chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Initial report received on 19 October 2007 from a nurse. A seven-year-old male patient, with no concurrent illnesses, or pre-existing medical history had received a left arm intramuscular dose of FLUZONE No Preservative 2007-2008 (lot number UZ461BA) on 04 October 2007. The following day, the patient began having swelling, redness, itchiness at the injection site that progressed to include the area between the shoulder and elbow with no joint involvement. At an unspecified amount of time after receiving the vaccine, the patient developed blistering below the injection site. The patient was evaluated by a physician and treated with BACTROBAN, BENADRYL, and ADVIL. No diagnostic tests or laboratory data were performed. At the time of this report, the patient was recovered and was to have testing for allergies.
Age: 15.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Body temperature increased, Formication, Injection site pain, Pruritus generalised
Clinical narrative: Initial report received on 14 November 2007 from a health care professional.  A 15-year-old female patient, who had a history of depression and attention deficit disorder, had received a sixth dose, left upper arm, intramuscular injection of FLUZONE SV 2007-2008, lot number U2479CA; and a third dose, right upper arm, intramuscular injection of GARDASIL, manufacturer MERCK, lot number 1266U; on 13 November 2007.  The patient subsequently woke up at midnight on the same day as vaccination and felt like bugs were crawling on her skin.  She also had generalized itching.  The next morning, she experienced soreness at of the left upper arm.  Examination in a medical office showed a low grade temperature of 100.3 degrees Fahrenheit with clear skin.  The patient was in no distress.  Treatment provided was not reported.  Concomitant medications included CONCERTA and PROZAC.  At the time of this report, the event was resolving.  A corrective version was treated on 15 November 2007 with the LRD of the previous version 14 November 2007 in order to amend the product described in this narrative to FLUZONE No Preservative 2007-2008 (previously documented as FLUZONE SV 2007-2008).  Follow-up information received on 07 January 2008 from a health care professional.  No laboratory testing was performed.  The patient recovered.
Sex: U
Vaccine: FLU3
Symptoms: Cellulitis, Erythema, Local reaction, Oedema peripheral, Pruritus
Clinical narrative: Initial non-serious report received from a purchaser on 18 October 2007.   A cluster of seven unidentified patients received injections of FLUZONE (lot number U2466AA) on various days at three different facilities.  The reporter indicated that many unusual reactions, which were more than local reactions, had been observed.  Five employees at a hospital location where FLUZONE was given with 23 gauge, one inch needles experienced arm swelling/cellulitis.  One individual received treatment with KEFLEX.  Two other facilities each had one patient with the same type of reactions.  Some patients complained of itching.  Some patients required doctor visits.  The reporter also indicated they have had many other patients with local reactions described as redness.  The reporter mentioned that they often prefill syringes for short periods of time.  Recovery status was not reported.  No additional information has been provided at the time of the report.  The reporter of this case is the same as for case 2007-03531, which involves cellulitis following receipt of FLUZONE, lot number U2446AA.
Sex: U
Vaccine: FLU3
Symptoms: Antibody test, Local reaction, Nonspecific reaction
Clinical narrative: Background Trivalent inactivated influenza vaccine (TIV) is not licensed for use in infants <6 months old, the group with the highest influenza hospitalization rates among children. Methods. In this prospective, open-label study, 2 doses of TIV were administered to healthy infants aged 10-22 weeks. Adverse reactions were assessed, and hemagglutination inhibition (HAI) antibody titers were determined. Weekly telephone surveillance for influenza-like illness was conducted during the influenza season. Results. A total of 42 infants were enrolled and completed the study. Mild local and systemic reactions were noted. In the first season (2004-2005), post vaccination HAI titers > 1:32 were noted for 3 1.6%, 47.4%, and 21.1% of 19 subjects for H1N1, H3N2, and B strains included in the vaccine, respectively. In the second season (2005-2006), post vaccination HAI titers > 1:32 were seen in 45.5%, 58.1%, and 0% of 23 subjects for HIND, H3N2, and B strains included in the vaccine, respectively. In the second season (2005-2006), postvaccination HAI titers >1:32 were seen in 45.5%, 59.1%, and 0% of 23 subjects for HINI, H3N2, and B strains included in the vaccine, respectively. Infants who were seronegative before vaccination (titers < 1:8) were significantly more likely to have a 4-fold rise in antibody liter after vaccination, compared with infants who had prevaccination titers >1:8 (P < .001). Conclusion. Two doses of TIV were found to be safe and moderately immunogenic against some influenza strains. The presence of preexisting maternally derived antibody was associated with significantly lower zero response rates to vaccination. Whether vaccination with TIV will prevent influenza in three young children remains to be determined.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Staphylococcal infection
Clinical narrative: A cluster of 2 unidentifiable patients, who received on an unspecified date FLUZONE (lot # U2484AA) and experienced "staph infection".  Initial report received on 22-October 2007 from a health care professional.  2 unidentifiable patients received on an unspecified date FLUZONE (lot # 00464AA) and experienced "staph infection".  There were no proven cultures.  No other information was provided.  Follow-up information received on 10 January 2008 from the original reporting health care professional.  The two patients have been identified, and this case will now serve as the case for the 55 year-old female patient.  Who had no concurrent illness, pre-existing medical conditions, or use of other medications at the time of administration was not provided.  The following day, after receiving the FLUZONE vaccine, the patient experienced the "staph infection."  No relevant diagnostic tests, or laboratory date were performed to confirm the diagnosis of "staph infection."  At the time of this report, the patient had recovered.  No other relevant radically significant information was provided.  Follow-up information was received 21 July 2008 from a health care provider.  The reporter reviewed the case information and had no new relevant medically significant information to provide at this time.  Follow-up information was received on 11 August 2008 from a health care provider.  The patient received an injection of FLUZONE in the left deltoid.  The patient's staph infection occurred at the injection site.  The reporter for this case is the same as for case 2008-00094, which is the case for the other identified patients, who was a 39-year-old male patient who developed a "staph infection" after administration of the FLUZONE SV 2007-2008 on 18 October 2007.
Sex: M
Vaccine: FLU3
Symptoms: Cellulitis
Clinical narrative: Initial non-serious report received from a non-health professional on 19-October 2007.  A male patient (age unknown) had received FLUZONE (lot number 02464AA; route/site of administration not indicated) on an unspecified date in 2007.  He developed cellulitis (location and onset date not reported) and received treatment with KEFLEX.  The FLUZONE vaccination was administered with a 23 gauge, one inch needle.  Patient outcome was not reported.  No additional information has been provided at the time of the report.  The reporter of this case is the same as for case 2007-03529, which involves cellulitis, swollen arm, itching and injection site redness following receipt of FLUZONE, lot number U2466AA.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: A 21-year-old female patient with no medical history, had received an intramuscular left deltoid injection of FLUZONE sv 2007-2008, lot number U2505AA on 13 November 2007 and one day later, the injection site became swollen, red, hot and sore.  Swelling was the size of a tennis ball.  The following day, swelling had increased to the size of a softball.  The entire arm was sore, muscular pain down to her fingers.  The patient was evaluated by her physician on 15 November 2007 and prescribed Prednizone.  The patient had not received any vaccines during the four weeks prior to receipt of FLOZONE.  Symptoms were still persistent at the time of the report and the patient had not recovered from the event.  No further information was provided.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: A 21-year-old female patient with no medical history, had received an intramuscular left deltoid injection of FLUZONE sv 2007-2008, lot number U2505AA on 13 November 2007 and one day later, the injection site became swollen, red, hot and sore.  Swelling was the size of a tennis ball.  The following day, swelling had increased to the size of a softball.  The entire arm was sore, muscular pain down to her fingers.  The patient was evaluated by her physician on 15 November 2007 and prescribed Prednizone.  The patient had not received any vaccines during the four weeks prior to receipt of FLOZONE.  Symptoms were still persistent at the time of the report and the patient had not recovered from the event.  No further information was provided.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Abnormal behaviour, Confusional state
Clinical narrative: Initial report received on 04 December 2007 from the patient's family member.  A 74-year-old female patient had received an injection of FLUZONE SV 2007-2008, lot number U253AA (not a valid sanofi pasteur lot number) on either 04 November 2007 or 30 November 2007.  Per the reporter, at an unspecified time post-vaccination, the patient experienced confusion.  She turned the wrong way going to the store and was unable to balance her checkbook.  The reporter indicated that this was abnormal for the patient.  An appointment was scheduled for medical examination.  At the time of this report, the patient had not recovered.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Gastritis, Nausea, Vomiting, Weight decreased
Clinical narrative: Initial report was received from a consumer on 01 January 2008.  A 43-year-old female patient with no medical history, had received a left deltoid (route not reported) injection of FLUZONE SV 2007-2008, lot number U2515AA during October 2007 (date not specified) and approximately one week following vaccination on 18 October 2007, she developed extreme nausea and vomiting and diarrhea.  The diarrhea subsided some time in December.  Relevant laboratory testing including an "upper GI" in which the results indicated gastritis.  Corrective treatments included NEXIUM.  The patient had not received FLUZONE in the past and was reported to have had sinus symptoms the day of vaccination.  The patient reported a 28 pound weight loss since October and at the time of the report, the symptoms of nausea and vomiting continued.  No further information was provided.  25/Jan/2008:  Corrective version was created for the purpose of re-ranking the adverse event terms.  The adverse event outcome for the event of diarrhea on the adverse event screen was also amended from not recovered to recovered.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray with contrast upper gastrointestinal tract
Clinical narrative: Initial report was received from a consumer on 01 January 2008.  A 43-year-old female patient with no medical history, had received a left deltoid (route not reported) injection of FLUZONE SV 2007-2008, lot number U2515AA during October 2007 (date not specified) and approximately one week following vaccination on 18 October 2007, she developed extreme nausea and vomiting and diarrhea.  The diarrhea subsided some time in December.  Relevant laboratory testing including an "upper GI" in which the results indicated gastritis.  Corrective treatments included NEXIUM.  The patient had not received FLUZONE in the past and was reported to have had sinus symptoms the day of vaccination.  The patient reported a 28 pound weight loss since October and at the time of the report, the symptoms of nausea and vomiting continued.  No further information was provided.  25/Jan/2008:  Corrective version was created for the purpose of re-ranking the adverse event terms.  The adverse event outcome for the event of diarrhea on the adverse event screen was also amended from not recovered to recovered.
Age: 25.0
Sex: M
Vaccine: FLUX, SMALL, TYP
Symptoms: Fatigue, Headache, Memory impairment, Myocarditis, Wheezing
Clinical narrative: Chronic headaches and fatigue with memory changes and wheezing when extremely tired- See clinic summary. Symptoms started after patient was diagnosed with myocarditis Oct 2003.
Age: 1.3
Sex: M
Vaccine: DTAP, HEPA, RV5, DTAP, HEPA, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: patient was administered ROTATEQ on 09/15/2008. 17 month old at the time. Not indicated for patients over 32 weeks. Per follow-up: Immunizations were not given according to package insert and protocol. Given off label inst.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Contusion, Injection site pain
Clinical narrative: I had a flu shot on October 2, 2008, Thursday at local store at about 11:30 AM appx. By mid afternoon my left arm and shoulder seemed very sore and painful. It seemed the shot was given much higher up on my arm, near the top close to the shoulder. Prior ones were lower down the arm. By Sunday evening I was in great pain and took some ALEVE, changed to aspirin if see if it would better for the pain. Then on Thursday AM (October 9th) this large bluish nodule appeared on top of my left hand near the knuckles. Went to ER at hospital said it was hematoma. Doctor there said I should take Ibuprofen to ease the pain in my arm and shoulder to help the inflammation I end up with a stiff or frozen shoulder (still can't get my arm up  over my head to this day. From ER went to primary doctor, was sent to hand specialist and a bone and joint clinic, now in physical therapy. also had shoulder X-Ray taken (10-15-08) may need MRI in the next week if not better. have been in therapy since October 20,2008. Now a large red spot has shown up on my back of arm near top. Seen Dr on Friday, October 30th to look at the red spot. Still not recovered yet, can't rise left hand on its own over myhead
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cyanosis, Erythema, Haematoma, Inflammation, Injected limb mobility decreased
Clinical narrative: I had a flu shot on October 2, 2008, Thursday at local store at about 11:30 AM appx. By mid afternoon my left arm and shoulder seemed very sore and painful. It seemed the shot was given much higher up on my arm, near the top close to the shoulder. Prior ones were lower down the arm. By Sunday evening I was in great pain and took some ALEVE, changed to aspirin if see if it would better for the pain. Then on Thursday AM (October 9th) this large bluish nodule appeared on top of my left hand near the knuckles. Went to ER at hospital said it was hematoma. Doctor there said I should take Ibuprofen to ease the pain in my arm and shoulder to help the inflammation I end up with a stiff or frozen shoulder (still can't get my arm up  over my head to this day. From ER went to primary doctor, was sent to hand specialist and a bone and joint clinic, now in physical therapy. also had shoulder X-Ray taken (10-15-08) may need MRI in the next week if not better. have been in therapy since October 20,2008. Now a large red spot has shown up on my back of arm near top. Seen Dr on Friday, October 30th to look at the red spot. Still not recovered yet, can't rise left hand on its own over myhead
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Pain in extremity, Periarthritis, Skin nodule
Clinical narrative: I had a flu shot on October 2, 2008, Thursday at local store at about 11:30 AM appx. By mid afternoon my left arm and shoulder seemed very sore and painful. It seemed the shot was given much higher up on my arm, near the top close to the shoulder. Prior ones were lower down the arm. By Sunday evening I was in great pain and took some ALEVE, changed to aspirin if see if it would better for the pain. Then on Thursday AM (October 9th) this large bluish nodule appeared on top of my left hand near the knuckles. Went to ER at hospital said it was hematoma. Doctor there said I should take Ibuprofen to ease the pain in my arm and shoulder to help the inflammation I end up with a stiff or frozen shoulder (still can't get my arm up  over my head to this day. From ER went to primary doctor, was sent to hand specialist and a bone and joint clinic, now in physical therapy. also had shoulder X-Ray taken (10-15-08) may need MRI in the next week if not better. have been in therapy since October 20,2008. Now a large red spot has shown up on my back of arm near top. Seen Dr on Friday, October 30th to look at the red spot. Still not recovered yet, can't rise left hand on its own over myhead
Age: 30.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood glucose, Blood pressure fluctuation, Delirium, Dissociation, Dizziness
Clinical narrative: After receiving first time FLUZONE pt complains of dizziness and feeling odd after 20 min. No respiratory distress. Later complain of difficulty breathing; tiredness; and increased dizziness. 2mg CHORPHENIRAMINE given times 2 days, blood pressure 133 0ver 104 after 10 minutes blood pressure 130 over 110 and patient complain of throat feeling smaller and difficulty breathing. 3ml EPINEPHRINE given. 911 called client transported to ER per ambulance.
Age: 30.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Electrocardiogram, Heart rate abnormal, Immediate post-injection reaction, Oxygen saturation
Clinical narrative: After receiving first time FLUZONE pt complains of dizziness and feeling odd after 20 min. No respiratory distress. Later complain of difficulty breathing; tiredness; and increased dizziness. 2mg CHORPHENIRAMINE given times 2 days, blood pressure 133 0ver 104 after 10 minutes blood pressure 130 over 110 and patient complain of throat feeling smaller and difficulty breathing. 3ml EPINEPHRINE given. 911 called client transported to ER per ambulance.
Age: 30.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pallor, Throat tightness
Clinical narrative: After receiving first time FLUZONE pt complains of dizziness and feeling odd after 20 min. No respiratory distress. Later complain of difficulty breathing; tiredness; and increased dizziness. 2mg CHORPHENIRAMINE given times 2 days, blood pressure 133 0ver 104 after 10 minutes blood pressure 130 over 110 and patient complain of throat feeling smaller and difficulty breathing. 3ml EPINEPHRINE given. 911 called client transported to ER per ambulance.
Age: 30.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood pressure increased, Dizziness, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: After receiving first time FLUZONE pt complains of dizziness and feeling odd after 20 min. No respiratory distress. Later complain of difficulty breathing; tiredness; and increased dizziness. 2mg CHORPHENIRAMINE given times 2 days, blood pressure 133 0ver 104 after 10 minutes blood pressure 130 over 110 and patient complain of throat feeling smaller and difficulty breathing. 3ml EPINEPHRINE given. 911 called client transported to ER per ambulance.
Age: 30.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Throat tightness
Clinical narrative: After receiving first time FLUZONE pt complains of dizziness and feeling odd after 20 min. No respiratory distress. Later complain of difficulty breathing; tiredness; and increased dizziness. 2mg CHORPHENIRAMINE given times 2 days, blood pressure 133 0ver 104 after 10 minutes blood pressure 130 over 110 and patient complain of throat feeling smaller and difficulty breathing. 3ml EPINEPHRINE given. 911 called client transported to ER per ambulance.
Age: 11.0
Sex: M
Vaccine: FLU3, HEPA, MNQ, TDAP, FLU3, HEPA, MNQ, TDAP
Symptoms: Erythema, Feeling cold, Feeling hot, Hot flush, Injection site pruritus
Clinical narrative: He said he did not feel good around 4PM yesterday. Around 9PM he said he was hot. His face, ears, neck, and shoulders were blood red and very hot to the touch. He then was saying he was hot, then going back to cold. He went back and forth on that. he said his arms around the shot sites were hot and itching the left arm had a little whelp that looked sort of like a small worm. Today it is much bigger than that and still hot and itching.
Age: 11.0
Sex: M
Vaccine: FLU3, HEPA, MNQ, TDAP, FLU3, HEPA, MNQ, TDAP
Symptoms: Injection site warmth, Malaise
Clinical narrative: He said he did not feel good around 4PM yesterday. Around 9PM he said he was hot. His face, ears, neck, and shoulders were blood red and very hot to the touch. He then was saying he was hot, then going back to cold. He went back and forth on that. he said his arms around the shot sites were hot and itching the left arm had a little whelp that looked sort of like a small worm. Today it is much bigger than that and still hot and itching.
Age: 11.0
Sex: M
Vaccine: FLU3, HEPA, MNQ, TDAP, FLU3, HEPA, MNQ, TDAP
Symptoms: Erythema, Feeling of body temperature change, Injection site pruritus, Injection site streaking, Injection site urticaria
Clinical narrative: He said he did not feel good around 4PM yesterday. Around 9PM he said he was hot. His face, ears, neck, and shoulders were blood red and very hot to the touch. He then was saying he was hot, then going back to cold. He went back and forth on that. he said his arms around the shot sites were hot and itching the left arm had a little whelp that looked sort of like a small worm. Today it is much bigger than that and still hot and itching.
Age: 11.0
Sex: M
Vaccine: FLU3, HEPA, MNQ, TDAP, FLU3, HEPA, MNQ, TDAP
Symptoms: Injection site warmth, Malaise, Skin warm
Clinical narrative: He said he did not feel good around 4PM yesterday. Around 9PM he said he was hot. His face, ears, neck, and shoulders were blood red and very hot to the touch. He then was saying he was hot, then going back to cold. He went back and forth on that. he said his arms around the shot sites were hot and itching the left arm had a little whelp that looked sort of like a small worm. Today it is much bigger than that and still hot and itching.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4, HEPA, HPV4, HEPA, HPV4
Symptoms: Facial pain, Facial palsy, Hypoaesthesia facial, Neurological examination, Similar reaction on previous exposure to drug
Clinical narrative: 11/07/2008 Pt c/o tingling of her tongue over the past week. Woke up this AM. Can not smile, taste, or completely close (L) eye. Pt's mother concerned b/c GARDASIL and HARVIX given 11/06/2008. The doctor documented that Pt with cold sores (L) corner of her mouth. Pt was Dx with Bell's Palsy and placed on Prednisone 40mg x 7days, Acycbovir 20mg x 7days, and Pt was to return to clinic in 1 week for a follow up. Some improvement in facial movement per Dr.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4, HEPA, HPV4, HEPA, HPV4
Symptoms: Ageusia, Facial palsy, Oral herpes, Paraesthesia oral
Clinical narrative: 11/07/2008 Pt c/o tingling of her tongue over the past week. Woke up this AM. Can not smile, taste, or completely close (L) eye. Pt's mother concerned b/c GARDASIL and HARVIX given 11/06/2008. The doctor documented that Pt with cold sores (L) corner of her mouth. Pt was Dx with Bell's Palsy and placed on Prednisone 40mg x 7days, Acycbovir 20mg x 7days, and Pt was to return to clinic in 1 week for a follow up. Some improvement in facial movement per Dr.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4, HEPA, HPV4, HEPA, HPV4
Symptoms: Ageusia, Facial palsy, Facial paresis, Oral herpes, Paraesthesia
Clinical narrative: 11/07/2008 Pt c/o tingling of her tongue over the past week. Woke up this AM. Can not smile, taste, or completely close (L) eye. Pt's mother concerned b/c GARDASIL and HARVIX given 11/06/2008. The doctor documented that Pt with cold sores (L) corner of her mouth. Pt was Dx with Bell's Palsy and placed on Prednisone 40mg x 7days, Acycbovir 20mg x 7days, and Pt was to return to clinic in 1 week for a follow up. Some improvement in facial movement per Dr.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4, HEPA, HPV4, HEPA, HPV4
Symptoms: Paraesthesia oral
Clinical narrative: 11/07/2008 Pt c/o tingling of her tongue over the past week. Woke up this AM. Can not smile, taste, or completely close (L) eye. Pt's mother concerned b/c GARDASIL and HARVIX given 11/06/2008. The doctor documented that Pt with cold sores (L) corner of her mouth. Pt was Dx with Bell's Palsy and placed on Prednisone 40mg x 7days, Acycbovir 20mg x 7days, and Pt was to return to clinic in 1 week for a follow up. Some improvement in facial movement per Dr.
Age: 56.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt complaint of S.O.B and wheezing, she also stated that the vaccine site was red, swollen warm to the touch. The on call Dr. gave her instructions to follow up with immunization the next morning.
Age: 56.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Wheezing
Clinical narrative: Pt complaint of S.O.B and wheezing, she also stated that the vaccine site was red, swollen warm to the touch. The on call Dr. gave her instructions to follow up with immunization the next morning.
Age: 56.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Injection site erythema, Injection site swelling, Injection site warmth, Wheezing
Clinical narrative: Pt complaint of S.O.B and wheezing, she also stated that the vaccine site was red, swollen warm to the touch. The on call Dr. gave her instructions to follow up with immunization the next morning.
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: C/o pain in left upper arm (shoulder to elbow) moving arm with difficuty due to pain. Stated,sl better today advised to call PMD
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: C/o pain in left upper arm (shoulder to elbow) moving arm with difficuty due to pain. Stated,sl better today advised to call PMD
Age: 58.0
Sex: M
Vaccine: FLU3, FLU3, FLUX
Symptoms: Chest discomfort, Cough, Hyperhidrosis, Nausea, Vision blurred
Clinical narrative: Received shot at approximately 12:00 Noon.  Went home and took a nap for about 1 hour.  Got up-felt lethargic. About 3:00 started feeling/sounding a little congested. He took some Claratin.  At approximately 4:00 breathing started getting more and more restricted, coughing, raspy voice, chest pain, swollen around eyes, Very red, blood shot eyes, oozing from eyes.  Breathing became difficult. He took Benadryl.  We tried to call the clinic.  We waited for them to call back.   (4:45)We drove there.  The nurse said to go to the emergency room.  At the emergency room (5:30) they took blood, gave him a shot of steroids, did a breathing treatment, took an xray.  He was told that he had had an allergic reaction.  He was released at approximately 8:30pm.  He was prescribed steroids and benydryl. Times are approximate-not exact.  Next day:  He is recovering but not back to normal.
Age: 58.0
Sex: M
Vaccine: FLU3, FLU3, FLUX
Symptoms: Blood test, Chest pain, Cough, Dysphonia, Dyspnoea
Clinical narrative: Received shot at approximately 12:00 Noon.  Went home and took a nap for about 1 hour.  Got up-felt lethargic. About 3:00 started feeling/sounding a little congested. He took some Claratin.  At approximately 4:00 breathing started getting more and more restricted, coughing, raspy voice, chest pain, swollen around eyes, Very red, blood shot eyes, oozing from eyes.  Breathing became difficult. He took Benadryl.  We tried to call the clinic.  We waited for them to call back.   (4:45)We drove there.  The nurse said to go to the emergency room.  At the emergency room (5:30) they took blood, gave him a shot of steroids, did a breathing treatment, took an xray.  He was told that he had had an allergic reaction.  He was released at approximately 8:30pm.  He was prescribed steroids and benydryl. Times are approximate-not exact.  Next day:  He is recovering but not back to normal.
Age: 58.0
Sex: M
Vaccine: FLU3, FLU3, FLUX
Symptoms: Eye discharge, Eye swelling, Hypersensitivity, Lethargy, Ocular hyperaemia
Clinical narrative: Received shot at approximately 12:00 Noon.  Went home and took a nap for about 1 hour.  Got up-felt lethargic. About 3:00 started feeling/sounding a little congested. He took some Claratin.  At approximately 4:00 breathing started getting more and more restricted, coughing, raspy voice, chest pain, swollen around eyes, Very red, blood shot eyes, oozing from eyes.  Breathing became difficult. He took Benadryl.  We tried to call the clinic.  We waited for them to call back.   (4:45)We drove there.  The nurse said to go to the emergency room.  At the emergency room (5:30) they took blood, gave him a shot of steroids, did a breathing treatment, took an xray.  He was told that he had had an allergic reaction.  He was released at approximately 8:30pm.  He was prescribed steroids and benydryl. Times are approximate-not exact.  Next day:  He is recovering but not back to normal.
Age: 58.0
Sex: M
Vaccine: FLU3, FLU3, FLUX
Symptoms: Upper respiratory tract congestion, X-ray
Clinical narrative: Received shot at approximately 12:00 Noon.  Went home and took a nap for about 1 hour.  Got up-felt lethargic. About 3:00 started feeling/sounding a little congested. He took some Claratin.  At approximately 4:00 breathing started getting more and more restricted, coughing, raspy voice, chest pain, swollen around eyes, Very red, blood shot eyes, oozing from eyes.  Breathing became difficult. He took Benadryl.  We tried to call the clinic.  We waited for them to call back.   (4:45)We drove there.  The nurse said to go to the emergency room.  At the emergency room (5:30) they took blood, gave him a shot of steroids, did a breathing treatment, took an xray.  He was told that he had had an allergic reaction.  He was released at approximately 8:30pm.  He was prescribed steroids and benydryl. Times are approximate-not exact.  Next day:  He is recovering but not back to normal.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received for the pregnancy registry for VARIVAX from a 26 year old female registered nurse with no known pertinent medical history or drug reactions/allergies who on approximately 11-AUG-2008, "4 weeks ago," was vaccinated with a dose of VARIVAX 0.5 ml. There was no concomitant therapy. On approximately 11-AUG-2008, "4 weeks ago," the patient underwent a pregnancy test which was noted to be positive. The last menstrual period was 01-Aug-2008. The estimated due date is 08-May-2009. Follow-up information was received from the registered nurse. She had a miscarriage at 12 to 13 weeks gestational age. Upon internal review the miscarriage was considered to be an other important medical event. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a health professional, for the Pregnancy Registry for GARDASIL concerning a 16 year old female who on 09-JUL-2007 was vaccinated intramuscularly with her first dose of GARDASIL (lot # 658094/0524U). On 22-OCT-2007 the patient was vaccinated intramuscularly with her second dose of GARDASIL (lot # 658563/1063U). The patient is now about 6 weeks pregnant with an estimated LMP of 12-JAN-2008 and a due date of 18-OCT-2008. The patient had a positive urine pregnancy test. Follow-up information has been received which indicated that on 14-MAR-2008, the patient underwent elective termination. Upon internal review, elective termination was considered to be an other important medical event. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Anogenital warts, Anorexia, Fungal infection, Genital lesion, Gynaecological examination abnormal
Clinical narrative: Information has been received from a mother and aunt concerning a 16 year old female patient with no known medical history, who was vaccinated with all three doses of GARDASIL by June 2008. Concomitant suspect vaccination included influenza virus vaccine (unspecified) (name and manufacturer unspecified). The consumer reported that her niece was HPV (unknown type) positive after getting all three doses of GARDASIL. The mother subsequently reported that about one month after receiving all three doses of GARDASIL her daughter had a yeast infection and then two weeks later had another infection. The patient was the due for her yearly checkup and so she went and had a pap test done and the test showed the patient had genital warts and a "large lesion on her insides". The mother stated that her daughter is going to a specialist and will have to get "some work done on her" for the lesions. The mother reported that the patient does not feel well and has a loss of appetite. It also reported that the patient received the flu vaccine and "wound up in the hospital" (specifics not provided). The patient sought unspecified medical attention. At the time of the report it was reported that the patient was not recovered. No further information is available.  1/28/2009 MR received for GYN visit 12/5/08 for colposcopy for (+) PAP smear. Final DX: Mild to moderate dysplasia with HPV.
Age: 16.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Malaise, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a mother and aunt concerning a 16 year old female patient with no known medical history, who was vaccinated with all three doses of GARDASIL by June 2008. Concomitant suspect vaccination included influenza virus vaccine (unspecified) (name and manufacturer unspecified). The consumer reported that her niece was HPV (unknown type) positive after getting all three doses of GARDASIL. The mother subsequently reported that about one month after receiving all three doses of GARDASIL her daughter had a yeast infection and then two weeks later had another infection. The patient was the due for her yearly checkup and so she went and had a pap test done and the test showed the patient had genital warts and a "large lesion on her insides". The mother stated that her daughter is going to a specialist and will have to get "some work done on her" for the lesions. The mother reported that the patient does not feel well and has a loss of appetite. It also reported that the patient received the flu vaccine and "wound up in the hospital" (specifics not provided). The patient sought unspecified medical attention. At the time of the report it was reported that the patient was not recovered. No further information is available.  1/28/2009 MR received for GYN visit 12/5/08 for colposcopy for (+) PAP smear. Final DX: Mild to moderate dysplasia with HPV.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Activities of daily living impaired, Blood test normal, Chest pain, Computerised tomogram normal
Clinical narrative: Information has been received from a registered nurse concerning her 17 year old daughter with an allergy to antibiotics and no other pertinent medical history, who on 22-APR-2008 was vaccinated with a 0.5 mL first dose of GARDASIL intramuscularly.  On 20-JUN-2008 the patient received the second dose of GARDASIL.  Concomitant therapy included hormone contraceptives (manufacturer unspecified).  On 22-SEP-2008 the patient experienced headache, dizziness, nausea, fatigue, chest pain and stomach pains.  The patient had her first CT Scan of the abdomen and blood work that were negative.  On 09-OCT-2008 the patient had another CT Scan of the abdomen and the pelvis due to increased pain; the results were negative.  On 22-OCT-2008 the patient received the third dose of GARDASIL.  Then on 03-NOV-2008, the patient had an upper GI that was negative.  On 04-NOV-2008 the patient had gastric emptying studies that were negative.  On 05-NOV-2008 the patient had X-rays and blood work that were negative.  The mother reported that her daughter was now "incapacitated", sleeping most of the day and was unable to get out the bed.  The pain in the patient's stomach and chest had persisted and continued to worsen.  The mother stated that "she continues to go down every day".  The patient had been out of school for the past week and was not able to participate in after school activities (the patient was a cheerleader).  At the time of this report, the patient had not recovered.  The patient's headache, dizziness, nausea, fatigue, "sleeping most of the day/unable to get out of bed", "out of school for the past week and not able to participate in after school activities", "continues to go down every day", chest pain and stomach pains were considered to be disabling.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Diagnostic procedure, Dizziness, Fatigue, Gastric emptying study, Headache
Clinical narrative: Information has been received from a registered nurse concerning her 17 year old daughter with an allergy to antibiotics and no other pertinent medical history, who on 22-APR-2008 was vaccinated with a 0.5 mL first dose of GARDASIL intramuscularly.  On 20-JUN-2008 the patient received the second dose of GARDASIL.  Concomitant therapy included hormone contraceptives (manufacturer unspecified).  On 22-SEP-2008 the patient experienced headache, dizziness, nausea, fatigue, chest pain and stomach pains.  The patient had her first CT Scan of the abdomen and blood work that were negative.  On 09-OCT-2008 the patient had another CT Scan of the abdomen and the pelvis due to increased pain; the results were negative.  On 22-OCT-2008 the patient received the third dose of GARDASIL.  Then on 03-NOV-2008, the patient had an upper GI that was negative.  On 04-NOV-2008 the patient had gastric emptying studies that were negative.  On 05-NOV-2008 the patient had X-rays and blood work that were negative.  The mother reported that her daughter was now "incapacitated", sleeping most of the day and was unable to get out the bed.  The pain in the patient's stomach and chest had persisted and continued to worsen.  The mother stated that "she continues to go down every day".  The patient had been out of school for the past week and was not able to participate in after school activities (the patient was a cheerleader).  At the time of this report, the patient had not recovered.  The patient's headache, dizziness, nausea, fatigue, "sleeping most of the day/unable to get out of bed", "out of school for the past week and not able to participate in after school activities", "continues to go down every day", chest pain and stomach pains were considered to be disabling.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Hypersomnia, Inappropriate schedule of drug administration, Nausea, X-ray gastrointestinal tract normal, X-ray normal
Clinical narrative: Information has been received from a registered nurse concerning her 17 year old daughter with an allergy to antibiotics and no other pertinent medical history, who on 22-APR-2008 was vaccinated with a 0.5 mL first dose of GARDASIL intramuscularly.  On 20-JUN-2008 the patient received the second dose of GARDASIL.  Concomitant therapy included hormone contraceptives (manufacturer unspecified).  On 22-SEP-2008 the patient experienced headache, dizziness, nausea, fatigue, chest pain and stomach pains.  The patient had her first CT Scan of the abdomen and blood work that were negative.  On 09-OCT-2008 the patient had another CT Scan of the abdomen and the pelvis due to increased pain; the results were negative.  On 22-OCT-2008 the patient received the third dose of GARDASIL.  Then on 03-NOV-2008, the patient had an upper GI that was negative.  On 04-NOV-2008 the patient had gastric emptying studies that were negative.  On 05-NOV-2008 the patient had X-rays and blood work that were negative.  The mother reported that her daughter was now "incapacitated", sleeping most of the day and was unable to get out the bed.  The pain in the patient's stomach and chest had persisted and continued to worsen.  The mother stated that "she continues to go down every day".  The patient had been out of school for the past week and was not able to participate in after school activities (the patient was a cheerleader).  At the time of this report, the patient had not recovered.  The patient's headache, dizziness, nausea, fatigue, "sleeping most of the day/unable to get out of bed", "out of school for the past week and not able to participate in after school activities", "continues to go down every day", chest pain and stomach pains were considered to be disabling.  Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, TD
Symptoms: Hypokinesia, Muscular weakness, Musculoskeletal pain, Pain in extremity, Periarthritis
Clinical narrative: Patient was administered Td and PNEUMOVAX 23 on 08/22/08, in different arms. Two or three days later, patient started experiencing soreness and weakness in both of her arms. Patient's arm weakness is getting worse and she is unable to hold arms above her head. The following follow up information was assessed as "serious and unexpected".  Follow up obtained on 11/05/2008: During a follow up conversation on 11/05/08, patient's doctor stated that the patient had recently been diagnosed with bilateral "frozen shoulder" and was undergoing physical therapy. The patient was seen in the clinic on 10/14/08 for a separate complaint and was noted to have persistent shoulder pain and weakness. She was given refills of NSAID and cyclobenzaprine. On 11/03/08 the patient informed the clinic that she was now receiving physical therapy for frozen shoulder. According to the doctor, the patient is unable to lift either arm above her hips. She has not been referred to neurology or orthopedics.
Sex: F
Vaccine: FLUX
Symptoms: Facial palsy
Clinical narrative: Initial information was received on 03 November 2008 from another manufacturer, document number 45208254, whose initial reporter was a consumer. This report was not medically confirmed. A female patient received the influenza vaccine, reported as the flu vaccine (manufacturer, lot number and date not reported). She developed Bells Palsy four days after receiving the influenza vaccine. Recovery date was not reported. No further information was provided. Documents held by sender: None.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Rash generalised, Rash macular
Clinical narrative: Initial report received on 04 November 2008 from a consumer (coworker). A 40 to 45 year old female patient, whose medical history, concomitant medications, and illness at time of vaccination were unknown, received an injection of ADACEL (lot number UF455AA) on 29 October 2008. Two days later, on 31 October 2008, the patient had "a strange rash over 1/3 of body that looked like blotchy poison ivy". Corrective treatment included "a shot of steroids and maybe antibiotics". The patient's recovery status was unknown. No other information was known by the reporter.
Age: 42.0
Sex: F
Vaccine: DT
Symptoms: Blood test, Radiculitis brachial
Clinical narrative: A 43 year-old female patient with a hand laceration received a right arm (route unknown) injection of DECAVAC, lot number U1958BA, on 21 April 2008 during an emergency room visit. The patient was subsequently evaluated by her physician on 05 November 2008 who diagnosed her with brachial neuritis. Laboratory testing was performed and the results were pending at the time of the report. According to the reporter, the patient initially refused vaccination and emergency room personnel would not discharge the patient without vaccination. Per the reporter, "the patient reacts like this to vaccines". No further information was provided at the time of the report. Documents held by sender: None.
Sex: F
Vaccine: DTP
Symptoms: Convulsion
Clinical narrative: This serious case was received from a health care professional on 06 November 2008, via another manufacturer (document number 45208302). A female patient (date of birth 13 July 1982) received a DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE as a child (manufacturer, lot number, and date of administration not known by the reporter). She subsequently experienced a seizure. The reporter had no other information about the adverse reaction, and the injection was administered at another location. The event was considered to be resolved. Documents held by sender: None.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Back pain, Chills, Headache, Hypoaesthesia, Laboratory test abnormal
Clinical narrative: Initial report received on 09 November 2008 from the consumers parent. An 11-year-old male patient with no concurrent illnesses, and unknown past medical history, had received an intramuscular injection of ADACEL, lot number C3003 (lot number UF452CA); and an intramuscular injection of MENACTRA (Lot number U2734AA) on 17 October 2008. The routes and sites of administration were not provided. At an unspecified amount of time later, the patient began having symptoms of severe headache (head pain), severe back pain/soreness (including low back pain), and his back was stiff with numbness and spasms. The patient was evaluated by his physician ten days later, and at that time, the back pain had improved somewhat, and the patient was additionally experiencing muscular tenderness, left arm pain, neck pain; and continued head pain. He also had chills, however he was afebrile. Diagnostic tests performed revealed the patient was positive for Lupus. Date, name, type and results of diagnostic tests were not provided. It was not reported whether the patient had received any corrective treatments. At the time of this report, the patient had not recovered. Documents held by sender: None.  11/26/2008 MR received from PCP including neuro consults.  Mencatra (U2734AA) and Adacel  (UF452CA) given 10/17/08. Pt RTO 10/23/08 with c/o muscle stiffness and soreness and arm and shoulder pain, as well as not sleeping well. Nummbness and tingling in fingers of L hand. Assessment: Muscular tenderness post vaccination. Returned 10/27/08 and 10/28/08 with c/o arm, head, neck and back pain-unimproved. Referred to neurology.  Neuro consult 10/28/08. Pt reported injection site burning following vax on 10/17/08 and since then has had H/A, neck pain, burning patches in extremities, difficulty sleeping and stiff neck. PE (+) for inability to flex head forward- severe pain. Sent for MRI. Started on neurontin. F/U 11/12/08 still with sx.  Sleeping better. Pain 10/10 all over. ? RSD. 1/20/2009 Additional records received from recent Neuro consult 12/9/08. PE WNL except decreased sensation to cold and pinprick on R arm from elbow to wrist. Likely conversion disorder, no neurological cause for sx. F/u with PCP 1/9/09 almost completely recovered from RSD.