chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: ADEN_4_7, FLUX, MEN, TDAP
Symptoms: Convulsion, Electroencephalogram abnormal, Epilepsy, Nausea, Partial seizures
Clinical narrative: A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353241USA. (8 patients in the exposed cohort experienced epilepsy, of the 8 patients in the exposed group age: 5 were in age group 19-24. Sex: 6 male. A male patient between the ages of 19-24 years experienced SEIZURES, (EPILEPSY, UNSPECIFIED) (confirmed). Patient was hospitalized from 06-Mar-2012 to 08-Mar-2012. The patient was an recruit. Adenovirus vaccine was administered on 07-Feb-2012. The patient also received meningococcal, Tdap, and influenza (inactivated or live attenuated) vaccines on 07-Feb-2012. The patient did not receive polio (inactivated), varicella, hepatitis B vaccines, pneumococcal, smallpox, yellow fever, MMR, hepatitis A, hepatitis B booster, TWINRIX, TWINRIX booster, or HPV vaccines. Medical History: G6PD Deficiency: 21-May-1992-ongoing. Nervous attacks; unknown start and stop date. Low grade headaches: unknown start and stop date. No history of alcohol abuse or tobacco use. Adverse events within 42 days of vaccination: Nausea: --2012 to --2012, no treatment given, outcome of adverse event is unknown. An EEG (electroencephalogram) was done and was abnormal. The results showed rhythmic theta activity consistent with partial onset seizures. The patient was treated with levetiracetam 500mg orally twice per day starting on 12-Mar-2012 and is continuing, Naproxen 250mg orally as needed, starting on 12-Mar-2012 and is continuing, and DILANTIN (start date and stop date not specified). The outcome of the event was not specified. This case was considered serious due to "Hospitalization". The severity of this event was not assessed. The medical monitor has assessed the causal relationship of this event as "Unassessable" to the adenovirus vaccine.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist via the agency (LRN MK4439) refers to a 19 years old female patient with latex allergy. The patient was vaccinated with dose 1 of VARIVAX (Merck) (reported lot # H011553; expiry date 11-JUN-2014) on 17-SEP-2012. Route was unknown. She also got a flu shot (not further specified) within 4 weeks prior to receiving VARIVAX (Merck). Exact vaccination date, route and lot number of the flu shot were not reported. Concomitant medications included: ENGERIX-B (first dose 23-AUG-2012, second dose 24-SEP-2012). On an unknown date the patient experienced itching. In September 2012, right after receiving the VARIVAX (Merck) injection, the patient experienced full body hives. However, it was unknown if the full body hives started on 17-SEP-2012. The patient said BENADRYL was just helping with itch and was not relieving the hives; they have not changed in size or "anything like that". It was unknown if there were any relevant laboratory tests. She was due to receive the second VARIVAX (Merck) injection on 17-OCT-2012. As of 13-OCT-2012, she still had full body hives and it was unknown if she was still experiencing itching. The relatedness for full body hives and itching was not reported for VARIVAX (Merck). Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site haematoma, Injection site swelling, Pain in extremity
Clinical narrative: On day of immunization, patient experienced more pronounced soreness in arm receiving injection than expected. Two days later she noticed small area of bruising at injection site and an area of redness and swelling about 4 inches below injection site that is approximately 4 inches wide by 3 inches high. She reports that she also has trouble lifting said arm above her waist.
Age: 1.09
Sex: F
Vaccine: HEPA, IPV, MMR, VARCEL
Symptoms: Body temperature increased, Rash
Clinical narrative: Rash on face, lip, ears and arm. Temp of 102.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Influenza like illness, Injection site erythema, Injection site induration, Injection site inflammation
Clinical narrative: THE PATIENT RECEIVED THE VACCINE AROUND 2 P.M. ON 11/5/12 IN THE PHARMACY SHE WORKS AT AND SHE CONTINUED TO WORK THAT DAY. BY THE TIME SHE GOT OFF WORK AND GOT HOME AROUND 7 P.M. HER ARM WAS RED, SWOLLEN, HARD AND VERY INFLAMMED. IT WAS ALSO HOT TO THE TOUCH. THIS REACTION COVERED THE MAJORITY OF HER UPPER LEFT ARM. TODAY IS 11/8/12 AND THE REACTION HAS JUST BARELY STARTED TO GO DOWN IN SIZE. ON THE NIGHT OF 11/5/12 THE PATIENT ALSO EXPERIENCED FLU-LIKE SYMPTOMS ALONG WITH DIARRHEA, NAUSEA AND VOMITING. THESE SYMPTOMS HAVE STARTED TO RESOLVE SLIGHTLY TODAY 11/8/12.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site warmth, Nausea, Vomiting
Clinical narrative: THE PATIENT RECEIVED THE VACCINE AROUND 2 P.M. ON 11/5/12 IN THE PHARMACY SHE WORKS AT AND SHE CONTINUED TO WORK THAT DAY. BY THE TIME SHE GOT OFF WORK AND GOT HOME AROUND 7 P.M. HER ARM WAS RED, SWOLLEN, HARD AND VERY INFLAMMED. IT WAS ALSO HOT TO THE TOUCH. THIS REACTION COVERED THE MAJORITY OF HER UPPER LEFT ARM. TODAY IS 11/8/12 AND THE REACTION HAS JUST BARELY STARTED TO GO DOWN IN SIZE. ON THE NIGHT OF 11/5/12 THE PATIENT ALSO EXPERIENCED FLU-LIKE SYMPTOMS ALONG WITH DIARRHEA, NAUSEA AND VOMITING. THESE SYMPTOMS HAVE STARTED TO RESOLVE SLIGHTLY TODAY 11/8/12.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Hyperhidrosis, Influenza like illness, Injection site erythema, Injection site induration
Clinical narrative: THE PATIENT RECEIVED THE VACCINE AROUND 2 P.M. ON 11/5/12 IN THE PHARMACY SHE WORKS AT AND SHE CONTINUED TO WORK THAT DAY. BY THE TIME SHE GOT OFF WORK AND GOT HOME AROUND 7 P.M. HER ARM WAS RED, SWOLLEN, HARD AND VERY INFLAMMED. IT WAS ALSO HOT TO THE TOUCH. THIS REACTION COVERED THE MAJORITY OF HER UPPER LEFT ARM. TODAY IS 11/8/12 AND THE REACTION HAS JUST BARELY STARTED TO GO DOWN IN SIZE. ON THE NIGHT OF 11/5/12 THE PATIENT ALSO EXPERIENCED FLU-LIKE SYMPTOMS ALONG WITH DIARRHEA, NAUSEA AND VOMITING. THESE SYMPTOMS HAVE STARTED TO RESOLVE SLIGHTLY TODAY 11/8/12.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site warmth, Vomiting
Clinical narrative: THE PATIENT RECEIVED THE VACCINE AROUND 2 P.M. ON 11/5/12 IN THE PHARMACY SHE WORKS AT AND SHE CONTINUED TO WORK THAT DAY. BY THE TIME SHE GOT OFF WORK AND GOT HOME AROUND 7 P.M. HER ARM WAS RED, SWOLLEN, HARD AND VERY INFLAMMED. IT WAS ALSO HOT TO THE TOUCH. THIS REACTION COVERED THE MAJORITY OF HER UPPER LEFT ARM. TODAY IS 11/8/12 AND THE REACTION HAS JUST BARELY STARTED TO GO DOWN IN SIZE. ON THE NIGHT OF 11/5/12 THE PATIENT ALSO EXPERIENCED FLU-LIKE SYMPTOMS ALONG WITH DIARRHEA, NAUSEA AND VOMITING. THESE SYMPTOMS HAVE STARTED TO RESOLVE SLIGHTLY TODAY 11/8/12.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Seizure cluster
Clinical narrative: Cluster seizures.
Age: 72.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Injection site rash, Injection site swelling
Clinical narrative: Arm was red. Rash angry looking site of injection was swollen and arm from shoulder down to elbow. Put cold packs and Benadryl every 4hrs around clock for 24hrs still red and swollen for 7 days. Went to Dr on 26 of Oct.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Pain in extremity, Paraesthesia, VIIth nerve paralysis
Clinical narrative: Employee had her flu shot as part of the PMH flu vaccination program. Employee's are hurt for a couple days and then emplyee began to feel tingling in various parts of her face and just did not feel well. Employee went to her PCP and then when symptoms got worse PCP told her to go to ER which she did. ER confirmed Bell's Palsy.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Dreamy state, Feeling hot, Presyncope, Vaccine positive rechallenge
Clinical narrative: PT STATES HE GOT HOT AND FELT LIKE HE WAS HAVING A DREAM AND WOKE UP.  PT DID VASO VAGAL AND WAS ONLY OUT ABOUT 20 SECONDS.  PT WAS IN A RECLINING BLOOD DRAWING CHAIR, HE WAS RECLINED AND PT BECAME ALERT.  THIS WAS SECOND TIME PT HAD THIS REACTION WITH ANTHRAX.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Right thigh with swelling induration 4x3 inches.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, MEN, OPV, RV1
Symptoms: Agitation, Crying, Decreased appetite, Hypersomnia, Pain
Clinical narrative: My son woke with a screaming cry and continued to scream, cry for the next three hours. Would not nurse, seemed to agitate him further if I tried to lay him back in my arms to rock him.  I have never heard this type of painful cry from him except on that day.  He seemed somewhat comfortable if I stood up and walked with him.  He slept a lot more than he ever had in the following 2 days.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, MEN, OPV, RV1
Symptoms: Screaming
Clinical narrative: My son woke with a screaming cry and continued to scream, cry for the next three hours. Would not nurse, seemed to agitate him further if I tried to lay him back in my arms to rock him.  I have never heard this type of painful cry from him except on that day.  He seemed somewhat comfortable if I stood up and walked with him.  He slept a lot more than he ever had in the following 2 days.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Blood culture negative, Pyrexia, White blood cell count normal
Clinical narrative: Developed a fever of 101.5 F.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Lymph node pain, Lymphadenopathy, Pain in extremity
Clinical narrative: Patient's left arm very sore after receiving shot.  Noticed that a lymph node in her left axilla was swollen and tender the next day.  Lymph node swelling and pain resolved on it's own after several days.
Age: 12.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain, Chills, Hyperhidrosis, Pyrexia
Clinical narrative: Extreme abdominal pain, fever, chills, sweating.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Headache, Pain, Pyrexia, Vomiting
Clinical narrative: Developed sudden fever of 103.4 (F) unrelieved by Tylenol and Motrin. Also severe body/joint pain, headache and vomiting.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Blood glucose decreased, Gait disturbance, Hypoglycaemia, Syncope
Clinical narrative: Patient and husband received IM influenza vaccination at clinic. After leaving, within an hour of injection, they drove a short distance to a family member's home; patient was unsteady walking and collapsed, unresponsive, outside. Husband also was found unresponsive in car. Emergency services personnel responded: patient's blood glucose level was documented at 11 mg/dl. Treated with 3 ampoules of 50% dextrose in the field at 3:15PM, followed by D10 in ER. Patient blood glucose normalized and patient was admitted to an outside hospital (accompanied husband, who required a higher level of care) about 7pm. Husband also extremely hypoglycemic: his report is separate. Do not have records from hospital.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient and husband received IM influenza vaccination at clinic. After leaving, within an hour of injection, they drove a short distance to a family member's home; patient was unsteady walking and collapsed, unresponsive, outside. Husband also was found unresponsive in car. Emergency services personnel responded: patient's blood glucose level was documented at 11 mg/dl. Treated with 3 ampoules of 50% dextrose in the field at 3:15PM, followed by D10 in ER. Patient blood glucose normalized and patient was admitted to an outside hospital (accompanied husband, who required a higher level of care) about 7pm. Husband also extremely hypoglycemic: his report is separate. Do not have records from hospital.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: PATIENT IS ONLY 57 YEARS OLD AND RECEIVED HIGH-DOSE FLU VACCINE.
Age: 6.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Rash generalised
Clinical narrative: Patient has rash covering entire body.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: PATIENT ONLY 62 YEARS OLD AND RECEIVED HIGH-DOSE FLU VACCINE.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Grip strength decreased, Hypoaesthesia, Muscular weakness
Clinical narrative: Left arm weakness, dull ache, grasp stregnth is decreased, numbness to wrist and hand, gets better at times.  Still continues with problems to this day.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Pain
Clinical narrative: Right thigh had redness and soreness, symptoms started 11/06/2012, Dr. treated reaction with Benadryl and Advil or Motrin.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Urticaria
Clinical narrative: Hives, dizziness.
Age: 1.97
Sex: F
Vaccine: DTAP, FLU3, HEPA, HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Bilateral redness and swelling at vaccine injection site. Patient prescribed cephalexin for treatment of possible cellulitis.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Activities of daily living impaired, Pruritus, Swelling face, Urticaria
Clinical narrative: Mom reports when she picked child up after school child complained of feeling itchy though he had not told anyone at school (around 2:30 PM). Child taken to GM home and then had hives all over body and nose and face swelling around 3:15 PM. GM gave Benadryl (unknown dose). Mom took child to Urgent Care- child got Benadryl and cortisone shot. Child missed school Wed- Friday of that week. Went to private MD on Friday 11/2/2012 for follow up and was given a PRN Rx which mom gave child only once. Child fine now. Private MD recommended no further doses of flu vaccine.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUN3
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Runny nose, fever.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood culture negative, Oedema peripheral, Pyrexia, White blood cell count normal
Clinical narrative: Fever of 102.1 F with left and right upper extremity swelling.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised, Urticaria
Clinical narrative: Woke up with hive looking rash on trunk, neck, inner arms and down inside of legs.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Accidental overdose, Acute respiratory failure, Blood glucose decreased, Blood insulin increased, Blood proinsulin decreased
Clinical narrative: Review of the ambulance report and Hospital reports document that the patient and his wife (state VAERS record TN-12-13) were found unresponsive in their vehicle at a residence about an hour after they had been to the clinic and received influenza vaccinations. The doses were reportedly the last two doses out of a multidose vial; no other patients had reported any adverse events. Insulin is stored in the same refrigerator as the influenza vaccine; the clinic staff deny pre-drawing syringes or inadvertently administering insulin. The patient's blood glucose was undetectable by the EMT staff and the patient was given IV dextrose, intubated, and transported to the ER. The patient was transferred to another hospital for admission, along with his wife (TN-12-13). The hospital discharge summary documented a final diagnosis of coma due to hypoglycemia secondary to accidental insulin overdose and acute respiratory failure secondary to coma.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Endotracheal intubation, Hypoglycaemic coma, Unresponsive to stimuli
Clinical narrative: Review of the ambulance report and Hospital reports document that the patient and his wife (state VAERS record TN-12-13) were found unresponsive in their vehicle at a residence about an hour after they had been to the clinic and received influenza vaccinations. The doses were reportedly the last two doses out of a multidose vial; no other patients had reported any adverse events. Insulin is stored in the same refrigerator as the influenza vaccine; the clinic staff deny pre-drawing syringes or inadvertently administering insulin. The patient's blood glucose was undetectable by the EMT staff and the patient was given IV dextrose, intubated, and transported to the ER. The patient was transferred to another hospital for admission, along with his wife (TN-12-13). The hospital discharge summary documented a final diagnosis of coma due to hypoglycemia secondary to accidental insulin overdose and acute respiratory failure secondary to coma.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Injected limb mobility decreased
Clinical narrative: Shoulder joint pain, claims unable to raise right arm.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Vertigo positional
Clinical narrative: Dizziness, vertigo during/after specific movements. i.e. attempting to lay down or turning head to the right when seated.  Symptoms have persisted for over a month.
Age: 55.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Fatigue, Pyrexia, Rash erythematous, Rash papular
Clinical narrative: Slight fever feel, then chills. Tired. Main effect was pimple like rash that appeared on forearms and elbow area, fingers.  Then spread to neck and ears, some at other parts of body distributed randomly. Raised red bumps 3mm diameter, itchy and will pop if squeezed releasing small amount of clear fluid.
Age: 55.0
Sex: M
Vaccine: FLUX
Symptoms: Rash pruritic
Clinical narrative: Slight fever feel, then chills. Tired. Main effect was pimple like rash that appeared on forearms and elbow area, fingers.  Then spread to neck and ears, some at other parts of body distributed randomly. Raised red bumps 3mm diameter, itchy and will pop if squeezed releasing small amount of clear fluid.
Age: 51.0
Sex: F
Vaccine: FLUX, TD
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills, aches, and fever.
Age: 78.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Pain
Clinical narrative: Pain for nine days. Swelling in both hands.
Age: 1.76
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site haematoma, Injection site oedema
Clinical narrative: Erythema and edema with mild bruising at site of injection.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Swelling, Urticaria
Clinical narrative: 4 inch long swelling with a little raised hived, that itches.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Dizziness, Gait disturbance, Hypoaesthesia, Muscular weakness
Clinical narrative: Projectile emesis; diarrhea; numbness in right (non vaccinated) arm; weakness-inability to walk; dizziness; some inability to talk or understand; vision problems; ringing in ears.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Speech disorder, Tinnitus, Visual impairment, Vomiting projectile
Clinical narrative: Projectile emesis; diarrhea; numbness in right (non vaccinated) arm; weakness-inability to walk; dizziness; some inability to talk or understand; vision problems; ringing in ears.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Pain, Pain in extremity, Tenderness
Clinical narrative: Took flu shot in left arm, have been having pain for over a month, hurts to sleep or raise arm with constant pain. Haven't had any treatment due to medical cost, I do work at same facility that gave shot, shot didn't hurt when given, however started hurting several hours alter and hasn't got better.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Axillary pain, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Itching, redness, and hardness/swelling (2-inch diameter) at injection site (right upper arm).  This progressed over 5 hours to redness and hardness/swelling of inside and back of upper arm along with pain in upper arm and in armpit lymphnode.  Swelling/redness progressively moved down upper arm to include inside of elbow area over next two days (through 11/08/2012).  Area feels warm to touch.  Patient went to Urgent Care at 6:00 PM on 11/06/2012 and was advised to take Benadryl and Aleve.  Patient was advised on 11/08/2012 by nurse to make appointment with Infectious Disease doctor for followup.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site warmth
Clinical narrative: Itching, redness, and hardness/swelling (2-inch diameter) at injection site (right upper arm).  This progressed over 5 hours to redness and hardness/swelling of inside and back of upper arm along with pain in upper arm and in armpit lymphnode.  Swelling/redness progressively moved down upper arm to include inside of elbow area over next two days (through 11/08/2012).  Area feels warm to touch.  Patient went to Urgent Care at 6:00 PM on 11/06/2012 and was advised to take Benadryl and Aleve.  Patient was advised on 11/08/2012 by nurse to make appointment with Infectious Disease doctor for followup.
Age: 11.0
Sex: M
Vaccine: FLUN3, HPV4, MNQ, TDAP, VARCEL
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Neck pain
Clinical narrative: Injection site redness/swelling/pain along with systemic fever, headache, neck pain.
Age: 11.0
Sex: M
Vaccine: FLUN3, HPV4, MNQ, TDAP, VARCEL
Symptoms: Pyrexia
Clinical narrative: Injection site redness/swelling/pain along with systemic fever, headache, neck pain.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Asthenia, Constipation, Crying, Irritability, Nasal congestion
Clinical narrative: Patient seemed weak and had a fever that first night. After that stuffy nose daily, irritable, constant crying, not sleeping well, constipated.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Poor quality sleep, Pyrexia
Clinical narrative: Patient seemed weak and had a fever that first night. After that stuffy nose daily, irritable, constant crying, not sleeping well, constipated.
Sex: F
Vaccine: RAB
Symptoms: Condition aggravated, Fatigue, Injection site erythema, Injection site swelling, Lymphadenopathy
Clinical narrative: Case number PHEH2012US021823 is an initial spontaneous report received from a physician on 26 Oct 2012: This report refers to an adult female patient. She was vaccinated with the first dose of post exposure series of RABAVERT (batch number: unknown) intramuscularly on an unspecified date in Oct 2012 and experienced migraine-like headache and exhaustion (see related case: PHEH2012US021623). The pharmacy delayed her second dose of vaccine due to the adverse reactions she was experiencing. She was vaccinated with the second dose of RABAVERT (batch number: unknown) intramuscularly on 25 Oct 2012. Later on, in the same day, she began experiencing redness and swelling at the injection site that measure about 3 inches in diameter, a worsening of her migraine-like headache, fatigue and swollen lymph nodes. The final outcome was reported as condition unchanged at the time of reporting. No further information about seriousness and causality was reported.
Sex: F
Vaccine: RAB
Symptoms: Migraine
Clinical narrative: Case number PHEH2012US021823 is an initial spontaneous report received from a physician on 26 Oct 2012: This report refers to an adult female patient. She was vaccinated with the first dose of post exposure series of RABAVERT (batch number: unknown) intramuscularly on an unspecified date in Oct 2012 and experienced migraine-like headache and exhaustion (see related case: PHEH2012US021623). The pharmacy delayed her second dose of vaccine due to the adverse reactions she was experiencing. She was vaccinated with the second dose of RABAVERT (batch number: unknown) intramuscularly on 25 Oct 2012. Later on, in the same day, she began experiencing redness and swelling at the injection site that measure about 3 inches in diameter, a worsening of her migraine-like headache, fatigue and swollen lymph nodes. The final outcome was reported as condition unchanged at the time of reporting. No further information about seriousness and causality was reported.
Age: 0.15
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Death
Clinical narrative: Child passed away 11/4/12. Autopsy pending - cause of death unknown.
Age: 29.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Culture negative, Imaging procedure, Injection site discomfort, Laboratory test normal, Pyrexia
Clinical narrative: Fever up to 101.8 with some LUE discomfort. ID consulted - imaging, lab, cultures, antibiotics ordered.
Age: 59.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood culture negative, Imaging procedure, Injection site erythema, Injection site warmth, Laboratory test normal
Clinical narrative: Fever up to 102.7 degrees F with RUE warmness/erythema: ID consulted. Imaging, lab, cultures, antibiotics ordered.
Age: 59.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Fever up to 102.7 degrees F with RUE warmness/erythema: ID consulted. Imaging, lab, cultures, antibiotics ordered.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Electromyogram abnormal, Guillain-Barre syndrome, Immunoglobulin therapy, Muscular weakness, Sensory loss
Clinical narrative: Sudden onset of upper and lower extremity weakness about 2 weeks after vaccine administration. Patient hospitalized for 9 days, diagnosed with Axonal Variant of Guillain-Barre. Treated with IVIG. Symptoms are improving at this time.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: 1 hr after vaccination left arm became very swollen and painful. Area grew down to elbow with redness and pain throughout. Patient back on 10/27/12 at 16:45 to report.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Musculoskeletal pain
Clinical narrative: Patient received Flu shot on 10/27/12 and noticed pain in shoulder shortly following administration. Patient called today to inquire since pain still exists and may be getting worse with difficulty raising arm - no rash present.
Age: 39.0
Sex: F
Vaccine: FLU3, MMR, PPV
Symptoms: Nausea, Pyrexia, Skin reaction, Skin warm
Clinical narrative: (R) arm dominate. (R) arm bright red - hot to touch. Very nausea. 101 temp at 2 PM 9/25/12 - by 8 PM 102 temp - nauseated. By 9/26 - fever reducing. 9/26 - took BENADRYL. Both vaccine in (R) arm.
Age: 42.0
Sex: F
Vaccine: FLU3, MMR, PPV
Symptoms: Chills, Grip strength decreased, Injected limb mobility decreased, Injection site rash, Nausea
Clinical narrative: (R) arm sore - next day - increased pain 9/25 / 7 AM - chills - difficulty with grip strength - afternoon 99.8 Temp. at 6:30 - feeling feverish, nauseated. Hard to move (R) arm. 9-27 - feeling much better. 10/1 - still hot with small knot. Rash 9/25/12 $ size below injection site. Hot to touch.
Age: 42.0
Sex: F
Vaccine: FLU3, MMR, PPV
Symptoms: Nodule, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: (R) arm sore - next day - increased pain 9/25 / 7 AM - chills - difficulty with grip strength - afternoon 99.8 Temp. at 6:30 - feeling feverish, nauseated. Hard to move (R) arm. 9-27 - feeling much better. 10/1 - still hot with small knot. Rash 9/25/12 $ size below injection site. Hot to touch.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain, swollen - at injection site - no redness. Applied ice. Swollen subsided 24 hrs. later. Has taken prior flu vaccine with similar reaction last year. Informed to have MD provide vaccine in the future.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives on face about 3 hrs. after vaccination. Took BENADRYL q 4 hours x 3 doses on 11/7/12 & one dose in arm 11/8/12 with good effect. No diff swallowing or breathing. Hives faint.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Dizziness, Fatigue, Heart rate irregular
Clinical narrative: Patient given flu shot after checking for any allergies or previous problems with flu vaccine. Pt tolerated well. Watched while RN gave her son his Flu shot. After getting up and walking to window to pay client c/o feeling lightheaded. Was seated in chair. Clt clammy, heart rate 108-160 and irregular SPO2 98-99% BP 160/100 ambulance called and arrived. Started IV. Pushed BENADRYL & Epi via ambulance personnel and then pt transported to ER. 330pm TC to daughter. Mother is being discharged from ER. Tired but feeling better.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Arm pain greater than 2 wks after the vaccine. Have had the same problem with other AFLURIA shots.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Mobility decreased, Musculoskeletal pain, X-ray
Clinical narrative: Severe pain - upper (shoulder) - movement became limited. Received shot Sept. 29, waited approx. two weeks before seeing family Dr. Had X-ray and saw orthopedic, who diagnosed bursitis caused by shot. Have been doing therapy for this since I saw orthopedic.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient experiencing arm pain & soreness after receiving vaccine. Was put on a MEDROL Dose Pak and helped while she was on it. Now pain seems to be returning. Same problem I have had with other patients receiving the AFLURIA.
Age: 46.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Abdominal discomfort, Chills, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Swelling and pain at injection site (R arm), stomach upset, fevers, chills. Treated with Ciprofloxacin and prednisone.
Age: 46.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Abdominal discomfort, Cellulitis, Chills, Injection site pain, Injection site swelling
Clinical narrative: Swelling and pain at injection site (R arm), stomach upset, fevers, chills. Treated with Ciprofloxacin and prednisone.
Age: 46.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Swelling and pain at injection site (R arm), stomach upset, fevers, chills. Treated with Ciprofloxacin and prednisone.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Erythema, Pain in extremity, Paraesthesia
Clinical narrative: Right leg - tingling/burning and pain. Pain has subsided. Leg also red.
Age: 16.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt presents 2 days post injection with (R) deltoid red, sore, slightly swollen. No fever. Appx 12cmx21cm area. Applied BENADRYL cream & instructed to take TYLENOL. Drew border with sharpie & told them to call back if area grows > 1/2 inch outside border. Also told can take oral BENADRYL and put steroid cream & ice later on that day.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Heart rate increased, Pain, Urticaria
Clinical narrative: 1/2 dollar size welts - bad aching all over, 100.3 temp. 168/ blood pressure norm 120/ 100 heart beat. 10-29-12 had shot didn't feel normal until 11/6. Couldn't do anything strenuous without rapid heart beat until 11-5-2012. Seven large welts, one with inch wide to my armpit.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haematoma, International normalised ratio increased, Pain in extremity
Clinical narrative: Patient received flu vaccination in office at office visit. That night her arm started bruising and very painful. Bruising was from injection site down to elbow. Patient is currently on COUMADIN. INR that day was 3.4.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUN3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth, Muscle tightness
Clinical narrative: Reddened area on (L) leg; warm to the touch; tightness of muscle.
Age: 1.11
Sex: M
Vaccine: FLU3, PNC
Symptoms: Injection site rash, Pyrexia, Rash
Clinical narrative: Received 2 injections. Flu on (R) thigh on Wednesday afternoon. Thursday noticed rash on (R) leg. Fever Sat. Rash had spread to chest & abdomen on (R) side. ZITHROMAX for ears. PREVNAR on (L) thigh. ORAPRED 15mg/5mL 1/2 teaspoon qd x5.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Induration, Local swelling, Pain
Clinical narrative: Patient stopped into clinic 11/7/12 to show me her arm. Baseball sized red area, slightly raised & hard. Area painful.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray normal, Chest discomfort, Cough, Diarrhoea, Dyspnoea
Clinical narrative: Patient had nausea, vomiting and diarrhea after receiving the vaccine. He also reported coughing and difficulty breathing, "chest pressure" as well as shaking. He visited ER x-ray did not show any infection.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Tremor, Vomiting
Clinical narrative: Patient had nausea, vomiting and diarrhea after receiving the vaccine. He also reported coughing and difficulty breathing, "chest pressure" as well as shaking. He visited ER x-ray did not show any infection.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Developed hives on chest and arm of vaccine administration. Developed difficulty breathing approximately 2 hours after receiving vaccine. Received BENADRYL, prednisone & epi.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Rash erythematous
Clinical narrative: Pt received flu vaccine on 10/11/12. One week after started noticing red raised dots on arms. On 10/23/12 had raised red prickly rash all over arms, groin, thighs, face, forehead with burning. Reported to occupational health & was started on MEDROL DOSE PAK.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Left arm pain.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Eye irritation, Hypoaesthesia oral, Ocular hyperaemia, Throat tightness, Vision blurred
Clinical narrative: After receiving vaccine 10:15 AM pt states "she noticed her eyes "burning", "blurred" & "red". Also c/o lower lip feeling "numb", "tightness" in throat. Symptoms began 2 hours after receiving flu shot, seen and treated in ER at 1515 PM with prednisone and BENADRYL.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Periarthritis
Clinical narrative: Flu shot (L) deltoid 10/09/12 progressive pain & decreased ROM started next day. No local redness or swelling. Now has frozen shoulder.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Circulatory collapse, Unresponsive to stimuli, Vomiting
Clinical narrative: Pt was very anxious when given immunization. After administration, she was sitting in a chair while waiting for others to receive flu shots. Pt stood up - collapsed into her mother's arms. She was unresponsive for approx 30 seconds. She then threw up. Placed cold compress on her forehead & she was responsive. EMS came to check her vital signs her O2 was 100% & blood pressure was 101/67. She was responsive, talking & walking. I contacted pt's home at 2:40pm (approx. 4 hours after initial event) and was told pt was normal & doing fine.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pruritus, Skin warm, Swelling
Clinical narrative: Erythema, pain/tenderness at injection site, swelling, warmth, pruritus after 24 hours (size 3 inch wide x 2 inch tall on 11-2-12). Advised to contact physician - ice area. Watch for increased area of redness. Take OTC BENADRYL every 6 hours.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt came in on 10-26-12 with red injection site, size of golf ball, warm to touch, we marked area and are watching. Returned on 10/27/12 - site was a littler larger called on 10/28/12 - said everything looked a lot better (not as red, did not get any bigger).
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: 10/26 - left arm swollen down to wrist from shoulder - pt went to hospital ER and received treatment.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Patient had syncopal episode after receiving MENACTRA & Tdap (BOOSTRIX) vaccines.
Age: 33.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: None. Order Tdap. Dtap given.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Shot for shingles received afternoon of 11-5-12. Morning of 11-7 noted pain and swelling at site of injection. Seen in clinic afternoon of 11-7-12. Red, very sore to touch measuring 40 x 50 mm. Was up middle of the night with headache. Took ibuprofen at that time.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: Localized pain and redness that started as a dime and grew to a half dollar per px. Ice helped pain. As of 11/5/12 reaction subsided.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, felt as if she passed out, light headed, dizzy.
Age: 41.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Nausea, headache, body aches, fever - site warm, red, hard and painful. Also stiffness neck.
Age: 41.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Musculoskeletal stiffness, Nausea, Pain, Pyrexia
Clinical narrative: Nausea, headache, body aches, fever - site warm, red, hard and painful. Also stiffness neck.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Hyperaesthesia
Clinical narrative: Varicella zoster onset 11/01/12 over right anterior thigh, right buttock. Hyperesthesia over right flank and RLQ of abdomen. Being treated with Acyclovir, Lidoderm patches, and Vicodin.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Pt states had soreness in (R) arm evening of immunization. More sore next day, then 3rd day HA and nausea, slight fever - no redness, swell or heat at site. 11/7/12 - still HA, nausea.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Discomfort, Electromyogram normal, Radiculitis brachial
Clinical narrative: Vaccine given 5/12, gradual progression of discomfort to area becoming significant by 9/12. NSAIDS tried, then Gabapentin and Neurology referred. Suspected brachial neuritis.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Pt. received VZV shot in La on 11-5-12. Came back to clinic on 11-7-12 c/o swelling & redness. She was seen by RN and encouraged to put cool compress several x daily and explained this is one of the side effects, and encouraged to see an M.D. if worsening occurs. 11-8-12 at 2:45PM mom states "It was still red this AM but not any worse".
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Swollen arm, red and painful.
Age: 11.0
Sex: F
Vaccine: TYP
Symptoms: Vomiting
Clinical narrative: Pt. vomited at 6 pm on the day of vaccination.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Back pain, Headache, Lethargy, Pain in extremity, Pyrexia
Clinical narrative: Received TDAP and MCV4 11/5/2012. Fever of 101.9 F, headache, back ache, sore arm 11/6/2012. 11/7/2012 Lethargy, mild temp. 11/8/2012 Back to school.
Age: 25.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Full blood count normal, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Swollen and tender right lower cervical lymphadenopathy and swollen lymph under (R) armpit, (R) upper deltoid is erythematous with increased warmth and tender to palpation, (R) arm and shoulder pain, arthralgia.
Age: 25.0
Sex: F
Vaccine: MNQ
Symptoms: Lymph node pain, Lymphadenopathy, Musculoskeletal pain, Pain in extremity
Clinical narrative: Swollen and tender right lower cervical lymphadenopathy and swollen lymph under (R) armpit, (R) upper deltoid is erythematous with increased warmth and tender to palpation, (R) arm and shoulder pain, arthralgia.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: Patient complaining of bump on the arm and warm to the touch.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling jittery, Pain in extremity
Clinical narrative: - (L) arm aches/pains. - Jitters.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Red, swollen, hardened area on (L) upper extremity. Completed series - 2nd booster 48 hrs ago.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Pain, Pruritus
Clinical narrative: (R) arm redness and swelling at injection site; swelling, redness from injection site to entire bicep; itching, soreness/pain, unable to move arm very much; 11/8/12 symptoms are diminishing; pt c/o area being hot.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: (R) arm redness and swelling at injection site; swelling, redness from injection site to entire bicep; itching, soreness/pain, unable to move arm very much; 11/8/12 symptoms are diminishing; pt c/o area being hot.
Sex: U
Vaccine: HEP, HEPA, HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with, 1 DF GARDASIL. Other suspect therapies included RECOMBIVAX HB and VAQTA. No concomitant medications were reported. On an unknown date the patient experienced incorrect storage of drug. No treatment information was reported. The outcome of incorrect storage of drug is unknown. Incorrect storage of drug is not related to VAQTA, RECOMBIVAX HB and GARDASIL. (Additional information has been requested. / Additional information is not expected.)
Age: 9.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 4 days ago pt received Tdap (L) deltoid - day after developed red and swelling about 4-5 cm improved but not resolved on day 4.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Oedema peripheral, Pain, Pruritus, Skin warm
Clinical narrative: Arm swelling, itchiness, warm to touch, pain with movement, temperature chills (4 days).
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral, Pruritus, Skin warm
Clinical narrative: Red, swollen, warm, itchy area on right arm about the size of a baseball.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Maternal exposure during pregnancy
Clinical narrative: Information has been received from a nurse practitioner, for GARDASIL (lot# was unknown), a Pregnancy Registry product, concerning a female patient of unknown age. The patient's history of previous pregnancies and live births was not known. The patient was vaccinated with dose 1 GARDASIL (Lot# was unknown) on unknown date. No concomitant medications were reported. Several years later the patient became pregnant. The LMP and EDD was not known. The patient was exposed to GARDASIL during trimester 1, 2 and 3. It was reported that the patient had a normal delivery. The infant's APGAR scores are not available. The patient received Dose 2 of GARDASIL (lot# was unknown) some time after delivery of her baby. Dose 3 had not been administered yet. Patient sought medical attention. No treatment information was reported. Nurse practitioner did not think this needed to be reported to the pregnancy registry. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Localized (mild-moderate) erythema, warmth, swelling at the injection site.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. The patient was vaccinated with lot # (666597/0768Z) dose, 1, 1 DF GARDASIL on 06-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On 06-NOV-2012 the patient experienced expired vaccine used, 1 day after onset of therapy. No treatment information was reported. Expired vaccine used is not related to GARDASIL. (Additional information has been requested. / Additional information is not expected.)
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Hypoaesthesia, Middle insomnia, Mobility decreased, Pain in extremity
Clinical narrative: See attached documents. Onset: 6 Day(s) ago. Severity level is severe (10). It occurs constantly. Location: upper arm. The pain radiates to the fingers. The pain is aching and sharp. The pain is aggravated by lifting. Associated symptoms include decreased mobility, night-time awakening, numbness in lower arm, tenderness and weakness. Additional information: Had a PNEUMOVAX  last Thursday and painful ever since.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: See attached documents. Onset: 6 Day(s) ago. Severity level is severe (10). It occurs constantly. Location: upper arm. The pain radiates to the fingers. The pain is aching and sharp. The pain is aggravated by lifting. Associated symptoms include decreased mobility, night-time awakening, numbness in lower arm, tenderness and weakness. Additional information: Had a PNEUMOVAX  last Thursday and painful ever since.
Age: 37.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Differential white blood cell count, Full blood count, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: 11/6/12 - Pt. woke up with fever, redness and tenderness in area of left bicep. Injection site was sore, hard, and swollen. Treated pain and fever with 600mg Ibuprofen on own. 11/7/12 - Woke up with fever up to 101.7 degrees F and continued with same symptoms in left arm. Again, took 600mg Ibuprofen. 11/8/12 - Fever 99.9 degrees F; continued arm symptoms. Dr. started her on Cephalexin 500mg BID x 7 days.
Age: 37.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: 11/6/12 - Pt. woke up with fever, redness and tenderness in area of left bicep. Injection site was sore, hard, and swollen. Treated pain and fever with 600mg Ibuprofen on own. 11/7/12 - Woke up with fever up to 101.7 degrees F and continued with same symptoms in left arm. Again, took 600mg Ibuprofen. 11/8/12 - Fever 99.9 degrees F; continued arm symptoms. Dr. started her on Cephalexin 500mg BID x 7 days.
Age: 37.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Cellulitis, Full blood count, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: 11/6/12 - Pt. woke up with fever, redness and tenderness in area of left bicep. Injection site was sore, hard, and swollen. Treated pain and fever with 600mg Ibuprofen on own. 11/7/12 - Woke up with fever up to 101.7 degrees F and continued with same symptoms in left arm. Again, took 600mg Ibuprofen. 11/8/12 - Fever 99.9 degrees F; continued arm symptoms. Dr. started her on Cephalexin 500mg BID x 7 days.
Age: 42.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Chest discomfort, Chest pain, Immediate post-injection reaction
Clinical narrative: Pt stated she felt tightness and pain in her chest immediately after receiving hepatitis B vaccine, in which that was the last injection given. A second set of vitals were taken and were normal, Dr was informed, pt was monitored for 15 min.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a other health professional refers to a female patient of unknown age. The patient was vaccinated with dose 2, 1 DF GARDASIL on 04-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced inappropriate schedule of vaccine administered. No treatment information was reported. The outcome of inappropriate schedule of vaccine administered is unknown. Inappropriate schedule of vaccine administered is not related to GARDASIL. (Additional information has been requested. / Additional information is not expected.)