chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Malaise, Pain, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 75-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. On 9th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 9th February 2019, several hours after receiving SHINGRIX, the patient experienced feeling unwell. On 12th February 2019, the patient experienced shingles, pain and painful rash. The patient was treated with gabapentin. On an unknown date, the outcome of the shingles was unknown and the outcome of the feeling unwell and pain were not recovered/not resolved and the outcome of the painful rash was recovering/resolving. The reporter considered the shingles, feeling unwell, pain and painful rash to be related to SHINGRIX. Additional details were provided as follows: On Saturday morning, the patient received 1st dose of SHINGRIX at her local pharmacy, in her left upper arm. By Saturday evening, the patient began to not feel well and by Sunday she felt very ill. On Monday the patient began to feel even worse and by Tuesday she had a painful, unilateral rash. The patient was in severe pain and saw her physician on Wednesday 13th February 2019 and was diagnosed with shingles. The patient received several medications including Gabapentin for the pain. The pain continued to be so extreme, she went to the emergency room on 17th February 2019 and was placed on several more medications. The patient had just started to feel like she was turning the corner and was able to get up and walk around. The reporter requested for reimbursement and was provided with the information from content that there was no reimbursement provided for vaccines. The reporter consented to follow up. The reporter provide permission to contact her physician for follow-up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received SHINGRIX (batch number X5XY4, expiry date 28th February 2020) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date). Concomitant products included ARANESP. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, myalgia, feeling bad and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site swelling, myalgia, feeling bad and injection site pain were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, myalgia, feeling bad and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient was to start a new therapy with ARANESP. This new therapy was for a condition that was reported after the patient had completed the 2 dose SHINGRIX schedule. The patient was presented with myalgia. The patient also reported pain, redness and swollen at injection site. The patient also reported felling terrible after receiving SHINGRIX to her pharmacist. The pharmacist was unsure which were had the injection site reaction. The pharmacist was unsure if the condition was related. The pharmacist was not familiar with the patient and took the information over the phone while the patient was trying to get the ARANESP. No additional details were provided.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Pain in extremity, Rash macular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of macular rash in a 69-year-old female patient who received SHINGRIX (batch number G72ZD, expiry date 24th November 2020) for prophylaxis. On 21st February 2019, the patient received SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced macular rash, injection site pain and injection site itching. On 21st February 2019, the patient experienced pain in arm. On an unknown date, the outcome of the macular rash was not recovered/not resolved and the outcome of the injection site pain and injection site itching were unknown and the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the macular rash, injection site pain, injection site itching and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The case was reported by patient's husband. The patient received vaccine on left arm. After receiving SHINGRIX, the patient experienced a sharp pain that went down her arm for a very short time for less than a couple of minutes. The patient also experienced soreness at the injection site and itching. It was reported that GSK could follow up if necessary.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site muscle pain in a 70-year-old male patient who received SHINGRIX for prophylaxis. On 21st February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 21st February 2019, less than a day after receiving SHINGRIX, the patient experienced injection site muscle pain. The patient was treated with TYLENOL. On 23rd February 2019, the outcome of the injection site muscle pain was recovered/resolved. It was unknown if the reporter considered the injection site muscle pain to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the pharmacist for himself. The patient received the SHINGRIX vaccine into the left deltoid. The patient experienced the expected muscular soreness at the injection site for 2 days in the left arm. The reporter provided the consent for follow up.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 27-Feb-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2019SA059185 (same reporter). This case involves a 4 months old male patient who experienced received vaccine PENTACEL outside of the shipping standard. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR for Immunisation; and ROTATEQ for Immunisation. On 26-Feb-2019, the patient received a 0.5 ml  injection of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ065AAA (expiry date: 16-Oct-2020) via unknown route in the left thigh. It was a case of actual medication error due to incorrect product storage. The PENTACEL shipment was received 25-FEB-2019 and shipped on 20-FEB-2019. It was reported that no adverse event was experienced. 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. List of documents held by sender: none.
Sex: M
Vaccine: HEPA, MENB, MNQ
Symptoms: Dyspnoea
Clinical narrative: Initial information received on 26-Feb-2019 regarding an unsolicited valid non-serious case received from a other health professional (Medical Assistant) via other company (Pfizer) under Manufacturer Report Number: 2018359728. This case involves a 18 years old male patient who experienced shortness of breath, while he received vaccines HEPATITIS A VACCINE, TRUMENBA and MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications, were not provided. On 27-Aug-2018, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U58338A via unknown route. On 27-Aug-2018, the patient received a dose of suspect TRUMENBA not produced by Sanofi Pasteur lot 560256 via unknown route. On 27-Aug-2018, the patient received a dose of suspect HEPATITIS A VACCINE not produced by Sanofi Pasteur lot number not reported via unknown route. On 28-Aug-2018, the patient developed a non-serious shortness of breath 1 day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, TRUMENBA and HEPATITIS A VACCINE. Lab test was not reported. Final diagnosis was shortness of breath. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Recovered/Resolved on an unknown date for shortness of breath.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Initial information received on 01-Mar-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 19 years old male patient who received an expired dose of MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was given. On 22-Feb-2019, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5823AB (expiry date: 22-Feb-2019),via intramuscular route in the left deltoid. It was unknown whether adverse event was received. 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.
Sex: M
Vaccine: DTAPIPVHIB, IPV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Initial information received on 01-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four years old male patient who received vaccine PENTACEL (lot number UJ104AA expiry 13-Oct-2020) instead of DAPTACEL (lot number and expiry date not reported) with IPV (VERO) [IPOL] (lot number P1A17 expiry 24-Apr-2020), so received two doses of polio vaccine on 01-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. It was a case of actual medication error due to extra dose administered and wrong vaccine administered. No adverse event was reported. 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. List of documents held by sender: none.
Age: 1.42
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Initial information received on 01-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 17 months old male patient who was inadvertently vaccinated with an expired dose of PENTACEL lot C5389AA (frequency once) via unknown route in the left thigh on 31-Jul-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation. It is an actual medication error case due to expired vaccine used. It was reported that the patient had PENTACEL that is 14 days after the expiration of product. It was unknown whether the patient had any harm or not. 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. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: Initial information received on 01-Mar-2019 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 5 months old patient of unknown gender who received vaccines ACT-HIB and 0.5 ml first single dose of PENTACEL (lot UI966AA (expiry date: 07-Jul-2020) via unknown route in the right thigh) instead of PEDIARIX on 01-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant therapy were not provided. It was a case of actual medication error due to inappropriate schedule of vaccine administered, extra dose administered and wrong vaccine administered. It was not confirmed whether patient developed any reaction to vaccine (reported that the patient would likely not develop any adverse reactions). 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. List of documents held by sender: none.
Sex: M
Vaccine: FLUR4
Symptoms: Influenza
Clinical narrative: Initial information received on 04-Mar-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 65 years old male immuno-compromised patient who received FLUBLOK QIV and still contracted flu this year. The patients past medical history, concomitant medication and family history were not provided. At the time of the event, the patient was immuno-compromised. On unknown date, in October 2018, the patient received a 0.5 mg dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number, expiry date not reported via unknown route in unknown administration site. On unknown date, the patient developed a non-serious an immuno-compromised patient who received FLUBLOK and still contracted flu this year (influenza like illness) with unknown latency following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. Lab data was not provided. Final diagnosis was an immuno-compromised patient who received FLUBLOK and still contracted flu this year. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for an immuno-compromised patient who received FLUBLOK and still contracted flu this year. List of documents held by sender - none.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Underdose
Clinical narrative: Initial information received on 04-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff). This case involves a 11-years-old female patient who received a 0.25 ml dose of vaccine FLUZONE QUADRIVALENT (prefilled syringe) batch number: UT6315TA, expiration date: 04-Jun-2019 via intramuscular route in the right deltoid on 01-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included was ADACEL, MENACTRA and HPV-9 VACCINE. It was an actual medication error due to vaccine underdose. A 11 year old female patient was administered a dose 0.25 ml FLUZONE QUADRIVALENT vaccine instead of 0.5ml. It was unknown whether patient experienced any adverse event following vaccination. 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.
Sex: M
Vaccine: DTAP
Symptoms: Autism spectrum disorder, Developmental regression
Clinical narrative: Initial information received on 01-Mar-2019 regarding an unsolicited valid serious case received from a consumer. This case is linked to case 2019SA060500 (same reported, patient's brother). This case involves a 36 months old male patient who experienced autism, while he received vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer lot number, expiry date not reported via unknown route in unknown administration site. On an unknown date, the patient experienced a serious autism (autism spectrum disorder) and  developmental regression unknown latency following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. This event was assessed as medically significant. (Other relevant tests included no lab data.) Final diagnosis was autism. It was not reported if the patient received a corrective treatment. The patient was not reported for developmental regression and for autism. According to reporter her children were normal and then started to regress. According to reporter adverse event is related to vaccine. List of documents held by sender- none.; Sender's Comments: This case concerns a child patient who presented with autism and developmental regression following vaccination with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer. The time to onset is unknown. Moreover, birth history, medical condition at the time of vaccination and lab tests ruling out alternate etiologies, particularly neurological, were not provided. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 62.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Client requested high dose flu vaccine stating his doctor said he needed the high dose formula because of his health. Nurse gave vaccine based on client's report, not realizing it was given out of age range until after dose was administered.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site pain, Injection site rash
Clinical narrative: Patient reported via email that he had a bruise/rash at the injection point. Patient reported that this spread in two line to the underarm area looking like an infection was spreading. Pt reported that it was quite painful on 3/2/2019, a little better on 3/3/2019, and was still tender on 3/4/2019. We have reached out in an effort to have patient return to clinic for an evaluation but have not heard back yet.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, RV1
Symptoms: Abdominal pain, Crying, Screaming
Clinical narrative: A couple hours after recieving vaccinations, my daughter started screaming crying. She had always been such a happy baby who rarely cried, so this was out of character for her. The screaming and crying lasted 5 whole days. We took numerous trips (3) to the doctor, and nothing was done. I should have taken her to the emergency room looking back, because I swear she was acting like she had a headache (possible brain swelling from reaction).
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Mobility decreased, Musculoskeletal pain, Neck pain
Clinical narrative: Recombinant Zoster Shingles vaccine. Arm was slightly sore on the day of and day after the vaccine. By about the 3rd day arm was getting more sore. Today is a week later and I can't lift my arm at all more than maybe several inches at the most. Was experiencing pain in my shoulder blade, neck and down my arm. Lying down makes it worse, better to prop my elbow on a pillow. Vaccine site is very sore to touch even with the slightest touch. Terrible headaches which I think might be due to the neck soreness. I would rate the pain at constantly an 8-10 on a scale of 1-10 with 10 being the worst. Very debilitating on my right side.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Recombinant Zoster Shingles vaccine. Arm was slightly sore on the day of and day after the vaccine. By about the 3rd day arm was getting more sore. Today is a week later and I can't lift my arm at all more than maybe several inches at the most. Was experiencing pain in my shoulder blade, neck and down my arm. Lying down makes it worse, better to prop my elbow on a pillow. Vaccine site is very sore to touch even with the slightest touch. Terrible headaches which I think might be due to the neck soreness. I would rate the pain at constantly an 8-10 on a scale of 1-10 with 10 being the worst. Very debilitating on my right side.
Age: 1.08
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Diarrhoea, Injection site rash, Irritability, Papule, Pyrexia
Clinical narrative: Patient is a 13 m male here for evaluation of rash & fever. Had 12mo vaccines 10 days ago, including MMR & VARIVAX: Rash started on chest, belly yesterday, today spread to back, face, top of thighs. No apparent pain or itching. Clingy, irritable, sleepy w/ more naps today. +PO, +UOP, no N/V. Runny stool today. Estimated lesion count: 50 on back 115 total. No vesicles, all dry or crusted papules.
Age: 1.08
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash, Skin lesion, Somnolence
Clinical narrative: Patient is a 13 m male here for evaluation of rash & fever. Had 12mo vaccines 10 days ago, including MMR & VARIVAX: Rash started on chest, belly yesterday, today spread to back, face, top of thighs. No apparent pain or itching. Clingy, irritable, sleepy w/ more naps today. +PO, +UOP, no N/V. Runny stool today. Estimated lesion count: 50 on back 115 total. No vesicles, all dry or crusted papules.
Age: 66.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Erythema, Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: Pt did not report adverse reaction to us until her next visit to the pharmacy. She said that her Right arm was red, swollen and very sore. She also stated that there was a small sore where the injection site was located. She did not have a definite length of time, but said it lasted for about a week. She did not seek medical attention at that time. Symptoms have resolved now.
Age: 0.92
Sex: F
Vaccine: DTAP, MMR
Symptoms: Hypersensitivity, Sensory processing disorder
Clinical narrative: My daughter developed severe allergies and sensory processing problems. Of course I can't prove the vaccines she received according to the CDC schedule at the time (she had all her shots on time up to age 2) are what caused her issues but I suspect they are.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Aching, slight nausea, fever 101.4.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around February 2010, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). In approximately 2010 [reported as shortly after receiving ZOSTAVAX], the patient suffered from shingles. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of her condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including, but not limited to, the following: The patient required and will continue to require healthcare services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. The outcome of the shingles was considered to be not recovered. Shingles was considered to be disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The schedule for SHINGRIX was 2 doses over 6 month span. The patient had received his 2nd dose of SHINGRIX during the 6 month timeframe and a week or so later developed a case of Shingles which was verified by a physician at a separate location. The reporter did not consent to follow-up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult male patient who received SHINGRIX (batch number TZ9L5, expiry date 22nd November 2020) for prophylaxis. On 20th August 2018, the patient received the 2nd 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 not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid and was having arm pain, till the time of reporting. The patient had notified his physician and no cause for the pain could be identified. The reporter was transferred to medical information system for discussion on pain seen beyond what noted in the product information. The reporter also stated he had heard of several other individuals that had complained about pain for weeks afterwards. The reporter also noted a lot of people complained about pain with the vaccination. This case was linked with US2019GSK041727, reported by the same reporter.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Sluggishness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 25th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 26th February 2019, 1 days after receiving SHINGRIX, the patient experienced tiredness and sluggishness. On an unknown date, the outcome of the tiredness and sluggishness were not recovered/not resolved. It was unknown if the reporter considered the tiredness and sluggishness to be related to SHINGRIX. Additional details were provided as follows: The anatomical location was right arm. On the day of reporting the patient woke up feeling very tired and sluggish. The reporter gave consent to follow up. The reporter gave permission for his physician to be contacted.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Back injury, Back pain, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 69-year-old male patient who received SHINGRIX for prophylaxis.  On 2nd February 2019, the patient received the 1st dose of SHINGRIX. On 3rd February 2019, 1 days after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. On 14th February 2019, the patient experienced back pain. On an unknown date, the outcome of the injection site erythema, injection site swelling and back pain were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling and back pain to be related to SHINGRIX. Additional details were provided as follows: The anatomical location of vaccine was left arm. The patient developed a red spot and swelling at the injection site the next day of vaccination. The red mark grew bigger over 4-5 days to the size of his hand. It resolved after 10 days. The patient had an achy back 12 days after receiving the vaccine but he is not associating that to the vaccine. The patient said he was shoveling ice and hurt his back. The reporter did not give consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, 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 female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional information was provided as follows: The age at vaccination was not reported. The reporter reported that all the women at her seniors group experienced pain and redness at the injection site for at least a week after getting SHINGRIX.  The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Pruritus, Pruritus generalised
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 61-year-old female patient who received SHINGRIX (batch number LL552, expiry date 20th June 2021) for prophylaxis. Previously administered products included SHINGRIX (on an unknown date received the 1st dose and had no adverse events). On 19th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 22nd February 2019, 3 days after receiving SHINGRIX, the patient experienced injection site itching, generalized pruritus and pruritus. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site itching, generalized pruritus and pruritus were unknown.  It was unknown if the reporter considered the injection site itching, generalized pruritus and pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient experienced itching at the injection site of the left arm, the entire arm itself, the back of the neck, and on the head. The patient received Benadryl, that helped her slightly. The reporter consented to follow up.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Hypoacusis
Clinical narrative: Within 5 mins patient experienced dizziness and hearing which she states like it was far away and also had crackling sounds noted. The episode lasted about 5 minutes and she was fine.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Pain in extremity, Pyrexia
Clinical narrative: Sore arm, red raised skin about 2x3 inches, headache, fever, chills for 1 and a half days.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin swelling
Clinical narrative: Sore arm, red raised skin about 2x3 inches, headache, fever, chills for 1 and a half days.
Age: 1.67
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Peripheral swelling
Clinical narrative: Redness & hardness at the injection site. Swelling of thigh.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Dizziness, Injection site pain, Nausea
Clinical narrative: High fever (102-103), dizziness, nausea and stomach discomfort, chills, aches, pain at injection site. Fever lasted 2 days. Able to resume normal activities after 3-4 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: High fever (102-103), dizziness, nausea and stomach discomfort, chills, aches, pain at injection site. Fever lasted 2 days. Able to resume normal activities after 3-4 days.
Age: 52.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Paraesthesia, Rash pustular
Clinical narrative: Patient has a mild case of shingles outbreak. She reports numbness and tingling in her face around the eye. She has one pustule on her nose. Her provider prescribed Valtrex therapy, which she began taking on 03/06/2019.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Contusion, Fall, Head injury, Influenza like illness
Clinical narrative: Patient reported severe tachycardia, palpitations for 12 hours prior to event, and reported fainting/losing consciousness at 6:00am Monday, March 4. Patient does not recall passing out, went back to bed, and when reawakening at 8:30am, reported injury to head, bruising and scraping to head and chin from fall from fainting. Lesser adverse events: patient reported severe flu-like symptoms, nausea, fever, chills for a couple days leading up to event. Patient reported all symptoms of tachycardia and flu-like symptoms subsiding when reawakening at 8:30am Monday March 4.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness, Nausea, Palpitations, Pyrexia, Skin abrasion
Clinical narrative: Patient reported severe tachycardia, palpitations for 12 hours prior to event, and reported fainting/losing consciousness at 6:00am Monday, March 4. Patient does not recall passing out, went back to bed, and when reawakening at 8:30am, reported injury to head, bruising and scraping to head and chin from fall from fainting. Lesser adverse events: patient reported severe flu-like symptoms, nausea, fever, chills for a couple days leading up to event. Patient reported all symptoms of tachycardia and flu-like symptoms subsiding when reawakening at 8:30am Monday March 4.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Syncope, Tachycardia
Clinical narrative: Patient reported severe tachycardia, palpitations for 12 hours prior to event, and reported fainting/losing consciousness at 6:00am Monday, March 4. Patient does not recall passing out, went back to bed, and when reawakening at 8:30am, reported injury to head, bruising and scraping to head and chin from fall from fainting. Lesser adverse events: patient reported severe flu-like symptoms, nausea, fever, chills for a couple days leading up to event. Patient reported all symptoms of tachycardia and flu-like symptoms subsiding when reawakening at 8:30am Monday March 4.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site swelling
Clinical narrative: Small bump the size of a pea on left thigh.
Age: 12.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Pt went back to sit on the chair in the waiting room after 3 vaccinations. Suddenly pt's mother told to nurse that pt passed out. Nurse elevated pt's both legs and let her lay down on the bench. Then nurse called pt's name, pt can answer her name after few seconds fainting. Pt's vital sign was BP: 98/48 mmHg, P:68  T:37 C. Pt's mother told nurse that pt didn't have dinner last night and she did't have breakfast today either. Nurse instructed pt's mother that pt needs eat before come to clinic. Pt's mother verbalized understanding. Nurse continuous checked pt until pt was stable then pt left with her parents @ 1040 am.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Syncope
Clinical narrative: Patient fainted approximately 5 minutes after receiving vaccination. Quickly came back and was put onto a bed with his knees elevated and was given juice. Was fine to leave office about 30 minutes later.
Age: 0.25
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV1
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Swelling at injection site. Size of a big lime, fever.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Rash macular, Rash maculo-papular
Clinical narrative: Generalized blotchy maculopapular rash within a few minutes of injection, no other systemic reaction or findings.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Rash, Rash macular, Rash maculo-papular
Clinical narrative: Generalized blotchy maculopapular rash within a few minutes of injection, no other systemic reaction or findings.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV1
Symptoms: Decreased appetite, Irritability, Pyrexia
Clinical narrative: Developed fever in the evening after vaccines were given earlier in the day, temp to 103, also noted to have some decreased appetite and increased fussiness. Fever did improve with anti-pyretics and symptoms had improved by the next morning, temp to 100, less fussy and still decreased appetite but with good urine output and accepting smaller feedings more frequently.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal rigidity, Decreased appetite, Headache, Injection site pain, Insomnia
Clinical narrative: Fever of 100.8; extreme pain and soreness in left with pain spreading down to fingers and up into shoulder and neck; muscle cramps in left arm and left leg; spasms in abdominal muscles on left side; loss of appetite; headache; blurred vision; all-over aches and pains; inability to sleep; unable to use left arm.  With the exception of soreness in the left arm, other side effects subsided 36 hours after onset.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Musculoskeletal disorder, Neck pain, Pain, Pain in extremity
Clinical narrative: Fever of 100.8; extreme pain and soreness in left with pain spreading down to fingers and up into shoulder and neck; muscle cramps in left arm and left leg; spasms in abdominal muscles on left side; loss of appetite; headache; blurred vision; all-over aches and pains; inability to sleep; unable to use left arm.  With the exception of soreness in the left arm, other side effects subsided 36 hours after onset.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vision blurred
Clinical narrative: Fever of 100.8; extreme pain and soreness in left with pain spreading down to fingers and up into shoulder and neck; muscle cramps in left arm and left leg; spasms in abdominal muscles on left side; loss of appetite; headache; blurred vision; all-over aches and pains; inability to sleep; unable to use left arm.  With the exception of soreness in the left arm, other side effects subsided 36 hours after onset.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Severe Fever.
Age: 8.0
Sex: M
Vaccine: IPV, TDAP
Symptoms: Body temperature increased, Cold sweat, Diarrhoea, Headache, Malaise
Clinical narrative: Per mother's report patient developed diarrhea and vomiting within one hour of vaccination. He also developed a temperature of 99.7, was cold and clammy, pale and was complaining of headache. Symptoms resolved within 12 hours. Experienced malaise for at least 24 hours after vaccination. Provider recommended that they push fluids, give TYLENOL as needed and gave ER precautions, also recommended to monitor for new signs or symptoms and that these symptoms should resolve within 24 hours.
Age: 8.0
Sex: M
Vaccine: IPV, TDAP
Symptoms: Pallor, Vomiting
Clinical narrative: Per mother's report patient developed diarrhea and vomiting within one hour of vaccination. He also developed a temperature of 99.7, was cold and clammy, pale and was complaining of headache. Symptoms resolved within 12 hours. Experienced malaise for at least 24 hours after vaccination. Provider recommended that they push fluids, give TYLENOL as needed and gave ER precautions, also recommended to monitor for new signs or symptoms and that these symptoms should resolve within 24 hours.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Lip swelling, Pruritus, Swelling, Urticaria
Clinical narrative: I began having occasional hives pop up and go away. On February 13, 2019, my lips became severely swollen. I had the 2nd SHINGRIX shot on February 20, 2020. and within 24 hours began severe hives on various parts of my body. They begin to ease up after a couple of days, but I still am having hives, swollen areas, and invisible itching. My top lip became swollen on February 28, 2019, and went away after about 24 hours. Then, again my top lip became swollen on March 5, 2019. I've been to an allergist and have a follow up scheduled on March 12, 2019.
Age: 0.42
Sex: F
Vaccine: HEP, IPV
Symptoms: Seizure like phenomena
Clinical narrative: Pt had seizure like activity the next morning.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Excessive redness and swelling at injection site.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Chills, exhaustion  and high fever for 24 hours.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Fatigue, Headache, Herpes virus infection, Influenza like illness
Clinical narrative: Last week I had the new shingles vaccine. Here's what's been happening: 1. Tuesday- flu like symptoms 2. Wed- Headache, fatigue, and a new herpes blister,itchiness on the extermeties (little red dots on my arms), plus PHN...killer pain. 3. Thurs -PHN, less itchy, another blister 4. Fri. - PHN subsiding 5. Sat. - New Blister! 6. Sun.- normal(?) 7. Mom.- New blister.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Post herpetic neuralgia, Pruritus, Rash, Rash erythematous
Clinical narrative: Last week I had the new shingles vaccine. Here's what's been happening: 1. Tuesday- flu like symptoms 2. Wed- Headache, fatigue, and a new herpes blister,itchiness on the extermeties (little red dots on my arms), plus PHN...killer pain. 3. Thurs -PHN, less itchy, another blister 4. Fri. - PHN subsiding 5. Sat. - New Blister! 6. Sun.- normal(?) 7. Mom.- New blister.
Age: 20.0
Sex: M
Vaccine: HEP
Symptoms: Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: HAD TINGLING SENSATION ON HIS TONGUE, AFTER 10 MINUTES OF VACCINATION, WITHIN 10 MIN AFTER TINGLING SENSATION ON TONGUE  STARTED HAVING TINGLING SENSATION ON THROAT.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: RN gave an 18 year old an adult dose of Hep A vaccine.
Sex: M
Vaccine: HEPA
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from the patient's mother and referred to a male patient of unknown age. No information regarding the patient's medical history, drug reactions and allergies was provided. On an unknown date, the patient was vaccinated with hepatitis A vaccine, inactivated (manufacturer unknown) (it was unspecified if it was VAQTA or HAVRIX and it could not be clarified) (dose, route of administration, lot number, expiration date were not provided) for prophylaxis. On an unknown date, the patient had a "side effect". On the time of the report, the patient's mother was on her way to the hospital but not further details were provided. The outcome of the event was unknown.  The relatedness between the event and suspected therapy was considered as related.
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Headache, Impaired work ability, Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 64-year-old patient who received SHINGRIX for prophylaxis. Concomitant products included beclometasone dipropionate (Qnasl). In February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced muscle pain, headache, fever and discomfort. On an unknown date, the outcome of the muscle pain, headache and discomfort were not recovered/not resolved and the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the muscle pain, headache, fever and discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX and had some bad reactions. The patient takes QNasal which was a steroid. The patient asked should I not had gotten the vaccine since the patient was on QNasal. The patient asked if QNasal was considered to be an immunosuppressant. The patient was worried about the 2nd dose being just as bad. The patient had 2 days of fever. And, stated that, the patient was on day 4 at the time of reporting and missed work due to muscle pain, headache and overall discomfort.
Sex: F
Vaccine: FLU4
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of adverse reaction in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. Previously administered products included ENGERIX B vaccine with an associated reaction of prophylaxis (received on an unknown date refer case, US2019034223). On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were reported as follows: The age at the vaccination was not reported. Nurse reporting the patient can't get flu shot unless she receives a hypoallergenic flu shot. She does not know if patient had previous reaction to a flu shot. Nurse stated, at the time of initial report, she was unable to find other details related to patient's flu vaccine details, including where she received vaccine, injection site location, lot number, expiration date, brand of flu vaccine and the physician.