chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.4
Sex: F
Vaccine: DTAP, MEN, TTOX
Symptoms: Full blood count normal, Hypotonia, Metabolic function test normal, Miosis, Oxygen saturation decreased
Clinical narrative: This female subject was enrolled in a prophylactic open study. On 26 June 2009, she received the dose of MENINGOCOCCAL-TETANUS TOXIOD. On 12 August 2009, 47 days after the 1st dose of INFANRIX, 47 days after the 1st dose of MENINGOCOCCAL-TETANUS TOXIOD, this 18-month old subject became floppy. The subject was hospitalised and the event was life-threatening and clinically significant (or requiring intervention). The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the floppy infant may have been caused by INFANRIX and MENINGOCOCCAL-TETANUS TOXIOD. Investigator Comments: Normally healthy child 'not acting right' when she awoke from a nap at 9.00pm on 12 August 2009. On arrival at ER (emergency room) child's extremities were flaccid and she could not hold her head up. At the time she was alert and demonstrated abdominal muscle breathing without respiratory distress, although her pulse oximeter reading was 79%. Demonstrated withdrawal to pain with PIV placement, crying on assessment and during PIV placement, remaining alert. On initial exam her pupils were round and reactive, she was crying and she slightly withdrew when stuck for blood but demonstrated no other muscle action except for movements of her head. Her neck was supple at all exams. Within 30 minutes her pupils became pinpoint and she became unresponsive to touch or voice. She was intubated at that time. PO was still 100% on oxygen and she still demonstrated abdominal breathing. CV: tachycardia. Lungs - clear. Abdomen - soft. Diaper area - no trauma, no rashes. Back: few papules consistent with mosquito bites. Extremities - flaccid, no bruising, warm and dry. Neuro: initially appeared alert with appropriate cry then deteriorated to unresponsive, but was able to cry again when initial preparations to intubation occurred. CT of head without contrast - normal. CBC and BMP - normal. Anesthesia at bedside for intubation - 50mcg of PROPOFOL. Fentanyl and Versed administered post-procedure. Child with spontaneous respirations. Placed on CPAP Fio2 50% rate 25. Transferred to hospital as in critical condition without confirmed diagnosis. No further information available at this time. Additional information 14 August 2009: On the evening of August 12 the child was with grandmother and upon mom's return home she noticed that the child was not acting as usual - the ER is very close by, so mom took the child in - (child became unresponsive, POx 79% and was intubated in ER then transferred to another hospital where continues to be intubated but slowly becoming responsive; head CT was negative).
Age: 1.4
Sex: F
Vaccine: DTAP, MEN, TTOX
Symptoms: Rash papular, Skin warm, Tachycardia, Unresponsive to stimuli
Clinical narrative: This female subject was enrolled in a prophylactic open study. On 26 June 2009, she received the dose of MENINGOCOCCAL-TETANUS TOXIOD. On 12 August 2009, 47 days after the 1st dose of INFANRIX, 47 days after the 1st dose of MENINGOCOCCAL-TETANUS TOXIOD, this 18-month old subject became floppy. The subject was hospitalised and the event was life-threatening and clinically significant (or requiring intervention). The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the floppy infant may have been caused by INFANRIX and MENINGOCOCCAL-TETANUS TOXIOD. Investigator Comments: Normally healthy child 'not acting right' when she awoke from a nap at 9.00pm on 12 August 2009. On arrival at ER (emergency room) child's extremities were flaccid and she could not hold her head up. At the time she was alert and demonstrated abdominal muscle breathing without respiratory distress, although her pulse oximeter reading was 79%. Demonstrated withdrawal to pain with PIV placement, crying on assessment and during PIV placement, remaining alert. On initial exam her pupils were round and reactive, she was crying and she slightly withdrew when stuck for blood but demonstrated no other muscle action except for movements of her head. Her neck was supple at all exams. Within 30 minutes her pupils became pinpoint and she became unresponsive to touch or voice. She was intubated at that time. PO was still 100% on oxygen and she still demonstrated abdominal breathing. CV: tachycardia. Lungs - clear. Abdomen - soft. Diaper area - no trauma, no rashes. Back: few papules consistent with mosquito bites. Extremities - flaccid, no bruising, warm and dry. Neuro: initially appeared alert with appropriate cry then deteriorated to unresponsive, but was able to cry again when initial preparations to intubation occurred. CT of head without contrast - normal. CBC and BMP - normal. Anesthesia at bedside for intubation - 50mcg of PROPOFOL. Fentanyl and Versed administered post-procedure. Child with spontaneous respirations. Placed on CPAP Fio2 50% rate 25. Transferred to hospital as in critical condition without confirmed diagnosis. No further information available at this time. Additional information 14 August 2009: On the evening of August 12 the child was with grandmother and upon mom's return home she noticed that the child was not acting as usual - the ER is very close by, so mom took the child in - (child became unresponsive, POx 79% and was intubated in ER then transferred to another hospital where continues to be intubated but slowly becoming responsive; head CT was negative).
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Induration
Clinical narrative: Noticed when went to bed last night redness and small bruise. Came to clinic and FNP noted small amount induration, erythema and small contusion.
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient report soreness to right deltoid and right arm swollen.
Sex: U
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Fall, Pallor, Syncope
Clinical narrative: Fell to floor - pale, fainted.  V/S taken 430p 94/68 P 64 R 18. 435p 98/70 64 - 18.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Crying, Immediate post-injection reaction, Loss of consciousness, Syncope, Vomiting projectile
Clinical narrative: Pt. received (1) Tdap in (L) arm then MENACTRA and VZV Rt arm. Then immediately had projectile vomiting. Pt. then fainted and vomited again while unconscious. Pt. then woke up and started crying stating "what happened to me"? V/S stable and remained in office x 30 min. No tx. given.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Local reaction (L) upper arm/tricep area. 4 cm x 4 cm mildly erythema, swollen, no TTP. BENADRYL is given by mouth.
Age: 12.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Induration, Pruritus, Swelling, Tenderness
Clinical narrative: Varicella vaccine reaction started 24 hours after receiving Varicella on 8/19/09. Pt reported itching prior to swelling and tenderness. Induration area 5 cm in diameter, no fever- pain or pain radiation, treated with BACTRIM DS 160 mg-800 mg tab. Take one PO Bid x 10 days.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dizziness, Nausea
Clinical narrative: Pt given vaccine about 11 o'clock, Ate lunch about noon. At approx 1 PM reported, diarrhea X 2, severe nausea, feeling faint. Placed in recliner IV fluids given - ZOFRAN - hydrated X 2 hrs.  VSS. Home with spouse.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site nodule
Clinical narrative: Knot in (L) arm 1 1/2 inch circle.
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: Parent of client called reporting that arm site where VARICELLA vaccine was given become swollen & had hive like reaction.  Client was seen by PMD & antibiotics prescribed.  Client called 8/20/09 & seen by PMD 8/19/2009.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Wheezing
Clinical narrative: Pt. had IZS 8-20-09, began wheezing by 10 p that eve - worsening by am 8-21-09.  Arrived for tx / received DUONEBXL plus 5 mg ALBUTEROL with unsatisfactory results.  No hx asthma.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Lip swelling, Oedema peripheral, Radioallergosorbent test negative, Rash
Clinical narrative: Rec'd HPV #1 12-16-08- No reaction. HPV#2 2-16-09- 2 wks after- severe abd pain, and facial swelling, lips and extremities swollen, no resp diff. rash on abdomen. HPV #3 6-16-09- 9 days after same reaction. Rx BENADRYL.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Swelling face, Vaccine positive rechallenge
Clinical narrative: Rec'd HPV #1 12-16-08- No reaction. HPV#2 2-16-09- 2 wks after- severe abd pain, and facial swelling, lips and extremities swollen, no resp diff. rash on abdomen. HPV #3 6-16-09- 9 days after same reaction. Rx BENADRYL.
Age: 72.0
Sex: F
Vaccine: PPV, TD
Symptoms: Erythema, Fall, Hyperhidrosis, Oedema peripheral, Tremor
Clinical narrative: At 3:30 pm pt developed swelling slight left arm redness advised to apply ice and take BENADRYL. At 8:30 pm pt became very shaky & diaphoretic - fell pt transferred by ambulance to ER - given steroids/advised to take BENADRYL 94 degrees x 24 degrees swelling decreased some redness left on 8/2109.
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left thigh, red swollen warm to touch around injection site. Keflex ZSO/5. 5ml PO BID; possible cellulitis.
Age: 23.0
Sex: F
Vaccine: FLU3, HPV4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Developed fever, pain, redness & swelling at area of injection site day after immunization - treated with MOTRIN & antibiotic.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, Unevaluable event
Clinical narrative: None Stated
Age: 55.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: fever
Age: 40.0
Sex: M
Vaccine: RAB
Symptoms: Anorexia, Anosmia, Brain oedema, Fall, Feeling abnormal
Clinical narrative: My husband received the vaccinations while standing was asked how he was feeling he said ok was then sent to the hallway of the emergency room so I could receive my vaccinations. The nurse said that we had to wait for 15 min. to be watched for any reactions.  My husband was not monitored for the 15 min. When he went into the hallway he said the last thing he remember was a warm fuzzy feeling. My husband then passed out and landed flat on his back in the hallway. As a result of his fall he has a fractured skull, brain bleeding and swelling.  He was admitted to the hospital and sent to ICU. At the present time he is home but still is in pain, has no appetite, nausea, no sense of smell and is still not himself.  8/31/09 Received hospital medical records of 8/20-8/21/2009. FINAL DX: subarachnoid/subdural bleed Records reveal patient experienced fall, head injury & headache immediately after receiving vaccine.  Neurosurg consult done.  Tx w/steroids.  Remained stable & d/c to home. ICD-9 codes for DC 401.9, 780.2, 401.9
Age: 40.0
Sex: M
Vaccine: RAB
Symptoms: Feeling hot, Intensive care, Loss of consciousness, Nausea, Pain
Clinical narrative: My husband received the vaccinations while standing was asked how he was feeling he said ok was then sent to the hallway of the emergency room so I could receive my vaccinations. The nurse said that we had to wait for 15 min. to be watched for any reactions.  My husband was not monitored for the 15 min. When he went into the hallway he said the last thing he remember was a warm fuzzy feeling. My husband then passed out and landed flat on his back in the hallway. As a result of his fall he has a fractured skull, brain bleeding and swelling.  He was admitted to the hospital and sent to ICU. At the present time he is home but still is in pain, has no appetite, nausea, no sense of smell and is still not himself.  8/31/09 Received hospital medical records of 8/20-8/21/2009. FINAL DX: subarachnoid/subdural bleed Records reveal patient experienced fall, head injury & headache immediately after receiving vaccine.  Neurosurg consult done.  Tx w/steroids.  Remained stable & d/c to home. ICD-9 codes for DC 401.9, 780.2, 401.9
Age: 40.0
Sex: M
Vaccine: RAB
Symptoms: Skull fracture
Clinical narrative: My husband received the vaccinations while standing was asked how he was feeling he said ok was then sent to the hallway of the emergency room so I could receive my vaccinations. The nurse said that we had to wait for 15 min. to be watched for any reactions.  My husband was not monitored for the 15 min. When he went into the hallway he said the last thing he remember was a warm fuzzy feeling. My husband then passed out and landed flat on his back in the hallway. As a result of his fall he has a fractured skull, brain bleeding and swelling.  He was admitted to the hospital and sent to ICU. At the present time he is home but still is in pain, has no appetite, nausea, no sense of smell and is still not himself.  8/31/09 Received hospital medical records of 8/20-8/21/2009. FINAL DX: subarachnoid/subdural bleed Records reveal patient experienced fall, head injury & headache immediately after receiving vaccine.  Neurosurg consult done.  Tx w/steroids.  Remained stable & d/c to home. ICD-9 codes for DC 401.9, 780.2, 401.9
Age: 14.0
Sex: M
Vaccine: MEN, TD
Symptoms: Headache, Injection site pain, Lethargy, Pain, Pyrexia
Clinical narrative: approx 12 hours after the shots my son became lethargic complaining of severe body aches, throbbing headache, pain at injection sites, blurred vision and had a fever of 102.4   ----------------------------------------------------Called pediatrician at 0500 hrs.  Was advised to give tylenol and motrin to combat the fever.  Approx 2 hours after doing this the fever subsided and he was finally able to sleep.
Age: 14.0
Sex: M
Vaccine: MEN, TD
Symptoms: Vision blurred
Clinical narrative: approx 12 hours after the shots my son became lethargic complaining of severe body aches, throbbing headache, pain at injection sites, blurred vision and had a fever of 102.4   ----------------------------------------------------Called pediatrician at 0500 hrs.  Was advised to give tylenol and motrin to combat the fever.  Approx 2 hours after doing this the fever subsided and he was finally able to sleep.
Age: 16.0
Sex: M
Vaccine: TDAP
Symptoms: Disturbance in attention, Dyskinesia, Erythema, Feeling hot, Listless
Clinical narrative: Pt was given shot on 08/18/09 in Left deltoid IM. He was sitting in a chair. Approx 1-2 minutes after injection his left arm was flexed toward body his legs went straight out and his head was flexed backwards and his face became red and he seemend not to be aware.  Apperaing to be a focal seizure lasting like 10-15 seconds maybe more but not more than a minute.  He then awoke was okay than like 30sec-1 minute later he became pale and listless place pateint from chair to floor. His mouth was clamped shut could not access airway, felt for pulse. He had one. I laid on side then approx 20-30 seconds later he was aroused and became aware stating all was okay. He was still very pale. Pulse 64 BP 108/60 laying down. Complaining that he was hot placed fan on him.  911 was already called.  He then wanted to sit up in chair was able to stand and sit in chair.  Fire rescue arriving to scene with him in chair AAOx3.  He was taken to Hospital ER via EMS.  He ambulated out of clinic.  He was discharged from Hospital same day with diagnosis of Vasal-Vagal as per family member Aunt.
Age: 16.0
Sex: M
Vaccine: TDAP
Symptoms: Pallor, Partial seizures, Presyncope, Reflexes abnormal
Clinical narrative: Pt was given shot on 08/18/09 in Left deltoid IM. He was sitting in a chair. Approx 1-2 minutes after injection his left arm was flexed toward body his legs went straight out and his head was flexed backwards and his face became red and he seemend not to be aware.  Apperaing to be a focal seizure lasting like 10-15 seconds maybe more but not more than a minute.  He then awoke was okay than like 30sec-1 minute later he became pale and listless place pateint from chair to floor. His mouth was clamped shut could not access airway, felt for pulse. He had one. I laid on side then approx 20-30 seconds later he was aroused and became aware stating all was okay. He was still very pale. Pulse 64 BP 108/60 laying down. Complaining that he was hot placed fan on him.  911 was already called.  He then wanted to sit up in chair was able to stand and sit in chair.  Fire rescue arriving to scene with him in chair AAOx3.  He was taken to Hospital ER via EMS.  He ambulated out of clinic.  He was discharged from Hospital same day with diagnosis of Vasal-Vagal as per family member Aunt.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Dehydration, Fatigue, Feeling hot, Flushing
Clinical narrative: 8 hours after shot: Tremors,vertigo,hot flushing, pallor, nausea,headache,lower back pain,fatigue & dehydration.  Pulse and respiration was high, blood pressure high.  Most symptoms resolved within 24 hours except for fatigue and headache.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Heart rate increased, Hypertension, Nausea, Pallor
Clinical narrative: 8 hours after shot: Tremors,vertigo,hot flushing, pallor, nausea,headache,lower back pain,fatigue & dehydration.  Pulse and respiration was high, blood pressure high.  Most symptoms resolved within 24 hours except for fatigue and headache.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Respiratory rate increased, Skin warm, Tremor, Vertigo
Clinical narrative: 8 hours after shot: Tremors,vertigo,hot flushing, pallor, nausea,headache,lower back pain,fatigue & dehydration.  Pulse and respiration was high, blood pressure high.  Most symptoms resolved within 24 hours except for fatigue and headache.
Age: 4.0
Sex: M
Vaccine: DPP, FLUN3, HEPA, IPV, MMR, SMALL
Symptoms: Diarrhoea, Dry throat, Headache, Immediate post-injection reaction, Injection site pain
Clinical narrative: Fever of 103, complaint of headache almost immediately, sore/dry throat, very irritable, soreness at sight, feet twitching, vomiting the next morning after shots, diarhea still going on-rash on day 3- The final vaccine was for chickenpox (but I was unclear if that is the same as smallpox)
Age: 4.0
Sex: M
Vaccine: DPP, FLUN3, HEPA, IPV, MMR, SMALL
Symptoms: Irritability, Muscle twitching, Oropharyngeal pain, Pyrexia, Rash
Clinical narrative: Fever of 103, complaint of headache almost immediately, sore/dry throat, very irritable, soreness at sight, feet twitching, vomiting the next morning after shots, diarhea still going on-rash on day 3- The final vaccine was for chickenpox (but I was unclear if that is the same as smallpox)
Age: 4.0
Sex: M
Vaccine: DPP, FLUN3, HEPA, IPV, MMR, SMALL
Symptoms: Vomiting
Clinical narrative: Fever of 103, complaint of headache almost immediately, sore/dry throat, very irritable, soreness at sight, feet twitching, vomiting the next morning after shots, diarhea still going on-rash on day 3- The final vaccine was for chickenpox (but I was unclear if that is the same as smallpox)
Age: 53.0
Sex: F
Vaccine: HEPA
Symptoms: Aldolase normal, Blood creatine phosphokinase normal, Blood test normal, C-reactive protein normal, Full blood count normal
Clinical narrative: Arm soreness never went away after vaccination. At first could not raise left arm straight up to to side without pain. Range of motion gradually decreased--cannot extend arm fully yet. Pain in left shoulder muscle so bad I cannot sleep on left side. Something in upper arm pops like it is sliding into place. Only treatment used is topical Voltaren gel. Over 6 months later I still have bad pain and cannot fully move/use left arm.
Age: 53.0
Sex: F
Vaccine: HEPA
Symptoms: Injected limb mobility decreased, Joint range of motion decreased, Myalgia, Nuclear magnetic resonance imaging normal, Pain in extremity
Clinical narrative: Arm soreness never went away after vaccination. At first could not raise left arm straight up to to side without pain. Range of motion gradually decreased--cannot extend arm fully yet. Pain in left shoulder muscle so bad I cannot sleep on left side. Something in upper arm pops like it is sliding into place. Only treatment used is topical Voltaren gel. Over 6 months later I still have bad pain and cannot fully move/use left arm.
Age: 53.0
Sex: F
Vaccine: HEPA
Symptoms: Red blood cell sedimentation rate normal
Clinical narrative: Arm soreness never went away after vaccination. At first could not raise left arm straight up to to side without pain. Range of motion gradually decreased--cannot extend arm fully yet. Pain in left shoulder muscle so bad I cannot sleep on left side. Something in upper arm pops like it is sliding into place. Only treatment used is topical Voltaren gel. Over 6 months later I still have bad pain and cannot fully move/use left arm.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: Patient given vaccin afternoon of 8/21/09. She bgan itching "everywhere" abou 8pm that evening. At 9pm she began to notice a generalized rash. About 10 pm she took 2 x 25 mg diphenhydramine. On the morning of 8/22/09 she was still itching and repeated the 2 x 25 mg diphenhydramine about 10:15 am. She returned to the pharmacy and was referred to urgent care asa she had non current PCP.
Age: 7.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Oedema peripheral, Pallor
Clinical narrative: Right deltoid area was a little pale 8/21/2009, elevated intensity/swelling 8/22/09, cool compress, Cephalexin 250/5 mg's i tsp QID.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Anaphylactic reaction, Lymphadenopathy, Pruritus, Urticaria, Wheezing
Clinical narrative: severe hives, itching, wheezing with prolonged reaction resulting in "flare ups" for weeks with anylphylaxis. Recently escalated to a systemic reaction involving lymphs glands believed to be linked to original reaction which was never completely resolved.  8/24/09 PCP records rec'd for DOS  8/20/09 with Impression: sinusitis, allergic reaction, seasonal allergies. Pt presented with c/o allergic reaction after being around a cat with onset 8/13/09. Developed swelling feet and face, itching, H/A and ear popping. Still reporting allergic sx from Td vax 6 weeks prior.  PE (+) for wheeze, boggy turbinates and pharyngeal injection, and sinus tenderness. Tx: steroids, abx, antihistamine.
Age: 45.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Abasia, Dizziness, Laboratory test normal, Vomiting
Clinical narrative: Severe dizziness cuasing inability to walk without assistance occurred approximately 4 hours post administration of vaccination.  Dizziness so severe resulted in vomitting, visit to ED followed by 2 full days in bed and while symptoms have improved substantially, dizziness still present 4 days post receipt of vaccine.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Arthritis, Blood creatinine increased, Blood test, Bursa disorder, Cellulitis
Clinical narrative: Administered just prior to discharge from hospital on 4/1/08.  Immediate pain at site of injection.  In the early hours of the morning of 4/2/08 blood pressure of 78/67, 94/67 and 109/76. Temp of 100.7 and 100.3.  At 8:40 am, BP of 97/62; 9:08 BP of 88/57.  Took to ER, followed by admission to hospital.  Bursa sac full of fluid, dehydration, low BP, fever, high creatinine level,elbow fully inflamed with pain from shoulder to the tips of fingers.  Arm had shown no inflammation at 3am on April 2, but fully inflamed at 8:30 am, indicating cellulitis.  Diagnosed with ATN and cellulitis. 11/23/09 Medical records received for dates 4/2/08 to 4/12/08. DX: LUE cellulitis vs acute vaccine reaction. Pt admitted for abdominal pain/bloated sx. Multiple diagnostics performed, upon dc/ pt given pneumovax left arm, pt. states immed at time of vax noted pain and increase erythema of next several hours at home. Pt states had weakness and malaise then fever, confusion, low BP, and decreased ROM. Pt went to ER. Sed rate 35(H), CRP 12.48(H). Pt admitted tx IV abx for cellulitis of left arm/elbow. Assessment: left elbow pain, limited ROM noted, erythema from left shoulder to elbow. Pt. dc in stable condition. Pt readmitted on 4/10/08 to 4/12/08 for  nausea and retching. DX: dehydration.  ICD9 codes: 999.39, 584.5, 682.3, 780.79,693.0, 780.6, 719.42, 401.9, 458.9, 276.50, 276.51, 584.9, 787.01.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Dehydration, Hypotension, Immediate post-injection reaction, Injection site pain, Laboratory test
Clinical narrative: Administered just prior to discharge from hospital on 4/1/08.  Immediate pain at site of injection.  In the early hours of the morning of 4/2/08 blood pressure of 78/67, 94/67 and 109/76. Temp of 100.7 and 100.3.  At 8:40 am, BP of 97/62; 9:08 BP of 88/57.  Took to ER, followed by admission to hospital.  Bursa sac full of fluid, dehydration, low BP, fever, high creatinine level,elbow fully inflamed with pain from shoulder to the tips of fingers.  Arm had shown no inflammation at 3am on April 2, but fully inflamed at 8:30 am, indicating cellulitis.  Diagnosed with ATN and cellulitis. 11/23/09 Medical records received for dates 4/2/08 to 4/12/08. DX: LUE cellulitis vs acute vaccine reaction. Pt admitted for abdominal pain/bloated sx. Multiple diagnostics performed, upon dc/ pt given pneumovax left arm, pt. states immed at time of vax noted pain and increase erythema of next several hours at home. Pt states had weakness and malaise then fever, confusion, low BP, and decreased ROM. Pt went to ER. Sed rate 35(H), CRP 12.48(H). Pt admitted tx IV abx for cellulitis of left arm/elbow. Assessment: left elbow pain, limited ROM noted, erythema from left shoulder to elbow. Pt. dc in stable condition. Pt readmitted on 4/10/08 to 4/12/08 for  nausea and retching. DX: dehydration.  ICD9 codes: 999.39, 584.5, 682.3, 780.79,693.0, 780.6, 719.42, 401.9, 458.9, 276.50, 276.51, 584.9, 787.01.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Musculoskeletal pain, Pain in extremity, Renal tubular necrosis, Urine analysis
Clinical narrative: Administered just prior to discharge from hospital on 4/1/08.  Immediate pain at site of injection.  In the early hours of the morning of 4/2/08 blood pressure of 78/67, 94/67 and 109/76. Temp of 100.7 and 100.3.  At 8:40 am, BP of 97/62; 9:08 BP of 88/57.  Took to ER, followed by admission to hospital.  Bursa sac full of fluid, dehydration, low BP, fever, high creatinine level,elbow fully inflamed with pain from shoulder to the tips of fingers.  Arm had shown no inflammation at 3am on April 2, but fully inflamed at 8:30 am, indicating cellulitis.  Diagnosed with ATN and cellulitis. 11/23/09 Medical records received for dates 4/2/08 to 4/12/08. DX: LUE cellulitis vs acute vaccine reaction. Pt admitted for abdominal pain/bloated sx. Multiple diagnostics performed, upon dc/ pt given pneumovax left arm, pt. states immed at time of vax noted pain and increase erythema of next several hours at home. Pt states had weakness and malaise then fever, confusion, low BP, and decreased ROM. Pt went to ER. Sed rate 35(H), CRP 12.48(H). Pt admitted tx IV abx for cellulitis of left arm/elbow. Assessment: left elbow pain, limited ROM noted, erythema from left shoulder to elbow. Pt. dc in stable condition. Pt readmitted on 4/10/08 to 4/12/08 for  nausea and retching. DX: dehydration.  ICD9 codes: 999.39, 584.5, 682.3, 780.79,693.0, 780.6, 719.42, 401.9, 458.9, 276.50, 276.51, 584.9, 787.01.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Discomfort, Fatigue, Feeling hot, Initial insomnia, Pyrexia
Clinical narrative: Pt had a fever of 102.7 F taken under arm at 11 pm, Saturday, August 22. The highest temperature of 103.6F was taken under arm at 2 am, Sunday, August 23. Pt was very tired, hot and uncomfortable, and she had trouble falling asleep. She kept waking up every 2-3 hours through the night. We gave her water and tried to cool her down. She still have fever of 102.3F when she woke up at 6:30 am August 23. The fever has come down by 12:00 pm August 23.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Sleep disorder
Clinical narrative: Pt had a fever of 102.7 F taken under arm at 11 pm, Saturday, August 22. The highest temperature of 103.6F was taken under arm at 2 am, Sunday, August 23. Pt was very tired, hot and uncomfortable, and she had trouble falling asleep. She kept waking up every 2-3 hours through the night. We gave her water and tried to cool her down. She still have fever of 102.3F when she woke up at 6:30 am August 23. The fever has come down by 12:00 pm August 23.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema, Rash macular, Urticaria
Clinical narrative: injection @ 2130--urticaria bilat hands, elbows et knees approx. 0015 (08/23/09).  Macular rash bilat upper extremites with edema present approx. 0100.   TX:  50 mg Benadryl upon arriving at home approx. 0040; 50 mg Benadryl approx 0415.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Blood creatine phosphokinase normal, Blood glucose increased, Cardiac function test normal, Chest pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 60 year old female with mild hyperlipidemia, no known drug allergy and no pre illness and a history of hysterectomy, lumpectomy and hernia repair on 08-MAY-2008 had yearly physical at provider's office and was vaccinated IM with the first dose of ZOSTAVAX (Merck) (lot # 658085/0882U) into right arm. Approximately 25-30 minutes after ZOSTAVAX (Merck) vaccination the patient began to have midsternal chest pain and fullness in throat. The patient experienced hypersensitivity, pharyngeal oedema and throat tightness. The patient ate ice all day to decrease throat symptom and then came to emergency room. Emergency room record received for date of service (DOS) on 08-MAY-2008 with diagnosis: allergic reaction to vaccine. Patient presented to emergency room with complain of substernal chest pain which radiated to the jaw and began approximately 30 minutes after receiving ZOSTAVAX (Merck). The patient experienced increased pain on deep breathing but no shortness of breath. The patient's throat felt with swollen. The patient's physical examination was within normal limits. The patient's full cardiac workup negative. Labs and diagnostics: CBC unremarkable, glucose 127, CK 64, CKMB 1.2, troponin I 0.05, myoglobin 37.2, EKG normal. The patient was treated with SOLU-MEDROL and MEDROL DOSEPAK. At the time of the report the outcome of the patient was unknown. The listing indicated that one or more of the events was considered to be immediately life-threatening. This originally reporting source was not provided. The VAERS ID # is 312015. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Electrocardiogram normal, Full blood count normal, Hypersensitivity, Myoglobin blood, Pain in jaw
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 60 year old female with mild hyperlipidemia, no known drug allergy and no pre illness and a history of hysterectomy, lumpectomy and hernia repair on 08-MAY-2008 had yearly physical at provider's office and was vaccinated IM with the first dose of ZOSTAVAX (Merck) (lot # 658085/0882U) into right arm. Approximately 25-30 minutes after ZOSTAVAX (Merck) vaccination the patient began to have midsternal chest pain and fullness in throat. The patient experienced hypersensitivity, pharyngeal oedema and throat tightness. The patient ate ice all day to decrease throat symptom and then came to emergency room. Emergency room record received for date of service (DOS) on 08-MAY-2008 with diagnosis: allergic reaction to vaccine. Patient presented to emergency room with complain of substernal chest pain which radiated to the jaw and began approximately 30 minutes after receiving ZOSTAVAX (Merck). The patient experienced increased pain on deep breathing but no shortness of breath. The patient's throat felt with swollen. The patient's physical examination was within normal limits. The patient's full cardiac workup negative. Labs and diagnostics: CBC unremarkable, glucose 127, CK 64, CKMB 1.2, troponin I 0.05, myoglobin 37.2, EKG normal. The patient was treated with SOLU-MEDROL and MEDROL DOSEPAK. At the time of the report the outcome of the patient was unknown. The listing indicated that one or more of the events was considered to be immediately life-threatening. This originally reporting source was not provided. The VAERS ID # is 312015. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Painful respiration, Pharyngeal oedema, Throat tightness, Troponin I increased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 60 year old female with mild hyperlipidemia, no known drug allergy and no pre illness and a history of hysterectomy, lumpectomy and hernia repair on 08-MAY-2008 had yearly physical at provider's office and was vaccinated IM with the first dose of ZOSTAVAX (Merck) (lot # 658085/0882U) into right arm. Approximately 25-30 minutes after ZOSTAVAX (Merck) vaccination the patient began to have midsternal chest pain and fullness in throat. The patient experienced hypersensitivity, pharyngeal oedema and throat tightness. The patient ate ice all day to decrease throat symptom and then came to emergency room. Emergency room record received for date of service (DOS) on 08-MAY-2008 with diagnosis: allergic reaction to vaccine. Patient presented to emergency room with complain of substernal chest pain which radiated to the jaw and began approximately 30 minutes after receiving ZOSTAVAX (Merck). The patient experienced increased pain on deep breathing but no shortness of breath. The patient's throat felt with swollen. The patient's physical examination was within normal limits. The patient's full cardiac workup negative. Labs and diagnostics: CBC unremarkable, glucose 127, CK 64, CKMB 1.2, troponin I 0.05, myoglobin 37.2, EKG normal. The patient was treated with SOLU-MEDROL and MEDROL DOSEPAK. At the time of the report the outcome of the patient was unknown. The listing indicated that one or more of the events was considered to be immediately life-threatening. This originally reporting source was not provided. The VAERS ID # is 312015. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Antinuclear antibody negative, Arthralgia, Blood creatine phosphokinase normal, Blood culture negative, C-reactive protein increased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 64 year old male with hypertension, helicobacter pylori infection, mitral valve prolapse, paroxysmal atrial fibrillation, glomerulonephritis proliferative and osteopenia and a history of PPD skin test positive and cataract extraction and placement of IOL in OS on 18-FEB-2008 was vaccinated SC with ZOSTAVAX (Merck) (lot # 659323/1613U) in left upper arm. Concomitant therapy included lisinopril (manufacturer unknown) and aspirin 81 QD. Subsequently the patient experienced arthralgia, chest discomfort, headache, inflammation, joint stiffness, malaise, musculoskeletal pain, myalgia, neck pain, pain, paraesthesia, pleuritic pain, polymyalgia rheumatica and steroid therapy. The patient was feeling well and there was no pre-existing illness at the time of vaccination. He was vaccinated on 18-FEB-2008 and did satisfactorily until 25-FEB-2008 when he felt a deep aching pain in his left shoulder that cleared about three weeks later. On 06-MAR-2008 the patient noticed tingling in his left hand and forearm, which lasted until about 20-APR-2008. On 17-APR-2008 mild chest tightness started. On 26-APR-2008 the patient noticed worsening headache, malaise, aching in shoulders, neck, knees and elsewhere started. Elevated sedimentation rates and C-reactive protein suggested an inflammation. Headache cleared on its own 7 days later, but rheumatic symptoms required low-dose prednisone for suppression. Polymyalgia rheumatica was diagnosed. The patient felt better by 06-MAY-2008 while taking prednisone. Received rheumatology office note of 23-MAY-2008. Final diagnosis: polymyalgia rheumatica. Record revealed patient was pain free and feeling well at that time. The patient had previously had pleuritic chest pain, now resolved. The patient was continued on slow steroid taper. Reviewed (primary care physician) PCP medical records of 29-APR-2008 to 06-MAY-2008, records revealed patient experienced arthralgia/myalgia worst in morning with stiffness in multiple joints, generalized headache (HA). Received additional medical records from patient via email which consisted of labs and healthcare providers contact information. Treated with tapering steroids starting on 23-MAY-2008. The listing indicated that one or more of the events was considered to be immediately life-threatening. This originally reporting source was not provided. The VAERS ID # is 314325. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest X-ray, Chest discomfort, Computerised tomogram head, Computerised tomogram normal, Electrocardiogram normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 64 year old male with hypertension, helicobacter pylori infection, mitral valve prolapse, paroxysmal atrial fibrillation, glomerulonephritis proliferative and osteopenia and a history of PPD skin test positive and cataract extraction and placement of IOL in OS on 18-FEB-2008 was vaccinated SC with ZOSTAVAX (Merck) (lot # 659323/1613U) in left upper arm. Concomitant therapy included lisinopril (manufacturer unknown) and aspirin 81 QD. Subsequently the patient experienced arthralgia, chest discomfort, headache, inflammation, joint stiffness, malaise, musculoskeletal pain, myalgia, neck pain, pain, paraesthesia, pleuritic pain, polymyalgia rheumatica and steroid therapy. The patient was feeling well and there was no pre-existing illness at the time of vaccination. He was vaccinated on 18-FEB-2008 and did satisfactorily until 25-FEB-2008 when he felt a deep aching pain in his left shoulder that cleared about three weeks later. On 06-MAR-2008 the patient noticed tingling in his left hand and forearm, which lasted until about 20-APR-2008. On 17-APR-2008 mild chest tightness started. On 26-APR-2008 the patient noticed worsening headache, malaise, aching in shoulders, neck, knees and elsewhere started. Elevated sedimentation rates and C-reactive protein suggested an inflammation. Headache cleared on its own 7 days later, but rheumatic symptoms required low-dose prednisone for suppression. Polymyalgia rheumatica was diagnosed. The patient felt better by 06-MAY-2008 while taking prednisone. Received rheumatology office note of 23-MAY-2008. Final diagnosis: polymyalgia rheumatica. Record revealed patient was pain free and feeling well at that time. The patient had previously had pleuritic chest pain, now resolved. The patient was continued on slow steroid taper. Reviewed (primary care physician) PCP medical records of 29-APR-2008 to 06-MAY-2008, records revealed patient experienced arthralgia/myalgia worst in morning with stiffness in multiple joints, generalized headache (HA). Received additional medical records from patient via email which consisted of labs and healthcare providers contact information. Treated with tapering steroids starting on 23-MAY-2008. The listing indicated that one or more of the events was considered to be immediately life-threatening. This originally reporting source was not provided. The VAERS ID # is 314325. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Inflammation, Joint stiffness, Malaise, Musculoskeletal pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 64 year old male with hypertension, helicobacter pylori infection, mitral valve prolapse, paroxysmal atrial fibrillation, glomerulonephritis proliferative and osteopenia and a history of PPD skin test positive and cataract extraction and placement of IOL in OS on 18-FEB-2008 was vaccinated SC with ZOSTAVAX (Merck) (lot # 659323/1613U) in left upper arm. Concomitant therapy included lisinopril (manufacturer unknown) and aspirin 81 QD. Subsequently the patient experienced arthralgia, chest discomfort, headache, inflammation, joint stiffness, malaise, musculoskeletal pain, myalgia, neck pain, pain, paraesthesia, pleuritic pain, polymyalgia rheumatica and steroid therapy. The patient was feeling well and there was no pre-existing illness at the time of vaccination. He was vaccinated on 18-FEB-2008 and did satisfactorily until 25-FEB-2008 when he felt a deep aching pain in his left shoulder that cleared about three weeks later. On 06-MAR-2008 the patient noticed tingling in his left hand and forearm, which lasted until about 20-APR-2008. On 17-APR-2008 mild chest tightness started. On 26-APR-2008 the patient noticed worsening headache, malaise, aching in shoulders, neck, knees and elsewhere started. Elevated sedimentation rates and C-reactive protein suggested an inflammation. Headache cleared on its own 7 days later, but rheumatic symptoms required low-dose prednisone for suppression. Polymyalgia rheumatica was diagnosed. The patient felt better by 06-MAY-2008 while taking prednisone. Received rheumatology office note of 23-MAY-2008. Final diagnosis: polymyalgia rheumatica. Record revealed patient was pain free and feeling well at that time. The patient had previously had pleuritic chest pain, now resolved. The patient was continued on slow steroid taper. Reviewed (primary care physician) PCP medical records of 29-APR-2008 to 06-MAY-2008, records revealed patient experienced arthralgia/myalgia worst in morning with stiffness in multiple joints, generalized headache (HA). Received additional medical records from patient via email which consisted of labs and healthcare providers contact information. Treated with tapering steroids starting on 23-MAY-2008. The listing indicated that one or more of the events was considered to be immediately life-threatening. This originally reporting source was not provided. The VAERS ID # is 314325. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Neck pain, Pain, Paraesthesia, Pleuritic pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 64 year old male with hypertension, helicobacter pylori infection, mitral valve prolapse, paroxysmal atrial fibrillation, glomerulonephritis proliferative and osteopenia and a history of PPD skin test positive and cataract extraction and placement of IOL in OS on 18-FEB-2008 was vaccinated SC with ZOSTAVAX (Merck) (lot # 659323/1613U) in left upper arm. Concomitant therapy included lisinopril (manufacturer unknown) and aspirin 81 QD. Subsequently the patient experienced arthralgia, chest discomfort, headache, inflammation, joint stiffness, malaise, musculoskeletal pain, myalgia, neck pain, pain, paraesthesia, pleuritic pain, polymyalgia rheumatica and steroid therapy. The patient was feeling well and there was no pre-existing illness at the time of vaccination. He was vaccinated on 18-FEB-2008 and did satisfactorily until 25-FEB-2008 when he felt a deep aching pain in his left shoulder that cleared about three weeks later. On 06-MAR-2008 the patient noticed tingling in his left hand and forearm, which lasted until about 20-APR-2008. On 17-APR-2008 mild chest tightness started. On 26-APR-2008 the patient noticed worsening headache, malaise, aching in shoulders, neck, knees and elsewhere started. Elevated sedimentation rates and C-reactive protein suggested an inflammation. Headache cleared on its own 7 days later, but rheumatic symptoms required low-dose prednisone for suppression. Polymyalgia rheumatica was diagnosed. The patient felt better by 06-MAY-2008 while taking prednisone. Received rheumatology office note of 23-MAY-2008. Final diagnosis: polymyalgia rheumatica. Record revealed patient was pain free and feeling well at that time. The patient had previously had pleuritic chest pain, now resolved. The patient was continued on slow steroid taper. Reviewed (primary care physician) PCP medical records of 29-APR-2008 to 06-MAY-2008, records revealed patient experienced arthralgia/myalgia worst in morning with stiffness in multiple joints, generalized headache (HA). Received additional medical records from patient via email which consisted of labs and healthcare providers contact information. Treated with tapering steroids starting on 23-MAY-2008. The listing indicated that one or more of the events was considered to be immediately life-threatening. This originally reporting source was not provided. The VAERS ID # is 314325. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.