration of ADACEL; lot number C4023AA. The events for the other patient was captured in case number 2012-00781. Initial report was received from a healthcare professional on 20 January 2012. A female patient (age not reported) had received an injection of ADACEL; sanofi pasteur Ltd. lot number C3023AA. On an unspecified date following vaccination, the patient developed redness, swelling and pain in arm. It is unknown is the patient received any corrective treatment. No further information was available at the time of this report. The patient outcome was not reported. Documents held by sender: none.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: Initial report was received on 22 December 2011 from a health care professional. A 63 year-old female patient (date of birth not reported) had received on 15 December 2011 an intramuscular injection of ADACEL (lot number and site of administration not reported) and six days later on 21 December 2011, experienced a "little knot" above the injection site that was slightly tender. Concomitant medication included ASPIRIN. The patient was not seen in the office. No further information was available at the time of the report. The patient's outcome was not recovered. Follow-up information was received from a health care professional on 24 February 2012. The patient did not receive any treatment. The patient's outcome was reported as recovered. Documents held by sender: none.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Fatigue, Headache, Malaise, Nausea
Clinical narrative: Initial report received from a consumer on 14 December 2011. A 32-year-old female patient with no concurrent illnesses and no known allergies had received an intramuscular injection of ADACEL (lot number unknown) on 09 December 2011 and 4 days later was found to have a large, red, itchy welt that was hot to touch 4 inches below the injection site. She also had a headache and nausea. At the time of this report, the patient had not recovered. Follow-up information was received from a healthcare professional on 02 March 2012. The patient received an Intramuscular injection of ADACEL; Sanofi Pasteur Ltd. lot number C3989AA in left deltoid. On 14 December 2011, the patient was feeling unwell and fatigued. Upon exam it showed left fluid in upper arm with lightly erythematous patch approximately "2" diameter and warm to the touch; no swelling and no drainage. The patient was advice to follow-up with his physician; however, the patient has not been seen since 14 December 2011. The patient outcome was not reported. Documents held by sender: None.