chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the 2 shot vaccine / shingles/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.   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. 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 reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient had the shingles vaccine and got the shingles. The patient stated it did not do him/her any good to get vaccinated and he/she got shingles anyway. 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 shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: I had both shingles shots. I still get shingles/ suspected Vaccination Failure; I still get shingles, not bad, but I do break out in the same place every time.; 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.   The patient's past medical history included shingles.   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 reported as follows: This case was reported by patient for himself/herself. The age at vaccination was not reported. The patient had both shingles shots and still got shingles, not bad, but it broke out in the same place every time. 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 confirmation for shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: HAD THE SHOT AND STILL GOT THEM/Suspected Vaccination Failure; HAD THE SHOT AND STILL GOT THEM; 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 reported as follows: This case was reported by patient for himself/herself. The age at vaccination was not reported. The patient had the shot and still got shingles.  The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the shot and still had the shingles/ Suspected Vaccination Failure; I had the shot and still had the 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 reported as follows: This case was reported by patient for himself/herself. The age at vaccination was not reported. The reported had the shot and still had the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination Failure; had the shots and I still 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 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. 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 case was reported by patient himself or herself. The age at vaccination was not reported. The patient had the shots and still got shingles.  The patient's doctor said it was mild case because the patient had the shots. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Illness, Vaccine positive rechallenge
Clinical narrative: so sick; was that awful; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of illness (received 1st dose on an unknown date and experienced illness and felt awful, refer case US2021AMR176096).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness and feeling bad. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness and feeling bad were unknown.   It was unknown if the reporter considered the sickness and feeling bad to be related to 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 received 2nd shot and was so sick and experienced severe side effects. The patient said he/she would not do that again. The patient said he/she would never had taken the shots if his/her body would react, it was awful.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR176096:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Genital herpes
Clinical narrative: Genital herpes outbreaks; Increased genital herpes outbreaks after both doses; This case was reported by a nurse via call center representative and described the occurrence of genital herpes in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included genital herpes.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced genital herpes and condition aggravated. On an unknown date, the outcome of the genital herpes and condition aggravated were recovered/resolved.   It was unknown if the reporter considered the genital herpes and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient felt increased genital herpes outbreaks after receiving the dose of Shingrix vaccine. The reporter was unable to provide. Adverse event information other than gender. The reporter consented to follow up. For the tolerance of 2nd dose, refer case US2021AMR176145, reported by the same reporter. The case is linked to the case US2021AMR177309 and US2021AMR177313 reported by the same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR176145:Same reporter. US-GLAXOSMITHKLINE-US2021AMR177309:Same reporter. Pt2 - 1st dose. US-GLAXOSMITHKLINE-US2021AMR177313:Same reporter. Pt2 - 2nd dose.
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Genital herpes, Vaccine positive rechallenge
Clinical narrative: Genital herpes outbreaks; Increased genital herpes outbreaks after both doses; This case was reported by a nurse via call center representative and described the occurrence of genital herpes in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of genital herpes (1st dose received on an unknown date and experienced increased genital herpes outbreaks). Concurrent medical conditions included genital herpes.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced genital herpes and condition aggravated. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the genital herpes and condition aggravated were unknown.   It was unknown if the reporter considered the genital herpes and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that, the patient experienced increased genital herpes outbreaks after receiving the dose of Shingrix vaccine. The reporter did not have any other information except patient's gender. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR176130:Same reporter. US-GLAXOSMITHKLINE-US2021AMR177309:Same reporter. Pt2 - 1st dose. US-GLAXOSMITHKLINE-US2021AMR177313:Same reporter. Pt2 - 2nd dose.
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 patient himself or herself. The age at vaccination was not reported. The patient stated that the he/she received shingles shot and experienced shingles 2 times. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset 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, 3 years 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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient got the shingle shot and 3 years later now had shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; still got it; 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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient got the shingle shot and still got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; shingles on my forehead / shingles over my eye visits to eye Dr, to make sure it did not get into eye/ Shingles shot gave me 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.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient got the shingle shot and then a little small amount of the shingles on the forehead over the eye.  The patient visited the eye doctor to make sure it did not get into eye. The patient stated that shingles shot gave him/ her shingles, and to not listen to this add. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the shot and I got the shingles 2 times/suspected vaccination failure; shingles 2 times; 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 reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient said well, she/he had the Shingles shot and got the Shingles 2 times in a year. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: my husband had both vaccines, but he came down with the shingles/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 male 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. 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 reported as follows: This case was reported by the wife for his husband. The age at vaccination was not reported. The reporter stated that her husband had both shingles vaccine, but he came down with the shingles. The reporter also stated that the doctor said the vaccine keeps you from getting a bad case of the shingles so beware. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Vaccination complication
Clinical narrative: reaction to the vaccine and almost lost his life. #GBS; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a male 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 guillain barre syndrome (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter's brother. The age at vaccination was not reported. The patient had a reaction to the shingles vaccine and almost lost his life. The reporter hash tagged Guillain Barre syndrome (GBS).
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: itching; Hives; This case was reported by a consumer via call center representative and described the occurrence of hives in a 18-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 13th August 2021, the patient received Boostrix (intramuscular) .5 ml. On 13th August 2021, less than a day after receiving Boostrix, the patient experienced hives. In August 2021, the patient experienced pruritus. The patient was treated with epinephrine (Epi Pen), steroids nos (Steroids) and hydroxyzine. On an unknown date, the outcome of the hives was recovered/resolved and the outcome of the pruritus was not recovered/not resolved.   It was unknown if the reporter considered the hives and pruritus to be related to Boostrix.  Additional details were reported as follows: The case was reported by the patient's father. The patient developed hives after receiving the Boostrix vaccine in left arm.  The patient went to the emergency department (ED) and was given an epi pen, steroids, and hydroxyzine. The majority of the hives all over her body went away 3 to 4 hours after the epi pen but still had itching on her face and hands. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Swollen tongue
Clinical narrative: tongue swelling; This case was reported by a physician via call center representative and described the occurrence of swollen tongue in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2021, the patient received the 1st dose of Shingrix. In August 2021, 3 hrs after receiving Shingrix, the patient experienced swollen tongue. On an unknown date, the outcome of the swollen tongue was recovered/resolved.   It was unknown if the reporter considered the swollen tongue to be related to Shingrix.  Additional details were reported as follows: Age at vaccination was not reported. Primary care physician reported that a patient got the 1st dose of Shingrix 1 or 2 days before from the date of reporting and 3 hours after the administration developed tongue swelling.  This event resolved with Benadryl gradually.  The patient had no hives, no lip swelling, no trouble breathing. No exact date of vaccination, lot number or expiration date provided since the vaccine was administered at a pharmacy.  The reporter did not consent to follow-up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Pain, Pyrexia
Clinical narrative: low-grade fever; Body aches; back ache; This case was reported by a consumer via call center representative and described the occurrence of fever in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   On 6th August 2021, the patient received the 1st dose of Shingrix. In August 2021, less than 2 weeks after receiving Shingrix, the patient experienced general body pain and back pain. On 18th August 2021, the patient experienced fever. On an unknown date, the outcome of the fever and general body pain were not recovered/not resolved and the outcome of the back pain was unknown.   It was unknown if the reporter considered the fever, general body pain and back pain to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The patient had past medical history of Rheumatoid Arthritis (RA).  The patient received 1st dose of Shingrix in the right deltoid and experienced side effects from the vaccine, which includes body aches and low-grade fever.  The reporter was unable to differentia l whether the body ache was coming from the vaccine or RA, but had back ache which was a different (new) location than usual location where she experiences aches due to RA.  The reporter was unsure whether the back ache was due to vaccine or RA. The patient also had a low-grade fever, which was experienced almost 2 weeks post the vaccination. The patient normal body temperature was 97-degree F and mentioned that she had fever (did not provide fever temperature).  However, she mentioned that her temperature had not crossed 100F. The body ache and fever were not completely resolved, and the severity had been the same from the day they experienced the side effects. The reporter consented to follow up.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: missed the third dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 23-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 (received first two doses on an unknown date in 2018).   On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, 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 pharmacist reported that, the patient missed the third dose of Twinrix. Till the time of reporting, the patient did not receive the third dose, which led to incomplete course of vaccination.  The reporter consented to follow up.
Age: 56.0
Sex: M
Vaccine: HEPA
Symptoms: Accidental underdose, Product administered to patient of inappropriate age
Clinical narrative: adult received first dose of Havrix pediatric formulation by error; adult received first dose of Havrix pediatric formulation; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 56-year-old male patient who received HAV (Havrix pediatric) (batch number 3HR79, expiry date 16th September 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th August 2021, the patient received the 1st dose of Havrix pediatric and Havrix Pre-Filled Syringe Device. On 20th August 2021, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were 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: Medical assistant reported that an adult patient received a dose of Havrix pediatric formulation by error, which led to accidental underdose and adult use of a child product. The reporter consented to follow up via email.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dysphagia, Headache, Pain in extremity, Rhinorrhoea
Clinical narrative: Was fine after my injection however next morning I got the normal side effects like sore arm runny nose and headache. However the headache has lasted five consecutive days, I find it hard to swallow and get hot and cold sweats. I don?t believe I was told symptoms could last more than 2 days and I?m in pain constantly
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Feeling abnormal, Muscular weakness
Clinical narrative: Tired and foggy 4 hrs after injection. Muscle aches and weakness next morning with back pain and joint pain
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Tired and foggy 4 hrs after injection. Muscle aches and weakness next morning with back pain and joint pain
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vision blurred
Clinical narrative: Severe Dizziness and blurred vision.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: The patient was scheduled for a second vaccine.  It was discovered after the administration of the Pfizer vaccine that the patient had initially received Johnson and Johnson as the first dose.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: Patient was scheduled for second dose.  patient was given pfizer vaccine and after was discovered patient had the J&J.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Neuralgia
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: pain (possible nerve pain) on the radial and ulnar nerve on the left arm.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: patient recieved vaccine on Friday 08/20, patients mother called on Tuesday 08/24, stating her son had a rash on torso that started on monday 08/21, no other symptoms present. patients mother gave him diphenhydramine and cortisone cream. relation to covid vaccine cannot be ruled out.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Lethargy, Pain
Clinical narrative: Body aches, lethargy, joint pain at 14 hours after dose 2. Fever, pain, chills, goosebumps, lethargy, weakness continued to worsen until approximately hour 36.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Piloerection, Pyrexia
Clinical narrative: Body aches, lethargy, joint pain at 14 hours after dose 2. Fever, pain, chills, goosebumps, lethargy, weakness continued to worsen until approximately hour 36.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Asthenia, Chills, Decreased appetite
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Abdominal Pain-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: appetite loss-Medium, Systemic: Weakness-Medium, Additional Details: Pt's husband reported on 8/24/21 pt was still feeling unwell from shot, ( achy, tired, GI upset , appetite loss). Rph advised pt to eat more even if not hungry, take ibuprofen for pain if needed and to advise with MD if symptoms do not subside or get worse.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Lethargy, Malaise, Pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Abdominal Pain-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: appetite loss-Medium, Systemic: Weakness-Medium, Additional Details: Pt's husband reported on 8/24/21 pt was still feeling unwell from shot, ( achy, tired, GI upset , appetite loss). Rph advised pt to eat more even if not hungry, take ibuprofen for pain if needed and to advise with MD if symptoms do not subside or get worse.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation, Hypoaesthesia, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Systemic: Described as electrical feeling in left side of brain-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Second day after receiving vaccination, pt stated having a localized rash and itching at injection site area. On day 3, pt stated electrical feeling in left side of brain, was instructed to follow up with md to assess
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: GUILLIAN BARRE SYNDROME; This spontaneous report received from a consumer concerned 100 patients of unspecified age, sex, race and ethnicity. 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, start therapy date were not reported, 1 total administered 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 Guillain Barre syndrome. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Guillain Barre syndrome was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 : This spontaneous report was received from a consumer and concerned 100 people who experienced Guillain Barre syndrome (GBS) an unspecified period of time after receiving the Janssen Covid-19 vaccine. Medical history and concomitant medications were not reported. No other additional details regarding symptoms, diagnostics, treatment, or outcome were provided. Information is limited in this case, and the occurrence of GBS could represent background incidence of such events in the general population. Therefore, the relationship of GBS to vaccination is considered unclassifiable due to insufficient information. Additional information will be requested.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINATION FAILURE; INAPPROPRIATE DOSE OF VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a female 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 not reported, batch number: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient received the vaccine and noticed some drip down her arm and was concerned that she did not receive the full dose (inappropriate dose of vaccine administered). On an unspecified date the patient had an antibody test (COVID-19 antibody test) which showed negative for antibodies (suspected immunological vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected immunological vaccination failure and inappropriate dose of vaccine administered was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint 90000190571.; Sender's Comments: V0.20210845363-covid-19 vaccine ad26.cov2.s -suspected immunological vaccination failure . This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient via a company representative concerned a 58 year old male unspecified race and ethnicity. 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 was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 19-AUG-2021 07:20, the patient underwent blood test (COVID-19 Antibody Test, Semi-Quantitative) to determine the level of antibodies. Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) less than 1.00 (Negative) (confirmed immunological vaccine failure) which means there were no detectible antibodies in patient. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210846558- covid-19 vaccine ad26.cov2.s-CONFIRMED IMMUNOLOGICAL VACCINE FAILURE . This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: CHILLS; HEADACHE; FEVER; This spontaneous report received from a consumer via a company representative concerned a 23 year old female. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced chills, headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, headache and fever was not reported. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINE FAILURE; SUSPECTED COVID-19 INFECTION; MILD LETHARGY; This spontaneous report received from a patient concerned a 66 year old male. Initial information was processed along with the additional information received on 24-AUG-2021. 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: not reported, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date in MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in MAR-2021, patient experienced mild symptoms such as headache, loss of taste (lasted longer) (suspected covid-19 infection), also experienced lethargy. On an unspecified date in APR-2021 (few days after Easter Sunday), the patient was tested positive for coronavirus disease (COVID-19) (suspected clinical vaccine failure). Patient was unsure which test was used for positive result. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and mild lethargy, and the outcome of suspected clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210846583. This report was associated with product quality complaint: 90000190822.; Sender's Comments: V0: 20210846926-Covid-19 vaccine ad26.cov2.-Suspected Clinical Vaccine Failure . This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Injection site pain, Intervertebral disc protrusion, Magnetic resonance imaging, Nerve compression, Pain in extremity
Clinical narrative: PINCHED NERVE; INTERVERTEBRAL DISC BULGING; VACCINATION SITE PAIN; INJECTION SITE PAIN; PAIN IN ARM; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight was 120 pounds, and height was 162.56 centimeters. The patient's past medical history included: neck surgery, bulging disc/disc problems, and tobacco user, and concurrent conditions included: pain, abstains from alcohol, osteoporosis, borderline diabetes, arthritis, penicillin allergy, and unknown antibiotic allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 24-MAY-2021 for covid-19 vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (solution for injection in pre-filled syringe, subcutaneous, batch number was not reported) 150 mg, 1 time every 12 weeks, therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On 2021, Laboratory data included: Magnetic resonance imaging (NR: not provided) Not provided. On 24-MAY-2021, the patient experienced pain in arm. On an unspecified date, the patient experienced pinched nerve, intervertebral disc bulging, vaccination site pain, and injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of risankizumab was not changed. The patient recovered from pain in arm on 27-MAY-2021, and vaccination site pain, and injection site pain, had not recovered from pinched nerve, and the outcome of intervertebral disc bulging was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: PINCHED NERVE; INTERVERTEBRAL DISC BULGING; VACCINATION SITE PAIN; INJECTION SITE PAIN; PAIN IN ARM; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight was 120 pounds, and height was 162.56 centimeters. The patient's past medical history included: neck surgery, bulging disc/disc problems, and tobacco user, and concurrent conditions included: pain, abstains from alcohol, osteoporosis, borderline diabetes, arthritis, penicillin allergy, and unknown antibiotic allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 24-MAY-2021 for covid-19 vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (solution for injection in pre-filled syringe, subcutaneous, batch number was not reported) 150 mg, 1 time every 12 weeks, therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On 2021, Laboratory data included: Magnetic resonance imaging (NR: not provided) Not provided. On 24-MAY-2021, the patient experienced pain in arm. On an unspecified date, the patient experienced pinched nerve, intervertebral disc bulging, vaccination site pain, and injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of risankizumab was not changed. The patient recovered from pain in arm on 27-MAY-2021, and vaccination site pain, and injection site pain, had not recovered from pinched nerve, and the outcome of intervertebral disc bulging was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: SWOLLEN LEGS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 MAY-2021, the patient experienced swollen legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen legs. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Vaccine administered after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no treatment medication provided. no concomitant medication provided. 02Apr2021 that they had power outage on 02Apr2021 and vials were in Freezer and Refrigerator where Temperature dropped to : Frozen Vaccine 47Minutes -13.79 C Refrigerator 59 Minutes 12 C and effected vials are: Lot no 003B21A, 100 doses Lot no 027B21A 100 doses Lot no 030B21A 100 doses Lot No 02B21A 140 doses HCP said that 63 doses were administered to 63 Patients. She provided all requested information of patients who received the effected Vaccine.