chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Full blood count normal, Injection site erythema, Injection site inflammation, Measles post vaccine, Pyrexia
Clinical narrative: mild cases of measles/ red and inflamed, small dots over arms, legs, trunk, and back/ fever 102F; injection site was red and inflamed; injection site was red and inflamed; This spontaneous report was received from a registered nurse and refers to a 12-month-old female patient. Concomitant therapies included hepatitis a virus vaccine inactivated (HAVRIX) and influenza virus vaccine (unspecified) (INFLUENZA VIRUS VACCINE (UNSPECIFIED)) (reported as second dose baby flu). There was no information about the patient's concurrent conditions or medical history provided.  On 22-JAN-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S013711, expiration date 01-NOV-2020, via subcutaneous route for 1 year wellness visit vaccines, reconstituted with sterile diluent (strength, exact dose, lot # and expiration date were not reported). On 31-JAN-2020, the patient experienced fever 102 degrees Fahrenheit (38.89 degree Celsius), small dots over arms, legs, trunk, and back, injection site redness and inflammation. The patient came in office on 02-JAN-2020, and as the treatment the patient received ibuprofen (MOTRIN), acetaminophen (TYLENOL) and diphenhydramine hydrochloride (BENADRYL). Complete blood count results was normal.  The reporter stated that this case was likely mild case of measles and would most likely not result in any samples being submitted to the Vaccine Program. Lot check was requested by the reporter.  The outcome of the events was unknown. The causality assessment between the events and suspect therapy was not provided. Additional information has been requested.  Upon internal review, the event of measles was considered to be medically significant.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2002USA001548: US-009507513-2002USA001507: US-009507513-2002USA001425: US-009507513-2002USA001134:
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: mild cases of measles/ red and inflamed, small dots over arms, legs, trunk, and back/ fever 102F; injection site was red and inflamed; injection site was red and inflamed; This spontaneous report was received from a registered nurse and refers to a 12-month-old female patient. Concomitant therapies included hepatitis a virus vaccine inactivated (HAVRIX) and influenza virus vaccine (unspecified) (INFLUENZA VIRUS VACCINE (UNSPECIFIED)) (reported as second dose baby flu). There was no information about the patient's concurrent conditions or medical history provided.  On 22-JAN-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S013711, expiration date 01-NOV-2020, via subcutaneous route for 1 year wellness visit vaccines, reconstituted with sterile diluent (strength, exact dose, lot # and expiration date were not reported). On 31-JAN-2020, the patient experienced fever 102 degrees Fahrenheit (38.89 degree Celsius), small dots over arms, legs, trunk, and back, injection site redness and inflammation. The patient came in office on 02-JAN-2020, and as the treatment the patient received ibuprofen (MOTRIN), acetaminophen (TYLENOL) and diphenhydramine hydrochloride (BENADRYL). Complete blood count results was normal.  The reporter stated that this case was likely mild case of measles and would most likely not result in any samples being submitted to the Vaccine Program. Lot check was requested by the reporter.  The outcome of the events was unknown. The causality assessment between the events and suspect therapy was not provided. Additional information has been requested.  Upon internal review, the event of measles was considered to be medically significant.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2002USA001548: US-009507513-2002USA001507: US-009507513-2002USA001425: US-009507513-2002USA001134:
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Feeling abnormal, Injection site pain, Malaise, Myalgia
Clinical narrative: felt lousy; she had aches and pains/ still felt achy; an issue with her vision; she couldn't read the small print on her credit card statement and things were blurry; muscle ached; Bone ached; she had aches and pains/ arm was so sore; she experienced tenderness at the site/ stung at the injection site; deadly ill/ sick; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (For tolerance of 1st dose refer case US2020019100).   On 29th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, 3 hrs after receiving Shingrix, the patient experienced feeling unwell, muscle pain, bone pain, pain in arm and injection site pain. On 31st January 2020, the patient experienced pain, abnormal vision and blurred vision. On an unknown date, the patient experienced feeling bad. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the feeling unwell, pain, muscle pain, bone pain and feeling bad were recovered/resolved and the outcome of the abnormal vision and blurred vision were not recovered/not resolved and the outcome of the pain in arm and injection site pain were unknown.   It was unknown if the reporter considered the feeling unwell, pain, muscle pain, bone pain, abnormal vision, blurred vision, feeling bad, pain in arm and injection site pain to be related to Shingrix.  Additional information received were as follows: This case was reported by patient herself. On 29th January 2020 at 2:00 PM, the patient received a dose of Shingrix. Post vaccination the patient felt lousy with sore arm and had stung and tenderness at the injection site.  The arm was so sore when lifting things. The patient was sick, deadly ill and every bone and muscle ached and she had pains which subsided but she noticed an issue with her vision at that time.   The patient claimed that she put glasses on and she couldn't read the small print on her credit card statement and things were blurry which she never experienced prior to the vaccination.  The patient's vision issues remain unchanged. The patient felt achy and sick but her symptoms were better. At the time of reporting all the side effects resolved except for the vision concerns.   The patient wondered if the vaccine was too strong for her small frame.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Vision blurred, Visual impairment
Clinical narrative: felt lousy; she had aches and pains/ still felt achy; an issue with her vision; she couldn't read the small print on her credit card statement and things were blurry; muscle ached; Bone ached; she had aches and pains/ arm was so sore; she experienced tenderness at the site/ stung at the injection site; deadly ill/ sick; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (For tolerance of 1st dose refer case US2020019100).   On 29th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, 3 hrs after receiving Shingrix, the patient experienced feeling unwell, muscle pain, bone pain, pain in arm and injection site pain. On 31st January 2020, the patient experienced pain, abnormal vision and blurred vision. On an unknown date, the patient experienced feeling bad. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the feeling unwell, pain, muscle pain, bone pain and feeling bad were recovered/resolved and the outcome of the abnormal vision and blurred vision were not recovered/not resolved and the outcome of the pain in arm and injection site pain were unknown.   It was unknown if the reporter considered the feeling unwell, pain, muscle pain, bone pain, abnormal vision, blurred vision, feeling bad, pain in arm and injection site pain to be related to Shingrix.  Additional information received were as follows: This case was reported by patient herself. On 29th January 2020 at 2:00 PM, the patient received a dose of Shingrix. Post vaccination the patient felt lousy with sore arm and had stung and tenderness at the injection site.  The arm was so sore when lifting things. The patient was sick, deadly ill and every bone and muscle ached and she had pains which subsided but she noticed an issue with her vision at that time.   The patient claimed that she put glasses on and she couldn't read the small print on her credit card statement and things were blurry which she never experienced prior to the vaccination.  The patient's vision issues remain unchanged. The patient felt achy and sick but her symptoms were better. At the time of reporting all the side effects resolved except for the vision concerns.   The patient wondered if the vaccine was too strong for her small frame.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain in extremity, Pain of skin
Clinical narrative: skin stings; Sore arm; fatigue for 2-3 days; slight headache; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number F49L5, expiry date 12th January 2021) for prophylaxis.   On 25th January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced pain in arm, fatigue, headache and stinging skin. On an unknown date, the outcome of the pain in arm, fatigue and headache were recovered/resolved and the outcome of the stinging skin was recovering/resolving.   It was unknown if the reporter considered the pain in arm, fatigue, headache and stinging skin to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix on the left arm. The patient experienced sore arm and fatigue for 2 to 3 days and slight headache presented on and off for 1 to 2 days. The stinging was a little better than day before reporting yesterday. This case has been linked with case US2020019154 (husband's case), reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Visual impairment
Clinical narrative: severe headaches; visual problems; This case was reported by a other health professional via interactive digital media and described the occurrence of headache 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 headache and abnormal vision. On an unknown date, the outcome of the headache and abnormal vision were recovered/resolved.   It was unknown if the reporter considered the headache and abnormal vision to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received shingles vaccine and  experienced severe headaches and vision problems.  This was going for about six weeks. The reporter asked that what was the treatment for these side effects.
Sex: M
Vaccine: MENB
Symptoms: Anaphylactic reaction, Heart rate increased, Hyperhidrosis, Hypotension, Presyncope
Clinical narrative: syncope event; anaphylaxis; profuse sweating; low BP (63/42),; heart rate was in the 150 range; vomitting; This case was reported by a nurse via sales rep and described the occurrence of presyncope in a adult male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, 15 min after receiving Bexsero, the patient experienced presyncope (serious criteria GSK medically significant), anaphylaxis (serious criteria GSK medically significant), sweating, low blood pressure, heart rate increased and vomiting. The patient was treated with epinephrine. On an unknown date, the outcome of the presyncope was recovering/resolving and the outcome of the anaphylaxis, sweating, low blood pressure, heart rate increased and vomiting were unknown.   It was unknown if the reporter considered the presyncope, anaphylaxis, sweating, low blood pressure, heart rate increased and vomiting to be related to Bexsero.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had a near syncope event accompanied by vomiting, profuse sweating, very low BP (63/42), heart rate was in the 150 range. The physician administered 0.3 mg of epinephrine intramuscularly and administered oxygen and patient started to recover and eventually transferred to hospital.  The patient was treated for anaphylaxis in the emergency department (ED) and discharged.      Lab Comments: The lab testes were performed on an unknown date.
Sex: M
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: syncope event; anaphylaxis; profuse sweating; low BP (63/42),; heart rate was in the 150 range; vomitting; This case was reported by a nurse via sales rep and described the occurrence of presyncope in a adult male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, 15 min after receiving Bexsero, the patient experienced presyncope (serious criteria GSK medically significant), anaphylaxis (serious criteria GSK medically significant), sweating, low blood pressure, heart rate increased and vomiting. The patient was treated with epinephrine. On an unknown date, the outcome of the presyncope was recovering/resolving and the outcome of the anaphylaxis, sweating, low blood pressure, heart rate increased and vomiting were unknown.   It was unknown if the reporter considered the presyncope, anaphylaxis, sweating, low blood pressure, heart rate increased and vomiting to be related to Bexsero.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had a near syncope event accompanied by vomiting, profuse sweating, very low BP (63/42), heart rate was in the 150 range. The physician administered 0.3 mg of epinephrine intramuscularly and administered oxygen and patient started to recover and eventually transferred to hospital.  The patient was treated for anaphylaxis in the emergency department (ED) and discharged.      Lab Comments: The lab testes were performed on an unknown date.
Sex: U
Vaccine: FLU4
Symptoms: Injection site reaction
Clinical narrative: injection site reactions are worse with this vaccine; This case was reported by a other health professional via sales rep and described the occurrence of injection site reaction in an unspecified number of patients who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown.   It was unknown if the reporter considered the injection site reaction to be related to FluLaval Quadrivalent.  Additional case details were reported as follows: The age at vaccination was not applicable for this report.. The reporter indicated that her practice did not use the Flulaval vaccine because the injection site reactions were worse with this vaccine than with other flu vaccines that they use. The reporter was unable to obtain additional details. The reporter would not provide her any additional information. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Pain in extremity, Product preparation issue
Clinical narrative: sore in the arm after the second dose; received only the adjuvant of Shingrix; received only the adjuvant of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 453S4, expiry date 19th March 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 2nd August 2019).   On 31st January 2020, the patient received the 2nd dose of Shingrix. On 31st January 2020, unknown after receiving Shingrix, the patient experienced inappropriate reconstitution technique and inappropriate dose of vaccine administered. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm, inappropriate reconstitution technique and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information received were as follows: A couple was administered with the 2nd dose of Shingrix but one of them received only the adjuvant of Shingrix, which led to inappropriate reconstitution technique and inappropriate dose of vaccine administered. The patient experienced sore in the arm after the 2nd dose of Shingrix. The reporter said that the male patient experienced more sore in the arm than the female patient. This case has been linked to US2020019077 reported by the same reporter. The reporter consented to follow up.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect dose administered, Pain in extremity, Product preparation issue
Clinical narrative: Sore in the arm; one of them received only the adjuvant of Shingrix; received only the adjuvant of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number 453S4, expiry date 19th March 2022) and (batch number 453s4, expiry date 19th March 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 2nd August 2019).   On 31st January 2020, the patient received the 2nd dose of Shingrix. On an unknown date, the dose was an unknown dose. On 31st January 2020, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information received were as follows: A couple was administered with the 2nd dose of Shingrix but one of them received only the adjuvant of Shingrix, which led to preparation of medication and inappropriate dose of vaccine administered. The patient experienced sore in the arm after the 2nd dose of Shingrix. The reporter consented to follow up. This case has been linked to US2020019073 (wife's case), reported by the same reporter.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Rash erythematous
Clinical narrative: Pain at the injection site; red bumps on his nose; Redness at injection site/redness went down all the way to his elbow.; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 31st January 2020, 17 days after receiving Shingrix, the patient experienced red rash. On an unknown date, the patient experienced injection site pain and localized erythema. The patient was treated with prednisone. On an unknown date, the outcome of the injection site pain and localized erythema were recovered/resolved and the outcome of the red rash was unknown.   It was unknown if the reporter considered the injection site pain, localized erythema and red rash to be related to Shingrix.  Additional details were provided as follows:  The patient received the Shingrix in right arm. The patient experienced pain and redness at the injection site after receiving Shingrix, within 2 to 3 days the redness went down all the way to his elbow. The patient went to his physician and he was given prednisone for 10 days. The event was recovered in total of 10 days. The patient experienced red bumps on his nose. No further details were provided. Consent to follow up was denied. This is 1 of the 5 cases, reported by same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Palpitations
Clinical narrative: Racing heart beat; He pulse was at 90 and it came down on its own.; This case was reported by a consumer via call center representative and described the occurrence of heart racing in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, less than a day after receiving Shingrix, the patient experienced heart racing and pulse rate increased. On an unknown date, the outcome of the heart racing and pulse rate increased were recovered/resolved.   It was unknown if the reporter considered the heart racing and pulse rate increased to be related to Shingrix.  Additional information received were as follows: On the day of vaccination, the patient was woke up at  the middle of night with racing heart beat. The patient pulse rate  was at 90 and it came down on it own. No further details were provided. Consent to follow up was denied.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Inflammation
Clinical narrative: Large area of inflammation on his arm; Red area of inflammation on his arm; Area is hot to the touch; This case was reported by a pharmacist via call center representative and described the occurrence of inflammation in a 88-year-old male patient who received Herpes zoster (Shingrix) (batch number 2437H, expiry date 28th March 2022) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced inflammation, erythema of extremities and feeling hot. On an unknown date, the outcome of the inflammation, erythema of extremities and feeling hot were unknown.   It was unknown if the reporter considered the inflammation, erythema of extremities and feeling hot to be related to Shingrix.  Additional information was provided as follows: The reporter was a pharmacist reporting on behalf of a consumer. The patient had a large, red area of inflammation on his arm and that area was hot to the touch. The area of redness on the arm was greater than 5 inches. Till the time of reporting the patient had not received the second dose. This case is linked with US2020019142, reported by same reporter.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Myalgia, Pain in extremity
Clinical narrative: The pain was like a burning sensation; sore arm / pain returned, this time in his thigh; muscle pain in the outside of his right upper leg/ muscle pain in another part of his right upper leg; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th October 2019, the patient received the 1st dose of Shingrix. In November 2019, less than a month after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the patient experienced burning sensation and pain in arm. The patient was treated with naproxen. On an unknown date, the outcome of the muscle pain and burning sensation were not recovered/not resolved and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the muscle pain, burning sensation and pain in arm to be related to Shingrix. Additional information received were as follows: The patient had sore arm post vaccination. Around mid to late November 2019, the patient started having muscle pain in the outside of his right upper leg.  After a week the patient took some naproxen and the pain resolved.  About 3 to 4 weeks later the pain returned, this time in his thigh, but still his right upper leg.  The pain was like a burning sensation and it was sporadic. The pain was not always present. The patient tried Naproxen again and the pain eventually resolved. At the time of reporting the patient had muscle pain in another part of his right upper leg. It was not as bad, but still has that burning sensation.  The patient does not notice the pain when sitting, but felt it when walking.  On 3rd February 2020, the patient received the 2nd dose of Shingrix today. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: severe reaction following the 2nd dose of Shingrix; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient for self. The age at vaccination was not reported. The age group was not reported but was selected as adult as per the vaccine indication. The patient reported having a severe reaction following vaccination. The reporter did not consent to follow up.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Malaise, Pain in extremity
Clinical narrative: arm is sore; not feeling well after receiving the vaccine; was given two doses of the Meningococcal B vaccine at the same time; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 17-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On 3rd February 2020, the patient received Bexsero. On 3rd February 2020, unknown after receiving Bexsero, the patient experienced overdose. On an unknown date, the patient experienced pain in arm and feeling unwell. On an unknown date, the outcome of the pain in arm, feeling unwell and overdose were unknown.   It was unknown if the reporter considered the pain in arm and feeling unwell to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. A grandmother, who was also a nurse practitioner, calling because her grandson was given two doses of the Meningococcal B vaccine at the same time, one in the left arm and one in the right arm, which led to overdose. She was stating one of the arm was sore.  The vaccine was administered in the physician's office. She thought the vaccine was Bexsero but not sure. She also states her grandson was not feeling well after receiving the vaccine.  She did not have information on the physician's office. No additional information provided.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Loss of personal independence in daily activities, Lymphadenopathy, Mass, Nasal congestion
Clinical narrative: Enlarged lymp node; Lump on her neck; activities of daily living impaired; had a sore arm; reports having a brief, short-lived cold; causing stuffiness; This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 3rd January 2020, 1 days after receiving Shingrix, the patient experienced pain in arm. In January 2020, the patient experienced cold and nasal congestion. On 17th January 2020, the patient experienced activities of daily living impaired. On 22nd January 2020, the patient experienced enlargement of lymph nodes and mass. On 3rd January 2020, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the enlargement of lymph nodes and mass were not recovered/not resolved and the outcome of the cold and nasal congestion were recovered/resolved and the outcome of the activities of daily living impaired was unknown.   It was unknown if the reporter considered the enlargement of lymph nodes, pain in arm, cold, nasal congestion, mass and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her left arm and had a sore arm the next day that only lasted for that day. Less than 2 weeks after vaccination, the patient was having a brief, short-lived cold. It takes as taking 4 days to decide it was going to become something other than causing stuffiness, and cold kept her from doing activities on 17th January 2020 and 18th January 2020. On 19th January 2020, the patient was up and going. On 22nd January 2020, 20 days after vaccination, the patient discovered a lump on her neck and lymphadenopathy scheduled a doctor's appointment. A few days later at the appointment, the physician discovered another lump that was an enlarged lymph node. The patient was having a full blood work up with no significant findings, next, an ultrasound will be scheduled to evaluate neck/ lymph nodes. The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Nasopharyngitis, Pain in extremity
Clinical narrative: Enlarged lymp node; Lump on her neck; activities of daily living impaired; had a sore arm; reports having a brief, short-lived cold; causing stuffiness; This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 3rd January 2020, 1 days after receiving Shingrix, the patient experienced pain in arm. In January 2020, the patient experienced cold and nasal congestion. On 17th January 2020, the patient experienced activities of daily living impaired. On 22nd January 2020, the patient experienced enlargement of lymph nodes and mass. On 3rd January 2020, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the enlargement of lymph nodes and mass were not recovered/not resolved and the outcome of the cold and nasal congestion were recovered/resolved and the outcome of the activities of daily living impaired was unknown.   It was unknown if the reporter considered the enlargement of lymph nodes, pain in arm, cold, nasal congestion, mass and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her left arm and had a sore arm the next day that only lasted for that day. Less than 2 weeks after vaccination, the patient was having a brief, short-lived cold. It takes as taking 4 days to decide it was going to become something other than causing stuffiness, and cold kept her from doing activities on 17th January 2020 and 18th January 2020. On 19th January 2020, the patient was up and going. On 22nd January 2020, 20 days after vaccination, the patient discovered a lump on her neck and lymphadenopathy scheduled a doctor's appointment. A few days later at the appointment, the physician discovered another lump that was an enlarged lymph node. The patient was having a full blood work up with no significant findings, next, an ultrasound will be scheduled to evaluate neck/ lymph nodes. The reporter consented to follow up.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Chills, Contraindication to vaccination, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Health Services received negative varicella titer on employee. Employee disclosed otezla use on health assessment given to Health Services, however when asked the vaccine screening questions answered "no" to all. She was given varicella vaccine by a nurse on 02/10/20. On 02/12/20 she called to report "really bad" chills as well as fatigue, body aches, and redness and swelling at the injection site that began 02/11/20. She disclosed to this writer that she takes otezla. Writer discussed with Health Medical Director who advised that employee notify her treating provider as well as watch for signs and symptoms of chicken pox.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain
Clinical narrative: Health Services received negative varicella titer on employee. Employee disclosed otezla use on health assessment given to Health Services, however when asked the vaccine screening questions answered "no" to all. She was given varicella vaccine by a nurse on 02/10/20. On 02/12/20 she called to report "really bad" chills as well as fatigue, body aches, and redness and swelling at the injection site that began 02/11/20. She disclosed to this writer that she takes otezla. Writer discussed with Health Medical Director who advised that employee notify her treating provider as well as watch for signs and symptoms of chicken pox.
Age: 43.0
Sex: F
Vaccine: FLUR4
Symptoms: Electromyogram abnormal, Hypoaesthesia, Joint swelling, Nerve conduction studies abnormal, Neuropathy peripheral
Clinical narrative: swelling of all joints thought to be serum sickness, was admitted and treated with steroids, the joint swelling resolved, patient was left with residual left hand tingling and numbness. EMG and NCS 10/25/2019  showed left median neuropathy. A repeat EMG 12/5/2019  showed some improvement but not back to normal. Patient currently has tingling and numbness in the left hand.
Age: 43.0
Sex: F
Vaccine: FLUR4
Symptoms: Paraesthesia, Serum sickness
Clinical narrative: swelling of all joints thought to be serum sickness, was admitted and treated with steroids, the joint swelling resolved, patient was left with residual left hand tingling and numbness. EMG and NCS 10/25/2019  showed left median neuropathy. A repeat EMG 12/5/2019  showed some improvement but not back to normal. Patient currently has tingling and numbness in the left hand.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Bursitis, Injected limb mobility decreased, Mobility decreased, Pain, Ultrasound scan abnormal
Clinical narrative: 1/14/20: Pt received the vaccine on 12/4/19 at 6:30pm and developed pain and limited mobility/inability to fully lift her left arm  (she reports approx 10-20 degrees range of motion) during daytime on 12/6/19. Later in December 2019 while traveling overseas, pt had Xray of her left arm, which showed no involvement of her bone. Pt saw her Primary Care Provider on 1/7/20 and was referred to an orthopaedist on 1/8/20, where pt received a cortisone shot (without much relief) and an ultrasound revealed inflammation in the bursa area of her left upper arm. Pt was also prescribed pain medication at that time, which has helped reduce pain to some degree. She has an ortho follow-up on 1/22/20.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: X-ray limb
Clinical narrative: 1/14/20: Pt received the vaccine on 12/4/19 at 6:30pm and developed pain and limited mobility/inability to fully lift her left arm  (she reports approx 10-20 degrees range of motion) during daytime on 12/6/19. Later in December 2019 while traveling overseas, pt had Xray of her left arm, which showed no involvement of her bone. Pt saw her Primary Care Provider on 1/7/20 and was referred to an orthopaedist on 1/8/20, where pt received a cortisone shot (without much relief) and an ultrasound revealed inflammation in the bursa area of her left upper arm. Pt was also prescribed pain medication at that time, which has helped reduce pain to some degree. She has an ortho follow-up on 1/22/20.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient reports that he noticed today that at the injection from his shingrex (#2)  there is a red circle about 2.5 inches in diameter, warm to touch, painful at  injection, no hives/rash. Patient denies any chest pain, shortness of air, throat  swelling, palpitations. Patient denies arm swelling.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Genital rash, Oral mucosal eruption, Rash, Rash pruritic
Clinical narrative: Mom called health department  at 1130am on 2/13/2020 and reported that patient was "broke out with a rash around his mouth and in his private area".  She is unsure of the time but stated she first noticed it "last night" and that he "acts like it itches" so she put "diaper rash cream on it and it made it some better". She was concerned that it was his immunizations received yesterday. RN asked if he was having any trouble breathing, eating or drinking and she reported "no".  Provider consulted,  and recommended that child be given "allergy medication, Benadryl or Zyrtec" and to follow instructions on label.  RN also educated Mom on monitoring for anaphylaxis and to call 911 if he was having any trouble breathing or swallowing. During phone call Mom additionally reported that now she see that the "rash is all over his body".
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: CHILD HAD NO SYMPTOMS.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Presyncope
Clinical narrative: Patient vasovagal after vaccine administration
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Pallor, Posture abnormal, Slow response to stimuli, Tremor
Clinical narrative: At approximately 3:00 PM, patient was waiting in clinic lobby as instructed for 15 min. post immunization, when she started shaking, loss of pinkness to skin and lips, slow to respond to conversation, unable to sit upright in chair. Patient was carried to exam room and laid down with feet elevated and ice pack applied to back of neck. At 3:25 PM Vital signs taken: BP 75/45, HR 50, Spo2 % 98. After rest, snack, and drink, patient returned to baseline. At 3:50 PM Vitals retaken: BP 85/56, HR 62, Spo2% 100.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; the patient was administered a dose of VARIVAX on 12/30/2019, that had been improperly stored; This spontaneous report was received from an office manager and refers to patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was provided.  On 30-DEC-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (lot # S021926, expiry date: 15-JUL-2021; exact dose, dose number, route and site of administration were not provided). The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT) (dose, lot number, expiry date and route of administration were not provided). No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 1.2 degrees Celsius for 3 hours and 9 minutes. There were no previous excursions related. Data logger was involved.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: very mild case of Shingles; slight rash; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The reporter was patients wife. The patient experienced a very mild case of Shingles and slight rash but no pain after receiving 1st dose of Shingrix. The reporter asked when it was safe for him to get second vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: big red spot 2x4 inches on my arm; This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced localized erythema. On an unknown date, the outcome of the localized erythema was not recovered/not resolved.   It was unknown if the reporter considered the localized erythema to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected an adult as per vaccine indication.  The patient received 1st dose of Shingrix 6 days ago and still have a big red spot 2,4 inches on arm. The reporter was just wondering if this was the normal about the side effects to last this long.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Contusion, Herpes zoster, Injection site erythema, Injection site pain
Clinical narrative: Pink Rash on her legs; Blotches on her legs; is uncomfortable for her to sleep; pain when bending down; confirmed with a case of Shingles; pain in her left leg; nerve pain and her leg; feels like burning sensation; dots on her left side of the back.; Redness at injection site; Soreness at injection site; bad bruise under the left arm; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included crohn's and immunocompromised (on immunosupresants). Concomitant products included mercaptopurine.   On 11th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 11th January 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema and injection site pain. On 13th January 2020, the patient experienced contusion. In January 2020, the patient experienced shingles, leg pain, nerve pain, burning sensation and rash. On an unknown date, the patient experienced red rash, blotchy, sleep disorder and pain. The patient was treated with dermatologicals nos (Calamine Lotion). On an unknown date, the outcome of the shingles was recovering/resolving and the outcome of the injection site erythema, injection site pain and contusion were recovered/resolved and the outcome of the leg pain and nerve pain were not recovered/not resolved and the outcome of the burning sensation, rash, red rash, blotchy, sleep disorder and pain were unknown.   It was unknown if the reporter considered the shingles, injection site erythema, injection site pain, contusion, leg pain, nerve pain, burning sensation, rash, red rash, blotchy, sleep disorder and pain to be related to Shingrix.  Additional information was provided as follows: The patient received the vaccine on her left arm. The same day of vaccination she experienced redness and soreness at injection site that lasted for 3 days. On the third day she experienced a bad bruise under the left arm which took 5 days to resolve.  About a week later from the day of vaccination she started to experience pain in her left leg. At the same time she experienced dots on her left side of the back.  She visited her physician and was confirmed with a case of Shingles. About 2 weeks after vaccination she started to experience pink rash and blotches on her legs, and from knee to groin area.  The Shingles on her back and legs got better and lighter.  The pain in her legs was ongoing and she described it as nerve pain and her leg feels like burning sensation.  It is uncomfortable for her to sleep and she had pain when bending down. The patient used calamine lotion on the affected area.  The patient experienced all the adverse events on the left side of the body. The reporter did not consented to follow up. This is 1 of the 5 cases reported by the same reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Pain, Pain in extremity, Rash, Rash erythematous
Clinical narrative: Pink Rash on her legs; Blotches on her legs; is uncomfortable for her to sleep; pain when bending down; confirmed with a case of Shingles; pain in her left leg; nerve pain and her leg; feels like burning sensation; dots on her left side of the back.; Redness at injection site; Soreness at injection site; bad bruise under the left arm; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included crohn's and immunocompromised (on immunosupresants). Concomitant products included mercaptopurine.   On 11th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 11th January 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema and injection site pain. On 13th January 2020, the patient experienced contusion. In January 2020, the patient experienced shingles, leg pain, nerve pain, burning sensation and rash. On an unknown date, the patient experienced red rash, blotchy, sleep disorder and pain. The patient was treated with dermatologicals nos (Calamine Lotion). On an unknown date, the outcome of the shingles was recovering/resolving and the outcome of the injection site erythema, injection site pain and contusion were recovered/resolved and the outcome of the leg pain and nerve pain were not recovered/not resolved and the outcome of the burning sensation, rash, red rash, blotchy, sleep disorder and pain were unknown.   It was unknown if the reporter considered the shingles, injection site erythema, injection site pain, contusion, leg pain, nerve pain, burning sensation, rash, red rash, blotchy, sleep disorder and pain to be related to Shingrix.  Additional information was provided as follows: The patient received the vaccine on her left arm. The same day of vaccination she experienced redness and soreness at injection site that lasted for 3 days. On the third day she experienced a bad bruise under the left arm which took 5 days to resolve.  About a week later from the day of vaccination she started to experience pain in her left leg. At the same time she experienced dots on her left side of the back.  She visited her physician and was confirmed with a case of Shingles. About 2 weeks after vaccination she started to experience pink rash and blotches on her legs, and from knee to groin area.  The Shingles on her back and legs got better and lighter.  The pain in her legs was ongoing and she described it as nerve pain and her leg feels like burning sensation.  It is uncomfortable for her to sleep and she had pain when bending down. The patient used calamine lotion on the affected area.  The patient experienced all the adverse events on the left side of the body. The reporter did not consented to follow up. This is 1 of the 5 cases reported by the same reporter.