chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got my first shot, flared up / same thing with the second shot, but they cleared up quickly/Suspected vaccination failure; Got my first shot, flared up / same thing with the second shot, but they cleared up quickly; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with dermatologicals nos (Calamine Lotion). 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 Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The age at vaccination and age group were not reported. The case was reported by the patient. The patient got 1st shot of Shingles vaccine and had them for 9 months last year, the events also flared up. The patient went on the antibiotics immediately. Same thing with the 2nd shot of Shingles vaccine, but they cleared up quickly calamine lotion was your best friend. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratoy test confirming shingles were not provided. For tolerance in 1st dose refer case US2021AMR111243.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR111243:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I have had them 4 times and I had the shot/Suspected vaccination failure; I have had them 4 times and I had the shot; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient have had Shingles vaccine and had them 4 times. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratoy test confirming shingles were not provided.
Age: 55.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Received ENGERIX-B a total of 4 times / most recent doses where on 5/10/21 and 12/14/2020; The first two are historical / most recent doses where on 5/10/21 and 12/14/2020; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 56-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   Co-suspect products included HBV (Engerix B adult) for prophylaxis.   Previously administered products included Engerix B (1st dose received on unknown date) and Engerix B (2nd dose received on unknown date).   On 10th May 2021, the patient received the 4th dose of Engerix B adult. On 14th December 2020, the patient received the 3rd dose of Engerix B adult. On 14th December 2020, not applicable after receiving Engerix B adult and unknown after receiving Engerix B adult, the patient experienced drug dose administration interval too long. On 10th May 2021, the patient experienced extra dose administered. On an unknown date, the outcome of the drug dose administration interval too long and extra dose administered were unknown.  Additional details were provided as follows: The patient received 2 doses as history in past. The patient received the 3rd dose of Engerix B later than recommended time interval, which led to lengthening of the schedule and received 4th dose apart from the schedule, which led to extra dose administered. The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, VARZOS
Symptoms: Electroencephalogram, Fall, Guillain-Barre syndrome, Lumbar puncture, Muscular weakness
Clinical narrative: Diagnosed with GBS / Hospitalized her for 5 nights to undergo testing/ Gullian-Barre Syndrome; Tingling in her arms and legs / Hospitalized her for 5 nights to undergo testing; legs were weak / Hospitalized her for 5 nights to undergo testing; fell down / Hospitalized her for 5 nights to undergo testing; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE MODERNA for prophylaxis and COVID-19 VACCINE MODERNA for prophylaxis.   On 1st December 2020, the patient received Shingrix. On 15th January 2021, the patient received the 1st dose of COVID-19 VACCINE MODERNA .05 ml. On 12th February 2021, the patient received the 2nd dose of COVID-19 VACCINE MODERNA .05 ml. On 1st March 2021, 90 days after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), tingling of extremity (serious criteria hospitalization), lower extremities weakness of (serious criteria hospitalization) and fall (serious criteria hospitalization). On an unknown date, the outcome of the guillain barre syndrome and tingling of extremity were recovering/resolving and the outcome of the lower extremities weakness of and fall were recovered/resolved.   It was unknown if the reporter considered the guillain barre syndrome, tingling of extremity, lower extremities weakness of and fall to be related to Shingrix.  Additional details were provided as follows: The patient experienced tingling in her arms and legs.  The patient went to the physician's office on 1st March 2021 and her legs were weak and she fell down.  The patient went to the emergency room, and the neurologist on duty hospitalized her for 5 nights to undergo testing. The patient had a brain scan which was negative, lumbar puncture which was negative and X-Rays were negative.  The patient then underwent an electroencephalogram and was diagnosed with guillain barre syndrome. Her symptoms at time of reporting were slightly improved.  On 1st March 2021, 45 days after receiving 1st dose and 17 days after receiving 2nd dose of Covid-19 vaccine Moderna, the patient experienced guillain barre syndrome, tingling of extremity, lower extremities weakness of and fall. It was unknown if the reporter considered the guillain barre syndrome, tingling of extremity, lower extremities weakness of and fall to be related to Covid-19 vaccine Moderna and Covid-19 vaccine Moderna. The emergency room visit was required. The reporter did not consent to follow-up.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, VARZOS
Symptoms: Paraesthesia, Scan brain, X-ray
Clinical narrative: Diagnosed with GBS / Hospitalized her for 5 nights to undergo testing/ Gullian-Barre Syndrome; Tingling in her arms and legs / Hospitalized her for 5 nights to undergo testing; legs were weak / Hospitalized her for 5 nights to undergo testing; fell down / Hospitalized her for 5 nights to undergo testing; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE MODERNA for prophylaxis and COVID-19 VACCINE MODERNA for prophylaxis.   On 1st December 2020, the patient received Shingrix. On 15th January 2021, the patient received the 1st dose of COVID-19 VACCINE MODERNA .05 ml. On 12th February 2021, the patient received the 2nd dose of COVID-19 VACCINE MODERNA .05 ml. On 1st March 2021, 90 days after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), tingling of extremity (serious criteria hospitalization), lower extremities weakness of (serious criteria hospitalization) and fall (serious criteria hospitalization). On an unknown date, the outcome of the guillain barre syndrome and tingling of extremity were recovering/resolving and the outcome of the lower extremities weakness of and fall were recovered/resolved.   It was unknown if the reporter considered the guillain barre syndrome, tingling of extremity, lower extremities weakness of and fall to be related to Shingrix.  Additional details were provided as follows: The patient experienced tingling in her arms and legs.  The patient went to the physician's office on 1st March 2021 and her legs were weak and she fell down.  The patient went to the emergency room, and the neurologist on duty hospitalized her for 5 nights to undergo testing. The patient had a brain scan which was negative, lumbar puncture which was negative and X-Rays were negative.  The patient then underwent an electroencephalogram and was diagnosed with guillain barre syndrome. Her symptoms at time of reporting were slightly improved.  On 1st March 2021, 45 days after receiving 1st dose and 17 days after receiving 2nd dose of Covid-19 vaccine Moderna, the patient experienced guillain barre syndrome, tingling of extremity, lower extremities weakness of and fall. It was unknown if the reporter considered the guillain barre syndrome, tingling of extremity, lower extremities weakness of and fall to be related to Covid-19 vaccine Moderna and Covid-19 vaccine Moderna. The emergency room visit was required. The reporter did not consent to follow-up.
Sex: F
Vaccine: MENB
Symptoms: Conjunctival hyperaemia, Fatigue, Headache, Inappropriate schedule of product administration, Nausea
Clinical narrative: This case was reported by an other health professional via call center representative and described the occurrence of general body pain in a 18-year-old female patient who received Men B NVS (BEXSERO) (batch number ABXA93AA, expiry date 28th February 2022) for prophylaxis. Co-suspect products included meningococcal B RECOMBINANT vaccine + aloh + omv pre-filled syringe device (BEXSERO Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (BEXSERO) (batch number ABXA93AA, expiry date 28th February 2022) for prophylaxis and meningococcal B RECOMBINANT vaccine + aloh + omv pre-filled syringe device (BEXSERO Pre-Filled Syringe Device) injection syringe for prophylaxis. On 19th May 2021, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 12th May 2021, the patient received the 1st dose of Bexsero (unknown) and Bexsero Pre-Filled Syringe Device. On 19th May 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device and not applicable after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On 20th May 2021, the patient experienced general body pain, fatigue, headache, conjunctival congestion, nausea, puffy eyes and sore throat. On an unknown date, the outcome of the general body pain, fatigue, headache, conjunctival congestion, nausea, puffy eyes, sore throat and drug dose administration interval too short were unknown. It was unknown if the reporter considered the general body pain, fatigue, headache, conjunctival congestion, nausea, puffy eyes and sore throat to be related to Bexsero, Bexsero Pre-Filled Syringe Device, Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follow: The patient received 1st dose on 12th May 2021 and 2nd dose on 19th May 2021. The patient experienced general body pain, fatigue, headache, nausea, conjunctival congestion, puffy eyes, sore throat on 20th May 2021. The patient received both vaccine 1 week apart which led to  shortening of vaccination schedule. The reporter consented to follow up.
Sex: F
Vaccine: MENB
Symptoms: Oropharyngeal pain, Pain, Periorbital swelling
Clinical narrative: This case was reported by an other health professional via call center representative and described the occurrence of general body pain in a 18-year-old female patient who received Men B NVS (BEXSERO) (batch number ABXA93AA, expiry date 28th February 2022) for prophylaxis. Co-suspect products included meningococcal B RECOMBINANT vaccine + aloh + omv pre-filled syringe device (BEXSERO Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (BEXSERO) (batch number ABXA93AA, expiry date 28th February 2022) for prophylaxis and meningococcal B RECOMBINANT vaccine + aloh + omv pre-filled syringe device (BEXSERO Pre-Filled Syringe Device) injection syringe for prophylaxis. On 19th May 2021, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 12th May 2021, the patient received the 1st dose of Bexsero (unknown) and Bexsero Pre-Filled Syringe Device. On 19th May 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device and not applicable after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On 20th May 2021, the patient experienced general body pain, fatigue, headache, conjunctival congestion, nausea, puffy eyes and sore throat. On an unknown date, the outcome of the general body pain, fatigue, headache, conjunctival congestion, nausea, puffy eyes, sore throat and drug dose administration interval too short were unknown. It was unknown if the reporter considered the general body pain, fatigue, headache, conjunctival congestion, nausea, puffy eyes and sore throat to be related to Bexsero, Bexsero Pre-Filled Syringe Device, Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follow: The patient received 1st dose on 12th May 2021 and 2nd dose on 19th May 2021. The patient experienced general body pain, fatigue, headache, nausea, conjunctival congestion, puffy eyes, sore throat on 20th May 2021. The patient received both vaccine 1 week apart which led to  shortening of vaccination schedule. The reporter consented to follow up.
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: received Engerix-B pediatric dose instead of an adult dose; received Engerix-B pediatric dose instead of an adult dose; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist was looking for medical information because the reporter realized the someone received Engerix-B pediatric dose instead of an adult dose, which led to underdose and adult use of a child product. At the moment of the call there were any details about patient involved but was going to search them.  The reporter also did not know if this error was for a first or second dose in patient´s vaccine schedule. The reporter consented to follow up by email.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Nausea, Pruritus, Pyrexia
Clinical narrative: Itching on the back of her neck and around the sides of her neck; Fever; Chills; Tiredness; Nausea / it came back about 10 days ago / nauseated morning and night; This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure high and diabetes. Concomitant products included atorvastatin calcium (Lipitor).   On 24th April 2021, the patient received the 1st dose of Shingrix (intramuscular). On 24th April 2021, 2 hrs after receiving Shingrix, the patient experienced fever, chills, tiredness and nausea. On 14th May 2021, the patient experienced pruritus. On 27th April 2021, the outcome of the fever and chills were recovered/resolved and the outcome of the tiredness was not recovered/not resolved. On an unknown date, the outcome of the nausea and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, tiredness, nausea and pruritus to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient herself. About 2 hours after receiving the Shingrix vaccine, the patient began to get fever, chills, tiredness and nausea. The fever, chills and tiredness all resolved in the few days. The nausea resolved after 3 days initially, then it came back about 10 days prior to the reporting. Since the nausea came back 10 days ago, the patient was nauseated morning and night. The patient reported that about 1 week prior to the reporting, she began itching on the back of her neck and around the sides of her neck. The patient was going to contact her health care professional on the nausea and itching on her neck since they had not resolved till the time of reporting. The reporter did not consent to follow up. The case has been liked with case US2021109086, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021109086:Same reporter. Husband's case.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pruritus, Pyrexia
Clinical narrative: Feel itching on the back of his neck and around the sides of his neck; Fever; Chills; Tiredness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th April 2021, the patient received the 1st dose of Shingrix (intramuscular). On 24th April 2021, 2 hrs after receiving Shingrix, the patient experienced fever, chills and tiredness. On 14th May 2021, the patient experienced pruritus. On 26th April 2021, the outcome of the fever, chills and tiredness were recovered/resolved. On an unknown date, the outcome of the pruritus was not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, tiredness and pruritus to be related to Shingrix.  Additional details were provided as follows: The case was reported by wife of the patient. About 2 hours after receiving the 1st Shingrix vaccine, the patient began to get fever, chills and tiredness and resolved two days later. The patient began to feel itching on the back of his neck and around the sides of his neck about one week ago from the date of reporting. The itching had not resolved. Caller reported her husband would contact his health care professional (HCP) for advice. The reporter did not consent to follow-up. The case had been linked with US2021109078 patient's wife case reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021109078:Same reporter. Wife's case.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Insomnia, Pain in extremity
Clinical narrative: pain at the injection site; Pain in her legs/pain; insomnia overnight; feeling some fatigue; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th May 2021, the patient received the 1st dose of Shingrix. In May 2021, less than a week after receiving Shingrix, the patient experienced injection site pain, pain in extremity, insomnia and fatigue. On an unknown date, the outcome of the injection site pain, pain in extremity, insomnia and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, pain in extremity, insomnia and fatigue to be related to Shingrix.  Additional details were reported as follows: The patient received the shingrix vaccine in her left arm. After getting the vaccine she experienced pain at the injection site and pain in her legs. She also experienced insomnia overnight and was feeling some fatigue. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received a Shingrix injection almost 3 years ago, but did not get dose 2 yet.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received almost 3 years before the reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The initials and date of birth of patient were unknown.  The patient did not receive the 2nd dose till the time of reporting which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received three doses of Shingrix; This case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first 2 doses received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received three doses of Shingrix, which led to extra dose administration. The reporter asked for information regarding this situation. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose / November 2019. Due to COVID / I passed the 2-6-month window. Today (05/21/2021), I received another dose; This case was reported by a consumer via call center representative and described the occurrence of social problem in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in November 2019).   On 21st May 2021, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The patient reported case for himself. The age at vaccination was not reported. The patient stated that due to COVID, he was unable to receive the second dose of Shingrix, therefore he passed the 2 to 6 month window. On the day of reporting (21st May 2021), the patient received another dose of Shingrix. The patient's physician said that he should restart the vaccine series, but the patient's pharmacist said that it was not necessary and the dose the patient received on the day of reporting was considered a second dose (completed the series). The patient wanted to confirm whether he should restart the series or the dose he received on the day of reporting was considered as series completed. The reporter was in hurry and did not allow to ask further questions. The reporter did not consent to follow-up.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose of Twinrix in November 2020 / patient had not yet received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 36-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received in November 2020, batch number: 9RT94, expiry date: 24th May 2022).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 21st May 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter called to report that, the patient was late for Twinrix second dose, between the first and second dose 6 months had passed. Till the time of the reporting the patient had not received the second dose, which led to incomplete course of vaccination. No further events were reported.
Sex: M
Vaccine: COVID19
Symptoms: Renal failure
Clinical narrative: STAGE 5 KIDNEY FAILURE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose once total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced stage 5 kidney failure. The action taken with covid-19 was not applicable. The outcome of stage 5 kidney failure was not reported. This report was serious (Disability Or Permanent Damage). This case, from the same reporter is linked to. Sender's Comments: COVID-19 VACCINE  stage 5 kidney failure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest discomfort, Chest pain, Chills, Dizziness
Clinical narrative: CHEST PAIN; DIZZINESS; SHORTNESS OF BREATH; SHE WAS UNABLE TO MOVE FOR WHOLE DAY; CRAWL TO THE BATHROOM; CHILLS; HEADACHE; FATIGUE; BURNING ARM; BODY ACHE; CHEST TIGHTNESS; LEFT ARM PAIN; LEFT SIDE OF BODY OUT OF IT; This spontaneous report received from a patient concerned a 27 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1806025, expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced left side of body out of it. On 15-MAY-2021, the subject experienced chest tightness. On 15-MAY-2021, the subject experienced left arm pain. On 15-MAY-2021, the subject experienced burning arm. On 15-MAY-2021, the subject experienced body ache. On 16-MAY-2021, the subject experienced she was unable to move for whole day. On 16-MAY-2021, the subject experienced crawl to the bathroom. On 16-MAY-2021, the subject experienced chills. On 16-MAY-2021, the subject experienced headache. On 16-MAY-2021, the subject experienced fatigue. On 18-MAY-2021, the subject experienced chest pain. On 18-MAY-2021, the subject experienced dizziness. On 18-MAY-2021, the subject experienced shortness of breath. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from she was unable to move for whole day, was recovering from crawl to the bathroom, had not recovered from fatigue, burning arm, headache, dizziness, shortness of breath, chills, left arm pain, and chest pain, and the outcome of left side of body out of it, chest tightness and body ache was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Gait disturbance, Headache, Movement disorder
Clinical narrative: CHEST PAIN; DIZZINESS; SHORTNESS OF BREATH; SHE WAS UNABLE TO MOVE FOR WHOLE DAY; CRAWL TO THE BATHROOM; CHILLS; HEADACHE; FATIGUE; BURNING ARM; BODY ACHE; CHEST TIGHTNESS; LEFT ARM PAIN; LEFT SIDE OF BODY OUT OF IT; This spontaneous report received from a patient concerned a 27 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1806025, expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced left side of body out of it. On 15-MAY-2021, the subject experienced chest tightness. On 15-MAY-2021, the subject experienced left arm pain. On 15-MAY-2021, the subject experienced burning arm. On 15-MAY-2021, the subject experienced body ache. On 16-MAY-2021, the subject experienced she was unable to move for whole day. On 16-MAY-2021, the subject experienced crawl to the bathroom. On 16-MAY-2021, the subject experienced chills. On 16-MAY-2021, the subject experienced headache. On 16-MAY-2021, the subject experienced fatigue. On 18-MAY-2021, the subject experienced chest pain. On 18-MAY-2021, the subject experienced dizziness. On 18-MAY-2021, the subject experienced shortness of breath. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from she was unable to move for whole day, was recovering from crawl to the bathroom, had not recovered from fatigue, burning arm, headache, dizziness, shortness of breath, chills, left arm pain, and chest pain, and the outcome of left side of body out of it, chest tightness and body ache was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Sensory disturbance
Clinical narrative: CHEST PAIN; DIZZINESS; SHORTNESS OF BREATH; SHE WAS UNABLE TO MOVE FOR WHOLE DAY; CRAWL TO THE BATHROOM; CHILLS; HEADACHE; FATIGUE; BURNING ARM; BODY ACHE; CHEST TIGHTNESS; LEFT ARM PAIN; LEFT SIDE OF BODY OUT OF IT; This spontaneous report received from a patient concerned a 27 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1806025, expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced left side of body out of it. On 15-MAY-2021, the subject experienced chest tightness. On 15-MAY-2021, the subject experienced left arm pain. On 15-MAY-2021, the subject experienced burning arm. On 15-MAY-2021, the subject experienced body ache. On 16-MAY-2021, the subject experienced she was unable to move for whole day. On 16-MAY-2021, the subject experienced crawl to the bathroom. On 16-MAY-2021, the subject experienced chills. On 16-MAY-2021, the subject experienced headache. On 16-MAY-2021, the subject experienced fatigue. On 18-MAY-2021, the subject experienced chest pain. On 18-MAY-2021, the subject experienced dizziness. On 18-MAY-2021, the subject experienced shortness of breath. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from she was unable to move for whole day, was recovering from crawl to the bathroom, had not recovered from fatigue, burning arm, headache, dizziness, shortness of breath, chills, left arm pain, and chest pain, and the outcome of left side of body out of it, chest tightness and body ache was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Blood iron, Blood test, Chest discomfort, Contusion
Clinical narrative: ORAL THRUSH; WHOLE BODY IS INFLAMED; EYE TWITCHING; LEG JERKING; PRESSURE UNDER HER RIB CAGE; HOT TO TOUCH; RASH ON UPPER ARM, CHEST, STOMACH; LEFT ARM SORE; UNEXPLAINED BLUE/PURPLE BRUISING ON FRONT AND BACK LEG; BAD TASTE; LOSING TASTE; BURNING IN THE MOUTH; SWOLLEN TONGUE; ITCHINESS ALL OVER THE BODY; SKIN FELT LIKE IT'S BURNING AND HOT TO TOUCH; LIPS NUMBING; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa allergy, abstain from alcohol, and non-smoker, and other pre-existing medical conditions included the patient had no known health condition and was taking supplements only. the patient never had allergy medications (never get seasonal allergies).The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced skin felt like it's burning and hot to touch. On APR-2021, the subject experienced lips numbing. On 08-APR-2021, the subject experienced itchiness all over the body. On 20-APR-2021, the subject experienced burning in the mouth. On 20-APR-2021, the subject experienced swollen tongue. On 20-APR-2021, the subject experienced bad taste. On 20-APR-2021, the subject experienced losing taste. On MAY-2021, the subject experienced unexplained blue/purple bruising on front and back leg. On MAY-2021, the subject experienced left arm sore. On 03-MAY-2021, Laboratory data included: Blood test (NR: not provided) normal white blood cells and iron level low, Platelet count (NR: not provided) normal, Serum iron (NR: not provided) low, and White blood cells (NR: not provided) Normal. On an unspecified date, the subject experienced oral thrush, whole body is inflamed, eye twitching, leg jerking, pressure under her rib cage, hot to touch, and rash on upper arm, chest, stomach. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. Treatment medications (dates unspecified) included: cetirizine hydrochloride, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine  was not applicable. The patient recovered from skin felt like it's burning and hot to touch, and rash on upper arm, chest, stomach, was recovering from pressure under her rib cage, had not recovered from swollen tongue, and burning in the mouth, and the outcome of itchiness all over the body, unexplained blue/purple bruising on front and back leg, eye twitching, leg jerking, left arm sore, whole body is inflamed, bad taste, losing taste, lips numbing, hot to touch and oral thrush was not reported. This report was non-serious. This case, from the same reporter is linked to 20210534998.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non serious.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyskinesia, Feeling hot, Hypoaesthesia oral, Inflammation, Muscle twitching
Clinical narrative: ORAL THRUSH; WHOLE BODY IS INFLAMED; EYE TWITCHING; LEG JERKING; PRESSURE UNDER HER RIB CAGE; HOT TO TOUCH; RASH ON UPPER ARM, CHEST, STOMACH; LEFT ARM SORE; UNEXPLAINED BLUE/PURPLE BRUISING ON FRONT AND BACK LEG; BAD TASTE; LOSING TASTE; BURNING IN THE MOUTH; SWOLLEN TONGUE; ITCHINESS ALL OVER THE BODY; SKIN FELT LIKE IT'S BURNING AND HOT TO TOUCH; LIPS NUMBING; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa allergy, abstain from alcohol, and non-smoker, and other pre-existing medical conditions included the patient had no known health condition and was taking supplements only. the patient never had allergy medications (never get seasonal allergies).The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced skin felt like it's burning and hot to touch. On APR-2021, the subject experienced lips numbing. On 08-APR-2021, the subject experienced itchiness all over the body. On 20-APR-2021, the subject experienced burning in the mouth. On 20-APR-2021, the subject experienced swollen tongue. On 20-APR-2021, the subject experienced bad taste. On 20-APR-2021, the subject experienced losing taste. On MAY-2021, the subject experienced unexplained blue/purple bruising on front and back leg. On MAY-2021, the subject experienced left arm sore. On 03-MAY-2021, Laboratory data included: Blood test (NR: not provided) normal white blood cells and iron level low, Platelet count (NR: not provided) normal, Serum iron (NR: not provided) low, and White blood cells (NR: not provided) Normal. On an unspecified date, the subject experienced oral thrush, whole body is inflamed, eye twitching, leg jerking, pressure under her rib cage, hot to touch, and rash on upper arm, chest, stomach. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. Treatment medications (dates unspecified) included: cetirizine hydrochloride, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine  was not applicable. The patient recovered from skin felt like it's burning and hot to touch, and rash on upper arm, chest, stomach, was recovering from pressure under her rib cage, had not recovered from swollen tongue, and burning in the mouth, and the outcome of itchiness all over the body, unexplained blue/purple bruising on front and back leg, eye twitching, leg jerking, left arm sore, whole body is inflamed, bad taste, losing taste, lips numbing, hot to touch and oral thrush was not reported. This report was non-serious. This case, from the same reporter is linked to 20210534998.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non serious.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oral candidiasis, Oral discomfort, Pain in extremity, Platelet count, Pruritus
Clinical narrative: ORAL THRUSH; WHOLE BODY IS INFLAMED; EYE TWITCHING; LEG JERKING; PRESSURE UNDER HER RIB CAGE; HOT TO TOUCH; RASH ON UPPER ARM, CHEST, STOMACH; LEFT ARM SORE; UNEXPLAINED BLUE/PURPLE BRUISING ON FRONT AND BACK LEG; BAD TASTE; LOSING TASTE; BURNING IN THE MOUTH; SWOLLEN TONGUE; ITCHINESS ALL OVER THE BODY; SKIN FELT LIKE IT'S BURNING AND HOT TO TOUCH; LIPS NUMBING; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa allergy, abstain from alcohol, and non-smoker, and other pre-existing medical conditions included the patient had no known health condition and was taking supplements only. the patient never had allergy medications (never get seasonal allergies).The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced skin felt like it's burning and hot to touch. On APR-2021, the subject experienced lips numbing. On 08-APR-2021, the subject experienced itchiness all over the body. On 20-APR-2021, the subject experienced burning in the mouth. On 20-APR-2021, the subject experienced swollen tongue. On 20-APR-2021, the subject experienced bad taste. On 20-APR-2021, the subject experienced losing taste. On MAY-2021, the subject experienced unexplained blue/purple bruising on front and back leg. On MAY-2021, the subject experienced left arm sore. On 03-MAY-2021, Laboratory data included: Blood test (NR: not provided) normal white blood cells and iron level low, Platelet count (NR: not provided) normal, Serum iron (NR: not provided) low, and White blood cells (NR: not provided) Normal. On an unspecified date, the subject experienced oral thrush, whole body is inflamed, eye twitching, leg jerking, pressure under her rib cage, hot to touch, and rash on upper arm, chest, stomach. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. Treatment medications (dates unspecified) included: cetirizine hydrochloride, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine  was not applicable. The patient recovered from skin felt like it's burning and hot to touch, and rash on upper arm, chest, stomach, was recovering from pressure under her rib cage, had not recovered from swollen tongue, and burning in the mouth, and the outcome of itchiness all over the body, unexplained blue/purple bruising on front and back leg, eye twitching, leg jerking, left arm sore, whole body is inflamed, bad taste, losing taste, lips numbing, hot to touch and oral thrush was not reported. This report was non-serious. This case, from the same reporter is linked to 20210534998.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non serious.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, SARS-CoV-2 test, Skin burning sensation, Swollen tongue, Taste disorder
Clinical narrative: ORAL THRUSH; WHOLE BODY IS INFLAMED; EYE TWITCHING; LEG JERKING; PRESSURE UNDER HER RIB CAGE; HOT TO TOUCH; RASH ON UPPER ARM, CHEST, STOMACH; LEFT ARM SORE; UNEXPLAINED BLUE/PURPLE BRUISING ON FRONT AND BACK LEG; BAD TASTE; LOSING TASTE; BURNING IN THE MOUTH; SWOLLEN TONGUE; ITCHINESS ALL OVER THE BODY; SKIN FELT LIKE IT'S BURNING AND HOT TO TOUCH; LIPS NUMBING; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa allergy, abstain from alcohol, and non-smoker, and other pre-existing medical conditions included the patient had no known health condition and was taking supplements only. the patient never had allergy medications (never get seasonal allergies).The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced skin felt like it's burning and hot to touch. On APR-2021, the subject experienced lips numbing. On 08-APR-2021, the subject experienced itchiness all over the body. On 20-APR-2021, the subject experienced burning in the mouth. On 20-APR-2021, the subject experienced swollen tongue. On 20-APR-2021, the subject experienced bad taste. On 20-APR-2021, the subject experienced losing taste. On MAY-2021, the subject experienced unexplained blue/purple bruising on front and back leg. On MAY-2021, the subject experienced left arm sore. On 03-MAY-2021, Laboratory data included: Blood test (NR: not provided) normal white blood cells and iron level low, Platelet count (NR: not provided) normal, Serum iron (NR: not provided) low, and White blood cells (NR: not provided) Normal. On an unspecified date, the subject experienced oral thrush, whole body is inflamed, eye twitching, leg jerking, pressure under her rib cage, hot to touch, and rash on upper arm, chest, stomach. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. Treatment medications (dates unspecified) included: cetirizine hydrochloride, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine  was not applicable. The patient recovered from skin felt like it's burning and hot to touch, and rash on upper arm, chest, stomach, was recovering from pressure under her rib cage, had not recovered from swollen tongue, and burning in the mouth, and the outcome of itchiness all over the body, unexplained blue/purple bruising on front and back leg, eye twitching, leg jerking, left arm sore, whole body is inflamed, bad taste, losing taste, lips numbing, hot to touch and oral thrush was not reported. This report was non-serious. This case, from the same reporter is linked to 20210534998.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non serious.