chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a quality control individual at a medical facility refers to a patient of unknown age. On 06-NOV-2012, the patient was vaccinated with a dose of M-M-R II (lot # 0682AE, exp: 26-JAN-2014) (Dose and route were not reported). No other co-suspects were reported. No concomitant medications were reported. The reported called for a patient who were administered M-M-R II that was exposed to an unsupported temperature excursion (10.1C for 96 hours). No adverse effect reported. This is one of seven reports from the same source. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site joint pain
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 23 year old female patient with no pertinent medical history and no drug reactions/allergies. On 29-JAN-2013 the patient was vaccinated with her first dose of GARDASIL (lot # H013831, exp. Date: 15-JAN-2014) in the arm. On 01-FEB-2013, the patient developed shoulder joint pain. The painful shoulder was the same one as the injection. The outcome of shoulder joint pain was reported as not recovered. The patient called the office for medical attention. No treatment was given and no lab diagnostics studies were performed. Additional information is not expected.
Age: 46.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 46 year old female patient who on 24-OCT-2012 at 1:27 pm, was vaccinated intramuscularly in the deltoid with the first dose of LIQUID PEDVAXHIB (lot#H012570, dose and expiration date not reported). The patient received LIQUID PEDVAXHIB in error when she was supposed to get an unspecified Hepatitis B Vaccine. There was no adverse event. This is one of several reports received from the same source (other patients are captured under MARRS # 1211USA004476, 1302USA004704 and 1302USA004705). Additional information is not expected.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Infection, Injection site erythema, Injection site swelling, Oedema peripheral, Pyrexia
Clinical narrative: The patient reported his whole arms get red & swollen, especially around the elbow area where the shot was given. Saw MD & got antibiotics for infection. Patient also had low grade fever.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Chills, Decreased appetite, Diarrhoea, Erythema
Clinical narrative: The patient reported his whole arms get red & swollen, especially around the elbow area where the shot was given. Saw MD & got antibiotics for infection. Patient also had low grade fever.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hyperhidrosis, Injection site swelling, Nasal mucosa biopsy, Urine analysis, Viral infection
Clinical narrative: The patient reported his whole arms get red & swollen, especially around the elbow area where the shot was given. Saw MD & got antibiotics for infection. Patient also had low grade fever.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Viral test positive
Clinical narrative: The patient reported his whole arms get red & swollen, especially around the elbow area where the shot was given. Saw MD & got antibiotics for infection. Patient also had low grade fever.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Biopsy bone marrow, Contusion, Fatigue, Feeling abnormal
Clinical narrative: March 17, 2010, I had a physical.  I was very healthy.  My platelets were 209,000.  On April 1, 2010, I had the Shingles Vaccine administered.  I went home feeling bad from the vaccine and had to go to bed.  Within weeks, I noticed bruising on legs, hips, and stomach.  By May 24, 2010, I had approximately 20 bruises on my legs, hip, across stomach.  I had lots of petechia's on legs.  I was very weak and tired.   On May 24, 2010, I saw Dr. Internal Medicine.  Blood test was taken and my platelets were only 6,000.  Dr. referred me to the Cancer Center. I was told I had I.T.P. I was put on high doses of Prednisone - 4.5 months.  June 2010, IVIG'S every 4 - 6 weeks until November 2011.  I had 4 treatments of Retuxin in June & July, 2010.  June 16, 2010, at the hospital I had a Bone Marrow Biopsy.  I was told I definately had I.T.P. in which there is NO cure. In 2011, I was taking IVIG's & Danazol.  After 15 times having IVIG's, they seem to quit working and the trauma was unbelieveable.  Platelets continued to drop to 6,000.  In April, 2011, I had appointment at another facility and the hematologist verified that the cause of having I.T.P. was due to the Shingles Vaccine.  There is NO Cure for I.T.P.  It is a bleeding disorder.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count, Idiopathic thrombocytopenic purpura, Immunoglobulin therapy, Petechiae, Platelet count decreased
Clinical narrative: March 17, 2010, I had a physical.  I was very healthy.  My platelets were 209,000.  On April 1, 2010, I had the Shingles Vaccine administered.  I went home feeling bad from the vaccine and had to go to bed.  Within weeks, I noticed bruising on legs, hips, and stomach.  By May 24, 2010, I had approximately 20 bruises on my legs, hip, across stomach.  I had lots of petechia's on legs.  I was very weak and tired.   On May 24, 2010, I saw Dr. Internal Medicine.  Blood test was taken and my platelets were only 6,000.  Dr. referred me to the Cancer Center. I was told I had I.T.P. I was put on high doses of Prednisone - 4.5 months.  June 2010, IVIG'S every 4 - 6 weeks until November 2011.  I had 4 treatments of Retuxin in June & July, 2010.  June 16, 2010, at the hospital I had a Bone Marrow Biopsy.  I was told I definately had I.T.P. in which there is NO cure. In 2011, I was taking IVIG's & Danazol.  After 15 times having IVIG's, they seem to quit working and the trauma was unbelieveable.  Platelets continued to drop to 6,000.  In April, 2011, I had appointment at another facility and the hematologist verified that the cause of having I.T.P. was due to the Shingles Vaccine.  There is NO Cure for I.T.P.  It is a bleeding disorder.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, VARZOS, VARZOS
Symptoms: Accidental exposure
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unspecified gender. On 08-FEB-2013 the patient was vaccinated with ZOSTAVAX (lot #, dose and route not reported) instead of PROQUAD (Merck). No adverse effects reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, VARZOS, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unspecified gender. On 08-FEB-2013 the patient was vaccinated with ZOSTAVAX (lot #, dose and route not reported) instead of PROQUAD (Merck). No adverse effects reported. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness & tingling throughout body & weakness only treatment so far is being placed on steroids.
Age: 56.0
Sex: F
Vaccine: HIBV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 56 year old female who on 23-OCT-2012 at 6:22 pm, was vaccinated intramuscularly in the deltoid with the dose of PEDVAXHIB (lot # H012570, dose and expiration date not reported). The patient received PEDVAXHIB in error when she was suppose to get an unspecified Hepatitis B Vaccine. The patient was vaccinated intramuscularly in the deltoid with a dose of RECOMBIVAX HB (lot number H014132, expiration date: 08-FEB-2015, dose not reported) on 15-NOV-2012 at 1:36 pm. There was no adverse event. This is one of several reports received from the same source (other patients are captured under MARRS # 1211USA004476, 1302USA004704 and 1302USA004703). Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with the first dose of GARDASIL and then did not received the 2nd dose until 2 years later. A 3rd dose may have been given 2 months after the 2nd dose. No vaccination dates were available. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report has been received from a pharmacist. The pharmacist stated that he was aware that ZOSTAVAX was being administered to people younger than 50 years of age, and that insurance would pay for the dose of ZOSTAVAX administered to people under the age of 50. At the time of report, she did not have any specific patients or situations to report. The information was not available on any specific patient. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Swollen tongue
Clinical narrative: Erythema & induration w/in 10 min of injection. Swelling of tongue after 15 minutes.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a nurse who is also the female patient of unknown age. No medical history or concurrent conditions were reported. The patient was not pregnant. On 05-FEB-2013 the patient was vaccinated with ZOSTAVAX, intramuscular. No dosage information, lot number or expiration date was reported. No other co-suspects were reported. No concomitant medications were reported. On 06-FEB-2013, the patient developed "redness, pruritus, warmth and swelling about the size of an orange" around the injection site. It is unknown if the patient sought medical attention or received treatment for the adverse event. The outcome of redness, pruritus, warmth and swelling about the size of an orange around the injection site was reported as not recovered. No causality statement was provided by the reporter. No further information was provided. Additional information is not expected.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Influenza like illness, Injected limb mobility decreased, Nausea, Pain
Clinical narrative: Swelling, severe pain, unable to raise left arm. Nausea, feels flu-like symptoms-no fever-chills, feels like she is going to pass out. Symptoms began 2.14.13.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Swelling, severe pain, unable to raise left arm. Nausea, feels flu-like symptoms-no fever-chills, feels like she is going to pass out. Symptoms began 2.14.13.
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to an unspecified patient. On an unknown date the patient was to received VARIVAX (Merck) however vaccinated with ZOSTAVAX (dose, route and lot # not reported) in error. Additional information has been requested.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 49.0
Sex: M
Vaccine: FLUX, TDAP
Symptoms: Dysphonia
Clinical narrative: 3 days after the vaccine, pt has been having hoarseness of voice.
Age: 1.02
Sex: F
Vaccine: DTAPIPV, MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: Rash.
Age: 63.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site pain, Nerve injury, Pain
Clinical narrative: Debilitating, non stop pain in place where shot hit a nerve. Can't carry or lift a dish without pain. All topicals for pain relief, ice packs, message, 4 bottles BIO PROZYME, red clover, agonizing movement to prevent frozen shoulder.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a quality control individual at a medical facility refers to a patient of unknown age. On 09-NOV-2012, the patient was vaccinated with a dose of MMR II (lot # 0234AE, exp: 26-JAN-2014) (Dose and route were not reported). No other co-suspects were reported. No concomitant medications were reported. The reported called for a patient who were administered MMR II that was exposed to an unsupported temperature excursion (10.1 C for 96 hours). No adverse effect reported. This is one of seven reports from the same source. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Local swelling, Musculoskeletal stiffness
Clinical narrative: Stiffness and swelling in the left shoulder decreased range of motion.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Loss of consciousness, Road traffic accident, X-ray normal
Clinical narrative: Approximately 15-20 minutes after receiving vaccine patient reportedly felt dizzy, then "passed out" while driving home - resulted in her rear ending auto in front of her.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a quality control individual at a medical facility refers to a patient of unknown age. on 08-NOV-2012, the patient was vaccinated with a dose of MMR II (lot # 0682AE, exp: 02-APR-2014) (Dose and route were not reported). NO other co-suspects were reported. No concomitant medications were reported. The reported called for a patient who was administered MMR II that was exposed to an unsupported temperature excursion (10.1C for 96 hours). No adverse effect reported. This is one of seven reports from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Erythema, Pain
Clinical narrative: Pt received varicella zoster on 2-12-13 SQ in the (R) upper thigh. 2 days later, mom reports red, sore area appx 3 " x 1 3/4" red circle. Told to give 50 mg BENADRYL Q6h, ADVIL Q6h, ice area, and cortisone cream on the area. Mom drew circle around spot. Pt came to office this morning because area increased by appx 1/2" outside circle. Doctor saw pt and instructed to continue treatment.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Drug administered at inappropriate site, Injected limb mobility decreased, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Flu shot injection given into left shoulder instead of left arm.  Within approximately 24 hours I was unable to raise upper left arm or rotate forward/backward beyond approx ~ 5 degrees.  Pain radiates downward from/thru rotator cuff downward into the bicep and tricep area's, occasionally all the way to left elbow.  Simple action such as dressing impossible with left arm.  I have sleep depravation due to heavy pain in my left shoulder/arm caused by even the  slightest movement or rolling onto my left side during sleep.  I am unable to use arm to help rise from prone position to seated position.  I have to hold left arm with my right just to get out of bed.  I am unable to lift anything heavier than 2-3 lbs. without initiating pain. At 2-1/2 months pain begin to subside and range of motion had slowly increased.  At 4 months my range of motion has increased to approximately 90 degrees upward (with the arm in a vertical or down position).  Visited my doctor after 4 weeks and received a steroid shot in shoulder.  Revisited doctor at 8 weeks and was referred to orthopedist. At week 10 he ordered an MRI and at week 12 was unable to determine cause of problem.  His opinion was nerve damage from injection and I was told to give it more time to heal.  If no improvement in a month to see him again.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Sleep disorder
Clinical narrative: Flu shot injection given into left shoulder instead of left arm.  Within approximately 24 hours I was unable to raise upper left arm or rotate forward/backward beyond approx ~ 5 degrees.  Pain radiates downward from/thru rotator cuff downward into the bicep and tricep area's, occasionally all the way to left elbow.  Simple action such as dressing impossible with left arm.  I have sleep depravation due to heavy pain in my left shoulder/arm caused by even the  slightest movement or rolling onto my left side during sleep.  I am unable to use arm to help rise from prone position to seated position.  I have to hold left arm with my right just to get out of bed.  I am unable to lift anything heavier than 2-3 lbs. without initiating pain. At 2-1/2 months pain begin to subside and range of motion had slowly increased.  At 4 months my range of motion has increased to approximately 90 degrees upward (with the arm in a vertical or down position).  Visited my doctor after 4 weeks and received a steroid shot in shoulder.  Revisited doctor at 8 weeks and was referred to orthopedist. At week 10 he ordered an MRI and at week 12 was unable to determine cause of problem.  His opinion was nerve damage from injection and I was told to give it more time to heal.  If no improvement in a month to see him again.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Expired drug administered
Clinical narrative: Was given expired Pentacel.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Gaze palsy, Musculoskeletal stiffness, Petit mal epilepsy, Unresponsive to stimuli
Clinical narrative: During Occupational Therapy Session at Babysitter's house, the child suddenly stiffened, eyes rolled up slightly, mouth remained opened and became completely non-responsive to his surroundings for approximately 15-20 seconds. Both his baby sitter and therapist attempted to rouse him by clapping hands loudly near him, making noises and calling his name. He finally roused himself and returned to his normal state as if nothing had happened.  A second incident occurred on 02/15/13 at 9:35am but only lasted for 5-10 seconds.  Child was not ill, not running a fever, has not had any falls or trauma to head and has not had a history of similar types of "absence seizures" in past.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Nausea, Pallor, Retching
Clinical narrative: Pt verbalized being nervous and having history of "passing out" stating he doesn't like needles. After vaccine was administered, Pt stopped talking, became pale and closed eyes, this lasted a few seconds, pt opened eyes and skin color became very pink, pt began to speak again, then color turned pale, pt stated he felt nausea, dry heaved twice, after approx 10 min pt color had returned to natural color and nausea had past.
Sex: F
Vaccine: HEP
Symptoms: Cardio-respiratory arrest neonatal, Convulsion
Clinical narrative: Heart stopped, stopped breathing and seizures... Given anti seizure medication and shipped to hospital. Continued testing and medications one week..parenteral nutrition, oxygen therapy... Monitor for seizures and developmental delays upon discharge.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Student pregnant 3 months. Gave HPV vaccine.
Age: 1.28
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 11 February 2013 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 2-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 4 doses of PENTACEL on 04 February 2011, 04 April 2011, 02 June 2011, and 15 March 2012 (lot numbers, routes, and sites of administration not reported). The subject developed a cough on 03 January 2013, approximately 9 months after the last dose, and a paroxysmal cough without a whoop on 04 January 2013. The subject also developed cold like symptoms on 31 December 2012 and posttussive vomiting and sleep disturbance (start date not reported). Laboratory testing included positive PCR on 09 January 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 09 January 2013 for 5 day. The subject was not hospitalized. At the time of final contact on 25 January 2013, the subject's cough was not persisting. The duration of the cough was reported at that time as 20 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.28
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 11 February 2013 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 2-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 4 doses of PENTACEL on 04 February 2011, 04 April 2011, 02 June 2011, and 15 March 2012 (lot numbers, routes, and sites of administration not reported). The subject developed a cough on 03 January 2013, approximately 9 months after the last dose, and a paroxysmal cough without a whoop on 04 January 2013. The subject also developed cold like symptoms on 31 December 2012 and posttussive vomiting and sleep disturbance (start date not reported). Laboratory testing included positive PCR on 09 January 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 09 January 2013 for 5 day. The subject was not hospitalized. At the time of final contact on 25 January 2013, the subject's cough was not persisting. The duration of the cough was reported at that time as 20 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 11 February 2013 from the Investigator participating in the study under the reference number M5A16. A case of pertussis disease in a 10-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; Lot number C4131AA received on 26 March 2012, lot number C4144AA received on 22 May 2012, and lot number C4270AA received on 27 July 2012 (routes and sites of administration not reported). The subject developed a cough on 07 December 2012, approximately 4 months after the last dose, and a paroxysmal cough with a whoop on 08 December 2012. The subject also developed cold like symptoms on 07 December 2012 and posttussive vomiting and sleep disturbance (start dates not reported). Laboratory testing included positive PCR on 09 December 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 09 December 2012 for 5 day. The subject was not hospitalized. At the time of final contact on 07 January 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 31 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 11 February 2013 from the Investigator participating in the study under the reference number M5A16. A case of pertussis disease in a 10-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; Lot number C4131AA received on 26 March 2012, lot number C4144AA received on 22 May 2012, and lot number C4270AA received on 27 July 2012 (routes and sites of administration not reported). The subject developed a cough on 07 December 2012, approximately 4 months after the last dose, and a paroxysmal cough with a whoop on 08 December 2012. The subject also developed cold like symptoms on 07 December 2012 and posttussive vomiting and sleep disturbance (start dates not reported). Laboratory testing included positive PCR on 09 December 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 09 December 2012 for 5 day. The subject was not hospitalized. At the time of final contact on 07 January 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 31 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: (L) arm 4 inches swelling & erythema no pain or fever at side of DTP.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Next am pt arms got red bumps at injection site- (R) deltoid. 1 3/4" x 1 1/4" (L) deltoid 4 1/2" x 2". Rx BENADRYL 3/4 tsp TID x 5 days warm compresses.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Pt not normally given adult dose Hep B until 19. Pt is only 18. No adverse reaction.
Age: 0.45
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Convulsion, Dyskinesia, Gaze palsy, Laboratory test, Mood altered
Clinical narrative: Vaccines DTaP/IPV/Hep B, PREVNAR, Hib, Rota Wednesday. Thursday baby woke up "altered". Noon had 3 min seizure eyes rolled back jerking ext -> ER then seen in office, awake but after ictal. Later approximately 3p had another seizure < 4 min same no ER. Friday hosp for complete workup - results (P).
Age: 0.45
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Postictal state
Clinical narrative: Vaccines DTaP/IPV/Hep B, PREVNAR, Hib, Rota Wednesday. Thursday baby woke up "altered". Noon had 3 min seizure eyes rolled back jerking ext -> ER then seen in office, awake but after ictal. Later approximately 3p had another seizure < 4 min same no ER. Friday hosp for complete workup - results (P).
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Aphasia, Diplegia, Electromyogram abnormal, Endotracheal intubation, Hyporeflexia
Clinical narrative: 3 wk after vaccination pt had acute paralysis of upper and lower extremities, required intubation & ventilation, and hospitalization. Pt also had severe pain in (L) arm immediately after vaccination.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Mechanical ventilation, Mobility decreased, Nerve conduction studies abnormal, Neurological examination abnormal
Clinical narrative: 3 wk after vaccination pt had acute paralysis of upper and lower extremities, required intubation & ventilation, and hospitalization. Pt also had severe pain in (L) arm immediately after vaccination.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: 3 wk after vaccination pt had acute paralysis of upper and lower extremities, required intubation & ventilation, and hospitalization. Pt also had severe pain in (L) arm immediately after vaccination.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Intussusception. After vaccine had watery stools x 5 days.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Wrong drug administered
Clinical narrative: Pt presented 2/13 for ppd placement; had mild diffuse redness at site. Evaluated by a provider, thought to be a mild allergic reaction.  Staff checked lot # and expiration date documented - it didn't match with tubersol, but did with Fluzone.  Pt informed of error, no adverse events expected, verbalized understanding.
Age: 1.73
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Eye movement disorder, Tonic clonic movements
Clinical narrative: A few tonic clonic jerks and eye rolling at breakfast while in her high chair.
Age: 11.0
Sex: M
Vaccine: FLUN3, TDAP
Symptoms: VIIth nerve paralysis
Clinical narrative: Flu Mist.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient came in on 2/15/2013 to report redness at the site that spanned about 4 inches in diameter. No other symptoms.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Right arm where vaccine was administered is raised, hard, red, and warm to touch.
Age: 30.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Back pain, Sleep disorder
Clinical narrative: 2/13 Distinct moderate back pain along lower half of spine not at all resembling muscle aches. 2/14 Pain mostly only in lower back but intense and sustained enough to disrupt sleep. 2/15 Persistent lower back pain distinct from normal muscle aches.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Insulin resistance test, Insulin resistant diabetes, Type 1 diabetes mellitus
Clinical narrative: Patient was diagnosed with type 1 diabetes.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site swelling, Joint stiffness
Clinical narrative: SWOLLEN INJECTION SITE, WITH NUMBNESS TO THE LEFT ARM AND LEFT SIDE OF BODY. SX RESOLVED EXCEPT FOR RESIDUAL SENSATION OF TIGHTNESS TO HIS LEFT HAND.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Blood test, Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: After receiving the flu shot I felt pain in my arm at the injection site.  This is normal. I've had a flu shot every year for at least the past ten years. However, the pain persisted and after a few weeks spread to my shoulder.  I called my doctor two or three times within the first month and was told to take Naproxen and use ice or steam on the area.  My arm became stiffer.  I made an appointment with this internist plus another appointment with a doctor outside of Northwestern.  I was told by my doctor to continue taking Aleve and icing the area and if it didn't improve, go to physical therapy.  I also did blood work at the other doctor's office, which proved nothing.  I went three times to a chiropractor who did massage, electronic stimulation, accupuncture, ultra sound on my arm with no real improvement.  I started with an integrated internist who sent me to an orthopedic doctor and a neurologist (appointment next week).  The orthopedic doctor ordered an MRI which showed a "frozen Shoulder".  He told me to take Naproxen twice per day and go to physical therapy, which I've been doing 2-3 times per week this month so far.  There is some improvement, but I still have pain and limited mobility in the shoulder.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Periarthritis, Ultrasound scan, X-ray
Clinical narrative: After receiving the flu shot I felt pain in my arm at the injection site.  This is normal. I've had a flu shot every year for at least the past ten years. However, the pain persisted and after a few weeks spread to my shoulder.  I called my doctor two or three times within the first month and was told to take Naproxen and use ice or steam on the area.  My arm became stiffer.  I made an appointment with this internist plus another appointment with a doctor outside of Northwestern.  I was told by my doctor to continue taking Aleve and icing the area and if it didn't improve, go to physical therapy.  I also did blood work at the other doctor's office, which proved nothing.  I went three times to a chiropractor who did massage, electronic stimulation, accupuncture, ultra sound on my arm with no real improvement.  I started with an integrated internist who sent me to an orthopedic doctor and a neurologist (appointment next week).  The orthopedic doctor ordered an MRI which showed a "frozen Shoulder".  He told me to take Naproxen twice per day and go to physical therapy, which I've been doing 2-3 times per week this month so far.  There is some improvement, but I still have pain and limited mobility in the shoulder.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient reporting pain in arm at site of injection.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Induration, Pain
Clinical narrative: Pt came in the office. Pt have reaction with MMR 30x29 mm induration, redness and pt complaining pain. Also, pt reacted on VARIVAX 21x21 mm redness no induration. Mom notice on 02/14/13.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Pain in extremity, Rash
Clinical narrative: Rash across chest & stomach. Arm swollen up - whole arm. Arm pain for 2 weeks.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (12 x 9 cm. area). Rt. arm swollen & red, pt put on Cephalexin 250 mg / 5ml TID x 10 days.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Condition aggravated, Discomfort, Erythema, Headache, Movement disorder
Clinical narrative: (1) Patient notes arm swelling, redness, discomfort, difficulty moving arm, also notes headache & flare of SVT --> 2/11/13 - started Z-PACK, EKG done & stable.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral, Supraventricular tachycardia
Clinical narrative: (1) Patient notes arm swelling, redness, discomfort, difficulty moving arm, also notes headache & flare of SVT --> 2/11/13 - started Z-PACK, EKG done & stable.
Sex: F
Vaccine: FLU3
Symptoms: Dysphemia
Clinical narrative: Stuttering started 1/12/13 2 days after flu shot was given.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Injection site is hot red & rash like.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Skin warm, Swelling
Clinical narrative: Swelling, warm to touch.
Age: 70.0
Sex: M
Vaccine: FLUX
Symptoms: Audiogram abnormal, Balance disorder, Dizziness, Ear pain, Headache
Clinical narrative: Terrible Headache, Whole Head Hurting, especially right ear. Antibiotic prescribed by Dr. on Monday, Friday woke up very dizzy/imbalanced/headache. Went to Dr. said ear was clear. ENT the next Wednesday 12/12/12, set up MRI and Audio tests. MRI results clear, Audiology tests result said balance system not working - nothing to be done. Set up app (for second opinion) for office visit, then ENT specialist. He said this was caused by Virus...I have not had a virus, but had gotten a flu shot the day before all this started. Coincidence? I don't know! I experience imbalance continuously.  Facility has me scheduled with PT at 1:00 on Tuesday 2/19/2013.
Age: 70.0
Sex: M
Vaccine: FLUX
Symptoms: Nuclear magnetic resonance imaging normal
Clinical narrative: Terrible Headache, Whole Head Hurting, especially right ear. Antibiotic prescribed by Dr. on Monday, Friday woke up very dizzy/imbalanced/headache. Went to Dr. said ear was clear. ENT the next Wednesday 12/12/12, set up MRI and Audio tests. MRI results clear, Audiology tests result said balance system not working - nothing to be done. Set up app (for second opinion) for office visit, then ENT specialist. He said this was caused by Virus...I have not had a virus, but had gotten a flu shot the day before all this started. Coincidence? I don't know! I experience imbalance continuously.  Facility has me scheduled with PT at 1:00 on Tuesday 2/19/2013.
Age: 0.13
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Flatulence, Immediate post-injection reaction, Irritability
Clinical narrative: Gas and irritability almost immediately after and for 2 weeks thereafter.
Age: 1.27
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Endotracheal intubation, Status epilepticus, Tonic clonic movements
Clinical narrative: Status epilepticus, whole body tonic-clonic activity requiring several anti-epileptic medications and intubation.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Injection site induration, Injection site mass, Pain
Clinical narrative: Large, hard bump at injection site, quarter-sized. All-over severe body, joint aches/pain.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Condition aggravated, Lumbar puncture, Migraine, Musculoskeletal pain
Clinical narrative: Started with pain and stiffness in my R neck and shoulder, quickly progressed to a full blown migraine.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Neck pain, Nuclear magnetic resonance imaging
Clinical narrative: Started with pain and stiffness in my R neck and shoulder, quickly progressed to a full blown migraine.
Age: 29.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Abdominal discomfort, Diarrhoea, Erythema, Infection, Muscle tightness
Clinical narrative: Fever, upset stomach, diarrhea, muscle tightness, extreme muscle soreness. Three days after, new symptoms of red streaking and swelling, further red skin and warmth to touch four days after. Went to urgent care clinic and was treated for infection caused by vaccine injection.
Age: 29.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Myalgia, Pyrexia, Skin warm, Swelling
Clinical narrative: Fever, upset stomach, diarrhea, muscle tightness, extreme muscle soreness. Three days after, new symptoms of red streaking and swelling, further red skin and warmth to touch four days after. Went to urgent care clinic and was treated for infection caused by vaccine injection.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, FLUX, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site vesicles, Irritability
Clinical narrative: Left thigh had vaccines of MMR, Varicella and flu given. Now with erythema 3" diameter and fluid filled vesicles 1" diameter within erythema. Edema of thigh as well, fussy child.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Dizziness, Dysstasia, Fatigue
Clinical narrative: Three episodes of vomiting every 3 to 4 hours, accompanied by diarrhea, chills, and extreme fatigue.  Dizziness and inability to stand, unaided.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Three episodes of vomiting every 3 to 4 hours, accompanied by diarrhea, chills, and extreme fatigue.  Dizziness and inability to stand, unaided.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased
Clinical narrative: About one week after shot, patient could not lift arm. Pt seeked therapy and 4 month later can now lift arm about 70 degrees.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Pt had a headache later in the day which has continued until today (2/16/13) and has a red, hot, itchy patch of skin at the injection site about 3 in x 4 in.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Pt states itching surrounding injection site approximately 2 inches and more below injection site. Warm to touch her doctor recommended ALLEGRA since pt said she could not have BENADRYL. Pt did not take ALLEGRA but did compresses to area and redness and itching has gone away within one day.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling, redness, to Lt arm where shots were given.
Sex: M
Vaccine: VARZOS
Symptoms: Heart rate increased, Pyrexia
Clinical narrative: This spontaneous report as received from the patient's wife refers to a male patient of unknown age who "about two days ago" (06-FEB-2013) was vaccinated with a dose of ZOSTAVAX (dose, route not reported) Product circular: 9989115. No concomitant Medications reported. "About two days ago" (06-FEB-2013), the patient developed high temperature and elevated heart rate after receiving ZOSTAVAX. The outcome of the events was unknown. The relatedness between the events and ZOSTAVAX was unknown. Additional information is not expected.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a male patient of unknown age. On 25-JUN-2012, 06-DEC-2012 and 04-FEB-2013, the patient was vaccinated with the first, second and third dose of GARDASIL (dose and route was not reported) (Lot # and expiration date were not reported). There was no adverse effect reported. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Redness, warmth, pain at injection site 8 x 13 cm (Right deltoid only) Fever.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Injection site induration, Injection site inflammation, Injection site pain
Clinical narrative: Headache, malaise, diarrhea. Injection site was inflamed and indurated in an area of 5cm x 10cm, and painful. This site reaction lasted 3.5 days and is not yet resolved.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Headache, malaise, diarrhea. Injection site was inflamed and indurated in an area of 5cm x 10cm, and painful. This site reaction lasted 3.5 days and is not yet resolved.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Mobility decreased, Musculoskeletal pain, Myalgia
Clinical narrative: Excruciating shoulder pain at the joint and deltoid muscle. Much, much more than regular shot pain. Still unable to lift arm above my shoulder, cannot use my left arm much due to shoulder pain.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Heart rate increased
Clinical narrative: 02/14/2013 noticed a rapid heart beat while lying in bed.  I was not aware of adverse reactions until I looked it up online and reviewed these.  Rapid heart rate has still continued through today and I am awaiting a doctor to return my call to report this reaction.  I am unsure of the outcome as of today.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Electroencephalogram, Epilepsy, Nuclear magnetic resonance imaging
Clinical narrative: Epileptic seizure, generalized.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Discomfort, Injection site pain, Mobility decreased, Pain, Sleep disorder
Clinical narrative: Chronic, fluctuating but ongoing right upper arm pain since date of vaccination in right arm, manifesting as deep intermittent aching, and intermittent shooting/twinge-ing pain radiating down upper arm, sometimes into shoulder area. Persistent soreness to the touch (esp. at and around site of vaccination), difficulty/pain with some arm movements and uses of muscles. Difficulty/pain sleeping on right side, getting comfortable in general. Have sought no treatment yet.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMR
Symptoms: Injection site erythema, Tenderness
Clinical narrative: Redness/Erythema surrounding IM injection site, approx. 1" in diameter. Tenderness to touch.
Age: 1.09
Sex: M
Vaccine: DTP, IPV, MMR, VARCEL
Symptoms: Erythema, Heat rash, Rash, Urticaria, Vomiting projectile
Clinical narrative: Started as what appeared to be a patch of hives on his left shoulder blade. By the next day it was worse and red, looking rash like and by Friday the 15th it covered his entire back and had spread to his chest, stomach, diaper area and legs. Does not appear to bother him. I need to note that my son had a cold prior to immunization and it was his first day of feeling better. He also will NOT eat eggs and when he had twice previously he projectile vomited. I was not asked if he has an egg allergy, nor did I understand that would potentially be an issue.
Age: 21.0
Sex: F
Vaccine: HEPA
Symptoms: Syncope
Clinical narrative: Syncope upon administration, helped pt to floor, BP 78/58, put in Trendelenburg position, 1220 p BP 100/62 went home at 139p.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Large area on Rt. arm became swollen/red and itchy. Pt. saw nurse at nursing home and took BENADRYL. Patient told us about this on 2/15.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Mass, Pain in extremity, Rash
Clinical narrative: Injection approx. 3:30 pm 2/15/13. On 2/17/13 pt. returned approx 11:30 AM to show arm with redness, whole arm soreness, lump under skin, complained of warm feeling in area, and 2 dots of rash. Area of redness observed approx. one inch x 1.25 inch. Inquired about treatment / seeing physician - This is a Sunday - Pt. went to walk-in clinic - later.
Age: 0.1
Sex: F
Vaccine: HEP
Symptoms: Feeding disorder neonatal, Feeding disorder of infancy or early childhood
Clinical narrative: This spontaneous report was received from a consumer concerning her daughter of an approximately 5 week old with no pertinent medical history and no drug reaction or allergies. On 05-FEB-2013, the patient was vaccinated with a dose of RECOMBIVAX HB (lot number and expiry date reported as H014132 and 08-FEB-2015 respectively, dose and route unspecified). There were no concomitant medications. On 05-FEB-2013 (within hours of vaccination), she noticed that the patient was having trouble sucking and feeding. She took the patient to the physician on an unknown date. No treatment was given. No diagnostic tests were performed. The outcome of trouble sucking and feeding was reported as not resolved as the patient was still having trouble sucking on breast, bottle and pacifier. The physician stated that he did not believe it to be related to RECOMBIVAX HB. Additional information has been requested.
Age: 0.38
Sex: F
Vaccine: PNC13
Symptoms: Fontanelle bulging, Pyrexia
Clinical narrative: 6-7 hours after shot was given, parent called stating that child has 103 fever and swollen fontanelle. Patient went to Emergency room where was evaluated by MD. Was offered a spinal tap but refused, was told by physician that she saw similar cases after immunizations (not specification on type of vaccine) and child was discharged.
Age: 0.55
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC, DTAP, FLUX
Symptoms: Grand mal convulsion
Clinical narrative: 945am son started shaking with arms up and eyes rolling. Was having a seizure. Took son to doctor office 2 blocks away immediately. Dr assisted right away. Son had another prolonged seizure. 911 was called. Son taken to ER room, had another seizure on its way. Son was treated but in very critical condition as kept on having multiple seizures and couldn't breathe. son transferred to another Hospital.
Age: 0.55
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC, DTAP, FLUX
Symptoms: Convulsion, Dyspnoea, Gaze palsy, Tremor
Clinical narrative: 945am son started shaking with arms up and eyes rolling. Was having a seizure. Took son to doctor office 2 blocks away immediately. Dr assisted right away. Son had another prolonged seizure. 911 was called. Son taken to ER room, had another seizure on its way. Son was treated but in very critical condition as kept on having multiple seizures and couldn't breathe. son transferred to another Hospital.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast cancer female
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 55 year old female patient. In July 2012 the patient was vaccinated with ZOSTAVAX (lot number not provided). In January 2013 the patient had discovered that she had breast cancer. The patient had started chemotherapy as treatment for adverse event. The patient had sought unspecified medical attention. The outcome of adverse event was unknown. Upon internal review, breast cancer was considered as to be medically significant event. Additional information has been requested.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEP, RV5
Symptoms: Condition aggravated, Convulsion, Electrocardiogram, Electroencephalogram, Lumbar puncture
Clinical narrative: Our daughter started having seizure after she woke up that day. She also run fever and was shaking.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEP, RV5
Symptoms: Nuclear magnetic resonance imaging, Pyrexia, Tremor
Clinical narrative: Our daughter started having seizure after she woke up that day. She also run fever and was shaking.