chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle disorder, Myalgia
Clinical narrative: Patient reports that since receiving the second dose of shingrix, her upper arm muscle "catches" describing it as the muscle dislocates. She reports that this causes a sudden and sharp pain and that sometimes she can "push the muscle back in place". This condition has lasted since receiving the vaccine and that it is ongoing.
Age: 49.0
Sex: F
Vaccine: PNC13
Symptoms: Contusion, Erythema, Injection site pain
Clinical narrative: per pt. "pain at injection site, bruising and red marks on arm that was not before the shot".
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Pt stated she broke out in rash on right side of chest wall 1 day after receiving Shingrix. Pt was prescribed Valtrex, Tylenol #3, and Gabapentin
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Patient had redness with the first dose
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: Inflammation, Mobility decreased, Pain
Clinical narrative: The patient removed bandaid at nigh on 8/22/19.  On 8/24/19 patient started to experience pain and inflammation to the point she cannot lift her arm above her head.  The pharmacist recommended to apply a cold pack to the area and start taking Ibuprofen 200mg two tablets every 6 hours.  And she will call back in two days.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain
Clinical narrative: Patient experienced very sensitive, painful injection site and flu like symptoms for 2 days,
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Varivax and Proquad was administered to the same patient at the same visit. The Medical Assistant who administered the immunizations did not know varicella was part of proquad. The parents of the patient was contacted and the patient had no adverse signs or symptoms. The Medical Assistant who administered the immunization received education on immunizations, was counseled on reading all labels, and participated in creating a label making it easy to identify between the MMRV and MMR to prevent this from happening in the future. The office will be educated on this.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus, Respiratory tract congestion
Clinical narrative: Sunday 8-25-19 Patient reported that she has large spread redness and swelling about 9 x 5 inches and also soreness on the left arm where she got Flu shot which was administered on 08-23-19 . She also said that she developed itchy throat and congestion the next day after she got Flu vaccine. She reported that the swelling and redness has decreased compared to the first day. She said she is taking Tylenol for pain relief. The patient confirmed that she did not have any symptoms such as difficulty breathing, hives, swelling of throat and tongue or dizziness. She was advised to follow up with her doctor and seek immediate medical attention if she developed serious allergic reactions.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm swollen, red and hot to the touch.  This started on 08/22/19 and has progressed slightly since parent first noticed it.  Parent treated child with Benadryl.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Got phone call from patient on 8/15; she got first shingrix shot on 8/13, said it hurt at the time; on 8/14, arm was "fine" per patient, though she didn't sleep on it, since it was a bit tender; by 8/15, she said arm was slightly swollen, and redness in area just below injection site. Reaction appears local, patient didn't report any flu-like symptoms. We told her that it's somewhat common, that it should go down in next day or so, but if by tomorrow night it's gotten worse, to seek medical attention (ideally her PCP, but Urgent Care if necessary.
Age: 15.0
Sex: M
Vaccine: IPV, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient had redness and swelling to the site of where varicella was administered minutes after vaccine was given. Patient complained of pain to site and site felt hot to touch.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Headache, Injection site induration, Injection site pain, Injection site reaction
Clinical narrative: Shingrix Vial Kit,  rx#6911326.  Within 2 hours, my upper left arm got very hot and hard and extremely painful.  My upper arm was very hot and hard for 7 full days with a huge red rash.  There was a large red mark about 5 x 6 inches.  I was nauseous, with severe headache and thickness in the head.  I vomited  and had muscle weakness.  The symptoms lasted for 7 days.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Muscular weakness, Nausea, Rash erythematous, Vomiting
Clinical narrative: Shingrix Vial Kit,  rx#6911326.  Within 2 hours, my upper left arm got very hot and hard and extremely painful.  My upper arm was very hot and hard for 7 full days with a huge red rash.  There was a large red mark about 5 x 6 inches.  I was nauseous, with severe headache and thickness in the head.  I vomited  and had muscle weakness.  The symptoms lasted for 7 days.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Emotional distress, Feeling hot, Headache, Induration
Clinical narrative: Shingrix Vial Kit,  rx#6911326.  Within 2 hours, my upper left arm got very hot and hard and extremely painful.  My upper arm was very hot and hard for 7 full days with a huge red rash.  There was a large red mark about 5 x 6 inches.  I was nauseous, with severe headache and thickness in the head.  I vomited  and had muscle weakness.  The symptoms lasted for 7 days.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain in extremity, Rash
Clinical narrative: Shingrix Vial Kit,  rx#6911326.  Within 2 hours, my upper left arm got very hot and hard and extremely painful.  My upper arm was very hot and hard for 7 full days with a huge red rash.  There was a large red mark about 5 x 6 inches.  I was nauseous, with severe headache and thickness in the head.  I vomited  and had muscle weakness.  The symptoms lasted for 7 days.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Pain, Rash erythematous
Clinical narrative: Patient came in to the pharmacy the day after the immunization was given. Presented with circular, flat, red rash around site of immunization on left arm. Complained of soreness and appearance of rash. Had full range of motion and had no complaints of fever or chills.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient reports the development of redness, heat and pain 2 inches below injection site
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Feeling hot, Pain
Clinical narrative: Patient reports the development of redness, heat and pain 2 inches below injection site
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling around injection site
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: HIVES   8/15/19-6 PM, Stomach area, left side, took 1 benadryl.  8/16/19-7 AM, Thigh, left side. 8/19/19-8 PM, wrist area, right arm.  8/19/19-9  PM, Palm, left hand, under thumb.  8/21/19 Stomach area, right side-large hive, took 1 benadryl.  8/21/19-Right arm, underside.    NONE as of 8/27/19
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Nausea, Oedema peripheral, Pain
Clinical narrative: Patient received 1st dose of shingrix vaccine at her pharmacy on 8/22/19. Sore arm started the evening after the vaccine; redness/swelling started the day following - started out localized and has spread over time. Mild redness and swelling down arm into left armpit. Arm is sore and there is a rash. She reports fever, achiness and headaches following vaccine. Some nausea.  She reports a fever until last Saturday night - no further fevers since. No further aching, nausea or headache as of evaluation today.   No significant ongoing pain or limitation in use of arm.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Rash
Clinical narrative: Patient received 1st dose of shingrix vaccine at her pharmacy on 8/22/19. Sore arm started the evening after the vaccine; redness/swelling started the day following - started out localized and has spread over time. Mild redness and swelling down arm into left armpit. Arm is sore and there is a rash. She reports fever, achiness and headaches following vaccine. Some nausea.  She reports a fever until last Saturday night - no further fevers since. No further aching, nausea or headache as of evaluation today.   No significant ongoing pain or limitation in use of arm.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest discomfort, Dyspnoea, Influenza like illness, Injection site rash, Pain
Clinical narrative: Pt received FLUZONE HD in left arm AND PNEUMOVAX 23 also in left arm SUNDAY AFTERNOON 8/25/19.  Pt stated she wanted in same arm as her right arm had arthritic pain.  Her huband also got it in same arm but had no reaction.  Monday  8/26/19, she reported she had the "worst flu like-symptoms....whole body aches....worst than arthritic pain."  She took apap extra strength (she is already on norco and celebrex).  Tuesday 8/27/19, she came to the pharmacy counter to share concerns about a rash on her inner arm (shots werer given in deltoid).  She reported her arm to be very sore.  I told her to immediately call her doctor and call me back.  Tuesday 8/27/19, 615pm. Pt called back stating she was on her way to to the hospital.  At the md office, her BP was 190150, she felt SOB and some tighness in her chest.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: Pt received FLUZONE HD in left arm AND PNEUMOVAX 23 also in left arm SUNDAY AFTERNOON 8/25/19.  Pt stated she wanted in same arm as her right arm had arthritic pain.  Her huband also got it in same arm but had no reaction.  Monday  8/26/19, she reported she had the "worst flu like-symptoms....whole body aches....worst than arthritic pain."  She took apap extra strength (she is already on norco and celebrex).  Tuesday 8/27/19, she came to the pharmacy counter to share concerns about a rash on her inner arm (shots werer given in deltoid).  She reported her arm to be very sore.  I told her to immediately call her doctor and call me back.  Tuesday 8/27/19, 615pm. Pt called back stating she was on her way to to the hospital.  At the md office, her BP was 190150, she felt SOB and some tighness in her chest.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Patient's arm has swelling, red, warm and tender under the vaccine injection area. Patient reports that her arm does not hurt, but has a predominant red area that is under the vaccine injection site. The first night her arm was sore, but the next day she work up to the red blotch.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Rash macular
Clinical narrative: Patient's arm has swelling, red, warm and tender under the vaccine injection area. Patient reports that her arm does not hurt, but has a predominant red area that is under the vaccine injection site. The first night her arm was sore, but the next day she work up to the red blotch.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Acoustic stimulation tests, Asthenia, Blister, Blood test, Chills
Clinical narrative: I will NEVER receive the second vaccination.  I took the first shot July 12, 2019.   I had a painful arm that woke me for 3 nights then a slight headache, achy & mild fatigue. Night 5 I developed chills so bad my whole body was shaking.    Woke on day 6 & I could not stand up.  Ears were ringing & room spinning.  Nearly passed out.  Crawled to bathroom & vomited. I had blisters in ear & inside lips.  Rt arm broke out in itchy rash.  Nauseated for 3 was.  I have debilitating brain fog.   At 6 weeks the dizziness has lessened but is still there.  Eyes are glassy  & ears still ringing.  Fatigue  is beyond description.  I have missed days of work.  I have had an EKG, an MRI, VNG & hearing test.  Am going to vestibular therapy and 4 doctors.  Neurologist started me on Prednisone which has intensified my fatigue and my gums have broken out with blisters. I am 59 with some immune issues.  I figured this would be the lesser of two evils.  I am fearing I have ruined my life.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Depressed level of consciousness, Dizziness, Dysstasia, Electrocardiogram, Fatigue
Clinical narrative: I will NEVER receive the second vaccination.  I took the first shot July 12, 2019.   I had a painful arm that woke me for 3 nights then a slight headache, achy & mild fatigue. Night 5 I developed chills so bad my whole body was shaking.    Woke on day 6 & I could not stand up.  Ears were ringing & room spinning.  Nearly passed out.  Crawled to bathroom & vomited. I had blisters in ear & inside lips.  Rt arm broke out in itchy rash.  Nauseated for 3 was.  I have debilitating brain fog.   At 6 weeks the dizziness has lessened but is still there.  Eyes are glassy  & ears still ringing.  Fatigue  is beyond description.  I have missed days of work.  I have had an EKG, an MRI, VNG & hearing test.  Am going to vestibular therapy and 4 doctors.  Neurologist started me on Prednisone which has intensified my fatigue and my gums have broken out with blisters. I am 59 with some immune issues.  I figured this would be the lesser of two evils.  I am fearing I have ruined my life.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Gingival blister, Glassy eyes, Headache, Impaired work ability
Clinical narrative: I will NEVER receive the second vaccination.  I took the first shot July 12, 2019.   I had a painful arm that woke me for 3 nights then a slight headache, achy & mild fatigue. Night 5 I developed chills so bad my whole body was shaking.    Woke on day 6 & I could not stand up.  Ears were ringing & room spinning.  Nearly passed out.  Crawled to bathroom & vomited. I had blisters in ear & inside lips.  Rt arm broke out in itchy rash.  Nauseated for 3 was.  I have debilitating brain fog.   At 6 weeks the dizziness has lessened but is still there.  Eyes are glassy  & ears still ringing.  Fatigue  is beyond description.  I have missed days of work.  I have had an EKG, an MRI, VNG & hearing test.  Am going to vestibular therapy and 4 doctors.  Neurologist started me on Prednisone which has intensified my fatigue and my gums have broken out with blisters. I am 59 with some immune issues.  I figured this would be the lesser of two evils.  I am fearing I have ruined my life.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lip blister, Middle insomnia, Nausea, Nuclear magnetic resonance imaging, Opticokinetic nystagmus tests
Clinical narrative: I will NEVER receive the second vaccination.  I took the first shot July 12, 2019.   I had a painful arm that woke me for 3 nights then a slight headache, achy & mild fatigue. Night 5 I developed chills so bad my whole body was shaking.    Woke on day 6 & I could not stand up.  Ears were ringing & room spinning.  Nearly passed out.  Crawled to bathroom & vomited. I had blisters in ear & inside lips.  Rt arm broke out in itchy rash.  Nauseated for 3 was.  I have debilitating brain fog.   At 6 weeks the dizziness has lessened but is still there.  Eyes are glassy  & ears still ringing.  Fatigue  is beyond description.  I have missed days of work.  I have had an EKG, an MRI, VNG & hearing test.  Am going to vestibular therapy and 4 doctors.  Neurologist started me on Prednisone which has intensified my fatigue and my gums have broken out with blisters. I am 59 with some immune issues.  I figured this would be the lesser of two evils.  I am fearing I have ruined my life.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in extremity, Rash, Rash pruritic, Tinnitus
Clinical narrative: I will NEVER receive the second vaccination.  I took the first shot July 12, 2019.   I had a painful arm that woke me for 3 nights then a slight headache, achy & mild fatigue. Night 5 I developed chills so bad my whole body was shaking.    Woke on day 6 & I could not stand up.  Ears were ringing & room spinning.  Nearly passed out.  Crawled to bathroom & vomited. I had blisters in ear & inside lips.  Rt arm broke out in itchy rash.  Nauseated for 3 was.  I have debilitating brain fog.   At 6 weeks the dizziness has lessened but is still there.  Eyes are glassy  & ears still ringing.  Fatigue  is beyond description.  I have missed days of work.  I have had an EKG, an MRI, VNG & hearing test.  Am going to vestibular therapy and 4 doctors.  Neurologist started me on Prednisone which has intensified my fatigue and my gums have broken out with blisters. I am 59 with some immune issues.  I figured this would be the lesser of two evils.  I am fearing I have ruined my life.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tremor, Vertigo, Vomiting
Clinical narrative: I will NEVER receive the second vaccination.  I took the first shot July 12, 2019.   I had a painful arm that woke me for 3 nights then a slight headache, achy & mild fatigue. Night 5 I developed chills so bad my whole body was shaking.    Woke on day 6 & I could not stand up.  Ears were ringing & room spinning.  Nearly passed out.  Crawled to bathroom & vomited. I had blisters in ear & inside lips.  Rt arm broke out in itchy rash.  Nauseated for 3 was.  I have debilitating brain fog.   At 6 weeks the dizziness has lessened but is still there.  Eyes are glassy  & ears still ringing.  Fatigue  is beyond description.  I have missed days of work.  I have had an EKG, an MRI, VNG & hearing test.  Am going to vestibular therapy and 4 doctors.  Neurologist started me on Prednisone which has intensified my fatigue and my gums have broken out with blisters. I am 59 with some immune issues.  I figured this would be the lesser of two evils.  I am fearing I have ruined my life.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Diplegia, Gait inability, Headache, Pain in extremity
Clinical narrative: I will NEVER receive the second vaccination.  I took the first shot July 12, 2019.   I had a painful arm that woke me for 3 nights then a slight headache, achy & mild fatigue. Night 5 I developed chills so bad my whole body was shaking.    Woke on day 6 & I could not stand up.  Ears were ringing & room spinning.  Nearly passed out.  Crawled to bathroom & vomited. I had blisters in ear & inside lips.  Rt arm broke out in itchy rash.  Nauseated for 3 was.  I have debilitating brain fog.   At 6 weeks the dizziness has lessened but is still there.  Eyes are glassy  & ears still ringing.  Fatigue  is beyond description.  I have missed days of work.  I have had an EKG, an MRI, VNG & hearing test.  Am going to vestibular therapy and 4 doctors.  Neurologist started me on Prednisone which has intensified my fatigue and my gums have broken out with blisters. I am 59 with some immune issues.  I figured this would be the lesser of two evils.  I am fearing I have ruined my life.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Discomfort, Head discomfort, Injection site pain, Pain, Pyrexia
Clinical narrative: Extreme discomfort/pain, body-wide. Sporadic shooting pains at various body points. Fever reached 101.5 before breaking. Head felt as though it was trapped in a vice. Symptoms began easing after approx. 36 hours. Injection site is still very sore.  NOTE: Apparently, some doctors--not mine, unfortunately--suggest taking pain relievers for 36-48 hours prior to receving the vaccine, whihc greatly reduces pain. THIS ADVICE SHOULD BE MANDATORY TO ALL WHO ARE GOING TO RECEIVE THIS VACCINE!
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Incomplete course of vaccination, Infection, Injection site pain, Peripheral swelling
Clinical narrative: On 8/27/18, patient came by the pharmacy to pick up an Augmentin RX. Upon counsel, she stated she was receiving this antibiotic due to an allergic/infective response following her Shingrix vaccine that was administered 8/22/19.   She stated on the morning of 8/23/19, she began having a low grade fever and the injection site was sore. By Sunday 8/25, she stated the arm was swollen with a red splotchy area, and was warm to the touch. She visited her PCP that prescribed the Shingrix today 8/27, and he gave her a 7 day course of Augmentin. She states it is better now than it was this weekend, but she will still be taking the antibiotic course. It has a visible red splotchy area. Patient has been advised by her PCP not to get the 2nd Shingrix vaccine of the series due to her reaction.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash macular, Skin warm
Clinical narrative: On 8/27/18, patient came by the pharmacy to pick up an Augmentin RX. Upon counsel, she stated she was receiving this antibiotic due to an allergic/infective response following her Shingrix vaccine that was administered 8/22/19.   She stated on the morning of 8/23/19, she began having a low grade fever and the injection site was sore. By Sunday 8/25, she stated the arm was swollen with a red splotchy area, and was warm to the touch. She visited her PCP that prescribed the Shingrix today 8/27, and he gave her a 7 day course of Augmentin. She states it is better now than it was this weekend, but she will still be taking the antibiotic course. It has a visible red splotchy area. Patient has been advised by her PCP not to get the 2nd Shingrix vaccine of the series due to her reaction.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Skin warm, Urticaria
Clinical narrative: Patient developed approx 10 hives larger than a quarter on his legs. Itchy, hot, no other symptoms. Zyrtec, hydrocortisone cream topically and patient was using  ice packs
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Feeling of body temperature change, Headache, Influenza like illness
Clinical narrative: Severe headache; total body muscle aches; severe tiredness; injection area and arm was tender and sore; loss of appetite for one day.  Hot/Cold most of the day.  In bed the majority of day.  Mostly flu like symptoms.  By the next day, 8/24/19, able to move and eat.  Arm was still sore and slight red patch at injection area was present.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Myalgia, Pain in extremity
Clinical narrative: Severe headache; total body muscle aches; severe tiredness; injection area and arm was tender and sore; loss of appetite for one day.  Hot/Cold most of the day.  In bed the majority of day.  Mostly flu like symptoms.  By the next day, 8/24/19, able to move and eat.  Arm was still sore and slight red patch at injection area was present.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Injection site reaction, Muscle twitching
Clinical narrative: Patient experienced discomfort with immunization, deltoid muscle twitching was observed as needle was placed in muscle and also throughout injecting contents. Patient shook arm and clenched fist of right hand. Patient left on own accord with no symptoms or signs of adverse effects.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Oropharyngeal pain
Clinical narrative: sore throat, cough
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Skin ulcer
Clinical narrative: On 8/26/19, 1 week after vaccination, the patient claims to have developed sores on one side of his face that are consistent with symptoms of shingles.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pruritus, Rash, Urticaria
Clinical narrative: Patient said starting feeling sick day after receiving shot, welts, rash and itching started and has progressed. Patient was seen and prescribed short steroid course on 8/19/19 but said still itching.  Spoke to her provider and provider said to tell patient to come in and get seen if not symptoms not improving. Called patient back and told her to call MD for appointment.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pruritus, Rash, Rash erythematous, Rubber sensitivity
Clinical narrative: patient arm @ site became red, itchy, and mildly erythematous eruption to bilateral arm & face apprx 10 mins after injection. patient was given 8mg dexamethasone. Vital signs stable. O2 Sat = 99%. patient discharged from clinic in good condition after 2-3 hours of monitoring in office.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Abdominal pain, Fatigue, Injection site erythema, Injection site warmth, Lethargy
Clinical narrative: Right arm has redness around injection site, hot. On 8-23-19 at 3am Started having cramping in her legs + abdomen, nausea, lethargic, area is red/warm to touch, Feels exhausted + has pain in right arm down to her fingers. Aggravated by moving it or pressure to it.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Muscle spasms, Nausea, Pain, Pain in extremity
Clinical narrative: Right arm has redness around injection site, hot. On 8-23-19 at 3am Started having cramping in her legs + abdomen, nausea, lethargic, area is red/warm to touch, Feels exhausted + has pain in right arm down to her fingers. Aggravated by moving it or pressure to it.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: patient reports swollen, red, and warmth about 4-6 inches of injection site.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever, chills and bodyaches for less than 36 hours - with spontaneous resolution. Asked to return for evaluation but cancelled appointment because she was feeling well
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Asthenia, Pallor, Skin warm
Clinical narrative: Patient became pale, weak, slightly warm. Advised rest + fluids, light snack + ER if symptoms became worse. After eating dinner, patient improved greatly
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eyelid rash, Ophthalmic herpes zoster
Clinical narrative: Got shingles on my face and left eye.  Had to go to my doctor and eye doctor.  Had to take Valtrex and steroid drops for my eye.  Full blown shingles attack
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Got shingles on my face and left eye.  Had to go to my doctor and eye doctor.  Had to take Valtrex and steroid drops for my eye.  Full blown shingles attack
Age: 13.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; a 13-year-old patient was administered the first dose of PROQUAD; This spontaneous report was received from a registered nurse, referring to a 13-years-old patient whose gender, pertinent medical history, drug reactions, allergies and concomitant medications were not reported.   The nurse reported that, on 30-JUL-2019, the patient was vaccinated with the first doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection series as prophylaxis (product administered to patient of inappropriate age) (albumin status, concentration, vaccine scheme frequency, route and anatomical location of vaccination, lot number and expiration date were unknown), along with varicella virus vaccine live (oka/merck) (VARIVAX) Merck sterile diluent; considered concomitant medications. No adverse effects were reported.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects; patient received the "1st dose" of GARDASIL 9 at the age of"13" in "2016" and is in the office "7/31/2019" to be administered the "2nd dose" of GARDASIL 9; This spontaneous report was received from a physician assistant and refers to 15-years-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On unknown date in 2016, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, lot # and expiration date were not reported) for prophylaxis at the age of 13. On 31-JUL-2019 (also reported as 2 years later), the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose and route of administration were not reported, lot # N021475 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 31-JAN-2020) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects were reported; one dose of expired PROQUAD was inadvertently administered to the patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-AUG-2019, the patient was inadvertently vaccinated with one dose of expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant human albumin) (lot # R011801, expiration date 19-MAY-2019, route of administration was not reported) for prophylaxis. The reporter verified that the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored properly through administration. No adverse effects were reported. The outcome of the events was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date in 2007, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the events herpes zoster was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: rash on her arm that spread through her back; This spontaneous report as received from a physician via a company representative refers to a 11-year-old female patient. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number, expiration date, dose and route of administration were not reported).  On an unspecified date, the patient experienced rash on her arm that spread through her back. It was reported that she returned to the office on an unspecified date with this event. On an unknown date, the patient recovered from the event.   The relatedness between the event and the vaccine was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: an improperly stored dose of VARIVAX was administered; No adverse effect; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reactions and allergies were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection (lot number: R009411, expiration date: 29-MAR-2020; dose and route of administration were not reported). The diluent used to reconstitute the vaccine was properly stored. The vaccine was stored in temperatures between 15 and 46 degrees Fahrenheit (-9 and 8 degrees Celsius, -3 degree Celsius) for 2 hours. There was no previous temperature excursion. Digital data lodger was involved. No adverse effect was reported.
Age: 4.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; four year old received improperly stored VAQTA; This spontaneous report was received from a licensed practical nurse and refers to a 4-year-old patient of unknown gender. Information regarding patient's pertinent medical history, concurrent condition, concomitant medication and drug allergies/reactions were not reported. On 21-AUG-2019, the patient received improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (product storage error), lot # S007770, expiration date 24-JUL-2020 (dose, frequency not reported) for prophylaxis. No adverse effect was reported. The temperature excursion included highest temperature above 47 degree Fahrenheit (46.8 F) for a total time of 30 minutes . There was no previous temperature excursion. The call as due to data logger.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; one patient received one dose of improperly stored ROTATEQ; This spontaneous report was received from an office manager and a healthcare business professional referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 01-AUG-2019, the patient received one dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # R025713 (verified to be a valid lot number), expiration date reported and established as 20-JUN-2020, for prophylaxis. The vaccine was improperly stored at a temperature of 33.9 degrees Fahrenheit during the time frame of 20 minutes. The previous temperature excursion was 30.3 degrees Fahrenheit for 93 hours and 50 minutes. The stability information was updated: total time and lowest temperature below 36 degrees Fahrenheit (30.3 degrees Fahrenheit) for 90 hours and 7 minutes, total time and lowest temperature below 36 degrees Fahrenheit (30.5 degrees Fahrenheit) for 1 hour 45 minutes and total time and lowest temperature below 36 degrees Fahrenheit (35.2 degrees Fahrenheit) for 2 hours 5 minutes. The most recent temperature as total time and lowest temperature below 36 degrees Fahrenheit (33.9 degrees Fahrenheit) was update to 40 minutes, instead of the previously reported 20 minutes. The call was made because of a data logger. No adverse effects were reported. No additional doses were administered.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: An improperly stored dose of PROQUAD was administered to the patient.; No adverse effects reported; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Patient's current conditions, medical history, concomitant medications, drug reactions or allergies were not reported.   On 22-AUG-2019, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) for prophylaxis, lot# R022571, expiration date on 04-FEB-2020. It was reported that with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was improperly stored. There were no adverse effects reported.   The temperature was from -14 °C to -10°C (-14.26°C) for 30 minutes, the previous temperature excursion was from -9°C to 8°C (6.28°C) for 48 hours. The call was because of a data logger.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Post herpetic neuralgia; Herpes Zoster; Information has been received from a lawyer referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On an unknown date, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for routine health maintenance and for the prevention of shingles.   On an unknown date, the patient experienced herpes zoster and post herpetic neuralgia. The patient did not recover from the events. The patient would continue to osuffer significant medical expenses, pain and suffering, and other damages The event of post herpetic neuralgia was determined to be disabled.   The reporter considered the events were related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: sore arm; inappropriate schedule of vaccine; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm and drug dose administration interval too long. On an unknown date, the outcome of the pain in arm and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Consumer states that her mother received dose 2 of Shingrix one year after dose 1, which led to which led to lengthening of the vaccination schedule.  She stated her mother also had a sore arm. The reporter did not give consent to follow up. Consumer did not have any more information for her mother's adverse event. This was 1 of 5 cases reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: sore arm; inappropriate schedule of vaccine; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm and drug dose administration interval too long. On an unknown date, the outcome of the pain in arm and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Consumer states that her mother received dose 2 of Shingrix one year after dose 1, which led to which led to lengthening of the vaccination schedule.  She stated her mother also had a sore arm. The reporter did not give consent to follow up. Consumer did not have any more information for her mother's adverse event. This was 1 of 5 cases reported by the same reporter.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th June 2019, the patient received the 1st dose of Shingrix. On 29th July 2019, 35 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The reporter had consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: tired/wiped out; Arm redness/ redness at injection site; Swollen arm/swelling at injection site; Arm hurts/ pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in April 2019).   On 17th August 2019, the patient received the 2nd dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site pain. On 18th August 2019, the patient experienced tiredness. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site pain were not recovered/not resolved and the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The caller was the patient. The patient stated that she got the 2nd dose of Shingrix shot in her left deltoid. The patient did not know if it was intramuscular or subcutaneous.  The patient's paperwork did not show the lot and expiration date. The patient said that her arm was still red and swollen and hurts at time of reporting. One day after vaccination, the patient experienced tiredness or wiped out. Outcome of redness, swelling and pain at injection site was reported as recovering in the source document however, it was reported as not recovered. Outcome of tired/wiped out was reported recovered/resolved with sequel the source document however, it was reported as recovered/resolved. The reporter was consented to follow up.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Headache, Malaise, Nausea, Oropharyngeal pain
Clinical narrative: Chills; nausea; sore throat; malaise; threw up; severe headache; This case was reported by a physician via call center representative and described the occurrence of chills in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On 12th August 2019, the patient received the 1st dose of Bexsero (intramuscular). On 20th August 2019, 8 days after receiving Bexsero, the patient experienced chills, nausea, sore throat, malaise, vomiting and headache. On an unknown date, the outcome of the chills, nausea, sore throat, malaise, vomiting and headache were unknown.   It was unknown if the reporter considered the chills, nausea, sore throat, malaise, vomiting and headache to be related to Bexsero.  Additional details were provided as follows: The reporting physician was the patient's parent. The patients experienced a severe headache and threw up a couple to times. The reporter was currently in the woods camping and was unable to provide any physician information and had limited phone service. The reporter did not consent to follow-up.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: Chills; nausea; sore throat; malaise; threw up; severe headache; This case was reported by a physician via call center representative and described the occurrence of chills in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On 12th August 2019, the patient received the 1st dose of Bexsero (intramuscular). On 20th August 2019, 8 days after receiving Bexsero, the patient experienced chills, nausea, sore throat, malaise, vomiting and headache. On an unknown date, the outcome of the chills, nausea, sore throat, malaise, vomiting and headache were unknown.   It was unknown if the reporter considered the chills, nausea, sore throat, malaise, vomiting and headache to be related to Bexsero.  Additional details were provided as follows: The reporting physician was the patient's parent. The patients experienced a severe headache and threw up a couple to times. The reporter was currently in the woods camping and was unable to provide any physician information and had limited phone service. The reporter did not consent to follow-up.
Sex: F
Vaccine: RAB
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pruritus, Pyrexia
Clinical narrative: flat, itchy, red spots on arms, legs and they moved to her abdomen; fever; redness and swelling around the injection site; redness and swelling around the injection site; redness and swelling around the injection site; Initial information received on 16-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 22 years old female patient who experienced flat, itchy, red spots on arms, legs and they moved to her abdomen, fever and redness and swelling around the injection site, while she received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included LORAZEPAM (LORAZEPAM).  On 13-May-2019, the patient received a dose of suspect RABIES (HDC) VACCINE lot N1K303M and expiry date: 29-Oct-2019 via unknown route in the left deltoid.  On an unknown date, following the vaccination the patient experienced hives (urticaria), fever (pyrexia), vaccination site inflammation with symptoms of vaccination site swelling and vaccination site erythema.  (Other relevant tests included no lab data.)  Final diagnosis was hives, fever, vaccination site inflammation with symptoms of vaccination site swelling and vaccination site erythema.  The patient was treated with PREDNISONE (PREDNISONE) for Product used for unknown indication and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Product used for unknown indication.  The outcome of the events was unknown at the time of reporting.  List of documents held by sender: none.
Sex: F
Vaccine: RAB
Symptoms: Urticaria, Vaccination site inflammation
Clinical narrative: flat, itchy, red spots on arms, legs and they moved to her abdomen; fever; redness and swelling around the injection site; redness and swelling around the injection site; redness and swelling around the injection site; Initial information received on 16-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 22 years old female patient who experienced flat, itchy, red spots on arms, legs and they moved to her abdomen, fever and redness and swelling around the injection site, while she received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included LORAZEPAM (LORAZEPAM).  On 13-May-2019, the patient received a dose of suspect RABIES (HDC) VACCINE lot N1K303M and expiry date: 29-Oct-2019 via unknown route in the left deltoid.  On an unknown date, following the vaccination the patient experienced hives (urticaria), fever (pyrexia), vaccination site inflammation with symptoms of vaccination site swelling and vaccination site erythema.  (Other relevant tests included no lab data.)  Final diagnosis was hives, fever, vaccination site inflammation with symptoms of vaccination site swelling and vaccination site erythema.  The patient was treated with PREDNISONE (PREDNISONE) for Product used for unknown indication and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Product used for unknown indication.  The outcome of the events was unknown at the time of reporting.  List of documents held by sender: none.