chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: Not feeling well; fever; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th September 2020, the patient received the 1st dose of Shingrix .5 ml. On 2nd October 2020, 5 days after receiving Shingrix, the patient experienced fever. On an unknown date, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was not recovered/not resolved and the outcome of the fever was unknown.   It was unknown if the reporter considered the feeling unwell and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by patient's wife. Patient's wife reported that her husband (patient) got 1st Shingrix shot and was still not feeling well. Patient developed a fever 5 days after Shingrix injection.  Document from pharmacy says patient received 1 ml but pharmacist said that was incorrect and patient got 0.5ml. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Altered state of consciousness, Asthenia, Confusional state, Headache, Influenza like illness
Clinical narrative: Not feeling well; fever; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th September 2020, the patient received the 1st dose of Shingrix .5 ml. On 2nd October 2020, 5 days after receiving Shingrix, the patient experienced fever. On an unknown date, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was not recovered/not resolved and the outcome of the fever was unknown.   It was unknown if the reporter considered the feeling unwell and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by patient's wife. Patient's wife reported that her husband (patient) got 1st Shingrix shot and was still not feeling well. Patient developed a fever 5 days after Shingrix injection.  Document from pharmacy says patient received 1 ml but pharmacist said that was incorrect and patient got 0.5ml. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Laboratory test, Pyrexia, SARS-CoV-2 test negative, Systemic inflammatory response syndrome
Clinical narrative: Not feeling well; fever; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th September 2020, the patient received the 1st dose of Shingrix .5 ml. On 2nd October 2020, 5 days after receiving Shingrix, the patient experienced fever. On an unknown date, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was not recovered/not resolved and the outcome of the fever was unknown.   It was unknown if the reporter considered the feeling unwell and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by patient's wife. Patient's wife reported that her husband (patient) got 1st Shingrix shot and was still not feeling well. Patient developed a fever 5 days after Shingrix injection.  Document from pharmacy says patient received 1 ml but pharmacist said that was incorrect and patient got 0.5ml. The reporter did not consent to follow-up.
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Blister
Clinical narrative: Blisters on hands and arms; This case was reported by a nurse via sales rep and described the occurrence of blister in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 7SK92, expiry date 19th June 2022) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number J3T44, expiry date 30th June 2021) for prophylaxis.   On 24th September 2020, the patient received the 1st dose of Shingrix and the 1st dose of Fluarix Quadrivalent 2020-2021 season. On 27th September 2020, 3 days after receiving Shingrix and Fluarix Quadrivalent 2020-2021 season, the patient experienced blister. On an unknown date, the outcome of the blister was recovered/resolved.   It was unknown if the reporter considered the blister to be related to Shingrix and Fluarix Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the first dose of Shingrix in right deltoid arm and Fluarix in left deltoid arm on 24th September 2020 and 3 days later experienced the symptoms.  The patient experienced blisters on hands and arms.  The reporter consented to follow up. The case has been linked with US2020199111, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020199111:same reporter
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: patient receiving a dose of Fluzone that was administered after it took to long to receive, no AE; Initial information received on 06-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves patient of unknown age who received a dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination on unspecified date. This vaccine was administered after it took to long to receive, as the shipment was to be received in two day, but it took three days and was reported that the product was not viable (PT: product storage error).  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to incorrect product storage. As the patient received it after the vaccine underwent temperature excursion.  No adverse event reported at the time of reporting.  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 Regulatory Authority 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.  There will be no information on the batch number for this case.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Injected limb mobility decreased, Injection site rash, No reaction on previous exposure to drug, Pyrexia
Clinical narrative: Message sent from to patient to Doctor's office: From: To:  Sent: 10/8/2020  3:38 PM MDT Subject: Other: Specify Below  Vaccine Poor Reaction. Dr. : FYI  after my pneumococcal 23 vaccine on Monday (10-5-20), I had to go to bed until 10 a.m. next day. Had a fever, felt very tired, had a red rash at the left arm injection site and  couldn't move that arm much for a couple of days. Had a fever up to 102.5 then it would drop and it was up and down all day Monday but returned to normal thereafter. I have never had a vaccine reaction before-- but I do seem to have a lower tolerance to drugs now than when younger. Didn't have a problem after flu vaccine last year. Just wanted you to know what happened. I seem ok now.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous
Clinical narrative: Message sent from to patient to Doctor's office: From: To:  Sent: 10/8/2020  3:38 PM MDT Subject: Other: Specify Below  Vaccine Poor Reaction. Dr. : FYI  after my pneumococcal 23 vaccine on Monday (10-5-20), I had to go to bed until 10 a.m. next day. Had a fever, felt very tired, had a red rash at the left arm injection site and  couldn't move that arm much for a couple of days. Had a fever up to 102.5 then it would drop and it was up and down all day Monday but returned to normal thereafter. I have never had a vaccine reaction before-- but I do seem to have a lower tolerance to drugs now than when younger. Didn't have a problem after flu vaccine last year. Just wanted you to know what happened. I seem ok now.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Started with rash on abdomen and under right breast.   Still have active rash in those areas as well as rash as on my scalp, back and buttocks.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: fever headache,body aches. after in jection
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Employee developed redness, swelling, warmth and discomfort within 24 hours of injection. This continued and areas of redness and swelling increased over the next 3 days maxing out at almost the entire upper arm. This remained stable for about 48 hours then slowly started to diminish.
Age: 37.0
Sex: M
Vaccine: MMR
Symptoms: Asthenia, Injection site pain
Clinical narrative: Patient stated that the shot hurt and was painful afterwards. I informed patient to sit in waiting area. Went to check on patient after processing another shot and prescriptions, patient stated that it was really painful. Advised patient to take Tylenol for pain, fever, or flu-like symptoms. Patient asked advice for weakness also, I advised patient to rest there after which I went back into the pharmacy to process scripts. Patient's spouse received M-M-R II shot this evening also but had no reaction. When I got back to check on patient, they had already left . I called the patient around 8:15 pm  and the next day 10/09/2020 around 9:40am but neither calls were answered
Age: 65.0
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None, Patient notified.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Injected limb mobility decreased, Injection site erythema, Injection site nodule
Clinical narrative: Day 1 - Medium Circular Red knot at shot site/warm and painful.  Hard to raise my arm.   About 6 hrs after shot, I started to experience extreme fatigue and over the course of the next couple of hours malaise.   Day 2 - Shot site was larger.  Developed tender lymph nodes under arm and in groin.   More difficulty raising/moving arm.  Ibuprofen made  malaise symptoms more bearable. Day 3 - Shot site was a Larger circle -  3x3inches.  Still painful.  Started taking Alleve to alleviate symptoms.  My normal temp is around 97.6 .  At around 8pm it was at 99.0.   Continued to manage symptoms with Alleve.   Day 4 - Just starting day.  Woke up with upset stomach, but I was able to sleep on my right side even though the shot site is still sore and is slightly larger than day 3 (3.5x3inches)  It is also itchy at the moment.  It has not impacted my ability to go about my daily routine, but the severity and duration of the side effects were unexpected.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth, Lymph node pain, Malaise
Clinical narrative: Day 1 - Medium Circular Red knot at shot site/warm and painful.  Hard to raise my arm.   About 6 hrs after shot, I started to experience extreme fatigue and over the course of the next couple of hours malaise.   Day 2 - Shot site was larger.  Developed tender lymph nodes under arm and in groin.   More difficulty raising/moving arm.  Ibuprofen made  malaise symptoms more bearable. Day 3 - Shot site was a Larger circle -  3x3inches.  Still painful.  Started taking Alleve to alleviate symptoms.  My normal temp is around 97.6 .  At around 8pm it was at 99.0.   Continued to manage symptoms with Alleve.   Day 4 - Just starting day.  Woke up with upset stomach, but I was able to sleep on my right side even though the shot site is still sore and is slightly larger than day 3 (3.5x3inches)  It is also itchy at the moment.  It has not impacted my ability to go about my daily routine, but the severity and duration of the side effects were unexpected.
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Abdominal pain upper, Diarrhoea, Vomiting
Clinical narrative: Patient received flu shot at 5:00 in the evening. Later that night, at about 3 AM, patient woke up experienceing vomiting, diarrhea, and stomach pain.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Skin warm, Swelling
Clinical narrative: redness, swelling, warm to the touch. treated with a compress, ibuprofen, and Benadryl. Arm still sore from the shot, arm is fully functional.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin discolouration, Skin warm
Clinical narrative: Patient said arm is swollen, red and blue, and hot.
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: full body hives
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Unevaluable event
Clinical narrative: Patient did not have any reacting at the time of vaccine administration. We have tried contacting to follow up on any reactions but parents have not answered our calls.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: HIGH TEMP; FEVER; PAIN AND SWELLING AT INJECTION SITE; BODY ACHES; FATIGUE
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity, Skin texture abnormal, Urticaria
Clinical narrative: patient described having usual soreness at the immunization site, but said the soreness started to travel down to fingertips. The next evening the patient noticed hive marks around the area. They marked the area affected and reports that it increased by about an inch the next morning. Marks are not itchy but described as not normal feeling.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Urticaria
Clinical narrative: Pt developed hives 2 days after infection and lips "felt a little swollen". This was not the patient's first flu shot and usually gets flu vaccines every year. Pt self-treated treated with single dose of  Benadryl with complete resolution of swollen lips- was seen at medical clinic the following morning with hive-like rash on torso and arms. Pt was advised to continue Benadryl and f/u with ER if symptoms worsen.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Around 3pm, Started with itchy ears and at nape of neck, moved to chest and groin area. First hives popped up at bra line. When I arrived at urgent care approximately at 6pm hives started showing themselves on stomach, arms, legs, and buttocks.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No reaction at time of vaccine administration. Tried contacting parent but our calls were not answered.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: 3 doses of PNEUMOV AX-23 were given yesterday which had expired; This spontaneous report was received from an administrator who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 05-OCT-2020, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, anatomical location and strength were not provided; lot number S026366 was confirmed to be valid, expiration date 17-SEP-2020) for prophylaxis. The vaccine has not undergone temperature excursion, and was supported up to one month after expiration. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S026366; expirationdate: 17-SEP-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 0.17
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AE reported; VAQTA being inadvertently being administered in an 8 week old female; VAQTA being inadvertently being administered in an 8 week old female; This spontaneous report as received from a registered nurse and refers to a 8-week-old female patient. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On an unknown date, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) 25U/0.5ml pediatric, prefilled syringe (route of administration and anatomical location were not provided; lot number T014835 was confirmed to be valid, expiration date was not reported but upon internal validation process, it was established as 17-JUL-2021) instead of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) for prophylaxis (wrong product administered). hepatitis a vaccine, inactivated (VAQTA) was registered to use for children and adolescent 12 months to 17 years, but was inadvertently administered to 8-week-old child (product administered to patient of inappropriate age).  No additional adverse event was reported, but it was planned to follow up with the parents of patient. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: T014835; expirationdate: 17-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: the patient was administered improperly stored VARlVAX; This spontaneous report as received from a medical assistant and refers to a 3-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 10-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, route of administration, anatomical location were not reported; lot number S025608 was confirmed to be valid, expiration date 18-AUG-2021) which was reconstituted with properly stored sterile diluent for prophylaxis. Administered dose of vaccine experienced multiple temperature excursions. It was stored in a temperature of -12.5 degrees Celsius for 1 minute and second time in temperature of -14 degrees Celsius for another1 minute. Data logger was involved. There were no previous excursions reported.
Sex: U
Vaccine: FLUX
Symptoms: Dyspnoea, Feeling abnormal, Viral infection
Clinical narrative: I was in the hospital a month after the flu shot. Breathing difficulties; Viral infection; feel terrible the next and several days after; This case was reported by a consumer via interactive digital media and described the occurrence of difficulty breathing in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, 1 day after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced difficulty breathing (serious criteria hospitalization), viral infection (serious criteria hospitalization) and feeling bad. On an unknown date, the outcome of the difficulty breathing, viral infection and feeling bad were recovered/resolved.   It was unknown if the reporter considered the difficulty breathing, viral infection and feeling bad to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient had reported the events for herself/himself. The age at vaccination was not reported. The patient experienced breathing difficulties and hospitalized a month after the flu shot. The reporter mentione that, they said it was a virus, but never told him/her what kind of virus and he/she should have paid attention to it. The reporter mentioned that, people were not spread lies, he/she knew when felt bad, and it was happened each time after a flu shot, perfectly fine the day he/she get it, felt terrible the next and several days after and that was not his/her imagination. This case had been linked with US2020AMR199551, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR199551:Same reporter
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: developed Shingles in early September; developed Shingles in early September; rash; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 21st January 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In September 2020, between 10 and 12 months after receiving Shingrix and between 7 and 9 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On 1st October 2020, the outcome of the vaccination failure was not recovered/not resolved. On an unknown date, the outcome of the shingles and rash were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient developed Shingles in early September and that it had not resolved till the time of reporting. He followed up with his dermatologist and was prescribed some cream to apply to the rash. The reporter consented to follow up
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac flutter, Dysgeusia
Clinical narrative: Fluttering Heart; Metallic Taste in her mouth; This case was reported by a consumer via call center representative and described the occurrence of heart fluttering in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th October 2020, the patient received the 1st dose of Shingrix (intramuscular). In October 2020, 4 hrs after receiving Shingrix, the patient experienced heart fluttering (serious criteria GSK medically significant) and taste metallic. On an unknown date, the outcome of the heart fluttering and taste metallic were unknown.   It was unknown if the reporter considered the heart fluttering and taste metallic to be related to Shingrix.  Additional details were provided as follows: Approximately four hours after receiving Shingrix, the patient had a metallic taste in her mouth and a fluttering heart. The patient was advised to consult with her physician. The reporter did not consult to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles on 02-Oct-2020 after two doses of Shingrix on 19-Dec-2018 and 30-Apr-2019/ suspected vaccination failure; shingles; This case was reported by a physician via call center representative and described the occurrence of suspected vaccination failure in a 89-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 19th December 2018, the patient received the 1st dose of Shingrix. On 30th April 2019, the patient received the 2nd dose of Shingrix. On 2nd October 2020, 653 days after receiving Shingrix and 521 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The physician reported that a patient experienced an episode of Shingles after two doses of Shingrix. The reporter did not consent to follow-up. This case was considered as suspected vaccination failure as details regarding laboratory confirmation was unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Malaise, Pyrexia
Clinical narrative: profound weakness; malaise; fever; This case was reported by a physician via call center representative and described the occurrence of weakness in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on October or November 2017).   In March 2018, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced weakness, malaise and fever. On an unknown date, the outcome of the weakness, malaise and fever were unknown.   It was unknown if the reporter considered the weakness, malaise and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. A physician reported that he received the 1st dose of Shingrix sometime around October or November 2017 and the 2nd dose around March 2018. After receiving the 2nd dose he experienced fever, malaise, and profound weakness. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Rash
Clinical narrative: fever to touch (all on the injection site); reddish spot /  (all on the injection site); swollen /  (all on the injection site); itching / (all on the injection site); rash on the elbow; This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 3C37A, expiry date 1st April 2022) for prophylaxis.   On 29th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 5th October 2020, 6 days after receiving Shingrix, the patient experienced injection site warmth, injection site erythema, injection site swelling, injection site itching and rash. On an unknown date, the outcome of the injection site warmth, injection site erythema, injection site swelling, injection site itching and rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site warmth, injection site erythema, injection site swelling, injection site itching and rash to be related to Shingrix.  Additional details were provided as follows: The patient after a week of receiving first dose of Shingrix experienced itching, swollen, reddish spot, fever to touch (all on the injection site) and rash on the elbow. The reporter mentioned that all the adverse events were ongoing as they all started on 5th October 2020.  The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral discomfort, Oral herpes
Clinical narrative: cold sore/sore; lip started to feel uncomfortable; This case was reported by a consumer via call center representative and described the occurrence of cold sores in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included imiquimod (Imiquimod Cream) cream for product used for unknown indication.   On 15th September 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Imiquimod Cream at an unknown dose and frequency. In September 2020, between 1 and 3 weeks after receiving Shingrix, the patient experienced cold sores and lip discomfort. The action taken with Imiquimod Cream was unknown. On an unknown date, the outcome of the cold sores was not recovered/not resolved and the outcome of the lip discomfort was unknown.   It was unknown if the reporter considered the cold sores and lip discomfort to be related to Shingrix.  Additional details were reported as follows: The patient developed what she thinks might be a cold sure approximately a week and a half ago from  the reporting day. The patient described it as the lip started to feel uncomfortable. The patient was was using a Imiqmod cream on her face following the vaccine and was not certain if that might have caused the sore. It was unknown if the reporter considered the cold sores and lip discomfort to be related to imiquimod. The reporter consented to follow up.
Age: 86.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Developed redness, itching, and warmth to her left upper anterior arm extending to her elbow.  Instructed to take second-generation antihistamine following by diphenhydramine if needed.  Hydrocortisone 1% topically as needed.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: REDNESS AND BLISTERS FROM SHOULDER TO ELBOW ON LEFT ARM
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Hypersensitivity, Induration, Swelling
Clinical narrative: Local hypersensitivity reactions measuring 2 inches or greater diameter of induration (swelling) constitute significant local reactions and are relative contraindications to future Influenza vaccination. This has been recorded in the allergy section of patient's chart. Please report this reaction to VAERS (Vaccine Adverse Event Reporting System)
Age: 62.0
Sex: F
Vaccine: TD
Symptoms: Headache, Hypoaesthesia, Musculoskeletal disorder, Paraesthesia
Clinical narrative: Symptoms: numbness and tingling of all fingers, headache, bilateral loss of arms usage
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Phlebitis, Rash macular, Skin warm
Clinical narrative: Arm inflamed and red the following morning and doctor told her she had phlebitis. Got a prescription for bactrim ds on wednesday morning. Big red blotch on arm and heading to axilla.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: High fever
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pain, Pyrexia
Clinical narrative: Shivers, pain and fever. Temperature 101.9. Took Acetaminophen 500 MG and Ibuprofen 200 MG around noon within two hours of the symptoms. Took a second dose of the same about six hours later. By bedtime around 10:45 pm temperature was back to normal at 97.8. The next morning temp was the same as the night before and the only reminder I have of the vaccine is a sore arm at the injection site.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Chest pain, Fatigue
Clinical narrative: Pt states she began to feel very fatigue and have some chest pain with back aches between the shoulders. these symptoms began later that same day.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Induration
Clinical narrative: 3 x 3.5cm induration
Age: 56.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Diarrhoea, Fatigue, Oropharyngeal pain, Pain in extremity, Quarantine
Clinical narrative: two hours after vaccines administered patient started to get a sore throat, runny nose, tiredness diarrhea  and achy arms. Patient took Ibuprofen and  Day quil. Provider stated to have him monitor symptoms due to it could be from shots or he could be coming down with something. Quarantine and  if symptoms don't improve may need to be tested for COVID.
Age: 56.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Rhinorrhoea
Clinical narrative: two hours after vaccines administered patient started to get a sore throat, runny nose, tiredness diarrhea  and achy arms. Patient took Ibuprofen and  Day quil. Provider stated to have him monitor symptoms due to it could be from shots or he could be coming down with something. Quarantine and  if symptoms don't improve may need to be tested for COVID.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Arm pain That has lasted since vaccination as well as numbness in Three outer fingers of same arm/side.
Age: 58.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Feeling abnormal, Injection site erythema, Injection site rash, Malaise, Pain
Clinical narrative: became "ill" Saturday evening after getting shot on Friday afternoon - spiked fever of 100.5 with aches, very sore R arm with redness and rash at injection site size of baseball, - felt bad on Sunday with body aches and soreness
Age: 58.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: became "ill" Saturday evening after getting shot on Friday afternoon - spiked fever of 100.5 with aches, very sore R arm with redness and rash at injection site size of baseball, - felt bad on Sunday with body aches and soreness
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: R deltoid area w redness, soreness, swelling tender to touch. pt felt body aches and fatigue. Tx w Keflex for possible cellulitis
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Heart rate decreased, Nervousness, Oxygen saturation normal
Clinical narrative: Patient came to see me today, said 30 min after she got the vaccine, she started to "feel her heart".   She said it felt slow, as if she had to take a deep breath to get enough oxygen, even when she's pre-occupied and working, senses her heart "slowed down".   10/9/20 @ 12:30 PM is when she came to tell me about this-  her HR- 97, pulse ox @ room air- 97 %.   She said she feels nervous right now about it.  She also said  has a history of anxiety, and Covid has made her anxious, also has a lot of family stress right now. She will contact her Dr. today to have it checked. Said she has gotten the Flu shot every year since she was 9 yrs old, thinks she'll never get another one now.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Injection site rash, Pyrexia
Clinical narrative: 2 weeks after shot she had fever of 103 and rash on arm where shot was given. It went away in a few weeks. Then 2 more weeks later the rash came back in the same spot on her arm but looked different. Instead of bumps its now flat red patches.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site joint pain, Injection site pain
Clinical narrative: For 2 days my arm was sore at injection site. 2 days later, I felt pain in my shoulder area (more in my rotator cuff area) but the injection site was tender to palpation. The pain increased for about a week and now is steady. I still have  pain in the same area and my injection site is also still tender to the touch.
Age: 35.0
Sex: M
Vaccine: YF
Symptoms: Ankle fracture, Fall, Head injury, Loss of consciousness, Syncope
Clinical narrative: Pt had a syncopial episode, causing pt to fall down, fracturing his right, lower tibia/ankle. Pt lost consciousness for about 1 minute, was A&O x3 upon regaining consciousness. Pt was caught by the vaccinator, although he still bumped his head on the tile floor.
Age: 35.0
Sex: M
Vaccine: YF
Symptoms: Tibia fracture, X-ray limb abnormal
Clinical narrative: Pt had a syncopial episode, causing pt to fall down, fracturing his right, lower tibia/ankle. Pt lost consciousness for about 1 minute, was A&O x3 upon regaining consciousness. Pt was caught by the vaccinator, although he still bumped his head on the tile floor.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Extreme pain at injection site lasting over 4 days. Pain started Monday following injection and still painful through Thursday. Pain better with Tylenol and ice, but still arm is hard to move.
Age: 60.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Fatigue, Malaise, Pain in extremity, Rash
Clinical narrative: Tiredness, sore arm,  bad torso rash, general feeling of unwell.
Age: 77.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Rash
Clinical narrative: Patient developed severe rash on body and went to the emergency department
Sex: F
Vaccine: PPV
Symptoms: Balance disorder, Mobility decreased, Pain
Clinical narrative: has been loosing her balance; can't lift her arm; area of injection is still sore and swollen; pain and soreness; This spontaneous report was received from an 87-year-old female patient reporting on herself. The patient's weight was reported as 118 (units not provided). Historical drugs included "Prevair" in 2016. The patient's medical history was not provided. She had no drug reactions or allergies.  On 19-AUG-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot#, expiration date, dose and route of administration were not reported) for prophylaxis. Since the day of vaccination, the patient had pain and soreness. She also reported that she could not lift her arm and had been loosing her balance since the shot area of injection was still sore and swollen. The patient did not seek medical attention and no treatment was given for the events. No laboratory diagnostic was performed. The outcome of all events was reported as not recovered/not resolved. The relatedness between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported.
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Sore Arm; swelling arm; This spontaneous report as received from a pharmacist referring to a 70-year-old male patient. The patient's historical medications, concurrent conditions drug allergies or reactions were not reported. His concomitant medications included losartan potassium (manufacturer unknow).  On 29-SEP-2020,  the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)  0.5 milliliter, intramuscular, once for prophylaxis, lot # T009743 and expiration date 27-JAN-2020. The patient believed this was his second dose, but could not confirm it.   On the same day of vaccination, the  patient experienced sore arm with swelling, the reporter stated that the swelling was not at the injection site, but it was near patient's biceps in the vaccinated arm. The swelling arm compare to the other patient's arm was about 1.5 the normal size. He sought for medical attention and none treatment was given.   The outcome of pain in extremity and peripheral swelling was reported as not recovered/not resolved.   The reporter did not assessed the causality relationship between the  pain in extremity and peripheral swelling with Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T009743; expirationdate: 27-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: Yes; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: VARZOS
Symptoms: Blindness, Herpes zoster
Clinical narrative: zoster related vision loss; Shingles; Information has been received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) as prescribed and/or administered by a pharmacist for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation), the patient was treated by a physician for shingles (herpes zoster) and zoster related vision loss (blindness). On an unknown date, the patient was admitted to the hospital due to the events. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. At the time of this report, the outcome of herpes zoster and blindness was unknown. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, blindness was determined to be a medically significant event.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2018, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation), the patient was treated by a healthcare provider for shingles (herpes zoster). On an unknown date, the patient was admitted to the hospital due to the event. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. At the time of this report, the outcome of herpes zoster was unknown. The lawyer considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: HPV4
Symptoms: Syringe issue, Underdose
Clinical narrative: vaccine drips down or leaks out of the syringe when injecting; good quantity of the first dose of the Gardasil vaccine drips down or leaks out of the syringe when injecting, should this dose be repeated; No additional information or AE/PQC reported; This spontaneous report was received from a consumer and refers to an adult patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On an unknown date, the patient was vaccinated with a good quantity of the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.  The quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine dripped down and leaked out of the syringe when injecting. The reported asked if the dose should be repeated. No additional information or event was reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: 3 doses of PNEUMOVAX-23 were given yesterday which had expired; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 05-OCT-2020 (reported as yesterday), the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (once, injection, lot number S026366, expiration date 17-SEP-2020; dose and route of administration were not provided) for prophylaxis (expired product administered).   The vaccine had not undergone a temperature excursion, and it was supported by the memo up to 1 month after expiration, so it did not require additional evaluation from the escalation team. Device was not available for evaluation (obtain was reported as false).  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: S026366; expirationdate: 17-SEP-2020; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA002558: US-009507513-2010USA002548:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: 3 doses of PNEUMOV AX-23 were given yesterday which had expired; This spontaneous report was received from an administrator who was reporting on patient of unknown age and gender. No information concerning patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies was provided.  On 05-OCT-2020, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, anatomical location and strength were not provided; lot number S026366 was confirmed to be valid, expiration date 17-SEP-2020) for prophylaxis. The vaccine has not undergone temperature excursion, and was supported up to one month after expiration. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: S026366; expirationdate: 17-SEP-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA002452: US-009507513-2010USA002548: