chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Erythema, Fatigue, Feeling abnormal, Neck pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 80-year-old female patient who received SHINGRIX. The patient's past medical history included shingles (shingles outbreak on New Years Eve, 31st December 2010). Concurrent medical conditions included nickel sensitivity (Nickel allergy and allergy to Ibuprofen and aspirin), drug allergy (allergy to Ibuprofen and aspirin) and fish allergy (reaction to bad fish - toxin ciguatera about 20 years ago which could affect her nervous system). Concomitant products included LUNESTA, Hydroxyzine, TYLENOL and VAGIFEM. On 25th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm, ear pain, localized erythema, neck pain, fatigue and feeling bad. The patient was treated with Cortisone Topical Cream and antihistamine. On an unknown date, the outcome of the pain in arm, ear pain, localized erythema, fatigue and feeling bad were recovered/resolved and the outcome of the neck pain was not recovered/not resolved. The reporter considered the pain in arm, ear pain, localized erythema, neck pain, fatigue and feeling bad to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient reported that her ear pain started within a day or so. The patient experienced really sore arm and a huge red area approximately 3.5 inches by 3.5 inches. The patient claimed that she felt lousy for four days and was exhausted during the day. The patient's neck and ear hurt where she had the shingles vaccine 7.5 years before the date of reporting. The patient had to cancel everything because she felt really bad. The patient was able to sleep because her physician told her to use Cortisone cream and take an antihistamine. The patient's arm pain lasted 5 to 6 days. She felt tired for 4 to 5 days. The patient had denied permission to contact their physician.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 80-year-old female patient who received SHINGRIX. The patient's past medical history included shingles (shingles outbreak on New Years Eve, 31st December 2010). Concurrent medical conditions included nickel sensitivity (Nickel allergy and allergy to Ibuprofen and aspirin), drug allergy (allergy to Ibuprofen and aspirin) and fish allergy (reaction to bad fish - toxin ciguatera about 20 years ago which could affect her nervous system). Concomitant products included LUNESTA, Hydroxyzine, TYLENOL and VAGIFEM. On 25th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm, ear pain, localized erythema, neck pain, fatigue and feeling bad. The patient was treated with Cortisone Topical Cream and antihistamine. On an unknown date, the outcome of the pain in arm, ear pain, localized erythema, fatigue and feeling bad were recovered/resolved and the outcome of the neck pain was not recovered/not resolved. The reporter considered the pain in arm, ear pain, localized erythema, neck pain, fatigue and feeling bad to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient reported that her ear pain started within a day or so. The patient experienced really sore arm and a huge red area approximately 3.5 inches by 3.5 inches. The patient claimed that she felt lousy for four days and was exhausted during the day. The patient's neck and ear hurt where she had the shingles vaccine 7.5 years before the date of reporting. The patient had to cancel everything because she felt really bad. The patient was able to sleep because her physician told her to use Cortisone cream and take an antihistamine. The patient's arm pain lasted 5 to 6 days. She felt tired for 4 to 5 days. The patient had denied permission to contact their physician.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Erythema, Fatigue, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 70-year-old female patient who received SHINGRIX. On 10th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 10th May 2018, 10 hrs after receiving SHINGRIX, the patient experienced chills and fever. On 11th May 2018, the patient experienced erythema, strength loss of, headache and tiredness. On 11th May 2018, the outcome of the chills and fever were recovered/resolved. On 12th May 2018, the outcome of the erythema, strength loss of, headache and tiredness were recovered/resolved. The reporter considered the chills, erythema, strength loss of, fever and headache to be related to SHINGRIX. It was unknown if the reporter considered the tiredness to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. At 10:00 hours, the patient received SHINGRIX. The patient stated on Thursday night about 10 hours after receiving the vaccine she had chills and a high fever but didn't take her temperature. She was up all night but by morning the chills and fever had resolved. One day after vaccination, the patient experienced erythema, strength loss of, headaches and tiredness. She however was extremely tired and stayed in bed all day. She also had a headache and her body was red all over. All events were resolved by Saturday. This case has been linked with case US2018086794, reported by the same reporter.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 70-year-old female patient who received SHINGRIX. On 10th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 10th May 2018, 10 hrs after receiving SHINGRIX, the patient experienced chills and fever. On 11th May 2018, the patient experienced erythema, strength loss of, headache and tiredness. On 11th May 2018, the outcome of the chills and fever were recovered/resolved. On 12th May 2018, the outcome of the erythema, strength loss of, headache and tiredness were recovered/resolved. The reporter considered the chills, erythema, strength loss of, fever and headache to be related to SHINGRIX. It was unknown if the reporter considered the tiredness to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. At 10:00 hours, the patient received SHINGRIX. The patient stated on Thursday night about 10 hours after receiving the vaccine she had chills and a high fever but didn't take her temperature. She was up all night but by morning the chills and fever had resolved. One day after vaccination, the patient experienced erythema, strength loss of, headaches and tiredness. She however was extremely tired and stayed in bed all day. She also had a headache and her body was red all over. All events were resolved by Saturday. This case has been linked with case US2018086794, reported by the same reporter.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 70-year-old female patient who received SHINGRIX. On 10th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 10th May 2018, 10 hrs after receiving SHINGRIX, the patient experienced chills and fever. On 11th May 2018, the patient experienced erythema, strength loss of, headache and tiredness. On 11th May 2018, the outcome of the chills and fever were recovered/resolved. On 12th May 2018, the outcome of the erythema, strength loss of, headache and tiredness were recovered/resolved. The reporter considered the chills, erythema, strength loss of, fever and headache to be related to SHINGRIX. It was unknown if the reporter considered the tiredness to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. At 10:00 hours, the patient received SHINGRIX. The patient stated on Thursday night about 10 hours after receiving the vaccine she had chills and a high fever but didn't take her temperature. She was up all night but by morning the chills and fever had resolved. One day after vaccination, the patient experienced erythema, strength loss of, headaches and tiredness. She however was extremely tired and stayed in bed all day. She also had a headache and her body was red all over. All events were resolved by Saturday. This case has been linked with case US2018086794, reported by the same reporter.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Bursitis, Joint range of motion decreased, Pain in extremity
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of joint range of motion decreased in a 38-year-old female patient who received BOOSTRIX (batch number 54B74, expiry date unknown). On 7th May 2018, the patient received BOOSTRIX. On 8th May 2018, 1 days after receiving BOOSTRIX, the patient experienced joint range of motion decreased and pain in arm. In May 2018, the patient experienced bursitis. On an unknown date, the outcome of the joint range of motion decreased, pain in arm and bursitis were not recovered/not resolved. It was unknown if the reporter considered the joint range of motion decreased, pain in arm and bursitis to be related to BOOSTRIX. Additional details were provided as follows: The patient experienced ongoing pain and restricted range of movement of left shoulder and chemical bursitis which was ongoing at the time of reporting. The reporter thought the vaccine was administered incorrectly (not further specified).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Diarrhoea, Nausea, Tremor
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of shivers in a 60-year-old female patient who received SHINGRIX. On 7th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. In May 2018, less than a week after receiving SHINGRIX, the patient experienced shivers, tremor, nausea, diarrhea and feelings of weakness. On an unknown date, the outcome of the shivers, tremor, nausea, diarrhea and feelings of weakness were recovered/resolved. It was unknown if the reporter considered the shivers, tremor, nausea, diarrhea and feelings of weakness to be related to SHINGRIX. Additional details were provided as follows: The reporter was Certified Medical Assistant. The patient received SHINGRIX on the left deltoid. On 10th May 2018, the patient called office to reschedule the vaccination date for her 2nd dose of SHINGRIX. During that conversation, the patient reported that she experienced shaking, cold shivers, nausea and diarrhea, and felt overall weak for 2-3 days post vaccination with her 1st dose of SHINGRIX.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Malaise, Myalgia, Nausea, Pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of nausea in a 78-year-old female patient who received SHINGRIX (batch number AS9CM, expiry date unknown). Concomitant products included VALTREX, vitamin D and Oestrogens. On 3rd May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a day after receiving SHINGRIX, the patient experienced nausea, unwell, muscle pain, swelling and lethargy. On an unknown date, the outcome of the nausea, unwell, muscle pain, swelling and lethargy were recovered/resolved. The reporter considered the nausea, unwell, muscle pain, swelling and lethargy to be probably related to SHINGRIX. Additional details were provided as follows: This case was reported by the nurse practitioner. The patient was extremely ill with aching, nausea and lethargy. The patient received the vaccine at a pharmacy. In May 2018, nausea, unwell, muscle pain, swelling and lethargy were resolved.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of nausea in a 78-year-old female patient who received SHINGRIX (batch number AS9CM, expiry date unknown). Concomitant products included VALTREX, vitamin D and Oestrogens. On 3rd May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a day after receiving SHINGRIX, the patient experienced nausea, unwell, muscle pain, swelling and lethargy. On an unknown date, the outcome of the nausea, unwell, muscle pain, swelling and lethargy were recovered/resolved. The reporter considered the nausea, unwell, muscle pain, swelling and lethargy to be probably related to SHINGRIX. Additional details were provided as follows: This case was reported by the nurse practitioner. The patient was extremely ill with aching, nausea and lethargy. The patient received the vaccine at a pharmacy. In May 2018, nausea, unwell, muscle pain, swelling and lethargy were resolved.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient received first SHINGRIX vaccine a little over 2 months ago. Patient had had a "funny bone like pain" in his arm he received the shot ever since. This occurs with pressure or when he applies pressure to something else with his arm. Goes all the way down his arm.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site atrophy, Product administered at inappropriate site
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site fat atrophy in a elderly female patient who received SHINGRIX (batch number T5242, expiry date 31st March 2020). On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site fat atrophy and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site fat atrophy and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site fat atrophy to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported this case via click to chat forum. The age at vaccination was not reported but could be 68 years or 69 years. The patient received a dose of SHINGRIX in the gluteal muscle, which led to vaccine administered at inappropriate site. The patient developed subcutaneous fat atrophy at the site of injection. No further information was reported.
Age: 18.0
Sex: M
Vaccine: ANTH, JEV1, SMALL, TYP
Symptoms: Blood creatine phosphokinase increased, Blood creatine phosphokinase normal, Brain natriuretic peptide normal, C-reactive protein increased, Chest X-ray normal
Clinical narrative: On 30 Jul 2017, pt reported onset of constant left-sided, sharp, pleuritic, nonradiating chest pain (CP).  Pain intensity rated as 7/10 using pain scale of 0 (=no pain) to 10 (=worst pain ever experienced). Pain was worse laying down and better with sitting. Accompanying symptoms included malaise, subjective fever and chills, headache, and nausea without vomiting. His smallpox vaccination site had a robust take with left axillary tenderness and swelling. Pt denied shortness of breath, dyspnea, dizziness, cough, and palpitations. Pt denied recent overseas travel, symptoms of recent infection or illness, and contact with sick contacts. Pt sought evaluation at local ER. In the ED, pt's temperature was 98.3 F with HR 99, RR 16, and BP 127/72. His physical exam was unremarkable. His CP was treated with ASA and Ibuprofen with some decrease in CP (Intensity level decreased from 7/10 to 4/10). Pt's Troponin I level and CRP were elevated and his ECG showed changes consistent with pericarditis. Pt was released with the Dx of acute myopericarditis and scheduled for Cardiology follow up the following day. On 31 Jul 2017, pt followed up with Dr, Cardiology. Pt remained probable myopericarditis, based on ECG changes, lab results and symptoms. He was prescribed NSAIDS (with PPI) until symptoms resolved. He was also prescribed Colchicine 0.6 mg 2x/day x 3 months and was placed on limited duty profile x 3 months, with recommended follow up in 6 weeks. In Oct 2017, on his own, pt decreased colchicine and resumed jogging, which resulted in ER visit with elevated Trop-I level. Pt was placed back on activity profile and resumption of 2x/day colchicine. In Mar 2018, at follow up appointment with Cardiology,  Medical Center, pt reported being asymptomatic x 1 month, except headaches and rare lightheadedness (x 10 min). At that time, he received instruction to discontinue his Colchicine, along with instructions to continue his profile x 2-3 weeks, then gradually increase physical activity.  Cardiology follow up was recommended in 1 month. As of 29 May 2018, pt has not yet followed up with Cardiologist, but has appointment scheduled for 13 Jun 2018.
Age: 18.0
Sex: M
Vaccine: ANTH, JEV1, SMALL, TYP
Symptoms: Chest pain, Chills, Dizziness, Ejection fraction normal, Electrocardiogram ST segment elevation
Clinical narrative: On 30 Jul 2017, pt reported onset of constant left-sided, sharp, pleuritic, nonradiating chest pain (CP).  Pain intensity rated as 7/10 using pain scale of 0 (=no pain) to 10 (=worst pain ever experienced). Pain was worse laying down and better with sitting. Accompanying symptoms included malaise, subjective fever and chills, headache, and nausea without vomiting. His smallpox vaccination site had a robust take with left axillary tenderness and swelling. Pt denied shortness of breath, dyspnea, dizziness, cough, and palpitations. Pt denied recent overseas travel, symptoms of recent infection or illness, and contact with sick contacts. Pt sought evaluation at local ER. In the ED, pt's temperature was 98.3 F with HR 99, RR 16, and BP 127/72. His physical exam was unremarkable. His CP was treated with ASA and Ibuprofen with some decrease in CP (Intensity level decreased from 7/10 to 4/10). Pt's Troponin I level and CRP were elevated and his ECG showed changes consistent with pericarditis. Pt was released with the Dx of acute myopericarditis and scheduled for Cardiology follow up the following day. On 31 Jul 2017, pt followed up with Dr, Cardiology. Pt remained probable myopericarditis, based on ECG changes, lab results and symptoms. He was prescribed NSAIDS (with PPI) until symptoms resolved. He was also prescribed Colchicine 0.6 mg 2x/day x 3 months and was placed on limited duty profile x 3 months, with recommended follow up in 6 weeks. In Oct 2017, on his own, pt decreased colchicine and resumed jogging, which resulted in ER visit with elevated Trop-I level. Pt was placed back on activity profile and resumption of 2x/day colchicine. In Mar 2018, at follow up appointment with Cardiology,  Medical Center, pt reported being asymptomatic x 1 month, except headaches and rare lightheadedness (x 10 min). At that time, he received instruction to discontinue his Colchicine, along with instructions to continue his profile x 2-3 weeks, then gradually increase physical activity.  Cardiology follow up was recommended in 1 month. As of 29 May 2018, pt has not yet followed up with Cardiologist, but has appointment scheduled for 13 Jun 2018.
Age: 18.0
Sex: M
Vaccine: ANTH, JEV1, SMALL, TYP
Symptoms: Electrocardiogram abnormal, Headache, Malaise, Myocarditis, Nausea
Clinical narrative: On 30 Jul 2017, pt reported onset of constant left-sided, sharp, pleuritic, nonradiating chest pain (CP).  Pain intensity rated as 7/10 using pain scale of 0 (=no pain) to 10 (=worst pain ever experienced). Pain was worse laying down and better with sitting. Accompanying symptoms included malaise, subjective fever and chills, headache, and nausea without vomiting. His smallpox vaccination site had a robust take with left axillary tenderness and swelling. Pt denied shortness of breath, dyspnea, dizziness, cough, and palpitations. Pt denied recent overseas travel, symptoms of recent infection or illness, and contact with sick contacts. Pt sought evaluation at local ER. In the ED, pt's temperature was 98.3 F with HR 99, RR 16, and BP 127/72. His physical exam was unremarkable. His CP was treated with ASA and Ibuprofen with some decrease in CP (Intensity level decreased from 7/10 to 4/10). Pt's Troponin I level and CRP were elevated and his ECG showed changes consistent with pericarditis. Pt was released with the Dx of acute myopericarditis and scheduled for Cardiology follow up the following day. On 31 Jul 2017, pt followed up with Dr, Cardiology. Pt remained probable myopericarditis, based on ECG changes, lab results and symptoms. He was prescribed NSAIDS (with PPI) until symptoms resolved. He was also prescribed Colchicine 0.6 mg 2x/day x 3 months and was placed on limited duty profile x 3 months, with recommended follow up in 6 weeks. In Oct 2017, on his own, pt decreased colchicine and resumed jogging, which resulted in ER visit with elevated Trop-I level. Pt was placed back on activity profile and resumption of 2x/day colchicine. In Mar 2018, at follow up appointment with Cardiology,  Medical Center, pt reported being asymptomatic x 1 month, except headaches and rare lightheadedness (x 10 min). At that time, he received instruction to discontinue his Colchicine, along with instructions to continue his profile x 2-3 weeks, then gradually increase physical activity.  Cardiology follow up was recommended in 1 month. As of 29 May 2018, pt has not yet followed up with Cardiologist, but has appointment scheduled for 13 Jun 2018.
Age: 18.0
Sex: M
Vaccine: ANTH, JEV1, SMALL, TYP
Symptoms: Pericarditis, Pleuritic pain, Pyrexia, Red blood cell sedimentation rate normal, Swelling
Clinical narrative: On 30 Jul 2017, pt reported onset of constant left-sided, sharp, pleuritic, nonradiating chest pain (CP).  Pain intensity rated as 7/10 using pain scale of 0 (=no pain) to 10 (=worst pain ever experienced). Pain was worse laying down and better with sitting. Accompanying symptoms included malaise, subjective fever and chills, headache, and nausea without vomiting. His smallpox vaccination site had a robust take with left axillary tenderness and swelling. Pt denied shortness of breath, dyspnea, dizziness, cough, and palpitations. Pt denied recent overseas travel, symptoms of recent infection or illness, and contact with sick contacts. Pt sought evaluation at local ER. In the ED, pt's temperature was 98.3 F with HR 99, RR 16, and BP 127/72. His physical exam was unremarkable. His CP was treated with ASA and Ibuprofen with some decrease in CP (Intensity level decreased from 7/10 to 4/10). Pt's Troponin I level and CRP were elevated and his ECG showed changes consistent with pericarditis. Pt was released with the Dx of acute myopericarditis and scheduled for Cardiology follow up the following day. On 31 Jul 2017, pt followed up with Dr, Cardiology. Pt remained probable myopericarditis, based on ECG changes, lab results and symptoms. He was prescribed NSAIDS (with PPI) until symptoms resolved. He was also prescribed Colchicine 0.6 mg 2x/day x 3 months and was placed on limited duty profile x 3 months, with recommended follow up in 6 weeks. In Oct 2017, on his own, pt decreased colchicine and resumed jogging, which resulted in ER visit with elevated Trop-I level. Pt was placed back on activity profile and resumption of 2x/day colchicine. In Mar 2018, at follow up appointment with Cardiology,  Medical Center, pt reported being asymptomatic x 1 month, except headaches and rare lightheadedness (x 10 min). At that time, he received instruction to discontinue his Colchicine, along with instructions to continue his profile x 2-3 weeks, then gradually increase physical activity.  Cardiology follow up was recommended in 1 month. As of 29 May 2018, pt has not yet followed up with Cardiologist, but has appointment scheduled for 13 Jun 2018.
Age: 18.0
Sex: M
Vaccine: ANTH, JEV1, SMALL, TYP
Symptoms: Tenderness, Troponin I increased
Clinical narrative: On 30 Jul 2017, pt reported onset of constant left-sided, sharp, pleuritic, nonradiating chest pain (CP).  Pain intensity rated as 7/10 using pain scale of 0 (=no pain) to 10 (=worst pain ever experienced). Pain was worse laying down and better with sitting. Accompanying symptoms included malaise, subjective fever and chills, headache, and nausea without vomiting. His smallpox vaccination site had a robust take with left axillary tenderness and swelling. Pt denied shortness of breath, dyspnea, dizziness, cough, and palpitations. Pt denied recent overseas travel, symptoms of recent infection or illness, and contact with sick contacts. Pt sought evaluation at local ER. In the ED, pt's temperature was 98.3 F with HR 99, RR 16, and BP 127/72. His physical exam was unremarkable. His CP was treated with ASA and Ibuprofen with some decrease in CP (Intensity level decreased from 7/10 to 4/10). Pt's Troponin I level and CRP were elevated and his ECG showed changes consistent with pericarditis. Pt was released with the Dx of acute myopericarditis and scheduled for Cardiology follow up the following day. On 31 Jul 2017, pt followed up with Dr, Cardiology. Pt remained probable myopericarditis, based on ECG changes, lab results and symptoms. He was prescribed NSAIDS (with PPI) until symptoms resolved. He was also prescribed Colchicine 0.6 mg 2x/day x 3 months and was placed on limited duty profile x 3 months, with recommended follow up in 6 weeks. In Oct 2017, on his own, pt decreased colchicine and resumed jogging, which resulted in ER visit with elevated Trop-I level. Pt was placed back on activity profile and resumption of 2x/day colchicine. In Mar 2018, at follow up appointment with Cardiology,  Medical Center, pt reported being asymptomatic x 1 month, except headaches and rare lightheadedness (x 10 min). At that time, he received instruction to discontinue his Colchicine, along with instructions to continue his profile x 2-3 weeks, then gradually increase physical activity.  Cardiology follow up was recommended in 1 month. As of 29 May 2018, pt has not yet followed up with Cardiologist, but has appointment scheduled for 13 Jun 2018.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Asthenia, Back pain, Chills, Feeling abnormal
Clinical narrative: Severe headache not relieved by pain/headache medicine. Headache lasted the entire day.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site pain, Injection site rash, Nausea, Neck pain
Clinical narrative: Severe headache not relieved by pain/headache medicine. Headache lasted the entire day.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Severe headache not relieved by pain/headache medicine. Headache lasted the entire day.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache
Clinical narrative: Severe headache not relieved by pain/headache medicine. Headache lasted the entire day.
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: PATIENT STILL EXPERIENCES VERY TENDER AND SORE TO TOUCH OR LYING ON THE INJECTION SITE (ON RIGHT ARM).
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Immediate post-injection reaction, Injection site rash, Injection site vesicles
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 68-year-old female patient who received SHINGRIX (batch number 49ST9, expiry date 4th July 2020). Concomitant products included Sumatriptan Succinate and CELEBREX. On 9th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 17th May 2018, 8 days after receiving SHINGRIX, the patient experienced shingles, injection site rash, injection site blisters, rash and tenderness. The patient was treated with Valacyclovir. On an unknown date, the outcome of the shingles, injection site rash, injection site blisters, rash and tenderness were unknown. The reporter considered the shingles, injection site rash, injection site blisters, rash and tenderness to be probably related to SHINGRIX. Additional details were provided as follows: The case was previously reported to physician. The patient reports that she developed a rash and blisters around the injection site. The patient then developed rash on neck and shoulder near the clavicle. It was painful to the touch. The patient had emailed pictures to the physician and discussed with him over the phone the symptoms as well. The physician suspected shingles, but decided to wait for a viral culture test from the vesicle fluid. The physician prescribed valacyclovir to the patient.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Pain, Rash, Viral test
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 68-year-old female patient who received SHINGRIX (batch number 49ST9, expiry date 4th July 2020). Concomitant products included Sumatriptan Succinate and CELEBREX. On 9th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 17th May 2018, 8 days after receiving SHINGRIX, the patient experienced shingles, injection site rash, injection site blisters, rash and tenderness. The patient was treated with Valacyclovir. On an unknown date, the outcome of the shingles, injection site rash, injection site blisters, rash and tenderness were unknown. The reporter considered the shingles, injection site rash, injection site blisters, rash and tenderness to be probably related to SHINGRIX. Additional details were provided as follows: The case was previously reported to physician. The patient reports that she developed a rash and blisters around the injection site. The patient then developed rash on neck and shoulder near the clavicle. It was painful to the touch. The patient had emailed pictures to the physician and discussed with him over the phone the symptoms as well. The physician suspected shingles, but decided to wait for a viral culture test from the vesicle fluid. The physician prescribed valacyclovir to the patient.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site rash, Injection site vesicles, Rash, Tenderness
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 68-year-old female patient who received SHINGRIX (batch number 49ST9, expiry date 4th July 2020). Concomitant products included Sumatriptan Succinate and CELEBREX. On 9th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 17th May 2018, 8 days after receiving SHINGRIX, the patient experienced shingles, injection site rash, injection site blisters, rash and tenderness. The patient was treated with Valacyclovir. On an unknown date, the outcome of the shingles, injection site rash, injection site blisters, rash and tenderness were unknown. The reporter considered the shingles, injection site rash, injection site blisters, rash and tenderness to be probably related to SHINGRIX. Additional details were provided as follows: The case was previously reported to physician. The patient reports that she developed a rash and blisters around the injection site. The patient then developed rash on neck and shoulder near the clavicle. It was painful to the touch. The patient had emailed pictures to the physician and discussed with him over the phone the symptoms as well. The physician suspected shingles, but decided to wait for a viral culture test from the vesicle fluid. The physician prescribed valacyclovir to the patient.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Blister, Bone pain, Burning sensation, Herpes zoster, Musculoskeletal pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 68-year-old female patient who received SHINGRIX (batch number 49ST9, expiry date 4th July 2020). Concomitant products included Sumatriptan Succinate and CELEBREX. On 9th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 17th May 2018, 8 days after receiving SHINGRIX, the patient experienced shingles, injection site rash, injection site blisters, rash and tenderness. The patient was treated with Valacyclovir. On an unknown date, the outcome of the shingles, injection site rash, injection site blisters, rash and tenderness were unknown. The reporter considered the shingles, injection site rash, injection site blisters, rash and tenderness to be probably related to SHINGRIX. Additional details were provided as follows: The case was previously reported to physician. The patient reports that she developed a rash and blisters around the injection site. The patient then developed rash on neck and shoulder near the clavicle. It was painful to the touch. The patient had emailed pictures to the physician and discussed with him over the phone the symptoms as well. The physician suspected shingles, but decided to wait for a viral culture test from the vesicle fluid. The physician prescribed valacyclovir to the patient.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Neck pain, Neuralgia, Pruritus, Rash erythematous
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 68-year-old female patient who received SHINGRIX (batch number 49ST9, expiry date 4th July 2020). Concomitant products included Sumatriptan Succinate and CELEBREX. On 9th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 17th May 2018, 8 days after receiving SHINGRIX, the patient experienced shingles, injection site rash, injection site blisters, rash and tenderness. The patient was treated with Valacyclovir. On an unknown date, the outcome of the shingles, injection site rash, injection site blisters, rash and tenderness were unknown. The reporter considered the shingles, injection site rash, injection site blisters, rash and tenderness to be probably related to SHINGRIX. Additional details were provided as follows: The case was previously reported to physician. The patient reports that she developed a rash and blisters around the injection site. The patient then developed rash on neck and shoulder near the clavicle. It was painful to the touch. The patient had emailed pictures to the physician and discussed with him over the phone the symptoms as well. The physician suspected shingles, but decided to wait for a viral culture test from the vesicle fluid. The physician prescribed valacyclovir to the patient.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Rash, Vaccination failure, Varicella virus test positive
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 68-year-old female patient who received SHINGRIX (batch number 49ST9, expiry date 4th July 2020). Concomitant products included Sumatriptan Succinate and CELEBREX. On 9th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 17th May 2018, 8 days after receiving SHINGRIX, the patient experienced shingles, injection site rash, injection site blisters, rash and tenderness. The patient was treated with Valacyclovir. On an unknown date, the outcome of the shingles, injection site rash, injection site blisters, rash and tenderness were unknown. The reporter considered the shingles, injection site rash, injection site blisters, rash and tenderness to be probably related to SHINGRIX. Additional details were provided as follows: The case was previously reported to physician. The patient reports that she developed a rash and blisters around the injection site. The patient then developed rash on neck and shoulder near the clavicle. It was painful to the touch. The patient had emailed pictures to the physician and discussed with him over the phone the symptoms as well. The physician suspected shingles, but decided to wait for a viral culture test from the vesicle fluid. The physician prescribed valacyclovir to the patient.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Laboratory test, Pruritus, Rash
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of chickenpox in a 76-year-old male patient who received SHINGRIX. The patient's past medical history included chickenpox. Previously administered products included ZOSTAVAX. On 10th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 12th April 2018, 2 days after receiving SHINGRIX, the patient experienced chickenpox. The patient was treated with antibiotics nos and Corticosteroid NOS. On an unknown date, the outcome of the chickenpox was unknown. It was unknown if the reporter considered the chickenpox to be related to SHINGRIX. Additional details were provided as follows: The allergist said he would do varicella titers but the patient was otherwise fine now. The allergist said he was not convinced it was due to SHINGRIX but wanted to know if there's data out there.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Varicella
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of chickenpox in a 76-year-old male patient who received SHINGRIX. The patient's past medical history included chickenpox. Previously administered products included ZOSTAVAX. On 10th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 12th April 2018, 2 days after receiving SHINGRIX, the patient experienced chickenpox. The patient was treated with antibiotics nos and Corticosteroid NOS. On an unknown date, the outcome of the chickenpox was unknown. It was unknown if the reporter considered the chickenpox to be related to SHINGRIX. Additional details were provided as follows: The allergist said he would do varicella titers but the patient was otherwise fine now. The allergist said he was not convinced it was due to SHINGRIX but wanted to know if there's data out there.
Age: 52.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Rash, Swelling
Clinical narrative: This spontaneous report as received from a  registered nurse regarding a 52 year old female patient. The patient's drug reactions/allergies included adhesive tape and sulfa allergy. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 19-APR-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscularly, lot # N032092 with expiration date 12-SEP-2018, for prophylaxis (anatomical location were not provided). On the same day, after receiving the PNEUMOVAX 23, the patient experienced rash, redness (erythema) that extended below the elbow joint, swelling in the arm (peripheral swelling) where the vaccine was administered and pain. The patient was seen in an emergency room for treatment and the patient was not admitted to the hospital. At the reporting time, the outcome of erythema, rash, peripheral swelling and pain was reported as resolved. Laboratory studies performed included blood work such as complete blood count (CBC), basic metabolic panel (BMP), C reactive protein and x-ray of left humerus, however results were not provided. The reporter did not assess the relatedness between PNEUMOVAX 23 and the aforementioned events.
Age: 52.0
Sex: F
Vaccine: PPV, PPV
Symptoms: C-reactive protein, Erythema, Full blood count, Injection site erythema, Injection site rash
Clinical narrative: This spontaneous report as received from a  registered nurse regarding a 52 year old female patient. The patient's drug reactions/allergies included adhesive tape and sulfa allergy. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 19-APR-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscularly, lot # N032092 with expiration date 12-SEP-2018, for prophylaxis (anatomical location were not provided). On the same day, after receiving the PNEUMOVAX 23, the patient experienced rash, redness (erythema) that extended below the elbow joint, swelling in the arm (peripheral swelling) where the vaccine was administered and pain. The patient was seen in an emergency room for treatment and the patient was not admitted to the hospital. At the reporting time, the outcome of erythema, rash, peripheral swelling and pain was reported as resolved. Laboratory studies performed included blood work such as complete blood count (CBC), basic metabolic panel (BMP), C reactive protein and x-ray of left humerus, however results were not provided. The reporter did not assess the relatedness between PNEUMOVAX 23 and the aforementioned events.
Age: 52.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Metabolic function test, Pain, Peripheral swelling, Rash, X-ray limb
Clinical narrative: This spontaneous report as received from a  registered nurse regarding a 52 year old female patient. The patient's drug reactions/allergies included adhesive tape and sulfa allergy. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 19-APR-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscularly, lot # N032092 with expiration date 12-SEP-2018, for prophylaxis (anatomical location were not provided). On the same day, after receiving the PNEUMOVAX 23, the patient experienced rash, redness (erythema) that extended below the elbow joint, swelling in the arm (peripheral swelling) where the vaccine was administered and pain. The patient was seen in an emergency room for treatment and the patient was not admitted to the hospital. At the reporting time, the outcome of erythema, rash, peripheral swelling and pain was reported as resolved. Laboratory studies performed included blood work such as complete blood count (CBC), basic metabolic panel (BMP), C reactive protein and x-ray of left humerus, however results were not provided. The reporter did not assess the relatedness between PNEUMOVAX 23 and the aforementioned events.
Age: 28.0
Sex: F
Vaccine: ANTH
Symptoms: Ear pain, Lymphadenopathy
Clinical narrative: Patient states that the day following her anthrax vaccination her left ear became painful to the touch. Patient states that her left ear was painful inside and out. Patient states the pain became worse 4 days after vaccination and felt like her lymph node in the left side of her neck was swelling. Patient states the pain began to lessen 5 days after vaccination. Patient states the outer ear no longer hurts but the inner ear still hurts when using a Q-tip. Patient was recommended to schedule an appointment with her primary care manager for follow up to her ear pain.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a 11 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 20-SEP-2007, the patient was vaccinated with VARIVAX (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis.   On 21-SEP-2010, the patient was vaccinated with PROQUAD (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT). On 27-SEP-2016, 9 years 8 days after onset of therapy the patient experienced herpes zoster. The outcome of herpes zoster was reported as not recovered/not resolved. Causal relationship between the event and suspect vaccines was not provided.
Sex: U
Vaccine: HPV9, MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report was received from an immunization official and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant medications, pertinent medical histories and drug reactions or allergies were not provided. On unknown dates, the patients were inadvertently administered improperly stored doses of M-M-R II injection (lot # N009172 with expiration date on 20-MAR-2019; doses and routes of administration were not reported), which was reconstituted with properly stored sterile diluent (manufacturer unknown). Other improperly stored suspect therapies included ROTATEQ (lot # N013885 with expiration date on 09-DEC-2018 and not valid lot # reported as N024400 with expiration date on 10-MAY-2019; doses were not reported) and GARDASIL 9 (lot # N025428 with expiration date on 19-JUN-2020 and lot # N021571 with expiration date on 29-APR-2020; doses and routes of administration were not reported). Administered doses of vaccines underwent a temperature excursion of 55 degrees Fahrenheit, which lasted for an unknown time frame. There was an unspecified previous temperature excursion. A digital data logger was involved in recording the excursion. No adverse effect was reported.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report refers to a 23 years old female patient and was received from the patient's husband. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On approximately 16-APR-2018 (reported as "about three weeks ago"), the patient was administered an unspecified varicella vaccine, which might have been VARIVAX injection (dose, route of administration, lot # and expiration date were not reported), as she needed to get vaccinated. Concomitant therapies included sterile diluent (manufacturer unknown). The patient might have been pregnant or gotten pregnant around the same time the vaccine was administered. She could have been about three weeks pregnant (last menstrual period (LMP) date in April 2018). The estimated due date was not provided. On 06-MAY-2018 (reported as "yesterday"), the patient found out she was pregnant by a urine pregnancy test, which was positive. The reporter stated, that the physician did not ask or check if she was pregnant or trying to become pregnant before the vaccine was administered. Trimesters of exposure included the first trimester. The pregnancy outcome was pending. No adverse effects were reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Tha patient's medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patient received a dose of VARIVAX, intramuscularly for prophylaxis; lot # was reported as N027699, expiration date 09-JUN-2019 (dose, strength, and frequency were unknown).  The patient also received a dose of M-M-R II for prophylaxis; lot # N013279, and expiration date 28-APR-2019 (dose, strength, and frequency were unknown). Both vaccines were administered intramuscularly instead of the recommended subcutaneous route on different unspecified dates. No adverse events were reported.