chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Dry skin, Erythema, Pain, Pruritus
Clinical narrative: rash / extended below ears to below chin near Adam's apple / described red bumps along front neckline and cheeks.; itchy; irritated; and burning (pain); redness; hives; blisters that are very symmetrical/ bilateral.; affected area reported as dried up and not as dark; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 14th October 2020, 2 days after receiving Shingrix, the patient experienced red rash, pruritus, skin irritation, pain burning, erythema, hives, blister and dry skin. On an unknown date, the outcome of the red rash, pruritus, skin irritation, pain burning, erythema, hives, blister and dry skin were not recovered/not resolved.   It was unknown if the reporter considered the red rash, pruritus, skin irritation, pain burning, erythema, hives, blister and dry skin to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose intramuscularly in right arm. After receiving 1st dose of Shingrix, the experienced rash, rash described red bumps along front neckline and cheeks, rash extended below ears to below chin near Adams apple, affected area as itchy, irritated and burning (pain) with redness, hives and blisters that are very symmetrical or bilateral. The affected area reported as dried up and not as dark. The itching and burning (pain) were slightly present. The reporter consent to follow up.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Skin irritation, Urticaria
Clinical narrative: rash / extended below ears to below chin near Adam's apple / described red bumps along front neckline and cheeks.; itchy; irritated; and burning (pain); redness; hives; blisters that are very symmetrical/ bilateral.; affected area reported as dried up and not as dark; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 14th October 2020, 2 days after receiving Shingrix, the patient experienced red rash, pruritus, skin irritation, pain burning, erythema, hives, blister and dry skin. On an unknown date, the outcome of the red rash, pruritus, skin irritation, pain burning, erythema, hives, blister and dry skin were not recovered/not resolved.   It was unknown if the reporter considered the red rash, pruritus, skin irritation, pain burning, erythema, hives, blister and dry skin to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose intramuscularly in right arm. After receiving 1st dose of Shingrix, the experienced rash, rash described red bumps along front neckline and cheeks, rash extended below ears to below chin near Adams apple, affected area as itchy, irritated and burning (pain) with redness, hives and blisters that are very symmetrical or bilateral. The affected area reported as dried up and not as dark. The itching and burning (pain) were slightly present. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: patient has shingles after receiving the first dose of Shingirx; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  After receiving 1st dose of Shingrix, the patient experienced shingles. The reporter consent to follow up.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm. Arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd October 2020, the patient received the 1st dose of Shingrix. On 22nd October 2020, 6 hrs after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm and experienced a sore arm.  The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Malaise
Clinical narrative: moderately severe reaction to the first Shingrix vaccine received (chills, sweats, malaise, HA) for 3 days; moderately severe reaction to the first Shingrix vaccine received (chills, sweats, malaise, HA) for 3 days; moderately severe reaction to the first Shingrix vaccine received (chills, sweats, malaise, HA) for 3 days; moderately severe reaction to the first Shingrix vaccine received (chills, sweats, malaise, HA) for 3 days; This case was reported by a other health professional via call center representative and described the occurrence of chills in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, sweating, malaise and headache. On an unknown date, the outcome of the chills, sweating, malaise and headache were recovered/resolved.   It was unknown if the reporter considered the chills, sweating, malaise and headache to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reorted. The patient experienced a moderately severe reaction of chills, sweats, malaise and headache for 3 days. The patient denied respiratory issues, anaphylactic type symptoms or muscle weakness. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This case was reported by a nurse via call center representative and described the occurrence of fever in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced fever and chills. On an unknown date, the outcome of the fever and chills were 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 age at the vaccination was not applicable. Within 24 to 72 hours, after receiving Shingrix, multiple patients experienced fever and chills and resolved within 72 hours. The reporter did not consent to follow up. This was 1 of 4 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020211992:same reporter US-GLAXOSMITHKLINE-US2020211991:same reporter US-GLAXOSMITHKLINE-US2020211989:same reporter
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Palpitations
Clinical narrative: heart palpitations; This case was reported by a pharmacist via call center representative and described the occurrence of palpitation in a 42-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number 5D4H4, expiry date 30th June 2021) for prophylaxis.   On 19th October 2020, the patient received Fluarix Quadrivalent 2020-2021 season (intramuscular). On 21st October 2020, 2 days after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced palpitation. On an unknown date, the outcome of the palpitation was unknown.   It was unknown if the reporter considered the palpitation to be related to Fluarix Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient received Fluarix Quadrivalent 2020-2021 season in left arm. After receiving Fluarix Quadrivalent 2020-2021 season, the patient started experiencing heart palpitations. On Thursday, 22nd October 2020, the patient went to the emergency room due to heart palpitations.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: severe pain in injection site since first Shingrix shot (Oct 10th 2020).; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th October 2020, the patient received the 1st dose of Shingrix. In October 2020, less than 3 weeks after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were as follows: Age at vaccination was around 65-67year old. Pharmacist reported that patient received dose of shingrix and since then she was experiencing severe pain in injection site. It was reported that patient's doctor gave her strong medication for the pain but patient was still suffering. The reporter consented to follow up. This case has been linked to US2020212988 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020212988:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Pain
Clinical narrative: flu like symptoms decribed as feeling achy; Feeling achy.; redness at the site of the injection into the right arm; sore right arm; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 21st October 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema, pain in arm and pain. On an unknown date, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the injection site erythema, pain in arm, influenza-like symptoms and pain were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, pain in arm, influenza-like symptoms and pain to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. It was reported that patient received dose of Shingrix and on that evening patient reported that redness at the site of the injection into the right arm, a sore right arm, and flu like symptoms described as feeling achy.     It was reported that all events has been resolved. The reporter consented to follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Erythema, Fatigue
Clinical narrative: Onset of achy all over, headache that night and got markedly worse next day with weakness chills tired weak. Arm is very red and erythematous. And sore. Red area about a 4 x 4 in size. No better on 10/29, dizzy worse muscle aches and fatigue causing me to be out of work
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Impaired work ability, Myalgia, Pain, Pain in extremity
Clinical narrative: Onset of achy all over, headache that night and got markedly worse next day with weakness chills tired weak. Arm is very red and erythematous. And sore. Red area about a 4 x 4 in size. No better on 10/29, dizzy worse muscle aches and fatigue causing me to be out of work
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Arm sore, arm swollen down to elbow, red, hot to touch for 3 days. Day 4 started to resolve. No medical treatment sought.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Computerised tomogram, Memory impairment, Neurological symptom, Urine analysis
Clinical narrative: neurological/ cognitive changes- memory related. unable to recall known location in home; misnamed colors known for a long time; forgot location of food items etc.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Redness, swollen, painful, warm to touch 4-5cm area on right thigh. Cellulitis of the lower limb.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy, C-reactive protein normal, Chest pain, Complement factor C3, Complement factor C4
Clinical narrative: The patient is a 68 yo female with a history colitis and GYN CA in remission who experienced a new dermatitis with onset temporally related to receipt of Shingrix #2 (receipt 24 SEP lot # 7AS54). The dermatitis is a macular, papular erythematous, pruritic dermatitis with sites to scalp, arms, back, chest, abdomen. There are no vesicles, pustules, petechiae or oral/mucosal lesions. She reported onset day 8 (verbalizes lesions present earlier, this was when she sought care) and was seen in ER day 9, 11 & 15 and saw PCP day 11 and 19. She has reported systemic symptoms of headache, dizziness and nausea(immediate post receipt) diarrhea with hematochezia (day 2-4), dyspnea, CP, difficulty swallowing and vision blurring (day 11), EKGs, CXRs, and lab work is essentially normal (including troponin T and CRP) or explained by steroid. Treatment has included famotidine, antihistamine, oatmeal baths and 3 courses of steroid (60 mgs x5 days, 20 mgs x3 days and 60 mgs x 7 days). We added cetirizine, labs for inflammatory markers and punch bx (see prior notes). On 28 OCT 2020 she reports dermatitis is mostly gone. She has stopped cetirizine because it was interfering with sleep. Oatmeal baths continue to be helpful. She is otherwise feeling well.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis, Diarrhoea, Dizziness, Dysphagia, Dyspnoea
Clinical narrative: The patient is a 68 yo female with a history colitis and GYN CA in remission who experienced a new dermatitis with onset temporally related to receipt of Shingrix #2 (receipt 24 SEP lot # 7AS54). The dermatitis is a macular, papular erythematous, pruritic dermatitis with sites to scalp, arms, back, chest, abdomen. There are no vesicles, pustules, petechiae or oral/mucosal lesions. She reported onset day 8 (verbalizes lesions present earlier, this was when she sought care) and was seen in ER day 9, 11 & 15 and saw PCP day 11 and 19. She has reported systemic symptoms of headache, dizziness and nausea(immediate post receipt) diarrhea with hematochezia (day 2-4), dyspnea, CP, difficulty swallowing and vision blurring (day 11), EKGs, CXRs, and lab work is essentially normal (including troponin T and CRP) or explained by steroid. Treatment has included famotidine, antihistamine, oatmeal baths and 3 courses of steroid (60 mgs x5 days, 20 mgs x3 days and 60 mgs x 7 days). We added cetirizine, labs for inflammatory markers and punch bx (see prior notes). On 28 OCT 2020 she reports dermatitis is mostly gone. She has stopped cetirizine because it was interfering with sleep. Oatmeal baths continue to be helpful. She is otherwise feeling well.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Electrocardiogram normal, Full blood count normal, Fungal test negative, Haematochezia, Headache
Clinical narrative: The patient is a 68 yo female with a history colitis and GYN CA in remission who experienced a new dermatitis with onset temporally related to receipt of Shingrix #2 (receipt 24 SEP lot # 7AS54). The dermatitis is a macular, papular erythematous, pruritic dermatitis with sites to scalp, arms, back, chest, abdomen. There are no vesicles, pustules, petechiae or oral/mucosal lesions. She reported onset day 8 (verbalizes lesions present earlier, this was when she sought care) and was seen in ER day 9, 11 & 15 and saw PCP day 11 and 19. She has reported systemic symptoms of headache, dizziness and nausea(immediate post receipt) diarrhea with hematochezia (day 2-4), dyspnea, CP, difficulty swallowing and vision blurring (day 11), EKGs, CXRs, and lab work is essentially normal (including troponin T and CRP) or explained by steroid. Treatment has included famotidine, antihistamine, oatmeal baths and 3 courses of steroid (60 mgs x5 days, 20 mgs x3 days and 60 mgs x 7 days). We added cetirizine, labs for inflammatory markers and punch bx (see prior notes). On 28 OCT 2020 she reports dermatitis is mostly gone. She has stopped cetirizine because it was interfering with sleep. Oatmeal baths continue to be helpful. She is otherwise feeling well.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Laboratory test, Nausea, Pathology test, Rash macular
Clinical narrative: The patient is a 68 yo female with a history colitis and GYN CA in remission who experienced a new dermatitis with onset temporally related to receipt of Shingrix #2 (receipt 24 SEP lot # 7AS54). The dermatitis is a macular, papular erythematous, pruritic dermatitis with sites to scalp, arms, back, chest, abdomen. There are no vesicles, pustules, petechiae or oral/mucosal lesions. She reported onset day 8 (verbalizes lesions present earlier, this was when she sought care) and was seen in ER day 9, 11 & 15 and saw PCP day 11 and 19. She has reported systemic symptoms of headache, dizziness and nausea(immediate post receipt) diarrhea with hematochezia (day 2-4), dyspnea, CP, difficulty swallowing and vision blurring (day 11), EKGs, CXRs, and lab work is essentially normal (including troponin T and CRP) or explained by steroid. Treatment has included famotidine, antihistamine, oatmeal baths and 3 courses of steroid (60 mgs x5 days, 20 mgs x3 days and 60 mgs x 7 days). We added cetirizine, labs for inflammatory markers and punch bx (see prior notes). On 28 OCT 2020 she reports dermatitis is mostly gone. She has stopped cetirizine because it was interfering with sleep. Oatmeal baths continue to be helpful. She is otherwise feeling well.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash papular, Red blood cell sedimentation rate normal, Total complement activity test, Vision blurred
Clinical narrative: The patient is a 68 yo female with a history colitis and GYN CA in remission who experienced a new dermatitis with onset temporally related to receipt of Shingrix #2 (receipt 24 SEP lot # 7AS54). The dermatitis is a macular, papular erythematous, pruritic dermatitis with sites to scalp, arms, back, chest, abdomen. There are no vesicles, pustules, petechiae or oral/mucosal lesions. She reported onset day 8 (verbalizes lesions present earlier, this was when she sought care) and was seen in ER day 9, 11 & 15 and saw PCP day 11 and 19. She has reported systemic symptoms of headache, dizziness and nausea(immediate post receipt) diarrhea with hematochezia (day 2-4), dyspnea, CP, difficulty swallowing and vision blurring (day 11), EKGs, CXRs, and lab work is essentially normal (including troponin T and CRP) or explained by steroid. Treatment has included famotidine, antihistamine, oatmeal baths and 3 courses of steroid (60 mgs x5 days, 20 mgs x3 days and 60 mgs x 7 days). We added cetirizine, labs for inflammatory markers and punch bx (see prior notes). On 28 OCT 2020 she reports dermatitis is mostly gone. She has stopped cetirizine because it was interfering with sleep. Oatmeal baths continue to be helpful. She is otherwise feeling well.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: Patient received the shot with no problems. Called on 10/28/2020 around 5pm and reported that she was hearing "sprinklers" in her ears. She said it had started that same day around noon but there are no sprinklers on in the area. She asked if this could be from the shot. I researched and found that ringing in the ear could come from the shot. She said that she wasn't worried about it. I informed her she may need to see her doctor if it did not go away but she said she was unconcerned and would still be getting a second shot. She said that she was sure it would go away and I again advised her to seek medical attention if it had not especially as we head into the weekend.  She said she was not concerned, she has had shingles in the past (age 19) and will not get them again she is going to continue with the vaccines just wanted to know if it was the vaccine or something else. I told her I couldn't be sure but it is possible.
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Pain, Vomiting
Clinical narrative: Patient had body aches, chills, and severe vomiting
Age: 79.0
Sex: F
Vaccine: FLUX, PPV, VARZOS
Symptoms: Dizziness, Erythema, Fatigue, Feeling hot, Headache
Clinical narrative: Dizziness; Tiredness; Headache; Sore arm; Feverish; Site swelling; Redness; Hot to touch; Tender; Nauseated; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On 16th September 2020, the patient received the 1st dose of Shingrix (intramuscular), Influenza vaccine Quadrivalent 2020-2021 season and PNEUMONIA VACCINE. On 16th September 2020, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced dizziness, tiredness, headache, pain in arm, fever, swelling, erythema, feeling hot, tenderness and nausea. On 19th September 2020, the outcome of the dizziness, tiredness, headache, pain in arm, fever, swelling, erythema, feeling hot, tenderness and nausea were recovered/resolved.   The reporter considered the dizziness, tiredness, headache, pain in arm, fever, swelling, erythema, feeling hot, tenderness and nausea to be related to Shingrix. It was unknown if the reporter considered the dizziness, tiredness, headache, pain in arm, fever, swelling, erythema, feeling hot, tenderness and nausea to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient had all three vaccines on the same day but relates the side effects to her Shingrix vaccine only.  The side effects started the evening of the vaccination day; but all symptoms resolved within three days. The reporter did not consent to follow-up. It was unknown if the reporter considered the dizziness, tiredness, headache, pain in arm, fever, swelling, erythema, feeling hot, tenderness and nausea to be related to PNEUMONIA VACCINE.
Age: 79.0
Sex: F
Vaccine: FLUX, PPV, VARZOS
Symptoms: Nausea, Pain in extremity, Pyrexia, Swelling, Tenderness
Clinical narrative: Dizziness; Tiredness; Headache; Sore arm; Feverish; Site swelling; Redness; Hot to touch; Tender; Nauseated; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On 16th September 2020, the patient received the 1st dose of Shingrix (intramuscular), Influenza vaccine Quadrivalent 2020-2021 season and PNEUMONIA VACCINE. On 16th September 2020, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced dizziness, tiredness, headache, pain in arm, fever, swelling, erythema, feeling hot, tenderness and nausea. On 19th September 2020, the outcome of the dizziness, tiredness, headache, pain in arm, fever, swelling, erythema, feeling hot, tenderness and nausea were recovered/resolved.   The reporter considered the dizziness, tiredness, headache, pain in arm, fever, swelling, erythema, feeling hot, tenderness and nausea to be related to Shingrix. It was unknown if the reporter considered the dizziness, tiredness, headache, pain in arm, fever, swelling, erythema, feeling hot, tenderness and nausea to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient had all three vaccines on the same day but relates the side effects to her Shingrix vaccine only.  The side effects started the evening of the vaccination day; but all symptoms resolved within three days. The reporter did not consent to follow-up. It was unknown if the reporter considered the dizziness, tiredness, headache, pain in arm, fever, swelling, erythema, feeling hot, tenderness and nausea to be related to PNEUMONIA VACCINE.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Myalgia, Pain in extremity
Clinical narrative: Sore arm; Headache; Fatigue; Muscle pain; Flu-like symptoms; This case was reported by a consumer and described the occurrence of pain in arm in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 13th October 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, headache, fatigue, muscle pain and influenza-like symptoms. On 19th October 2020, the outcome of the pain in arm, headache, fatigue, muscle pain and influenza-like symptoms were resolved with sequelae.   It was unknown if the reporter considered the pain in arm, headache, fatigue, muscle pain and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the vaccine was given in right deltoid muscle.  The patient experienced sore arm, headache, fatigue, muscle pain and flu-like symptoms after the vaccine administration. All of those symptoms seemed to get better but on the reporting date, the patient was having a second wave of all those symptoms.  The reporter did not consent to follow-up. The reporter had also mentioned about unnamed pharmacy.
Age: 74.0
Sex: F
Vaccine: FLUX, PPV, UNK, VARZOS
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain at the injection site/ tenderness at the injection site; Swelling at the injection site; Injection site warmth; Injection site redness; Fevers; Body warmth; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis, MMR (MEASLES/MUMPS/RUBELLA) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On 8th September 2020, the patient received the 1st dose of Shingrix, Influenza vaccine Quadrivalent 2020-2021 season, MMR (MEASLES/MUMPS/RUBELLA) and PNEUMONIA VACCINE. On 9th September 2020, 1 days after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced injection site pain, injection site swelling, injection site warmth, injection site erythema, fever and feeling of warmth. On 15th September 2020, the outcome of the injection site pain and injection site swelling were recovered/resolved. On an unknown date, the outcome of the injection site warmth, injection site erythema, fever and feeling of warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site warmth, injection site erythema, fever and feeling of warmth to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient had received Shingrix along with three other vaccines (unknown manufacturers influenza, MMR, and Pneumonia) on 8th September 2020. She received all 4 vaccinations in her left arm on that day.  The patient developed pain and swelling at the injection site, next day after vaccination date which got resolved later. She also developed redness, warmth and tenderness at injection site next day after vaccination date, which had not resolved till the time of reporting. She further developed fevers, "body warmth" that "came and went" that started on next day of vaccination date and continued to be ongoing. The reporter who was related to the patient consented to follow-up and gave consent to follow-up at HCP. The patient would briefly confirm details on the call. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site inflammation, fever and feeling of warmth to be related to MMR and PNEUMONIA VACCINE.
Age: 74.0
Sex: F
Vaccine: FLUX, PPV, UNK, VARZOS
Symptoms: Pyrexia
Clinical narrative: Pain at the injection site/ tenderness at the injection site; Swelling at the injection site; Injection site warmth; Injection site redness; Fevers; Body warmth; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis, MMR (MEASLES/MUMPS/RUBELLA) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On 8th September 2020, the patient received the 1st dose of Shingrix, Influenza vaccine Quadrivalent 2020-2021 season, MMR (MEASLES/MUMPS/RUBELLA) and PNEUMONIA VACCINE. On 9th September 2020, 1 days after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced injection site pain, injection site swelling, injection site warmth, injection site erythema, fever and feeling of warmth. On 15th September 2020, the outcome of the injection site pain and injection site swelling were recovered/resolved. On an unknown date, the outcome of the injection site warmth, injection site erythema, fever and feeling of warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site warmth, injection site erythema, fever and feeling of warmth to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient had received Shingrix along with three other vaccines (unknown manufacturers influenza, MMR, and Pneumonia) on 8th September 2020. She received all 4 vaccinations in her left arm on that day.  The patient developed pain and swelling at the injection site, next day after vaccination date which got resolved later. She also developed redness, warmth and tenderness at injection site next day after vaccination date, which had not resolved till the time of reporting. She further developed fevers, "body warmth" that "came and went" that started on next day of vaccination date and continued to be ongoing. The reporter who was related to the patient consented to follow-up and gave consent to follow-up at HCP. The patient would briefly confirm details on the call. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site inflammation, fever and feeling of warmth to be related to MMR and PNEUMONIA VACCINE.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: arm pain; exacerbated with movement; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 19th June 2020, the patient received the 2nd dose of Shingrix. On 20th June 2020, 1 days after receiving Shingrix, the patient experienced pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the injected limb mobility decreased was unknown.   It was unknown if the reporter considered the pain in arm and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The reporter stated that there were no events associated with 1st dose of Shingrix. The patient received the 2nd dose Shingrix in left deltoid, he experienced left arm pain. The patient reports that to this day, the arm pain was still there and was exacerbated with movement The reporter consented to follow up. No further information was available.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache
Clinical narrative: Headaches; Shivering; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced headache and shivering. On an unknown date, the outcome of the headache and shivering were unknown.   It was unknown if the reporter considered the headache and shivering to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingrix, the patient had headaches and shivering. The patient was very vague about any other side effects. The patient stated, he wanted more information as to whether he would have the same side effects if he got the 2nd dose. The patient did not want to provide any other PII or any information regarding his healthcare professional. The reporter did not consent to follow up. No healthcare professional information was provided.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient that received expired ActHIB vaccine, no AE; Initial information received on 30-Sep-2020 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to cases 2020SA271354 and 2020SA271357 (same reporter).  This case involves a patient (age and gender not reported) who received an expired HIB (PRP/T) VACCINE (Box lot UJ055AAA; Diluent lot U6205AC and expiration date: 22-Apr-2020; powder expiration date: 17-Nov-2020) via unknown route in unknown administration site for prophylactic vaccination on 24-Aug-2020 (PT: expired product administered).  The patient's medical history, past treatment, vaccinations, family history and concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used (same day latency) as the vaccine (diluent) was expired on 22-Apr-2020 and was given on 24-Aug-2020.  No adverse event was reported at the time of reporting.  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: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: a patient received an expired dose of ActHIB vaccine, NO AE; Initial information received on 30-Sep-2020 regarding an unsolicited valid non-serious case from a nurse.   This case is linked to case 2020SA271339 and 2020SA271357 (same reporter).  This case involves a patient (unknown demographics) who received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (batch number, expiry date, via an unknown route at an unknown administration site) (expired product administered) on 21-Apr-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to expired vaccine used (latency: same day)  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.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: A patient received an expired ActHIB vaccine, NO AE; Initial information received on 30-Sep-2020 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to case 2020SA271339 and 2020SA271354 (same reporter).  This case involves a patient (unknown demographics) who received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot number: UI959AAA and expiry date: 07-Mar-2020, via an unknown route and at an unknown administration site) (expired product administered) on 23-Jul-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to expired vaccine used (latency: same day)  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: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: patient got Gillian Barre and almost died from the flu shot; Initial information received on 19-Oct-2020 regarding an unsolicited valid serious case from a non-health care processional (patient's mother) via social media.  This case involves a female patient of an unknown age who got Gillian Barre and almost died (Guillain-Barre syndrome), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed Gillian Barre and almost died (Guillain-Barre syndrome), (Unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was not reported for the event Guillain-Barre syndrome.  Information on the batch number to be requested.; Sender's Comments: This case involves a female patient who presented with Guillain-Barre syndrome, after vaccination with INFLUENZA VACCINE. The time to onset is unknown. Moreover, patient's medical condition at the time of vaccination and lab tests were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: a patient was administered an expired dose of ActHib, no AE; Initial information was received on 06-Oct-2020 regarding an unsolicited valid non-serious case from the nurse via phone.  This case involves a 15 month old female patient who was vaccinated with a 0.5 mL dose of an expired HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ079AAA and expiration date 02-Oct-2020) via an unknown route in the right thigh on 06-Oct-2020 for prophylactic vaccination (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  The patient was concomitantly vaccinated with PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVENAR) and INFLUENZA VACCINE [FLU] for prophylactic vaccination on 06-Oct-2020.  This was case of an actual medication error case due to expired vaccine used (latency was same day).  At the time of reporting, no adverse event was reported to the patient.  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: M
Vaccine: FLU4
Symptoms: Rash, Rash erythematous
Clinical narrative: a red rash almost like a heat rash on upper torso; Initial information received on 12-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer(patient). This case involved a male patient who had a red rash almost like a heat rash on upper torso, while he received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].   Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, around 10 am he received the vaccine. He noticed on Sunday and today that he had a red rash almost like a heat rash on upper torso (latency approximately 2 days).   Other relevant tests were not reported.  Final diagnosis was a red rash almost like a heat rash on upper torso.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome was unknown.  There will be no information regarding batch number for this case.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Induration, Mass, Peripheral swelling
Clinical narrative: LARGE RED LUMP DEVELOPED ON RIGHT UPPER ARM APPROXIMATELY 2 HOURS POST VACCINE. ARM CONTINUED TO SWELL, GET RED, HOT AND THE SWELLING MIGRATED DOWN AND AROUND HER BICEP. EMERGENCY ROOM GAVE HER ORAL CEPHALEXIN TO TREAT CELLULITUS OF HER ARM AND SENT PATIENT HOME ON CEPHALEXIN 500MG FOUR TIMES DAILY FOR 7 DAYS WITH INSTRUCTIONS TO FOLLOW UP WITH HER PCP.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Ultrasound Doppler
Clinical narrative: LARGE RED LUMP DEVELOPED ON RIGHT UPPER ARM APPROXIMATELY 2 HOURS POST VACCINE. ARM CONTINUED TO SWELL, GET RED, HOT AND THE SWELLING MIGRATED DOWN AND AROUND HER BICEP. EMERGENCY ROOM GAVE HER ORAL CEPHALEXIN TO TREAT CELLULITUS OF HER ARM AND SENT PATIENT HOME ON CEPHALEXIN 500MG FOUR TIMES DAILY FOR 7 DAYS WITH INSTRUCTIONS TO FOLLOW UP WITH HER PCP.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient reported redness and tenderness with swelling to the injection site.   Warm compress recommended, observation of increase swelling and antibiotic given.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Contusion, Differential white blood cell count, Full blood count, Metabolic function test
Clinical narrative: Pain in upper arm and shoulder  within 30 minutes of injection.  Continued for 3 weeks and became swollen and bruised. Pain continues at present, 2 months later. Injection site was higher and nearer to shoulder joint than any injection I have previously received.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Peripheral swelling, Ultrasound Doppler, X-ray limb
Clinical narrative: Pain in upper arm and shoulder  within 30 minutes of injection.  Continued for 3 weeks and became swollen and bruised. Pain continues at present, 2 months later. Injection site was higher and nearer to shoulder joint than any injection I have previously received.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait inability, Headache, Movement disorder, Muscular weakness, Urinary incontinence
Clinical narrative: Severe headache starting at 5AM the next morning; followed by muscle weakness, inability to move, walk, sit up, loss of bladder control. On 10/29 I am able to sit up and walk but still have a severe headache.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Walking aid user
Clinical narrative: Severe headache starting at 5AM the next morning; followed by muscle weakness, inability to move, walk, sit up, loss of bladder control. On 10/29 I am able to sit up and walk but still have a severe headache.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Tenderness
Clinical narrative: Patient c/o redness, lumpy  and swelling at injection site.  Painful to touch, soreness.    Evaluated by provider, marked area for observation of increased redness.  Provided recommendations of ER if symptoms  get worse or develop fever, streaks on arm.
Age: 73.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Hypoaesthesia, Myalgia, Neck pain, Pain
Clinical narrative: Pt has bicep and ticeps pain once in a while. Also, from the top of the shoulder to the back of the neck there is pain and when he turns in neck there is pain. There is tingling from the inside of the wrist to the elbow. When he leans on it feels numb and tingly and painful.
Age: 73.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Pt has bicep and ticeps pain once in a while. Also, from the top of the shoulder to the back of the neck there is pain and when he turns in neck there is pain. There is tingling from the inside of the wrist to the elbow. When he leans on it feels numb and tingly and painful.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever 100 F, body aches, headache, lasting 36 hours
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Injection site pain, Nausea, Pain, Pyrexia
Clinical narrative: Pain at injection site, headache, fever (99.3 degrees), body aches, nausea  for approximately 24 hours
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: pain in shoulder
Age: 79.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Inflammation, Swelling
Clinical narrative: PATIENT RECEIVED VACCINE AROUND NOON TIME, BY THE EARLY EVENING, PATIENT WAS EXPERIENCING SOME REDNESS AND INFLAMMATION. PATIENT WAS INSTRUCTED TO TAKE PAIN RELIEVER AND TO DO COLD COMPRESSES. BY NIGHTTIME, SWELLING HAD PROGRESSED AND PATIENT WAS INSTRUCTED TO TAKE 50MG OF BENADRYL. BY THE NEXT DAY, SWELLING HAD NOT IMPROVED. PATIENT WAS INSTRUCTED TO GO TO THE DOCTOR ASAP.