chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Loss of personal independence in daily activities, Malaise, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of unwell in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced unwell, generalized aching, chills, fever, influenza-like symptoms and activities of daily living impaired. On an unknown date, the outcome of the unwell, generalized aching, chills, fever, influenza-like symptoms and activities of daily living impaired were recovered/resolved. It was unknown if the reporter considered the unwell, generalized aching, chills, fever, influenza-like symptoms and activities of daily living impaired to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient did receive SHINGRIX some weeks before the reporting date and the patient became ill the next day of the vaccination day with generalized aches, chills, fever and heavy flu-like symptoms. These were severe enough to disabled the patient for a day but only lasted 24 to 36 hours. The reporter asked if those were the common response. It was interesting that they both (the patient's family member who received SHINGRIX refer case US2018GSK151444) reacted exactly the same. The reporter said that any information could offer here would be appreciated. The reporter said that he was recently retired hospital pharmacist so please do not hesitate to offer him provider information. He understood the pharmacology as well as the supply chain issues. This case was one of the 4 link cases, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of unwell in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced unwell, generalized aching, chills, fever, influenza-like symptoms and activities of daily living impaired. On an unknown date, the outcome of the unwell, generalized aching, chills, fever, influenza-like symptoms and activities of daily living impaired were recovered/resolved. It was unknown if the reporter considered the unwell, generalized aching, chills, fever, influenza-like symptoms and activities of daily living impaired to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient did receive SHINGRIX some weeks before the reporting date and the patient became ill the next day of the vaccination day with generalized aches, chills, fever and heavy flu-like symptoms. These were severe enough to disabled the patient for a day but only lasted 24 to 36 hours. The reporter asked if those were the common response. It was interesting that they both (the patient's family member who received SHINGRIX refer case US2018GSK151444) reacted exactly the same. The reporter said that any information could offer here would be appreciated. The reporter said that he was recently retired hospital pharmacist so please do not hesitate to offer him provider information. He understood the pharmacology as well as the supply chain issues. This case was one of the 4 link cases, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of blood glucose increased in a male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included type II diabetes mellitus. On 17th August 2018, the patient received SHINGRIX. On 17th August 2018, less than a day after receiving SHINGRIX, the patient experienced blood glucose increased. On an unknown date, the outcome of the blood glucose increased was recovered/resolved. It was unknown if the reporter considered the blood glucose increased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Being diabetic, Type II, the patient checked his glucose regularly. At about 11:35 AM, the patient received first of two SHINGRIX doses. After the injection, the patient's glucose was running at least 45 to 55 points higher than normal for the next 36 hours (plus or minus). The pharmacist was contacted by the patient on Saturday AM said that higher glucose was not a listed side effect. The issue had passed so, no harm, no foul. The patient thought that GlaxoSmithKline might wished to know the patient's experience.
Sex: U
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient complained about sore arm.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of rash in a elderly 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 rash and pruritus. The patient was treated with Antihistamines and BENADRYL. On an unknown date, the outcome of the rash and pruritus were unknown. It was unknown if the reporter considered the rash and pruritus to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving SHINGRIX, the patient experienced rash and non-specific skin eruption. The patient went to urgent care due to rash from vaccine and suggested over the counter antihistamines for itching. Also suggested BENADRYL just at night.
Sex: M
Vaccine: DTAP
Symptoms: Fatigue
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fatigue in a male patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis. Concurrent medical conditions included dog bite. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was unknown. It was unknown if the reporter considered the fatigue to be related to dTpa vaccine. Additional information was reported as follows: The age at vaccination was not reported. The patient was bitten by a dog and vaccinated with dTpa vaccine by the hospital. The patinet had a visit to the office on the date of reporting and was complaining of lingering fatigue. The reporter was unsure if the event experienced by the patient was related to the vaccine but wanted to explore the underlying causes and was curious if it had been reported or linked in the past.  The patient was also provided with the Medical Affairs number.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms 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 influenza-like symptoms and general body pain. On an unknown date, the outcome of the influenza-like symptoms and general body pain were unknown. It was unknown if the reporter considered the influenza-like symptoms and general body pain to be related to SHINGRIX. Additional details reported as follows: When asked for more specific information reporter stated her mother was in bed for full day following her SHINGRIX doses. This case has been linked with US2018GSK155286, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX for prophylaxis. On 2nd May 2018, the patient received the 1st dose of SHINGRIX. On 2nd May 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, injection site erythema, injection site swelling and injection site pain. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the injection site erythema and injection site pain were not recovered/not resolved and the outcome of the injection site swelling was recovering/resolving. It was unknown if the reporter considered the influenza-like symptoms, injection site erythema, injection site swelling and injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the nurse for herself. The age at vaccination was not reported. The patient experienced redness, swelling and pain at the administration site. Symptoms began the day of vaccination. In 2018, less than a year after receiving SHINGRIX the patient experienced flu-like symptoms for a few days following the vaccine. At the time of this report, the swelling went down but redness and pain persisted. The reporter agreed to be followed up. This case has been linked with US2018GSK152347, reported by same reporter.
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The reporter said that her arm was barely sore (not enough to complain) at the injection site and not red at all (after the first shot of SHINGRIX, refer case US2018151874) and that was not different than after getting a flu shot. This case has been linked cases US2018GSK153694 (2nd dose of SHINGRIX) and US2018GSK152142 for different patient, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tingling in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced tingling and numbness. On an unknown date, the outcome of the tingling and numbness were not reported. It was unknown if the reporter considered the tingling and numbness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician told that numbness and tingling were the top 5 side effects for SHINGRIX and that he was aware of 3 nurses that had the same side effect. This case was 1 of the 4 cases, reported by same reporter.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer and described the occurrence of pain in arm in a 70-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 2nd May 2018 (experienced aches and pain, headache and debilitation: please refer case US2018151134 )). On 6th June 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The reporter stated that, after vaccination with SHINGRIX, the patient had sore arm. This case was linked with case US2018151134, reported by the same reporter for the same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms 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 influenza-like symptoms and unwell. On an unknown date, the outcome of the influenza-like symptoms and unwell were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms and unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by the patient's friend. The reporter was calling for medical information and availability of SHINGRIX (refer case US2018151043). While discussing this reporter mentioned her friend experienced flu-like symptoms and was really ill. The reporter was not asked further probing details since she just mentioned that in conversation and that was not the reason for her calling. This case has been linked to case US2018GSK157011, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms 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 influenza-like symptoms and unwell. On an unknown date, the outcome of the influenza-like symptoms and unwell were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms and unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by the patient's friend. The reporter was calling for medical information and availability of SHINGRIX (refer case US2018151043). While discussing this reporter mentioned her friend experienced flu-like symptoms and was really ill. The reporter was not asked further probing details since she just mentioned that in conversation and that was not the reason for her calling. This case has been linked to case US2018GSK157010, reported by the same reporter.
Sex: U
Vaccine: MENB
Symptoms: Rash
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of rash in a patient who received BEXSERO (batch number 116901A, expiry date unknown) for prophylaxis. On an unknown date, the patient received BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced rash on neck, arm, and chest of the side of BEXSERO injection. This event was occurred in past 6 weeks from the date of reporting. This is 1 of the 3 linked cases reported by the same reporter.
Sex: U
Vaccine: MENB
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a patient who received BEXSERO (batch number 165801, expiry date unknown) for prophylaxis. On an unknown date, the patient received BEXSERO. On an unknown date, less than a year 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: The age at vaccination was not reported. The patient experienced large red mark about 5 in less round the injection site. This event was occurred in past 6 weeks from the date of reporting. This is 1 of the 3 linked cases reported by the same reporter.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Patient endorses symptoms of arm soreness, general malaise, fatigue, and fever (101.8 degrees Fahrenheit) for one day. Symptoms have now resolved.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Injection site pain, Listless, Pain
Clinical narrative: Soreness at injection site, overall achy feeling, listless, feverish. Treated with aspirin during daytime hours and ALEVE at night. Same reactions were experienced with the first dose of SHINGRIX, although I experienced severe chills and severe weakness on that occasion (March 2018) Symptoms continued on and off for a week in that case. Length of symptoms this time not yet known, as I'm still experiencing them as of this report.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Soreness at injection site, overall achy feeling, listless, feverish. Treated with aspirin during daytime hours and ALEVE at night. Same reactions were experienced with the first dose of SHINGRIX, although I experienced severe chills and severe weakness on that occasion (March 2018) Symptoms continued on and off for a week in that case. Length of symptoms this time not yet known, as I'm still experiencing them as of this report.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Condition aggravated, Fatigue, Headache, Oral herpes
Clinical narrative: Documented on 8/8- Recent SHINGRIX vaccine (left arm 8/2/18 at Pharmacy). That evening noticed arm was exceptionally sore. Next day began having generalized body aches, chills, HA, fatigue, feverish. Husband also got the vaccine but was fine. Symptoms continued x 3 days after vaccine. Still does not feel 100%. Within past 24 hours started having fever blisters on upper lip. H/oOfever blister, flare up with stress, illness, etc. Progressing more rapidly than normal.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Documented on 8/8- Recent SHINGRIX vaccine (left arm 8/2/18 at Pharmacy). That evening noticed arm was exceptionally sore. Next day began having generalized body aches, chills, HA, fatigue, feverish. Husband also got the vaccine but was fine. Symptoms continued x 3 days after vaccine. Still does not feel 100%. Within past 24 hours started having fever blisters on upper lip. H/oOfever blister, flare up with stress, illness, etc. Progressing more rapidly than normal.
Age: 18.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Dizziness, Headache, Musculoskeletal stiffness, Neck pain, Pain
Clinical narrative: Fever, headaches, body aches, sore/stiff neck, dizziness/lightheadedness.
Age: 18.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Pyrexia
Clinical narrative: Fever, headaches, body aches, sore/stiff neck, dizziness/lightheadedness.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion
Clinical narrative: Patient is complaining of multiple bruises. Bruises are appearing in multiple areas of the body including both arms and chest area. Unsure if related to bruises. Patient did report taking aspirin 81mg and has since stopped taking.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: Pt complains of not being able to move arm is extremely painful and after aspercreme ibuprofen and massaging muscle and arm still can't move arm without pain.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Cold sweat, Dizziness, Feeling hot, Headache, Immediate post-injection reaction
Clinical narrative: Pt received vaccines in the office and immediately felt hot and clammy. Was able to get to her car where she drank something cold and sat in the air conditioning and felt a little better. Cont to have headache and dizziness all afternoon. Approx 5 hrs after administration, pt fainted at home. She continued to have a headache all evening, vomited once but slept well and woke the next morning feeling well.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Syncope, Vomiting
Clinical narrative: Pt received vaccines in the office and immediately felt hot and clammy. Was able to get to her car where she drank something cold and sat in the air conditioning and felt a little better. Cont to have headache and dizziness all afternoon. Approx 5 hrs after administration, pt fainted at home. She continued to have a headache all evening, vomited once but slept well and woke the next morning feeling well.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Large indurated, red firm area covering about 3 in by 2 in. After 8 days the swelling is improved but the firmness and dark red area is still present.
Age: 9.0
Sex: F
Vaccine: HPV2
Symptoms: Asthenia, Heart rate increased, Influenza, Nasopharyngitis, Nausea
Clinical narrative: Initial cold and flu symptoms (When no cold or flu symptoms at all in the weeks leading up to vaccination, booster shot of CERVARIX for HPV prevention) Nausea (vomiting, twice on Sunday 26th August Extremely persistent high temperatures, up to 38.8 degrees celsius up to one week after the vaccination, healed only by medical intervention with visit to Doctor (who confirmed a very high heart rate) and taking of liquid panado syrup and medication to dry up water in ears and cold effects. No antibiotics given. Desire to sleep for bouts in the daytime, up to 2 hours at a time, in addition to night time sleep. Small spots on hands and face, disappeared after four days of vaccination. Loss of energy.
Age: 9.0
Sex: F
Vaccine: HPV2
Symptoms: Pyrexia, Rash, Somnolence, Vomiting
Clinical narrative: Initial cold and flu symptoms (When no cold or flu symptoms at all in the weeks leading up to vaccination, booster shot of CERVARIX for HPV prevention) Nausea (vomiting, twice on Sunday 26th August Extremely persistent high temperatures, up to 38.8 degrees celsius up to one week after the vaccination, healed only by medical intervention with visit to Doctor (who confirmed a very high heart rate) and taking of liquid panado syrup and medication to dry up water in ears and cold effects. No antibiotics given. Desire to sleep for bouts in the daytime, up to 2 hours at a time, in addition to night time sleep. Small spots on hands and face, disappeared after four days of vaccination. Loss of energy.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Skin lesion
Clinical narrative: Per provider notes, " patient got his Varicella vaccine 2 weeks ago and developed a rash 3 days ago and has about 12 lesions over his trunk and buttocks area. Patient has been well-appearing with no fever and is eating well. He has no other symptoms." No testing, no antiviral treatment. "Symptomatic care discussed with mom and the fact that this a vaccine side effect. Patient to follow up with her PCP for new concerns. Patient is happy and well-appearing and discussed contagiousness".
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Blood glucose, Blood pressure immeasurable, Erythema, Eye movement disorder, Incontinence
Clinical narrative: PT WENT TO LOBBY TO SIT AND WAIT 15 MIN. PT HAD APPARENT SEIZURE WHILE SITTING IN CHAIR. HIS EYES ROLLED BACK, CLENCHED FIST WITH ARMS SLIGHTLY MOVING. HIS FACE BECAME RED, THEN SUDDENLY WENT VERY ASHEN IN COLOR, LIPS PALE. PULSE VERY FAINT. PT INCONTINENT OF URINE. 911 CALLED . AFTER ASSESSMENT, THEY STARTED IV AND TRANSPORTED TO ER. PER EMT, BP WAS 68 WITH UNHEARABLE LOWER NUMBER.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Muscle contractions involuntary, Pallor, Pulse abnormal, Seizure, Urinary incontinence
Clinical narrative: PT WENT TO LOBBY TO SIT AND WAIT 15 MIN. PT HAD APPARENT SEIZURE WHILE SITTING IN CHAIR. HIS EYES ROLLED BACK, CLENCHED FIST WITH ARMS SLIGHTLY MOVING. HIS FACE BECAME RED, THEN SUDDENLY WENT VERY ASHEN IN COLOR, LIPS PALE. PULSE VERY FAINT. PT INCONTINENT OF URINE. 911 CALLED . AFTER ASSESSMENT, THEY STARTED IV AND TRANSPORTED TO ER. PER EMT, BP WAS 68 WITH UNHEARABLE LOWER NUMBER.
Age: 22.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Unevaluable event
Clinical narrative: Vaccines given by agency (a contracted agency). Unknown lot number for Tdap.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: INCHES LONG, NOT RAISED, WARM TO TOUCH, PINK IN COLOR, ABOUT 5 INCHES IN WIDTH, DENY ITCHING, LOCATION NOT AT THE INJECTION SITE (ISOLATED PINK PATCH FURTHER DOWN THE UPPER ARM).
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus generalised, Urticaria
Clinical narrative: Itching all over body with red hives. ZYRTEC was taken and red hives decreased in size but did not alleviate itching. The patient was instructed to contact PCP to discuss the need of an oral steroid and instructed to take BENADRYL OTC. Unknown if the patient contacted PCP after pharmacy consult. Patient received SHINGRIX a week prior to influenza vaccination at PCP - lot number unknown.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Injection site pain, Pyrexia
Clinical narrative: Symptoms begin the evening of vaccination. Patient had extreme soreness at injection site. Stated he had fever, chills, and joint pain for "a day or two".
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Pyrexia
Clinical narrative: Patient had complain of feeling fatigued after first shot. Patient still wanted 2nd shot. 2nd shot was administered 8/25. Patient's Wife called on 8/26 to say that patient had a fever of over 102 degrees, and extreme joint pain.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Urticaria
Clinical narrative:  "Hi I believe I read they want to track side effects of the vaccination for Shingles. 14 hours after I received the vaccination I awoke with fever and teeth chattering chills that lasted throughout the night. I took acetaminophen that helped reduce the fever. Tuesday I was not feeling quite right, but no more fever. I also have a 2 inch welt on my arm that's slowly improving. No need to reply, just sharing my experience post vaccination."
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Fever, headache, site red and swollen, Hot to touch.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redden site, swelling, pain.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 16 year old female patient. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 06-AUG-2018, the patient was vaccinated with improperly stored GARDASIL 9 (dosing details unknown, lot# R001262, expiry date: unknown) in the left deltoid for prophylaxis in a public health clinic/hospital using public funds (Incorrect product storage). The patient had one dose of GARDASIL 9 previously. No prescription drug treatment was required for the experience. The patient did not receive any reverse reactions to the vaccine. The vaccine was stored at a temperature of 0 Celsius (C) degree to 1 C degree for 41 hours, below 0 C degree (-0.01) for 27 hours and between 9 C degree to 25 C degree (16.4) for 12 hours 30 minutes. Previous temperature excursion were 0 C degree to 1 C degree for 27 hours. Data logger was involved. No adverse effect reported. No product quality complaint (PQC) was involved.  This is one of two reports from the same reporter. Sender's Comments: US-009507513-1808USA003706.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 78-year-old female patient who received SHINGRIX (batch number G933B, expiry date 22nd November 2020) for prophylaxis. Concomitant products included SHINGRIX. On 18th August 2018, the patient received the 2nd dose of SHINGRIX. On 18th August 2018, less than a day after receiving SHINGRIX, the patient experienced chills and drug dose administration interval too short. On an unknown date, the outcome of the chills was not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown. It was unknown if the reporter considered the chills to be related to SHINGRIX. Additional details were provided as follows: The patient got 1st dose of SHINGRIX on 20th July 2018. The patient received 2nd dose of SHINGRIX at shorter than recommended interval, which led to shortening of vaccination schedule. The patient also experienced chills after the vaccine for the last 2 days before the date of reporting that had not resolved.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Extensive swelling of vaccinated limb, Joint swelling, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 62-year-old female patient who received SHINGRIX (batch number 32PE4, expiry date 23rd January 2021) and (batch number TP5E5, expiry date 15th November 2020) for prophylaxis. On 10th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, neck swelling, labored breathing and swelling of elbows. On an unknown date, the outcome of the extensive swelling of vaccinated limb, neck swelling and labored breathing were recovered/resolved and the outcome of the swelling of elbows was unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, neck swelling, labored breathing and swelling of elbows to be related to SHINGRIX. Additional details reported as follows: The patient received SHINGRIX on left deltoid. The patient experienced swelling the size of a baseball, in the arm where the vaccine was given. The swelling went down to the elbow and up to the neck. The patient experienced labored breathing. The swelling took 3 weeks to resolve and the labored breathing lasted one evening.  The healthcare professional did not know how soon after the dose of SHINGRIX that the events started. The patient did no go to the emergency room.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of erythematous rash in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 11th August 2018, the patient received SHINGRIX. In August 2018, less than a month after receiving SHINGRIX, the patient experienced erythematous rash. On an unknown date, the outcome of the erythematous rash was unknown. It was unknown if the reporter considered the erythematous rash to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a Nurse Practitioner (NP). The patient received SHINGRIX on an unknown deltoid. The nurse practitioner reported that the patient experienced a red rash on her chest and under breast after receiving SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX for prophylaxis. On 2nd May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, injection site erythema, injection site swelling and injection site pain. On an unknown date, the outcome of the influenza-like symptoms and injection site swelling were recovered/resolved and the outcome of the injection site erythema and injection site pain were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, injection site erythema, injection site swelling and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced redness, swelling and pain at the administration site. Symptoms began the day of vaccination. The patient experienced flu-like symptoms for a few days following the vaccine. Actually the patient had to leave work and go home to bed. At the time of this report, the swelling went down but redness and pain persisted. The reporter agreed to be followed up. This case has been linked with US2018GSK152346, reported by same reporter.
Age: 54.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Client was advised to get TDP by his PP. The birthdate on the forms had the wrong year of birth so there was no record. When the client # was entered into record it showed that he had been given a TDP on 8/16/2016.  The client is deaf and his wife said he did not have a TDP in 2016. I told her to contact pharmacy in regards to this matter.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Redden arm but not at site of injection, very sore arm and swollen.
Age: 1.0
Sex: M
Vaccine: PNC13, VARCEL
Symptoms: Abnormal behaviour, Blood glucose, Differential white blood cell count, Full blood count, Hypersensitivity
Clinical narrative: Shortly after the child received a vaccines in the mother with the front desk in child started to act odd  the child started vomiting was brought back into the exam room and patient continued to vomit and became lethargic we assumed the patient was having a reaction to the vaccine possibly a vasovagal and possibly a seizure since the patient seemed to be post ictal we gave the child oxygen head and monitored because of the lethargy 911 was called and EMT he has came and took the child to the emergency department I found out that on route to the hospital the child developed a rash and worsened patient was given a shot of epi and the patient began to recover apparently the child had a allergic reaction to either the chickenpox vaccine or the Prevnar vaccine I spoke to the mother while she was in the emergency department and she states that the child was doing much better.
Age: 1.0
Sex: M
Vaccine: PNC13, VARCEL
Symptoms: Lethargy, Metabolic function test, Postictal state, Rash, Vomiting
Clinical narrative: Shortly after the child received a vaccines in the mother with the front desk in child started to act odd  the child started vomiting was brought back into the exam room and patient continued to vomit and became lethargic we assumed the patient was having a reaction to the vaccine possibly a vasovagal and possibly a seizure since the patient seemed to be post ictal we gave the child oxygen head and monitored because of the lethargy 911 was called and EMT he has came and took the child to the emergency department I found out that on route to the hospital the child developed a rash and worsened patient was given a shot of epi and the patient began to recover apparently the child had a allergic reaction to either the chickenpox vaccine or the Prevnar vaccine I spoke to the mother while she was in the emergency department and she states that the child was doing much better.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Crying, Erythema, Feeling hot, Pyrexia, Rash
Clinical narrative: Pt developed a rash 10 days after her MMR vaccine. It is nonpruritic. She has had low grade fevers up to 99. It gets more red when she gets hot. She had mild URI symptoms following her immunizations. Mom says, "Every time she gets her shots, she cries for 2-3 days." She says that she can not hold her and it is not normal crying but this last time was the worst. On the first 2 days after her immunizations, she would hold her head and cry.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Upper respiratory tract infection
Clinical narrative: Pt developed a rash 10 days after her MMR vaccine. It is nonpruritic. She has had low grade fevers up to 99. It gets more red when she gets hot. She had mild URI symptoms following her immunizations. Mom says, "Every time she gets her shots, she cries for 2-3 days." She says that she can not hold her and it is not normal crying but this last time was the worst. On the first 2 days after her immunizations, she would hold her head and cry.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Caesarean section, Exposure during pregnancy, Foetal heart rate decreased, Premature labour
Clinical narrative: I was 32 weeks pregnant, I went for my regular check up and received the Tdap shot as recommended. Almost 2 weeks later I went into preterm labor. Then had to have emergency C section due to my daughter's heart rate dropping. I had a healthy pregnancy with no issues before I received the Tdap shot. Although I have no actual proof I truly believe this caused it, after extensive research. I am reporting so late due to not being knowledgeable about vaccine reaction or VAERS.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Chills, Dizziness, Dyspnoea, Headache, Injection site erythema
Clinical narrative: Pt wife states during phone call to clinic 8/29/18 that after leaving clinic on 8/27/18 at appx 1230, they went shopping at which time pt began to c/o nausea and dizziness.  Pt wife took him home and he went to bed.  Pt began running fevers up to 101 F on Tuesday 8/28/18, with continued nausea and dizziness, c/o HA, rt arm pain, and chills.  Wife states that he slept all day on Tuesday.  Tues during the night, pt woke up and "couldn't breathe", wife administered inhaler.  Wife states that pt still "feels terrible" 8/29/18 and rt arm is red at injection site with minimal swelling. Wife states that pt takes many meds for RA, is immune compromised, and has COPD.  Nurse advised wife that pt's body is building immunity to the vaccines and he may feel bad due to being immune compromised.  Nurse advised pt wife to call PCP 8/29/18 and explain s/s to see if PCP recommends being seen in office or Urgent care.  Nurse JW asked pt wife to advise how he is doing and if seen by PCP. 8/30/2018, pt wife left VM to notify that his "symptoms are subsiding, no longer has HA or dizziness", still has a "slight fever."  Wife states that she spoke with PCP 8/29/18 who prescribed a z-pack.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Injection site swelling, Nausea, Pain in extremity, Pyrexia, Somnolence
Clinical narrative: Pt wife states during phone call to clinic 8/29/18 that after leaving clinic on 8/27/18 at appx 1230, they went shopping at which time pt began to c/o nausea and dizziness.  Pt wife took him home and he went to bed.  Pt began running fevers up to 101 F on Tuesday 8/28/18, with continued nausea and dizziness, c/o HA, rt arm pain, and chills.  Wife states that he slept all day on Tuesday.  Tues during the night, pt woke up and "couldn't breathe", wife administered inhaler.  Wife states that pt still "feels terrible" 8/29/18 and rt arm is red at injection site with minimal swelling. Wife states that pt takes many meds for RA, is immune compromised, and has COPD.  Nurse advised wife that pt's body is building immunity to the vaccines and he may feel bad due to being immune compromised.  Nurse advised pt wife to call PCP 8/29/18 and explain s/s to see if PCP recommends being seen in office or Urgent care.  Nurse JW asked pt wife to advise how he is doing and if seen by PCP. 8/30/2018, pt wife left VM to notify that his "symptoms are subsiding, no longer has HA or dizziness", still has a "slight fever."  Wife states that she spoke with PCP 8/29/18 who prescribed a z-pack.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Injection site bruising, Pyrexia, Tremor
Clinical narrative: Awakened during the night following the vaccine with chills, shakes, large bruise at site of injection, fever, weakness, tremor in right arm; slowly over a few weeks all symptoms except the tremor have resolved; The tremor continues as of submission date; Neurology consult has been ordered.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Dizziness, Headache, Injection site erythema
Clinical narrative: Shortly after the vaccination, I had muscle pain, redness and swelling at the injection site. I woke up at 4:00 am 8-23-18 with headache, fever, muscle ache, nausea, stomach ache, and weakness.  I was unable to get out of bed to do anything but go to the bathroom. The fever broke about 4:00 pm, with the other symptoms lasting until the next day, 8-24-18. I was dizzy and nauseous through 8-25-18.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Mobility decreased, Myalgia, Nausea
Clinical narrative: Shortly after the vaccination, I had muscle pain, redness and swelling at the injection site. I woke up at 4:00 am 8-23-18 with headache, fever, muscle ache, nausea, stomach ache, and weakness.  I was unable to get out of bed to do anything but go to the bathroom. The fever broke about 4:00 pm, with the other symptoms lasting until the next day, 8-24-18. I was dizzy and nauseous through 8-25-18.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Shortly after the vaccination, I had muscle pain, redness and swelling at the injection site. I woke up at 4:00 am 8-23-18 with headache, fever, muscle ache, nausea, stomach ache, and weakness.  I was unable to get out of bed to do anything but go to the bathroom. The fever broke about 4:00 pm, with the other symptoms lasting until the next day, 8-24-18. I was dizzy and nauseous through 8-25-18.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: BELL'S PALSY, LEFT SIDE (SAME SIDE AS VACCINE).
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Pronounced tender lump with erythema at the injection site.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Injection site swelling
Clinical narrative: PATIENT STATED HER THE INJECTION SITE SWOLLEN UP, AND SHE RAN A TEMPERATURE.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Lethargy, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient reported red, swollen arm which was hot to the touch and painful. Patient also reported several days of lethargy.
Age: 62.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Erythema, Lymphadenopathy, Pyrexia
Clinical narrative: Patient experienced fever, chills, redness on the left arm, and swelling of her lymph nodes. She had very similar symptoms during the first dose of SHINGRIX. The lymph node swelling began yesterday and is still present, is not as severe as during her first dose
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Immediate left arm swelling, redness and pain in area of injection.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Tingling, Pins and needles feeling down arm. Continued for 2 weeks before patient reported symptoms to pharmacy.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Abdominal discomfort, Asthenia, Dizziness, Feeling abnormal, Inappropriate affect
Clinical narrative: Within 2 minutes of receiving the Meningococcal vaccine, the patient became very dizzy and weak feeling - had to sit down - "zoned out" for a moment - did not respond to questions - stared without blinking. Then his muscles started cramping, spasming in legs, arms and neck. Patient said his stomach felt odd. Then he began to laugh uncontrollably and then trembled uncontrollably. Took patient to the nearby pediatric clinic where a doctor, nurse, technician all began to evaluate the patient and get his vital signs. After about 15 minutes, the symptoms began to disappear as quickly as they started, except the patient said he felt like he had brain fog. He was asked to lie down and rest in a patient exam room for further observation. Patient was released after 20 minutes with no further complaints or symptoms of an adverse reaction.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Muscle spasms, Staring, Tremor, Unresponsive to stimuli
Clinical narrative: Within 2 minutes of receiving the Meningococcal vaccine, the patient became very dizzy and weak feeling - had to sit down - "zoned out" for a moment - did not respond to questions - stared without blinking. Then his muscles started cramping, spasming in legs, arms and neck. Patient said his stomach felt odd. Then he began to laugh uncontrollably and then trembled uncontrollably. Took patient to the nearby pediatric clinic where a doctor, nurse, technician all began to evaluate the patient and get his vital signs. After about 15 minutes, the symptoms began to disappear as quickly as they started, except the patient said he felt like he had brain fog. He was asked to lie down and rest in a patient exam room for further observation. Patient was released after 20 minutes with no further complaints or symptoms of an adverse reaction.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Local reaction, Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: NECK AND SHOULDER STIFFNESS, LOCAL REACTION(RASH) GETTING LARGER, ARM SWELLING DOWN TO ELBOW, HEADACHE AND FATIGUE SINCE INJECTION ON 8-29-18.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: NECK AND SHOULDER STIFFNESS, LOCAL REACTION(RASH) GETTING LARGER, ARM SWELLING DOWN TO ELBOW, HEADACHE AND FATIGUE SINCE INJECTION ON 8-29-18.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Back pain, Erythema, Injection site rash, Pain in extremity, Peripheral swelling
Clinical narrative: Patient's left arm had some severe swelling, pain, redness, hot to the touch, and rash on the entire arm that was injected. Patient also stated that her back began to ache.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Rash, Skin warm
Clinical narrative: Patient's left arm had some severe swelling, pain, redness, hot to the touch, and rash on the entire arm that was injected. Patient also stated that her back began to ache.
Age: 24.0
Sex: M
Vaccine: HPV9, VARCEL
Symptoms: Urticaria
Clinical narrative: Urticaria on left hand and right side.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: An itchy rash that started at the injection site the morning after injection. It is raised, and red, warm to the touch. After calling the pharmacy which gave the shot they advised to use BENADRYL cream and or ibuprofen. Advised if the rash got worse to go to my campus health center which will be done in the morning.