chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: HPV4, TDAP, VARCEL, HPV4, TDAP, VARCEL
Symptoms: Eyelid function disorder, VIIth nerve paralysis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 years old male patient with medical history and no pre-existed illness treated intramuscularly into left arm with the first dose of GARDASIL (lot #: 672233/1561AA) on 11-APR-2012. Suspect therapy given subcutaneously into the left arm included a first dose (also reported as second dose) of VARIVAX (lot #670988/0972AA). Concomitant medications included ADACEL (lot #C4707AA). The patient tolerated vaccines well, child went home, slept fine overnight. The following morning child awoke and child told his parents "my face feels slower on the left side, especially around my left eye". Child had history of eye twitching in the past - Dad felt that child had experienced this (eye twitching) in the past when child has been fatigued. Dad and the patient state that the patient's left side of face appeared "somewhat slack and droopy" 2 days following his vaccine administration - child noted having difficulty closing his left eyelid and smiling on the left side of his face. These symptoms became progressively worse on 12-APR-2012. Dad recognized child's symptoms as being "Bell's Palsy" (Dad experienced Bell's Palsy in 2007 - Right side of Dad's face, unknown cause). Dad felt that child left side of face was less slack in nature today - child was able to somewhat close his left eye on his own but was unable to smile using the left side of his mouth. Child did have feeling (sensation to touch and pain) on the left side of his face. Normal facial pigmentation. No history of chest pain. No history of shortness of breath (SOB). No history of smoking/drinking or drug usage. Normal taste sensation on his tongue. No history of LOC. No word slurring noted. Child had been able to carry on daily activities appropriately. No history of fever. Sleeping well. No rashes report. No joint pain or joint swelling. No head trauma. No rapid heart rate/no palpitations noted. At time of the report, the patient's outcome was unknown. No further information is available. The original reporting source was not provided. The VAERS ID # is 454206. It was reported that the patient's experiences were considered non-serious.
Age: 17.0
Sex: M
Vaccine: HPV4, TDAP, VARCEL, HPV4, TDAP, VARCEL
Symptoms: Eyelid function disorder, Hypoaesthesia, Sensory disturbance, VIIth nerve paralysis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 years old male patient with medical history and no pre-existed illness treated intramuscularly into left arm with the first dose of GARDASIL (lot #: 672233/1561AA) on 11-APR-2012. Suspect therapy given subcutaneously into the left arm included a first dose (also reported as second dose) of VARIVAX (lot #670988/0972AA). Concomitant medications included ADACEL (lot #C4707AA). The patient tolerated vaccines well, child went home, slept fine overnight. The following morning child awoke and child told his parents "my face feels slower on the left side, especially around my left eye". Child had history of eye twitching in the past - Dad felt that child had experienced this (eye twitching) in the past when child has been fatigued. Dad and the patient state that the patient's left side of face appeared "somewhat slack and droopy" 2 days following his vaccine administration - child noted having difficulty closing his left eyelid and smiling on the left side of his face. These symptoms became progressively worse on 12-APR-2012. Dad recognized child's symptoms as being "Bell's Palsy" (Dad experienced Bell's Palsy in 2007 - Right side of Dad's face, unknown cause). Dad felt that child left side of face was less slack in nature today - child was able to somewhat close his left eye on his own but was unable to smile using the left side of his mouth. Child did have feeling (sensation to touch and pain) on the left side of his face. Normal facial pigmentation. No history of chest pain. No history of shortness of breath (SOB). No history of smoking/drinking or drug usage. Normal taste sensation on his tongue. No history of LOC. No word slurring noted. Child had been able to carry on daily activities appropriately. No history of fever. Sleeping well. No rashes report. No joint pain or joint swelling. No head trauma. No rapid heart rate/no palpitations noted. At time of the report, the patient's outcome was unknown. No further information is available. The original reporting source was not provided. The VAERS ID # is 454206. It was reported that the patient's experiences were considered non-serious.
Age: 3.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Malaise
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 3 years old female patient with no previous illness and no history on 13-APR-2002 was vaccinated IM with the dose 1 GARDASIL (dose not reported, lot # 1561AA) onto right arm and SC with dose 2 VARIVAX (Merck) (dose not reported, lot # 1273AA) onto right arm. There were no other concomitant medicines. Shortly after vaccines c/o pain, swelling, lump and redness at site. By same evening and until Sunday arm welted over the swelling and itching overall just didn't feel well. Patient was treated with ADVIL, BENADRYL, heat/cold to swelling, still swollen and sore on 17-APR-2002 but started improving. All AEs were assessed as non serious. The patient had no conditions. Outcome was unknown at the time of reporting. The patient had the following previous vaccination illness: Abdominal pain, screaming for 12 hours-Rotavirus (ROTASHIELD)-1-0.30. No further information is available. The original reporting source was not provided. The VAERS ID # is 454399.
Age: 3.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Oedema peripheral, Pruritus, Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 3 years old female patient with no previous illness and no history on 13-APR-2002 was vaccinated IM with the dose 1 GARDASIL (dose not reported, lot # 1561AA) onto right arm and SC with dose 2 VARIVAX (Merck) (dose not reported, lot # 1273AA) onto right arm. There were no other concomitant medicines. Shortly after vaccines c/o pain, swelling, lump and redness at site. By same evening and until Sunday arm welted over the swelling and itching overall just didn't feel well. Patient was treated with ADVIL, BENADRYL, heat/cold to swelling, still swollen and sore on 17-APR-2002 but started improving. All AEs were assessed as non serious. The patient had no conditions. Outcome was unknown at the time of reporting. The patient had the following previous vaccination illness: Abdominal pain, screaming for 12 hours-Rotavirus (ROTASHIELD)-1-0.30. No further information is available. The original reporting source was not provided. The VAERS ID # is 454399.
Age: 3.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 3 years old female patient with no previous illness and no history on 13-APR-2002 was vaccinated IM with the dose 1 GARDASIL (dose not reported, lot # 1561AA) onto right arm and SC with dose 2 VARIVAX (Merck) (dose not reported, lot # 1273AA) onto right arm. There were no other concomitant medicines. Shortly after vaccines c/o pain, swelling, lump and redness at site. By same evening and until Sunday arm welted over the swelling and itching overall just didn't feel well. Patient was treated with ADVIL, BENADRYL, heat/cold to swelling, still swollen and sore on 17-APR-2002 but started improving. All AEs were assessed as non serious. The patient had no conditions. Outcome was unknown at the time of reporting. The patient had the following previous vaccination illness: Abdominal pain, screaming for 12 hours-Rotavirus (ROTASHIELD)-1-0.30. No further information is available. The original reporting source was not provided. The VAERS ID # is 454399.
Age: 3.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Malaise, Pruritus
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 3 years old female patient with no previous illness and no history on 13-APR-2002 was vaccinated IM with the dose 1 GARDASIL (dose not reported, lot # 1561AA) onto right arm and SC with dose 2 VARIVAX (Merck) (dose not reported, lot # 1273AA) onto right arm. There were no other concomitant medicines. Shortly after vaccines c/o pain, swelling, lump and redness at site. By same evening and until Sunday arm welted over the swelling and itching overall just didn't feel well. Patient was treated with ADVIL, BENADRYL, heat/cold to swelling, still swollen and sore on 17-APR-2002 but started improving. All AEs were assessed as non serious. The patient had no conditions. Outcome was unknown at the time of reporting. The patient had the following previous vaccination illness: Abdominal pain, screaming for 12 hours-Rotavirus (ROTASHIELD)-1-0.30. No further information is available. The original reporting source was not provided. The VAERS ID # is 454399.
Age: 17.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Body temperature increased, Malaise
Clinical narrative: This report was identified from a line listing obtained on request by the company from the FDA under the Freedom of Information Act. A 17 years old male patient was vaccinated into left arm with the first dose of GARDASIL on 21-MAY-2012. No other co-suspects were reported. Concomitant therapy included CLARITIN. On 23-MAY-2012 the patient experienced body temperature 103 and not feeling well. The patient was reported to school nurse and nurse sent him home. No treatment information was reported. The outcome of the patient was unknown. This report was considered not serious, ER visit by the agency. The original reporting source was not provided. The VAERS ID # is 45668-3. No further information is available.
Sex: M
Vaccine: HEPA, HPV4, VARCEL, HPV4, HEPA, HPV4, VARCEL
Symptoms: Dizziness, Heart rate decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act refers to a male patient. The patient was vaccinated with a dose of GARDASIL (manufacture unknown) experienced pale on an unspecified date. The patient's outcome was unknown. Additional information is not expected. The original reporting source was not provided. The VAERS ID # is 456817. The patient subsequently experienced dizziness and heart rate decreased at therapy with GARDASIL (MARRS # 1207USA012298).
Sex: M
Vaccine: HEPA, HPV4, VARCEL, HPV4, HEPA, HPV4, VARCEL
Symptoms: Dizziness, Heart rate decreased, Pallor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act refers to a male patient. The patient was vaccinated with a dose of GARDASIL (manufacture unknown) experienced pale on an unspecified date. The patient's outcome was unknown. Additional information is not expected. The original reporting source was not provided. The VAERS ID # is 456817. The patient subsequently experienced dizziness and heart rate decreased at therapy with GARDASIL (MARRS # 1207USA012298).
Sex: M
Vaccine: HEPA, HPV4, VARCEL, HPV4, HEPA, HPV4, VARCEL
Symptoms: Dizziness, Heart rate decreased, Hypotension
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act refers to a male patient. The patient was vaccinated with a dose of GARDASIL (manufacture unknown) experienced pale on an unspecified date. The patient's outcome was unknown. Additional information is not expected. The original reporting source was not provided. The VAERS ID # is 456817. The patient subsequently experienced dizziness and heart rate decreased at therapy with GARDASIL (MARRS # 1207USA012298).
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, VARCEL, HPV4, HEPA, HPV4, VARCEL
Symptoms: Dizziness, Heart rate decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act refers to a 13 years old male patient who had illness of pale with previous HPV vaccine (no brand name, captured in MARRS #1208USA007160). The patient was vaccinated in left arm with the third dose of GARDASIL (lot # 667194/1271Z) on 25-MAY-2012. Other suspect therapies included the first dose of VARIVAX (Merck) (as reported lot # 0780Z) in right arm. Concomitant therapy included the first dose of HAVRIX (lot# AHAVB509AA) in right arm. On 25-MAY-2012 the patient experienced dizziness and heart rate decreased. The patient reported feeling dizzy. The patient had lay down and got mom and doctor into the room. The patient's heart rate was 55-60 and blood pressure (BP) was low and the patient was responsive. The patient required an emergency room visit. Additional information is not expected. The original reporting source was not provided. The VAERS ID # is 456817.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, VARCEL, HPV4, HEPA, HPV4, VARCEL
Symptoms: Dizziness, Heart rate decreased, Pallor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act refers to a 13 years old male patient who had illness of pale with previous HPV vaccine (no brand name, captured in MARRS #1208USA007160). The patient was vaccinated in left arm with the third dose of GARDASIL (lot # 667194/1271Z) on 25-MAY-2012. Other suspect therapies included the first dose of VARIVAX (Merck) (as reported lot # 0780Z) in right arm. Concomitant therapy included the first dose of HAVRIX (lot# AHAVB509AA) in right arm. On 25-MAY-2012 the patient experienced dizziness and heart rate decreased. The patient reported feeling dizzy. The patient had lay down and got mom and doctor into the room. The patient's heart rate was 55-60 and blood pressure (BP) was low and the patient was responsive. The patient required an emergency room visit. Additional information is not expected. The original reporting source was not provided. The VAERS ID # is 456817.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, VARCEL, HPV4, HEPA, HPV4, VARCEL
Symptoms: Dizziness, Heart rate decreased, Hypotension
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act refers to a 13 years old male patient who had illness of pale with previous HPV vaccine (no brand name, captured in MARRS #1208USA007160). The patient was vaccinated in left arm with the third dose of GARDASIL (lot # 667194/1271Z) on 25-MAY-2012. Other suspect therapies included the first dose of VARIVAX (Merck) (as reported lot # 0780Z) in right arm. Concomitant therapy included the first dose of HAVRIX (lot# AHAVB509AA) in right arm. On 25-MAY-2012 the patient experienced dizziness and heart rate decreased. The patient reported feeling dizzy. The patient had lay down and got mom and doctor into the room. The patient's heart rate was 55-60 and blood pressure (BP) was low and the patient was responsive. The patient required an emergency room visit. Additional information is not expected. The original reporting source was not provided. The VAERS ID # is 456817.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Head injury, Headache, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. The listing indicated that all events were considered to be not serious. On 11-JUN-2012 patient was administered the second dose of GARDASIL (lot number 1696AA) intramuscularly in right arm and had no reaction at time of administration, but upon leaving the office, fainted and hit his head on the waiting room floor. The patient did not have other medicines. The doctor was summoned and checked him over and took BP. Brought back to exam room by wheelchair, observed, administered ibuprofen for head pain, but recovered fully and allowed to leave the office. There were no laboratory data, no history and no previous illness. No further information is available. The original reporting source was not provided.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, RV1, RV1
Symptoms: Intestinal obstruction, Intussusception
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). There were no concurrent medications. On 3 July 2012 the subject received 2nd dose of ROTARIX lyophilized formulation (1 ml, oral). On 5 July 2012, 2 days after vaccination with ROTARIX lyophilized formulation, the subject experienced intussusception, intestinal obstruction, bleeding from stool, stomach was inflamed, vomiting green contents, crying and irritated. The physician sent the infant subject to the hospital emergency room due to the events. They performed an x-ray and determined that the subject had an intussusception and bowel obstruction. Surgery was performed two days later to correct the problem and the events have now resolved. Exact date the events resolved was unknown but the infant subject was seen by the physician's office on 16 July 2012 and was fine. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). On an unspecified date in July 2012, the events were resolved. The physician considered the events were probably related to vaccination with ROTARIX lyophilized formulation.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, RV1, RV1
Symptoms: Crying, Gastritis, Haematochezia, Intestinal obstruction, Intussusception
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). There were no concurrent medications. On 3 July 2012 the subject received 2nd dose of ROTARIX lyophilized formulation (1 ml, oral). On 5 July 2012, 2 days after vaccination with ROTARIX lyophilized formulation, the subject experienced intussusception, intestinal obstruction, bleeding from stool, stomach was inflamed, vomiting green contents, crying and irritated. The physician sent the infant subject to the hospital emergency room due to the events. They performed an x-ray and determined that the subject had an intussusception and bowel obstruction. Surgery was performed two days later to correct the problem and the events have now resolved. Exact date the events resolved was unknown but the infant subject was seen by the physician's office on 16 July 2012 and was fine. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). On an unspecified date in July 2012, the events were resolved. The physician considered the events were probably related to vaccination with ROTARIX lyophilized formulation.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, RV1, RV1
Symptoms: Irritability, Surgery, Vomiting, X-ray abnormal
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). There were no concurrent medications. On 3 July 2012 the subject received 2nd dose of ROTARIX lyophilized formulation (1 ml, oral). On 5 July 2012, 2 days after vaccination with ROTARIX lyophilized formulation, the subject experienced intussusception, intestinal obstruction, bleeding from stool, stomach was inflamed, vomiting green contents, crying and irritated. The physician sent the infant subject to the hospital emergency room due to the events. They performed an x-ray and determined that the subject had an intussusception and bowel obstruction. Surgery was performed two days later to correct the problem and the events have now resolved. Exact date the events resolved was unknown but the infant subject was seen by the physician's office on 16 July 2012 and was fine. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). On an unspecified date in July 2012, the events were resolved. The physician considered the events were probably related to vaccination with ROTARIX lyophilized formulation.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, RV1, RV1
Symptoms: Intussusception
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). There were no concurrent medications. On 3 July 2012 the subject received 2nd dose of ROTARIX lyophilized formulation (1 ml, oral). On 5 July 2012, 2 days after vaccination with ROTARIX lyophilized formulation, the subject experienced intussusception, intestinal obstruction, bleeding from stool, stomach was inflamed, vomiting green contents, crying and irritated. The physician sent the infant subject to the hospital emergency room due to the events. They performed an x-ray and determined that the subject had an intussusception and bowel obstruction. Surgery was performed two days later to correct the problem and the events have now resolved. Exact date the events resolved was unknown but the infant subject was seen by the physician's office on 16 July 2012 and was fine. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). On an unspecified date in July 2012, the events were resolved. The physician considered the events were probably related to vaccination with ROTARIX lyophilized formulation.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Musculoskeletal pain
Clinical narrative: Heaviness in the chest, left arm numb, break out on left side of face, scabs face & ears and scalp.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest discomfort, Hypoaesthesia, Rash, Scab
Clinical narrative: Heaviness in the chest, left arm numb, break out on left side of face, scabs face & ears and scalp.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anti-transglutaminase antibody, Antibody test, Antineutrophil cytoplasmic antibody, Antinuclear antibody, Bacterial test
Clinical narrative: Clinical pharmacist reported to me per phone on 8/1/12 that client was admitted to Hosp. 7/21/12 and remains in hosp. This client was seen at H.D. for HPV series of vaccine #3, 2 & 1. Last date 7/10/12.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Body temperature increased, Borrelia test, CSF lymphocyte count increased, CSF myelin basic protein, Computerised tomogram abdomen
Clinical narrative: Clinical pharmacist reported to me per phone on 8/1/12 that client was admitted to Hosp. 7/21/12 and remains in hosp. This client was seen at H.D. for HPV series of vaccine #3, 2 & 1. Last date 7/10/12.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram head, Cytomegalovirus test, Double stranded DNA antibody, Dyskinesia, Encephalopathy
Clinical narrative: Clinical pharmacist reported to me per phone on 8/1/12 that client was admitted to Hosp. 7/21/12 and remains in hosp. This client was seen at H.D. for HPV series of vaccine #3, 2 & 1. Last date 7/10/12.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Epstein-Barr virus test, Fatigue, Feeling abnormal, Flow cytometry, Hallucination, auditory
Clinical narrative: Clinical pharmacist reported to me per phone on 8/1/12 that client was admitted to Hosp. 7/21/12 and remains in hosp. This client was seen at H.D. for HPV series of vaccine #3, 2 & 1. Last date 7/10/12.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Herpes simplex serology, Laboratory test, Lumbar puncture, Mental status changes, Nuclear magnetic resonance imaging brain
Clinical narrative: Clinical pharmacist reported to me per phone on 8/1/12 that client was admitted to Hosp. 7/21/12 and remains in hosp. This client was seen at H.D. for HPV series of vaccine #3, 2 & 1. Last date 7/10/12.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Repetitive speech, Rubella antibody test, Stereotypy, Thyroid stimulating immunoglobulin, Unresponsive to stimuli
Clinical narrative: Clinical pharmacist reported to me per phone on 8/1/12 that client was admitted to Hosp. 7/21/12 and remains in hosp. This client was seen at H.D. for HPV series of vaccine #3, 2 & 1. Last date 7/10/12.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Varicella virus test, Viral test
Clinical narrative: Clinical pharmacist reported to me per phone on 8/1/12 that client was admitted to Hosp. 7/21/12 and remains in hosp. This client was seen at H.D. for HPV series of vaccine #3, 2 & 1. Last date 7/10/12.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Unevaluable event
Clinical narrative: Clinical pharmacist reported to me per phone on 8/1/12 that client was admitted to Hosp. 7/21/12 and remains in hosp. This client was seen at H.D. for HPV series of vaccine #3, 2 & 1. Last date 7/10/12.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test normal, Feeling of body temperature change, Injection site pain, Lymphadenopathy, Musculoskeletal pain
Clinical narrative: Severe pain in left arm from Tetanus shot at injection site, I was hot and cold and I had pain shooting down my left arm. Woke up to a pain above my collar bone to find a lump just above it. I went to my express care and the doctor informed me my lymph nodes were swollen. I set a appointment with my doctor, found two more tiny lumps before my appointment, and doctor took my blood work, which came back fine. She prescribed antibiotics (doxycycline) and said it was a reaction to the shot. I'm currently taking the medicine. I have a follow up in a month.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Red blood cell count normal, Vaccination complication, White blood cell count normal
Clinical narrative: Severe pain in left arm from Tetanus shot at injection site, I was hot and cold and I had pain shooting down my left arm. Woke up to a pain above my collar bone to find a lump just above it. I went to my express care and the doctor informed me my lymph nodes were swollen. I set a appointment with my doctor, found two more tiny lumps before my appointment, and doctor took my blood work, which came back fine. She prescribed antibiotics (doxycycline) and said it was a reaction to the shot. I'm currently taking the medicine. I have a follow up in a month.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature decreased, Chills, Dehydration, Headache
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 54 years old female patient with allergies to iodinated contrast media, allergies to indomethacin. The patient was vaccinated with ZOSTAVAX (0.65 ml, lot # 0256AE, expiration date 14-MAR-2013) on 28-JUN-2012. Concomitant therapy included VALTREX, it prescribed on 30-APR-2012 for the flu, not in sufficient quantity for the patient to have still been taking it at the time of ZOSTAVAX administration. The patient returned to the pharmacy on 06-AUG-2012. Approximately on 23-JUL-2012 the patient "flu from hell for the past two weeks" and experienced chills, low body temperature of 93.5 degrees Fahrenheit, vomiting for 320 hours, dehydration, severe headache and severe joint aches. The patient was hospitalized at an unspecified facility on unspecified dates. The outcome was reported as recovered/resolved. The patient sought medical attention because she was hospitalized. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza, Vomiting
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 54 years old female patient with allergies to iodinated contrast media, allergies to indomethacin. The patient was vaccinated with ZOSTAVAX (0.65 ml, lot # 0256AE, expiration date 14-MAR-2013) on 28-JUN-2012. Concomitant therapy included VALTREX, it prescribed on 30-APR-2012 for the flu, not in sufficient quantity for the patient to have still been taking it at the time of ZOSTAVAX administration. The patient returned to the pharmacy on 06-AUG-2012. Approximately on 23-JUL-2012 the patient "flu from hell for the past two weeks" and experienced chills, low body temperature of 93.5 degrees Fahrenheit, vomiting for 320 hours, dehydration, severe headache and severe joint aches. The patient was hospitalized at an unspecified facility on unspecified dates. The outcome was reported as recovered/resolved. The patient sought medical attention because she was hospitalized. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, FLUN3, IPV, MMR, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: 4 year vaccines were given on 08-15-12. Pt. started with a hive-like rash on (L) leg after vaccines were administered. BENADRYL given and rash resolved.
Age: 0.21
Sex: M
Vaccine: HIBV, IPV, PNC13, RV5
Symptoms: Pyrexia, Vomiting, White blood cell count increased
Clinical narrative: Infant developed fever to 102.9 within 12 hours following vaccine administration. Had 2 episodes of vomiting.
Age: 67.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Dyspnoea, Injection site erythema, Injection site swelling
Clinical narrative: Large red swelling at ZOSTAVAX injection site extending to the elbow. Difficulty breathing at bedtime plus or minus 4 1/2 hrs after.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Bed sharing, Death, Sudden infant death syndrome
Clinical narrative: We would like to report that this death occurred within one week of 2 month vaccines. Coroner reported cause of death undetermined - possible SIDS vs. co-sleeping.
Age: 18.0
Sex: M
Vaccine: HEP, MNQ, TDAP
Symptoms: Acute myocardial infarction, Arteriospasm coronary
Clinical narrative: Coronary spasm, acute myocardial infarction.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Pancreatitis
Clinical narrative: Pancreatitis.
Sex: F
Vaccine: HPV4
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Premature baby, Wrong drug administered
Clinical narrative: Information has been received from a physician and a Registered Nurse for GARDASIL, a Pregnancy Registry Product, concerning a female infant. The infant's mother (captured in case # 1101USA03064) was vaccinated IM inadvertently with a 0.5ml dose of GARDASIL (lot#666162/0565Z) instead of an unnamed influenza vaccine on 25-JAN-2011. Concomitant therapy included prenatal vitamins (unspecified). On an unspecified date, a pregnancy test ultrasound was performed and found pregnancy. Patient's last menstrual period was 15-NOV-2010. Expected date of delivery was 22-AUG-2011. On 24-JUL-2011 at 35 weeks and 6 days of gestation, the mother delivered a female baby (premature baby), with apgar score were 8 and 9, birth weight 4 lbs 15.8 Oz. Pediatric medical records were received and reviewed; no adverse experiences related to the prenatal exposure or to other Merck Products were identified. Additional information is not expected.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Wrong technique in drug usage process
Clinical narrative: Patient was given the hib vaccine that was reconstituted with the wrong diluent. Vaccine will be repeated.
Age: 24.0
Sex: M
Vaccine: VARCEL
Symptoms: Cold sweat, Fall, Loss of consciousness, Pallor, Tremor
Clinical narrative: 5:50 pm: Inject 0.23 ml VARIVAX. Pt becomes unconscious, slips to floor. Shakes x 3 sec, pale. 911 called. Recovers after 15 seconds with cold, clammy skin. Uses cold pak to face. BP taken 5 times. Skin color returns to normal. Pt states no adverse effects. Leaves 50 minutes after reaction 6:40 pm.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Rash maculo-papular, Rash pruritic
Clinical narrative: Maculopapular itchy rash arms and legs.
Age: 32.0
Sex: F
Vaccine: HEPAB
Symptoms: Dizziness, Hyperhidrosis, Hypoaesthesia, Nausea
Clinical narrative: Light headed, diaphoretic, very mild numbness in (rt) hand, mild nausea. Did not loose consciousness. Pt alert with good color & talking. Pulse 64 & strong.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 48 hrs after injection developed redness and swelling at injection site.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash papular
Clinical narrative: Erythematous papular confluent 3-4 cm.
Age: 17.0
Sex: M
Vaccine: HPV4, IPV
Symptoms: Syncope
Clinical narrative: Client in room 10 min after injections left & fainted in lobby in chair. Did not have breakfast or anything to eat prior to coming to health department was given food & drink before leaving health department.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Rash (itchy, painful at injection site). 2 1/2 inches started Thurs AM.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site mass, Joint swelling, Tenderness, Vaccination site pain
Clinical narrative: Pt described lump tender at site of vaccination later that day then noted pain --> L arm to radial aspect wrist with some swelling & tenderness she did not treat - came into office 8/10/12 approximately exam some minor swelling L wrist minor tenderness no erythema no mass or tenderness at injection site. Of note pt had IV infusion in wrist area 2 wks prior to vaccine - no adverse events post IV infusion.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Small fluid filled rash noted - took to urgent care 8/4/12 & Dx with chicken pox - had VARIVAX #1 12/02/02 #2 12/11/07.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Crying, Injection site haematoma, Musculoskeletal pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Bruising at site of injection. Major pain and soreness for 10 days. Pain in arm and shoulder. Stiffness in arm. Patient in tears.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Culture negative, Depressed level of consciousness, Electrocardiogram abnormal, Electroencephalogram normal, Gaze palsy
Clinical narrative: The patient received routine immunizations at his well baby visit on 4/6/12; a few hours later he was noted to be sleeping longer than his usual nap. Mom found him difficult to arouse, limp and with his eyes "rolled back". He transported to ER then hosp. for 2 days and was normal by exam and monitoring. His LP, septic w/o cultures. Chemistry panel and toxic screen were normal. An out-pt. EEG was normal. Mild pulmonic stenosis. Hemodynamically stable, no arrythmia, atrial septal defect.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Hypotonia, Laboratory test normal, Lumbar puncture normal, QRS axis abnormal, Somnolence
Clinical narrative: The patient received routine immunizations at his well baby visit on 4/6/12; a few hours later he was noted to be sleeping longer than his usual nap. Mom found him difficult to arouse, limp and with his eyes "rolled back". He transported to ER then hosp. for 2 days and was normal by exam and monitoring. His LP, septic w/o cultures. Chemistry panel and toxic screen were normal. An out-pt. EEG was normal. Mild pulmonic stenosis. Hemodynamically stable, no arrythmia, atrial septal defect.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Toxicologic test normal
Clinical narrative: The patient received routine immunizations at his well baby visit on 4/6/12; a few hours later he was noted to be sleeping longer than his usual nap. Mom found him difficult to arouse, limp and with his eyes "rolled back". He transported to ER then hosp. for 2 days and was normal by exam and monitoring. His LP, septic w/o cultures. Chemistry panel and toxic screen were normal. An out-pt. EEG was normal. Mild pulmonic stenosis. Hemodynamically stable, no arrythmia, atrial septal defect.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Mobility decreased, Pain in extremity, Rash
Clinical narrative: Patient developed large rash and pain in injected arm on 7/27. Presented on 7/28 and could barely move her arm. Followed up with her on 7/30 and she was doing better. She self treated w/ibuprofen, ice, and BENADRYL.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Joint injury, Loss of consciousness
Clinical narrative: After receiving shot, patient waited 15 minutes then drove to get some food. Patient got out of car and felt dizzy then passed out and hurt wrist. Some bystanders helped her to her feet.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Cold sweat, Dizziness, Protein urine present, Staring, Yawning
Clinical narrative: We cked out of Dr. office at 201 pm took elevator down 2 floors she was laughing/joking and just as about to walk through - to have blood drawn (came back normal) said felt dizzy - Lab tech she doesnt like shots - said dizzy she drew blood by 205 she shut her eyes after blank cold stare, and yawned several times - cold clammy - so still like frozen - her BP was 121/63 in appt when left office was - 88 about. BP was 121/63 when cked in Dr. office - shot was given - Patient asked- if suppose to hurt ? - was laughing and planning lunch and afternoon plans and just like that she stopped and said "I feel dizzy - really dizzy" - lab teach OR your fine - I explained something is wrong she is not afraid of shots - (grew up in hospitals) he proceed and as taking off rubber strip about 204 pm patient was like frozen and staring out at nothing - just as fast she shut her eyes and the lab tech put her head back she kept yawning - and then just stopped - perfectly still - cold and clammy you couldn't even tell if she was breathing - I told please call code help me move her she was like frozen in the chair  couldn't move her - she came too about 235-240 pm - said felt dizzy still and like she was out off her body - taken back up
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Cold sweat, Feeling cold, Pallor
Clinical narrative: We cked out of Dr. office at 201 pm took elevator down 2 floors she was laughing/joking and just as about to walk through - to have blood drawn (came back normal) said felt dizzy - Lab tech she doesnt like shots - said dizzy she drew blood by 205 she shut her eyes after blank cold stare, and yawned several times - cold clammy - so still like frozen - her BP was 121/63 in appt when left office was - 88 about. BP was 121/63 when cked in Dr. office - shot was given - Patient asked- if suppose to hurt ? - was laughing and planning lunch and afternoon plans and just like that she stopped and said "I feel dizzy - really dizzy" - lab teach OR your fine - I explained something is wrong she is not afraid of shots - (grew up in hospitals) he proceed and as taking off rubber strip about 204 pm patient was like frozen and staring out at nothing - just as fast she shut her eyes and the lab tech put her head back she kept yawning - and then just stopped - perfectly still - cold and clammy you couldn't even tell if she was breathing - I told please call code help me move her she was like frozen in the chair  couldn't move her - she came too about 235-240 pm - said felt dizzy still and like she was out off her body - taken back up
Age: 16.0
Sex: F
Vaccine: HEP, HPV4, MNQ
Symptoms: Dizziness, Syncope
Clinical narrative: Patient fainted & slid to floor following immunizations. After patient laying down and given fluids pt still feeling faint, dizzy.
Age: 19.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Muscle tightness
Clinical narrative: Muscular tightness (R) deltoid - couldn't lift arm. Onset within 2 hrs. lasted 72 hours Tx with MOTRIN.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Gaze palsy, Loss of consciousness
Clinical narrative: About 2 minutes after administration of BOOSTRIX shot IM (right arm), pt experienced a brief episode loss of consciousness with eyes rolled back, but regained. Paramedics were notified, arrived and spoke with pt.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site vesicles, Oedema peripheral, Pain in extremity
Clinical narrative: Erythema & swelling of arm with pain 3.0 x 5.5 area of large confluent vesicles at site treated with DIPROLENE ointment, VALTREX 1 gm tid x 1 wk, area bandaged.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Fall, Tremor
Clinical narrative: After receiving MENACTRA pt. fell back onto exam table - shook for 1-2 seconds & then sat back up by herself - total incident time 5-7 seconds.
Age: 8.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, Pain in extremity, Wrong drug administered
Clinical narrative: Mother brought child to Doctor to get Varicella #2.  Instead Doctor gave her Hep A #2. She just received her Hep A #2 three weeks earlier from Dr. Then he wanted to give client her 2nd Varicella and her mother woudn't allow it. Mother stated client stated she had more pain in Left arm due to 3rd Hep !.  Told mother to give Ibruprofen as needed, maybe use a cool compress on area and move the arm around.
Age: 48.0
Sex: F
Vaccine: ANTH
Symptoms: Dizziness, Influenza like illness, Pain, Pain in extremity, Pyrexia
Clinical narrative: Initial flu-like symptoms.  Achy, fever, light-headed, progressing to soreness in torso and arm.  Arm and torso felt heavy like a stone.
Age: 48.0
Sex: F
Vaccine: ANTH
Symptoms: Sensation of heaviness
Clinical narrative: Initial flu-like symptoms.  Achy, fever, light-headed, progressing to soreness in torso and arm.  Arm and torso felt heavy like a stone.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash maculo-papular
Clinical narrative: Macular/papular rash, right back and chest followed nerve distribution.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Pt was given 1) Tdap, 2) HPV, 3) MCV-4, 4) Varicella, in the above order. Pt fainted after the 4th shot. Regained consciousness instantly. BP after fainting 122/64 HR 84 & regular.
Age: 15.0
Sex: M
Vaccine: TYP
Symptoms: Computerised tomogram, Dizziness, Facial bones fracture, Fall, Loss of consciousness
Clinical narrative: Pt felt dizzy after vaccination, passed out and fell, hitting tile floor.  LOC x 5 seconds.  Pt dx c left orbital fracture (lateral & inferior wall).  Pt hadn't eaten breakfast prior to vaccination.
Age: 45.0
Sex: M
Vaccine: MMR
Symptoms: Cough, Dyspnoea, Urticaria
Clinical narrative: Hives difficulty breathing including cough within about 30 min. of the MMR vaccine. Treated in Emergency Room with epinephrine and "breathing treatment". Resolved.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pallor
Clinical narrative: Pt was seated during administration.  Within 5 minutes patient became pale and light headed.  Pt was reclined on table with feet elevated.  After 20 minutes, patient felt better to leave.
Age: 5.0
Sex: M
Vaccine: DTAP, VARZOS
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Injection site rash, Injection site vesicles, Oedema peripheral, Pain in extremity
Clinical narrative: PAINFUL SWOLLEN RED ARM. NOT HOT TO THE TOUCH. BLISTERS/BUMPS AT INJECTION SITE.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Erythema, Feeling hot, Lymphadenopathy, Pruritus
Clinical narrative: Starting itching, swelling, hot, red with rash. First noticed rash on forearm. Pain under arm with swollen lymph in axilla area. Continued to worsen over several days. By 08/13/2012 showed to Medical Doctor and started ice and heat. Started looking and feeling better by 08/16/2012. No other treatments. MD stated reaction to the vaccination.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Swelling, Vaccination complication
Clinical narrative: Starting itching, swelling, hot, red with rash. First noticed rash on forearm. Pain under arm with swollen lymph in axilla area. Continued to worsen over several days. By 08/13/2012 showed to Medical Doctor and started ice and heat. Started looking and feeling better by 08/16/2012. No other treatments. MD stated reaction to the vaccination.
Age: 64.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Burning sensation, Dizziness, Dyspnoea, Throat tightness
Clinical narrative: Dizzy, light headed, burning sensation on the chest. And 2 min after c/o throat tightness w/ difficulty breathing.
Age: 1.02
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Local reaction, Rash
Clinical narrative: Patient received MMR, varicella & PREVNAR 13 vaccines on 8/17/2012. Parent noted local reaction "rash" 8/18/2012. Patient seen in office 8/19/2012 - left thigh at injection site red, firm, slightly tender. No fluctuance, blanches well. About 3 cm in diameter. Treatment: MOTRIN, BENADRYL, cool compresses per dr.
Age: 29.0
Sex: F
Vaccine: FLUN3
Symptoms: Dyspnoea, Ear, nose and throat examination, Nausea, Tachycardia
Clinical narrative: TACHYCARDIA, DIFFICULTY BREATHING, NAUSEA.
Age: 0.43
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Electroencephalogram normal, Muscle twitching, Posture abnormal, Pupil fixed, Staring
Clinical narrative: Staring to right with fixed pupils and right hand twitching with fist postured outward, then fell asleep. Happened again on 08/02/2012 and 08/07/2012 same time of day.
Age: 0.43
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Sudden onset of sleep
Clinical narrative: Staring to right with fixed pupils and right hand twitching with fist postured outward, then fell asleep. Happened again on 08/02/2012 and 08/07/2012 same time of day.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling @ injection site.
Age: 58.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Headache, Injection site cellulitis, Injection site discolouration, Injection site erythema
Clinical narrative: Pt states that she woke up to find redness @ right arm approx 1.5 x 2 inches in size.  By that evening it was 2.5 X 3 inches in size. By next Am, redness was 5 X 6 inches, "about the size of a lemon", between her elbow and underarm.  Stated it looked like cellulitis, had a black dot in the center, was very itchy.  c/o headache.  Went to facility, was given Benadryl and Prednisone.  Also used ice, hydrocortisone cream and Advil.
Age: 58.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pruritus
Clinical narrative: Pt states that she woke up to find redness @ right arm approx 1.5 x 2 inches in size.  By that evening it was 2.5 X 3 inches in size. By next Am, redness was 5 X 6 inches, "about the size of a lemon", between her elbow and underarm.  Stated it looked like cellulitis, had a black dot in the center, was very itchy.  c/o headache.  Went to facility, was given Benadryl and Prednisone.  Also used ice, hydrocortisone cream and Advil.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: MCV-4 vaccine given in clinic on 8/14/12. Injection site became swollen, reddened, & warm to touch by 8/16/12. Golf ball size.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Contusion, Erythema, Pain, Pruritus
Clinical narrative: Welt, redness, hot to touch 3"x3" area with smooth edge. "Felt on fire" painful to touch - started day of vaccine. Today heat is resolved, area very itchy & pink in color - feels bruised.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm, Urticaria
Clinical narrative: Welt, redness, hot to touch 3"x3" area with smooth edge. "Felt on fire" painful to touch - started day of vaccine. Today heat is resolved, area very itchy & pink in color - feels bruised.
Age: 16.0
Sex: F
Vaccine: HEP, HEPA, IPV, MNQ, TDAP, VARCEL
Symptoms: Cold sweat, Dizziness, Gaze palsy, Pallor, Skin discolouration
Clinical narrative: Clammy palms, dizziness, dusty color skin, paleness, unresponsive, eyes rolled.
Age: 16.0
Sex: F
Vaccine: HEP, HEPA, IPV, MNQ, TDAP, VARCEL
Symptoms: Unresponsive to stimuli
Clinical narrative: Clammy palms, dizziness, dusty color skin, paleness, unresponsive, eyes rolled.