chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; the patient recived improperly stored dose of Proquad; 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, drug reactions, allergies and concomitant medications were not provided.  On 16-JUL-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S035100, expiration date was not reported but upon internal validation, it was established as 03-MAY-2021 for prophylaxis (exact dose, vaccine schedule, route of administration and anatomical location were not provided). The vaccine was reconstituted with sterile diluent (STERILE DILUENT).  The temperature excursion was from 15 degrees Fahrenheit (F) to 46 degrees Fahrenheit (34.5 F) for 1 hr 22 min and 30 sec minutes. The previous temperature excursions was reported as following: form 6 degrees Fahrenheit to 14 degrees Fahrenheit (9 F) for 52 min. The digital data logger was involved. No adverse symptoms were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle aches; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 70-year-old 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 muscle pain. On an unknown date, the outcome of the muscle pain was unknown.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received Shingrix and experienced muscle aches and patient want to know could patient take naproxen for these symptoms.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Burning sensation, Flank pain, Herpes zoster, Hot flush
Clinical narrative: paresthesia; flank pain; shingles/shingles flare up/shingles pain; vasculitis; left leg pain; low back pain; Sciatica; hot flashes; tingling of left thigh; burning sensation; numbness of left thigh/eft leg numbness; This case was reported by a lawyer and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles and vasculitis. On an unknown date, the outcome of the shingles and vasculitis were unknown.   It was unknown if the reporter considered the shingles and vasculitis to be related to Shingrix.  The initial information was received on 29 July 2020 via medical record. As per medical record the patient had historical condition of shingles in 2017.The patient took shingrix 50 mcg inj glax on 30 September 2018. The patient had shingles flare up and hot flashes on 13 January 2020. The patient also had Sciatica,Low back pain,Leg pain on 22 February 2020.The patient was discharged on same day on 15 Novemver 2018 and in the discharged diagnosis the patient had paresthesia and flank pain.The patient experienced numbness/tingling of left thigh and burning sensation and shingles pain on 19 November 2019.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Pain, Pain in extremity, Paraesthesia, Sciatica
Clinical narrative: paresthesia; flank pain; shingles/shingles flare up/shingles pain; vasculitis; left leg pain; low back pain; Sciatica; hot flashes; tingling of left thigh; burning sensation; numbness of left thigh/eft leg numbness; This case was reported by a lawyer and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles and vasculitis. On an unknown date, the outcome of the shingles and vasculitis were unknown.   It was unknown if the reporter considered the shingles and vasculitis to be related to Shingrix.  The initial information was received on 29 July 2020 via medical record. As per medical record the patient had historical condition of shingles in 2017.The patient took shingrix 50 mcg inj glax on 30 September 2018. The patient had shingles flare up and hot flashes on 13 January 2020. The patient also had Sciatica,Low back pain,Leg pain on 22 February 2020.The patient was discharged on same day on 15 Novemver 2018 and in the discharged diagnosis the patient had paresthesia and flank pain.The patient experienced numbness/tingling of left thigh and burning sensation and shingles pain on 19 November 2019.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Vasculitis
Clinical narrative: paresthesia; flank pain; shingles/shingles flare up/shingles pain; vasculitis; left leg pain; low back pain; Sciatica; hot flashes; tingling of left thigh; burning sensation; numbness of left thigh/eft leg numbness; This case was reported by a lawyer and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles and vasculitis. On an unknown date, the outcome of the shingles and vasculitis were unknown.   It was unknown if the reporter considered the shingles and vasculitis to be related to Shingrix.  The initial information was received on 29 July 2020 via medical record. As per medical record the patient had historical condition of shingles in 2017.The patient took shingrix 50 mcg inj glax on 30 September 2018. The patient had shingles flare up and hot flashes on 13 January 2020. The patient also had Sciatica,Low back pain,Leg pain on 22 February 2020.The patient was discharged on same day on 15 Novemver 2018 and in the discharged diagnosis the patient had paresthesia and flank pain.The patient experienced numbness/tingling of left thigh and burning sensation and shingles pain on 19 November 2019.
Sex: M
Vaccine: VARZOS
Symptoms: Blindness unilateral
Clinical narrative: Loss of vision in the left eye; This case was reported by a pharmacist via call center representative and described the occurrence of loss of vision in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 5S43T, expiry date 5th March 2022) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced loss of vision (serious criteria GSK medically significant). On an unknown date, the outcome of the loss of vision was not recovered/not resolved.   It was unknown if the reporter considered the loss of vision to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and loss of vision in the left eye. The reporter did not consent to follow up.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Chills, Pain, Rash
Clinical narrative: Chills, body aches for two days. On third day, rash visible in right arm pit. No visible irritation at injection site.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Headache, Nasal congestion, Pain, Tremor
Clinical narrative: Patient states 2 hours after the injection she developed Body pain, shaking, headache, nasal congestion and cough that lasted for 2 days.  While speaking to pt still have cough
Age: 9.0
Sex: F
Vaccine: HEPA
Symptoms: Headache, Vomiting
Clinical narrative: 20 minutes after administration patient had first episode of emesis. Sat for another ten minutes and then patient had several more episdoes of emesis. This went on for about an hour. Patient also reported a headache during this time. After an hour, patient stated she felt better.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Patient reported itching 3 days(7/13/20)after vaccination, she took photo which showed redness and swelling at the injection site, significant swelling on the right posterior arm, estimated measurement from image showed 8cm wide and 5cm in length. No swelling or redness at site today (8/10/20), site showed brusing.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain, Palpitations
Clinical narrative: severe shaking, chills, a racing heart, pounding in my head, nausea, and painful body aches
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: severe shaking, chills, a racing heart, pounding in my head, nausea, and painful body aches
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Condition aggravated, Cough, Dizziness, Fatigue
Clinical narrative: Client received shot in the AM of 8/7/20. Client became tired as day went on and was super tired by the evening of the 7th. Client has tinnitus and that was exacerbated and became very loud. The client started a rash that started across her lower back and went to her upper back. She had chills the evening of the 7th but did not take her temperature. Rash was itchy on Saturday and she had small areas on her leg with a rash. She took a bath on Saturday with baking soda and oils that gave her some relief from the itch. The itching was better on Sunday and client developed a headache on Sunday evening. The headache is just dull today, but client feels a little "woozie". Client says she kind of has a cough today., and still is itchy to the rash areas. The client said her tinnitus is not as loud today. Client went to work but I encouraged her to go home and rest. She asked if she should call the clinic and be seen. I encouraged her to call and tell them her symptoms and see what their advice is.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Rash, Rash pruritic, Tinnitus
Clinical narrative: Client received shot in the AM of 8/7/20. Client became tired as day went on and was super tired by the evening of the 7th. Client has tinnitus and that was exacerbated and became very loud. The client started a rash that started across her lower back and went to her upper back. She had chills the evening of the 7th but did not take her temperature. Rash was itchy on Saturday and she had small areas on her leg with a rash. She took a bath on Saturday with baking soda and oils that gave her some relief from the itch. The itching was better on Sunday and client developed a headache on Sunday evening. The headache is just dull today, but client feels a little "woozie". Client says she kind of has a cough today., and still is itchy to the rash areas. The client said her tinnitus is not as loud today. Client went to work but I encouraged her to go home and rest. She asked if she should call the clinic and be seen. I encouraged her to call and tell them her symptoms and see what their advice is.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Headache, Hypersomnia, Lethargy, Urticaria
Clinical narrative: Lethargic.- slept close to 48 hours, hives in the whole torso area, stomach cramps and headache - all of these symptoms are persisting for a 3rd day
Age: 16.0
Sex: M
Vaccine: MENB, VARCEL
Symptoms: Feeling abnormal, Limb discomfort, Pain in extremity, Paraesthesia oral, Sensory disturbance
Clinical narrative: 8-6-20 - Midnight - Pt reports started getting a strange feeling in Left arm that he received shots in. Got slightly worse - then leveled in intensity. Woke up - Left arm continued with discomfort - slight tingling in tongue - that resolved. 8-7-20 9AM (L) Arm discomfort reports on how he is holding his arm. Reports after the shots in left arm - arm was sore x 1wk. Day after (L) arm felt strange sensation. Had worked out with weights - heavy workout - Did arm curls with left arm - vigorously. Has taken nothing for discomfort. Referred to Medical Provider if S/S worsen or do not  improve for follow up.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Blister, Peripheral swelling
Clinical narrative: Thigh swelling and blisters
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event
Clinical narrative: No adverse reaction noted.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Nausea, Pain, Palpitations
Clinical narrative: woke up to chills, fever, muscle aches, queasiness.  Fever was around 101 for about 20 hours, now at 100 still at 32 hours.  at it's highest was 101.8, several times.  Dizziness and heart palpitations most of the day.  Really sore body.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: woke up to chills, fever, muscle aches, queasiness.  Fever was around 101 for about 20 hours, now at 100 still at 32 hours.  at it's highest was 101.8, several times.  Dizziness and heart palpitations most of the day.  Really sore body.
Age: 13.0
Sex: M
Vaccine: FLU4, MNQ, TDAP
Symptoms: Loss of consciousness, Posture abnormal, Presyncope
Clinical narrative: After administering the first two vaccines in the patient's left arm, I proceeded to give him his last vaccine in his right arm.  In between each vaccination I asked if he was okay and we discussed where he went to school, etc.  Right after injecting the third vaccine, the patient looked as if he just sloped over and was resting his head on the wall.  His mom was giving him a hard time about being tough, I immediately realized the patient was not playing around.  The patient's mom and I got him laying down flat and bent his legs up.  I checked for pulse and signs of breathing.  The patient woke up about 10 to 15 seconds later and was able to tell me his name, his mom's name and where he was.  I then had the technician grab the BP cuff from our immunization kit, and checked it.  It was 135/88.  The patient's mom was very upset and still wanted 911 to be called so we did from the pharmacy.   They arrived and also said he was fine to go home and didn't believe it was an actual reaction from the vaccine but more of a vagal response. The patient's mom signed paper work that he would not be taken to the ER and left.  She was very thankful for how I handled the situation and that I remained calm.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt complained of nausea, fever, chills, headache, body ache. Redness, warmth and swelling at injection side.  Took tylenol / ibprofen.   Swelling and redness improved on 3rd day after vaccination.  Other symptoms resolved.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Pt complained of nausea, fever, chills, headache, body ache. Redness, warmth and swelling at injection side.  Took tylenol / ibprofen.   Swelling and redness improved on 3rd day after vaccination.  Other symptoms resolved.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Fatigue, Musculoskeletal stiffness
Clinical narrative: Slightly elevated temperature, muscle stiffness, and overall fatigue for 2 days
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; Nurse reported administered GARDASIL9 after temperature excursion; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided.  On 23-JUL-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter (lot # reported as 16374 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), expiration date reported as 16-FEB-2022, route of administration was not provided). There was no adverse effect reported. The vaccine underwent a temperature excursion of 8 degrees Celsius (C) (8.83 C) for 20 hours. The digital data logger was involved. There were no previous temperature excursions reported.
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Haematuria
Clinical narrative: loss of balance; gross hematuria; This case was reported by a consumer via other manufacturer and described the occurrence of loss of balance in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced loss of balance and hematuria. On an unknown date, the outcome of the loss of balance and hematuria were unknown.   It was unknown if the reporter considered the loss of balance and hematuria to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced gross hematuria and loss of balance.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Dizziness, Injection site erythema, Injection site haemorrhage, Injection site pain
Clinical narrative: sick feeling in her stomach; wooziness; itcy rash on the same arm she received the injection; to develop a painful rash on the bicep; redness at at the site of the injection and pain; redness at at the site of the injection and pain; blood on the bandaid when she removed it from the injection site; This case was reported by a consumer via call center representative and described the occurrence of stomach discomfort in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st July 2020, the patient received the 1st dose of Shingrix. On 31st July 2020, less than a day after receiving Shingrix, the patient experienced injection site hemorrhage. On 1st August 2020, the patient experienced stomach discomfort, wooziness, itchy rash, painful rash, injection site erythema and injection site pain. On an unknown date, the outcome of the stomach discomfort, wooziness, itchy rash, painful rash, injection site hemorrhage, injection site erythema and injection site pain were unknown.   It was unknown if the reporter considered the stomach discomfort, wooziness, itchy rash, painful rash, injection site hemorrhage, injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm and there was extra blood on the band aid when she removed it from the injection site. The patient had a sick feeling in her stomach, wooziness an itchy rash on the same arm she received the injection but it was along the inner arm, not at the injection site and redness at the site of the injection and pain. The reporter asked was it normal to develop a painful rash on the bicep, not at the injection site. The patient still had some of the rash left and some pain but not as much as there was before.  The reporter wanted to know if had shingles in the past would cause her side effects to be more pronounced.  The reporter provided Medical Disclaimer, and PI from content and gave the reporter the number to had her HCP call Medical Information and sent the Shingrix PI through. The reporter did not consent to follow up.  The reporter stated she did not have any HCP contact. This case linked with US2020150010, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020150010:same repoter
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: sick feeling in her stomach; wooziness; itcy rash on the same arm she received the injection; to develop a painful rash on the bicep; redness at at the site of the injection and pain; redness at at the site of the injection and pain; blood on the bandaid when she removed it from the injection site; This case was reported by a consumer via call center representative and described the occurrence of stomach discomfort in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st July 2020, the patient received the 1st dose of Shingrix. On 31st July 2020, less than a day after receiving Shingrix, the patient experienced injection site hemorrhage. On 1st August 2020, the patient experienced stomach discomfort, wooziness, itchy rash, painful rash, injection site erythema and injection site pain. On an unknown date, the outcome of the stomach discomfort, wooziness, itchy rash, painful rash, injection site hemorrhage, injection site erythema and injection site pain were unknown.   It was unknown if the reporter considered the stomach discomfort, wooziness, itchy rash, painful rash, injection site hemorrhage, injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm and there was extra blood on the band aid when she removed it from the injection site. The patient had a sick feeling in her stomach, wooziness an itchy rash on the same arm she received the injection but it was along the inner arm, not at the injection site and redness at the site of the injection and pain. The reporter asked was it normal to develop a painful rash on the bicep, not at the injection site. The patient still had some of the rash left and some pain but not as much as there was before.  The reporter wanted to know if had shingles in the past would cause her side effects to be more pronounced.  The reporter provided Medical Disclaimer, and PI from content and gave the reporter the number to had her HCP call Medical Information and sent the Shingrix PI through. The reporter did not consent to follow up.  The reporter stated she did not have any HCP contact. This case linked with US2020150010, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020150010:same repoter
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: sore arm; body aches; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st July 2020, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain in arm and general body pain. On an unknown date, the outcome of the pain in arm and general body pain were recovered/resolved.   It was unknown if the reporter considered the pain in arm and general body pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient had the Shingrix vaccine. He had a sore arm and body aches for two days.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Fatigue; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix and had fatigue. The reporter wanted to know could fatigue last for 1week.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever of 105 degrees Fahrenheit; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2020, the patient received Shingrix. In July 2020, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The patient experienced fever of 105 degrees F. The asked pharmacist further questions about temperatures in clinical studies. This case has been linked with US2020148713, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020148713:same reporter
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Aching, redness and swelling at the injection site; Redness and swelling at the injection site; Swelling at the injection site; dizziness; Pain upon movement of her left arm/; shivers; fatigue; not feeling well; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2020, the patient received the 2nd dose of Shingrix. On 30th July 2020, less than a day after receiving Shingrix, the patient experienced feeling unwell. On 31st July 2020, the patient experienced injection site pain, injection site erythema, injection site swelling, dizziness, pain upon movement, shivers and fatigue. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, dizziness, pain upon movement, feeling unwell, shivers and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, dizziness, pain upon movement, feeling unwell, shivers and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her left arm yesterday at her cardiologist office and started not feeling well. The patient was feeling worse, has aching, redness and swelling at the injection site.  The patient was also experiencing shivers, fatigue and pain upon movement of her left arm. The reporter consented to follow up.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Malaise, Pain
Clinical narrative: Aching, redness and swelling at the injection site; Redness and swelling at the injection site; Swelling at the injection site; dizziness; Pain upon movement of her left arm/; shivers; fatigue; not feeling well; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2020, the patient received the 2nd dose of Shingrix. On 30th July 2020, less than a day after receiving Shingrix, the patient experienced feeling unwell. On 31st July 2020, the patient experienced injection site pain, injection site erythema, injection site swelling, dizziness, pain upon movement, shivers and fatigue. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, dizziness, pain upon movement, feeling unwell, shivers and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, dizziness, pain upon movement, feeling unwell, shivers and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her left arm yesterday at her cardiologist office and started not feeling well. The patient was feeling worse, has aching, redness and swelling at the injection site.  The patient was also experiencing shivers, fatigue and pain upon movement of her left arm. The reporter consented to follow up.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives; Itching; This case was reported by a other health professional via call center representative and described the occurrence of hives in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   In July 2020, the patient received the 1st dose of Bexsero. In July 2020, 30 min after receiving Bexsero, the patient experienced hives and pruritus. On an unknown date, the outcome of the hives and pruritus were unknown.   It was unknown if the reporter considered the hives and pruritus to be related to Bexsero.  Additional case details were reported as follows: A last week before from the reporting date, the patient received the 1st dose of Bexsero and 30 minutes later developed itching and hives. The reporter consent to follow up. Clinical supervisor did not provide lot number or expiration of the vaccine because he said that it happened in another facility. He did not provide initials of the patient either.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Erythema
Clinical narrative: Weak feeling; Lightheadedness; Diarrhea; Shivers; Sore arm; Red patch; This case was reported by a consumer via call center representative and described the occurrence of weakness in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 29th July 2020, less than a day after receiving Shingrix, the patient experienced pain in arm and skin red. On 30th July 2020, the patient experienced shivers. On 2nd August 2020, the patient experienced weakness, light headedness and diarrhea. On an unknown date, the outcome of the weakness, light headedness and diarrhea were not recovered/not resolved and the outcome of the shivers, pain in arm and skin red were recovered/resolved.   It was unknown if the reporter considered the weakness, light headedness, diarrhea, shivers, pain in arm and skin red to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and developed a red patch and sore arm that has since resolved.  The following day the patient came down with shivers that also has since resolved. The patient had experiencing diarrhea, lightheadedness, and a weak feeling that was unknown if related to Shingrix vaccine.  These symptoms were still ongoing. The reporter did not consent to follow up. The reporter did not consent to HCP follow up and stated she would follow up on her own.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Weak feeling; Lightheadedness; Diarrhea; Shivers; Sore arm; Red patch; This case was reported by a consumer via call center representative and described the occurrence of weakness in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 29th July 2020, less than a day after receiving Shingrix, the patient experienced pain in arm and skin red. On 30th July 2020, the patient experienced shivers. On 2nd August 2020, the patient experienced weakness, light headedness and diarrhea. On an unknown date, the outcome of the weakness, light headedness and diarrhea were not recovered/not resolved and the outcome of the shivers, pain in arm and skin red were recovered/resolved.   It was unknown if the reporter considered the weakness, light headedness, diarrhea, shivers, pain in arm and skin red to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and developed a red patch and sore arm that has since resolved.  The following day the patient came down with shivers that also has since resolved. The patient had experiencing diarrhea, lightheadedness, and a weak feeling that was unknown if related to Shingrix vaccine.  These symptoms were still ongoing. The reporter did not consent to follow up. The reporter did not consent to HCP follow up and stated she would follow up on her own.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 31st July 2020, 2 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had Shingles.  The patient gives consent to follow up with physician but unable to provide full contact information details.  The patient unable to provide lot number and expiration date. The reporter consented to follow up.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity, Rash
Clinical narrative: Allergic reaction; Allergic reaction (rash); This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced allergic reaction and rash. On an unknown date, the outcome of the allergic reaction and rash were unknown.   It was unknown if the reporter considered the allergic reaction and rash to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient had an allergic reaction rash after receiving a Flu vaccine manufacturer unknown 15 years ago prior to the reporting date. Conservatively captured the event.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: fever of 101 F; chills; This case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th August 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 5th August 2020, 1 days after receiving Shingrix, the patient experienced fever and chills. On an unknown date, the outcome of the fever was not recovered/not resolved and the outcome of the chills was recovered/resolved.   It was unknown if the reporter considered the fever and chills to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm and woke up at 1am with a fever of 101 degrees F and chills. The chills had resolved at this time, but the fever persists. The reporter consented to follow up. The reporter did not does not had vaccine information for this AE.
Sex: U
Vaccine: VARZOS
Symptoms: Contusion, Screaming
Clinical narrative: Bruised and screamed all over; Bruised and screamed all over; This case was reported by a pharmacist via call center representative and described the occurrence of screaming in an unspecified number of  adult patients who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced screaming and contusion. On an unknown date, the outcome of the screaming and contusion were unknown.   It was unknown if the reporter considered the screaming and contusion to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The received Shingrix and bruised and screamed all over. The reporter did not consent to follow up.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Diarrhoea, Haematochezia
Clinical narrative: Infant developed loose stools with bright red flecks of blood several hours after immunization
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pain, Skin warm, Swelling
Clinical narrative: red area with swelling, heat, pain, area is hard
Age: 0.58
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional adverse effects were reported; patient, seven months of age, inadvertently received PNEUNOVAX 23, instead of PREVNAR 13; This spontaneous report was received from a medical assistant and refers to a 7-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-JUL-2020, the patient was inadvertently vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 ml, once, lot # S028601, expiration date 02-JUN-2021 (injection site and route of administration were not reported) for prophylaxis instead of pneumococcal 13v conj vaccine (crm197)(PREVNAR 13) (exact dose, injection site, route of administration, lot # and expiration date were not reported). No additional adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no other AE details to report; expired Proquad administered to patient; This spontaneous report was received via company representative and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 04-AUG-2020, the patient was vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) lot # R030799, expiration date 22-APR-2022 (dose and route of administration were not reported), for prophylaxis. No other adverse event details were reported. The outcome of the event was unknown.
Sex: U
Vaccine: TYP
Symptoms: Product dose omission
Clinical narrative: Missed a dose of Vivotif; Spontaneous report received on 23JUN2020.  A healthcare professional reported that a consumer who "missed a dose of Vivotif" (PT: Product dose omission). The consumer was receiving Vivotif for immunisation. The reporter stated that, the consumer had missed a dose of Vivotif. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: It was reported that a consumer missed a dose of vivotif. Information on when the consumer started taking vivotif, and which number dose was missed was limited. Vivotif dose should be taken every other day, and the causality of missed dose is assessed as not applicable to vivotif due to the nature of the event.; Sender's Comments: It was reported that a consumer missed a dose of vivotif. Information on when the consumer started taking vivotif, and which number dose was missed was limited. Vivotif dose should be taken every other day, and the causality of missed dose is assessed as not applicable to vivotif due to the nature of the event.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoaesthesia
Clinical narrative: Afterwards she had a shingles outbreak on her leg,; and numbness in that area; This case was reported by a consumer via sales rep and described the occurrence of shingles in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles outbreak before receiving 1st dose of shingrix when she was pregnant).   In June 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced shingles and numbness in leg. On an unknown date, the outcome of the shingles and numbness in leg were unknown.   It was unknown if the reporter considered the shingles and numbness in leg to be related to Shingrix.  Additional details were reported as follows: The patient received 1st Shingrix shot approximately 2 months ago from reporting date at a local pharmacy. Afterwards she had a shingles outbreak on her leg, and numbness in that area. She did not decide whether to receive 2nd dose or not and planned to call her physician's office. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Coronavirus infection, Pyrexia
Clinical narrative: fever of 100; covid; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On 2nd August 2020, the patient received the 2nd dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced fever and coronavirus infection. On an unknown date, the outcome of the fever and coronavirus infection were unknown.   It was unknown if the reporter considered the fever and coronavirus infection to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received 2nd dose of vaccine and had fever of 100 degree F. The patient was concerned whether it was due to shingle shot or covid. The event coronavirus infection was capture conservatively since no follow up was possible for the case.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: the side effect of body aches last; How high a fever?; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced general body pain and fever. On an unknown date, the outcome of the general body pain and fever were unknown.   It was unknown if the reporter considered the general body pain and fever to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The patient asked how long does the side effect of body aches last after a Shringrix vaccination.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site mass, Injection site pain, Nausea
Clinical narrative: headache; nauseous; Lump where she received Shingrix; pain at the injection site; Felt wiped out  / tired; This case was reported by a consumer via call center representative and described the occurrence of headache in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included belimumab (Benlysta) solution for injection in pre-filled syringe for drug use for unknown indication, belimumab pre-filled syringe device injection syringe (batch number Unknown, expiry date unknown) for drug use for unknown indication, TETANUS TOXOID (TETANUS VACCINE) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On 30th July 2020, the patient received Shingrix. In June 2020, the patient started Benlysta 1 dosage form(s) weekly and belimumab pre-filled syringe device. On 29th July 2020, the patient received TETANUS VACCINE and PNEUMONIA VACCINE. On 30th July 2020, less than a day after receiving Shingrix and less than a week after starting Benlysta and belimumab pre-filled syringe device, the patient experienced tiredness. On 31st July 2020, the patient experienced headache, nausea, injection site lump and injection site pain. The action taken with Benlysta was unknown. On an unknown date, the outcome of the headache, nausea, tiredness, injection site lump and injection site pain were not recovered/not resolved.   The reporter considered the headache, nausea, tiredness, injection site lump and injection site pain to be related to Shingrix. It was unknown if the reporter considered the headache, nausea and tiredness to be related to Benlysta and belimumab pre-filled syringe device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: On 13th June 2020 the patient start taking Benlysta for 7 weeks.  On 1st August 2020 would be her 8th dose.  On 29th July 2020, the patient received pneumonia and tetanus vaccines  On 30th July 2020 same day after receiving Shingrix and one day after receiving pneumonia and tetanus patient experienced felt wiped out and tired. Two days after receiving pneumonia and tetanus vaccines the patient experienced headache, nausea, injection site lump and injection site pain.   The patient was not sure if she would take her Benlysta after the day of reporting. The reporter did not consent to follow up.
Age: 78.0
Sex: F
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 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 18th February 2020, 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 recovered/resolved.   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 had a sore arm for approximately two days. Thereporter did not consent to follow up.
Sex: F
Vaccine: PNC13
Symptoms: Chills, Pyrexia
Clinical narrative: chills; fever of 101 for over 24 hours; This is a spontaneous report from contactable physician via Pfizer Sales Representative.   A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose on an unspecified date for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced chills and fever of 101 for over 24 hours after the administered dose on an unspecified date.  The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: PNC13, UNK
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Arm was red/Skin red; Swollen arm/Arm was swollen; This is a spontaneous report based on the information received by Pfizer from Corporation (Manufacturer report number: USA-20200305623). A contactable pharmacist and a consumer reported that a 58-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date not reported), via an unspecified route of administration from an unspecified date at single dose for immunization; and lenalidomide (REVLIMID 25 mg, lot number: A2804A), oral from Aug2017 at 25 mg, 1x/day, (25 milligram, 1 in 1 D (day), from Jul2018 at 10 mg, 1x/day, (10 milligram, 1 in 1 D (day), from Nov2018 at 5 mg, 1x/day, (5 milligram, 1 in 1 D (day), from Oct2019 at 10 mg, 1x/day, (10 milligram, 1 in 1 D (day), from Nov2019 at 20 mg, daily, (20 milligram, 28 in 28 D (day), for multiple myeloma. Medical history included ongoing multiple myeloma. Concomitant medication included dexamethasone and ixazomib citrate (NINLARO). The patient experienced arm was red/skin red and swollen arm/arm was swollen on May2019. The action taken in response to the events for lenalidomide was unknown. Patient was treated with Anti histamines for the events Arm was red, Arm was swollen. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Had a low grade fever the next day.