chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Erythema, Headache, Peripheral swelling, Pyrexia
Clinical narrative: Patient reported very red, swollen, and hot all the way down left arm and into lymph nodes in underarm. Also experienced upset stomach, fever, and headache.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Patient reported very red, swollen, and hot all the way down left arm and into lymph nodes in underarm. Also experienced upset stomach, fever, and headache.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dyspnoea, Headache, Periorbital oedema, Rhinorrhoea
Clinical narrative: Shortly after injection I began coughing. Overnight I developed shortness of breath and generalized facial swelling, periorbital edema, and around the nose. My sinuses were full of clear mucus and I had a headache upon waking at 5 AM. At 5:30 AM I took a XYZAL and an ALLEGRA and the swelling had subsided almost completely by noon.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling face
Clinical narrative: Shortly after injection I began coughing. Overnight I developed shortness of breath and generalized facial swelling, periorbital edema, and around the nose. My sinuses were full of clear mucus and I had a headache upon waking at 5 AM. At 5:30 AM I took a XYZAL and an ALLEGRA and the swelling had subsided almost completely by noon.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Blood test, Escherichia test, Fatigue, Nausea
Clinical narrative: Beginning 1 day after the routine exam and HPV shot patient began complaining of nausea, stomach ache, sore throat and being very tired. Unfortunately the same condition almost 3 weeks since the exam/vaccine.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Oropharyngeal pain, Parasite stool test, Salmonella test, Streptococcus test, Urine analysis
Clinical narrative: Beginning 1 day after the routine exam and HPV shot patient began complaining of nausea, stomach ache, sore throat and being very tired. Unfortunately the same condition almost 3 weeks since the exam/vaccine.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Haematochezia, Intussusception
Clinical narrative: Patient presented to clinic for 4 month well child check and received his Rotavirus Immunization on 5/21/2018. On 5/31/2018 the mother of the child called the Pediatrics Clinic and spoke to the Triage RN with concerns of bloody stools. Patient was scheduled for an appointment with Dr. on 5/31/2018, PCP not available. Dr. suspected Intussusception upon assessment of child at appointment. Dr. spoke to another Dr. at hospital ED. Patient was air transported to ED for further evaluation and workup. Confirmed Intussusception upon arrival to hospital.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Peripheral swelling
Clinical narrative: Pt stated that her arm swelled up down to elbow, was seen at urgent care and given steroids to relieve swelling. She also reported that she was unable to move the arm. She went to the urgent care the same day that the injection was given 8/28/18, and reported the issue to the pharmacy on 9/6/18, a little over 1 week, at this point the patient states that she still has some swelling down to the
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Oropharyngeal pain, Swollen tongue, Urticaria
Clinical narrative: Client received vaccination in clinic, called about an hour later from the ER, reported that she started to develop hives, swollen tongue with throat pain about 20 minutes after the vaccine. She took two doses of BENADRYL and improved. She still went to be seen at the ER and she was given a prescription for a prednisone taper, but has elected not to take it. Reports that she is fully recovered today.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Soreness at the site of the injection, muscle aches, fever, shivering, fatigue.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Headache, Pain
Clinical narrative: Left arm, red, raised welt, size of a grapefruit. Headache, Body aches, Chills, Fever, Extreme fatigue.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Urticaria
Clinical narrative: Left arm, red, raised welt, size of a grapefruit. Headache, Body aches, Chills, Fever, Extreme fatigue.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Hyperhidrosis, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nausea in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced nausea, stomach pain, chills and sweating. On an unknown date, the outcome of the nausea, stomach pain, chills and sweating were unknown. It was unknown if the reporter considered the nausea, stomach pain, chills and sweating to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that she experienced nausea, sweats, stomach pain, and chills. The patient did not want to give details at time of reporting and was in a hurry. The patient was transferred to GRC after minimal information collection. The patient was given all the information she needed. The patient had a severe reaction to the SHINGRIX vaccine and would call back again if she had another reaction to the second shot of the SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis. On 25th August 2018, the patient received the 2nd dose of SHINGRIX (subcutaneous). In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. On 25th August 2018, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the injection site erythema and injection site swelling to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that patient received the SHINGRIX subcutaneously, which led to incorrect route of drug administration. Afterwards the patient experienced redness and swelling at the injection site and the surrounding arm area. The health care professional did not have detailed information because the administration occurred at a different location.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.  It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional stated that the patient got a dose of SHINGRIX and complained of having a sore arm after administration of SHINGRIX. The healthcare professional said the patient was reluctant to get the 2nd dose due to the sore arm.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and general malaise. On an unknown date, the outcome of the injection site pain and general malaise were recovered/resolved. It was unknown if the reporter considered the injection site pain and general malaise to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) was calling for another purpose and this case was mentioned casually. No patient specific information was available. The age at vaccination was not applicable for this report. The age group was not reported but was selected adult as per vaccine indication. The healthcare professional (HCP) reported that some patients expressed injection site pain or reported general malaise after SHINGRIX. All the events resolved within a few days of onset.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Lethargy, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of lethargy in a 81-year-old female patient who received SHINGRIX for prophylaxis. On 27th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 28th August 2018, 1 days after receiving SHINGRIX, the patient experienced lethargy, injection site erythema, fever and injection site swelling. The patient was treated with BENADRYL. On an unknown date, the outcome of the lethargy, injection site erythema, fever and injection site swelling were recovering/resolving. It was unknown if the reporter considered the lethargy, injection site erythema, fever and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. The patient received SHINGRIX vaccine in the left deltoid. The physician stated that the patient woke up on the date of reporting with lethargy, 3 to 4 inch erythema at injection site, fever of 101.4 degree, and swelling at the injection site. The physician gave the patient BENADRYL and her fever went down to 100 degrees in the past hour, on the time of reporting. No further details were provided by the reporter.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Rash, Skin warm
Clinical narrative: This case was reported by a pharmacist via out of hour services and described the occurrence of upset stomach in a 50-year-old female patient who received SHINGRIX for prophylaxis. In August 2018, the patient received SHINGRIX. In August 2018, less than a month after receiving SHINGRIX, the patient experienced upset stomach, rash and skin warm. On an unknown date, the outcome of the upset stomach, rash and skin warm were not recovered/not resolved. It was unknown if the reporter considered the upset stomach, rash and skin warm to be related to SHINGRIX. Additional details were reported as follows: The pharmacist reported that the SHINGRIX vaccine was administered to a plus 50 year old woman about two weeks ago and she experienced an upset stomach and rash that subsided. Two weeks later, the rash had come back and it was very warm and she had an upset stomach again. The patient was a nurse and was very upset.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Erythema, Feeling abnormal, Feeling hot, Injection site rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of upset stomach in a 79-year-old female patient who received SHINGRIX for prophylaxis. On 18th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, several days after receiving SHINGRIX, the patient experienced upset stomach, feeling bad, extremities hot feeling of, injection site rash and erythema of extremities. On an unknown date, the outcome of the upset stomach, feeling bad, extremities hot feeling of, injection site rash and erythema of extremities were not recovered/not resolved. It was unknown if the reporter considered the upset stomach, feeling bad, extremities hot feeling of, injection site rash and erythema of extremities to be related to SHINGRIX. Additional details were reported as follows: A couple days later, the patient experienced an upset stomach as well as a localized rash on her arm around the injection site but it did extend (the rash was the size of a hand). This reaction went away but then about 2 weeks later, it came back. The healthcare professional stated that the patient feels like absolute garbage and her arm was red and hot and she had an upset stomach again. The healthcare professional didn't have lot or expiration date at this time. The patient's husband received the vaccine at the same time and he tolerated well without any issues.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of nausea in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 27th August 2018 16:00, the patient received the 2nd dose of SHINGRIX (intramuscular). In August 2018, 12 hrs after receiving SHINGRIX, the patient experienced nausea, headache, pain in arm, fever, muscle pain, vomiting and chills. On an unknown date, the outcome of the nausea, headache, fever, muscle pain, vomiting and chills were recovered/resolved and the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the nausea, headache, pain in arm, fever, muscle pain, vomiting and chills to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for himself. On 28th August 2018, the patient experienced nausea, vomiting, headache, chills, fever, muscle pain, and arm soreness about 12 hours after receiving SHINGRIX vaccine. In August 2018, all of the adverse events resolved after about 24 hours except the arm soreness. The HCP did not have vaccine information available.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of nausea in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 27th August 2018 16:00, the patient received the 2nd dose of SHINGRIX (intramuscular). In August 2018, 12 hrs after receiving SHINGRIX, the patient experienced nausea, headache, pain in arm, fever, muscle pain, vomiting and chills. On an unknown date, the outcome of the nausea, headache, fever, muscle pain, vomiting and chills were recovered/resolved and the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the nausea, headache, pain in arm, fever, muscle pain, vomiting and chills to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for himself. On 28th August 2018, the patient experienced nausea, vomiting, headache, chills, fever, muscle pain, and arm soreness about 12 hours after receiving SHINGRIX vaccine. In August 2018, all of the adverse events resolved after about 24 hours except the arm soreness. The HCP did not have vaccine information available.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of rash in a 61-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included ENBREL. On 22nd August 2018, the patient received the 1st dose of SHINGRIX. On 25th August 2018, 3 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unchanged. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The patient developed a rash on their trunk and neck, according to the reporter. The rash seemed to be expanding. The reporter did not have lot number or expiration, as the vaccine was administered elsewhere.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of sickness in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient got really sick after first dose of SHINGRIX and did not want to proceed with 2nd dose in series. No further information was available at the time of report.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of generalized muscle aches in a 59-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 28th August 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 28th August 2018, less than a day after receiving SHINGRIX, the patient experienced generalized muscle aches. On an unknown date, the outcome of the generalized muscle aches was not recovered/not resolved. It was unknown if the reporter considered the generalized muscle aches to be related to SHINGRIX. Additional information was reported as follows: This case was reported by the patient's wife. In June 2018, the patient received the 1st dose of SHINGRIX without any adverse events. The patient experienced muscle pain after the 2nd dose of SHINGRIX. This case was linked to case US2018157105, reported by the same patient.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of hives in a 73-year-old female patient who received SHINGRIX (batch number 957J3, expiry date 15th November 2020) for prophylaxis. On 21st August 2018, the patient received the 1st dose of SHINGRIX(intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced hives and pruritus. In August 2018, the outcome of the hives and pruritus were recovered/resolved. It was unknown if the reporter considered the hives and pruritus to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in right arm. The pharmacist reported that the patient broke out with hives on her right back shoulder along with itching. The hives and itching was four by four in inches. This lasted for a couple of days. No further details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and joint pain. On an unknown date, the outcome of the fever and joint pain were unknown. It was unknown if the reporter considered the fever and joint pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. Caller heard from the physician that he had seen three patients who after receiving SHINGRIX experienced low grade fever and joint aches. This case linked with cases US2018157973 and US2018157969, reported by the same reporter.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received SHINGRIX (batch number G933B, expiry date 22nd November 2020) for prophylaxis. On 16th August 2018, the patient received SHINGRIX (intramuscular) .5 ml. In August 2018, less than a month after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The pharmacist did not know when the patient started noticing the symptoms. This case has been linked with cases US2018158121 and US2018GSK160732 reported by the same reporter.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site pain in a 63-year-old male patient who received SHINGRIX (batch number EK279, expiry date 31st March 2020) for prophylaxis. On 26th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 26th March 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 10th April 2018, the outcome of the injection site pain was recovered/resolved. The reporter considered the injection site pain to be related to SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pyrexia, Swelling face
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site swelling in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (on her forehead). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema, fever, forehead swelling and red face. On an unknown date, the outcome of the injection site swelling, injection site erythema, fever, forehead swelling and red face were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site erythema, fever, forehead swelling and red face to be related to SHINGRIX. Additional details were provided as follows: The patient's initials and date of birth were unknown. The age at vaccination was not reported. The patient also had swelling and redness on her forehead where she previously had shingles in the past. The symptoms lasted for a couple of days. The reporter agreed for follow up contact.
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, less than a week after receiving BEXSERO, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown. It was unknown if the reporter considered the injection site erythema to be related to BEXSERO. Additional details were provided as follows: This case was reported by Certified Medical Assistant (CMA). The age at vaccination was not reported. The reporter said the patient called the day after she got the immunization to report a red spot about the size of a silver dollar on her arm where she was given the shot. The reporter agreed for follow up contact.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Nausea
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a adult female patient who received SHINGRIX (batch number MY2B2, expiry date unknown) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, chills and nausea. On an unknown date, the outcome of the injection site pain, chills and nausea were unknown. It was unknown if the reporter considered the injection site pain, chills and nausea to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Influenza like illness, Loss of personal independence in daily activities, Nausea, Pain in extremity
Clinical narrative: This case was reported by a non-health professional via sales rep and described the occurrence of swelling arm in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 17th August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 1 day after receiving SHINGRIX, the patient experienced swelling arm, pain in arm, numbness, nausea and influenza-like symptoms. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the swelling arm, pain in arm, numbness, nausea and influenza-like symptoms were unknown. It was unknown if the reporter considered the swelling arm, pain in arm, numbness, nausea and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The patient experienced severe swelling on the arm, pain outside of arm, under arm numbness into the muscles. All symptoms started 24 to 30 hours after injection. The patient had half day loss of work. The patient took 8 days for swelling to go down. The reporter was agreed to provide follow up information.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: This case was reported by a non-health professional via sales rep and described the occurrence of swelling arm in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 17th August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 1 day after receiving SHINGRIX, the patient experienced swelling arm, pain in arm, numbness, nausea and influenza-like symptoms. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the swelling arm, pain in arm, numbness, nausea and influenza-like symptoms were unknown. It was unknown if the reporter considered the swelling arm, pain in arm, numbness, nausea and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The patient experienced severe swelling on the arm, pain outside of arm, under arm numbness into the muscles. All symptoms started 24 to 30 hours after injection. The patient had half day loss of work. The patient took 8 days for swelling to go down. The reporter was agreed to provide follow up information.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Headache, Lethargy, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of lethargy in a 16-year-old male patient who received BEXSERO for prophylaxis. On 21st August 2018, the patient received the 1st dose of BEXSERO. In August 2018, less than a week after receiving BEXSERO, the patient experienced lethargy, headache, fatigue and fever. On an unknown date, the outcome of the lethargy, headache, fatigue and fever were unknown. It was unknown if the reporter considered the lethargy, headache, fatigue and fever to be related to BEXSERO. Additional information was reported as follows: The patient was around 16.5 years old and complained of headache, fatigue or lethargy and fever. On 22nd August 2018, the following day after vaccination, the patient was brought to the emergency department for evaluation. The patient was monitored and released. The physician given permission to contact him, preferably by phone.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Lymphadenopathy
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms and axillary lymph nodes enlarged. On an unknown date, the outcome of the influenza-like symptoms and axillary lymph nodes enlarged were unknown. It was unknown if the reporter considered the influenza-like symptoms and axillary lymph nodes enlarged to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient had flu like symptoms and axillary lymph node swelling. The reporter was unsure if the lymph node swelling was a side effect from the vaccine. The reporter agreed to provide follow up information.
Age: 47.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Muscle spasms, Myalgia, Pain in extremity
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 47-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received on 13th June 2018, refer case US2018155246). Concurrent medical conditions included rheumatoid arthritis. On 20th August 2018 17:00, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 21st August 2018, 1 days after receiving SHINGRIX, the patient experienced activities of daily living impaired. On an unknown date, the patient experienced pain in arm, muscle pain and muscle spasm. On an unknown date, the outcome of the pain in arm, muscle spasm and activities of daily living impaired were unknown and the outcome of the muscle pain was not recovered/not resolved. It was unknown if the reporter considered the pain in arm, muscle pain, muscle spasm and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: This case was reported by physician for himself. The patient received 2nd dose of SHINGRIX on left deltoid and experienced a pain during administration. The night after receiving the vaccination was horrible because of the pain. The patient went into work the next day but had to leave because of the arm pain, he stated that there was muscle spasms and muscle pain. The patient said the pain went away for a little bit of time but restarted on the day before reporting. The patient said, he was experiencing the same pain as he felt last week. The patient had denied permission to contact their physician.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Pruritus, Urticaria
Clinical narrative: MOM CALLED HEALTH DEPARTMENT AND LEFT MESSAGE FOR RETURN PHONE CALL ON 9-6-18.  RETURNED PHONE CALL AND SPOKE TO MOM. MOM STATES CHILD RECEIVED GARDASIL 9 VACCINE ON 8-24-18 AND BEGAN HAVING HIVES AND ITHCING ALL OVER ON 8-31-18. MOM STATES SHE HAS GIVEN CHILD BENADRYL AND CLARITIN AND THAT THIS DID HELP. INSTRUCTED MOM OF IMPORTANCE OF FOLLOWING UP WITH CHILD'S REGULAR MD, DR. MOM TO TAKE TEEN TO NEAREST EMERGENCY ROOM IF SHE DEVELOPS ANY SIGNS AND SYMPTOMS OF DISTRESS.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: PATIENT REPORTS WAKING IN THE MIDDLE OF SLEEP WITH ARM PAIN AT APPROXIMATELY 3 AM AND COULD NOT RETURN TO SLEEP THIS LASTED THE WHOLE DAY OF 7/27/2018 BUT RESOLVED BY NEXT DAY.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Nausea, Vomiting
Clinical narrative: Pt with nausea immediately after vaccine. Mom reports that nausea continued from 9/5 - 9/6/18.  Pt vomited twice during the evening of 9/5/18. However, also noted was the fact that pt's sister concurrently with viral stomach process also experiencing nausea and vomiting.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Peripheral swelling, Type III immune complex mediated reaction
Clinical narrative: Arthus reaction in right arm started approximately 4 hours after injection. Swelling increased for 24 hours.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation, Injection site pain, Muscle oedema
Clinical narrative: Soreness at injection site; edema of deltoid muscle; inflammation with a line of redness on side opposite the injection site. Rubbing injection site, massaging affected muscle, elevation and icing for 8 hours. Icing, massage, and elevation were followed with compression stocking applied to left arm. Ibuprofen 400 mg given at 12 hrs after injection to mitigate pain from edema. Edema continued to progress past the elbow, eventually reaching the wrist joint by day 5. Compression stocking seemed to reduce how quickly the edema progressed towards the wrist, however never halted it completely. Pain was reduced by 72 hrs despite no improvement of the edema. Physician was contacted after 24 hrs and photo of reaction forwarded for her records. Pt was not seen in office after reaction occurred. Full function and reduction in edema was complete by day 7.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Induration, Injection site pain, Injection site swelling, Malaise, Myalgia
Clinical narrative: Pt called today, 9/6/18 reporting  that his advrese effects be reported to the VAERS: Myalgia, severe pain in injection site that kept patient up all night (he even had to take an opioid), malaise, nausea, firm/tender hand, swelling at injection site.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Tenderness
Clinical narrative: Pt called today, 9/6/18 reporting  that his advrese effects be reported to the VAERS: Myalgia, severe pain in injection site that kept patient up all night (he even had to take an opioid), malaise, nausea, firm/tender hand, swelling at injection site.
Age: 61.0
Sex: F
Vaccine: HEP, HEPA, TYP
Symptoms: Asthenia, Dizziness, Fatigue, Insomnia, Limb discomfort
Clinical narrative: 20 MINUTES AFTER ADMINISTRATION CLIENT "FEELS VERY TIRED, HEAD LIGHTEN AND WEAK" AND SLEEPS FOR 2 1/2 HOURS CLIENTS TAKES TRAMADOL AT NIGHT BUT IS NO ABLE TO SLEEP. CLIENT FEELING BETTER THE NEXT DAY (TODAY) BUT NO TOTALLY FINE. ARM I S SORE. SPOUSE HAS THE SAME VACCINES AT THE SAME TIME AND HAS NO SIDE EFFECTS.
Age: 61.0
Sex: F
Vaccine: HEP, HEPA, TYP
Symptoms: Somnolence
Clinical narrative: 20 MINUTES AFTER ADMINISTRATION CLIENT "FEELS VERY TIRED, HEAD LIGHTEN AND WEAK" AND SLEEPS FOR 2 1/2 HOURS CLIENTS TAKES TRAMADOL AT NIGHT BUT IS NO ABLE TO SLEEP. CLIENT FEELING BETTER THE NEXT DAY (TODAY) BUT NO TOTALLY FINE. ARM I S SORE. SPOUSE HAS THE SAME VACCINES AT THE SAME TIME AND HAS NO SIDE EFFECTS.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation, Peripheral swelling
Clinical narrative: Patient received vaccine in left deltoid on 9/4/18. Vaccine was administered by pharmacy. On 9/6/18, the patient called the pharmacy and reported that her arm was swollen and inflamed. I, pharmacy manager advised patient to come in to see her administration site. The patient did come into the pharmacy. I did notice her arm was swollen and red from her elbow to her shoulder. I advised her to ice down the affected area and take TYLENOL as well as BENADRYL. I also advised her to go to the ER or doctors office if swelling didnt improve. I also contacted her primary doctor and let them know the situation. The pharmacy will continue calling the patient to see if there is any improvement
Age: 65.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Rash papular, Skin warm
Clinical narrative: The day after the injection there was a very large, very warm raised rash. It was the size of my forearm. The injection was on a Monday and is still there today which is Thursday. It's still warm and red, but getting better.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient reports high grade fever. Symptoms improved within 24 hours.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Right arm pain that patient states is "all the way to the bone" for over 4 weeks after injection. Patient describes as an aching pain.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Rotator cuff syndrome
Clinical narrative: Patient says vaccine caused rotator cuff tear possibly due to administration site.
Age: 7.0
Sex: M
Vaccine: HEPA
Symptoms: Nasopharyngitis, Urticaria
Clinical narrative: Hives developed 6 days afterward, treated with BENADRYL with resolution on 2 different occasions. Child developed cold 2 days after hives.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient experienced redness and swelling at inject site immediately after injection. A little over 24 hours later she experienced a separate red, swollen site about 2 inches below the original site. This new red spot was about 2 inches in diameter and was swollen and sore. On 9/6/18 the new spot was not as swollen or as sore but was still red.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Condition aggravated, Diarrhoea, Fibromyalgia, Headache
Clinical narrative: Exacerbation of fibromyalgia symptoms (neck pain, lower back pain, flu- like symptoms). Loose bowels after evening meal for over a week. Itchy burning rash at original shingles site for 5 days. Rash gone but several times a day itch and burn at the site. On and off flu like symptoms continue, headaches and sinus problems.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Injection site pruritus, Injection site rash, Neck pain
Clinical narrative: Exacerbation of fibromyalgia symptoms (neck pain, lower back pain, flu- like symptoms). Loose bowels after evening meal for over a week. Itchy burning rash at original shingles site for 5 days. Rash gone but several times a day itch and burn at the site. On and off flu like symptoms continue, headaches and sinus problems.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Sinus disorder
Clinical narrative: Exacerbation of fibromyalgia symptoms (neck pain, lower back pain, flu- like symptoms). Loose bowels after evening meal for over a week. Itchy burning rash at original shingles site for 5 days. Rash gone but several times a day itch and burn at the site. On and off flu like symptoms continue, headaches and sinus problems.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Injection site hypoaesthesia, Injection site pain, Injection site reaction, Muscular weakness
Clinical narrative: Patient complained of 4 days of marked numbness in the right upper extremity, especially at the shoulder and bicep. On the day of vaccination pain and numbness were moderate. On day #2 pain improved but numbness was at its worse; patient had weakness of right upper extremity. On days #3 and #4 symptoms improved. On day #5 symptoms were completely resolved. Patient did have phlebotomy at the right antecubital fossa after receiving vaccination. On 9/6/18 physical exam showed normal cranial nerves use and normal muscle strength.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Asthenia, Hypoaesthesia, Immediate post-injection reaction, Incomplete course of vaccination, Pain in extremity
Clinical narrative: Patient complained of 4 days of marked numbness in the right upper extremity, especially at the shoulder and bicep. On the day of vaccination pain and numbness were moderate. On day #2 pain improved but numbness was at its worse; patient had weakness of right upper extremity. On days #3 and #4 symptoms improved. On day #5 symptoms were completely resolved. Patient did have phlebotomy at the right antecubital fossa after receiving vaccination. On 9/6/18 physical exam showed normal cranial nerves use and normal muscle strength.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Father called and stated that the child had redness around shot where the Polio was given and that patient had a low grade fever (unknown amount as father does not have thermometer). Has been napping today. No other symptoms. Has not given any medication.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus
Clinical narrative: Pt called ~4 hours post-vaccine asking if she could use itch cream on her injection site. Intermittent itching lasting for past hour. Band-Aid had been removed (latex free). No hives, redness, or swelling noted.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Myalgia, Nausea
Clinical narrative: Patient was experiencing muscle pain on both arms, headache, queasy, and fatigue in the evening, and noticed a few red spots near the injection site on 9/6, (2 days after the injection was given).
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site pain, Myalgia, Nausea
Clinical narrative: Patient was experiencing muscle pain on both arms, headache, queasy, and fatigue in the evening, and noticed a few red spots near the injection site on 9/6, (2 days after the injection was given).
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Chills, Decreased appetite, Diarrhoea, Nausea, Pyrexia
Clinical narrative: Nausea, no appetite 1.5 hour later, explosive diarrhea 5-6 hours later (x3), fever, shaking, chills (7 hours later...for 3 hours). I was given the geriatric dose... there were two identification numbers on the 2 papers on the pharmacy Prescription printed RX 6410170 N it says that it was FLUAD 2018-2019 0.5 MI  Inj Seqi Influenza Vac Type A&B Surfa Lot# yf36905 exp 5/16/2019 08/7/2015 given: on the yellow paper, handwritten (Pharmacist) wrote: vaccine FLUAD; Lot No 250790, Site of Inj. L7; Exp Date 4-30-2019; rt of admin IM, MFR Seqirus. Vis Version 8/7/2015. Dosage 0.5.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Tremor
Clinical narrative: Nausea, no appetite 1.5 hour later, explosive diarrhea 5-6 hours later (x3), fever, shaking, chills (7 hours later...for 3 hours). I was given the geriatric dose... there were two identification numbers on the 2 papers on the pharmacy Prescription printed RX 6410170 N it says that it was FLUAD 2018-2019 0.5 MI  Inj Seqi Influenza Vac Type A&B Surfa Lot# yf36905 exp 5/16/2019 08/7/2015 given: on the yellow paper, handwritten (Pharmacist) wrote: vaccine FLUAD; Lot No 250790, Site of Inj. L7; Exp Date 4-30-2019; rt of admin IM, MFR Seqirus. Vis Version 8/7/2015. Dosage 0.5.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dysphagia, Nausea, Pyrexia
Clinical narrative: Patient received SHINGRIX in clinic on 8/13/18 and within 2 hours developed nausea, vomiting, difficulty swallowing, wheezing, fever, chills, weakness. He was seen  2 days after IZ and he still had wheezing on exam and had been unable to eat that day due to nausea.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting, Wheezing
Clinical narrative: Patient received SHINGRIX in clinic on 8/13/18 and within 2 hours developed nausea, vomiting, difficulty swallowing, wheezing, fever, chills, weakness. He was seen  2 days after IZ and he still had wheezing on exam and had been unable to eat that day due to nausea.
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Headache, Injection site pain, Injection site reaction, Injection site vesicles
Clinical narrative: Very painful and hot injection site day one. Day 2 had fever, chills, headache, muscle aches and lethargy as well as the painful arm. Day 3 painful arm and red rash at and around the injection. At the injection site there appears to be a blister.
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Injection site warmth, Lethargy, Myalgia, Pyrexia, Rash erythematous
Clinical narrative: Very painful and hot injection site day one. Day 2 had fever, chills, headache, muscle aches and lethargy as well as the painful arm. Day 3 painful arm and red rash at and around the injection. At the injection site there appears to be a blister.
Age: 78.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site cellulitis, Injection site erythema, Pain in extremity
Clinical narrative: Patient woke up the next morning with redness between the injection site on the left arm and the elbow. She went to see her doctor who diagnosed her with cellulitis and prescribed an antibiotic to take for 10 days. She states that her arm is also sore.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: ON 7/6/18: LEFT ARM WAS SWOLLEN AND PAINFUL. TOOK ADVIL 200MG 3 TIMES A DAY FOR 1 DAY AND SWELLING DECREASED BUT PAIN STILL PERSISTED. HAD SHARP PAIN WHEN LIFT UP LEFT ARM. HAD TO HOLD ON ARM TO PUT PUT IT DOWN DUE TO PAIN. HAD NUMBNESS IN LEFT FINGERS. ON 8/10/18, PT HAD A VISIT WITH DR. COMPLAINED ABOUT THE PAIN AND NUMBNESS DUE TO THE THE SIDE EFECTS OF THE SHINGRIX SHOT. PER DR, PAIN GENERALLY SHOULD GO AWAY BUT LETS COME BACK TO OFFICE IN NOVEMBER TO REEVALUATE AND GO TO PHARMACY TO INFORM WHAT HAD HAPPENED. ON 9/6/18, PT INFORMED US AT STORE ABOUT ADVERSE REACTIONS, THEREFORE; WE ARE SUBMITTING THIS FORM.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Influenza like illness, Swelling
Clinical narrative: Noted feeling very tired almost flu like symptoms that evening and next day looked red and angry...still puffy on day 3..she states she is ok but wants glaxo to know.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient complained of large red swelling on left arm near where vaccination was given. Patient and pharmacist do not remember if was given IM or SQ, but large swelling area located on the back of upper left arm. Area was warm to the touch. Patient complained of slight pain, but nothing severe enough to interfere with daily activities.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Patient complained of large red swelling on left arm near where vaccination was given. Patient and pharmacist do not remember if was given IM or SQ, but large swelling area located on the back of upper left arm. Area was warm to the touch. Patient complained of slight pain, but nothing severe enough to interfere with daily activities.
Age: 60.0
Sex: F
Vaccine: FLUR4, PNC13
Symptoms: Dizziness, Headache, Hyperhidrosis, Musculoskeletal pain, Neck pain
Clinical narrative: Patient reported having severe headache, severe neck and shoulder pain, mild dizziness and sweating for the past couple of days after receiving the vaccination.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Cough
Clinical narrative: Patient states he developed a dry hacky cough the day following the AFLURIA injection, cough is only mildly resolved by OTC treatment and continues to persist. Patient states he has not seeked medical attention at this time.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, HIBV, MMRV, PNC13
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Rash macular
Clinical narrative: - Right upper thigh over MMR-V and PREVNAR areas in right upper outer thigh Area. There was a small raised pink area 3-4mm with approximately 4cm surrounding. Blotchy erythema noted which was - non tender -& not indurated(few min later looked less intense).
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt. stated that she has a fist size red area on her arm where the shot was given. When asked, Patient said, "yes it is warm to the touch". Recommended ER or Walk in Clinic. Pt. declined and asked us to call her Dr. in the morning.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion
Clinical narrative: Patient reported today that she developed a large area of bruising the day after injection, I asked her if she has pain in the area and she needs to contact her physician to follow up.
Age: 80.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injected limb mobility decreased
Clinical narrative: Patient could not raise his right arm 4-5 hours after receiving the vaccination. Recommended cold compress and pain relievers/anti-inflammatory meds as needed and to contact MD if symptoms didn't resolve by the following morning. Patient will contact his PCP if needed.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed shingles on the same arm in which the vaccine was administered. Seen at urgent care and treated with valacyclovir tablets, triamcinolone cream and cephalexin capsules for 7 days.