chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Condition aggravated, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of neuropathy in a 85-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included neuralgia (right side median nerve injury from prior surgery). Concurrent medical conditions included neuropathy. Concomitant products included gabapentin, Losartan, vitamin D, ANDROGEL and Metoprolol XR. On 14th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 14th June 2018, less than a day after receiving SHINGRIX, the patient experienced neuropathy (serious criteria GSK medically significant), condition aggravated, injection site pain, arthralgia, injection site itching, injection site rash and somnolence. On an unknown date, the outcome of the neuropathy, injection site pain, arthralgia and somnolence were recovered/resolved and the outcome of the condition aggravated was unknown and the outcome of the injection site itching and injection site rash were recovering/resolving. The reporter considered the neuropathy, condition aggravated, injection site pain, arthralgia, injection site itching, injection site rash and somnolence to be related to SHINGRIX. Additional details were provided as follows: The patient was the reporting physician. The patient experienced soreness and pruritic rash on the upper right arm around where he had the SHINGRIX injection. The patient reported that the rash had improved but was still present and was about 10 by 8 centimeters in size. The patient also reported of experiencing arthralgias in both large and small joints as well as a flare up of right sided neuralgia that lasted for about 2 days. The patient related the neuralgia to a nerve injury he had related to a prior surgery. The patient reported that all events except the rash had resolved and did not require medical intervention. The contact details of the pharmacy was provided.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Neuralgia, Neuropathy peripheral, Somnolence
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of neuropathy in a 85-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included neuralgia (right side median nerve injury from prior surgery). Concurrent medical conditions included neuropathy. Concomitant products included gabapentin, Losartan, vitamin D, ANDROGEL and Metoprolol XR. On 14th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 14th June 2018, less than a day after receiving SHINGRIX, the patient experienced neuropathy (serious criteria GSK medically significant), condition aggravated, injection site pain, arthralgia, injection site itching, injection site rash and somnolence. On an unknown date, the outcome of the neuropathy, injection site pain, arthralgia and somnolence were recovered/resolved and the outcome of the condition aggravated was unknown and the outcome of the injection site itching and injection site rash were recovering/resolving. The reporter considered the neuropathy, condition aggravated, injection site pain, arthralgia, injection site itching, injection site rash and somnolence to be related to SHINGRIX. Additional details were provided as follows: The patient was the reporting physician. The patient experienced soreness and pruritic rash on the upper right arm around where he had the SHINGRIX injection. The patient reported that the rash had improved but was still present and was about 10 by 8 centimeters in size. The patient also reported of experiencing arthralgias in both large and small joints as well as a flare up of right sided neuralgia that lasted for about 2 days. The patient related the neuralgia to a nerve injury he had related to a prior surgery. The patient reported that all events except the rash had resolved and did not require medical intervention. The contact details of the pharmacy was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Malaise
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of malaise 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 malaise, flu like symptoms and fatigue. On an unknown date, the outcome of the malaise, flu like symptoms and fatigue were unknown. It was unknown if the reporter considered the malaise, flu like symptoms and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional stated that many of his patients complain about malaise, flu like symptoms and fatigue for several days after receiving SHINGRIX. No further information was provided.
Age: 1.0
Sex: F
Vaccine: TDAP
Symptoms: Condition aggravated, Rash, Similar reaction on previous exposure to drug, Urticaria
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of rash in a 1-year-old female patient who received DTaP vaccine for prophylaxis. Co-suspect products included DTaP vaccine for prophylaxis and DTaP vaccine for prophylaxis. On an unknown date, the patient received the 1st dose of DTaP vaccine, the 2nd dose of DTaP vaccine and the 3rd dose of DTaP vaccine. On an unknown date, less than a year after receiving DTaP vaccine, DTaP vaccine and DTaP vaccine, the patient experienced rash, hives, condition aggravated and condition aggravated. On an unknown date, the outcome of the rash, hives, condition aggravated and condition aggravated were unknown. It was unknown if the reporter considered the rash and hives to be related to DTaP vaccine, DTaP vaccine and DTaP vaccine. It was unknown if the reporter considered the condition aggravated to be related to DTaP vaccine. It was unknown if the reporter considered the condition aggravated to be related to DTaP vaccine. Additional details were provided as follows: This case was reported by an optometrist who did not administer the vaccines. The healthcare professional called to question whether an 18 year old patient could receive MENVEO despite having had rash and hives to a DTaP vaccine at approximately 1 year of age. The DTaP vaccine was unknown. The healthcare professional stated that the patient, when around 1 year of age, received 3 doses of DTaP and the rash and hives worsened with each dose. No other information was available.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020) for prophylaxis. On 18th June 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) .5 ml. On 18th June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema and intramuscular formulation administered by other route were unknown. The reporter considered the injection site erythema to be related to SHINGRIX. Additional information was received as follows: The patient was administered the vaccine subcutaneously on the back of her left arm, which led to the redness around the injection site and intramuscular formulation administered by other route.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of rash 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, several days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient developed a rash on the arm a few days after vaccination. A field representative called into medical information to initiate an adverse event report on behalf of the health care professional. She was given minimal information. The health care professional was going to follow up with once they contact, where it was administered to gather batch information.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, Pain, Pyrexia, Urticaria
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of hives in a 44-year-old female patient who received ENGERIX B adult (batch number GR55T, expiry date 28th August 2020) for prophylaxis. Previously administered products included Hepatitis B vaccine (In 2000, received 1st dose). On 18th June 2018, the patient received the 2nd dose of ENGERIX B adult (intramuscular) 1 ml. On 18th June 2018, less than a day after receiving ENGERIX B adult, the patient experienced hives (serious criteria life threatening and other: serious as per reporter), fever (serious criteria life threatening and other: serious as per reporter) and drug dose administration interval too long. On 19th June 2018, the patient experienced shooting pain (serious criteria life threatening and other: serious as per reporter). The patient was treated with BENADRYL. On an unknown date, the outcome of the hives, shooting pain, fever and drug dose administration interval too long were unknown. The reporter considered the hives and fever to be possibly related to ENGERIX B adult. It was unknown if the reporter considered the shooting pain to be related to ENGERIX B adult. Additional details were provided as follows: No adverse event of previous vaccines was reported. The patient received ENGERIX B adult in the left deltoid. After receiving ENGERIX B adult, the patient developed a fever of over 102 degrees F and hives all over her body and in her mouth. One day after receiving ENGERIX B adult, the patient experienced shooting pain. The patient's primary care provider advised her over the phone to take BENADRYL every 6 hours. After 3 or 4 days, the patient missed a dose of BENADRYL and the hives returned. The patient missed 2 days of work. The reporting healthcare professional had an appointment with the patient on the reporting day.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth, Malaise
Clinical narrative: This is spontaneous report from a contactable consumer. This consumer reported for his wife. A female patient of an unspecified age received PREVNAR 13, (lot# unknown) via an unspecified route of administration on 22Jun2018 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient was not feeling well that her left upper arm at the injection site was hot to touch and red (redness was about the size of the fist) on an unspecified date. The outcome of events was unknown.
Age: 0.33
Sex: M
Vaccine: HIBV, IPV, PNC13, RV5, TDAP
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable consumer. A 4 month-old male patient received for immunization PREVNAR 13,(lot T85621, expiry date 31Mar2020, NDC 00005197101) via an unspecified route of administration in the left thigh at 13:30 at physician's office at 0.5 ml single, the second dose of TDAP, (GSK, lot 2N43Z, expiry date 12Apr2020) intramuscular in the right thigh, the second dose of HIB, (Sanofi Pasteur, lot UI917AA, expiry date 09Oct2019) intramuscular in the right thigh, the second dose of POLIO, (Sanofi Pasteur, lot N1G51, expiry date 02Aug2019) intramuscular in the right thigh, Rotavirus, (Merck, lot N013992,expiry date 27Jan2019) oral, all on 12Jun2018. No other vaccines were administered within 4 weeks. The patient medical history and concomitant medications were none. The patient had previously received for immunization the first dose of diphtheria, tetanus and acellular pertussis, hib vaccine, polio vaccine, rotavirus vaccine on an unspecified date in 2018. The patient experienced rash in Jun2018. Due to the event he was visited at the physician's office on 14Jun2018. He had a follow up appointment on 20Jun2018. The doctor wrote that the rash was clearing up but spreading. Outcome was unknown.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A 8-decade-old female patient received received pneumococcal PREVNAR 13, via an unspecified route of administration on unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced swelling at the injection site on an unspecified date. Outcome of the event was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: M
Vaccine: PNC13
Symptoms: Mobility decreased, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age received pneumococcal PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunisation. Medical history included allergy to shrimp where the patient reported being in the restaurant having shrimp and having anaphylactic reaction to it. The patient's concomitant medications were not reported. On an unspecified date, after PREVNAR 13 vaccination, the patient had soreness that he had restricted arm movement. The outcome of the events was unknown. Information regarding batch number has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Decreased appetite, Injection site inflammation, Injection site pain, Injection site rash
Clinical narrative: Pain near injection site on date of injection. Following day felt ill, achy, upset stomach and no appetite. On Tuesday developed rash below injection site, swollen and inflamed. Personally talked to pharmacist around noon. Around 8 PM went to Hospital ER.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Malaise, Pain, Urine analysis
Clinical narrative: Pain near injection site on date of injection. Following day felt ill, achy, upset stomach and no appetite. On Tuesday developed rash below injection site, swollen and inflamed. Personally talked to pharmacist around noon. Around 8 PM went to Hospital ER.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Influenza like illness, Pain
Clinical narrative: Got my second SHINGRIX shot 6/28/2018, just after noon. 12 hours later really bad flu-like symptoms - chills, bad body aches, light headed, headache...I had a similar reaction to the first shot 2 months ago.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient came in 2 days post injection with red/tenderness and bruising at injection site, area was hot to touch. Instructed patient to use OTC analgesics to see if that soothed it and to come back tomorrow to let us see it again. Told her to watch to make sure it doesn't get worse.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Somnolence
Clinical narrative: 6/26/2018 Painless erythema, warmth, and swelling to left deltoid approximately the size of a deck of cards no fever or other symptoms. Taken to Dr. and treatment ibuprofen and to begin KEFLEX oral TID if continues the next day. 6/27/2018 swelling, erythema, and warmth decreased and KEFLEX started. 6/28/2018 all symptoms to left deltoid resolved. 6/29/2018 patient awoke with headache from temple to temple around back of the head and sleepiness. Physician called and follow up appointment same day, which is today @ 350pm. Below recovery section unknown due to follow up appointment today.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash developed on 10/19/17. Patient self treated with BENADRYL cream. Rash cleared in 9 days.
Age: 0.5
Sex: F
Vaccine: RV1
Symptoms: Product preparation error, Rash
Clinical narrative: Patient was given the diluent for the ROTARIX vaccine. The diluent given was not mixed with the powder ROTARIX. This took place on 6/18/2018. Upon inventory today is when it was observed that this action was done. The count did match. Upon further investigation it was revealed that only the diluent was given. Parent of child notified. Parent states patient has a rash on the back of her head, that started 3 days ago. Patient will come in on 7/2/18 for evaluation and re-vaccination.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary mass, Neck mass, Pain
Clinical narrative: On 6/17/18 in the afternoon, noticed a golf ball size lump on neck and under arm, both on the right side. It was quite painful. By 6/19/18 it was the size of 1/2 a grapefruit. Went to see the doctor and they determined since she had not been bitten by anything and wasn't taking any meds that it had to be from the vaccine. Told her to take ALLEGRA and use ice and to come back if not better in a week. By 6/23/18 she was all better.
Age: 9.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient temporarily relocated due to hurricane, deficient in vaccines per country standards. Was ordered and given a combination vaccine QUADRACEL at age 9, not recommended over age 6.
Age: 21.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Client was give MMR vaccine instead of MCV4- No adverse effect.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Insomnia, Pain in extremity
Clinical narrative: Patient stated, "I had Part 2 of the Pneumo vaccine @ 10:30 am on Tuesday, June 26, 2018. The injection site burned a bit, but as the day wore on my left arm became more and more painful as well as swollen. By 6pm that night I could not even push my car door open and even having clothing brush across the upper arm area was painful. The upper arm area was swollen and red from the injection site down to my elbow joint. I was only able to sleep on my back or right side Tuesday night. Wednesday, the 27th was no better, still painful and more swollen. By the end of the day Wednesday, the arm tissue was so swollen that the swollen area extended out over the elbow joint and the skin area was reddened. My right upper arm measured 10 inches in circumference and the swollen left upper arm measured 11 inches. I developed chills and went to bed about 10:30 pm. I took a plain (not PM) ALEVE gelcapsule. If the symptoms did not dissipate by Thursday morning when I got up, I planned to go to Urgent Care to make sure there was nothing else going on. On Thursday morning, the pain had subsided, but the swelling was still quite apparent as was the redness, all in the area from the injection site down to the elbow joint. At 8pm on Thursday night, the swelling and redness continued."
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Tenderness
Clinical narrative: Patient stated, "I had Part 2 of the Pneumo vaccine @ 10:30 am on Tuesday, June 26, 2018. The injection site burned a bit, but as the day wore on my left arm became more and more painful as well as swollen. By 6pm that night I could not even push my car door open and even having clothing brush across the upper arm area was painful. The upper arm area was swollen and red from the injection site down to my elbow joint. I was only able to sleep on my back or right side Tuesday night. Wednesday, the 27th was no better, still painful and more swollen. By the end of the day Wednesday, the arm tissue was so swollen that the swollen area extended out over the elbow joint and the skin area was reddened. My right upper arm measured 10 inches in circumference and the swollen left upper arm measured 11 inches. I developed chills and went to bed about 10:30 pm. I took a plain (not PM) ALEVE gelcapsule. If the symptoms did not dissipate by Thursday morning when I got up, I planned to go to Urgent Care to make sure there was nothing else going on. On Thursday morning, the pain had subsided, but the swelling was still quite apparent as was the redness, all in the area from the injection site down to the elbow joint. At 8pm on Thursday night, the swelling and redness continued."
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Feeling hot, Headache, Injection site pain
Clinical narrative: Awakened with a sharp pain in the left temple, (headache) which continued for several hours. Aspirin dulled it somewhat. High fever at the same time (4:30 PM) Very hot under blanket, upon removing blanket, severe chills. (Could not take temp. as my teeth were actually chattering together if I got out of bed. Fever lowered about 7:30 Am and stayed at about 100.1 throughout the day. (Last time I took temp. was at 10PM when it was at 100.) Joint aches throughout body. These eased during the day. Injection site and upper arm painful at the same time.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Awakened with a sharp pain in the left temple, (headache) which continued for several hours. Aspirin dulled it somewhat. High fever at the same time (4:30 PM) Very hot under blanket, upon removing blanket, severe chills. (Could not take temp. as my teeth were actually chattering together if I got out of bed. Fever lowered about 7:30 Am and stayed at about 100.1 throughout the day. (Last time I took temp. was at 10PM when it was at 100.) Joint aches throughout body. These eased during the day. Injection site and upper arm painful at the same time.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Cold sweat, Dizziness, Headache, Injection site swelling
Clinical narrative: Fever, muscle pain, chills, cold sweats, headachess, dizziness, extreme swelling at injection site lasting 3 days.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever, muscle pain, chills, cold sweats, headachess, dizziness, extreme swelling at injection site lasting 3 days.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: AXILLA ON SAME SIDE WITH LYMPHADENOPATHY. REQUIRED ICE AND NSAIDs.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Syncope
Clinical narrative: 10x8cm injection site redness on left arm, had some vasovagal syncope while in the office to follow up on reaction.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Red, hot, painful oval (6 cm x 4 cm) approxmately 10 cm below injection site on Right deltoid.
Age: 21.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Client at clinic for MCV4 vaccine for college and was given MMR in error. No side effects stated or adverse outcome.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Swelling and painful from the elbow up to the neck Sx last 3-4 days. Patient still experiencing some very mild pain 6/28.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Blister
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of blister in a 67-year-old female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced blister and back pain. On an unknown date, the outcome of the blister and back pain were not recovered/not resolved. It was unknown if the reporter considered the blister and back pain to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) reported that the patient received dose of SHINGRIX 1 week before the date of reporting but did not have exact date. The patient experienced 6 to 8 blisters in the right lower abdominal area spreading towards the back. The patient was also having pain in this same area. The symptoms had not resolved at the time of reporting. The patient came to the doctor's office because of this issue. No additional information was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of local swelling in a male patient who received SHINGRIX for prophylaxis. On 17th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 19th June 2018, 2 days after receiving SHINGRIX, the patient experienced local swelling. On an unknown date, the outcome of the local swelling was not recovered/not resolved. It was unknown if the reporter considered the local swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in the left arm. The patient received SHINGRIX on Sunday and on the date of reporting (this morning) he woke up and noted swelling under his arm. The patient noted that it was on the same arm as the injection but it was underneath his arm. The call was disconnected when asked caller for his last name and would be on lookout for duplicate report in case consumer calls back.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Feeling cold, Headache, Immediate post-injection reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received SHINGRIX (batch number B9739, expiry date 30th November 2018) for prophylaxis. Concomitant products included Calcium, Aspirin and fish oil. On 7th June 2018 10:30, the patient received the 1st dose of SHINGRIX. On 7th June 2018, immediately after receiving SHINGRIX, the patient experienced pain in arm, skin warm, headache, general body pain, welts, tiredness and erythema of extremities. On 7th June 2018 03:00, the patient experienced chills, influenza-like symptoms and feeling unwell. On an unknown date, the outcome of the pain in arm, skin warm, headache, general body pain, chills, influenza-like symptoms, welts, tiredness, feeling unwell and erythema of extremities were recovered/resolved. The reporter considered the pain in arm, skin warm, headache, general body pain, chills, influenza-like symptoms, welts, tiredness, feeling unwell and erythema of extremities to be related to SHINGRIX. Additional details reported as follows: Concomitant medication also included CENTRUM SILVER. The patient reported that she received the SHINGRIX vaccine around 10:30 AM on the left arm and experienced sore arm immediately after vaccination. In the afternoon by 3:00 PM, 4 hours and 30 minutes after vaccination the patient experienced chills, didn't feel well and had flu like symptoms. The patient claimed that she didn't feel well for 3 days. Each day she would feel a little better but the day of vaccination she was tired. She expected her sore arm; however, she had a red arm welt that was approximately three inches in diameter that was warm to the touch (latency of 1 hours). All of her symptoms had resolved and she felt fine at the reporting time. The patient provided contact details of the physician.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise, Pain, Pain in extremity, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received SHINGRIX (batch number B9739, expiry date 30th November 2018) for prophylaxis. Concomitant products included Calcium, Aspirin and fish oil. On 7th June 2018 10:30, the patient received the 1st dose of SHINGRIX. On 7th June 2018, immediately after receiving SHINGRIX, the patient experienced pain in arm, skin warm, headache, general body pain, welts, tiredness and erythema of extremities. On 7th June 2018 03:00, the patient experienced chills, influenza-like symptoms and feeling unwell. On an unknown date, the outcome of the pain in arm, skin warm, headache, general body pain, chills, influenza-like symptoms, welts, tiredness, feeling unwell and erythema of extremities were recovered/resolved. The reporter considered the pain in arm, skin warm, headache, general body pain, chills, influenza-like symptoms, welts, tiredness, feeling unwell and erythema of extremities to be related to SHINGRIX. Additional details reported as follows: Concomitant medication also included CENTRUM SILVER. The patient reported that she received the SHINGRIX vaccine around 10:30 AM on the left arm and experienced sore arm immediately after vaccination. In the afternoon by 3:00 PM, 4 hours and 30 minutes after vaccination the patient experienced chills, didn't feel well and had flu like symptoms. The patient claimed that she didn't feel well for 3 days. Each day she would feel a little better but the day of vaccination she was tired. She expected her sore arm; however, she had a red arm welt that was approximately three inches in diameter that was warm to the touch (latency of 1 hours). All of her symptoms had resolved and she felt fine at the reporting time. The patient provided contact details of the physician.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received SHINGRIX (batch number B9739, expiry date 30th November 2018) for prophylaxis. Concomitant products included Calcium, Aspirin and fish oil. On 7th June 2018 10:30, the patient received the 1st dose of SHINGRIX. On 7th June 2018, immediately after receiving SHINGRIX, the patient experienced pain in arm, skin warm, headache, general body pain, welts, tiredness and erythema of extremities. On 7th June 2018 03:00, the patient experienced chills, influenza-like symptoms and feeling unwell. On an unknown date, the outcome of the pain in arm, skin warm, headache, general body pain, chills, influenza-like symptoms, welts, tiredness, feeling unwell and erythema of extremities were recovered/resolved. The reporter considered the pain in arm, skin warm, headache, general body pain, chills, influenza-like symptoms, welts, tiredness, feeling unwell and erythema of extremities to be related to SHINGRIX. Additional details reported as follows: Concomitant medication also included CENTRUM SILVER. The patient reported that she received the SHINGRIX vaccine around 10:30 AM on the left arm and experienced sore arm immediately after vaccination. In the afternoon by 3:00 PM, 4 hours and 30 minutes after vaccination the patient experienced chills, didn't feel well and had flu like symptoms. The patient claimed that she didn't feel well for 3 days. Each day she would feel a little better but the day of vaccination she was tired. She expected her sore arm; however, she had a red arm welt that was approximately three inches in diameter that was warm to the touch (latency of 1 hours). All of her symptoms had resolved and she felt fine at the reporting time. The patient provided contact details of the physician.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Neck pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever in a 82-year-old female patient who received SHINGRIX (batch number TP5E5, expiry date 15th November 2020) for prophylaxis. On 18th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In June 2018, less than a week after receiving SHINGRIX, the patient experienced fever, nausea, general body pain, neck pain and pain in arm. The patient was treated with Pain Reliever (Nos). On an unknown date, the outcome of the fever was unchanged and the outcome of the nausea was unknown and the outcome of the general body pain, neck pain and pain in arm were recovering/resolving. The reporter considered the fever, nausea, general body pain, neck pain and pain in arm to be related to SHINGRIX. Additional information was received as follows: This case was reported by a pharmacy intern as the patient reported symptoms to pharmacy. On 18th June 2018, there were no vaccinations other than SHINGRIX was given to the patient. It was unknown if the patient received any other vaccines within 4 weeks prior to the SHINGRIX first dose. The patient received SHINGRIX on the right arm. It was unknown exactly how soon the symptoms started after the vaccine was administered. The patient's doctor told her to take over the counter medications to relieve her pain which was described as being everywhere, specifically in her neck, arms, and legs. The pharmacy had standing order for SHINGRIX. The patient had the physician's office visit because of the symptoms but did not have an emergency room visit due to the symptoms and was not hospitalized for the symptoms. The responsible physician was unknown, but the reporter who was a pharmacist intern granted permission to be contacted at the pharmacy with further related questions.
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved. The reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician stated that, the patient experienced fever (body temperature 101 degree F) for 2 days. The physician believed the fever was related to the SHINGRIX. The reporter agreed to be followed up. Lab Comments: On an unknown date, the patient's body temperature was recorded to be 101 degree F.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced pain and erythema. On an unknown date, the outcome of the pain and erythema were unknown. It was unknown if the reporter considered the pain and erythema to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not applicable for this report. The age group was not reported, but was selected as adult as per the vaccine indication. The nurse shared during meeting with the sales representative that two or three patients had called to let the office know that they had experienced pain and redness. The reporter did not agree to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a adult male patient who received SHINGRIX for prophylaxis. In April 2018, 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. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional information was reported as follows: The patient was a physician at the practice from where the reporter called to report the adverse event. The patient received his first dose in April 2018. He experienced flu like symptoms for about 5 days. The patient may not receive the second dose due to this experience.
Sex: F
Vaccine: HEPA
Symptoms: Epstein-Barr virus infection, Hepatic enzyme increased
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of Epstein-Barr virus infection in a female patient who received HAVRIX 1440 adult for prophylaxis. In January 2018, the patient received HAVRIX 1440 adult. In January 2018, less than a month after receiving HAVRIX 1440 adult, the patient experienced Epstein-Barr virus infection (serious criteria hospitalization). On an unknown date, the outcome of the Epstein-Barr virus infection was unknown. The reporter considered the Epstein-Barr virus infection to be unrelated to HAVRIX 1440 adult. Additional information was received as follows: The age at vaccination was not reported. The patient developed Epstein Barr virus shortly after receiving HAVRIX vaccine and was hospitalized for one week in January 2018. The physician told the patient that they did not think there was a correlation between getting vaccinated and getting the Epstein Barr virus. The patient had elevated liver enzymes.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Papule, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Erythematous, itchy rash with papules and some vesicles on flexor surfaces of both upper arms, L antecubital region, and some on L Achilles region. Looks like shingles rash, but in a more widespread distribution.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Erythematous, itchy rash with papules and some vesicles on flexor surfaces of both upper arms, L antecubital region, and some on L Achilles region. Looks like shingles rash, but in a more widespread distribution.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HEP, PNC13, RV5
Symptoms: Injection site reaction, Rash pustular
Clinical narrative: Local papular rash on both lateral thighs, no systemic symptoms. Happened at 2 and 4 month visits too, bilaterally.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Patient received the vaccine at her normal check-up, and had a brief syncopal episode 3 minutes later. Had no loss of consciousness, and no fall. Returned to normal within 15 minutes.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Arm swollen, red and a bit warm to the touch. Mom will continue to ice and keep and eye on area.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Sweaty, weak, nausea and vomiting, severe headache, dizziness, weakness, sensitive to light, extremely fatigued, soreness at injection site. These symptoms started when I awoke at 7:00 am on June 27, 2018 and lasted until the next morning, aprox. 7:00 am.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea, Photophobia, Vomiting
Clinical narrative: Sweaty, weak, nausea and vomiting, severe headache, dizziness, weakness, sensitive to light, extremely fatigued, soreness at injection site. These symptoms started when I awoke at 7:00 am on June 27, 2018 and lasted until the next morning, aprox. 7:00 am.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Severe chills around 5 hours after vaccination and a fever of 102 F.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient was given the vaccine the wrong route and developed a reaction by the afternoon day of. Patient had redness to area, little bit of warmth to the skin and pretty sore.
Age: 16.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: The patient received Yellow Fever vaccine on 6/25/2018. Varicella vaccine administered today. As of right now, no known adverse reaction.
Age: 69.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Rash generalised
Clinical narrative: Patient described a full body rash that developed later in the day. She said the rash resolved with a short course of prednisone.
Age: 38.0
Sex: M
Vaccine: HEPA
Symptoms: Guillain-Barre syndrome, Nerve conduction studies
Clinical narrative: He developed Guillain-Barre syndrome in late May, 2018, after receiving hepatitis A vaccination about five weeks before. I am not certain of the exact formulation of the hep A vaccine which was given, if this was "HAVRIX" or the other one.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Product administered at inappropriate site
Clinical narrative: When the pharmacist was rubbing the alcohol on the top of my shoulder I thought that was a strange place for a shot. She told me there would be a small stick, the stick didn't hurt but she injected the medicine into my shoulder joint. The pain was so bad I thought I was going to scream. I have a VERY high pain tolerance. By the time I got home (about 3 miles) I could tell it was not letting up any. Within an hour I could not move my arm out from my body. I put ice on it and took naproxen. I could not stand for anything to touch it and it was swollen. I called my own doctor and went to the office today and when she saw it she told me I needed to go to the pharmacy and tell them it looked awful and to find out why she would give me a shot on top of my shoulder. The pharmacist said she was looking for muscle (I have no muscle up there, I have a bicep). She told me just to keep putting ice on it and taking TYLENOL or whatever. When I got home she called me and told me to alternate heat and cold and to be sure and use the arm to keep it from freezing up. I am scared to death to get the 2nd shot in this series. She told me to notify you.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: Patient had flu like symptoms with first shot but reported that with second vaccines symptoms were much more severe - high fever, chills, fatigue, so much in fact that she had to cancel appointments and stay home after the second vaccine. Patient had been consulted that the side effects may be worse after second vaccine but opted to get vaccine due to benefit over risks but wanted to report due to concerns that the side effect.
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Cold sweat, Fall, Immediate post-injection reaction, Loss of consciousness, Pallor
Clinical narrative: Syncopal episode immediately after vaccine administration. Patient fell to floor, noted to be pale, cool and clammy. Consciousness recovered within 1 minute. Vitals noted to be stable. Patient was able to walk unassisted after resting for 10-15 minutes.
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Syncopal episode immediately after vaccine administration. Patient fell to floor, noted to be pale, cool and clammy. Consciousness recovered within 1 minute. Vitals noted to be stable. Patient was able to walk unassisted after resting for 10-15 minutes.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Disorientation, Hyperhidrosis, Loss of consciousness, Nervousness, Pallor
Clinical narrative: Patient passed out within 10 minutes of receiving vaccine. He was very nervous about receiving the shot to begin with. After passing out, he was pale skinned, disoriented and sweating.
Age: 1.33
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: Had MMR and has developed rash and fever. Rash (MMR dose #1 given 6/18. Rash started yesterday- ); Fussy (since Monday Possible prodromal stage); and Fever No sick contacts, URI symptoms, exposures, travel. Consistent with transient rash as an adverse side effect of MMR vaccine, in combination with a fever, most likely attributable to the measles vaccine virus, less likely attributable to a viral exanthem or contacts exposure. Unlikely due to wild-type measles.  Physical exam is consistent with measles exam thumb. She has no lymphadenopathy. Chest no pain of joints. The rash is not consistent with wheels or bradycardia. She is overall nontoxic child with intermittent periods of play, no dehydration, a little bit fussy. No angioedema, no wheezes, no wheal and flare, no urticaria. No history of seizure.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Malaise, Pain, Pyrexia
Clinical narrative: Patient had shots 1 and 2 at pharmacy. With BOTH shot 1 and shot 2, he had severe chills, fever 102, aches, exhaustion. Fever brought down by acetaminophen. Aches treated with ibuprofen. Total duration of feeling crummy: 36-40 hours.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Malaise, Pyrexia, Swelling
Clinical narrative: Swelling and redness (+/- 4cm). Fever 102, malaise lasting for approx. 24 hours.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: Moderate pain in arm, enough to disturb sleep. Fatigue and general achiness. Fever above 100 degrees.
Age: 0.08
Sex: M
Vaccine: UNK
Symptoms: Abnormal behaviour, Crying, Decreased eye contact, Feeling abnormal, Injection site swelling
Clinical narrative: My son spiked a fever. He completely started staring blankly at a wall after his first nap after the vaccines. It was not his normal. He would cry out in pain whimpering for almost three weeks after the vaccines, when he never did that before. His thighs were swollen for a few days and he acted very different. My son normally is a happy baby and he regressed and was quiet, wouldn't make any eye contact and was miserable. His body broke out in tiny red dots that went away after a few days.
Age: 0.08
Sex: M
Vaccine: UNK
Symptoms: Pain, Pyrexia, Rash erythematous, Rash generalised, Staring
Clinical narrative: My son spiked a fever. He completely started staring blankly at a wall after his first nap after the vaccines. It was not his normal. He would cry out in pain whimpering for almost three weeks after the vaccines, when he never did that before. His thighs were swollen for a few days and he acted very different. My son normally is a happy baby and he regressed and was quiet, wouldn't make any eye contact and was miserable. His body broke out in tiny red dots that went away after a few days.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Chills, Headache, Injection site pain, Malaise
Clinical narrative: PATIENT STATES THAT SHE DEVELOPED A HEADACHE, SHIVERS, FEELING UNWELL, STAYED IN BED THE NEXT DAY. EXPERIENCED PAIN IN THE ARM A DISTANCE FROM THE INJECTION SITE, FROM SHOULDER TO ELBOW AND THE AREA ON THE SIDE OF HER CHEST.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Injection site pain, Injection site pruritus, Local reaction
Clinical narrative: Fever, Chills, redness, local injection site reaction (approximately 6 inches in diameter), pain and itching at injection site.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, Chills, redness, local injection site reaction (approximately 6 inches in diameter), pain and itching at injection site.
Age: 1.08
Sex: F
Vaccine: ADEN_4_7
Symptoms: Condition aggravated, Eczema
Clinical narrative: Eczema flare.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pruritus, Rash
Clinical narrative: Patient presented to the pharmacy with a swollen forearm and hand associated with tiny bumps. Complained of itching also.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Rash, Rash pruritic, Urticaria
Clinical narrative: The patient called the same evening she received the vaccine complaining of a headache and hives and an itching rash on her face abdomen and legs. The pharmacist on duty advised her to use BENADRYL for her reaction and call her primary care doctor if she continued to have itching or if her symptoms worsened. I spoke with her 2 days later and her rash had subsided.