chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Injection site erythema, Injection site induration
Clinical narrative: Head to toe joint pain and body aches, Raging headache. Localized hot red "egg" with a tingling sensation. Had a smaller similar reaction to the first shot and thought it may be an infection from shot but now know it was a milder overall reaction to the immunization.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Injection site reaction, Muscle twitching
Clinical narrative: Head to toe joint pain and body aches, Raging headache. Localized hot red "egg" with a tingling sensation. Had a smaller similar reaction to the first shot and thought it may be an infection from shot but now know it was a milder overall reaction to the immunization.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper
Clinical narrative: Patient complains of pain at upper epigastric areas that is sharp and discomforting. Start shortly after vaccination.
Age: 21.0
Sex: M
Vaccine: HEPA
Symptoms: Fall, Loss of consciousness
Clinical narrative: Pt. received his second Hep A vaccination about a year and a half after his first dose (which had no issues), he was fine immediately following but while standing in the waiting room within 3 minutes of the vaccine he passed out and fell down to the ground. I immediately ran over to him and by the time I got there he had come to and was asking what happened. Said he has never had any issues with seizures or fainting before and seemed to be completely fine from that point on. EMS was called immediately and were there within 5 minutes of the incident. They talked to the patient for about 5-10 minutes and checked his vitals/BP and seemed to think patient was fine.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain
Clinical narrative: Injection site muscle pain. Chills and shivering.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site plaque, Injection site pruritus
Clinical narrative: 4.4 cm x 2.6 cm oval-shaped erythematous, slightly indurated, and warm plaque on the left lateral upper arm at the deltoid, with some overlying scaling. It is only mildly tender, but not significant. Because of the itchiness, I prescribed triamcinolone 0.025% topical ointment to be applied twice daily for up to 7 days I discussed the use of ice to the area for 10-15 minutes at a time for comfort, and the use of analgesics like Tylenol or ibuprofen as needed. Will report to VAERS. She does not have another DTaP vaccine until she is 11 years old, when she will receive the Tdap, and I think this is likely okay at that time.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site reaction, Injection site warmth, Skin exfoliation
Clinical narrative: 4.4 cm x 2.6 cm oval-shaped erythematous, slightly indurated, and warm plaque on the left lateral upper arm at the deltoid, with some overlying scaling. It is only mildly tender, but not significant. Because of the itchiness, I prescribed triamcinolone 0.025% topical ointment to be applied twice daily for up to 7 days I discussed the use of ice to the area for 10-15 minutes at a time for comfort, and the use of analgesics like Tylenol or ibuprofen as needed. Will report to VAERS. She does not have another DTaP vaccine until she is 11 years old, when she will receive the Tdap, and I think this is likely okay at that time.
Age: 12.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: RASH ALL AROUND THE BODY.
Age: 1.17
Sex: F
Vaccine: ADEN_4_7, HEPA, HIBV, MMRV, PNC13
Symptoms: Abnormal behaviour, Aggression, Crying, Decreased appetite, Insomnia
Clinical narrative: 24 hours after shots my daughter was have some strange behavior. She was hitting herself in the face, digging in her mouth, bitting down on her pacifier really aggressively, crying, insomnia, loss of appetite, the next day she was have seizure like activity all morning. That night the seizure like activity lasted over 3 min and she had 3 different episodes. She stopped breathing for a moment. We took her to two different Emergency Rooms and her primary care that day but they told us it was because of a fever. There was no fever noted.
Age: 1.17
Sex: F
Vaccine: ADEN_4_7, HEPA, HIBV, MMRV, PNC13
Symptoms: Pyrexia, Respiratory arrest, Seizure like phenomena
Clinical narrative: 24 hours after shots my daughter was have some strange behavior. She was hitting herself in the face, digging in her mouth, bitting down on her pacifier really aggressively, crying, insomnia, loss of appetite, the next day she was have seizure like activity all morning. That night the seizure like activity lasted over 3 min and she had 3 different episodes. She stopped breathing for a moment. We took her to two different Emergency Rooms and her primary care that day but they told us it was because of a fever. There was no fever noted.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Patient started with left upper arm erythema, pain, swelling 8pm 2/18/19. Symptoms migrated to forearm. I saw the patient today (2/21/19) and other than mild erythema, swelling on the forearm  proximal to the elbow, and mild pain her symptoms are much improved. No problems, pain or erythema at injection site. Patient had been applying ice, keeping it elevated and Ibuprofen 400 mg. No signs of systemic allergy or anaphylaxis.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Patient started with left upper arm erythema, pain, swelling 8pm 2/18/19. Symptoms migrated to forearm. I saw the patient today (2/21/19) and other than mild erythema, swelling on the forearm  proximal to the elbow, and mild pain her symptoms are much improved. No problems, pain or erythema at injection site. Patient had been applying ice, keeping it elevated and Ibuprofen 400 mg. No signs of systemic allergy or anaphylaxis.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient states a rash has developed on the arm she got her SHINGRIX vaccine in. There are no other symptoms and it is not painful.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Pyrexia
Clinical narrative: Joint aches, fever, fatigue, headache.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis in Left arm around injection site.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased, Feeling jittery, Heart rate increased, Nervousness
Clinical narrative: Increased BP, heart rate, nervousness, jittery.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient called clinic 02/21/2019 and reported month of pain of the left shoulder and upper arm.  Reports seeing primary care physician and being in physical therapy for months. Reports old shoulder injury at this location due to work as flight attendant closing overhead bins, but was not having symptoms until having this vaccine. Patient continues physical therapy at this time.
Age: 22.0
Sex: M
Vaccine: ANTH, FLU4, SMALL
Symptoms: Arteriogram coronary normal, Atelectasis, Brain natriuretic peptide increased, Brain natriuretic peptide normal, C-reactive protein normal
Clinical narrative: On 11 Dec 2018, patient presented to ER for evaluation of midsternal, pleuritic chest pain characterized as a tightness, which began morning of 10 Dec, made worse with deep inspiration, and laying supine. Patient notes that the pain was intermittent throughout most the day (12/10/18), but after he awoke from sleep, the pain became constant. He was admitted x 24 hours. He was discharged on ASA 975 mg 3x/day until symptom free x 24 hours, then 2x/day x 1 week, then once daily x 1 week, with colchicine 0.6mg BID x 3 months. (Also, placed on Protonix daily) Activity restriction x 6 months.
Age: 22.0
Sex: M
Vaccine: ANTH, FLU4, SMALL
Symptoms: Chest X-ray normal, Chest discomfort, Chest pain, Computerised tomogram coronary artery normal, Computerised tomogram thorax abnormal
Clinical narrative: On 11 Dec 2018, patient presented to ER for evaluation of midsternal, pleuritic chest pain characterized as a tightness, which began morning of 10 Dec, made worse with deep inspiration, and laying supine. Patient notes that the pain was intermittent throughout most the day (12/10/18), but after he awoke from sleep, the pain became constant. He was admitted x 24 hours. He was discharged on ASA 975 mg 3x/day until symptom free x 24 hours, then 2x/day x 1 week, then once daily x 1 week, with colchicine 0.6mg BID x 3 months. (Also, placed on Protonix daily) Activity restriction x 6 months.
Age: 22.0
Sex: M
Vaccine: ANTH, FLU4, SMALL
Symptoms: Decreased activity, Ejection fraction normal, Electrocardiogram ST segment elevation, Electrocardiogram T wave abnormal, Electrocardiogram T wave inversion
Clinical narrative: On 11 Dec 2018, patient presented to ER for evaluation of midsternal, pleuritic chest pain characterized as a tightness, which began morning of 10 Dec, made worse with deep inspiration, and laying supine. Patient notes that the pain was intermittent throughout most the day (12/10/18), but after he awoke from sleep, the pain became constant. He was admitted x 24 hours. He was discharged on ASA 975 mg 3x/day until symptom free x 24 hours, then 2x/day x 1 week, then once daily x 1 week, with colchicine 0.6mg BID x 3 months. (Also, placed on Protonix daily) Activity restriction x 6 months.
Age: 22.0
Sex: M
Vaccine: ANTH, FLU4, SMALL
Symptoms: Electrocardiogram abnormal, Middle insomnia, Nuclear magnetic resonance imaging heart, Painful respiration, Pleuritic pain
Clinical narrative: On 11 Dec 2018, patient presented to ER for evaluation of midsternal, pleuritic chest pain characterized as a tightness, which began morning of 10 Dec, made worse with deep inspiration, and laying supine. Patient notes that the pain was intermittent throughout most the day (12/10/18), but after he awoke from sleep, the pain became constant. He was admitted x 24 hours. He was discharged on ASA 975 mg 3x/day until symptom free x 24 hours, then 2x/day x 1 week, then once daily x 1 week, with colchicine 0.6mg BID x 3 months. (Also, placed on Protonix daily) Activity restriction x 6 months.
Age: 22.0
Sex: M
Vaccine: ANTH, FLU4, SMALL
Symptoms: Red blood cell sedimentation rate normal, Troponin T increased
Clinical narrative: On 11 Dec 2018, patient presented to ER for evaluation of midsternal, pleuritic chest pain characterized as a tightness, which began morning of 10 Dec, made worse with deep inspiration, and laying supine. Patient notes that the pain was intermittent throughout most the day (12/10/18), but after he awoke from sleep, the pain became constant. He was admitted x 24 hours. He was discharged on ASA 975 mg 3x/day until symptom free x 24 hours, then 2x/day x 1 week, then once daily x 1 week, with colchicine 0.6mg BID x 3 months. (Also, placed on Protonix daily) Activity restriction x 6 months.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a 61 year old patient of unknown gender. Concomitant therapies included sterile diluent. Information about pertinent medical history and drug reactions/allergies was not provided. On 21-JAN-2019, the patient was inadvertently vaccinated with VARIVAX lot # R013302, expiration date 08-MAY-2020, intramuscularly for prophylaxis (strength, dose detail and anatomical location were not reported). The patient was supposed to receive SHINGRIX. No adverse effects were reported.
Age: 0.17
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Information has been received from a medical assistant referring to a 2 months old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 13-FEB-2019, the patient was vaccinated with VARIVAX (strength, dose, frequency, batch/lot # and expiration date were not reported) subcutaneously for prophylaxis. No known adverse effects were reported.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 12 month old patient of unknown gender. Information about medical history, concurrent condition and concomitant medication was unknown. On 09-NOV-2018 the patient received an improperly stored dose of VARIVAX (lot # R012417, expiry date: 28-OCT-2019; dose, frequency and route were not reported) for prophylaxis, which was reconstituted with properly stored sterile diluent. No adverse effects were reported. There was no previous temperature excursion. It was also reported that temperature was from 15 Fahrenheit to 46 Fahrenheit for 8 hours and the data logger was involved. Sender's Comments: US-009507513-1902USA007542: US-009507513-1902USA007540: US-009507513-1902USA007543: US-009507513-1902USA007546: US-009507513-1902USA007547: US-009507513-1902USA007545: US-009507513-1902USA007539: US-009507513-1902USA007538: US-009507513-1902USA007536: US-009507513-1902USA007541: US-009507513-1902USA007537: US-009507513-1902USA007544: US-009507513-1902USA007549: US-009507513-1902USA007550: US-009507513-1901USA008772.
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 8 year old patient of unknown gender. Information about medical history, concurrent condition and concomitant medication was unknown. On 13-NOV-2018 the patient received an improperly stored dose of VARIVAX (lot # N021721, expiry date: 23-AUG-2010; dose, frequency and route were not reported) for prophylaxis (product storage error), which was reconstituted with properly stored sterile diluent. No adverse effects were reported. There was no previous temperature excursion. It was also reported that temperature was from 15 Fahrenheit to 46 Fahrenheit for 8 hours and the data logger was involved. Sender's Comments: US-009507513-1902USA007542: US-009507513-1902USA007540: US-009507513-1902USA007543: US-009507513-1902USA007546: US-009507513-1902USA007547: US-009507513-1902USA007545: US-009507513-1902USA007539: US-009507513-1902USA007538: US-009507513-1902USA007536: US-009507513-1902USA007541: US-009507513-1902USA007548: US-009507513-1902USA007537: US-009507513-1902USA007544: US-009507513-1902USA007550: US-009507513-1901USA008772.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 4 year old patient of unknown gender. Information about medical history, concurrent condition and concomitant medication was unknown. On 16-NOV-2018, the patient received an improperly stored dose of PROQUAD (lot # N021721, expiry date: 10-AUG-2019; dose, frequency and route were not reported) for prophylaxis, which was reconstituted with properly stored sterile diluent. No adverse effects were reported. There was no previous temperature excursion. It was also reported that temperature was from 15 Fahrenheit to 46 Fahrenheit for 8 hours and the data logger was involved. Sender's Comments: US-009507513-1902USA007548: US-009507513-1902USA007542: US-009507513-1902USA007540: US-009507513-1902USA007543: US-009507513-1902USA007546: US-009507513-1902USA007547: US-009507513-1902USA007545: US-009507513-1902USA007539: US-009507513-1902USA007538: US-009507513-1902USA007536: US-009507513-1902USA007541: US-009507513-1902USA007549: US-009507513-1902USA007537: US-009507513-1902USA007544: US-009507513-1901USA008772.
Sex: M
Vaccine: MMR
Symptoms: Malaise
Clinical narrative: This spontaneous report was received from a consumer (patient's father) via other company (Pfizer) regarding to a male patient of unknown age. The patient's concurrent conditions, historical conditions, past drugs and concomitant medications were unknown. On an unknown date, the patient might had got vaccinated with M-M-R II (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis. On an unknown date, the patient had been sick for 7 years because of vaccines. The reporter had whole list of vaccines but did not provide. The reporter was aware that vaccines cause illness, there was a percent that does, and that was 1%. There was nothing specific that reporter wants to know. The reporter wanted to speak with someone about vaccines. The outcome of malaise was unknown. The reporter considered malaise to be related (reported as, because of vaccines) to M-M-R II.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 67-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (patient had chickenpox twice once as a child and when she was 36 years old). On 8th February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced headache, general body pain, weakness, tiredness, nausea, injection site swelling, injection site erythema, injection site warmth and skin warm. On an unknown date, the outcome of the headache, general body pain, weakness, tiredness, nausea, injection site swelling, injection site erythema, injection site warmth and skin warm were recovering/resolving. It was unknown if the reporter considered the headache, general body pain, weakness, tiredness, nausea, injection site swelling, injection site erythema, injection site warmth and skin warm to be related to SHINGRIX. Additional details were reported as follows: The patient had the SHINGRIX last Friday and had these symptoms since terrible headache and body aches and very weak and tired and nausea. The patient injection site was still swollen and pink and warm to the touch, most of her upper left arm all the way around. The patient stated that each day had improved symptom wise and hopefully tomorrow it would be gone. The patient was just concerned about getting the 2nd shot. The patient was interested in GSK opinion.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Nausea, Pain, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 67-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (patient had chickenpox twice once as a child and when she was 36 years old). On 8th February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced headache, general body pain, weakness, tiredness, nausea, injection site swelling, injection site erythema, injection site warmth and skin warm. On an unknown date, the outcome of the headache, general body pain, weakness, tiredness, nausea, injection site swelling, injection site erythema, injection site warmth and skin warm were recovering/resolving. It was unknown if the reporter considered the headache, general body pain, weakness, tiredness, nausea, injection site swelling, injection site erythema, injection site warmth and skin warm to be related to SHINGRIX. Additional details were reported as follows: The patient had the SHINGRIX last Friday and had these symptoms since terrible headache and body aches and very weak and tired and nausea. The patient injection site was still swollen and pink and warm to the touch, most of her upper left arm all the way around. The patient stated that each day had improved symptom wise and hopefully tomorrow it would be gone. The patient was just concerned about getting the 2nd shot. The patient was interested in GSK opinion.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Lymphadenopathy, Pain, Vaccine positive rechallenge
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in a 18-year-old female patient who received BEXSERO for prophylaxis. Previously administered products included BEXSERO (1st dose received on 28th December 2018, refer case US2019GSK031816). On 8th February 2019, the patient received the 2nd dose of BEXSERO. In February 2019, less than a week after receiving BEXSERO, the patient experienced pain. On an unknown date, the patient experienced swelling and enlargement of lymph nodes. Rechallenge with BEXSERO was positive. On an unknown date, the outcome of the pain, swelling and enlargement of lymph nodes were unknown. It was unknown if the reporter considered the pain, swelling and enlargement of lymph nodes to be related to BEXSERO. Additional details were reported as follows: The patient experienced more severe swelling and extreme pain along with a line up to her lymph nodes per the patient's dad as the physician told the reporter. There were no other vaccines given at the same time and BEXSERO both times was given in the same arm.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site swelling in a female patient who received 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 injection site swelling, injection site pain and fever. On an unknown date, the outcome of the injection site swelling, injection site pain and fever were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site pain and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fever, swelling at injection site and general soreness at injection site for 4 to 5 days. The reporter did not agree to follow up from GlaxoSmithKline.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced side effects with the 1st dose of SHINGRIX and those side effects were not specified. For tolerance to 2nd dose of SHINGRIX, refer case US2019GSK025463.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in arm in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of adverse event (1st dose received on unknown date, refer case US2019027724). On 14th February 2019, the patient received the 2nd dose of SHINGRIX. On 14th February 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The batch number and expiry date was not reported. The patient received 2nd dose of SHINGRIX and experienced sore arm same day in morning. The patient did not wish to provide date of birth.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pain, Swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in a 18-year-old female patient who received BEXSERO for prophylaxis. On 28th December 2018, the patient received the 1st dose of BEXSERO. On an unknown date, less than a month after receiving BEXSERO, the patient experienced pain and swelling. On an unknown date, the outcome of the pain and swelling were recovered/resolved. It was unknown if the reporter considered the pain and swelling to be related to BEXSERO. Additional details were reported as follows: The reporter had a doctor told the reporter on the day of reporting of an adverse event with BEXSERO. The patient had severe pain and swelling that resolved. There were no other vaccines given at the same time and BEXSERO both times was given in the same arm. For tolerance after 2nd dose refer case US2019GSK026353.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye pain, Fatigue, Hypokinesia, Influenza like illness, Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 55-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received in late November). On 9th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In February 2019, 10 hrs after receiving SHINGRIX, the patient experienced influenza-like symptoms, general body pain, fever, fatigue, movements reduced, injection site erythema, injection site pain and vein disorder. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the influenza-like symptoms, general body pain, fever, fatigue, movements reduced and vein disorder were recovered/resolved and the outcome of the injection site erythema and injection site pain were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, general body pain, fever, fatigue, movements reduced, injection site erythema, injection site pain and vein disorder to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX at around 2:00 pm. The patient reported having the same symptoms as with the 1st dose but they were even more severe. They started approximately 10 hours after the 2nd dose and he was incapacitated all day Sunday. On 11th February 2019, 1 day 10 hrs. after receiving 2nd dose, the patient was feeling better but the veins in his right hand were bulging. Also, the injection site on his right arm was red and sore. The patient reports that the sharp pain in his left eye that occurred due to adult onset of Chickenpox and Shingles 5 years ago, has almost totally resolved since receiving the first dose of the SHINGRIX vaccine. The patient would feel the pain in his eye 15 to 25 times a day. At the time of reporting the patient goes days without feeling it and may have it 1 to 2 times in a day if it occurs. The reporter did not give consent to follow up. This case has been linked to the US2019025000, reported for the dose 2 of the same patient.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pyrexia, Vaccine positive rechallenge, Vein disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 55-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received in late November). On 9th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In February 2019, 10 hrs after receiving SHINGRIX, the patient experienced influenza-like symptoms, general body pain, fever, fatigue, movements reduced, injection site erythema, injection site pain and vein disorder. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the influenza-like symptoms, general body pain, fever, fatigue, movements reduced and vein disorder were recovered/resolved and the outcome of the injection site erythema and injection site pain were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, general body pain, fever, fatigue, movements reduced, injection site erythema, injection site pain and vein disorder to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX at around 2:00 pm. The patient reported having the same symptoms as with the 1st dose but they were even more severe. They started approximately 10 hours after the 2nd dose and he was incapacitated all day Sunday. On 11th February 2019, 1 day 10 hrs. after receiving 2nd dose, the patient was feeling better but the veins in his right hand were bulging. Also, the injection site on his right arm was red and sore. The patient reports that the sharp pain in his left eye that occurred due to adult onset of Chickenpox and Shingles 5 years ago, has almost totally resolved since receiving the first dose of the SHINGRIX vaccine. The patient would feel the pain in his eye 15 to 25 times a day. At the time of reporting the patient goes days without feeling it and may have it 1 to 2 times in a day if it occurs. The reporter did not give consent to follow up. This case has been linked to the US2019025000, reported for the dose 2 of the same patient.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Feeling abnormal, Inappropriate schedule of product administration
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of chills in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received in January 2018). In July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, 10 hrs after receiving SHINGRIX, the patient experienced chills, injection site pain, tremor, injected limb mobility decreased, tiredness and weakness. On an unknown date, the patient experienced feels awful, influenza-like symptoms, drug dose administration interval too long and product supply issue. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the chills, injection site pain, tremor, injected limb mobility decreased, tiredness, weakness, feels awful and influenza-like symptoms were recovered/resolved and the outcome of the drug dose administration interval too long and product supply issue were unknown. It was unknown if the reporter considered the chills, injection site pain, tremor, injected limb mobility decreased, tiredness, weakness, feels awful and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the consumer for her mother. The patient stated after 2nd dose of SHINGRIX, she felt horrible and had bad flu like symptoms. The patient stated all symptoms resolved within hours to a day following vaccination. The patient stated that her 2nd dose of SHINGRIX was delayed due to a shortage of Supply. Did not collect the lot or expiration date of the vaccine. No additional details were provided. The reporter gave consent to follow up. This case has been linked to the US2019025046, reported for the dose 1 of the same patient.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injected limb mobility decreased, Injection site pain, Product supply issue, Tremor
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of chills in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received in January 2018). In July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, 10 hrs after receiving SHINGRIX, the patient experienced chills, injection site pain, tremor, injected limb mobility decreased, tiredness and weakness. On an unknown date, the patient experienced feels awful, influenza-like symptoms, drug dose administration interval too long and product supply issue. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the chills, injection site pain, tremor, injected limb mobility decreased, tiredness, weakness, feels awful and influenza-like symptoms were recovered/resolved and the outcome of the drug dose administration interval too long and product supply issue were unknown. It was unknown if the reporter considered the chills, injection site pain, tremor, injected limb mobility decreased, tiredness, weakness, feels awful and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the consumer for her mother. The patient stated after 2nd dose of SHINGRIX, she felt horrible and had bad flu like symptoms. The patient stated all symptoms resolved within hours to a day following vaccination. The patient stated that her 2nd dose of SHINGRIX was delayed due to a shortage of Supply. Did not collect the lot or expiration date of the vaccine. No additional details were provided. The reporter gave consent to follow up. This case has been linked to the US2019025046, reported for the dose 1 of the same patient.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of chills in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received in January 2018). In July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, 10 hrs after receiving SHINGRIX, the patient experienced chills, injection site pain, tremor, injected limb mobility decreased, tiredness and weakness. On an unknown date, the patient experienced feels awful, influenza-like symptoms, drug dose administration interval too long and product supply issue. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the chills, injection site pain, tremor, injected limb mobility decreased, tiredness, weakness, feels awful and influenza-like symptoms were recovered/resolved and the outcome of the drug dose administration interval too long and product supply issue were unknown. It was unknown if the reporter considered the chills, injection site pain, tremor, injected limb mobility decreased, tiredness, weakness, feels awful and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the consumer for her mother. The patient stated after 2nd dose of SHINGRIX, she felt horrible and had bad flu like symptoms. The patient stated all symptoms resolved within hours to a day following vaccination. The patient stated that her 2nd dose of SHINGRIX was delayed due to a shortage of Supply. Did not collect the lot or expiration date of the vaccine. No additional details were provided. The reporter gave consent to follow up. This case has been linked to the US2019025046, reported for the dose 1 of the same patient.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Inappropriate schedule of product administration, Injection site pain, Malaise
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of Injection site tenderness in a elderly female patient who received 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 drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown. Additional details were reported as follows: The age at vaccination was not reported. The physician stated his wife was late for the second dose of the SHINGRIX series, which led to lengthening of the vaccination schedule. Follow up information received from physician on 11th February 2019: The patient's demographic details were updated. The VAERS details were updated. This was an inquiry about receiving SHINGRIX vaccine 2nd dose late, complicated by need for surgery when vaccine finally available creating the question. The reporter asked it's safe to take SHINGRIX vaccine post operatively. The patient did well after surgery and had access to SHINGRIX. The reporter stated that the patient decided to get the 2nd dose at 3 weeks post-op. However, she developed a UTI the day of vaccination, which caused me to call GlaxoSmithKline for guidance with receiving the vaccine in lieu of an illness. The discussion lead to a decision that the urinary tract infection was a minor illness like a cold and there was no contraindication to receiving the SHINGRIX. The patient had her 2nd SHINGRIX dose on 30th January 2019 exactly 3 weeks post-operation. Within 24hrs, she experienced tenderness, but no swelling or erythema at the injection site. She also felt minor malaise, loss of energy, stayed in bed for 24hrs. She never had any fever, chills, nausea or vomiting. By 2nd day post vaccination she was better and the urinary tract infection had improved but not completely resolved. The reporter mentioned, her urinary tract infection was lower tract cystitis, with dysuria, and frequency. She started OTC Pyridium initially and within 24hrs. added antibiotic- MACROBID 100mg, bid x 5 days. The urinary tract infection abated in 24hrs of starting antibiotic and completely resolved within the 5 days.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blister, Erythema, Gastric disorder, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of skin warm in a 80-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included fibromyalgia and shingles (5 years before the date of reporting). Concurrent medical conditions included post herpetic neuralgia. On 8th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 8th February 2019, less than a week after receiving SHINGRIX, the patient experienced feeling unwell. On 9th February 2019, the patient experienced skin warm, erythema of extremities, swelling arm and blister. In February 2019, the patient experienced influenza-like symptoms, weakness, gastric disorder and injection site coloration. On an unknown date, the patient experienced neuropathic pain. On an unknown date, the outcome of the skin warm, erythema of extremities, swelling arm, feeling unwell, influenza-like symptoms, weakness, gastric disorder, blister, injection site coloration and neuropathic pain were not recovered/not resolved. It was unknown if the reporter considered the skin warm, erythema of extremities, swelling arm, feeling unwell, influenza-like symptoms, weakness, gastric disorder, blister, injection site coloration and neuropathic pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient experienced the entire upper part of her arm, just below the injection site had redness, swelling, and warmth in the area. She also noted other symptoms that had not resolved at the date of reporting. The patient's husband was a physician and he stated that the redness appeared to be red patches, oval and almost a pre blister state but noted it was not shingles. Less than a week after receiving SHINGRIX, the patient experienced flu like symptoms, stomach problems and weakness. On 13th February 2018, the patient called back and stated she had been seen by her dermatologist, who said it was not shingles but that the patient was having a reaction to the SHINGRIX vaccine. The reporter also noted she had black and blue at the site of the injection, she had pain like her neuropathy in her face, feet and back. The patient also noted she just had not felt right since receiving SHINGRIX last Friday.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of skin warm in a 80-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included fibromyalgia and shingles (5 years before the date of reporting). Concurrent medical conditions included post herpetic neuralgia. On 8th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 8th February 2019, less than a week after receiving SHINGRIX, the patient experienced feeling unwell. On 9th February 2019, the patient experienced skin warm, erythema of extremities, swelling arm and blister. In February 2019, the patient experienced influenza-like symptoms, weakness, gastric disorder and injection site coloration. On an unknown date, the patient experienced neuropathic pain. On an unknown date, the outcome of the skin warm, erythema of extremities, swelling arm, feeling unwell, influenza-like symptoms, weakness, gastric disorder, blister, injection site coloration and neuropathic pain were not recovered/not resolved. It was unknown if the reporter considered the skin warm, erythema of extremities, swelling arm, feeling unwell, influenza-like symptoms, weakness, gastric disorder, blister, injection site coloration and neuropathic pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient experienced the entire upper part of her arm, just below the injection site had redness, swelling, and warmth in the area. She also noted other symptoms that had not resolved at the date of reporting. The patient's husband was a physician and he stated that the redness appeared to be red patches, oval and almost a pre blister state but noted it was not shingles. Less than a week after receiving SHINGRIX, the patient experienced flu like symptoms, stomach problems and weakness. On 13th February 2018, the patient called back and stated she had been seen by her dermatologist, who said it was not shingles but that the patient was having a reaction to the SHINGRIX vaccine. The reporter also noted she had black and blue at the site of the injection, she had pain like her neuropathy in her face, feet and back. The patient also noted she just had not felt right since receiving SHINGRIX last Friday.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Peripheral swelling, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of skin warm in a 80-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included fibromyalgia and shingles (5 years before the date of reporting). Concurrent medical conditions included post herpetic neuralgia. On 8th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 8th February 2019, less than a week after receiving SHINGRIX, the patient experienced feeling unwell. On 9th February 2019, the patient experienced skin warm, erythema of extremities, swelling arm and blister. In February 2019, the patient experienced influenza-like symptoms, weakness, gastric disorder and injection site coloration. On an unknown date, the patient experienced neuropathic pain. On an unknown date, the outcome of the skin warm, erythema of extremities, swelling arm, feeling unwell, influenza-like symptoms, weakness, gastric disorder, blister, injection site coloration and neuropathic pain were not recovered/not resolved. It was unknown if the reporter considered the skin warm, erythema of extremities, swelling arm, feeling unwell, influenza-like symptoms, weakness, gastric disorder, blister, injection site coloration and neuropathic pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient experienced the entire upper part of her arm, just below the injection site had redness, swelling, and warmth in the area. She also noted other symptoms that had not resolved at the date of reporting. The patient's husband was a physician and he stated that the redness appeared to be red patches, oval and almost a pre blister state but noted it was not shingles. Less than a week after receiving SHINGRIX, the patient experienced flu like symptoms, stomach problems and weakness. On 13th February 2018, the patient called back and stated she had been seen by her dermatologist, who said it was not shingles but that the patient was having a reaction to the SHINGRIX vaccine. The reporter also noted she had black and blue at the site of the injection, she had pain like her neuropathy in her face, feet and back. The patient also noted she just had not felt right since receiving SHINGRIX last Friday.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Hypokinesia, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult male patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (five years ago) and shingles (five years ago). Concurrent medical conditions included eye pain. In November 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In November 2018, 10 hrs after receiving SHINGRIX, the patient experienced influenza-like symptoms, general body pain, fever, fatigue, movements reduced, injection site erythema and injection site pain. On an unknown date, the outcome of the influenza-like symptoms, general body pain, fever, fatigue, movements reduced, injection site erythema and injection site pain were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, general body pain, fever, fatigue, movements reduced, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of the SHINGRIX in late November 2018 at around 2:00 pm, on a Sunday. Approximately 10 to 12 hours after receiving the vaccine, the patient began to experience flu like symptoms which included, body aches, fever, fatigue, he could not bend down. The injection site was red and sore. Around 2:00 pm on Monday, the patient started to feel significantly better, with lingering soreness and redness at the injection site, and body aches, and everything started to resolve by Thursday or Friday. The reporter did not give consent to follow up. This case has been linked to the US2019GSK031818, reported for the dose 1 of the same patient.