chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity, Product administered at inappropriate site, Tendon injury
Clinical narrative: Her doctor thinks she has a damaged tendon / experienced tendon problem on her right arm / radiating into her neck; that went up into her neck; Her doctor mentioned / vaccine could be administered higher than normal, on the tendon; Had arm pain that went up into her neck / rolling around on the floor in severe pain / right arm has been hurting for 2 years; This case was reported by a nurse via call center representative and described the occurrence of tendon injury in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number ER5ZB, expiry date 9th June 2021) for prophylaxis.   On 1st March 2019, the patient received Shingrix (intramuscular). On 1st March 2019, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On an unknown date, the patient experienced tendon injury, pain in arm and neck pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the tendon injury and neck pain were not recovered/not resolved and the outcome of the pain in arm was recovered/resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the tendon injury, pain in arm and neck pain to be related to Shingrix.  Additional details were provided as follows: The patient was reporting for herself. The age at vaccination was not reported. The patient received Shingrix in right arm. After receiving Shingrix, the patient had arm pain that went up into her neck and was rolling around on the floor in severe pain but did not go to the hospital, her doctor told her it would resolve.  The patient went back to get the 2nd dose in her left arm and did not have any complications from the 2nd dose in the left arm.  Her right arm had been hurting for 2 years. The patient stated her doctor thought she had a damaged tendon and she was taking Tylenol daily. The patient stated, her arm pain got worse in cold weather and she would like to know what she could take. At the time of reporting, the patient was experiencing this adverse event and symptoms were worsening. The patient said that, her doctor mentioned that, it could be due to vaccine injection site, that vaccine could be administered higher than normal, on the tendon which led to vaccine administered at inappropriate site was. No further information was provided.  The reporter consented to follow up not asked.  The batch number of Shingrix was reported as ER52B which was corrected to ER5ZB as per sales data sheet.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Taking them a long time to get over it / knocked for a loop / not expecting / pain, to last for so long; This case was reported by a consumer via call center representative and described the occurrence of pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   The reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's friend. The patient was non-diabetic (negative for diabetes) and she was healthy, active, exercised and had healthy diet. The patient was in her late 70's/early 80's. The age at vaccination was not reported.  It was unknwon if the rection occurred after 1st or 2nd  shot of shingrix. The reporter mentioned that, the patient told her taking them a long time to get over it, they were knocked for a loop and not expecting the side ffects, such as pain, to last for so long. The reporter provided limited information.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021017003:Same reporter US-GLAXOSMITHKLINE-US2021017036:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: COVID-19
Clinical narrative: Developed Covid-19 disease; This case was reported by a other health professional via call center representative and described the occurrence of covid-19 in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th August 2020, the patient received the 1st dose of Shingrix. On 1st December 2020, 113 days after receiving Shingrix, the patient experienced covid-19. On an unknown date, the outcome of the covid-19 was resolved with sequelae.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient developed Covid-19 disease after vaccination with 1st dose. Till the time of reporting patient was not feeling the best and healthcare professional wanted to postpone, probably, the 2nd dose until patient fully recovers from the Covid-19. The reporter was asked for information regarding the probable late 2nd dose of the Shingrix for a patient. The agent did not consider this an adverse event since Covid-19 case was several months after first dose and healthcare professional focused on the probable late 2nd dose and not on the Covid-19. For tolerance with 2nd dose refer case US2021AMR024456. No consent for follow-up was collected by the agent . ; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR024456:same reporter
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Incomplete course of vaccination, Malaise, Nausea, Pyrexia
Clinical narrative: May have been / an allergic reaction / Nausea; May have been / an allergic reaction / Fever; May have been / an allergic reaction / Small rash; May have been / an allergic reaction / did not feel well; Allergic reaction; She has not had her second dose; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced nausea, fever, rash, feeling unwell, allergic reaction and incomplete course of vaccination. On an unknown date, the outcome of the nausea, fever, rash and feeling unwell were recovered/resolved and the outcome of the allergic reaction and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the nausea, fever, rash, feeling unwell and allergic reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for the 2nd dose. The patient received the 1st dose of Shingrix on left arm. The physician thought her symptoms after the first dose, might have been the result of an allergic reaction. The did not feel well, had nausea, a fever and a small rash. Patient did not remember the location of rash. Till the time of reporting patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: May have been / an allergic reaction / Nausea; May have been / an allergic reaction / Fever; May have been / an allergic reaction / Small rash; May have been / an allergic reaction / did not feel well; Allergic reaction; She has not had her second dose; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced nausea, fever, rash, feeling unwell, allergic reaction and incomplete course of vaccination. On an unknown date, the outcome of the nausea, fever, rash and feeling unwell were recovered/resolved and the outcome of the allergic reaction and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the nausea, fever, rash, feeling unwell and allergic reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for the 2nd dose. The patient received the 1st dose of Shingrix on left arm. The physician thought her symptoms after the first dose, might have been the result of an allergic reaction. The did not feel well, had nausea, a fever and a small rash. Patient did not remember the location of rash. Till the time of reporting patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: pain at the injection site / like " a punch in the arm."; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows:  The patient reported case for herself. The age at vaccination was not reported, but it could be 52 or 53 years. The patient stated that within 3 hours of dose 1 she had left arm pain at the injection site. The patient stated it felt like a punch in the arm. The patient shared vaccine experience during meeting to this agent. The reporter did not consent to follow up. For tolerance of 2nd dose refer case US2021047798.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021047798:same patient, same reporter, 2nd dose
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia
Clinical narrative: pain at the injection site; myalgia; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received in 2019, refer case US2021047797).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site pain and myalgia. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and myalgia were recovered/resolved.   It was unknown if the reporter considered the injection site pain and myalgia to be related to Shingrix.  Additional information was provided as follows: The case was reported by patient herself. The age at vaccination was not reported, but it could eb 53 or 54 years. The patient stated that within 3 hours of receiving dose 2, she experienced left arm pain at the injection site that resolved after 3 days.  She stated experiencing myalgia 1 day after her dose that lasted for 3 days and resolved. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021047797:same patient, same reporter, 1st dose
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site pain, Injection site reaction, Insomnia, Movement disorder
Clinical narrative: felt a popping or burst at the injection site / popping sound heard; pain, at the injection site, when he went to use his left arm/pain on his left arm; pain / has awakened him; pain on his left arm is evident when he moves to reach back for his seat belt / to put on his coat; injection site may have been a little low on his arm; This case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of no adverse event (1st dose received on 13th August 2020).   On 5th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 5th December 2020, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On 7th December 2020, the patient experienced injection site discomfort, pain in arm, poor sleep and activities of daily living impaired. On an unknown date, the outcome of the injection site discomfort, pain in arm, poor sleep, activities of daily living impaired and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site discomfort, pain in arm, poor sleep and activities of daily living impaired to be related to Shingrix.  Additional details were reported as follows: The patient felt a popping or burst at the injection site when he moved his left arm behind his head. The patient did not thinking too much of the popping sound heard, but began to have consistent pain, at the injection site, when he went to use his left arm. The patient reported that pain on his left arm was evident when he moves to reach back for his seat belt, when he moves to put on his coat, it had awakened him in the middle of the night when he turns over in bed on the left side. The patient reported that when he experiences pain, he rubs the area of the injection site on the left arm that helps to dissipate the pain. The patient went to see his Health Care Professional and the only thing his HCP told him was the Shingrix injection site might have been a little low on his arm, which led to vaccine administered at inappropriate site. No medication was prescribed for pain. The patient did not take Tylenol or Ibuprofen for the pain. The patient would like to talk to someone from safety team, to see if others have experienced this type of adverse event. The patient did not given permission to his contact Health Care Professional. The reporter did not consented to follow up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: felt a popping or burst at the injection site / popping sound heard; pain, at the injection site, when he went to use his left arm/pain on his left arm; pain / has awakened him; pain on his left arm is evident when he moves to reach back for his seat belt / to put on his coat; injection site may have been a little low on his arm; This case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of no adverse event (1st dose received on 13th August 2020).   On 5th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 5th December 2020, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On 7th December 2020, the patient experienced injection site discomfort, pain in arm, poor sleep and activities of daily living impaired. On an unknown date, the outcome of the injection site discomfort, pain in arm, poor sleep, activities of daily living impaired and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site discomfort, pain in arm, poor sleep and activities of daily living impaired to be related to Shingrix.  Additional details were reported as follows: The patient felt a popping or burst at the injection site when he moved his left arm behind his head. The patient did not thinking too much of the popping sound heard, but began to have consistent pain, at the injection site, when he went to use his left arm. The patient reported that pain on his left arm was evident when he moves to reach back for his seat belt, when he moves to put on his coat, it had awakened him in the middle of the night when he turns over in bed on the left side. The patient reported that when he experiences pain, he rubs the area of the injection site on the left arm that helps to dissipate the pain. The patient went to see his Health Care Professional and the only thing his HCP told him was the Shingrix injection site might have been a little low on his arm, which led to vaccine administered at inappropriate site. No medication was prescribed for pain. The patient did not take Tylenol or Ibuprofen for the pain. The patient would like to talk to someone from safety team, to see if others have experienced this type of adverse event. The patient did not given permission to his contact Health Care Professional. The reporter did not consented to follow up.
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Illness
Clinical narrative: became ill; This case was reported by a consumer via call center representative and described the occurrence of illness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA SHOT) for prophylaxis.   On an unknown date, the patient received Shingrix and PNEUMONIA SHOT. On an unknown date, unknown after receiving Shingrix, the patient experienced illness. On an unknown date, the outcome of the illness was unknown.   It was unknown if the reporter considered the illness to be related to Shingrix.  Additional details provided as follow: This case was reported by the patient's friend. The age group was not reported but it was selected as adult as per vaccine indication. The dates, patient demographics or specifics of the event were not known. Formulation of shingrix was not specified. The patient received Shingrix and pneumonia shot on the same day and became ill. No further information was provided
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group at vaccination was not reported but was captured as an adult as per vaccine indication. The reporter reported that, the patient had pain at the injection site after receiving the first dose of the shingrix vaccine. No further details were provided. The reporter did not consented to follow up.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: is hard to move around; left arm still hurts / is aching all the time / her right arm also hurt; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included surgery (recently had done on back and face or lip.).   On 18th January 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injected limb mobility decreased and pain in arm. On an unknown date, the outcome of the injected limb mobility decreased and pain in arm were not recovered/not resolved.   The reporter considered the injected limb mobility decreased and pain in arm to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient herself. The patient did not want to provide her email address and did not have a personal fax number. The had her 1st shingles shot, she could not find documentation that specifically it was Shingrix or Zostax, but the pharmacist told her that it was a 2 dose series. The patient provided contact information for the pharmacy who administered the shot. The patient did not have the lot number, expiration date or product name or NDC available on the paperwork she had. The paperwork said shingles zoster. The patient was given the shot in the left deltoid. The patient did not look at the size of the needle thus she did not know if it was given intramuscularly. The patient stated that her left arm still hurts, it was aching all the time and was hard to move around. The patient was concerned that perhaps the pharmacist might have injected improperly because she had never had a problem with any other injections and she was healthy for her age. The patient was concerned that left arm pain could be the sign of the heart attack but she had conclude that if that was the case she would have died by the time of report. The patient did not reported the left arm pain to her physician because she did not want to go to the physician. The patient had some surgery recently done on her back and face or lip and indicated that she had something taken off her back and 2 things taken off her face. The patient was not relating this to Shingrix just said that was the reason she was not in the mood to got to the physician right before the report. The patient also mentioned that at one point since the shot, her right arm also hurt, might be the right arm pain was due to sympathy pain. The right arm pain had recovered. The patient stated that she was hesitant about getting the 2nd dose of the Zoster (Shingrix) series. The reporter consented to follow up.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Gait disturbance, Gout, Pain
Clinical narrative: gout in the left lower big toe joint area / appeared on 3/4/2021 and is ongoing; sharp excruciating pain; is debilitating; and he can not walk.; shoulder pain; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd March 2021, the patient received the 1st dose of Shingrix (intramuscular). On 3rd March 2021, less than a day after receiving Shingrix, the patient experienced shoulder pain. On 4th March 2021, the patient experienced gout and pain. In March 2021, the patient experienced debility and unable to walk. On an unknown date, the outcome of the shoulder pain was recovered/resolved and the outcome of the gout, pain, debility and unable to walk were not recovered/not resolved.   It was unknown if the reporter considered the shoulder pain, gout, pain, debility and unable to walk to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. The patient experienced shoulder pain. The shoulder pain lasted and resolved in two to three days. One day after vaccination, the patient experienced gout and pain. The patient also reported gout in the left lower big toe joint area. He described the gout as a sharp excruciating pain. He states that the gout appeared on 4th March 2021 and was ongoing.  Less than a week after vaccination, the patient experienced debility and unable to walk. The patient stated that this gout was debilitating and he could not walk. He reported that he had not changed his diet.  The reporter consented to follow up
Age: 66.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site pain, Mobility decreased, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: Remained with pain / at the injection site; Remained with pain / muscle weakness; Muscle stiffness; Is limiting range of motion; Is painful; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 66-year-old male patient who received HAV (Havrix) (batch number 3C7ZG, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th September 2020, the patient received the 1st dose of Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, less than 6 months after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced injection site pain, muscle weakness, muscle stiffness, mobility decreased and pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the muscle weakness, muscle stiffness, mobility decreased and pain were unknown.   It was unknown if the reporter considered the injection site pain, muscle weakness, muscle stiffness, mobility decreased and pain to be related to Havrix and Havrix Pre-Filled Syringe Device.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient was administered Havrix first dose and remained with pain and at the injection site and muscle weakness.  The patient did not have induration. The patient had muscle stiffness that was limiting range of motion and after a while was painful. The reporter did not consent to follow-up.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Bone pain, Feeling cold, Gastrointestinal pain, Headache
Clinical narrative: headache; every bone in her body hurt; painful GI cramping; freezing to death; her joints hurt; This case was reported by a consumer via call center representative and described the occurrence of headache in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th January 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 26th January 2021, less than a day after receiving Shingrix, the patient experienced headache, bone pain, gastrointestinal cramps, feeling cold and joint pain. On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the bone pain, gastrointestinal cramps, feeling cold and joint pain were recovered/resolved.   It was unknown if the reporter considered the headache, bone pain, gastrointestinal cramps, feeling cold and joint pain to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. The patient reported that she received shingrix dose and had headache, was freezing to death, her joints and every bone in her body started to hurt on the evening of vaccination day. The patient reported laying on her couch for 3 days. The reporter reported painful GI cramping, which started on the evening of the same day. The reporter reported that the freezing, joint/bone pain, and gastrointestinal cramping resolved after 2 to 3 days. The reporter reported that about having no temperature or flu after taking the vaccine. The patient was unable to provide the email/fax number of her physician, her own fax number, as well as the dose, lot number or expiration date of the second shingrix dose.  The patient declined to provide her address and phone number. The reporter consented to follow up.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain
Clinical narrative: headache; every bone in her body hurt; painful GI cramping; freezing to death; her joints hurt; This case was reported by a consumer via call center representative and described the occurrence of headache in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th January 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 26th January 2021, less than a day after receiving Shingrix, the patient experienced headache, bone pain, gastrointestinal cramps, feeling cold and joint pain. On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the bone pain, gastrointestinal cramps, feeling cold and joint pain were recovered/resolved.   It was unknown if the reporter considered the headache, bone pain, gastrointestinal cramps, feeling cold and joint pain to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. The patient reported that she received shingrix dose and had headache, was freezing to death, her joints and every bone in her body started to hurt on the evening of vaccination day. The patient reported laying on her couch for 3 days. The reporter reported painful GI cramping, which started on the evening of the same day. The reporter reported that the freezing, joint/bone pain, and gastrointestinal cramping resolved after 2 to 3 days. The reporter reported that about having no temperature or flu after taking the vaccine. The patient was unable to provide the email/fax number of her physician, her own fax number, as well as the dose, lot number or expiration date of the second shingrix dose.  The patient declined to provide her address and phone number. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased
Clinical narrative: Having a very high heartrate; This case was reported by a consumer via call center representative and described the occurrence of heart rate high in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced heart rate high. On an unknown date, the outcome of the heart rate high was unknown.   It was unknown if the reporter considered the heart rate high to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The age at vaccination was not reported. The reporter declined to provide any demographics. The patient had very high heartrate, after receiving second dose of Shingrix a year ago from the reporting date. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Pain
Clinical narrative: body aches; malaise; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix received in November 2020). Concomitant products included COVID 19 VACCINE and COVID 19 VACCINE.   On 10th March 2021 11:00, the patient received the 2nd dose of Shingrix. On 10th March 2021, less than a day after receiving Shingrix, the patient experienced general body pain and malaise. On an unknown date, the outcome of the general body pain and malaise were not recovered/not resolved.   It was unknown if the reporter considered the general body pain and malaise to be related to Shingrix.  Additional details were provided as follows: The patient reported case for herself. The patient reported before 2nd dose, the patient was vaccinated with two Covid Shots in January 2021 and 8th February 2021, Respectively. The patient received Shingrix at around 11Am and at 3 or 4 PM, the patient experienced body ache and malaise. The patient stated that, these symptoms got worse through the night and were still present and not resolved.  The patient did not consented to follow up. The patient declined to give any demographic information (including initials, gender, and date of birth), declined the consent to follow-up with the HCP (health care provider). The patient was unable to provide the dosage, route of administration, and lot or expiration date for the second dose.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Head discomfort, Initial insomnia, Neuralgia, Paraesthesia
Clinical narrative: "can't lay down on a pillow," there is tingling of the head/nerve sensations; "head can't lay down on a pillow,"; was unable to fall asleep; This case was reported by a consumer and described the occurrence of tingling in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th November 2020, the patient received the 1st dose of Shingrix (intramuscular). In November 2020, less than a week after receiving Shingrix, the patient experienced tingling, head discomfort and trouble falling asleep. The patient was treated with trazodone and melatonin. On an unknown date, the outcome of the tingling, head discomfort and trouble falling asleep were recovering/resolving.   The reporter considered the tingling, head discomfort and trouble falling asleep to be possibly related to Shingrix.  Additional details were reported as follows: The case was reported by the patient himself. The patient experienced adverse events within a week after 1st dose of Shingrix. The patient stated that he could not lay down on the pillow, there was tingling of the head, nerve sensation and that he was unable to fall asleep. The patient then had Trazodone and Melatonin to calm things down. The patient had visited the health care professional (HCP) and was told that everything looks good. The patient thought the adverse events might have been caused from the Shingrix vaccine because of the timing of the vaccine as well as information that he found online. The patient would follow up with the HCP details for safety to contact. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles outbreak; This case was reported by a nurse via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced a shingles outbreak before receiving the second dose. The patient did not received the second dose. The reporter consented to follow up.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discomfort, Musculoskeletal stiffness
Clinical narrative: discomfort at the injection site; stiffness; This case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number CL335, expiry date unknown) for prophylaxis.   On 16th September 2020, the patient received the 1st dose of Shingrix. On 16th September 2020, 30 min after receiving Shingrix, the patient experienced injection site discomfort and stiffness. On 16th September 2020, the outcome of the injection site discomfort and stiffness were recovered/resolved.   It was unknown if the reporter considered the injection site discomfort and stiffness to be related to Shingrix.  Additional information was provided as follows: This case was reported by patient himself. The patient received 1st dose of Shingrix in left deltoid and experienced discomfort at the injection site and stiffness which both started about a half hour after the vaccination was received and which were resolved 2 hours after the vaccination. The patient did not ask any questions about Shingrix but gives consent to email Shingrix PI (package insert). The reporter gives consent to follow up with his healthcare professional. The reporter consented to follow up. For the tolerance of 2nd dose, refer case- US2021AMR063144, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063144:same reporter
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Communication disorder, Dizziness, Gait disturbance, Lethargy, Somnolence
Clinical narrative: called to pt vehicle for n/v, minimally communicative down syndrome adult in presence of mother, pt unsteady on feet, scant yellow vomit. Pt escorted to observation tent. While in observation pt O2 sat decreased to 80%, pt became lethargic & dizzy. EMS called at 1334, arrived at 1340.  EMS onsite O2 applied and O2 sat improved to 92%, somnolence continued, VS obtained glucose 101, BP 126/74, pulse 77, O2 93%. Pt left site via stretcher with EMS in route to nearest ER for futher eval & tx.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: called to pt vehicle for n/v, minimally communicative down syndrome adult in presence of mother, pt unsteady on feet, scant yellow vomit. Pt escorted to observation tent. While in observation pt O2 sat decreased to 80%, pt became lethargic & dizzy. EMS called at 1334, arrived at 1340.  EMS onsite O2 applied and O2 sat improved to 92%, somnolence continued, VS obtained glucose 101, BP 126/74, pulse 77, O2 93%. Pt left site via stretcher with EMS in route to nearest ER for futher eval & tx.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Underdose
Clinical narrative: Due to an error in mixing, the patient only received the diluent
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Patient experienced extreme fatigue for 48 hours requiring rest most of the day.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pain, Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: Approximately 48 hours after receiving the vaccine, i developed what may  be described as "Covid Arm": A warm, red large circle surrounding the injection site that was tender to the touch and itchy at times. Additionally, I developed a hard mass under the skin at the injection site. The redness and itchiness lasted about a week. The redness increased with touch and after showers. The itchiness slighlt subsided with topical cortisone. The pain/tenderness surrounding the hard mass lasted about 12 days. I'm currently 13 days out from receipt of vaccination and continue to have the hard mass under the injection site.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Soreness, redness,  swelling and itching on shot site. Used cold compress
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Haematemesis, Haemoglobin, Nausea
Clinical narrative: Reported nausea with bloody emesis x 1 on 3-18-21 at 2247 .  sent to Emergency Room for rule out of GI bleed.  Diagnosis of nausea and vomiting from ED physician.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dry skin, Feeling hot, Flushing, Pruritus, Rash
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash erythematous
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction, Flushing, Palpitations
Clinical narrative: 3/19/2021   Patient  was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, she experienced an adverse reaction with the following symptoms:  . Complained of a heart racing and feeling flushed   Assessment : Time of assessment. 0920a   Actions taken:  Vitals sign taken BP- 121/78. HR- 94, O2 - 100%. Recheck at 0921- 78  Waited in observation 30 mins         Medications administered: No medication administered.   Disposition:The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system.       Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 3/19/2021  9:11 AM 0.3 mL 12/11/2020 Intramuscular   Manufacturer: Pfizer, Inc   Lot: ER8727   NDC: 59267-1000-1          Electronically signed by , RN at 3/19/2021 11:52 AM  Immunization on 3/19/2021
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Progress Notes (Nurse Practitioner) ? ?  Cosigned by: MD at 3/18/2021  2:57 PM Expand AllCollapse All    COVID VACCINE CLINIC 3/16/2021    Date:  3/16/2021    Subjective Patient is a 70 y.o. female who was seen at COVID Vaccine Clinic today for her first  dose of the COVID 19 vaccination.    She was given the Pfizer vaccination in the left deltoid muscle in the medical bay by staff given prior allergic rxn to unspecified eye gtt.   During her 30 minute waiting period after the injection, the patient began to experience headache.  She denied rash or SOA   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to red flag findings.   PMH anaphylaxis to unspecified eye gtss, prompting vaccine to be given under observation in medical bay. During 30" observation period, pt developed mild headache. Pt treated with Tylenol 500 mg tab x 2.      ALLERGY REVIEW OF SYSTEMS:  Patient complains of headaches    Mild headache during 30" observation period: CONT negative HENT negative Eyes negative Respiratory negative Skin negative GI negative Musculo negative     Previous Reactions: anaphylaxis to an unspecified eye gtt as a teenager        Objective    Vitals Vitals:   03/16/21 1522 BP: 110/68 Pulse: 55            Physical Exam Constitutional:      Appearance: Normal appearance.  HENT:     Head: Normocephalic.     Nose: Nose normal.     Mouth/Throat:     Mouth: Mucous membranes are moist.     Pharynx: No oropharyngeal exudate.  Eyes:     Pupils: Pupils are equal, round, and reactive to light.  Cardiovascular:     Rate and Rhythm: Normal rate.  Pulmonary:     Effort: Pulmonary effort is normal.     Breath sounds: Normal breath sounds.  Skin:    General: Skin is warm and dry.  Neurological:     General: No focal deficit present.     Mental Status: She is alert and oriented to person, place, and time.  Psychiatric:        Behavior: Behavior normal.    Clinically, pt developed a mild headache during 30" observation. She was administered her vaccine Dose #1 of 2 in the medical bay after reporting having anaphylaxis to an unspecified eye gtt as a teenager.     Assessment/Plan  Treatment included: observation, Tylenol, snacks Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health)         Electronically Signed 3/16/2021 3:23 PM
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Pyrexia, Seizure, Vomiting
Clinical narrative: Mini seizure; Diarrhea; Slight temperature; Vomiting; A spontaneous report was received from a consumer concerning an 84-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events of slight temperature/fever, vomiting, diarrhea and short seizure early in the morning.  The patient's medical history include type 1 diabetic, history of mini seizures and had a pacemaker installed a week ago-did have check up after and was good. Concomitant medications reported were levetiracetam  - anti seizure, Insulin 2 times per day taking for type 1 diabetes.  On 22 Jan 2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: 029120A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  He was fine after taking vaccine, but on 28 Jan 2021 started developing symptoms.  On 28 Jan 2021, the patient experienced the events of slight temperature, vomiting and diarrhea. On the same day, patient experienced the event of mini seizers for about 5 min in early morning and took levetiracetam. No other treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patient's history of seizure was a strong confounder of the event of short seizure early in the morning.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Nausea, Pyrexia
Clinical narrative: Headache, fever over 100, chills, weakness, nausea and vomiting  subsiding by the second day.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Headache, fever over 100, chills, weakness, nausea and vomiting  subsiding by the second day.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: The Rph from the pharmacy, was the immunizer that administered Covid vaccine for the health facility. He was incorrectly given a list of patients that needed to receive a second dose of the Covid vaccine . Unfortunately, the patients had already received their second dose on 2/2/2021 and received a third dose. The patients  were not able to communicate the receipt of the second dose earlier.  The dose had not been updated in the patient's chart correctly. Once the error had been discovered, vaccinations were stopped until a correct patient list could be produced. Facility was instructed to watch and monitor the patients for adverse effects and report them through the VAERS reporting system.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Pain, Pain in extremity, Ultrasound Doppler abnormal
Clinical narrative: Woke up with pain in left leg lower calf on  February 26 one week after my second vaccine. Had pain and throbbing in leg couldn?t sleep with pain so on  the evening of March 3rd I went to urgent care . Doctor didn?t think it was blood clot because I had no swelling or redness in my leg but gave me a script for ultrasound. I couldn?t get an appointment until  the morning of March 5th . Was diagnosed with a very large blood clot in lower leg  going up past my knee. I am now in Eliquis blood thinner for 3 months while they run tests
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Swollen tongue
Clinical narrative: Pt received vaccination around 9am on 3/18. Started having lip swelling next day and presented back to the pharmacy on 3/19 around 1:15pm. Pt states he was having no tongue swelling or any other symptoms, just swelling of the lower lip. We administered 25mg of benadryl and kept an eye on him in pharmacy for 15 minutes and he said he was feeling fine and would check back with us. Pt is an associate so pharmacy is keeping an eye on him.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Nausea, Pyrexia
Clinical narrative: Fever, chills, nauseous, diarrhea, headache  Took Tylenol  Lasted 2 1/2 days
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Formication, Paraesthesia, Pruritus, Sleep disorder
Clinical narrative: Shot was given at 1:12pm, immediately could taste the vaccine in the back of my throat. Went to waiting area for 15 minutes. Left to  go home, my face cheeks started to turn red within the next 30 minutes. A couple of hours later my skin was tingling, itching, even inside my ears, around my ankles. Took some Benadryl, knowing that it was an allergic reaction, but it didn't help. Couldn't sleep, felt like my skin was crawling. Around 4 am my skin finally calmed down. Sent a message to my Dr. to let him know what happened. Still some lingering itching the next day. Today is Friday March 19, most everything is back to normal.