chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MENB
Symptoms: Contusion, Injection site erythema, Joint range of motion decreased
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in an unspecified number of patients who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site erythema, contusion and joint range of motion decreased. On an unknown date, the outcome of the injection site erythema, contusion and joint range of motion decreased were unknown. It was unknown if the reporter considered the injection site erythema, contusion and joint range of motion decreased to be related to BEXSERO. Additional details were provided as follows: The health care professional could not provide patients demographics, lot number or expiration dates. The age at vaccination was not provided. After receiving BEXSERO, the patients experienced redness at and around injection site, bruising and limited range of motion. This case has been linked to the case US2019051643, reported by the same reporter.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Chills, Feeling abnormal, Headache, Lethargy
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tremor in a 52-year-old female patient who received SHINGRIX for prophylaxis. On 14th March 2019, the patient received SHINGRIX. On 14th March 2019, less than a day after receiving SHINGRIX, the patient experienced tremor, chills, pain and feeling abnormal. On 15th March 2019, the patient experienced lethargy and headache. On 17th March 2019, the patient experienced chest pain. On 19th March 2019, the patient experienced neck swelling. On 15th March 2019, the outcome of the tremor, chills and pain were recovered/resolved. On an unknown date, the outcome of the feeling abnormal was unknown and the outcome of the lethargy and headache were not recovered/not resolved and the outcome of the chest pain and neck swelling were recovered/resolved. The reporter considered the tremor, chills, pain, feeling abnormal, lethargy, headache, chest pain and neck swelling to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient for herself. The patient had never had any type of reaction to previous vaccines. The patient began shaking, having chills, hurting everywhere and having pulsating pain in different parts of her body on the night of the vaccination. The next morning (15th March 2019), the patient felt normal but lethargic and had a headache that started in the back of her head, then moved around to different parts of the head. She felt the same on Saturday (16th March 2019). On Sunday (17th March 2019), the patient started having chest pains and a really bad headache. The chest pain resolved but she slept until 1:30 yesterday and woke up with a bad headache. On 19th March 2019, the patient woke up with a slight headache but noticed her neck looked swollen at times but it came and went. At the time of this report, it looked normal. The patient provided the consent for follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Swelling, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tremor in a 52-year-old female patient who received SHINGRIX for prophylaxis. On 14th March 2019, the patient received SHINGRIX. On 14th March 2019, less than a day after receiving SHINGRIX, the patient experienced tremor, chills, pain and feeling abnormal. On 15th March 2019, the patient experienced lethargy and headache. On 17th March 2019, the patient experienced chest pain. On 19th March 2019, the patient experienced neck swelling. On 15th March 2019, the outcome of the tremor, chills and pain were recovered/resolved. On an unknown date, the outcome of the feeling abnormal was unknown and the outcome of the lethargy and headache were not recovered/not resolved and the outcome of the chest pain and neck swelling were recovered/resolved. The reporter considered the tremor, chills, pain, feeling abnormal, lethargy, headache, chest pain and neck swelling to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient for herself. The patient had never had any type of reaction to previous vaccines. The patient began shaking, having chills, hurting everywhere and having pulsating pain in different parts of her body on the night of the vaccination. The next morning (15th March 2019), the patient felt normal but lethargic and had a headache that started in the back of her head, then moved around to different parts of the head. She felt the same on Saturday (16th March 2019). On Sunday (17th March 2019), the patient started having chest pains and a really bad headache. The chest pain resolved but she slept until 1:30 yesterday and woke up with a bad headache. On 19th March 2019, the patient woke up with a slight headache but noticed her neck looked swollen at times but it came and went. At the time of this report, it looked normal. The patient provided the consent for follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Pain in extremity, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old female patient who received SHINGRIX (batch number E3Z7E, expiry date unknown) for prophylaxis. On 14th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 15th March 2019, 1 days after receiving SHINGRIX, the patient experienced pain in arm and erythema of extremities. In March 2019, the patient experienced pruritus and injection site pain. In March 2019, the outcome of the injection site pain was recovered/resolved. On 18th March 2019, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the erythema of extremities and pruritus were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, erythema of extremities, pruritus and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient for herself. The patient stated that she received her 1st dose of SHINGRIX into the left deltoid in the evening of 14th March 2019 and her arm was red and sore which she read was normal and it seemed to fade away and on 20th March 2019, it seemed redder than it had been. The patient further clarified that she had a big red circle and it was sore, which started the day after. The soreness went away after about three days. The patient stated it was a little itchy too, then clarified just every once in a while. The patient did not feel like she really had to scratch it. The patient also experienced pain at the injection site which lasted for a day or two. The patient did not have any other information to provide regarding location of vaccine, expiry date was unknown to her. The batch number of SHINGRIX was reported as E3272, which was corrected to E3Z7E as per sales data sheet.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Contusion, Injection site erythema, Joint range of motion decreased
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a adolescent male patient who received BEXSERO (batch number 15E301A, expiry date 31st May 2018) for prophylaxis. On 4th February 2018, the patient received the 1st dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site erythema, bruising and joint range of motion decreased. On an unknown date, the outcome of the injection site erythema, bruising and joint range of motion decreased were recovered/resolved. It was unknown if the reporter considered the injection site erythema, bruising and joint range of motion decreased to be related to BEXSERO. Additional details were provided as follows: Following 1st dose of BEXSERO, the patient experienced redness at and around injection site, bruising and limited range of motion. The events remained for over a week before fully resolving. This case has been linked to the case US2019GSK055816, reported by the same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 68-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. In February 2019, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: Exact date of vaccination was not provided. The healthcare professional could not provide batch number and expiration date.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Hypoaesthesia, Neuropathy peripheral
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of neuropathy in a 57-year-old female patient who received SHINGRIX for prophylaxis. On 8th March 2019, the patient received SHINGRIX. In March 2019, less than a month after receiving SHINGRIX, the patient experienced neuropathy (serious criteria GSK medically significant), numbness and weakness. The patient was treated with gabapentin, ibuprofen and methylprednisolone (Medrol). On an unknown date, the outcome of the neuropathy, numbness and weakness were not recovered/not resolved. It was unknown if the reporter considered the neuropathy, numbness and weakness to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine in left arm. The side effects listed extend from the patient's left arm up to her ear. The effects had not resolved till the date of reporting.
Age: 0.42
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 28-Jan-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a four-months-old (reported as 1 day shy of 5 months) female patient who received 0.25 ml dose of vaccine FLUZONE QUADRIVALENT (lot number: UT6315SA, expiry date: 30-Jun-2019) via intramuscular route in the left thigh on 24-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. The patient was not given any other vaccines during this visit. It was a case of actual medication error due to inappropriate age at vaccine administration. It was not reported if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: none. Follow-up information received on 20-Mar-2019 regarding an unsolicited valid non-serious case received from a Nurse. The report contains no new information.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, IPV, RVX
Symptoms: Expired product administered, Irritability, Skin warm
Clinical narrative: Initial information received on 20-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 6 months old female patient who experienced irritable and warm, while she received expired vaccine DAPTACEL (expired on (23 of February). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HIB VACCINE;POLIO VACCINE and ROTAVIRUS VACCINE. IBV and CBV. On 18-Mar-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number, expiry date 23 Feb via unknown route in the right thigh "reported as right leg". On an unknown date, the patient developed a non-serious irritable and warm following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. It was also a actual medication error due to expired vaccine used. Lab test not reported. Final diagnosis was warm and irritable. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for irritable and as Unknown for warm. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RVX
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 20-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 2 months old female patient who received a single dose of 0.25 ml vaccine FLUZONE (lot UI998AD, expiry date 30-Jun-2019) via unknown route in the right thigh. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PARACETAMOL PEDIARIX; PREVNAR 13; PEDVAXHIB; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE). It was an actual medication error due to inappropriate age at vaccine administration. There were no side effects at the time of this report. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, Impaired driving ability, Injection site pain, Joint range of motion decreased, Loss of personal independence in daily activities
Clinical narrative: Pregnancy History- routine pregnancy (2nd child); vaccine administered at beginning of third trimester. EDD 2/19/18. Birth weight- 6lbs, 8 oz. I received the flu vaccine by a nurse of midwives practice. Immediately upon injection into the high left part of my arm (really, shoulder), I knew something was wrong. It wasn't the pinch of the needle, nor the normal soreness that follows the flu shot (I'd received fairly regularly in the past). It was an immediate, intense pain. Nonetheless, I still assumed that it would fade away. About three hours later, I was experiencing significant pain. My range of motion was decreasing dramatically. The weight of holding my arm up was becoming unbearable. Of course, I just figured I was having a strange reaction, and it would fade after a few days time. It did not. Several weeks later, after I was no longer able to use my left arm (my husband had to assist me with dressing, I was unable to drive, I could not do anything with my arm, including lift my 1 year old child), I contacted my provider, along with a general practitioner and an orthopedic doctor. All suggested using tylenol to limit pain. I am not someone to take medication when I am pregnant, but I was getting desperate and my life was significantly affected. Nothing helped. The GP suggested I go to physical therapy. I could not even begin to move my arm, I was not able to do exercises. I was not able to attend my prenatal yoga classes, either, obviously. After two full months of this symptom, I began to freak out wondering how I would labor for the birth of my child in this kind of pain that refused to go away. I decided to try a chiropractor that specialized in Active Release Technique. This is the first thing that helped me find relief. I saw Dr and Dr for treatment, and this is the only thing that helped me. I still see them for treatment because the pain relief is not permanent, and my arm flares up again at various points. I should note that I have zero injuries from sports or anything else that could be responsible for this; it was a direct result of the improper placement of the shot into my arm (too high and possibly too deep). This has been a serious drag for me that has cost me financially and affected my personal and professional life.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Musculoskeletal disorder
Clinical narrative: Pregnancy History- routine pregnancy (2nd child); vaccine administered at beginning of third trimester. EDD 2/19/18. Birth weight- 6lbs, 8 oz. I received the flu vaccine by a nurse of midwives practice. Immediately upon injection into the high left part of my arm (really, shoulder), I knew something was wrong. It wasn't the pinch of the needle, nor the normal soreness that follows the flu shot (I'd received fairly regularly in the past). It was an immediate, intense pain. Nonetheless, I still assumed that it would fade away. About three hours later, I was experiencing significant pain. My range of motion was decreasing dramatically. The weight of holding my arm up was becoming unbearable. Of course, I just figured I was having a strange reaction, and it would fade after a few days time. It did not. Several weeks later, after I was no longer able to use my left arm (my husband had to assist me with dressing, I was unable to drive, I could not do anything with my arm, including lift my 1 year old child), I contacted my provider, along with a general practitioner and an orthopedic doctor. All suggested using tylenol to limit pain. I am not someone to take medication when I am pregnant, but I was getting desperate and my life was significantly affected. Nothing helped. The GP suggested I go to physical therapy. I could not even begin to move my arm, I was not able to do exercises. I was not able to attend my prenatal yoga classes, either, obviously. After two full months of this symptom, I began to freak out wondering how I would labor for the birth of my child in this kind of pain that refused to go away. I decided to try a chiropractor that specialized in Active Release Technique. This is the first thing that helped me find relief. I saw Dr and Dr for treatment, and this is the only thing that helped me. I still see them for treatment because the pain relief is not permanent, and my arm flares up again at various points. I should note that I have zero injuries from sports or anything else that could be responsible for this; it was a direct result of the improper placement of the shot into my arm (too high and possibly too deep). This has been a serious drag for me that has cost me financially and affected my personal and professional life.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Allergy test, Anaphylactic reaction, Decreased appetite, Eczema, Injection site swelling
Clinical narrative: Three separate adverse events/reactions. First, child experienced swelling at the vaccine injection site, along with a moderate fever of 101-102 for approximately 48 hours. Fever was treated with extra hydration (water). Child was not interested in eating or drinking much for approximately 96 hours, and lost approximately 1.5 lbs. Second, child experienced eczema breakouts on her face and back and arms within 48 hours of administration. This has not went away with passage of time and is being treated with prescription hydrocortizone and regular ezcema moisture cream (Aveeno). Third, child experienced an anaphylactic reaction on 3/13/19, approximately 3 weeks after receiving the vaccine to food and drink that she had consumer regularly. Child had consumed a cinnamon bagel with almond  butter, something she had regularly eaten since about 7 months old. Almond butter contained soy. Child consumer approximately 3 oz of Whole Milk during the meal, something she had also been drinking without issue for approximately 8 weeks at the time. Child immediately experienced swelling and hives on the face and neck, swelling of the lips and tongue, and wheezing. child was transported by ambulance from school to Hospital. Findings suggested a localized anaphylactic reaction, cause not determined in emergency room. Allergy test results pending.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Lip swelling, Pyrexia, Swelling, Swelling face, Swollen tongue
Clinical narrative: Three separate adverse events/reactions. First, child experienced swelling at the vaccine injection site, along with a moderate fever of 101-102 for approximately 48 hours. Fever was treated with extra hydration (water). Child was not interested in eating or drinking much for approximately 96 hours, and lost approximately 1.5 lbs. Second, child experienced eczema breakouts on her face and back and arms within 48 hours of administration. This has not went away with passage of time and is being treated with prescription hydrocortizone and regular ezcema moisture cream (Aveeno). Third, child experienced an anaphylactic reaction on 3/13/19, approximately 3 weeks after receiving the vaccine to food and drink that she had consumer regularly. Child had consumed a cinnamon bagel with almond  butter, something she had regularly eaten since about 7 months old. Almond butter contained soy. Child consumer approximately 3 oz of Whole Milk during the meal, something she had also been drinking without issue for approximately 8 weeks at the time. Child immediately experienced swelling and hives on the face and neck, swelling of the lips and tongue, and wheezing. child was transported by ambulance from school to Hospital. Findings suggested a localized anaphylactic reaction, cause not determined in emergency room. Allergy test results pending.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Urticaria, Weight decreased, Wheezing
Clinical narrative: Three separate adverse events/reactions. First, child experienced swelling at the vaccine injection site, along with a moderate fever of 101-102 for approximately 48 hours. Fever was treated with extra hydration (water). Child was not interested in eating or drinking much for approximately 96 hours, and lost approximately 1.5 lbs. Second, child experienced eczema breakouts on her face and back and arms within 48 hours of administration. This has not went away with passage of time and is being treated with prescription hydrocortizone and regular ezcema moisture cream (Aveeno). Third, child experienced an anaphylactic reaction on 3/13/19, approximately 3 weeks after receiving the vaccine to food and drink that she had consumer regularly. Child had consumed a cinnamon bagel with almond  butter, something she had regularly eaten since about 7 months old. Almond butter contained soy. Child consumer approximately 3 oz of Whole Milk during the meal, something she had also been drinking without issue for approximately 8 weeks at the time. Child immediately experienced swelling and hives on the face and neck, swelling of the lips and tongue, and wheezing. child was transported by ambulance from school to Hospital. Findings suggested a localized anaphylactic reaction, cause not determined in emergency room. Allergy test results pending.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Hypoaesthesia, Injection site pain
Clinical narrative: During call to schedule second dose of SHINGRIX vaccine, patient states she experienced some side effects following the first injection that made her question whether she wanted to get the second dose.  Patient reported some pain starting at the injection site in her arm that radiated down to her hip on the same side and then lead to a "strip of numbness" along that one side of her body where the pain had radiated from initially. She also reported some swelling in her left foot that developed a few days following the injection that resolved with the rest of her symptoms within about a week--- she had contacted her doctor's office via phone to inquire about her symptoms when they first started so that they were aware as she continued to monitor them at home. She has no residual symptoms or issues at this time, but is hesitant to receive the second dose.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Asthenia, Chills, Headache, Hyperhidrosis
Clinical narrative: Weakness, headache, chills, fever (sweats), severe nausea and abdominal pain started approximately 10:30 pm and lasted until 4:00 am although the headache lasted till after 9 am the next day 3/28.  Utilized Advil and Pepto Bismol to alleviate symptoms.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Weakness, headache, chills, fever (sweats), severe nausea and abdominal pain started approximately 10:30 pm and lasted until 4:00 am although the headache lasted till after 9 am the next day 3/28.  Utilized Advil and Pepto Bismol to alleviate symptoms.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a researcher refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-MAR-2019 the patient was vaccinated with improperly stored ROTATEQ lot # R016790 (expiry date: 20-APR-2020), orally for prophylaxis. It was stated that the vaccine underwent a temperature excursion of -1.8 degree Celsius for 33 minutes; Previous temperature excursion included 11.3 degree Celsius for 30 minutes. The call was because of a "data logger". Dose administered after initial warm excursion. No adverse effects reported.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received SHINGRIX for prophylaxis. On 16th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. 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 provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient experienced SHINGRIX on right arm. The patient experienced pain in right arm after receiving SHINGRIX. For tolerance of 2nd dose of SHINGRIX refer case US2019GSK055859.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Cold sweat, Fatigue, Feeling abnormal, Nausea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of nausea in a female patient who received SHINGRIX (batch number T73K2, expiry date 9th June 2021) and (batch number ZT25S, expiry date 6th July 2021) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, the dose was an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced nausea, tiredness, cold sweat, blister and feeling abnormal. On an unknown date, the outcome of the nausea, tiredness, cold sweat, blister and feeling abnormal were not reported. It was unknown if the reporter considered the nausea, tiredness, cold sweat, blister and feeling abnormal to be related to SHINGRIX. Additional information were reported as follows: The batch number ZT25S, expiry date 6th July 2021, reported for SHINGRIX adjuvant. The patient received SHINGRIX in the left deltoid. The patient had experienced nausea, extremely tired, cold sweats, blister on opposite arm of injection site and stomach. The patient stated she felt like she had been beat up. The pharmacist asked how long does the side effects last after receiving SHINGRIX injection.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Got a shot of the PREVNAR 13 drug from my doctor on my annual visit. After that noticed a pain in my upper arm muscle area at the injection site. This pain comes and goes especially if I use the muscles in this area.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Eschar, Pain, Urticaria
Clinical narrative: Pt was given first dose of SHINGRIX 0.5 ml IM on 1/15/19 after proper counseling and review of benefits VS risks. Pt stated that he developed a painful cluster of silver and red welts on his buttock a week later. No other clusters appeared on other parts of his body. Welts popped and produced eschar after a few more weeks. Pt denied other symptoms such as SOB or itching.
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Confusional state, Decreased appetite, Discomfort, Dizziness
Clinical narrative: Yes, I did have tetanus booster shot, but I do not know any details. Headache, lethargy, no appetite, dizziness, lightheadedness, discomfort from head to toe, fever, general weakness, sleepiness (24 hours a day), some confusion.
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Lethargy, Pyrexia, Somnolence
Clinical narrative: Yes, I did have tetanus booster shot, but I do not know any details. Headache, lethargy, no appetite, dizziness, lightheadedness, discomfort from head to toe, fever, general weakness, sleepiness (24 hours a day), some confusion.
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site mass, Injection site oedema, Injection site warmth
Clinical narrative: Patient called to report a reaction to the SHINGRIX vaccine administered in left deltoid intramuscularly on 3/25/19. That was three days ago. She reports that the site of the vaccine became very red and edematous. A golf ball size lump developed and her entire arm was edematous and she could not lift it. Each day it seems to be getting worse - more red, hot, larger lump at the site. Currently, the vaccine site has a lump the size of a softball and her entire arm is tight within her shirt sleeve. She has been using ice packs and at times alternated hot to cold on the arm. I advised her to see her primary care physician locally as soon as possible. She stated that she is going to do that right away this morning.
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral
Clinical narrative: Patient called to report a reaction to the SHINGRIX vaccine administered in left deltoid intramuscularly on 3/25/19. That was three days ago. She reports that the site of the vaccine became very red and edematous. A golf ball size lump developed and her entire arm was edematous and she could not lift it. Each day it seems to be getting worse - more red, hot, larger lump at the site. Currently, the vaccine site has a lump the size of a softball and her entire arm is tight within her shirt sleeve. She has been using ice packs and at times alternated hot to cold on the arm. I advised her to see her primary care physician locally as soon as possible. She stated that she is going to do that right away this morning.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site reaction, Injection site urticaria, Irritability
Clinical narrative: MMR vaccine given in the wrong location. Needle Insertion was inferior to the right deltoid, midline with the acromion process, needle was angled superior and distal. Vaccine solution injected too close to the dermis, red intradermal wheel seen and palpated. Immediate blotchy, reddened localized reaction which resolved after cold compress and approximately 15 minutes. Red intradermal wheel resolved later that evening. Continued consolable at times fussiness seen currently. BENADRYL given after local reaction resolved, reddened wheel still visible. I told the nurses and doctor I believed the vaccine was administered wrong immediately. The nurse said I could leave the office, stating "it's just a little red" "it's just a local reaction". I stated I wanted to wait and breastfed and re-assess in a few minutes. Then the doctor came in. I also told her I  believed it was administered wrong, her response was, "They (referring to the nurses) give these all day long". Then wanted to given BENADRYL. I feel my concern was not addressed even though the doctor and nurses saw where the injection site was due to the band aide placement. I asked to speak with the manager at check-out who was not available but did call the next day. The manager was rude and insisted multiple times I send her a picture of my son with his shirt off to file a complaint. I declined. The picture was taken on my phone at the request of Dr., to show the allergist, while in the office with Dr. and the nurse hold son on the exam table. It shows the wrong insertion site/band aide placement and reddened wheel location.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Local reaction, Product administered at inappropriate site, Rash macular
Clinical narrative: MMR vaccine given in the wrong location. Needle Insertion was inferior to the right deltoid, midline with the acromion process, needle was angled superior and distal. Vaccine solution injected too close to the dermis, red intradermal wheel seen and palpated. Immediate blotchy, reddened localized reaction which resolved after cold compress and approximately 15 minutes. Red intradermal wheel resolved later that evening. Continued consolable at times fussiness seen currently. BENADRYL given after local reaction resolved, reddened wheel still visible. I told the nurses and doctor I believed the vaccine was administered wrong immediately. The nurse said I could leave the office, stating "it's just a little red" "it's just a local reaction". I stated I wanted to wait and breastfed and re-assess in a few minutes. Then the doctor came in. I also told her I  believed it was administered wrong, her response was, "They (referring to the nurses) give these all day long". Then wanted to given BENADRYL. I feel my concern was not addressed even though the doctor and nurses saw where the injection site was due to the band aide placement. I asked to speak with the manager at check-out who was not available but did call the next day. The manager was rude and insisted multiple times I send her a picture of my son with his shirt off to file a complaint. I declined. The picture was taken on my phone at the request of Dr., to show the allergist, while in the office with Dr. and the nurse hold son on the exam table. It shows the wrong insertion site/band aide placement and reddened wheel location.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Rash
Clinical narrative: 4 cm circular rash.
Age: 0.33
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt was given an extra Heb B he was not due for it at the time it was ordered.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, a male patient of unknown age, and his spouse. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In March 2016, at age 63, the patient was administered the ZOSTAVAX by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from his ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a researcher refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-MAR-2019 the patient was vaccinated with improperly stored ROTATEQ lot # R016790 (expiry date: 20-APR-2020), orally for prophylaxis. It was stated that the vaccine underwent a temperature excursion of -1.8 degree celsius for 33 minutes; Previous temperature excursion included 11.3 degree celsius for 30 minutes. The call was because of a "data logger". Dose administered after initial warm excursion. No adverse effects reported.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received on 17th December 2018, refer case US2018228726) and ZOSTAVAX (Received on an unknown date). On 17th March 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain in arm and influenza like illness. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm and influenza like illness were unknown. It was unknown if the reporter considered the pain in arm and influenza like illness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX yesterday at noon. The patient received SHINGRIX and had a sore arm. The patient stated that it worse than anything and she has felt like she has the flu for a day or so. Her call disconnected abruptly. This case linked with US2018228726, reported by same reporter for the same patient.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Lymphocyte count decreased, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (for tolerance of 1st dose refer case US2019049135). On 11th March 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 12th March 2019, 1 days after receiving SHINGRIX, the patient experienced pain, chills, fever, fatigue, erythema of extremities, swelling arm and skin warm. On an unknown date, the outcome of the pain, chills, fever, fatigue, erythema of extremities, swelling arm and skin warm were recovered/resolved. It was unknown if the reporter considered the pain, chills, fever, fatigue, erythema of extremities, swelling arm and skin warm to be related to SHINGRIX. Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient received SHINGRIX on right arm. The patient experienced aches, chills, fever, and fatigue. The patient's right arm was swollen, red and hot to the touch. It was reported that the patient had scheduled blood work after receiving the 2nd dose of SHINGRIX and the patient's absolute lymphocyte count was low. The reporter was not sure if it was caused by the vaccine and also reported that she would call the doctor regarding the lab result.
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (for tolerance of 1st dose refer case US2019049135). On 11th March 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 12th March 2019, 1 days after receiving SHINGRIX, the patient experienced pain, chills, fever, fatigue, erythema of extremities, swelling arm and skin warm. On an unknown date, the outcome of the pain, chills, fever, fatigue, erythema of extremities, swelling arm and skin warm were recovered/resolved. It was unknown if the reporter considered the pain, chills, fever, fatigue, erythema of extremities, swelling arm and skin warm to be related to SHINGRIX. Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient received SHINGRIX on right arm. The patient experienced aches, chills, fever, and fatigue. The patient's right arm was swollen, red and hot to the touch. It was reported that the patient had scheduled blood work after receiving the 2nd dose of SHINGRIX and the patient's absolute lymphocyte count was low. The reporter was not sure if it was caused by the vaccine and also reported that she would call the doctor regarding the lab result.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Patient reported excessive swelling of feet and the hand of the arm injected. Swelling resolved in feet by 3/17, but hand was still swollen on 3/17.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Low grade fever, chills and shaking,  Severe muscle aches to the point of barely being able to get out of bed. Two days later very large raised red area at injection site 3 1/2 inch circle with small bumps and very itchy. Lower than normal blood pressure. Feeling REALLY bad lasted for about 3 days.  Feeling bad for about  a week. Not feeling normal lasted about 2 weeks.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia, Tremor
Clinical narrative: Low grade fever, chills and shaking,  Severe muscle aches to the point of barely being able to get out of bed. Two days later very large raised red area at injection site 3 1/2 inch circle with small bumps and very itchy. Lower than normal blood pressure. Feeling REALLY bad lasted for about 3 days.  Feeling bad for about  a week. Not feeling normal lasted about 2 weeks.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Chest X-ray normal, Computerised tomogram head abnormal, Influenza, Influenza A virus test positive, Pyrexia
Clinical narrative: Patient was given vaccines on the morning of 03/22/2019 and had a normal well child exam with no fever at time of vaccination. Later in the day patient started to develop a fever. On 03/23/2019 patient was brought into hospital with Dx: seizures/status epilepticus. At the time of hospitalization patient was also diagnosed with influenza A. Patient brother was diagnosed with influenza A the week prior.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Seizure, Status epilepticus, White blood cell count normal
Clinical narrative: Patient was given vaccines on the morning of 03/22/2019 and had a normal well child exam with no fever at time of vaccination. Later in the day patient started to develop a fever. On 03/23/2019 patient was brought into hospital with Dx: seizures/status epilepticus. At the time of hospitalization patient was also diagnosed with influenza A. Patient brother was diagnosed with influenza A the week prior.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Adverse effects similar to first injection with slightly less severity. Slightly swollen site, painful upon touching, pain builds over 12 hrs. hrs 13-15 stomach pain, nausea need to be prone, after 24 hrs pain not as severe and declining, injection site still tender after 48 hr.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Moderate pain at injection site within a couple of hours of receiving injection. Woke up 13 hrs later with headache, lowgrade fever, chills, and muscle aches all over. Those symptoms lasted most of that day, and subsided in the evening, 27 hrs after injection.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Muscle pain, feeling tired, headache, fever-like, upset stomach. In to day 2 of these side effects.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous report as received from a medical technician, refers to a 24 year old female patient. No patient's medical history, drug reactions, allergies or concurrent conditions were reported. On 10-AUG-2018, the patient was vaccinated with the first dose of GARDASIL 9 (lot number R004689 with expiration date on 29-NOV-2020) for prophylaxis, however route of administration was not reported. On 25-MAR-2019, the primary reporter stated that the patient was in the office to receive the second or third dose of GARDASIL 9 series as the patient was unsure if she already received the second dose or not. At the time of reporting it was unknown if the patient had recovered from the event.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received from a lawyer regarding a case in litigation involving a female patient, history not provided. In 2010, at age 77 years, the patient was administered the ZOSTAVAX by a healthcare provider at a county board of health for long term prevention of shingles and zoster related conditions. On an unknown date the patient was treated at a medical center for the following injuries resulting from ZOSTAVAX use: herpes zoster. Outcome was not provided. Additional information has been requested.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Injection site pain, Pallor, Peripheral coldness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of lightheadedness in a 64-year-old patient who received SHINGRIX for prophylaxis. On 16th March 2019, the patient received the 1st dose of SHINGRIX. On 18th March 2019, 2 days after receiving SHINGRIX, the patient experienced lightheadedness, pale skin, coldness of skin and injection site pain. On 18th March 2019, the outcome of the lightheadedness, pale skin and coldness of skin were recovered/resolved. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the lightheadedness, pale skin, coldness of skin and injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was received via chat. The patient received the dose of the SHINGRIX vaccine in the left arm. In the morning of the date of reporting, the patient while sitting at the breakfast table her husband noticed that she was pale and cold to touch. The patient reported injection site pain of her left arm. The lightheadedness had resolved and it only lasted a minute. The cold to touch and pale skin had resolved. The left arm injection site pain has not resolved. The patient gave permission to contact her physician regarding these events.