chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Disorientation, Pain in extremity
Clinical narrative: Arm pain; Not know where I was; This case was reported by a consumer and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a day after receiving Shingrix, the patient experienced pain in arm and disorientation. On an unknown date, the outcome of the pain in arm and disorientation were unknown.   It was unknown if the reporter considered the pain in arm and disorientation to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced pain in arm, for few days after receiving Shingrix. The patient taken a nap a few hours latter and woke up in home not know where was. The reporter asked is this a side effect.
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Ear pain, Erythema, Herpes zoster, Rash vesicular
Clinical narrative: Shingles; severe left ear pain; "Pimple" on the inside of the ear; nonpruitic vesicular lesion in her ear with surrounding erythema; Erythema; This case was reported by a pharmacist via sales rep and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th December 2019, the patient received the 1st dose of Shingrix. On 27th December 2019, 7 days after receiving Shingrix and an unknown time after starting acyclovir, the patient experienced shingles, ear pain, pimples, vesicular eruption and erythema. The patient was treated with acyclovir, prednisone and analgesic, nos (Analgesics). On an unknown date, the outcome of the shingles was unknown and the outcome of the ear pain and erythema were not recovered/not resolved and the outcome of the pimples and vesicular eruption were recovering/resolving.   It was unknown if the reporter considered the shingles, ear pain, pimples, vesicular eruption and erythema to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient presented to the emergency room with 24 hours of severe left ear pain. She reported developed a pimple on the inside of her ear that she unsuccessfully tried to pop using a sterilized needle. The patient experienced a nonpruitic vesicular lesion in her ear with surrounding erythema but no purulence. On 30th December 2019 reported that her ear was about 65 percent better but continued pain and erythema. The patient experienced Shingles within a week after vaccination.  The reporter said that since Shingrix was an inactivated vaccination, she could not have developed shingles from the vaccine, recommended that since the only contraindication for Shingrix was an allergic reaction, and this was not, that he recommend she receive the 2nd dose when she was  due for it. It be possible that the process of her immune system responding to the vaccine could have reactivated a latent zoster infection. The reporter said that it seems like a crazy coincidence that she just happened to have shingles a week after the vaccination, if they were totally unrelated.
Sex: F
Vaccine: FLU4
Symptoms: Ocular hyperaemia, Vision blurred
Clinical narrative: Red right eye; Blurry vision from right eye; This case was reported by a consumer via call center representative and described the occurrence of eye red in a 63-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2018-2019 season) for prophylaxis.   In October 2018, the patient received the 1st dose of Fluarix Quadrivalent 2018-2019 season (intramuscular). On an unknown date, 2 months after receiving Fluarix Quadrivalent 2018-2019 season, the patient experienced eye red and blurred vision. On an unknown date, the outcome of the eye red and blurred vision were recovered/resolved.   The reporter considered the eye red and blurred vision to be related to Fluarix Quadrivalent 2018-2019 season.  Additional details were provided as follows: The age at vaccination was not reported. Post vaccination the patient had eye problems with redness and blurriness of her right eye. These eye symptoms started two months after vaccination and did not resolved until April 2019. The reporter consented to follow up. This case was linked to another case US2020000878 reported for the same patient (2nd dose).
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: headache; fatigue; shivering; fever; This case was reported by a consumer via call center representative and described the occurrence of headache in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, fatigue, chills and fever. On an unknown date, the outcome of the headache, fatigue, chills and fever were unknown.   It was unknown if the reporter considered the headache, fatigue, chills and fever to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. No further information provided on voicemail. The phone number for patient was left.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Eye disorder, Injection site bruising, Insomnia, Musculoskeletal pain
Clinical narrative: arm pain/ pain and it's spreading down to her fingertips (digits); Shoulder pain up to neck; Pain it's spreading down to distal joints / Wrist pain / Elbow pain; Shoulder pain up to neck/ pain is increasing and the pain is radiating to her neck; bruises at injection site; sleeplessness; Muscle pain; Nerve pain; Noticed changes with her eyes (asked about dry eyes); Tingling in fingertips; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th November 2019, the patient received the 1st dose of Shingrix. On 1st January 2020, 44 days after receiving Shingrix, the patient experienced tingling of extremity. On an unknown date, the patient experienced pain in arm, shoulder pain, arthralgia, neck pain, injection site bruising, sleeplessness, myalgia, nerve pain and eye disorder. On an unknown date, the outcome of the pain in arm, shoulder pain, arthralgia, neck pain, sleeplessness, myalgia, nerve pain, eye disorder and tingling of extremity were unknown and the outcome of the injection site bruising was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, shoulder pain, arthralgia, neck pain, injection site bruising, sleeplessness, myalgia, nerve pain, eye disorder and tingling of extremity to be related to Shingrix.  Additional details were provided as follows: Post vaccination the patient experienced pain in the right arm. The patient continued having this pain and it spread down to her fingertips (digits) and distal joints. The patient experienced muscle pain, wrist pain, elbow pain, shoulder pain up to her neck, nerve pain (neuralgia) and injection site bruise.  The patient also noticed changes with her eyes (asked about dry eyes but could not confirm that she has dry eyes). S Additionally, the patient had tingling in her fingertips that started about 2 days before the reporting. The patient used medicated eye drops.  The reporter did not consent to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Neck pain, Neuralgia, Pain in extremity, Paraesthesia
Clinical narrative: arm pain/ pain and it's spreading down to her fingertips (digits); Shoulder pain up to neck; Pain it's spreading down to distal joints / Wrist pain / Elbow pain; Shoulder pain up to neck/ pain is increasing and the pain is radiating to her neck; bruises at injection site; sleeplessness; Muscle pain; Nerve pain; Noticed changes with her eyes (asked about dry eyes); Tingling in fingertips; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th November 2019, the patient received the 1st dose of Shingrix. On 1st January 2020, 44 days after receiving Shingrix, the patient experienced tingling of extremity. On an unknown date, the patient experienced pain in arm, shoulder pain, arthralgia, neck pain, injection site bruising, sleeplessness, myalgia, nerve pain and eye disorder. On an unknown date, the outcome of the pain in arm, shoulder pain, arthralgia, neck pain, sleeplessness, myalgia, nerve pain, eye disorder and tingling of extremity were unknown and the outcome of the injection site bruising was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, shoulder pain, arthralgia, neck pain, injection site bruising, sleeplessness, myalgia, nerve pain, eye disorder and tingling of extremity to be related to Shingrix.  Additional details were provided as follows: Post vaccination the patient experienced pain in the right arm. The patient continued having this pain and it spread down to her fingertips (digits) and distal joints. The patient experienced muscle pain, wrist pain, elbow pain, shoulder pain up to her neck, nerve pain (neuralgia) and injection site bruise.  The patient also noticed changes with her eyes (asked about dry eyes but could not confirm that she has dry eyes). S Additionally, the patient had tingling in her fingertips that started about 2 days before the reporting. The patient used medicated eye drops.  The reporter did not consent to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Heart rate increased, Hypertension
Clinical narrative: Blotchy red rash; Sore arm/finger aching; Weakness; Increased pulse rate; Racy heart; Achy joint; Body ache; Shoulder ache; High Blood Pressure/blood pressure was 200/94; Shivering; Nausea; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 2nd January 2020, less than an hour after receiving Shingrix, the patient experienced pain in arm, weakness, heart rate increased, palpitation, joint pain, general body pain, shoulder pain, blood pressure high, shivering and nausea. On 3rd January 2020, the patient experienced red rash. The patient was treated with non-drug therapy (Warm Compress). On an unknown date, the outcome of the pain in arm, weakness, heart rate increased, palpitation, joint pain, general body pain, shoulder pain, blood pressure high, shivering, nausea and red rash were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, weakness, heart rate increased, palpitation, joint pain, general body pain, shoulder pain, blood pressure high, shivering, nausea and red rash to be related to Shingrix.  Additional details were provided as follows: Within ten minutes after receiving the Shingrix vaccine, the patient arm was sore. By 4pm she applied warm compress on it.  By 5pm she started feeling weak, racy heart and achy joints. By 5:30 PM her blood pressure was 200/94, and pulse was 85.  Around 6:15 she took medications for her blood pressure.  By 10:30pm her body was aching along with joints, shoulders and her fingers. She was also experienced shivering, nausea and racy heart. On the day of reporting morning she noticed blotchy rash with redness below the injection site covering 4 inches of area. The patient still experiencing all the side effects. No further details were provided. The reporter did not consent to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Musculoskeletal pain, Nausea, Pain, Pain in extremity
Clinical narrative: Blotchy red rash; Sore arm/finger aching; Weakness; Increased pulse rate; Racy heart; Achy joint; Body ache; Shoulder ache; High Blood Pressure/blood pressure was 200/94; Shivering; Nausea; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 2nd January 2020, less than an hour after receiving Shingrix, the patient experienced pain in arm, weakness, heart rate increased, palpitation, joint pain, general body pain, shoulder pain, blood pressure high, shivering and nausea. On 3rd January 2020, the patient experienced red rash. The patient was treated with non-drug therapy (Warm Compress). On an unknown date, the outcome of the pain in arm, weakness, heart rate increased, palpitation, joint pain, general body pain, shoulder pain, blood pressure high, shivering, nausea and red rash were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, weakness, heart rate increased, palpitation, joint pain, general body pain, shoulder pain, blood pressure high, shivering, nausea and red rash to be related to Shingrix.  Additional details were provided as follows: Within ten minutes after receiving the Shingrix vaccine, the patient arm was sore. By 4pm she applied warm compress on it.  By 5pm she started feeling weak, racy heart and achy joints. By 5:30 PM her blood pressure was 200/94, and pulse was 85.  Around 6:15 she took medications for her blood pressure.  By 10:30pm her body was aching along with joints, shoulders and her fingers. She was also experienced shivering, nausea and racy heart. On the day of reporting morning she noticed blotchy rash with redness below the injection site covering 4 inches of area. The patient still experiencing all the side effects. No further details were provided. The reporter did not consent to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations, Rash erythematous, Rash macular
Clinical narrative: Blotchy red rash; Sore arm/finger aching; Weakness; Increased pulse rate; Racy heart; Achy joint; Body ache; Shoulder ache; High Blood Pressure/blood pressure was 200/94; Shivering; Nausea; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 2nd January 2020, less than an hour after receiving Shingrix, the patient experienced pain in arm, weakness, heart rate increased, palpitation, joint pain, general body pain, shoulder pain, blood pressure high, shivering and nausea. On 3rd January 2020, the patient experienced red rash. The patient was treated with non-drug therapy (Warm Compress). On an unknown date, the outcome of the pain in arm, weakness, heart rate increased, palpitation, joint pain, general body pain, shoulder pain, blood pressure high, shivering, nausea and red rash were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, weakness, heart rate increased, palpitation, joint pain, general body pain, shoulder pain, blood pressure high, shivering, nausea and red rash to be related to Shingrix.  Additional details were provided as follows: Within ten minutes after receiving the Shingrix vaccine, the patient arm was sore. By 4pm she applied warm compress on it.  By 5pm she started feeling weak, racy heart and achy joints. By 5:30 PM her blood pressure was 200/94, and pulse was 85.  Around 6:15 she took medications for her blood pressure.  By 10:30pm her body was aching along with joints, shoulders and her fingers. She was also experienced shivering, nausea and racy heart. On the day of reporting morning she noticed blotchy rash with redness below the injection site covering 4 inches of area. The patient still experiencing all the side effects. No further details were provided. The reporter did not consent to follow up.
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster oticus, Product administered to patient of inappropriate age
Clinical narrative: Inappropriate Age at Vaccine Administration"; shingles; This case was reported by a consumer via call center representative and described the occurrence of herpes zoster otitis externa in a 45-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles ( 6 times in ear). Previously administered products included Shingrix (1st dose received on an unknown date).   On 28th December 2019, the patient received the 2nd dose of Shingrix. In December 2019, 2 days after receiving Shingrix, the patient experienced herpes zoster otitis externa (serious criteria GSK medically significant). On an unknown date, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the herpes zoster otitis externa and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the herpes zoster otitis externa to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient's mother. The patient had mild case of shingles in her ear. The reporter stated that, the patient responded well to the treatment for the Shingles. The reporter adviced that, health care professional could follow up with medical  information. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Off label use, Product administered to patient of inappropriate age
Clinical narrative: Shingles after receiving the second dose of Shingrix; Off label use; Inappropriate age at vaccine administration; Off label use; Inappropriate age at vaccine administration; This case was reported by a physician via call center representative and described the occurrence of shingles in a 46-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes zoster otitis externa (experienced 6 times).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, not applicable after receiving Shingrix and 2 days after receiving Shingrix, the patient experienced shingles, off label use, inappropriate age at vaccine administration, off label use and inappropriate age at vaccine administration. On an unknown date, the outcome of the shingles, off label use, inappropriate age at vaccine administration, off label use and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the patient's parent. The reporter stated that, 2 days after receiving shingrix vaccine,the patient had shingles. The patient experienced shingles 6 times till the time of reporting. The reporter stated that, the immunologist prescribed the vaccine despite the patient´s age, which led to inappropriate age at vaccine administration and off label use. The reporter consented to follow up.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Bronchitis, Cough
Clinical narrative: Bronchitis; Cough; This case was reported by a physician via call center representative and described the occurrence of bronchitis in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   In December 2019, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, 4 days after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced bronchitis and cough. On an unknown date, the outcome of the bronchitis and cough were not recovered/not resolved.   It was unknown if the reporter considered the bronchitis and cough to be related to Shingrix.  Additional details were reported as follows: In mid October 2019, the patient received 1st dose of Shingrix. The patient received Shingrix approximately one week ago prior to reporting and around four days after receiving the vaccine, he developed bronchitis and describes that she has been coughing. Reporter did not consent to follow-up. This case has been linked with another case US2020000943, reported by same reporter.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Bronchitis, Cough
Clinical narrative: Bronchitis; Cough; This case was reported by a physician via call center representative and described the occurrence of bronchitis in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   In December 2019, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, 4 days after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced bronchitis and cough. On an unknown date, the outcome of the bronchitis and cough were not recovered/not resolved.   It was unknown if the reporter considered the bronchitis and cough to be related to Shingrix.  Additional details were reported as follows: In mid October 2019, the patient received 1st dose of Shingrix. The patient received Shingrix approximately one week ago prior to reporting and around four days after receiving the vaccine, he developed bronchitis and describes that she has been coughing. Reporter did not consent to follow-up. This case has been linked with another case US2020000938, reported by same reporter.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th December 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 28th December 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and experienced a sore arm the day of vaccination. It has gotten better and now the pain was level 1 on the scale of 1 to 10 with 10 being the most painful. Reporter consented to follow up. This case has been linked with US2020000946, reported by same reporter.
Age: 68.0
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 68-year-old male patient who received Herpes zoster (Shingrix) (batch number 22LG2, expiry date 26th November 2021) for prophylaxis.   On 17th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In October 2019, 2 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and and 2 days after the patient developed Shingles. The Patient went to see a doctor and was diagnosed with shingles. The reported batch number corresponds to Shingrix adjuvant. The patient took medication to treat the shingles and the shingles resolved. The patient received the 2nd dose of Shingrix on 20th December 2019 with no issues.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Fatigue, Headache, Incomplete course of vaccination, Wheezing
Clinical narrative: Incomplete course of vaccination; fatigue; headache; shortness of breath; wheezing; This case was reported by a nurse via call center representative and described the occurrence of fatigue in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 1st May 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 1st May 2019, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fatigue, headache, shortness of breath and wheezing. On an unknown date, the patient experienced incomplete course of vaccination. On 4th May 2019, the outcome of the fatigue, headache, shortness of breath and wheezing were recovered/resolved. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the fatigue, headache, shortness of breath and wheezing to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and experienced fatigue, headache, shortness of breath and wheezing. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Limited information was provided by the nurse practitioner (NP) because the first injection was given by another facility.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Redness spreading down right arm. Skin feels hot to touch. Fever x 2 days. + arm pain
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Cardiac monitoring, Dizziness, Electrocardiogram, Electroencephalogram
Clinical narrative: Child began having symptoms of extreme fatigue, dizziness and frequent fainting. Over the course of a few months became so severe, she was taken out of school and put in a wheelchair for her own safety.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Postural orthostatic tachycardia syndrome, Syncope, Tilt table test positive, Wheelchair user
Clinical narrative: Child began having symptoms of extreme fatigue, dizziness and frequent fainting. Over the course of a few months became so severe, she was taken out of school and put in a wheelchair for her own safety.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pain in extremity
Clinical narrative: Extreme pain in right arm the night following injection. It hurt to even move my arm for 15 days. Had to take 600mg ibuprofen during this time. I am still experiencing frequent muscle pain  during the day and it wakes me up at night. I was told that I may have pain for a few days but it is now close to 3 months. I was reminded that it is time for my second dose of Shingrix but I will not be getting another injection of this drug. After the first few days I called my doctors office and the pharmacy neither of which were much help. They told me to continue Ibuprofen which I now take daily.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Hyperhidrosis, Pallor, Presyncope, Seizure like phenomena, Slow response to stimuli
Clinical narrative: I was called to see a patient who was here for vaccines only after she had a reaction. Historical report to me was from the nurse in attendance,  and less so from the mother of patient and patient's  two brothers who were in the room.  patient received only HPV vaccine, was noted to become pale, then shake with seizure-like movements and then had near-syncope episode. Still responding, but slowly. Diaphoretic.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Tremor
Clinical narrative: I was called to see a patient who was here for vaccines only after she had a reaction. Historical report to me was from the nurse in attendance,  and less so from the mother of patient and patient's  two brothers who were in the room.  patient received only HPV vaccine, was noted to become pale, then shake with seizure-like movements and then had near-syncope episode. Still responding, but slowly. Diaphoretic.
Age: 0.5
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: New Medical Assistant gave this patient Pediarix and Hepatitis B at the same time.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: Fever around 101-102 with measles like rash. The rash started January 12th. Rash mainly on stomach, knees, neck and nose.
Age: 3.0
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Erythema, Gait disturbance, Injection site erythema, Injection site swelling, Rash erythematous
Clinical narrative: Dose #1 (2019) DTaP Infanrix:  Child began experiencing sudden reaction and symptoms of Erythema in Face - More expressed in Left Cheek - Pediatrician on call explained it looked like "Slapped Cheek Syndrome".  Reaction lasted a few hours.  No treatment administered.  Dose #2 (2020) DTaP Infanrix:  DTaP Infanrix Vaccine administered during Pediatrician appointment on 1/10/2020 at approximately 4:00PM.  Friday night child woke up at 12:45AM (1/11/2020) complaining that "It hurts inside".  Child was limping and had a stiff walk with strong difficulty walking.  Parents (we) had to pick child up and carry child back to bed.  We stayed with child through the night.  In the morning around 7:00AM child had the same complaint and behavior.  After about 30 minutes child slowly started walking normally.  The following morning (1/12/2020) child woke up with a red rash within a 2-inch radius of the vaccination site - left thigh.  We called the pediatrician on-shift and the doctor explained that it was a strong immune response and that it is not common, but it is not uncommon, and that he had seen it other times.  He mentioned it would likely resolve within the week and gave us some suggestions for area treatment.  The rash progressed throughout the day with increased redness, swelling, and covered most of child's left thigh.  The impacted area was approximately 4 by 3 inches, which we marked with a sharpie to monitor spreading.  After child's bath we applied a thick layer of over-the-counter Cortizone overnight.  This morning (1/13/2020) the symptoms had noticeably improved but not resolved.  We have pictures of the reaction and progression.
Age: 3.0
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Vaccination site rash
Clinical narrative: Dose #1 (2019) DTaP Infanrix:  Child began experiencing sudden reaction and symptoms of Erythema in Face - More expressed in Left Cheek - Pediatrician on call explained it looked like "Slapped Cheek Syndrome".  Reaction lasted a few hours.  No treatment administered.  Dose #2 (2020) DTaP Infanrix:  DTaP Infanrix Vaccine administered during Pediatrician appointment on 1/10/2020 at approximately 4:00PM.  Friday night child woke up at 12:45AM (1/11/2020) complaining that "It hurts inside".  Child was limping and had a stiff walk with strong difficulty walking.  Parents (we) had to pick child up and carry child back to bed.  We stayed with child through the night.  In the morning around 7:00AM child had the same complaint and behavior.  After about 30 minutes child slowly started walking normally.  The following morning (1/12/2020) child woke up with a red rash within a 2-inch radius of the vaccination site - left thigh.  We called the pediatrician on-shift and the doctor explained that it was a strong immune response and that it is not common, but it is not uncommon, and that he had seen it other times.  He mentioned it would likely resolve within the week and gave us some suggestions for area treatment.  The rash progressed throughout the day with increased redness, swelling, and covered most of child's left thigh.  The impacted area was approximately 4 by 3 inches, which we marked with a sharpie to monitor spreading.  After child's bath we applied a thick layer of over-the-counter Cortizone overnight.  This morning (1/13/2020) the symptoms had noticeably improved but not resolved.  We have pictures of the reaction and progression.
Age: 3.0
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Gait disturbance, Pain, Rash erythematous, Vaccination site reaction
Clinical narrative: Dose #1 (2019) DTaP Infanrix:  Child began experiencing sudden reaction and symptoms of Erythema in Face - More expressed in Left Cheek - Pediatrician on call explained it looked like "Slapped Cheek Syndrome".  Reaction lasted a few hours.  No treatment administered.  Dose #2 (2020) DTaP Infanrix:  DTaP Infanrix Vaccine administered during Pediatrician appointment on 1/10/2020 at approximately 4:00PM.  Friday night child woke up at 12:45AM (1/11/2020) complaining that "It hurts inside".  Child was limping and had a stiff walk with strong difficulty walking.  Parents (we) had to pick child up and carry child back to bed.  We stayed with child through the night.  In the morning around 7:00AM child had the same complaint and behavior.  After about 30 minutes child slowly started walking normally.  The following morning (1/12/2020) child woke up with a red rash within a 2-inch radius of the vaccination site - left thigh.  We called the pediatrician on-shift and the doctor explained that it was a strong immune response and that it is not common, but it is not uncommon, and that he had seen it other times.  He mentioned it would likely resolve within the week and gave us some suggestions for area treatment.  The rash progressed throughout the day with increased redness, swelling, and covered most of child's left thigh.  The impacted area was approximately 4 by 3 inches, which we marked with a sharpie to monitor spreading.  After child's bath we applied a thick layer of over-the-counter Cortizone overnight.  This morning (1/13/2020) the symptoms had noticeably improved but not resolved.  We have pictures of the reaction and progression.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Lip swelling, Pharyngeal swelling, Pruritus
Clinical narrative: Patient said that she was itchy all over, that she felt that her lips and throat was swelling.  She felt like she was burning internally and itchy internally.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Limb discomfort
Clinical narrative: Swelling in arm where shot was administered from injection site to above elbow. Redness, hot to touch, felt like a burning sensation. Pain. Stiffness. Uncomfortable to sleep on that arm .
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness
Clinical narrative: Swelling in arm where shot was administered from injection site to above elbow. Redness, hot to touch, felt like a burning sensation. Pain. Stiffness. Uncomfortable to sleep on that arm .
Age: 68.0
Sex: F
Vaccine: FLUA3
Symptoms: Discomfort, Insomnia, Limb discomfort, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: pain/soreness on arm  uncomfortable hard to sleep on  stiffness patient received a cortison shot on 1/8/2020
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Pain, Pain in extremity
Clinical narrative: Per patient's wife:  I thought the discomfort and pain will go away, but as of today (written on 1/9/20), it is still hurting. He has severe pain every time he move his left upper extremity.  He has been taking Ibuprofen 400mg po every 6 hours.    Patient did received a flu shot in the right arm on the same day.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse effect; The patient received dose of PROQUAD and dose of VARIVAX on the same day; The patient received dose of PROQUAD and dose of VARIVAX on the same day; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concomitant medications and concurrent conditions was provided.    On 27-DEC-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # S011952, expiration date 16-APR-2021 (dose and route of administration were not reported) for prophylaxis and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S021732, expiration date 10-JAN-2021, albumin status recombinant Human albumin (rHA) not provided but established upon internal validation (dose and route of administration were not reported) for prophylaxis. No adverse effects reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2017, pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, anatomical location and route of administration were not specified), as prescribed and/or administered by a physician for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, pt was treated by a health care provider for shingles. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was reported as not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Erythema, Extensive swelling of vaccinated limb, Pain in extremity, Skin warm
Clinical narrative: Swelling; Hot area; Discomfort; Arm soreness; Redness; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th December 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 28th December 2019, less than a day after receiving Shingrix, the patient experienced pain in arm and erythema. On an unknown date, the patient experienced extensive swelling of vaccinated limb, skin warm and discomfort. On an unknown date, the outcome of the extensive swelling of vaccinated limb, pain in arm, erythema, skin warm and discomfort were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, pain in arm, erythema, skin warm and discomfort to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and experienced arm soreness and redness about a size of a quarter the day of vaccination.  The area was swollen, painful and hot to touch. The area was getting bigger and bigger, it was 5 inches long and 4 inches wide.  Her pain was on a level of 8 on scale of 1 to 10 with 10 being the most painful. The patient was in discomfort.  Reporter consented to follow up. This case has been linked with US2020000941, reported by same reporter.
Sex: M
Vaccine: PPV
Symptoms: Lung disorder, Pneumonia, Pyrexia
Clinical narrative: Emergency room with penumonia. The next year the same thing; High fever; lungs plugged, the whole thing; This is a spontaneous report from a contactable consumer. A 66-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration on an unspecified date at a single dose for prevention. The patient's medical history and concomitant medications were not reported. The patient got a vaccine for pneumonia and within a week the patient had the disease. At a regular check-up the patient got the pneumonia vaccine as recommended. One week later, patient was in the hospital with pneumonia. He though just coincidence. The next year, the same thing. One week after the shot, in the emergency room with pneumonia. High fever, lungs plugged, the whole thing. The outcome of events was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Injection site swelling, Migraine, Pain
Clinical narrative: swelling on the right arm where he got the injection; Migraine/he is experiencing pain specifically a migraine headache; This is a spontaneous report from a contactable pharmacist. A 47-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, strength: 0.5 ml, lot number: AG8353, expiration date: Jun2021), intramuscularly into right arm on an unspecified date at 0.5 ml, single for prevention. Medical history included diabetes, high blood pressure, and obese from an unknown date and unknown if ongoing. Concomitant medication included insulin human, insulin human injection, isophane (HUMULIN) 75 to 80 units twice a day for diabetes, insulin lispro (HUMALOG) 75 to 80 units twice a day for diabetes. The patient was given the vaccine a couple days ago and he was experienced swelling on the right arm where he got the injection in Jan2020 and he was experiencing pain specifically a migraine headache in Jan2020. With the patient's right arm swelling, at first time it was small and then in the last couple of days it was growing then the symptoms started a couple days ago. Both events were reported as serious per medically significant. The outcome of the events was not resolved.; Sender's Comments: Based on the information currently provided, the vaccination with PREVNAR 13 in triggering the onset of vaccination site swelling and migraine headache cannot be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Middle insomnia, Seizure
Clinical narrative: Patient reports that 12 hours after the vaccine was administered, she woke up in the night freezing cold and "convulsing".  She got out of bed, took some Tylenol, and went back to bed and it resolved.
Age: 70.0
Sex: M
Vaccine: FLUA3
Symptoms: Asthenia, Chest pain, Dizziness, Electrocardiogram normal, Pyrexia
Clinical narrative: Patient was dizziness, feverish, weak and had chest pain
Age: 70.0
Sex: M
Vaccine: YF
Symptoms: Fatigue, Headache, Musculoskeletal stiffness, Neck pain
Clinical narrative: Stiff neck and pain in neck and part way up back of head, could not get relief from pain from midnight till about 5 the next morning took ibuprofen and was finally able to sleep awhile.   On day three now and pain and stiffness is better but still has some pain and stiffness and feel tired.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: RIGHT ARM PAIN
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Limb discomfort, Pain, Pain in extremity, Tenderness
Clinical narrative: Patient received Afluria flu shot, about 1 & 1/2 to 2 weeks post flu shot experienced lots of heaviness, sore to touch, and radiating pain from elbow down to hand. Patient did report over the last week that it seemed to be getting better. C technique/3 finger estimation was used when administered to determine location of deltoid at time of administration.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: Received 2nd dose of Shindrix vaccine @ 10 a.m. As with the 1st dose on 10/31/19, my arm from shoulder to elbow became very sore with a constant nerve like ache. In the early evening, I began severe chills and a severe intractable headache, followed by generalized and severe muscle aching with some muscle contractions in extremities. All the above lasted over 16 hr. The headache did not subside entirely until this a.m. about 10 a.m. I am still weak and perspire if I expend any energy. I have never had any body aches as severe as these were! The injection site never became swollen or reddened, and I did not develop an elevated temp. Not sure if this was due to the immunization but was feeling fine and healthy, not in contact with any known person with sxs.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle contractions involuntary, Myalgia, Neuralgia
Clinical narrative: Received 2nd dose of Shindrix vaccine @ 10 a.m. As with the 1st dose on 10/31/19, my arm from shoulder to elbow became very sore with a constant nerve like ache. In the early evening, I began severe chills and a severe intractable headache, followed by generalized and severe muscle aching with some muscle contractions in extremities. All the above lasted over 16 hr. The headache did not subside entirely until this a.m. about 10 a.m. I am still weak and perspire if I expend any energy. I have never had any body aches as severe as these were! The injection site never became swollen or reddened, and I did not develop an elevated temp. Not sure if this was due to the immunization but was feeling fine and healthy, not in contact with any known person with sxs.
Sex: U
Vaccine: VARZOS
Symptoms: Device leakage
Clinical narrative: Nurse attempted to draw up Shingrix vaccine after diluent was mixed. The nurse reported that about half of the vaccine leaked around the seal where the needle was inserted. She reports that this has occurred more than once in the last three weeks, but not previous to that time.
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased
Clinical narrative: 4 days after shingrix shot patient blood sugar was elevated to 350 an took about 2 weeks until it stabilized
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema multiforme, Laboratory test normal, Streptococcus test negative
Clinical narrative: Erythema Multiforme Rash. Antihistamines; Derm, Consult Recovery slowly
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Chills, Feeling hot, Vomiting
Clinical narrative: On 1.26.19 called on call dr - mother says patient feels hot & shivering & vomited Tylenol. Advised: cool rag to head. offer Tylenol after clear liquids tolerated. Call back if no better. 1.28.19 - spoke with mom & patient is much better. No fever or vomiting.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Administered wrong vaccine
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: (R) ARM Swelling, Red and waRmth.
Sex: M
Vaccine: VARZOS
Symptoms: Ataxia, Blood lactic acid increased, Blood pressure decreased, Chills, Hypotension
Clinical narrative: Pt received 2nd dose of Shingrix vaccine at 1600. No problems prior to administration. Fine immediately post. Went to gym but did no arm exercises. At 2000 I received a all asking me, spouse, to pick him up as he was ill and unable to drive. He displayed blurry vision, ataxia and severe Lt arm pain (site of injection). Opted to take him to ED. By now, approx. 2020 he displayed rigors. Temp spiked from afebrile to 100.8 in hour and BP dropped to 90/52 which is relative hypotension for him. Fluid resuscitated with 2L of NSS. Initial Lactate was elevated to 2.6, 2nd dropped to 1.2 post fluids. Pain was temporarily relieved with .05mg of Dilaudid. He was discharged at 0130 1/3/20. Today continues with Lt arm pain (5-6/10) will see PCP regarding pain control. Tylenol is not effective and NSAIDs are out of the picture due to renal insufficiency. He did fine with the first dose, just having just an achy arm. I appears that the side effects he experienced are listed as possible but severely exacerbated in my husband. No signs of anaphylaxis.