chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had shots and still got shingles\ suspected vaccination failure; got shingles; This case was reported by a consumer via interactive digital 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 2nd dose of Shingles vaccine and the 1st 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. 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: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles shots and still got shingles, at least it was not as bad if did not get the Shingles shots. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; got shingles; miserable; This case was reported by a consumer via interactive digital 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), shingles and feeling miserable. On an unknown date, the outcome of the vaccination failure, shingles and feeling miserable were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles twice. The patient felt miserable. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital 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's friend. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. The reporter stated that, Shingles vaccine did not prevent shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; spreading rash; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Shingrix for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and generalized rash. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and generalized rash were not recovered/not resolved.   The reporter considered the vaccination failure, shingles and generalized rash to be related to Shingrix.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient thought, he/she might get shingles after receiving Shingles vaccine. He/she had an increasingly spreading rash over body. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: missed the second dose by 4 years; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date 4 years ago).   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 information was provided as follow: The patient was the reporter. The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The patient enquired that he/she had missed the deadline for the second dose by 4 years, so could he/she still take it
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Pain, Post herpetic neuralgia
Clinical narrative: exacerbated her PHN /taking herpes medication to help with the PHN pain; Pain; exacerbated her PHN; This case was reported by a consumer via call center representative and described the occurrence of post herpetic neuralgia in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included post herpetic neuralgia and shingles. Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced post herpetic neuralgia, pain and condition aggravated. On an unknown date, the outcome of the post herpetic neuralgia, pain and condition aggravated were not recovered/not resolved.   The reporter considered the post herpetic neuralgia, pain and condition aggravated to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient for herself. The age at vaccination was not reported. The patient received 2 doses of Shingrix 19 months ago and post herpetic neuralgia was flare-up lasted for the past 19 months since the patient got her last dose of Shingrix. The patient believed that the Shingrix vaccine may had exacerbated her post herpetic neuralgia symptoms and made her post herpetic neuralgia last longer. The patient also mentioned that taking herpes medication from a friend to be seen if it would be help with the post herpetic neuralgia pain. Referred her to health care professional. MI phone number was provided. The reporter consented to follow-up.
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Expired product administered, No adverse event
Clinical narrative: administrated with an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number bc75g, expiry date 29th August 2021) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 3rd September 2021, the patient received Rotarix lyophilized formulation (oral) and Rotarix Oral Applicator Device. On 3rd September 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 reported as follows: Medical assistance reported that a patient was administrated with an expired dose of Rotarix which led to expired vaccine used.  No adverse event was reported . The reporter consented to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Peripheral swelling
Clinical narrative: arm became swollen; swollen area is hard; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 2nd September 2021, 1 days after receiving Shingrix, the patient experienced swelling arm and induration. On an unknown date, the outcome of the swelling arm and induration were not recovered/not resolved.   It was unknown if the reporter considered the swelling arm and induration to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient herself. The patient received the dose of Shingrix and one day after the vaccination the patient's arm became swollen and the swollen area was hard. The patient stated that, her arm was still swollen at the time of reporting. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations, Pyrexia, Urticaria
Clinical narrative: fever (99 degrees/102.6); Heart was racing; hives on chest, throat, arms and inside area of elbows; This case was reported by a consumer via call center representative and described the occurrence of fever in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included paracetamol (Tylenol) unknown for fever.   On 22nd June 2021, the patient received the 1st dose of Shingrix (intramuscular). On 23rd June 2021 03:00, the patient started Tylenol at an unknown dose and frequency. In June 2021, 15 hrs after receiving Shingrix, the patient experienced heart racing and hives. On 22nd June 2021, the patient experienced fever. The patient was treated with benadryl (nos) (Benadryl). The action taken with Tylenol was unknown. On an unknown date, the outcome of the fever, heart racing and hives were recovered/resolved.   It was unknown if the reporter considered the fever, heart racing and hives to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. The patient received the 1st dose of Shingrix and 7 hours later developed a fever (99 degree F), she took Tylenol by 3 am and 15 hours later her fever went up to 102.6 degree F, and her heart was racing.  Within 24 hours the fever was gone, but then 24 hours after vaccination, she noticed hives on her chest, throat and arms and on inside area of elbows.  Health care professional suggested Benadryl and the hives went away the next day. The patient was referred to her health care professional. It was unknown if the reporter considered the fever, heart racing and hives to be related to Tylenol. The patient did not want to disclose any more personal information. The reporter did not consent to follow-up.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose on 8/14/2021 given earlier after dose 1 on 7/24/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 14th August 2021, the patient received the 2nd dose of Shingrix. On 14th August 2021, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: On 24th July 2021, the patient received 1st dose of Shingrix with batch number 44dx9 and expiry date 28th October 2022. The patient received 2nd dose earlier than the recommended schedule, which led to shortening of vaccination schedule. The was patient not immunocompromised. No other details of the vaccine. The reporter consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: one of the vials was expired/ was administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA379A, expiry date 31st August 2021) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. An employee health nurse administered Menveo which got expired on 31st August 2021, which led to expired vaccine used. After the dose was given and the nurse went to complete the documentation, the nurse noticed that one of the vials was expired.  The nurse enquired to provide information regarding the effectiveness of the dose in this situation. The batch number of other Menveo vial was AMVA379A and expiry date July 2021. No additional information provided.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late Dose/did not taken 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received years ago).   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 reported as follows: The case was reported by the patient. The age at vaccination was not applicable for this report. The patient did not take 2nd dose of Shingrix till the time of reporting which led to incomplete course of vaccination. The patient called to see if he need to take 2nd vaccine or do he had to start over.  The patient could not answer most of the safety question due to getting vaccines years ago and he could not remember. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Social problem
Clinical narrative: first Shingrix vaccine in August of 2020, and then the pandemic hit; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in August 2020).   On an unknown date, 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 the case for herself. The age at vaccination is not applicable for this report. The patient did not received 2nd dose yet due to the pandemic hit and she got a letter from her pharmacy that the first dose was more than 2 to 6 months ago, which led to social problem. The patient is about to start Nucala in the coming weeks and questioned restarting the vaccine series since the first dose was more than 6 months ago. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Discomfort, Ear pain, Headache, Ocular hyperaemia
Clinical narrative: Discomfort; Had severe pain all over her body; pain on head; pain on scalp; pain in ear; redness in left eye; difficulty seeing; sensitive to light (photosensitive); blisters on face; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 9ZJ25, expiry date 23rd January 2023) for prophylaxis.   Concurrent medical conditions included multiple sclerosis and rheumatoid arthritis (which treated with Methotrexate).   On 20th August 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In August 2021, less than 3 weeks after receiving Shingrix, the patient experienced blister. On 20th August 2021, the patient experienced general body pain, headache, scalp pain, ear pain, eye red, visual impairment and photosensitivity. On 23rd August 2021, the patient experienced discomfort. The patient was treated with paracetamol (Tylenol) and non-drug therapy (Ice Pack (No Medication)). On 21st August 2021, the outcome of the eye red was recovered/resolved. On 27th August 2021, the outcome of the general body pain was recovered/resolved. On an unknown date, the outcome of the headache, scalp pain, ear pain, visual impairment, photosensitivity and blister were recovered/resolved and the outcome of the discomfort was recovering/resolving.   It was unknown if the reporter considered the general body pain, headache, scalp pain, ear pain, eye red, visual impairment, photosensitivity, blister and discomfort to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient herself. The patient had reported these adverse events to the CDC, her pharmacy, her doctor, State Health Department, County Health Department and the Immunization Division for her state. The patient received a dose of Shingrix and she felt fine for first hours after the vaccine then she had severe pain all over her body for approximately 7 days, the pain on her head and scalp was all over head and scalp but also, a plum sized circle of pain over her left ear, like a circle of gunshots that moved from over her ear to the top of her head to the back of her head, had redness in her left eye and went away on the first night, had difficulty seeing for a couple days, was sensitive to light which resolved within 4 days and had blisters on the lower part of her face which resolved within 5 days. The patient called an Urgent Care office about 3 days after the vaccine and they recommended Tylenol by mouth and Ice packs for her discomfort, which she said did help. Medicine of doctor had cancelled the 2nd dose of her vaccine. The reporter consented to follow-up with herself and with her doctor.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain of skin, Photosensitivity reaction, Visual impairment
Clinical narrative: Discomfort; Had severe pain all over her body; pain on head; pain on scalp; pain in ear; redness in left eye; difficulty seeing; sensitive to light (photosensitive); blisters on face; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 9ZJ25, expiry date 23rd January 2023) for prophylaxis.   Concurrent medical conditions included multiple sclerosis and rheumatoid arthritis (which treated with Methotrexate).   On 20th August 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In August 2021, less than 3 weeks after receiving Shingrix, the patient experienced blister. On 20th August 2021, the patient experienced general body pain, headache, scalp pain, ear pain, eye red, visual impairment and photosensitivity. On 23rd August 2021, the patient experienced discomfort. The patient was treated with paracetamol (Tylenol) and non-drug therapy (Ice Pack (No Medication)). On 21st August 2021, the outcome of the eye red was recovered/resolved. On 27th August 2021, the outcome of the general body pain was recovered/resolved. On an unknown date, the outcome of the headache, scalp pain, ear pain, visual impairment, photosensitivity and blister were recovered/resolved and the outcome of the discomfort was recovering/resolving.   It was unknown if the reporter considered the general body pain, headache, scalp pain, ear pain, eye red, visual impairment, photosensitivity, blister and discomfort to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient herself. The patient had reported these adverse events to the CDC, her pharmacy, her doctor, State Health Department, County Health Department and the Immunization Division for her state. The patient received a dose of Shingrix and she felt fine for first hours after the vaccine then she had severe pain all over her body for approximately 7 days, the pain on her head and scalp was all over head and scalp but also, a plum sized circle of pain over her left ear, like a circle of gunshots that moved from over her ear to the top of her head to the back of her head, had redness in her left eye and went away on the first night, had difficulty seeing for a couple days, was sensitive to light which resolved within 4 days and had blisters on the lower part of her face which resolved within 5 days. The patient called an Urgent Care office about 3 days after the vaccine and they recommended Tylenol by mouth and Ice packs for her discomfort, which she said did help. Medicine of doctor had cancelled the 2nd dose of her vaccine. The reporter consented to follow-up with herself and with her doctor.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis contact, Herpes zoster, Rash, Urticaria
Clinical narrative: ER said is either shingles/possible shingles; Facial rash; Hive at the end of her right eye; possible poison ivy; This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2021, the patient received the 1st dose of Shingrix (intramuscular). In June 2021, less than 3 months after receiving Shingrix, the patient experienced shingles, rash, hives and poison ivy rash. On an unknown date, the outcome of the shingles and poison ivy rash were unknown and the outcome of the rash and hives were not recovered/not resolved.   It was unknown if the reporter considered the shingles, rash, hives and poison ivy rash to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The patient received 1st dose of Shingrix 10 weeks ago from the date of reporting. The patient asked was this a live virus vaccine, could the patient get shingles from it. The patient recently broke out in a rash on the right side of her face and had a hive at the end of her right eye.  The patient went to urgent care and was diagnosed with, shingles or poison ivy, one healthcare professional stated it might be shingles and another healthcare professional said it might be poison ivy. The patient states she did not believe it was shingles. Emergency room visit required. The reporter did not consent to follow-up. No other information provided.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Breast pain, Contusion, Peripheral swelling
Clinical narrative: armpit swollen; big bruise on left breast; armpit painful; painful bruise on breast; This case was reported by a consumer via call center representative and described the occurrence of local swelling in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th August 2021, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced local swelling, contusion of breast, axillary pain and breast pain. On an unknown date, the outcome of the local swelling, contusion of breast, axillary pain and breast pain were not recovered/not resolved.   The reporter considered the local swelling, contusion of breast, axillary pain and breast pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by the consumer for herself. The patient's concomitant medications included unspecified other medications. The patient received Shingirx in left deltoid.  She states that her left armpit swelled up really bad and she developed a big bruise on her left breast.  The patient said her both the armpit and the breast were painful though the breast was not as painful as it was.  The patient did not have the lot number/expiration date of the shot but provided her pharmacy contact information who should have that on file.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 11Sep2020, never returned for second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 11th September 2020 with batch number 22ND2 and expiry date 16th September 2022).   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 patient received 1st dose of Shingrix and never returned for second dose. Till the time of reporting, the patient did not receive the 2nd dose of the vaccine, which led to incomplete course of vaccination. VAERS details reported for 1st dose of Shingrix. The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Shingrix three doses; This case was reported by a pharmacist via and described the occurrence of extra dose administered in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number BM27F, expiry date 14th November 2022) for prophylaxis.   Previously administered products included Shingrix (received 2 doses on an unknown date).   On 7th September 2021, the patient received the 3rd dose of Shingrix. On 7th September 2021, 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 are as follows: The patient received 3rd dose of Shingrix, which led to extra dose administered. The reporter did not consented to follow-up.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: dose one years ago, dose two months ago; This case was reported by a pharmacist and described the occurrence of drug dose administration interval too long in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number PK5B921, expiry date 15th November 2021) for prophylaxis.   Previously administered products included Shingrix (1st dose received 3 years ago).   On 24th June 2021, the patient received the 2nd dose of Shingrix. On 24th June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided are as follows: The patient received 2nd dose of Shingrix (a few months ago) later than the recommended interval, which led to lengthening of vaccination schedule. The reporter did not had administration date, lot number or expiration date for 1st dose of Shingrix. The reporter consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose over a year ago, late second dose; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose years ago via intramuscular on unknown deltoid).   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 provided were as follows: The case was reported by patient himself. Age at vaccination was not applicable for this report. Till the time of reporting patient did not received the 2nd dose of Shingrix which led to incomplete course of vaccination but was planning to get the second dose. Patient declined to provide any demographic information. Reporter did not consented to follow-up.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue
Clinical narrative: chills; achy joints; tired; This case was reported by a consumer and described the occurrence of chills in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th September 2021, the patient received the 1st dose of Shingrix (intramuscular). On 7th September 2021, 5 hrs after receiving Shingrix, the patient experienced chills, joint pain and tiredness. On an unknown date, the outcome of the chills, joint pain and tiredness were recovered/resolved.   It was unknown if the reporter considered the chills, joint pain and tiredness to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient's wife. The patient received a dose of Shingrix in right arm and had chills, achy joints and being tired. Since all the symptoms were recovered. The patient was referred to health care professional. Medical information number was provided. The reporter consented to follow-up. The case was linked with case US2021192878 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021192878:same reporter
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Peripheral swelling, Pruritus, Rash erythematous, Tenderness
Clinical narrative: swelling in the arm; tenderness; Moderna red rash\started experiencing a red rash on my arm; soreness; still experiencing pain at the injection site.; redness at the injection site that was about 2 inch big,redness at the injection site that got bigger about 4 inch; iitching on hand ,tching on arm,itching on leg,itching on foot; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in the arm), TENDERNESS (tenderness), PRURITUS (iitching on hand ,tching on arm,itching on leg,itching on foot), RASH ERYTHEMATOUS (Moderna red rash\started experiencing a red rash on my arm) and VACCINATION SITE ERYTHEMA (redness at the injection site that was about 2 inch big,redness at the injection site that got bigger about 4 inch) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The medical history was not provided by the reporter.  Concomitant products included IBUPROFEN for Headache, PARACETAMOL (TYLENOL) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced PRURITUS (iitching on hand ,tching on arm,itching on leg,itching on foot) and VACCINATION SITE ERYTHEMA (redness at the injection site that was about 2 inch big,redness at the injection site that got bigger about 4 inch). On an unknown date, the patient experienced PERIPHERAL SWELLING (swelling in the arm), TENDERNESS (tenderness), RASH ERYTHEMATOUS (Moderna red rash\started experiencing a red rash on my arm), MYALGIA (soreness) and VACCINATION SITE PAIN (still experiencing pain at the injection site.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Itching, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (swelling in the arm), TENDERNESS (tenderness), MYALGIA (soreness) and VACCINATION SITE PAIN (still experiencing pain at the injection site.) had not resolved, PRURITUS (iitching on hand ,tching on arm,itching on leg,itching on foot) and VACCINATION SITE ERYTHEMA (redness at the injection site that was about 2 inch big,redness at the injection site that got bigger about 4 inch) had resolved and RASH ERYTHEMATOUS (Moderna red rash\started experiencing a red rash on my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment includes ice patch patient states that she was scheduled to receive her second vaccine on 08Sept2021 and does not know if she should based on the symptoms that she experienced with the first.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Event outcome & additional event is added
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: swelling in the arm; tenderness; Moderna red rash\started experiencing a red rash on my arm; soreness; still experiencing pain at the injection site.; redness at the injection site that was about 2 inch big,redness at the injection site that got bigger about 4 inch; iitching on hand ,tching on arm,itching on leg,itching on foot; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in the arm), TENDERNESS (tenderness), PRURITUS (iitching on hand ,tching on arm,itching on leg,itching on foot), RASH ERYTHEMATOUS (Moderna red rash\started experiencing a red rash on my arm) and VACCINATION SITE ERYTHEMA (redness at the injection site that was about 2 inch big,redness at the injection site that got bigger about 4 inch) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The medical history was not provided by the reporter.  Concomitant products included IBUPROFEN for Headache, PARACETAMOL (TYLENOL) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced PRURITUS (iitching on hand ,tching on arm,itching on leg,itching on foot) and VACCINATION SITE ERYTHEMA (redness at the injection site that was about 2 inch big,redness at the injection site that got bigger about 4 inch). On an unknown date, the patient experienced PERIPHERAL SWELLING (swelling in the arm), TENDERNESS (tenderness), RASH ERYTHEMATOUS (Moderna red rash\started experiencing a red rash on my arm), MYALGIA (soreness) and VACCINATION SITE PAIN (still experiencing pain at the injection site.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Itching, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (swelling in the arm), TENDERNESS (tenderness), MYALGIA (soreness) and VACCINATION SITE PAIN (still experiencing pain at the injection site.) had not resolved, PRURITUS (iitching on hand ,tching on arm,itching on leg,itching on foot) and VACCINATION SITE ERYTHEMA (redness at the injection site that was about 2 inch big,redness at the injection site that got bigger about 4 inch) had resolved and RASH ERYTHEMATOUS (Moderna red rash\started experiencing a red rash on my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment includes ice patch patient states that she was scheduled to receive her second vaccine on 08Sept2021 and does not know if she should based on the symptoms that she experienced with the first.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Event outcome & additional event is added
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction, Myocardial infarction, Visual impairment
Clinical narrative: HEART ATTACK; BIT OF GLARE IN  EYESIGHT; RAPID AND EXTREME SIDE EFFECTS; This spontaneous report received from a patient of 4 decade old, of unspecified sex and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: pre multiple sclerosis symptoms. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN)1 total was administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  The patient reported that on an unspecified date, the patient experienced the largest heart attack ever(shooting pain to back and the very intense tingling in arm), bit of glare in eyesight and rapid and extreme side effects.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart attack, shooting pain to my back, tingling in my arm/arm felt like taken bullet, bit of glare in my eyesight, rapid and extreme side effects was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: V0: 20210910814-Covid-19 Vaccine Ad26.Cov2.S- Heart attack. 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).
Sex: F
Vaccine: COVID19
Symptoms: Brain injury, Cardiac disorder, Guillain-Barre syndrome, Magnetic resonance imaging head, Magnetic resonance imaging heart
Clinical narrative: GUILLAIN BARRE SYNDROME; BRAIN DAMAGE; HEART DAMAGE; This spontaneous report received from a consumer concerned a 48 year old female of unspecified race and ethnic origin The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported,1 total, administered on an unspecified date in APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On unspecified date in JUN-2021, the patient was hospitalized (number of days hospitalized was unspecified) and diagnosed with Guillain barre syndrome, the magnetic resonance imaging indicated brain and heart damage (date unspecified), she could not stand, inability to walk, had limited feeling below knees and no feeling in her fingertips. She was in rehab until last week and had regained ability to walk in rehab. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart damage, brain damage and guillain barre syndrome was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210915626-covid-19 vaccine ad26.cov2.s- brain damage, heart damage. 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).  20210915626-covid-19 vaccine ad26.cov2.s-Guillain Barre syndrome. This event(s) is labeled per RA and is therefore considered potentially related.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE DUE TO TEMPERATURE EXCURSION; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a 34 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, and expiry: 02-OCT-2021) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-JUN-2021, the patient experienced out of specification product use. On an unspecified date, the patient experienced administration of expired vaccine due to temperature excursion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine due to temperature excursion and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915719, 20210915623, 20210915661, 20210916907, 20210917163, 20210916553, 20210916768, 20210917515, 20210917226, 20210916697, 20210916910, 20210915852, 20210915646, 20210916965, 20210916658, 20210916300, 20210916584, 20210916811 and 20210918425.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Injection site pain, SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: INJECTION SITE PAIN FOR 2 WEEKS; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 7 decade old, male. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, and heart issues, and patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on left arm on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  After receiving the vaccine on MAR-2021, on an unspecified date the patient experienced injection site pain for 2 weeks. Patient went to his physician and had routine blood work due to his history of diabetes and heart issues. On AUG-2021 physician called and told patient that he tested negative for COVID-19 antibody test (confirmed immunological vaccine failure) and needed to get the COVID vaccine. When patient told physician that he had in March, physician told it looked like patient had no vaccine and no protection. Patient was concerned as was going on a cruise soon. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000192884.; Sender's Comments: V0: 20210918278-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: PARTIAL DOSE ADMINISTERED; This spontaneous report received from a consumer concerned a 22 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced partial dose administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose administered was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SEVERE REACTION; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 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 severe reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe reaction was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Headache, Hyperhidrosis, Nausea
Clinical narrative: FEELING DIZZY/LIGHT HEADED/FEELING GOING TO PASS OUT; SWEATY HANDS; SHORTNESS OF BREATH; NAUSEA THAT COMES AND GOES IN WAVES; HEADACHE THAT COMES AND GOES IN WAVES; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included: lyme disease, and concurrent conditions included: thyroid, non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 04321A, expiry: UNKNOWN) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-SEP-2021, the patient experienced nausea that comes and goes in waves. On 03-SEP-2021, the patient experienced headache that comes and goes in waves. On 11-SEP-2021, the patient experienced feeling dizzy/light headed/feeling going to pass out. On 11-SEP-2021, the patient experienced sweaty hands. On 11-SEP-2021, the patient experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache that comes and goes in waves, nausea that comes and goes in waves, feeling dizzy/light headed/feeling going to pass out, sweaty hands and shortness of breath was not reported. This report was non-serious.