chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in arm in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain in arm and general body pain. On an unknown date, the outcome of the pain in arm and general body pain were unknown. It was unknown if the reporter considered the pain in arm and general body pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced side effects described as, sore arm, general aches and pains after receiving SHINGRIX.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 28-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (shingles back in 2017). In November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shivering, fever and general body pain. On an unknown date, the outcome of the shivering, fever and general body pain were recovered/resolved. It was unknown if the reporter considered the shivering, fever and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, could be 27 to 28 yrs. The patient 28 year old who was now in healthy condition. Since the patient insurance would not cover the 2nd dose vaccine to patient under 50, so the patient decided to pay for both doses out of pocket. The patient received a dose of SHINGRIX and experienced shivering, fever and body aches. The patient wanted to know how long would SHINGRIX be effective for the patient to prevent a shingles flare up. All side effects subsided within 24 to 48 hours. This case was 1 of the 2 cases, reported by the same reporter for the same patient.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint swelling, Pain, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling of elbows in a 73-year-old female patient who received SHINGRIX (batch number DD43M, expiry date unknown) for prophylaxis. On 20th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 21st September 2018, 1 days after receiving SHINGRIX, the patient experienced swelling of elbows, pain and hives. On an unknown date, the outcome of the swelling of elbows, pain and hives were recovered/resolved. It was unknown if the reporter considered the swelling of elbows, pain and hives to be related to SHINGRIX. Additional details were received as follows: The patient experienced swelling from shoulder to elbow, pain and hives following the vaccination with a dose of SHINGRIX. These events lasted about 1 week. The pharmacist was unable to provide the expiration date of the SHINGRIX as the pharmacy system truncates the date.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dysphonia, Erythema, Fatigue, Hypersensitivity, Immediate post-injection reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included psoriasis (but it was well controlled and that was usually just on patient's hands and fingers.). Previously administered products included ZOSTAVAX (in 2010). Concomitant products included SHINGRIX and acyclovir. On 20th January 2019, the patient received the 2nd dose of SHINGRIX. On 20th January 2019, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 21st January 2019, the patient experienced limbs stiffness, injected limb mobility decreased and tiredness. On 22nd January 2019, the patient experienced generalized rash, allergic reaction, itchy rash, hoarseness, hand swelling and erythema of extremities. The patient was treated with ZANTAC, ZYRTEC and prednisone. On an unknown date, the outcome of the injection site pain, limbs stiffness, injected limb mobility decreased, tiredness, generalized rash, allergic reaction, itchy rash, hoarseness, hand swelling and erythema of extremities were unknown. It was unknown if the reporter considered the injection site pain, limbs stiffness, injected limb mobility decreased, tiredness, generalized rash, allergic reaction, itchy rash, hoarseness, hand swelling and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: On 10th November 2018, the patient received 1st shot of SHINGRIX without issue. The patient did not have batch number or information on how much or how from pharmacy, where she got it. The patient experienced hurt when she got it. One day after receiving SHINGRIX, the patient experienced her arm was stiff hard to move her arm and she was very tired. Two days after receiving SHINGRIX, the patient experienced, rash on her arms and legs and her fingers and hands were swollen and red. The patient sounded hoarse on the phone while talking to her friend. The patient stated that the rash was on her left upper arm and under the arm and on the right (the side she had the shot on) the rash was on her lower arm and then on both thighs and it wrapped around the back of her legs to her buttocks. She noted it was flat and just slightly itchy. The patient physician prescribed a prednisone taper (starting at 6 tablets on Tuesday and decreasing from there) the tablets are 4mg tablets she states. She was also prescribed ZANTAC and ZYRTEC to help. She called at the date of reporting concerned these may reduce the effectiveness of the SHINGRIX. The patient also noted that she stopped taking acyclovir 48 hours before the vaccine and would remain off of it for 2 weeks, even though she knows she did not have to. She stated she also did this with the first shot as well. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness, Peripheral swelling, Rash generalised
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included psoriasis (but it was well controlled and that was usually just on patient's hands and fingers.). Previously administered products included ZOSTAVAX (in 2010). Concomitant products included SHINGRIX and acyclovir. On 20th January 2019, the patient received the 2nd dose of SHINGRIX. On 20th January 2019, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 21st January 2019, the patient experienced limbs stiffness, injected limb mobility decreased and tiredness. On 22nd January 2019, the patient experienced generalized rash, allergic reaction, itchy rash, hoarseness, hand swelling and erythema of extremities. The patient was treated with ZANTAC, ZYRTEC and prednisone. On an unknown date, the outcome of the injection site pain, limbs stiffness, injected limb mobility decreased, tiredness, generalized rash, allergic reaction, itchy rash, hoarseness, hand swelling and erythema of extremities were unknown. It was unknown if the reporter considered the injection site pain, limbs stiffness, injected limb mobility decreased, tiredness, generalized rash, allergic reaction, itchy rash, hoarseness, hand swelling and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: On 10th November 2018, the patient received 1st shot of SHINGRIX without issue. The patient did not have batch number or information on how much or how from pharmacy, where she got it. The patient experienced hurt when she got it. One day after receiving SHINGRIX, the patient experienced her arm was stiff hard to move her arm and she was very tired. Two days after receiving SHINGRIX, the patient experienced, rash on her arms and legs and her fingers and hands were swollen and red. The patient sounded hoarse on the phone while talking to her friend. The patient stated that the rash was on her left upper arm and under the arm and on the right (the side she had the shot on) the rash was on her lower arm and then on both thighs and it wrapped around the back of her legs to her buttocks. She noted it was flat and just slightly itchy. The patient physician prescribed a prednisone taper (starting at 6 tablets on Tuesday and decreasing from there) the tablets are 4mg tablets she states. She was also prescribed ZANTAC and ZYRTEC to help. She called at the date of reporting concerned these may reduce the effectiveness of the SHINGRIX. The patient also noted that she stopped taking acyclovir 48 hours before the vaccine and would remain off of it for 2 weeks, even though she knows she did not have to. She stated she also did this with the first shot as well. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included psoriasis (but it was well controlled and that was usually just on patient's hands and fingers.). Previously administered products included ZOSTAVAX (in 2010). Concomitant products included SHINGRIX and acyclovir. On 20th January 2019, the patient received the 2nd dose of SHINGRIX. On 20th January 2019, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 21st January 2019, the patient experienced limbs stiffness, injected limb mobility decreased and tiredness. On 22nd January 2019, the patient experienced generalized rash, allergic reaction, itchy rash, hoarseness, hand swelling and erythema of extremities. The patient was treated with ZANTAC, ZYRTEC and prednisone. On an unknown date, the outcome of the injection site pain, limbs stiffness, injected limb mobility decreased, tiredness, generalized rash, allergic reaction, itchy rash, hoarseness, hand swelling and erythema of extremities were unknown. It was unknown if the reporter considered the injection site pain, limbs stiffness, injected limb mobility decreased, tiredness, generalized rash, allergic reaction, itchy rash, hoarseness, hand swelling and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: On 10th November 2018, the patient received 1st shot of SHINGRIX without issue. The patient did not have batch number or information on how much or how from pharmacy, where she got it. The patient experienced hurt when she got it. One day after receiving SHINGRIX, the patient experienced her arm was stiff hard to move her arm and she was very tired. Two days after receiving SHINGRIX, the patient experienced, rash on her arms and legs and her fingers and hands were swollen and red. The patient sounded hoarse on the phone while talking to her friend. The patient stated that the rash was on her left upper arm and under the arm and on the right (the side she had the shot on) the rash was on her lower arm and then on both thighs and it wrapped around the back of her legs to her buttocks. She noted it was flat and just slightly itchy. The patient physician prescribed a prednisone taper (starting at 6 tablets on Tuesday and decreasing from there) the tablets are 4mg tablets she states. She was also prescribed ZANTAC and ZYRTEC to help. She called at the date of reporting concerned these may reduce the effectiveness of the SHINGRIX. The patient also noted that she stopped taking acyclovir 48 hours before the vaccine and would remain off of it for 2 weeks, even though she knows she did not have to. She stated she also did this with the first shot as well. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dysphonia, Erythema, Fatigue, Joint swelling, Musculoskeletal stiffness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included psoriasis (but it was well controlled and that was usually just on patient's hands and fingers.). Previously administered products included ZOSTAVAX (in 2010). Concomitant products included SHINGRIX and acyclovir. On 20th January 2019, the patient received the 2nd dose of SHINGRIX. On 20th January 2019, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 21st January 2019, the patient experienced limbs stiffness, injected limb mobility decreased and tiredness. On 22nd January 2019, the patient experienced generalized rash, allergic reaction, itchy rash, hoarseness, hand swelling and erythema of extremities. The patient was treated with ZANTAC, ZYRTEC and prednisone. On an unknown date, the outcome of the injection site pain, limbs stiffness, injected limb mobility decreased, tiredness, generalized rash, allergic reaction, itchy rash, hoarseness, hand swelling and erythema of extremities were unknown. It was unknown if the reporter considered the injection site pain, limbs stiffness, injected limb mobility decreased, tiredness, generalized rash, allergic reaction, itchy rash, hoarseness, hand swelling and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: On 10th November 2018, the patient received 1st shot of SHINGRIX without issue. The patient did not have batch number or information on how much or how from pharmacy, where she got it. The patient experienced hurt when she got it. One day after receiving SHINGRIX, the patient experienced her arm was stiff hard to move her arm and she was very tired. Two days after receiving SHINGRIX, the patient experienced, rash on her arms and legs and her fingers and hands were swollen and red. The patient sounded hoarse on the phone while talking to her friend. The patient stated that the rash was on her left upper arm and under the arm and on the right (the side she had the shot on) the rash was on her lower arm and then on both thighs and it wrapped around the back of her legs to her buttocks. She noted it was flat and just slightly itchy. The patient physician prescribed a prednisone taper (starting at 6 tablets on Tuesday and decreasing from there) the tablets are 4mg tablets she states. She was also prescribed ZANTAC and ZYRTEC to help. She called at the date of reporting concerned these may reduce the effectiveness of the SHINGRIX. The patient also noted that she stopped taking acyclovir 48 hours before the vaccine and would remain off of it for 2 weeks, even though she knows she did not have to. She stated she also did this with the first shot as well. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling, Rash, Rash erythematous
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included psoriasis (but it was well controlled and that was usually just on patient's hands and fingers.). Previously administered products included ZOSTAVAX (in 2010). Concomitant products included SHINGRIX and acyclovir. On 20th January 2019, the patient received the 2nd dose of SHINGRIX. On 20th January 2019, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 21st January 2019, the patient experienced limbs stiffness, injected limb mobility decreased and tiredness. On 22nd January 2019, the patient experienced generalized rash, allergic reaction, itchy rash, hoarseness, hand swelling and erythema of extremities. The patient was treated with ZANTAC, ZYRTEC and prednisone. On an unknown date, the outcome of the injection site pain, limbs stiffness, injected limb mobility decreased, tiredness, generalized rash, allergic reaction, itchy rash, hoarseness, hand swelling and erythema of extremities were unknown. It was unknown if the reporter considered the injection site pain, limbs stiffness, injected limb mobility decreased, tiredness, generalized rash, allergic reaction, itchy rash, hoarseness, hand swelling and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: On 10th November 2018, the patient received 1st shot of SHINGRIX without issue. The patient did not have batch number or information on how much or how from pharmacy, where she got it. The patient experienced hurt when she got it. One day after receiving SHINGRIX, the patient experienced her arm was stiff hard to move her arm and she was very tired. Two days after receiving SHINGRIX, the patient experienced, rash on her arms and legs and her fingers and hands were swollen and red. The patient sounded hoarse on the phone while talking to her friend. The patient stated that the rash was on her left upper arm and under the arm and on the right (the side she had the shot on) the rash was on her lower arm and then on both thighs and it wrapped around the back of her legs to her buttocks. She noted it was flat and just slightly itchy. The patient physician prescribed a prednisone taper (starting at 6 tablets on Tuesday and decreasing from there) the tablets are 4mg tablets she states. She was also prescribed ZANTAC and ZYRTEC to help. She called at the date of reporting concerned these may reduce the effectiveness of the SHINGRIX. The patient also noted that she stopped taking acyclovir 48 hours before the vaccine and would remain off of it for 2 weeks, even though she knows she did not have to. She stated she also did this with the first shot as well. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dysphonia, Erythema, Fatigue, Hypersensitivity, Immediate post-injection reaction
Clinical narrative: I had my first SHINGRIX shot 11/10/2018, no reaction. I had my second SHINGRIX shot 1/20/2019  my arm was stiff and I was tired the next day. The second day I woke up with a red flat non itching rash covering my left upper arm which later expanded into my hand. (I had shot in right arm). My right wrist and hand were red and swollen. Both hands were red and swollen. Both fronts of my thighs were covered with the rash and by the time I went to the doctor at noon on 01/22, it had spread around to my hips and butt. My voice was hoarse. Dr prescribed prednisone, ZYRTEC and ZANTAC for 6 days.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness, Peripheral swelling, Rash generalised
Clinical narrative: I had my first SHINGRIX shot 11/10/2018, no reaction. I had my second SHINGRIX shot 1/20/2019  my arm was stiff and I was tired the next day. The second day I woke up with a red flat non itching rash covering my left upper arm which later expanded into my hand. (I had shot in right arm). My right wrist and hand were red and swollen. Both hands were red and swollen. Both fronts of my thighs were covered with the rash and by the time I went to the doctor at noon on 01/22, it had spread around to my hips and butt. My voice was hoarse. Dr prescribed prednisone, ZYRTEC and ZANTAC for 6 days.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash pruritic
Clinical narrative: I had my first SHINGRIX shot 11/10/2018, no reaction. I had my second SHINGRIX shot 1/20/2019  my arm was stiff and I was tired the next day. The second day I woke up with a red flat non itching rash covering my left upper arm which later expanded into my hand. (I had shot in right arm). My right wrist and hand were red and swollen. Both hands were red and swollen. Both fronts of my thighs were covered with the rash and by the time I went to the doctor at noon on 01/22, it had spread around to my hips and butt. My voice was hoarse. Dr prescribed prednisone, ZYRTEC and ZANTAC for 6 days.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dysphonia, Erythema, Fatigue, Joint swelling, Musculoskeletal stiffness
Clinical narrative: I had my first SHINGRIX shot 11/10/2018, no reaction. I had my second SHINGRIX shot 1/20/2019  my arm was stiff and I was tired the next day. The second day I woke up with a red flat non itching rash covering my left upper arm which later expanded into my hand. (I had shot in right arm). My right wrist and hand were red and swollen. Both hands were red and swollen. Both fronts of my thighs were covered with the rash and by the time I went to the doctor at noon on 01/22, it had spread around to my hips and butt. My voice was hoarse. Dr prescribed prednisone, ZYRTEC and ZANTAC for 6 days.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling, Rash, Rash erythematous
Clinical narrative: I had my first SHINGRIX shot 11/10/2018, no reaction. I had my second SHINGRIX shot 1/20/2019  my arm was stiff and I was tired the next day. The second day I woke up with a red flat non itching rash covering my left upper arm which later expanded into my hand. (I had shot in right arm). My right wrist and hand were red and swollen. Both hands were red and swollen. Both fronts of my thighs were covered with the rash and by the time I went to the doctor at noon on 01/22, it had spread around to my hips and butt. My voice was hoarse. Dr prescribed prednisone, ZYRTEC and ZANTAC for 6 days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Feeling abnormal, Headache, Influenza like illness, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 21st January 2019, the patient received the 2nd dose of SHINGRIX. On 21st January 2019, several hours after receiving SHINGRIX, the patient experienced muscle pain, influenza-like symptoms, joint pain, headache, foggy feeling in head and injection site pain. On an unknown date, the outcome of the muscle pain, influenza-like symptoms, joint pain, headache and foggy feeling in head were recovering/resolving and the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the muscle pain, influenza-like symptoms, joint pain, headache, foggy feeling in head 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 2nd dose of SHINGRIX injection in left deltoid at the pharmacy on 21st January 2019, around 12 noon. Within a couple of hours, they started having miserable side effects further described as terrible muscle aches, like the worst case of flu ever; joint aches; headache; felt in a fog; and soreness at the injection site. On 23rd January 2019, she finally feels better but still had soreness at the left deltoid at the injection site. The reporter did not know lot or expiration date. The reporter gave consent to follow up. This case has been linked with case US2019012770, reported by the same reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 21st January 2019, the patient received the 2nd dose of SHINGRIX. On 21st January 2019, several hours after receiving SHINGRIX, the patient experienced muscle pain, influenza-like symptoms, joint pain, headache, foggy feeling in head and injection site pain. On an unknown date, the outcome of the muscle pain, influenza-like symptoms, joint pain, headache and foggy feeling in head were recovering/resolving and the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the muscle pain, influenza-like symptoms, joint pain, headache, foggy feeling in head 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 2nd dose of SHINGRIX injection in left deltoid at the pharmacy on 21st January 2019, around 12 noon. Within a couple of hours, they started having miserable side effects further described as terrible muscle aches, like the worst case of flu ever; joint aches; headache; felt in a fog; and soreness at the injection site. On 23rd January 2019, she finally feels better but still had soreness at the left deltoid at the injection site. The reporter did not know lot or expiration date. The reporter gave consent to follow up. This case has been linked with case US2019012770, reported by the same reporter.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Influenza like illness, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 58-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 31st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. On 1st June 2018, 1 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced influenza-like symptoms and fever. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the influenza-like symptoms and fever were recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the influenza-like symptoms and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for the 2nd dose of SHINGRIX. The patient received 1st dose of SHINGRIX on right arm. A day after receiving 1st dose of SHINGRIX, the patient experienced fever and flu like symptoms which lasted for a couple days. It has been over 6 months and till the time of reporting, the patient had not received the second dose of SHINGRIX, which led to incomplete course of vaccination. No further details were provided. The reporter did not consent to follow-up.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 80-year-old male patient who received SHINGRIX for prophylaxis.  On 21st January 2019, the patient received the 2nd dose of SHINGRIX. On 22nd January 2019, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms. On 24th January 2019, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The reporter was the wife of the patient. On Monday evening from the reporting date,  the patient received his SHINGRIX. The next day following the injection, the patient experienced flu like symptoms. On 24th January 2019, the reporter indicated that the symptom had all resolved. The reporter did not consent to follow-up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Feeling abnormal, Headache, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 60-year-old male patient who received SHINGRIX for prophylaxis. On 21st January 2019, the patient received SHINGRIX. In January 2019, several hours after receiving SHINGRIX, the patient experienced muscle pain, influenza-like symptoms, joint pain, headache, foggy feeling in head, nausea, injection site hemorrhage, injection site pain and tissue damage. On 21st January 2019, the patient experienced localized erythema. On an unknown date, the outcome of the muscle pain, joint pain, headache, foggy feeling in head and nausea were recovering/resolving and the outcome of the influenza-like symptoms, localized erythema, injection site hemorrhage, injection site pain and tissue damage were unknown. It was unknown if the reporter considered the muscle pain, influenza-like symptoms, joint pain, headache, foggy feeling in head, nausea, localized erythema, injection site hemorrhage, injection site pain and tissue damage to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in left deltoid at the pharmacy and later that day, experienced miserable side effects further described as terrible muscle aches (like worst case of flu ever), joint aches, headache, felt like in a fog, and nausea. In addition, she stated that blood was dripping down her husband's arm after his injection. After a couple of hours, he experienced a redness area about 9cm below the injection site. The patient woke up on 23th January 2019 feeling better except his arm was still sore at injection site and there was a red spot below the injection site that was getting bigger. The area on the skin is red, somewhat circular, flat to the skin, about 9cm in circumference. The caller feels like this was an injection error by the pharmacist. She was concerned about possible tissue damage from the injection and absorption of the vaccine if given incorrectly. Referred caller to the health care professional. The reporter gave consent to follow up. This case has been linked with case US2019012757, reported by the same reporter.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site haemorrhage, Injection site pain, Myalgia, Nausea, Tissue injury
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 60-year-old male patient who received SHINGRIX for prophylaxis. On 21st January 2019, the patient received SHINGRIX. In January 2019, several hours after receiving SHINGRIX, the patient experienced muscle pain, influenza-like symptoms, joint pain, headache, foggy feeling in head, nausea, injection site hemorrhage, injection site pain and tissue damage. On 21st January 2019, the patient experienced localized erythema. On an unknown date, the outcome of the muscle pain, joint pain, headache, foggy feeling in head and nausea were recovering/resolving and the outcome of the influenza-like symptoms, localized erythema, injection site hemorrhage, injection site pain and tissue damage were unknown. It was unknown if the reporter considered the muscle pain, influenza-like symptoms, joint pain, headache, foggy feeling in head, nausea, localized erythema, injection site hemorrhage, injection site pain and tissue damage to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in left deltoid at the pharmacy and later that day, experienced miserable side effects further described as terrible muscle aches (like worst case of flu ever), joint aches, headache, felt like in a fog, and nausea. In addition, she stated that blood was dripping down her husband's arm after his injection. After a couple of hours, he experienced a redness area about 9cm below the injection site. The patient woke up on 23th January 2019 feeling better except his arm was still sore at injection site and there was a red spot below the injection site that was getting bigger. The area on the skin is red, somewhat circular, flat to the skin, about 9cm in circumference. The caller feels like this was an injection error by the pharmacist. She was concerned about possible tissue damage from the injection and absorption of the vaccine if given incorrectly. Referred caller to the health care professional. The reporter gave consent to follow up. This case has been linked with case US2019012757, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved. It was unknown if the reporter considered the sickness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that a friend told him that her doctor (patient) was very sick for several days after he received SHINGRIX.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site bruising in a 65-year-old female patient who received SHINGRIX (batch number HM3NC, expiry date 13th April 2021) for prophylaxis. On 22nd January 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In January 2019, less than a week after receiving SHINGRIX, the patient experienced injection site bruising, injection site erythema, injection site warmth, injection site swelling, injection site mass and injection site induration. On an unknown date, the outcome of the injection site bruising, injection site erythema, injection site warmth, injection site swelling, injection site mass and injection site induration were not recovered/not resolved. It was unknown if the reporter considered the injection site bruising, injection site erythema, injection site warmth, injection site swelling, injection site mass and injection site induration to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left arm. After receiving the SHINGRIX, the patient developed bruising, redness, warmth, swelling and a hard mass at the injection site.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site bruising in a 65-year-old female patient who received SHINGRIX (batch number HM3NC, expiry date 13th April 2021) for prophylaxis. On 22nd January 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In January 2019, less than a week after receiving SHINGRIX, the patient experienced injection site bruising, injection site erythema, injection site warmth, injection site swelling, injection site mass and injection site induration. On an unknown date, the outcome of the injection site bruising, injection site erythema, injection site warmth, injection site swelling, injection site mass and injection site induration were not recovered/not resolved. It was unknown if the reporter considered the injection site bruising, injection site erythema, injection site warmth, injection site swelling, injection site mass and injection site induration to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left arm. After receiving the SHINGRIX, the patient developed bruising, redness, warmth, swelling and a hard mass at the injection site.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Mobility decreased, Nausea, Pain
Clinical narrative: Arm is so sore that I can't lay on it or raise it above shoulder level. Feel achy, tired, nauseous  and have a headache.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm is so sore that I can't lay on it or raise it above shoulder level. Feel achy, tired, nauseous  and have a headache.
Age: 11.0
Sex: M
Vaccine: MEN
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Skin tightness
Clinical narrative: Red, swollen, warm, and tight skin. Started a few hours after injection and has continued and gotten worse over the last 2 days. 1/30/19 at 11:10am - received injection. 1/30/19 at 9pm - site was red, 1/31/19 at 9pm  - site was red, warm and swollen. 2/1/19 at 10am - his school nurse called and concerned about his arm. It is still red, warm, and swollen. Nurse requested me to contact his doctor's office.
Age: 47.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Local reaction, Muscular weakness
Clinical narrative: Systemic Reactions: Grade 3: fatigue, myalgia, muscle weakness beginning <8hrs of vaccination and continuing for 2 days; Grade 2: fever and chills beginning <8hrs of vaccination and continuing for 24h Local Reactions: Grade 2-3: Injection site pain beginning <8h of vaccination and resolving over 5 days.
Age: 47.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Systemic Reactions: Grade 3: fatigue, myalgia, muscle weakness beginning <8hrs of vaccination and continuing for 2 days; Grade 2: fever and chills beginning <8hrs of vaccination and continuing for 24h Local Reactions: Grade 2-3: Injection site pain beginning <8h of vaccination and resolving over 5 days.
Age: 47.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Systemic Reactions: Grade 3: fatigue, myalgia, muscle weakness beginning <8hrs of vaccination and continuing for 2 days; Grade 2: fever and chills beginning <8hrs of vaccination and continuing for 24h Local Reactions: Grade 2-3: Injection site pain beginning <8h of vaccination and resolving over 5 days.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Seizure, Somnolence, Syncope
Clinical narrative: Fainting and seizure/ convulsions. Very Hard to awaken next morning.
Age: 1.5
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 5-6 cm erythematous patch overlying R thigh injection sites with induration at one of the injection sites (unclear which vaccine site). Appeared 1 day after vaccination. Patch resolved within 1 day but induration resolving more slowly, still palpable although small (approx 3-4 mm) on 02/01/19.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 20-JUN-2018, the patient was vaccinated with first dose in the HPV vaccination series with GARDASIL 9 (Lot #, expiration date, route and anatomical location were not reported), on 08-OCT-2018, the patient was vaccinated with second dose of HPV vaccination series with GARDASIL 9 (Lot #, expiration date, route and anatomical location were not reported) and on 02-JAN-2019, the patient was in the pharmacy for her third dose of GARDASIL 9 (Lot #, expiration date, route and anatomical location were not reported) (Inappropriate schedule of product administration). It was reported that this was an altered dosing schedule. No adverse effects were reported.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient had appx 3 inch of swelling and redness around site of injection as well as pain at the injection site.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye pain, Insomnia, Pruritus generalised
Clinical narrative: Stabbing pain over left eye 1/27/2019, random severe itching over body, centering on rear shoulders, around torso at bottom of ribs and rear of hips at top of pelvic bone. Increases during day and caused sleepless nights 1/30/2019 and 1/31/2019.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Decreased appetite, Injection site rash, Rash
Clinical narrative: Strong stomach pain for several days, lingering stomach pain 1 week after vaccination. The pain was bad enough to require bed rest for one full day, and lasted about 4 days at that level of pain. There was a corresponding reduction in appetite, although eating did not seem to worsen stomach pain. No nausea. One week later and I still have some stomach pain. What is unusual is a rash inside the left arm running in a line from wrist to shoulder, which remains as of this writing one week after vaccination. No sensation regarding the rash: no pain, itch, or other sensation. My GP said it looked like shingles without blisters. I also reported the symptom to the pharmacy where vaccination took place. No explanation for the "rash", which I have never experienced before. Several years ago I received the previous version of the Zoster vaccination and had no side effects of any kind.
Age: 4.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, Incorrect route of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Information has been received from a nurse referring to a 4 years old patient of unknown gender. Information about the patient's concomitant medication, pertinent medical history and drug reactions was not provided. On 04-JAN-2019, the patient received a dose of ZOSTAVAX (route reported as intramuscular, lot # N025703 and expiration date16-DEC-2018; frequency was unknown) for prophylaxis (inappropriate schedule of product administration, expired product administered and incorrect route of product administration). No adverse effects were reported.
Sex: M
Vaccine: PNC13
Symptoms: Abdominal pain upper, Dermatitis, Diarrhoea, Discomfort, Pruritus
Clinical narrative: This is a spontaneous report from a contactable pharmacist (patient). A 68-year-old male patient received PREVNAR 13, via an unspecified route of administration on 29Dec2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he received the vaccine on 29Dec2018 and the next day he woke up with "lower stomach pain, diarrhea and a low grade fever". However on 04Jan2019 he broke out with a rash under his chin, neck, both arms and legs, and shoulder. He had "severe itching, was sensitive to touch and uncomfortable". He thought he had shingles but that was ruled out by his dermatologist, who told him it was dermatitis. He was prescribed a steroid cream. As per caller most of the rash has gone away but on his left breast there "a patch and looks like it's spreading". The outcome of the events was unknown. The information on the lot number and expiration date had been requested.
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia, Rash, Tenderness
Clinical narrative: This is a spontaneous report from a contactable pharmacist (patient). A 68-year-old male patient received PREVNAR 13, via an unspecified route of administration on 29Dec2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he received the vaccine on 29Dec2018 and the next day he woke up with "lower stomach pain, diarrhea and a low grade fever". However on 04Jan2019 he broke out with a rash under his chin, neck, both arms and legs, and shoulder. He had "severe itching, was sensitive to touch and uncomfortable". He thought he had shingles but that was ruled out by his dermatologist, who told him it was dermatitis. He was prescribed a steroid cream. As per caller most of the rash has gone away but on his left breast there "a patch and looks like it's spreading". The outcome of the events was unknown. The information on the lot number and expiration date had been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 65-year-old female patient received PREVNAR 13 (lot number X39679, expiration date not provided), via an unspecified route of administration on the left deltoid on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that vaccine was given in left deltoid and the arm became red and painful with symptoms lasted 2 to 3 days. It was stated that the event occurred on an unspecified date after use of product. Outcome of the events was recovered on an unspecified date.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Musculoskeletal pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 71-year-old female patient received PREVNAR 13 (lot number X34315, expiration date not provided) via an unspecified route of administration on left deltoid on an unspecified date at a single dose as immunization. The patient's medical history and concomitant medications were not reported. No other vaccine was given at the same time as PREVNAR 13. It was reported that the patient had a very painful shoulder. The patient also had fever symptoms lasted approximately one week. She was out of work for one week. It was stated that the events occurred on an unspecified date after use of product. Outcome of the event of fever was recovered on an unspecified date while unknown on the remaining event.
Age: 94.0
Sex: M
Vaccine: VARZOS
Symptoms: Death, Injection site erythema, Pain in extremity, Sudden death
Clinical narrative: I am sure the staff of the hospital where he received both doses (this was his second dose) do not see a connection between receiving this dose and his death, about 12 hours or less later. I am sure this has not been reported. I am not positive of the time of injection, nor the exact time of death, but it is roughly about 9-11 hours apart. I am not sure he got the right medicine. After the first dose, he complained seriously for a week of arm pain and injection site redness. This dose was easy! according to him. My brother spoke with him about 6 or 7pm that evening. No pain at all, but it had only been a few hours. He collapsed with sudden death at home that evening and was found dead the following day. It was clearly sudden (and unexpected); he had his gym bag packed and ready to go the next morning by the kitchen door. Even at 94, he still went to an exercise class three times a week and was very active. I had seen him exactly one week prior and he was totally fine. I will always be suspicious of this dose of SHINGRIX.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Musculoskeletal stiffness, Nausea
Clinical narrative: Headache forehead, nausea, stiff neck. Stiff neck, pain at base of skull and nausea became worse. I am still experiencing all the adverse effects on 9th day.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Pruritus, Skin lesion
Clinical narrative: Multiple raised reddish-purple closed lesions anterior lower extremities from upper thighs to ankles  worse on medial aspect. Lesions are pruritic. BENADRYL 25-50mg po q 6-8 hrs, MEDROL dosepak. Follow up scheduled pending.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling hot, Headache, Lethargy, Sinus disorder
Clinical narrative: At first, cold chills, then hot, then headache in back of neck, then sinus involvement, then headache in front of head, and major lethargy for the next 24 hours.