chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Injection site pain, Injection site swelling, Neck pain, Pain
Clinical narrative: She presented to the pharmacy with swelling and severe pain at the injection site.; The pain radiated down her arm and up to her neck and was described as her "arm was on fire".; The pain radiated down her arm and up to her neck and was described as her "arm was on fire".; The pain radiated down her arm and up to her neck and was described as her "arm was on fire".; She presented to the pharmacy with swelling and severe pain at the injection site.; This spontaneous report was received from a pharmacist referring to a 61 year old female patient. The patient's medical history included psoriasis. The patient's medical history, concomitant medications, and historical drugs were not reported.  On 09-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 ml, intramuscularly in the right deltoid with lot # T021485, and expiration date 15-MAR-2022 for prophylaxis.   On 10-OCT-2020, the patient presented to the pharmacy with swelling and severe pain at the injection site. The pain radiated down her arm (pain in extremity) and up to her neck and was described as her "arm was on fire"(feeling abnormal ). She went to her primary care physician and received unknown care, and the last contact the pharmacist had with the patient was on 10-OCT-2020.   At the time of the report, the outcome of injection site swelling and injection site pain was reported as not resolved. The outcome of pain in extremity, feeling abnormal and neck pain was unknown. The reporter did not mention the causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccination. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T021485; expirationdate: 15-MAR-2022; 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 suggest a causal association with the device or device constituent
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: She presented to the pharmacy with swelling and severe pain at the injection site.; The pain radiated down her arm and up to her neck and was described as her "arm was on fire".; The pain radiated down her arm and up to her neck and was described as her "arm was on fire".; The pain radiated down her arm and up to her neck and was described as her "arm was on fire".; She presented to the pharmacy with swelling and severe pain at the injection site.; This spontaneous report was received from a pharmacist referring to a 61 year old female patient. The patient's medical history included psoriasis. The patient's medical history, concomitant medications, and historical drugs were not reported.  On 09-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 ml, intramuscularly in the right deltoid with lot # T021485, and expiration date 15-MAR-2022 for prophylaxis.   On 10-OCT-2020, the patient presented to the pharmacy with swelling and severe pain at the injection site. The pain radiated down her arm (pain in extremity) and up to her neck and was described as her "arm was on fire"(feeling abnormal ). She went to her primary care physician and received unknown care, and the last contact the pharmacist had with the patient was on 10-OCT-2020.   At the time of the report, the outcome of injection site swelling and injection site pain was reported as not resolved. The outcome of pain in extremity, feeling abnormal and neck pain was unknown. The reporter did not mention the causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccination. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T021485; expirationdate: 15-MAR-2022; 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 suggest a causal association with the device or device constituent
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient was inadvertently vaccinated with an expired dose of PNEUMOVAX23; This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications and drug reactions/allergies.  On 10-OCT-2020, the patient was vaccinated with and expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S025133, expiration date: 15-SEP-2020) dose reported as 1 shot (dosage regimen, route of administration and anatomical location were not reported) for prophylaxis. No additional adverse event details were provided combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S025133; expirationdate: 15-SEP-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: Patient was inadvertently administered an expired dose of PNEUMOVAX 23; This initial spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies, and concomitant medications were not reported.   On 11-OCT-2020, the patient was inadvertently administered an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), one shot, lot # S025133 (expiration date of 15-SEP-2020), for prophylaxis. No additional details or product quality complaints were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S025133; expirationdate: 15-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: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Side effects / aches in my muscles; 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 Herpes zoster (Shingrix) for prophylaxis.   On 6th October 2020, the patient received the 1st dose of Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. The patient was still feeling aches in muscles. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Memory impairment
Clinical narrative: get forgetful; This case was reported by a consumer via interactive digital media and described the occurrence of forgetfulness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced forgetfulness. On an unknown date, the outcome of the forgetfulness was unknown.   It was unknown if the reporter considered the forgetfulness to be related to Shingrix.  Additional details were provided as follows:  The patient received shingrix shot. The patient was very forgetful about a lot of things ever.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Vertigo
Clinical narrative: Vertigo; Very very sick; This case was reported by a consumer via interactive digital media and described the occurrence of vertigo 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, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vertigo and sickness. On an unknown date, the outcome of the vertigo and sickness were recovered/resolved.   It was unknown if the reporter considered the vertigo and sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient had vertigo for six weeks after flu shot and was very very sick.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Muscle spasms
Clinical narrative: Intense headache; Shivering/chills; Horrible stomach ache; Muscle cramps; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shringrex (1st dose received on an unknown date).   On 8th October 2020, the patient received the 2nd dose of Shingrix. In October 2020, 12 hrs after receiving Shingrix, the patient experienced headache, shivering, stomach pain and muscle cramp. On an unknown date, the outcome of the headache, shivering, stomach pain and muscle cramp were unknown.   It was unknown if the reporter considered the headache, shivering, stomach pain and muscle cramp to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Age group was captured as adult as per vaccine indication. The patient received 2nd dose of Shingrix vaccine at noon yesterday from the date of reporting.  12 hours later the patient began an intense headache, shivering/chills, horrible stomachache, and muscle cramps.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Rash starting around his wrists then moving to his legs and stomach; Itching; This case was reported by a consumer via call center representative and described the occurrence of rash in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th October 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In October 2020, less than a day after receiving Shingrix, the patient experienced rash and pruritus. On an unknown date, the outcome of the rash and pruritus were not recovered/not resolved.   The reporter considered the rash and pruritus to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. Consumer reported that he received the firste dose of shingrix on 5th october,2020 and had events like break out in a rash started around his wrists then moved to his legs and stomach.  He reported itching as well which started at the same time. The symptoms still have not resolved. The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles activation after having the first dose; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 75P7G, expiry date 17th April 2022) for prophylaxis.   On 25th September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix and experienced shingles which was not recovered till the time of reporting. The reporter did not consented to follow up. No further information was available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain and injection site rash. On an unknown date, the outcome of the injection site pain and injection site rash were unknown. It was unknown if the reporter considered the injection site pain and injection site rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. A pharmacist reported a few patients experienced injection site pain and injection site rash after the administration of SHINGRIX. The reporter consented to follow up. This is 5 of the 5 link cases, reported by same reporter. Sender's Comments:  US-GLAXOSMITHKLINE-US2020201572:same reporter US-GLAXOSMITHKLINE-US2020201575:same reporter US-GLAXOSMITHKLINE-US2020201576:same reporter US-GLAXOSMITHKLINE-US2020AMR202100:same reporter
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site streaking, Local reaction, Pruritus, Tenderness
Clinical narrative: Injection-site reaction; Redness at injection site/red streak half an inch from the injection site; Itchiness; Arm is tender to the touch; This case was reported by a consumer via call center representative and described the occurrence of local reaction in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th October 2020, the patient received the 1st dose of Shingrix. On 7th October 2020, less than a day after receiving Shingrix, the patient experienced local reaction, injection site erythema, pruritus and tenderness. On an unknown date, the outcome of the local reaction, injection site erythema, pruritus and tenderness were not recovered/not resolved.   It was unknown if the reporter considered the local reaction, injection site erythema, pruritus and tenderness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced redness at the injection site, itchiness, and her arm is tender to the touch. She states it started out as a small, red streak half an inch from the injection site on wednesday night. On Thursday morning, she noticed it started to spread down and around to the back of the right arm. She states the reaction was ongoing still the time of reporting, but the redness was not as red and the tenderness was not as tender.  For 1st dose refer case US2020AMR202892. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR202892:same reporter
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site erythema, Injection site streaking, Pain in extremity, Pruritus
Clinical narrative: Injection-site reaction; Redness at injection site/red streak half an inch from the injection site; Itchiness; Arm is tender to the touch; This case was reported by a consumer via call center representative and described the occurrence of local reaction in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th October 2020, the patient received the 1st dose of Shingrix. On 7th October 2020, less than a day after receiving Shingrix, the patient experienced local reaction, injection site erythema, pruritus and tenderness. On an unknown date, the outcome of the local reaction, injection site erythema, pruritus and tenderness were not recovered/not resolved.   It was unknown if the reporter considered the local reaction, injection site erythema, pruritus and tenderness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced redness at the injection site, itchiness, and her arm is tender to the touch. She states it started out as a small, red streak half an inch from the injection site on wednesday night. On Thursday morning, she noticed it started to spread down and around to the back of the right arm. She states the reaction was ongoing still the time of reporting, but the redness was not as red and the tenderness was not as tender.  For 1st dose refer case US2020AMR202892. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR202892:same reporter
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tenderness
Clinical narrative: Injection-site reaction; Redness at injection site/red streak half an inch from the injection site; Itchiness; Arm is tender to the touch; This case was reported by a consumer via call center representative and described the occurrence of local reaction in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th October 2020, the patient received the 1st dose of Shingrix. On 7th October 2020, less than a day after receiving Shingrix, the patient experienced local reaction, injection site erythema, pruritus and tenderness. On an unknown date, the outcome of the local reaction, injection site erythema, pruritus and tenderness were not recovered/not resolved.   It was unknown if the reporter considered the local reaction, injection site erythema, pruritus and tenderness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced redness at the injection site, itchiness, and her arm is tender to the touch. She states it started out as a small, red streak half an inch from the injection site on wednesday night. On Thursday morning, she noticed it started to spread down and around to the back of the right arm. She states the reaction was ongoing still the time of reporting, but the redness was not as red and the tenderness was not as tender.  For 1st dose refer case US2020AMR202892. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR202892:same reporter
Age: 69.0
Sex: M
Vaccine: FLUA4, PNC13, VARZOS
Symptoms: Cough, Fatigue, Pain, Pain in extremity, Sluggishness
Clinical narrative: Cough; Tired; Pain in arms; Achy; Slow; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR 13) for prophylaxis and QUADRIVALENT INFLUENZA VACCINES (FLUAD QUADRIVALENT) for prophylaxis.   On 5th October 2020 17:00, the patient received Shingrix .5 ml, PREVNAR 13 .5 ml and FLUAD QUADRIVALENT .5 ml. On 5th October 2020, less than a day after receiving Shingrix, the patient experienced tiredness, pain in arm, pain and sluggishness. On 7th October 2020, the patient experienced cough. On an unknown date, the outcome of the tiredness, pain in arm, pain, sluggishness and cough were not recovered/not resolved.   It was unknown if the reporter considered the tiredness, pain in arm, pain, sluggishness and cough to be related to Shingrix.  Additional details were provided as follows: The case was reported by the wife of the patient. The patient received Shingrix, Prevnar13, and Fluad65+QIV PFS 2020-2021 on 5th October 2020 at around 5 pm. By nighttime the patient was slow, achy, tired and had pain in arms. On 7th October 2020, the patient developed a cough. The patient's symptoms were not resolved, but symptoms were getting better. This case has been linked with US2020202289 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020202289:same reporter
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on unknown date). Concurrent medical conditions included migraine. Concomitant products included paracetamol, aspirin, caffeine (Excedrin Migraine).   On 30th September 2020, the patient received the 2nd dose of Shingrix. On 2nd October 2020, 2 days after receiving Shingrix and an unknown time after starting Excedrin Migraine, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated with 2nd dose of Shingrix. 2 days after vaccination patient experienced a headache but was not sure if it was migrainous. The patient normally aborts a migraine with Excedrin Migraine, but cannot get rid of it. At time of report, the headache was still present. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Myalgia
Clinical narrative: muscle / pain; joint pain; headache; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th October 2020, the patient received Shingrix. On 5th October 2020, less than a day after receiving Shingrix, the patient experienced muscle pain, joint pain and headache. On an unknown date, the outcome of the muscle pain and joint pain were not recovered/not resolved and the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the muscle pain, joint pain and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated with Shingrix 1 week before reporting since then, she had muscle and joint pain, that had not resolved. The patient initially had  headache but it was resolved. The reporter did not consent to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Rash pruritic
Clinical narrative: rash / 3 inches below injection site / down the arm that is slightly itchy.; redness at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number 3454N, expiry date 23rd August 2022) for prophylaxis.   On 8th October 2020, the patient received the 2nd dose of Shingrix. On 11th October 2020, 3 days after receiving Shingrix, the patient experienced itchy rash. In October 2020, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovering/resolving and the outcome of the itchy rash was recovered/resolved.   It was unknown if the reporter considered the injection site erythema and itchy rash to be related to Shingrix.  Additional details were provided as follows: After receiving 2nd dose of Shingrix, patient experienced redness at the injection site and rash about 3 inches below injection site, half way down the arm that is slightly itchy. The redness at the injection site, which was resolving, going away. The reporter consent to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster
Clinical narrative: red mark at the outside side of the thumb base; had shingles on her left thumb and hand; 8-10 blisters /  3 blisters in the palm side of the thumb base; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st May 2020, the patient received the 1st dose of Shingrix. On 5th July 2020, 45 days after receiving Shingrix, the patient experienced shingles and blister. On an unknown date, the patient experienced erythema. On an unknown date, the outcome of the shingles and erythema were unknown and the outcome of the blister was recovered/resolved.   It was unknown if the reporter considered the shingles, blister and erythema to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of shingrix in left arm and experienced shingles on left thumb and hand with around 8-10 blisters on the outer part of the thumb base and around 3 blisters in the palm side of the thumb base. The reporter mentioned that blisters were resolved but had a red mark at the outside of the thumb base of the left hand. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: delayed her 2nd dose due to fear of COVID 19; Chills; mild arm soreness; body aches; Tiredness; did not go to work; This case was reported by a consumer via call center representative and described the occurrence of chills in a 58-year-old female 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. On an unknown date, the patient received the 2nd dose of Shingrix. In October 2019, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced chills, pain in arm, general body pain and tiredness. On an unknown date, the patient experienced activities of daily living impaired and social problem. On an unknown date, the outcome of the chills, pain in arm, general body pain, tiredness and social problem were unknown and the outcome of the activities of daily living impaired was recovered/resolved.   It was unknown if the reporter considered the chills, pain in arm, general body pain, tiredness and activities of daily living impaired to be related to Shingrix.  Additional case details were reported as follows: The patient reported case for herself. The age at vaccination was not reported. The vaccine lot and expiration date unknown. Patient reported body aches, chills, mild arm soreness, tiredness. The patient reported these symptoms started 18 to 24 hours after. Patient reported that the 3rd day after the vaccine she did not go to worked, but on the 4th day she was ok. The patient described it as a mild reaction. The patient was delayed her 2nd dose due to fear of COVID 19. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Social problem
Clinical narrative: delayed her 2nd dose due to fear of COVID 19; Chills; mild arm soreness; body aches; Tiredness; did not go to work; This case was reported by a consumer via call center representative and described the occurrence of chills in a 58-year-old female 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. On an unknown date, the patient received the 2nd dose of Shingrix. In October 2019, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced chills, pain in arm, general body pain and tiredness. On an unknown date, the patient experienced activities of daily living impaired and social problem. On an unknown date, the outcome of the chills, pain in arm, general body pain, tiredness and social problem were unknown and the outcome of the activities of daily living impaired was recovered/resolved.   It was unknown if the reporter considered the chills, pain in arm, general body pain, tiredness and activities of daily living impaired to be related to Shingrix.  Additional case details were reported as follows: The patient reported case for herself. The age at vaccination was not reported. The vaccine lot and expiration date unknown. Patient reported body aches, chills, mild arm soreness, tiredness. The patient reported these symptoms started 18 to 24 hours after. Patient reported that the 3rd day after the vaccine she did not go to worked, but on the 4th day she was ok. The patient described it as a mild reaction. The patient was delayed her 2nd dose due to fear of COVID 19. The reporter did not consent to follow up.
Sex: F
Vaccine: FLUX
Symptoms: Blindness unilateral, Headache, Madarosis, Rash
Clinical narrative: lost vision completely in one eye; rashes; severe headaches; hair in her eyebrows fell out; Initial information received on 08-Oct-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional.  This case involves a seven-year-old female patient who lost vision completely in one eye (Blindness unilateral), had rashes (rash), severe headaches (headache) and hair in her eyebrows fell out (madarosis), while she received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient lost vision completely in one eye (Blindness unilateral), had rashes (rash), severe headaches (headache) and hair in her eyebrows fell out (madarosis) (unknown latency) following the administration of INFLUENZA VACCINE. Event blindness was assessed as medically significant. The patient was hospitalized for these events for a week.  Other relevant tests not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, outcome was unknown for all the events.  Information on the batch number was requested.; Sender's Comments: This poorly documented case concerns a seven-year-old female patient who experienced Blindness unilateral, rash, headache and madarosis after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset was unknown. Moreover, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: Flu; sick; Initial information was received on 08-Oct-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via  (social media) .     This case involves a patient with unknown demographics who experienced flu (influenza) and sick (malaise), while patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date in 2007, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) and sick (malaise), unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for flu and sick.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Death, Influenza
Clinical narrative: passed away a week after the flu; Initial information was received on 09-Oct-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional.  This case involves a female patient (age unspecified) who passed away a week after the flu (influenza), while she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient passed away a week after the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. This event was leading to death.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was fatal.  It is unknown if an autopsy was done. The cause of death was captured as Influenza.  Information on lot number was requested.; Sender's Comments: This case reported involved a female patient (age unspecified) who passed away a week after influenza following vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination, concomitant medications, lab /radiological investigation excluding other etiologies and detail autopsy report would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.; Reported Cause(s) of Death: passed away a week after the flu
Age: 16.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A patient was administered Flublok vaccine inadvertently, no AE; Initial information was received on 03-Oct-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case is linked to case 2020SA273662 (same reporter).  This case involves a 16 year old male patient who was administered INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] inadvertently (product administered to patient of inappropriate age)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient received no other vaccines.   On 03-Oct-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot UJ463AA, expiry date: 19-Mar-2021, Strength: standard) once via intramuscular route in the left arm for prophylactic vaccination.  It was a case of an actual medication error due to product administered to patient of inappropriate age (latency same day).  The pharmacist stated that they were having an event and two patients of age (11 and 16) were inadvertently given the Flublok immunization  At the time of report, 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.
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Computerised tomogram abnormal, Facial paralysis, Magnetic resonance imaging abnormal
Clinical narrative: suddenly felt the left side of his mouth drop; Initial information was received on 05-Oct-2020 regarding an unsolicited valid serious case received from a consumer or non health care professional.  This case involves a 69 year-old male patient who suddenly felt the left side of his mouth drop (facial paralysis), while he received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Vaccination(s) included Influenza vaccine for prophylactic vaccination every year but it was not sure if High Dose. Past medical history, medical treatment(s) and family history were not provided. No other vaccine was given.  Concomitant medications were not reported.   On 30-Sep-2020, the patient received 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (single dose vial) (lot UJ484AB and expiry date 30-Jun-2021) via unknown route in the left arm for prophylactic vaccination.  On 01-Oct-2020, the patient suddenly felt the left side of his mouth drop (facial paralysis) 1 day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. This event was assessed as medically significant.  Case Detail: The patient was driving his car and suddenly felt the left side of his mouth drop. He tried to smile and noticed that it did not look right. The patient thought that he was having a stroke so he went to the emergent room.   Relevant laboratory test results included: Computerized tomogram - On an unknown date in Oct-2020: [Bells Palsy] and Magnetic resonance imaging: [Bells Palsy]  It was not reported if the patient received any corrective treatment.  At the time of reporting, patient was recovering from the event (he started to get back the feeling on the left side of face).  It was also reported that patient supposed this was related to the flu vaccine.; Sender's Comments: This case involves a 69 year-old male patient who experienced facial paralysis one day following the vaccination with FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset was compatible. Laboratory test included computerized tomogram and magnetic resonance imaging. Further information regarding condition during vaccination, previous medical and allergic history and laboratory details excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Headache, Syncope, Vomiting
Clinical narrative: Fainting, vomiting, headache, exhausted
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: Blister rupture, Injection site pain, Injection site vesicles
Clinical narrative: States painful blisters appeared below injections site. Afebrile. Blisters burst after 2-3 days.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age, Product prescribing error
Clinical narrative: pt received high dose influenza vaccine at request of provider instead of regular dose influenza.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Deafness unilateral, Ear congestion, Headache, Lymph node pain
Clinical narrative: Per patient, had not had flu shot since 19 years old. About 10  hours after receiving injection, reported ringing in ears- primarily left ear. The next morning, reported full feeling in ears with some hearing loss in left ear.  Around 22 hours after injection, reported headache, lymph nodes hurt and cough.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Tinnitus
Clinical narrative: Per patient, had not had flu shot since 19 years old. About 10  hours after receiving injection, reported ringing in ears- primarily left ear. The next morning, reported full feeling in ears with some hearing loss in left ear.  Around 22 hours after injection, reported headache, lymph nodes hurt and cough.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Joint range of motion decreased, Skin warm
Clinical narrative: Patient experienced redness, warmth, and limited range of motion
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Bursitis, Inflammation, Insomnia, Joint range of motion decreased
Clinical narrative: Less than 48 hours after flu vaccine I began to experience shoulder pain and limited range of motion that gradually worsened over the course of 2-3 weeks.  Simple tasks that required me to lift my arm up, such as getting dressed and combing my hair became very difficult and painful.  I have also had difficulty sleeping due to shoulder pain at night.  My family doctor diagnosed me with subacromial bursitis caused by improper administration of the flu vaccine.  He explained that the vaccine was administered too high on my arm and entered the joint rather than my deltoid muscle.  At present my family doctor has prescribed Voltaren cream to reduce inflammation and pain.  As of today, 10/15/2020, symptoms have not yet subsided and treatment with Voltaren continues.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of personal independence in daily activities, Product administered at inappropriate site
Clinical narrative: Less than 48 hours after flu vaccine I began to experience shoulder pain and limited range of motion that gradually worsened over the course of 2-3 weeks.  Simple tasks that required me to lift my arm up, such as getting dressed and combing my hair became very difficult and painful.  I have also had difficulty sleeping due to shoulder pain at night.  My family doctor diagnosed me with subacromial bursitis caused by improper administration of the flu vaccine.  He explained that the vaccine was administered too high on my arm and entered the joint rather than my deltoid muscle.  At present my family doctor has prescribed Voltaren cream to reduce inflammation and pain.  As of today, 10/15/2020, symptoms have not yet subsided and treatment with Voltaren continues.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Swelling
Clinical narrative: Severe localized swelling with redness
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pyrexia
Clinical narrative: fever, fatigue
Age: 17.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Erythema, Feeling abnormal, Headache, Nausea, Skin warm
Clinical narrative: Received Fluarix in left arm and Trumenba in right arm the morning of 10/9/20.  Mom called at about 3:00pm that day to report that he said he "felt a little funny" after the Trumenba in right arm was administered but they didn't think anything of it.  45 min after the vaccine he c/o h/a.  Mom became concerned and called us when he called for her and he was in the bathroom floor saying he had the worst h/a he had ever had and he felt nauseous.  Provider advised that he drink down about 30 oz of Gatorade now and then continue to hydrate throughout the day with water. Provider recommended that if he continued to feel concerned to take him to the hospital.  Mom said she didn't feel the need to take him to the hospital. Redness and tactile warmth lasted until 10/10/20 and patient said he "felt like he was coming down with something" but by that night, he was completely fine.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE reported; expired dose of MMR II was inadvertently administered; This spontaneous report was received from a pharmacy technician and refers to a 12-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 05-OCT-2020, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (Batch#R029224, expiration date reported as 02-OCT-2020, but upon internal validation was established as invalid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)) (exact dose, dose number, route of administration and anatomical location were not reported) for prophylaxis. No other adverse events were reported. The reporter would like to know if this was a valid dose. No prior temperature excursions on the product.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Her medical history, concurrent conditions and concomitant medications were not provided. On or about 13-OCT-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) at a pharmacy for the long-term prevention of shingles and zoster-related conditions (dose, route of administration, site of administration and lot # were not provided). Subsequently, the patient was treated by a provider for the following injuries resulting from the zoster vaccine live (ZOSTAVAX) use: herpes zoster. The outcome of the event was unknown. The lawyer felt the event was related to zoster vaccine live (ZOSTAVAX).
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Injection site reaction
Clinical narrative: Tenderness; headache; tired; bad shivering for about 1 ½ hours. (AE: Shivering); rash / tender in touch / no itching / 5 inches away from injection site/rash on arm/Vesicular rash/it feels like shingles; it tingles; feeling ill; This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 5th October 2020, the patient received the 2nd dose of Shingrix. On 5th October 2020, 8 hrs after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced shivering. On 6th October 2020, the patient experienced headache and tiredness. In October 2020, the patient experienced vesicular rash, tingling and feeling unwell. On an unknown date, the patient experienced tenderness. On an unknown date, the outcome of the vesicular rash, tingling and tenderness were unknown and the outcome of the shivering was recovered/resolved and the outcome of the headache, tiredness and feeling unwell were not recovered/not resolved.   It was unknown if the reporter considered the vesicular rash, shivering, headache, tiredness, tingling, tenderness and feeling unwell to be related to Shingrix.  Additional details were reported as follows: The reporter is the patient herself. The patient 2nd dose of shingrix and experienced bad shivering for about 1 and half hour, headache, tired, rash almost like shingles, does not looked like shingles, but feels it, because it tingles. The patient described rash as tender in touch with no itching. The reporter mentioned that, rash was not at injection site, but was in same arm, 5 inches away from injection site and felt still ill at the day of reporting. The patient also experienced aches, was tired and flu like symptoms which lasted for 36 hours after receiving 1st dose of shingrix 2 months ago. Lot and expiration date were not provided. The reporter did not consent to follow up. For tolerance of 1st dose, refer case US2020201539.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020201539:same reporter