chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Pain in extremity, Rash erythematous
Clinical narrative: The night following administration, patient awoke due to pain spreading down the inside of the right arm. Patient presented to pharmacy the day following administration with painful swelling and a raised red rash down the inside of right arm. The rash was not localized to the area where the vaccine was administered, but spread from lymph nodes by armpit down to just below the elbow. I instructed patient to see a medical provider for treatment, and to inform me of the outcome; 24 hours later, however, I have not heard back from patient. Of note, the patient has had PREVNAR and has received FLUZONE HD in the past, both without issue; therefore, I suspect the PNEUMOVAX is the culprit.  Although both vaccines were administered in the same arm by patient request, they were spaced out by approximately 1 inch.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Swelling
Clinical narrative: The night following administration, patient awoke due to pain spreading down the inside of the right arm. Patient presented to pharmacy the day following administration with painful swelling and a raised red rash down the inside of right arm. The rash was not localized to the area where the vaccine was administered, but spread from lymph nodes by armpit down to just below the elbow. I instructed patient to see a medical provider for treatment, and to inform me of the outcome; 24 hours later, however, I have not heard back from patient. Of note, the patient has had PREVNAR and has received FLUZONE HD in the past, both without issue; therefore, I suspect the PNEUMOVAX is the culprit.  Although both vaccines were administered in the same arm by patient request, they were spaced out by approximately 1 inch.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Rash, Skin warm
Clinical narrative: "...rash for 3 days, red, hot, down her arm. She just used ice and it went away."
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Fatigue, Feeling hot, Flushing, Nausea
Clinical narrative: Employee stated felt hot and flushed 2-3 hours after vaccination and experienced nausea, fatigue, vomiting and diarrhea for 4 days after vaccination.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Employee stated felt hot and flushed 2-3 hours after vaccination and experienced nausea, fatigue, vomiting and diarrhea for 4 days after vaccination.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Malaise, Vomiting
Clinical narrative: The patient was administered the vaccine and then felt ill and vomited.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Loss of consciousness, Pain, Peripheral swelling, Swelling
Clinical narrative: Extreme swelling of arm, patient said she got up in the night to take something for pain and passed out, swelling continued next day, suggested BENADRYL and contacting primary doctor.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Erythema, Injection site pain, Injection site ulcer, Peripheral swelling
Clinical narrative: Patient reported that the next day her upper arm was red and swollen. That subsided somewhat, then she presented to the pharmacy 9 days later with a sore on her arm about an inch or 2 lower than injection site that looked a yellow/white color and that the patient said hurt when it was touched or and pressure put on it.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pain in extremity, Rash erythematous, Rash pruritic, Swelling
Clinical narrative: Patient's arm was "very sore" the night of the vaccination and developed a pink, itchy, and swollen rash that resolved with ice. That night her arm hurt and was hard to sleep on it. The next morning the patient noticed redness and firmness at the vaccine site; the following day she noticed that the red area was extending proximally. Reports no fevers and no chills.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination site induration
Clinical narrative: Patient's arm was "very sore" the night of the vaccination and developed a pink, itchy, and swollen rash that resolved with ice. That night her arm hurt and was hard to sleep on it. The next morning the patient noticed redness and firmness at the vaccine site; the following day she noticed that the red area was extending proximally. Reports no fevers and no chills.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Injection site swelling, Pain
Clinical narrative: Patient came to pharmacy on 10/8/2017 to report redness and swelling in his upper right arm and he suspected it may be due to the FLUZONE HD and PNEUMOVAX 23 vaccines he got in his arm on 10/6/2017. Patient stated his arm did hurt to move. When asked when the symptoms started, patient said he noticed it the morning of 10/7/2017. Upon inspection, the pharmacist noticed that patient had localized redness and swelling in the right arm from the shoulder area to the elbow area and patient was advised by pharmacist to visit to local emergency room as soon as possible.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Wrong vaccine was given to patient. Immunization selection tool selected Fluarix Quad, patient's insurance was billed for FLUARIX QUAD, but FLUZONE HIGH DOSE was administered. No adverse reaction was reported by the patient.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Dysstasia, Muscle disorder, Neuropathy peripheral, Pain in extremity
Clinical narrative: On 9/25 she got FLUZONE and PNEUMOVAX 23 vaccine both on the right arm. THE SYMPTOMS STARTED 9/25/17 AT NIGHT.  SYMPTOMS: FEVER  (103 F) PAIN AND SWELLING IN THE RIGHT ARM. Next day she couldn't stand up, her muscles wouldn't work. She has neuropathy. Pharmacist called Dr.  to report the incident. She took ibuprofen and Tylenol and she put lidocaine in the area. Dr. diagnosed the patient with cellulitis and prescribed medrol pack, keflex and recommended to put ice pack in the area.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: On 9/25 she got FLUZONE and PNEUMOVAX 23 vaccine both on the right arm. THE SYMPTOMS STARTED 9/25/17 AT NIGHT.  SYMPTOMS: FEVER  (103 F) PAIN AND SWELLING IN THE RIGHT ARM. Next day she couldn't stand up, her muscles wouldn't work. She has neuropathy. Pharmacist called Dr.  to report the incident. She took ibuprofen and Tylenol and she put lidocaine in the area. Dr. diagnosed the patient with cellulitis and prescribed medrol pack, keflex and recommended to put ice pack in the area.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site inflammation, Injection site pain, Injection site pustule
Clinical narrative: Sensitive to touch painful; inflammation pimple-like small pus --on the spot of Flu Injection.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injected limb mobility decreased, Pain, Pruritus, Skin warm
Clinical narrative: SHE STARTED TO FEEL ITCHING, SORE, REDNESS, HOT, AND DIFFICULTY TO MOVE THE LEFT ARM. SHE WENT TO DOCTOR AND SHE PRESCRIBED MEDROL PACK.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient received FLUZONE HIGH DOSE instead of FLUZONE QUAD.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red, raised, site reaction, silver dollar size, warm, hurts to touch. No treatment. Outcome -n/a.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: Patient had a bad reaction with swelling and redness that followed all down her muscle in the left arm. She went to a rapid care clinic and got shots and a MEDROL DOSEPAK.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Burning sensation, Chills, Dysphonia, Erythema
Clinical narrative: The night of her PNEUMOVAX vaccine, the patient reported shivering, being "freezing", teeth chattering, and right hand contracting with it being hard to pull her fingers back down. Patient took TYLENOL 1000 mg with some relief. The next morning she reported a fever of 99.8 F and felt weak and hoarse. The following day she reported a light pinkish/red mark/line that was hard under the line and burned/stung. Reported that it was hard to move arm using shoulder muscle. Pain was relieved by TYLENOL and icing.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Mobility decreased, Muscle contractions involuntary, Pain, Pyrexia
Clinical narrative: The night of her PNEUMOVAX vaccine, the patient reported shivering, being "freezing", teeth chattering, and right hand contracting with it being hard to pull her fingers back down. Patient took TYLENOL 1000 mg with some relief. The next morning she reported a fever of 99.8 F and felt weak and hoarse. The following day she reported a light pinkish/red mark/line that was hard under the line and burned/stung. Reported that it was hard to move arm using shoulder muscle. Pain was relieved by TYLENOL and icing.
Age: 17.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Impressive swelling and redness of upper arm surrounding site of administration, mildly itchy, not painful per patient.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Diarrhoea, Mobility decreased, Pain
Clinical narrative: PATIENT HAD CHILLS, ACHES AND PAINS, AND DIARRHEA. HE WAS CONFINED TO THE BED FOR ABOUT 72 HOURS AND WAS VERY WEAK.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal discomfort, Dizziness, Erythema, Peripheral swelling, Skin warm
Clinical narrative: 3 inch wide red area approx 2/3 of the way around his arm. Patient reported redness, swelling, warmth in that area. Also reported dizziness and upset stomach. Patient came back to the pharmacy 5 days after injection and said symptoms were resolving.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site nodule, Injection site swelling, Pyrexia
Clinical narrative: Patient developed a swollen, raised, red nodule on left arm in deltoid region of vaccine administration on 10/6. Later that day, patient developed a fever, and went to MD's office and received antibiotics for diagnosed cellulitis in left arm. Patient continues to take antibiotics at the time of this report and is reported today to be feeling a bit better.
Age: 56.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Eyelid oedema, Peripheral swelling, Pruritus, Rash generalised, Swelling face
Clinical narrative: Broke out with hives/rash all over body, itching, swollen hands and around eyes starting on 10/4/2017 at around 8pm. Swelling around face started getting worse 8 hours later, 4/5/17 at 5am and went to the ER. They gave patient IV of I think steroids and an Epi shot. After about an hour symptoms got better and they sent her home with some prescribed medicines. After 20 hours the sypmtoms came back and she went back to the ER where they gave some more of the same and sent her home with Zyrtec. The symptoms get severe and then after taking Zyrtec they subside but never completely go away and then about 8 hours they are back again. It is still persisting and it is now 7pm on 10/8/17.
Age: 56.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Urticaria
Clinical narrative: Broke out with hives/rash all over body, itching, swollen hands and around eyes starting on 10/4/2017 at around 8pm. Swelling around face started getting worse 8 hours later, 4/5/17 at 5am and went to the ER. They gave patient IV of I think steroids and an Epi shot. After about an hour symptoms got better and they sent her home with some prescribed medicines. After 20 hours the sypmtoms came back and she went back to the ER where they gave some more of the same and sent her home with Zyrtec. The symptoms get severe and then after taking Zyrtec they subside but never completely go away and then about 8 hours they are back again. It is still persisting and it is now 7pm on 10/8/17.
Age: 56.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Pruritus, Rash, Throat irritation
Clinical narrative: Broke out with hives/rash all over body, itching, swollen hands and around eyes starting on 10/4/2017 at around 8pm. Swelling around face started getting worse 8 hours later, 4/5/17 at 5am and went to the ER. They gave patient IV of I think steroids and an Epi shot. After about an hour symptoms got better and they sent her home with some prescribed medicines. After 20 hours the sypmtoms came back and she went back to the ER where they gave some more of the same and sent her home with Zyrtec. The symptoms get severe and then after taking Zyrtec they subside but never completely go away and then about 8 hours they are back again. It is still persisting and it is now 7pm on 10/8/17.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Chest discomfort, Cough, Loss of personal independence in daily activities, Musculoskeletal pain, Neck pain
Clinical narrative: Day 1 - soreness in neck and shoulders that became worse as the evening progressed. Day 2 - soreness especially in neck and shoulder areas, but ached all over my body. Day 3 - Soreness greatly lessened, but tightness is chest began. Days 4 and 5 - tightness in chest and frequent coughing Treatment - Tylenol every 4 hours; rest; stayed home from work two days.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Pain
Clinical narrative: Day 1 - soreness in neck and shoulders that became worse as the evening progressed. Day 2 - soreness especially in neck and shoulder areas, but ached all over my body. Day 3 - Soreness greatly lessened, but tightness is chest began. Days 4 and 5 - tightness in chest and frequent coughing Treatment - Tylenol every 4 hours; rest; stayed home from work two days.
Age: 66.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Malaise, Pyrexia
Clinical narrative: Pt experience localized redness around the site of the pneumonia shot, + low grade fever, just not feeling well, two weeks later was informed of the reaction and patient stated he never went to doctor and has recovered and feels fine today.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Computerised tomogram head normal, Dizziness, Headache, Muscular weakness
Clinical narrative: Approximately 3 hours after vaccine administration, patient began to experience sever headache. The next morning at 11:00am the patient very suddenly began to experience lightheadedness, nausea, facial swelling and rigors. We then took patient to her MD who concluded vaccine reaction versus prior viral infection. The symptoms subsided. During her 2 days off from work she had episodes of vertigo and episodes of lower extremity weakness. Her lower extremity weakness has no longer reoccurred and her vertigo is improving. She did have a CT of the head on day 3 which was negative. Otherwise, no signs of cold or flu like symptoms.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Swelling face, Vertigo
Clinical narrative: Approximately 3 hours after vaccine administration, patient began to experience sever headache. The next morning at 11:00am the patient very suddenly began to experience lightheadedness, nausea, facial swelling and rigors. We then took patient to her MD who concluded vaccine reaction versus prior viral infection. The symptoms subsided. During her 2 days off from work she had episodes of vertigo and episodes of lower extremity weakness. Her lower extremity weakness has no longer reoccurred and her vertigo is improving. She did have a CT of the head on day 3 which was negative. Otherwise, no signs of cold or flu like symptoms.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: Patient stated he has a redness around the site of injection which began Saturday morning after receiving the shot Friday. Patient stated on Sunday (today) that it has spread to a wider circle around the shot. Patient is now just waiting for redness to go away and if gets worse will head to doctor.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Dyspnoea, Heart rate irregular, Paraesthesia oral, Presyncope
Clinical narrative: Shortness of breath, tingling lips, erratic heartbeat, dizziness and near fainting 2x. Pulse 80, considered going to ER, but situation resolved in an hour with relaxation and breathing. Could be unrelated to vaccine, but thought reasonable to report.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient presented with redness and warmth at site of injection with no limited range of motion. TYLENOL had been taken. I advised the patient to continue TYLENOL and to take one dose of BENADRYL. She was also advised to seek medical attention if symptoms worsened or did not improve after 2 days. Upon following up with patient, symptoms had resolved.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Generalized itchy rash.
Age: 75.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Dysstasia
Clinical narrative: Patient called and stated that after receiving vaccinations (FLUAD and PNEUMOVAX 23), she had to be hospitalized approx. 7 hours later due to "inability to stand up". She stated that the doctors were unable to determine the cause.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Concussion, Depressed mood, Disturbance in social behaviour, Electroencephalogram, Fall
Clinical narrative: Pt had 3 series, after 2nd, patient constantly had leg cramps, after 3rd, she started having seizures, in the time we have been to hospital on several emergencies, We have done our research, We were on 3 medicines at one time to control seizures, She has been in Hospital for a week in testings, monitors to watch night seizures, She is now under the care of neurologist, she has to continue to go up in doses of medicine after seizures. She now has symtoms of menopause, which I have seen is another adverse effect. My daughter was a runner, she loved swimming, but had to stop all, because she has no warnings of the seizures. She has fell out at school several times resulting in concussions. She is
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Flank pain, Impaired driving ability, Laboratory test, Loss of personal independence in daily activities, Menopausal symptoms
Clinical narrative: Pt had 3 series, after 2nd, patient constantly had leg cramps, after 3rd, she started having seizures, in the time we have been to hospital on several emergencies, We have done our research, We were on 3 medicines at one time to control seizures, She has been in Hospital for a week in testings, monitors to watch night seizures, She is now under the care of neurologist, she has to continue to go up in doses of medicine after seizures. She now has symtoms of menopause, which I have seen is another adverse effect. My daughter was a runner, she loved swimming, but had to stop all, because she has no warnings of the seizures. She has fell out at school several times resulting in concussions. She is
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle spasms, Nuclear magnetic resonance imaging, Seizure
Clinical narrative: Pt had 3 series, after 2nd, patient constantly had leg cramps, after 3rd, she started having seizures, in the time we have been to hospital on several emergencies, We have done our research, We were on 3 medicines at one time to control seizures, She has been in Hospital for a week in testings, monitors to watch night seizures, She is now under the care of neurologist, she has to continue to go up in doses of medicine after seizures. She now has symtoms of menopause, which I have seen is another adverse effect. My daughter was a runner, she loved swimming, but had to stop all, because she has no warnings of the seizures. She has fell out at school several times resulting in concussions. She is
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Injection site erythema
Clinical narrative: HEADACHES, DIZZINESS, JOINT PAIN, EXHAUSTION, RACING HEARTBEAT, HIVES ON FACE, CHEST AND ARMS. INJECTION SITE SWOLLEN, RED AND HOT TO TOUCH.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site warmth, Palpitations, Urticaria
Clinical narrative: HEADACHES, DIZZINESS, JOINT PAIN, EXHAUSTION, RACING HEARTBEAT, HIVES ON FACE, CHEST AND ARMS. INJECTION SITE SWOLLEN, RED AND HOT TO TOUCH.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Lethargy, Nausea, Rash macular
Clinical narrative: Wed. nite started with headache. Thursday headache was gone. Thursday, lethargic, nausea. Friday, morning face to abdomen had blotchy rash. Saturday, resolved.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Redness, swelling on injection site for approximately 1 week. Fever and body aches approximately 1 week.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dizziness, Headache
Clinical narrative: Patient reported experiencing dizziness, headache, and cough as of 3:00 PM day after getting flu shot.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Pt reported swelling and soreness in vaccination area as of day after vaccine.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Myalgia, Rash vesicular
Clinical narrative: Pt. states severe muscles aches/pains and blister like rash (not at site) but on 5 different areas of body. Currently taking BENADRYL. Will contact MD if doesn't subside in a couple of date.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Patient called me Saturday morning when the pharmacy opened. She stated she could not raise her right arm without significant pain. She came in to the store to show me. Her bicep area was very swollen, warm to the touch and she was holding her shoulder close to her body due to pain. I instructed TYLENOL/ice and rest until Mon which  she experienced breathing difficulties to go to ER.
Age: 17.0
Sex: F
Vaccine: UNK, UNK, FLU4, MENB
Symptoms: Back pain, Body temperature increased, Chills, Fatigue, Headache
Clinical narrative: Patient woke up the morning after receiving vaccines with a headache, body-aches, arm pain, muscle aches, and bilateral tingling to arms and legs. Patient reported she was experiencing numbness in both hands that was causing her to drop things. Patient was brought in for an appointment to assess symptoms on 8/24/17. Exam was normal except for diffuse muscle tenderness. Plan to hydrate with 70oz fluid in 24 hrs and give either Ibuprofen or Acetaminophen. Patient/Parent reported to still be experiencing numbness in feet and fingertips and tingling in arms and legs. patient also had generalized weakness and had a fever of 101.4 Patient is still (as of 10/5/17) complaining of leg weakness that is interfering with activities.
Age: 17.0
Sex: F
Vaccine: UNK, UNK, FLU4, MENB
Symptoms: Hypoaesthesia, Malaise, Myalgia, Paraesthesia, Peripheral coldness
Clinical narrative: Patient woke up the morning after receiving vaccines with a headache, body-aches, arm pain, muscle aches, and bilateral tingling to arms and legs. Patient reported she was experiencing numbness in both hands that was causing her to drop things. Patient was brought in for an appointment to assess symptoms on 8/24/17. Exam was normal except for diffuse muscle tenderness. Plan to hydrate with 70oz fluid in 24 hrs and give either Ibuprofen or Acetaminophen. Patient/Parent reported to still be experiencing numbness in feet and fingertips and tingling in arms and legs. patient also had generalized weakness and had a fever of 101.4 Patient is still (as of 10/5/17) complaining of leg weakness that is interfering with activities.
Age: 17.0
Sex: F
Vaccine: UNK, UNK, FLU4, MENB
Symptoms: Skin warm
Clinical narrative: Patient woke up the morning after receiving vaccines with a headache, body-aches, arm pain, muscle aches, and bilateral tingling to arms and legs. Patient reported she was experiencing numbness in both hands that was causing her to drop things. Patient was brought in for an appointment to assess symptoms on 8/24/17. Exam was normal except for diffuse muscle tenderness. Plan to hydrate with 70oz fluid in 24 hrs and give either Ibuprofen or Acetaminophen. Patient/Parent reported to still be experiencing numbness in feet and fingertips and tingling in arms and legs. patient also had generalized weakness and had a fever of 101.4 Patient is still (as of 10/5/17) complaining of leg weakness that is interfering with activities.
Age: 17.0
Sex: F
Vaccine: UNK, UNK, FLU4, MENB
Symptoms: Asthenia, Grip strength decreased, Headache, Hypoaesthesia, Loss of personal independence in daily activities
Clinical narrative: Patient woke up the morning after receiving vaccines with a headache, body-aches, arm pain, muscle aches, and bilateral tingling to arms and legs. Patient reported she was experiencing numbness in both hands that was causing her to drop things. Patient was brought in for an appointment to assess symptoms on 8/24/17. Exam was normal except for diffuse muscle tenderness. Plan to hydrate with 70oz fluid in 24 hrs and give either Ibuprofen or Acetaminophen. Patient/Parent reported to still be experiencing numbness in feet and fingertips and tingling in arms and legs. patient also had generalized weakness and had a fever of 101.4 Patient is still (as of 10/5/17) complaining of leg weakness that is interfering with activities.
Age: 17.0
Sex: F
Vaccine: UNK, UNK, FLU4, MENB
Symptoms: Muscular weakness, Myalgia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Patient woke up the morning after receiving vaccines with a headache, body-aches, arm pain, muscle aches, and bilateral tingling to arms and legs. Patient reported she was experiencing numbness in both hands that was causing her to drop things. Patient was brought in for an appointment to assess symptoms on 8/24/17. Exam was normal except for diffuse muscle tenderness. Plan to hydrate with 70oz fluid in 24 hrs and give either Ibuprofen or Acetaminophen. Patient/Parent reported to still be experiencing numbness in feet and fingertips and tingling in arms and legs. patient also had generalized weakness and had a fever of 101.4 Patient is still (as of 10/5/17) complaining of leg weakness that is interfering with activities.
Age: 17.0
Sex: F
Vaccine: UNK, UNK, FLU4, MENB
Symptoms: Pyrexia
Clinical narrative: Patient woke up the morning after receiving vaccines with a headache, body-aches, arm pain, muscle aches, and bilateral tingling to arms and legs. Patient reported she was experiencing numbness in both hands that was causing her to drop things. Patient was brought in for an appointment to assess symptoms on 8/24/17. Exam was normal except for diffuse muscle tenderness. Plan to hydrate with 70oz fluid in 24 hrs and give either Ibuprofen or Acetaminophen. Patient/Parent reported to still be experiencing numbness in feet and fingertips and tingling in arms and legs. patient also had generalized weakness and had a fever of 101.4 Patient is still (as of 10/5/17) complaining of leg weakness that is interfering with activities.
Age: 39.0
Sex: M
Vaccine: FLU4, HEP, MMR
Symptoms: Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Numbing in hands and feet, pain in hands and feet, face went numb about 3 weeks after shot while hands and feet were numb. Ended in ER admitted for 8 days. Continue to have severe pain in feet. Flu vaccine 3/18/17. Hep B adult, MMP 3/20/17.
Age: 39.0
Sex: M
Vaccine: FLU4, HEP, MMR
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Pain in extremity
Clinical narrative: Numbing in hands and feet, pain in hands and feet, face went numb about 3 weeks after shot while hands and feet were numb. Ended in ER admitted for 8 days. Continue to have severe pain in feet. Flu vaccine 3/18/17. Hep B adult, MMP 3/20/17.
Age: 72.0
Sex: M
Vaccine: UNK, FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Patient reported soreness in the arm the day after getting the vaccine and his symptoms got worse in a couple of days, couldn't move his arm and saw his doctor after 5 days, his doctor took an X-ray and found out that there were calcium deposits at the site of injection. Patient continues to feel sore and is unable to move his arm even after almost being a month of vaccination.
Age: 72.0
Sex: M
Vaccine: UNK, FLU3
Symptoms: Calcinosis, Injection site reaction, Mobility decreased, Pain in extremity, X-ray abnormal
Clinical narrative: Patient reported soreness in the arm the day after getting the vaccine and his symptoms got worse in a couple of days, couldn't move his arm and saw his doctor after 5 days, his doctor took an X-ray and found out that there were calcium deposits at the site of injection. Patient continues to feel sore and is unable to move his arm even after almost being a month of vaccination.
Age: 44.0
Sex: M
Vaccine: FLUC4, HEP, FLUC4, HEP
Symptoms: Rash generalised
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 44-year-old male patient who received ENGERIX B (batch number 2KJ42, expiry date April 2019). Previously administered products included flu vaccine. Concurrent medical conditions included diabetes. Concomitant products included Levothyroxine, FLUCELVAX, JANUMET and allopurinol. On 25th August 2017, the patient received the 1st dose of ENGERIX B 1 ml. On 26th August 2017, 1 days after receiving ENGERIX B, the patient experienced rash and pruritus. The patient was treated with (nos) BENADRYL and MEDROL. On an unknown date, the outcome of the rash and pruritus were not recovered/not resolved. It was unknown if the reporter considered the rash and pruritus to be related to ENGERIX B. Additional details were provided as follows: The patient received the flu vaccine every year, and had never experienced any problems. The pharmacist reported that the patient who developed an itchy rash after receiving ENGERIX B and FLUCELAVAX. The rash was treated with a MEDROl dose pack, but the patient had now returned to the pharmacy stating that the rash had not improved. Previously he had stated it was improving with the MEDROl dose pack. It was unknown if the patient was seen by his physician, but a prescription for MEDROL was called in by the office.
Age: 44.0
Sex: M
Vaccine: FLUC4, HEP, FLUC4, HEP
Symptoms: Pruritus, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 44-year-old male patient who received ENGERIX B (batch number 2KJ42, expiry date April 2019). Previously administered products included flu vaccine. Concurrent medical conditions included diabetes. Concomitant products included Levothyroxine, FLUCELVAX, JANUMET and allopurinol. On 25th August 2017, the patient received the 1st dose of ENGERIX B 1 ml. On 26th August 2017, 1 days after receiving ENGERIX B, the patient experienced rash and pruritus. The patient was treated with (nos) BENADRYL and MEDROL. On an unknown date, the outcome of the rash and pruritus were not recovered/not resolved. It was unknown if the reporter considered the rash and pruritus to be related to ENGERIX B. Additional details were provided as follows: The patient received the flu vaccine every year, and had never experienced any problems. The pharmacist reported that the patient who developed an itchy rash after receiving ENGERIX B and FLUCELAVAX. The rash was treated with a MEDROl dose pack, but the patient had now returned to the pharmacy stating that the rash had not improved. Previously he had stated it was improving with the MEDROl dose pack. It was unknown if the patient was seen by his physician, but a prescription for MEDROL was called in by the office.
Age: 81.0
Sex: F
Vaccine: FLU4, PNC13, FLU3, PNC13
Symptoms: Blood pressure increased, Chest pain, Chills, Injected limb mobility decreased, Neck pain
Clinical narrative: Patient called back reporting severe pain and immobility hours after vaccination. We could not suggest OTC NSAID at the time because of her Warfarin use. Ice was suggested to reduce inflammation for that evening. We then followed up with patient to check progress of healing daily over the weekend. It took us until Tuesday to recommend using VOLTAREN Gel to her physician, which he agreed to and we furnished at no charge. Immunizing Pharmacist administered both vaccinations to a single arm due to prior mastectomy per our best practices. Patient had indicated by pointing to the site of injection that it seemed different than prior years. With both vaccinations given, space was needed between the two and perhaps too high.
Age: 81.0
Sex: F
Vaccine: FLU4, PNC13, FLU3, PNC13
Symptoms: Pain in extremity, Tremor
Clinical narrative: Patient called back reporting severe pain and immobility hours after vaccination. We could not suggest OTC NSAID at the time because of her Warfarin use. Ice was suggested to reduce inflammation for that evening. We then followed up with patient to check progress of healing daily over the weekend. It took us until Tuesday to recommend using VOLTAREN Gel to her physician, which he agreed to and we furnished at no charge. Immunizing Pharmacist administered both vaccinations to a single arm due to prior mastectomy per our best practices. Patient had indicated by pointing to the site of injection that it seemed different than prior years. With both vaccinations given, space was needed between the two and perhaps too high.
Age: 81.0
Sex: F
Vaccine: FLU4, PNC13, FLU3, PNC13
Symptoms: Mobility decreased, Pain
Clinical narrative: Patient called back reporting severe pain and immobility hours after vaccination. We could not suggest OTC NSAID at the time because of her Warfarin use. Ice was suggested to reduce inflammation for that evening. We then followed up with patient to check progress of healing daily over the weekend. It took us until Tuesday to recommend using VOLTAREN Gel to her physician, which he agreed to and we furnished at no charge. Immunizing Pharmacist administered both vaccinations to a single arm due to prior mastectomy per our best practices. Patient had indicated by pointing to the site of injection that it seemed different than prior years. With both vaccinations given, space was needed between the two and perhaps too high.
Age: 3.0
Sex: M
Vaccine: HEPA, HEPA, PNC13
Symptoms: Confusional state, Electrocardiogram, Gait disturbance, Hyperventilation, Incoherent
Clinical narrative: Pt. received PREVNAR 13 and Hep A on 10-06-17 at doctor's office during a nurse visit. Pt. tolerated immunizations well during administration and immediately after injections. Pt. was walking out of office after receiving immunizations and started to collapse. Pt's. eyes rolled back and patient didn't respond to mother. Pt. did not fall to floor as mother was able to stop fall. No injuries noted. Pt. seen after event for possible seizure vs. syncope by Dr. Pt. had normal exam by Dr. Pt. seen several hours later at Hospital to follow up. Pt. had normal exam and normal EKG at hospital.
Age: 3.0
Sex: M
Vaccine: HEPA, HEPA, PNC13
Symptoms: Pallor, Seizure, Syncope
Clinical narrative: Pt. received PREVNAR 13 and Hep A on 10-06-17 at doctor's office during a nurse visit. Pt. tolerated immunizations well during administration and immediately after injections. Pt. was walking out of office after receiving immunizations and started to collapse. Pt's. eyes rolled back and patient didn't respond to mother. Pt. did not fall to floor as mother was able to stop fall. No injuries noted. Pt. seen after event for possible seizure vs. syncope by Dr. Pt. had normal exam by Dr. Pt. seen several hours later at Hospital to follow up. Pt. had normal exam and normal EKG at hospital.
Age: 3.0
Sex: M
Vaccine: HEPA, HEPA, PNC13
Symptoms: Electrocardiogram normal, Eye movement disorder, Fall, Syncope, Unresponsive to stimuli
Clinical narrative: Pt. received PREVNAR 13 and Hep A on 10-06-17 at doctor's office during a nurse visit. Pt. tolerated immunizations well during administration and immediately after injections. Pt. was walking out of office after receiving immunizations and started to collapse. Pt's. eyes rolled back and patient didn't respond to mother. Pt. did not fall to floor as mother was able to stop fall. No injuries noted. Pt. seen after event for possible seizure vs. syncope by Dr. Pt. had normal exam by Dr. Pt. seen several hours later at Hospital to follow up. Pt. had normal exam and normal EKG at hospital.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site mass, Oedema peripheral
Clinical narrative: Erythema at injection site with enlarging lump and development of axillary edema and erythema, with no appearance of infection, worsening over a period of 3 weeks. Initial symptom onset with 1 hour of injection.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC, VARCEL
Symptoms: Aphasia, Autism spectrum disorder, Communication disorder, Decreased eye contact
Clinical narrative: This spontaneous report was received from a consumer referring to her daughter, a 1 year old female patient. The patient was not taking concomitant medication and did not experience any allergies or drug reaction. On an unknown date in 2015, the patient was vaccinated with an unspecified vaccine, administered orally, was a 1 year of age recommended vaccine (dose, strength, lot number and expiration date were not reported), besides, she also was vaccinated on an unknown date in 2015, with another  unspecified vaccine, was a 1 year of age recommended vaccine (dose, strength,  lot number and expiration date were not reported). On an unknown date in 2015, 1 to 2 months after vaccination with unspecified vaccines, the patient  stopped talking and also stopped using sign language to communicate, she also decreased eye contact, at age of 2,the patient was diagnosed with autism (autism  spectrum disorder), also reported as medical history. The outcome for autism spectrum disorder was not recovered, and the causality between unspecified vaccines with the event previously mentioned was related. Upon internal review, autism spectrum disorder, was determined to be medically significant. There was no product quality complaint involved. Follow up information has been received on 27-SEP-2017, from the physician referring to the 1 year old female patient (also reported as 3 year old patient). The patient's birthweight was of 3436 grams.. On 04-MAY-2015, the patient was vaccinated with VAQTA intramuscularly, first dose, lot # K026529, expiration date  02-JUN-2017, for prophylaxis; varicella virus vaccine live (oka/merck)(manufacturer unknown) (strength, dose, route of administration, lot# and expiration date were not provided) for prophylaxis; and the first dose of PREVNAR-13 intramuscularly, lot# L13063 (strength and expiration date were not provided). It was reported that the patient was diagnosed with autism spectrum disorder on 19-APR-2017 (previously reported as at age of 2). There was no temperature excursion as a result of a reading from a digital data logger. The outcome for autism (autism spectrum disorder) was still reported as not recovered, and the causality between the event and VAQTA, varicella virus vaccine live (oka/merck)(manufacturer unknown) and PREVNAR-13 was reported as related.
Sex: U
Vaccine: HPV4
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report was received from a friend of patient's parent referring to a child patient of unknown age and gender. The patient pertinent medical history and concurrent condition were not provided; concomitant medications were unknown by reporter. On an unknown date, the patient was vaccinated with GARDASIL for prophylaxis (strength, dose, route, Lot # and expiration date were not reported). When the reporter mentioned to their friends that decided to vaccinate their child, one of them told them how their child had an unspecified bad reaction to GARDASIL (adverse reaction) on an unknown date. It was unknown if any laboratory test was performed. The reporter was shocked and sad that the patient had to go throught that, however, they decided to vaccinnate their child with the GARDASIL after read stories; pharmaceutical pamphlets and understood the pros and cons to the vaccine. After hear the story, they still made the decision to go forward in spite of the risk as was better than to get a Human Papillomavirus Infection. At the reporting time, the outcome of the adverse reaction was unknown. The reporter considered the adverse reaction to be related to GARDASIL.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report has been received from a registered nurse concerning a 4 year old male patient. The patient had no medical history, drug allergies or concurrent conditions. The patient's concomitant therapies included loratadine (CLARITIN) (also reported as Claritin). On 12-SEP-2017, the patient was vaccinated with a dose of PROQUAD with lot number N009773 and expiration date on 28-SEP-2018 (also reported as 20-SEP-2018) (dose, dose number, route of administration and anatomical location were not provided), administered for prophylaxis instead of a dose of VARIVAX. It was reported that the patient did not sought medical attention, no treatment was given for the event and no lab diagnostics or studies were performed. No adverse effects were reported, therefore the patient's present status at the time of reporting was reported as recovered.
Age: 27.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse practitioner referring to a 27 year old pregnant female patient. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. It was stated that the patient had a known down's syndrome baby. On 03-OCT-2017, the patient was vaccinated, due to a human error, with a dose GARDASIL 9 lot # reported as N017542 with expiration date 21-NOV-2019, instead of a dose of diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown), for prophylaxis (strength, dose and route of administration were not reported). Concomitant therapies included prenatal vitamins(unspecified), iron (unspecified) and ranitidine hydrochloride(ZANTAC). Initial exposure to GARDASIL 9 was at 28 week(s). The pregnancy outcome was outcome pending. No adverse effects were reported. Lot number N017542 is an invalid lot number for dose GARDASIL 9.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This spontaneous report has been received from a medical assistant concerning a 65 year old female patient. The patient's concurrent conditions included multiple sclerosis since April 2017. Concomitant therapies included several unknown hypertension medications. The patient had no drug reactions or allergies. On 03-OCT-2017 the patient was vaccinated with PNEUMOVAX 23)with lot number N013521 and expiration date on 23-JAN-2019 (dose, dose number and anatomical location were not provided), administered intramuscularly for prophylaxis. On 03-OCT-2017, after getting the vaccine, the patient experienced swelling (peripheral swelling) and redness of whole upper arm down to elbow (erythema). It was reported that an unspecified treatment was given for the events. No lab diagnostics or studies were performed. At the time of reporting, the patient was recovering from peripheral swelling and erythema and the causal relationship between PNEUMOVAX 23 and the events was unknown.   This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1710USA002314:
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative, and refers to a female patient of unknown age. No information about the patient´s medical history and concurrent conditions were provided. On an unknown date, the patient was vaccinated with a dose PNEUMOVAX 23, intramuscular (also reported as intramuscular or subcutaneous), for prophylaxis, (dose, frequency, lot number and expiration date were not provided). Concomitant medications included an unspecified flu shot. No product quality complaint (PQC) was involved. On an unknown date, the patient experienced rash. The outcome of rash was unknown. The causal relationship between PNEUMOVAX 23 and rash was not provided.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Body temperature increased, Neck pain, Paraesthesia oral, Vaccination complication
Clinical narrative: Patient report a temperature of 102.8 degrees at noon on 10/05/2017. She also noted some lower back pain that radiated to her neck. She report lip and tongue tingling, but no difficulty in breathing. She went to the Clinic at 4:20 pm. She was given 50mg diphenhydramine IV, along with 125mg Methylprednisolone and 1mg ondansetron. She felt better immediately and said she was breathing more easily. She was sent home on a tapering dose of prednisone: 20mg three times a day for 1 day, 20mg twice a day for 1 day and 20mg once a day for 1 day. She was told to take diphenhydramine 50mg orally each day. There were no labs drawn. The suspected a reaction to the flu shot (AFLURIA), since she did not receive any other medication that day.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Bradycardia, Immediate post-injection reaction, Oxygen saturation decreased
Clinical narrative: Patient had symptoms of bradycardia immediately with Heart rate going from 166 to 140 BPM. He also experienced desaturation on 09/28 at 2100.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Pain
Clinical narrative: Patient immediately felt pain after receiving the vaccination. She describes having symptoms of bursitis. She has yet to see a doctor about this. I advised her to go at once.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Soreness left shoulder - moist heat and anti inflammatory medication.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: I used a new needle after drawing up dose of flu serum as pt. mom said she had had a local reaction in previous years. The child complained of redness and swelling to mother Friday evening. Site is red, puffy, warm to touch with a hardness to center of red area. Mother placed warm/damp towels to pt. arm with verbalize comfort.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site swelling, Pain, White blood cell count increased
Clinical narrative: Received both FLUZONE and PNEUMOVAX in each arm. Arm where PNEUMOVAX was injected began to swell the next morning. Pain on scale 1-10 was reported 10. Went to hospital. Was given morphine drip due to the pain. Was discharged at 4pm and followed up with PCP. Elevated WBC and put on prednisone and abx. Pt still complaining on 10/9 of loss of mobilty in that arm.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever (103) for several hours, chills, dizziness, vomited once (prob from dizziness), extremely achy muscles entire body. Next day, drained, and a bit achy, but able to go to work.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Fever (103) for several hours, chills, dizziness, vomited once (prob from dizziness), extremely achy muscles entire body. Next day, drained, and a bit achy, but able to go to work.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: TWO DAYS AFTER VACCINATION SITE BECAME RED WARM, ITCHY. It worsened over 3 days then began to resolve. Came to MD office for first time since shot on 10/09 for eval. Left arm with 6x4 red area. Pt states it is getting better.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: Employee C/O tongue numbness, right arm very tingly and r thumb numbness 15 minutes after receiving shot. Took 50mg of Benadryl po at worksite. Sent to the ER for treatment.