chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other adverse effects were reported; patient received an expired PROQUAD dose; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were unknown. Concomitant therapies included sterile diluent (STERILE DILUENT).  On 19-JUN-2020, the patient was vaccinated with an expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), injection, lot # R026362, expiration date 15-MAR-2020, 1 dosage form (strength, exact dose and route of administration were not reported) for prophylaxis. No other adverse effects were reported. The outcome of the events was unknown.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Injection site erythema, Injection site pain
Clinical narrative: shingles blisters in the back; shingles blisters in the back; left upper arm I have a large painful, red and hot rash.; left upper arm I have a large painful, red and hot rash.; left upper arm I have a large painful, red and hot rash.; about 5 inches below the site of injection with redness and swelling; pain about 5 inches below the site of injection; about 5 inches below the site of injection with redness; This case was reported by a consumer and described the occurrence of shingles in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2020, the patient received the 1st dose of Shingrix. In July 2020, 48 hrs after receiving Shingrix, the patient experienced shingles, blister, heat rash, painful rash, red rash, swelling, pain and erythema. The patient was treated with paracetamol (Tylenol), non-drug therapy (Ice Pack (No Medication)) and valaciclovir (Valacyclovir). On an unknown date, the outcome of the shingles, blister, heat rash, painful rash, red rash, swelling, pain and erythema were not recovered/not resolved.   It was unknown if the reporter considered the shingles, blister, heat rash, painful rash, red rash, swelling, pain and erythema to be related to Shingrix.  Additional details were provided as follows: The patient received dose of shingrix in the left deltoid. The reporter stated that on 10th July 2020,at 6 pm, about 48 hours after vaccination the patient had shingles blisters 7 numbers water filled and all within 2 inch radius.These on left back about 8 to 10 inches away from injection site. Additionally, on the left upper arm the patient had a large painful, red and hot rash. The patient had shingles blister around the T3 nerve ending. On 9th July 2020 at around 2 pm, less than 24 hours after vaccination, the patient had pain about 5 inches below the site of injection with redness and swelling. The patient received Tylenol, ice and valcyclovir 100 mg three times a day for 7 days as a treatment. The reporter consented to follow up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Miliaria, Pain, Rash
Clinical narrative: shingles blisters in the back; shingles blisters in the back; left upper arm I have a large painful, red and hot rash.; left upper arm I have a large painful, red and hot rash.; left upper arm I have a large painful, red and hot rash.; about 5 inches below the site of injection with redness and swelling; pain about 5 inches below the site of injection; about 5 inches below the site of injection with redness; This case was reported by a consumer and described the occurrence of shingles in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2020, the patient received the 1st dose of Shingrix. In July 2020, 48 hrs after receiving Shingrix, the patient experienced shingles, blister, heat rash, painful rash, red rash, swelling, pain and erythema. The patient was treated with paracetamol (Tylenol), non-drug therapy (Ice Pack (No Medication)) and valaciclovir (Valacyclovir). On an unknown date, the outcome of the shingles, blister, heat rash, painful rash, red rash, swelling, pain and erythema were not recovered/not resolved.   It was unknown if the reporter considered the shingles, blister, heat rash, painful rash, red rash, swelling, pain and erythema to be related to Shingrix.  Additional details were provided as follows: The patient received dose of shingrix in the left deltoid. The reporter stated that on 10th July 2020,at 6 pm, about 48 hours after vaccination the patient had shingles blisters 7 numbers water filled and all within 2 inch radius.These on left back about 8 to 10 inches away from injection site. Additionally, on the left upper arm the patient had a large painful, red and hot rash. The patient had shingles blister around the T3 nerve ending. On 9th July 2020 at around 2 pm, less than 24 hours after vaccination, the patient had pain about 5 inches below the site of injection with redness and swelling. The patient received Tylenol, ice and valcyclovir 100 mg three times a day for 7 days as a treatment. The reporter consented to follow up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Swelling
Clinical narrative: shingles blisters in the back; shingles blisters in the back; left upper arm I have a large painful, red and hot rash.; left upper arm I have a large painful, red and hot rash.; left upper arm I have a large painful, red and hot rash.; about 5 inches below the site of injection with redness and swelling; pain about 5 inches below the site of injection; about 5 inches below the site of injection with redness; This case was reported by a consumer and described the occurrence of shingles in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2020, the patient received the 1st dose of Shingrix. In July 2020, 48 hrs after receiving Shingrix, the patient experienced shingles, blister, heat rash, painful rash, red rash, swelling, pain and erythema. The patient was treated with paracetamol (Tylenol), non-drug therapy (Ice Pack (No Medication)) and valaciclovir (Valacyclovir). On an unknown date, the outcome of the shingles, blister, heat rash, painful rash, red rash, swelling, pain and erythema were not recovered/not resolved.   It was unknown if the reporter considered the shingles, blister, heat rash, painful rash, red rash, swelling, pain and erythema to be related to Shingrix.  Additional details were provided as follows: The patient received dose of shingrix in the left deltoid. The reporter stated that on 10th July 2020,at 6 pm, about 48 hours after vaccination the patient had shingles blisters 7 numbers water filled and all within 2 inch radius.These on left back about 8 to 10 inches away from injection site. Additionally, on the left upper arm the patient had a large painful, red and hot rash. The patient had shingles blister around the T3 nerve ending. On 9th July 2020 at around 2 pm, less than 24 hours after vaccination, the patient had pain about 5 inches below the site of injection with redness and swelling. The patient received Tylenol, ice and valcyclovir 100 mg three times a day for 7 days as a treatment. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Somnolence
Clinical narrative: needed a nap; I was "wiped out" / fatigue; This case was reported by a physician via sales rep and described the occurrence of fatigue in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced fatigue and somnolence. On an unknown date, the outcome of the fatigue and somnolence were recovered/resolved.   It was unknown if the reporter considered the fatigue and somnolence to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the next day of vaccination, the patient was wiped out and needed a nap. The fatigue lasted about 12 hours, then was ok again.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: 3 inch by 3 inch red area on left arm; soreness at injection site; Swelling at the injection site; low grade temperature at the injection site; low grade temperature 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 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st January 2020, the patient received the 1st dose of Shingrix (injection). On 21st January 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site pain, injection site swelling, injection site warmth and fever. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site swelling, injection site warmth and fever were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, injection site swelling, injection site warmth and fever to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient had a 3 inch by 3-inch red area on the site of the injection in the left arm.   The patient also had soreness, low grade temperature, and swelling at the injection site.  The patient wanted to know if she would be okay and not get shingles if she did not get the 2nd injection.   Medical Disclaimer provided to caller, along with PI and consumer facts provided in content. The reporter was consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Chest discomfort, Chest pain, Chills, Disturbance in attention
Clinical narrative: coud not see straight; could not focus; exhausted; dry scratchy chest; back pain; sinus pain; felt like she would pass out; difficulty yawning and swallowing; trouble walking; chest pain; feeling terrible; difficulty breathing/difficulty yawning; chills; This case was reported by a consumer via call center representative and described the occurrence of chest pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season).   On 12th February 2020, the patient received the 1st dose of Shingrix (intramuscular). In February 2020, less than a day after receiving Shingrix and less than a month after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced chills. In April 2020, the patient experienced difficulty breathing. On an unknown date, the patient experienced chest pain, feels awful, visual impairment, concentration impaired, exhaustion, chest abnormal feeling of, back pain, sinus pain, felt faint, swallowing difficult and walking difficulty. On an unknown date, the outcome of the chest pain, feels awful, visual impairment, exhaustion, chest abnormal feeling of, difficulty breathing, back pain and sinus pain were not recovered/not resolved and the outcome of the chills was recovered/resolved and the outcome of the concentration impaired was recovering/resolving and the outcome of the felt faint, swallowing difficult and walking difficulty were unknown.   It was unknown if the reporter considered the chest pain, feels awful, chills, visual impairment, concentration impaired, exhaustion, chest abnormal feeling of, difficulty breathing, back pain, sinus pain, felt faint, swallowing difficult and walking difficulty to be related to Shingrix.  Additional case details were reported as follows: The patient received 1st dose of Shingrix and experienced chills the first night.  She then developed the other events chest pain, feeling terrible, dry scratchy chest, back pain and sinus pain. One month later, she felt like she would pass out, could not see straight, could not focus and was exhausted.  The patient's primary care physician assistant informed her that her reaction was not typical for a Shingrix vaccination. In April, she had difficulty breathing. She had been tested 3 times for COVID and the results were all negative. Her oxygen levels were high but she has difficulty yawning and swallowing. She took an immune system test and the results were borderline.  She used to be a hiker, but now had trouble walking down the road. The patient received her flu shot 2 weeks prior with no ill effects The reporter consent to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Dysphagia, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: coud not see straight; could not focus; exhausted; dry scratchy chest; back pain; sinus pain; felt like she would pass out; difficulty yawning and swallowing; trouble walking; chest pain; feeling terrible; difficulty breathing/difficulty yawning; chills; This case was reported by a consumer via call center representative and described the occurrence of chest pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season).   On 12th February 2020, the patient received the 1st dose of Shingrix (intramuscular). In February 2020, less than a day after receiving Shingrix and less than a month after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced chills. In April 2020, the patient experienced difficulty breathing. On an unknown date, the patient experienced chest pain, feels awful, visual impairment, concentration impaired, exhaustion, chest abnormal feeling of, back pain, sinus pain, felt faint, swallowing difficult and walking difficulty. On an unknown date, the outcome of the chest pain, feels awful, visual impairment, exhaustion, chest abnormal feeling of, difficulty breathing, back pain and sinus pain were not recovered/not resolved and the outcome of the chills was recovered/resolved and the outcome of the concentration impaired was recovering/resolving and the outcome of the felt faint, swallowing difficult and walking difficulty were unknown.   It was unknown if the reporter considered the chest pain, feels awful, chills, visual impairment, concentration impaired, exhaustion, chest abnormal feeling of, difficulty breathing, back pain, sinus pain, felt faint, swallowing difficult and walking difficulty to be related to Shingrix.  Additional case details were reported as follows: The patient received 1st dose of Shingrix and experienced chills the first night.  She then developed the other events chest pain, feeling terrible, dry scratchy chest, back pain and sinus pain. One month later, she felt like she would pass out, could not see straight, could not focus and was exhausted.  The patient's primary care physician assistant informed her that her reaction was not typical for a Shingrix vaccination. In April, she had difficulty breathing. She had been tested 3 times for COVID and the results were all negative. Her oxygen levels were high but she has difficulty yawning and swallowing. She took an immune system test and the results were borderline.  She used to be a hiker, but now had trouble walking down the road. The patient received her flu shot 2 weeks prior with no ill effects The reporter consent to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Gait disturbance, Immunology test, Oxygen saturation increased, SARS-CoV-2 test negative, Sinus pain
Clinical narrative: coud not see straight; could not focus; exhausted; dry scratchy chest; back pain; sinus pain; felt like she would pass out; difficulty yawning and swallowing; trouble walking; chest pain; feeling terrible; difficulty breathing/difficulty yawning; chills; This case was reported by a consumer via call center representative and described the occurrence of chest pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season).   On 12th February 2020, the patient received the 1st dose of Shingrix (intramuscular). In February 2020, less than a day after receiving Shingrix and less than a month after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced chills. In April 2020, the patient experienced difficulty breathing. On an unknown date, the patient experienced chest pain, feels awful, visual impairment, concentration impaired, exhaustion, chest abnormal feeling of, back pain, sinus pain, felt faint, swallowing difficult and walking difficulty. On an unknown date, the outcome of the chest pain, feels awful, visual impairment, exhaustion, chest abnormal feeling of, difficulty breathing, back pain and sinus pain were not recovered/not resolved and the outcome of the chills was recovered/resolved and the outcome of the concentration impaired was recovering/resolving and the outcome of the felt faint, swallowing difficult and walking difficulty were unknown.   It was unknown if the reporter considered the chest pain, feels awful, chills, visual impairment, concentration impaired, exhaustion, chest abnormal feeling of, difficulty breathing, back pain, sinus pain, felt faint, swallowing difficult and walking difficulty to be related to Shingrix.  Additional case details were reported as follows: The patient received 1st dose of Shingrix and experienced chills the first night.  She then developed the other events chest pain, feeling terrible, dry scratchy chest, back pain and sinus pain. One month later, she felt like she would pass out, could not see straight, could not focus and was exhausted.  The patient's primary care physician assistant informed her that her reaction was not typical for a Shingrix vaccination. In April, she had difficulty breathing. She had been tested 3 times for COVID and the results were all negative. Her oxygen levels were high but she has difficulty yawning and swallowing. She took an immune system test and the results were borderline.  She used to be a hiker, but now had trouble walking down the road. The patient received her flu shot 2 weeks prior with no ill effects The reporter consent to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Visual impairment
Clinical narrative: coud not see straight; could not focus; exhausted; dry scratchy chest; back pain; sinus pain; felt like she would pass out; difficulty yawning and swallowing; trouble walking; chest pain; feeling terrible; difficulty breathing/difficulty yawning; chills; This case was reported by a consumer via call center representative and described the occurrence of chest pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season).   On 12th February 2020, the patient received the 1st dose of Shingrix (intramuscular). In February 2020, less than a day after receiving Shingrix and less than a month after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced chills. In April 2020, the patient experienced difficulty breathing. On an unknown date, the patient experienced chest pain, feels awful, visual impairment, concentration impaired, exhaustion, chest abnormal feeling of, back pain, sinus pain, felt faint, swallowing difficult and walking difficulty. On an unknown date, the outcome of the chest pain, feels awful, visual impairment, exhaustion, chest abnormal feeling of, difficulty breathing, back pain and sinus pain were not recovered/not resolved and the outcome of the chills was recovered/resolved and the outcome of the concentration impaired was recovering/resolving and the outcome of the felt faint, swallowing difficult and walking difficulty were unknown.   It was unknown if the reporter considered the chest pain, feels awful, chills, visual impairment, concentration impaired, exhaustion, chest abnormal feeling of, difficulty breathing, back pain, sinus pain, felt faint, swallowing difficult and walking difficulty to be related to Shingrix.  Additional case details were reported as follows: The patient received 1st dose of Shingrix and experienced chills the first night.  She then developed the other events chest pain, feeling terrible, dry scratchy chest, back pain and sinus pain. One month later, she felt like she would pass out, could not see straight, could not focus and was exhausted.  The patient's primary care physician assistant informed her that her reaction was not typical for a Shingrix vaccination. In April, she had difficulty breathing. She had been tested 3 times for COVID and the results were all negative. Her oxygen levels were high but she has difficulty yawning and swallowing. She took an immune system test and the results were borderline.  She used to be a hiker, but now had trouble walking down the road. The patient received her flu shot 2 weeks prior with no ill effects The reporter consent to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Antibody test negative, Blood test, Chest X-ray, Chest discomfort, Chest pain
Clinical narrative: coud not see straight; could not focus; exhausted; dry scratchy chest; back pain; sinus pain; felt like she would pass out; difficulty yawning and swallowing; trouble walking; chest pain; feeling terrible; difficulty breathing/difficulty yawning; chills; This case was reported by a consumer via call center representative and described the occurrence of chest pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season).   On 12th February 2020, the patient received the 1st dose of Shingrix (intramuscular). In February 2020, less than a day after receiving Shingrix and less than a month after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced chills. In April 2020, the patient experienced difficulty breathing. On an unknown date, the patient experienced chest pain, feels awful, visual impairment, concentration impaired, exhaustion, chest abnormal feeling of, back pain, sinus pain, felt faint, swallowing difficult and walking difficulty. On an unknown date, the outcome of the chest pain, feels awful, visual impairment, exhaustion, chest abnormal feeling of, difficulty breathing, back pain and sinus pain were not recovered/not resolved and the outcome of the chills was recovered/resolved and the outcome of the concentration impaired was recovering/resolving and the outcome of the felt faint, swallowing difficult and walking difficulty were unknown.   It was unknown if the reporter considered the chest pain, feels awful, chills, visual impairment, concentration impaired, exhaustion, chest abnormal feeling of, difficulty breathing, back pain, sinus pain, felt faint, swallowing difficult and walking difficulty to be related to Shingrix.  Additional case details were reported as follows: The patient received 1st dose of Shingrix and experienced chills the first night.  She then developed the other events chest pain, feeling terrible, dry scratchy chest, back pain and sinus pain. One month later, she felt like she would pass out, could not see straight, could not focus and was exhausted.  The patient's primary care physician assistant informed her that her reaction was not typical for a Shingrix vaccination. In April, she had difficulty breathing. She had been tested 3 times for COVID and the results were all negative. Her oxygen levels were high but she has difficulty yawning and swallowing. She took an immune system test and the results were borderline.  She used to be a hiker, but now had trouble walking down the road. The patient received her flu shot 2 weeks prior with no ill effects The reporter consent to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Computerised tomogram, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: coud not see straight; could not focus; exhausted; dry scratchy chest; back pain; sinus pain; felt like she would pass out; difficulty yawning and swallowing; trouble walking; chest pain; feeling terrible; difficulty breathing/difficulty yawning; chills; This case was reported by a consumer via call center representative and described the occurrence of chest pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season).   On 12th February 2020, the patient received the 1st dose of Shingrix (intramuscular). In February 2020, less than a day after receiving Shingrix and less than a month after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced chills. In April 2020, the patient experienced difficulty breathing. On an unknown date, the patient experienced chest pain, feels awful, visual impairment, concentration impaired, exhaustion, chest abnormal feeling of, back pain, sinus pain, felt faint, swallowing difficult and walking difficulty. On an unknown date, the outcome of the chest pain, feels awful, visual impairment, exhaustion, chest abnormal feeling of, difficulty breathing, back pain and sinus pain were not recovered/not resolved and the outcome of the chills was recovered/resolved and the outcome of the concentration impaired was recovering/resolving and the outcome of the felt faint, swallowing difficult and walking difficulty were unknown.   It was unknown if the reporter considered the chest pain, feels awful, chills, visual impairment, concentration impaired, exhaustion, chest abnormal feeling of, difficulty breathing, back pain, sinus pain, felt faint, swallowing difficult and walking difficulty to be related to Shingrix.  Additional case details were reported as follows: The patient received 1st dose of Shingrix and experienced chills the first night.  She then developed the other events chest pain, feeling terrible, dry scratchy chest, back pain and sinus pain. One month later, she felt like she would pass out, could not see straight, could not focus and was exhausted.  The patient's primary care physician assistant informed her that her reaction was not typical for a Shingrix vaccination. In April, she had difficulty breathing. She had been tested 3 times for COVID and the results were all negative. Her oxygen levels were high but she has difficulty yawning and swallowing. She took an immune system test and the results were borderline.  She used to be a hiker, but now had trouble walking down the road. The patient received her flu shot 2 weeks prior with no ill effects The reporter consent to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Hyperhidrosis, Injection site pain, Irritability, Pulmonary function test
Clinical narrative: coud not see straight; could not focus; exhausted; dry scratchy chest; back pain; sinus pain; felt like she would pass out; difficulty yawning and swallowing; trouble walking; chest pain; feeling terrible; difficulty breathing/difficulty yawning; chills; This case was reported by a consumer via call center representative and described the occurrence of chest pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season).   On 12th February 2020, the patient received the 1st dose of Shingrix (intramuscular). In February 2020, less than a day after receiving Shingrix and less than a month after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced chills. In April 2020, the patient experienced difficulty breathing. On an unknown date, the patient experienced chest pain, feels awful, visual impairment, concentration impaired, exhaustion, chest abnormal feeling of, back pain, sinus pain, felt faint, swallowing difficult and walking difficulty. On an unknown date, the outcome of the chest pain, feels awful, visual impairment, exhaustion, chest abnormal feeling of, difficulty breathing, back pain and sinus pain were not recovered/not resolved and the outcome of the chills was recovered/resolved and the outcome of the concentration impaired was recovering/resolving and the outcome of the felt faint, swallowing difficult and walking difficulty were unknown.   It was unknown if the reporter considered the chest pain, feels awful, chills, visual impairment, concentration impaired, exhaustion, chest abnormal feeling of, difficulty breathing, back pain, sinus pain, felt faint, swallowing difficult and walking difficulty to be related to Shingrix.  Additional case details were reported as follows: The patient received 1st dose of Shingrix and experienced chills the first night.  She then developed the other events chest pain, feeling terrible, dry scratchy chest, back pain and sinus pain. One month later, she felt like she would pass out, could not see straight, could not focus and was exhausted.  The patient's primary care physician assistant informed her that her reaction was not typical for a Shingrix vaccination. In April, she had difficulty breathing. She had been tested 3 times for COVID and the results were all negative. Her oxygen levels were high but she has difficulty yawning and swallowing. She took an immune system test and the results were borderline.  She used to be a hiker, but now had trouble walking down the road. The patient received her flu shot 2 weeks prior with no ill effects The reporter consent to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, SARS-CoV-2 test negative, Spinal pain, Vision blurred
Clinical narrative: coud not see straight; could not focus; exhausted; dry scratchy chest; back pain; sinus pain; felt like she would pass out; difficulty yawning and swallowing; trouble walking; chest pain; feeling terrible; difficulty breathing/difficulty yawning; chills; This case was reported by a consumer via call center representative and described the occurrence of chest pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season).   On 12th February 2020, the patient received the 1st dose of Shingrix (intramuscular). In February 2020, less than a day after receiving Shingrix and less than a month after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced chills. In April 2020, the patient experienced difficulty breathing. On an unknown date, the patient experienced chest pain, feels awful, visual impairment, concentration impaired, exhaustion, chest abnormal feeling of, back pain, sinus pain, felt faint, swallowing difficult and walking difficulty. On an unknown date, the outcome of the chest pain, feels awful, visual impairment, exhaustion, chest abnormal feeling of, difficulty breathing, back pain and sinus pain were not recovered/not resolved and the outcome of the chills was recovered/resolved and the outcome of the concentration impaired was recovering/resolving and the outcome of the felt faint, swallowing difficult and walking difficulty were unknown.   It was unknown if the reporter considered the chest pain, feels awful, chills, visual impairment, concentration impaired, exhaustion, chest abnormal feeling of, difficulty breathing, back pain, sinus pain, felt faint, swallowing difficult and walking difficulty to be related to Shingrix.  Additional case details were reported as follows: The patient received 1st dose of Shingrix and experienced chills the first night.  She then developed the other events chest pain, feeling terrible, dry scratchy chest, back pain and sinus pain. One month later, she felt like she would pass out, could not see straight, could not focus and was exhausted.  The patient's primary care physician assistant informed her that her reaction was not typical for a Shingrix vaccination. In April, she had difficulty breathing. She had been tested 3 times for COVID and the results were all negative. Her oxygen levels were high but she has difficulty yawning and swallowing. She took an immune system test and the results were borderline.  She used to be a hiker, but now had trouble walking down the road. The patient received her flu shot 2 weeks prior with no ill effects The reporter consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Nausea, Skin lesion
Clinical narrative: fatigue; nausea; lesions on chin; dose 1 in November 2019 / dose 2 on June 15, 2020; This case was reported by a pharmacist via sales rep and described the occurrence of fatigue in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose in November 2019).   On 15th June 2020, the patient received the 2nd dose of Shingrix. On 15th June 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced fatigue, nausea and skin lesion. On an unknown date, the outcome of the fatigue, nausea, skin lesion and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the fatigue, nausea and skin lesion to be related to Shingrix.  Additional details were reported as follows: The age group was not reported but was captured as adult as per vaccine indication. The patient received dose 2 and experienced unspecified lesions on the chin, nausea and fatigue. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthtening of vaccination schedule. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Crying, Headache, Herpes zoster, Neck pain, Neuropathy peripheral
Clinical narrative: neuropathy feeling near her eye / left side of her face and scalp and the top front corner around her eye; bad headaches / back of the head; it brought her to tears; didn't go in for 2nd because of pandemic; shingles; pain on the back of the neck, base of neck; This case was reported by a consumer via call center representative and described the occurrence of neuropathy in a 65-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 muscle spasm (around age 10, the patient was taken to the hospital for a brain infection).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On 7th June 2020, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced neuropathy (serious criteria GSK medically significant), headache, neck pain, crying and social problem. The patient was treated with prednisone and antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the neuropathy, shingles, headache, crying and social problem were unknown and the outcome of the neck pain was recovered/resolved.   It was unknown if the reporter considered the neuropathy, shingles, headache, neck pain and crying to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received 1st dose in fall of 2019, she did not remember if it was given intramuscularly.  The patient did not go for 2nd dose because of pandemic. On 6th July 2020, the patient experienced mild case of shingles. The patient stated that her case of shingles was not that bad. She described her shingles symptoms as bad headaches and extreme pain on the back of the neck, base of neck to the back of the head which only lasted for a minute and happened several times but it brought her to tears. She said that it was pretty much resolved but that she would still have some neuropathy feeling near her eye and on the left side of her face and scalp and the top front corner around her eye. She was prescribed prednisone and an unspecified antiviral medication. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Social problem
Clinical narrative: neuropathy feeling near her eye / left side of her face and scalp and the top front corner around her eye; bad headaches / back of the head; it brought her to tears; didn't go in for 2nd because of pandemic; shingles; pain on the back of the neck, base of neck; This case was reported by a consumer via call center representative and described the occurrence of neuropathy in a 65-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 muscle spasm (around age 10, the patient was taken to the hospital for a brain infection).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On 7th June 2020, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced neuropathy (serious criteria GSK medically significant), headache, neck pain, crying and social problem. The patient was treated with prednisone and antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the neuropathy, shingles, headache, crying and social problem were unknown and the outcome of the neck pain was recovered/resolved.   It was unknown if the reporter considered the neuropathy, shingles, headache, neck pain and crying to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received 1st dose in fall of 2019, she did not remember if it was given intramuscularly.  The patient did not go for 2nd dose because of pandemic. On 6th July 2020, the patient experienced mild case of shingles. The patient stated that her case of shingles was not that bad. She described her shingles symptoms as bad headaches and extreme pain on the back of the neck, base of neck to the back of the head which only lasted for a minute and happened several times but it brought her to tears. She said that it was pretty much resolved but that she would still have some neuropathy feeling near her eye and on the left side of her face and scalp and the top front corner around her eye. She was prescribed prednisone and an unspecified antiviral medication. The reporter consented to follow up.
Age: 0.5
Sex: M
Vaccine: PNC13
Symptoms: Dermatitis diaper, Rash
Clinical narrative: patient received it after excursion; The patient should have received the Prevnar 13 at four months, but he was behind; it was a rash, a diaper rash; The total excursion was for 8 hours and 30 minutes. The lowest temperature reached was 35.6 degrees Fahrenheit.; This is a spontaneous report from a contactable other healthcare professional (HCP). A 6-month-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, pre-filled syringe pen), on Feb2020 (0.5ml injection pre-filled syringe) (lot number: AL8456, expiry date: Jul2021, NDC number: 0005-1971-01) in right thigh at 0.5 ml, single; (lot number: W33489) on Feb2020 at a single dose; on 16Jun2020 14:30 at a single dose, all via an unspecified route of administration for immunisation. There was none of medical history. Concomitant medication included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP, lot Number: C5611BA, Manufacturer: Sanofi), hib vaccine (HIB, Manufacturer: Sanofi, Lot Number: UJ09944), polio vaccine inact (IPV, Manufacturer: Sanofi, Lot Number: P1E70), all for immunisation. It was stored out of range patient received it. There were two excursions, one in May and one in June. The total excursion was for 8 hours and 30 minutes. The lowest temperature reached was 35.6 degrees Fahrenheit. It was after the Jun2020 excursion when administered after the excursion. She confirmed it was administered after the excursion, but clarified it was only one patient who received after the excursion. This patient received it after it was involved in the excursion for 5.5 hours. It was a few days later where the excursion continued for 2 hours. She clarified and explained the patient had received the Prevnar 13 in between the excursion total time frame. The patient was behind on receiving the Prevnar 13. The patient should have received the Prevnar 13 at four months, but he was behind. He was behind on all his vaccines due to the virus. She stated they did not have many patients coming in at this time. It was a rash, a diaper rash on an unspecified date in 2020. The outcome of events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 11.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: nurse accidentally administered Trumenba instand of Menactra / no AE; Initial information was received on 18-Jul-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 11 year old male patient who received MENINGOCOCCAL VACCINE B RFHBPA/FHBPB [TRUMENBA] instead of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number and Expiry date unknown) via unknown route in unknown administration site for Prophylactic vaccination, on an unknown date.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to wrong vaccine administered.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case
Sex: U
Vaccine: MNQ, UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: the patient was given an extra dose of MMRV accidentally instead of Menactra/No AE; Based on information received on 15-Jul-2020, the report previously considered as non-case became valid: reason: wrong vaccine administered (medication error).   Initial information received on 14-Jul-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves an 11-year-old patient (gender not reported) who accidentally received MEASLES VACCINE;MUMPS VACCINE;RUBELLA VACCINE;VARICELLA ZOSTER VACCINE [MMRV] instead of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (wrong product administered).  Medical history, medical treatment(s), vaccination(s) and family history and concomitant therapies were not provided.  On an unknown date, the patient accidentally received a third dose of suspect MMRV not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for prophylactic vaccination instead of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (formulation: Solution for injection).  It was a case of an actual medication error due to wrong vaccine administered. Reporter wanted to confirm how soon can before the patient can get the Menactra vaccination.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Follow-up information regarding an unsolicited valid non-serious case was received on 15-Jul-2020 from a nurse.  The report previously considered as non-case became valid: wrong vaccine administered (medication error). Entire narrative was updated accordingly.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: a patient was given two injections of Menactra by mistake, in the right deltoid and in the left deltoid on the same day,No AE; Initial information received on 17-Jul-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case involves a 12 years old female patient who received two doses of 0.5 mL of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] Injection (lot number: U6596AA expiry date 24-May-2021) via an intramuscular route in the right deltoid and the other dose in the left deltoid by mistake for prophylactic vaccination on 17-Jul-2020 respectively.  Concomitant therapy received by patient was a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot and expiry date was not reported) via an unknown route in the right deltoid and also received a dose of HPV VACCINE (lot and expiry date was not reported) via an unknown route in the left deltoid for prophylactic vaccination on an unknown date respectively.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  It was an a case of an actual medication error case due to extra dose administered.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: products were out of range for 3 weeks/No AE; Products were out of range for 3 week Products: Apidra, Ipol, ActHIB, Tubersol, Elitek (7.5 and 1.5) and Fabrazyme Lot and expiration for all products unavailable. Stability data not reported in source document and there is no vaccine administered hence case considered as non case.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired ACT-HIB was administered to patient, no AE; Initial information received on 20-Jul-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 15 months old male patient who received an expired fourth dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot: UI959AA, expiry date: 19-Jun-2020) once via an unknown route in the left thigh for prophylactic vaccination on 20-Jul-2020.  The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for prophylactic vaccination.  It was an actual medication error due to expired vaccine used.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.