chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Heart rate increased, Palpitations
Clinical narrative: About three days after my second does, my heart was pounding, beating rapidly and was fluttering. This happened mostly at night when I was trying to go to bed. It lasted for about three weeks. It was very scary, but I did not report it at the time.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antibody test, Blood test abnormal, Heart rate increased, Hyperthyroidism, Insomnia
Clinical narrative: On April 16TH admitted to hospital for high heart rate, blood tests done and found out  thyroid was very high a problem I had never had. Sent home  with endocrinologist referral.  April 18th went to hospital heart rate over 200bpm, unable to sleep all weekend,  lost 10 lbs. Dr stated again thyroid off charts given metoprolol via IV and script for it.  Diagnosis hyperythyroid.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thyroid function test abnormal, Weight decreased
Clinical narrative: On April 16TH admitted to hospital for high heart rate, blood tests done and found out  thyroid was very high a problem I had never had. Sent home  with endocrinologist referral.  April 18th went to hospital heart rate over 200bpm, unable to sleep all weekend,  lost 10 lbs. Dr stated again thyroid off charts given metoprolol via IV and script for it.  Diagnosis hyperythyroid.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Condition aggravated, Fatigue, General physical condition abnormal, Malaise
Clinical narrative: Fever Sore arm Fatigue General malaise Asthma triggered Body aches
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever Sore arm Fatigue General malaise Asthma triggered Body aches
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Patient reports on 8/27/21 itching to the right upper arm and warm to touch. 9/4/21 Patient noticed arm itching, erythema and redness.  Patient denies any fever or any other symptoms. Patient denies taking any new medication or any other medication in the right arm.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Hypotension, Injection site pain, Presyncope
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: near syncope-Medium, Systemic: Hypotension-Medium, Systemic: Weakness-Medium
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Headache, Muscle spasms, Pain in extremity
Clinical narrative: Severe leg pain and joint; lower back is absolutely hurting bad; Headache; joint pain; spasm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Severe leg pain and joint), BACK PAIN (lower back is absolutely hurting bad), HEADACHE (Headache), ARTHRALGIA (joint pain) and MUSCLE SPASMS (spasm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Severe leg pain and joint), BACK PAIN (lower back is absolutely hurting bad), HEADACHE (Headache), ARTHRALGIA (joint pain) and MUSCLE SPASMS (spasm). At the time of the report, PAIN IN EXTREMITY (Severe leg pain and joint), BACK PAIN (lower back is absolutely hurting bad), ARTHRALGIA (joint pain) and MUSCLE SPASMS (spasm) was resolving and HEADACHE (Headache) outcome was unknown.            Relevant concomitant medications were not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Aug-2021: Additional information included new events.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia, Tremor
Clinical narrative: severe arm pain; shaking; Fever not reduced with TylenolAdvil; Severe chills and chills in spine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe arm pain), TREMOR (shaking), PYREXIA (Fever not reduced with TylenolAdvil) and CHILLS (Severe chills and chills in spine) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     The patient's past medical history included Colon operation (Colonic interposition). Concurrent medical conditions included Achalasia (Immunosupressed "Colonic interposition" for achalasia: 15/16 previous surgeries) and Iodine allergy.    On 20-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Aug-2021, the patient experienced PAIN IN EXTREMITY (severe arm pain), TREMOR (shaking), PYREXIA (Fever not reduced with TylenolAdvil) and CHILLS (Severe chills and chills in spine). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (severe arm pain), TREMOR (shaking), PYREXIA (Fever not reduced with TylenolAdvil) and CHILLS (Severe chills and chills in spine) had not resolved.            No concomitant medications was reported. The dose of the vaccine was 0.5 milliliter.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vaccination complication
Clinical narrative: Report a side effect; Started getting dizziness/ dizziness all day; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Started getting dizziness/ dizziness all day) and VACCINATION COMPLICATION (Report a side effect) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002f21a) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Started getting dizziness/ dizziness all day). On an unknown date, the patient experienced VACCINATION COMPLICATION (Report a side effect). At the time of the report, DIZZINESS (Started getting dizziness/ dizziness all day) had not resolved and VACCINATION COMPLICATION (Report a side effect) outcome was unknown.            No concomitant medications were provided. Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Aug-2021: Follow-up received on 22-AUG-2021 contains significant follow-up: Adverse event were added
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE; improperly stored temperature excursion vaccine administered; This spontaneous has been received from a medical assistant, concerning a 11 years old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medication were not reported.  On 14-JUL-2021, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # T026324 has been verified to be valid, expiration date reported as 22-FEB-2023; strength, dose and route was not provided) for prophylaxis. The temperature of excursion was 19.7 Celsius degree for 7 hours. No previous temperature excursion or digital logger involved. No additional adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026324; expirationdate: 22-FEB-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE or PQC reported; temperature excursion and was administered; This spontaneous report as received from a registered nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On an unknown date in August 2021, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength was not reported, 1 time dose, lot# 1707487, expiration date: 23-MAR-2022) orally for prophylaxis.  It was reported that, on 25-AUG-2021, the suspect vaccine was exposed to a temperature of  50.5 Fahrenheit (F) for a time frame of 1 hour. No digital data logger was reported. There were no previous temperature excursions. No other adverse event (AE) information was provided. It was also reported that Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot# T012806, expiration date: 14-APR-2022; lot# T016198, expiration date: 11-MAY-2022) was involved in the temperature excursion, but not administrated.   This is one of the two report from the same reporter.; Sender's Comments:  US-009507513-2108USA007439:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE or PQC reported; temperature excursion and was administered; This spontaneous report as received from a registered nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On an unknown date in August 2021, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength was not reported, 1 time dose, lot# 1707487, expiration date: 23-MAR-2022) orally for prophylaxis.  It was reported that, on 25-AUG-2021, the suspect vaccine was exposed to a temperature of 50.5 Fahrenheit (F) for a time frame of 1 hour. No digital data logger was reported. There were no previous temperature excursions. No other adverse event (AE) information was provided. It was also reported that Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot# T012806, expiration date: 14-APR-2022; lot# T016198, expiration date: 11-MAY-2022) was involved in the temperature excursion, but was not administrated.  This is one of the two report from the same reporter.; Sender's Comments:  US-009507513-2108USA007369:
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: sick; 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.   On 24th August 2021, the patient received Shingles vaccine. In August 2021, less than a week after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was not recovered/not resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The patient had received 'booster' for Shingles two days ago and feeling sick right now, it's a good thing to get vaccine. The reporter probably would have had an extreme case if he/she actually gotten through it. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: singles; This case was reported by a consumer via  interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided are as follows: The case reported by patient for himself/herself. Age at vaccination was not reported. The patient received a dose of Shingles vaccine and got shingles within 24 hours after vaccination. Shingles were ultimately cured with home remedies within six months. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction
Clinical narrative: shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (have had chicken pox).   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   The reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient reported that, he/she had the Shingles shot and immediately got shingles not really, it gave him/her shingles immediately.  The patient reported that, the vaccine gave him/her shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Disability, Laboratory test normal, Movement disorder, Pain, Rheumatoid factor negative
Clinical narrative: I'm still crippled up I can't make a fist with my right or left hand; Excruciating pain; This case was reported by a consumer via media and described the occurrence of movement disorder in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In December 2020, the patient received Shingles vaccine. On an unknown date, less than 9 months after receiving Shingles vaccine, the patient experienced movement disorder (serious criteria disability) and pain. On an unknown date, the outcome of the movement disorder and pain were not recovered/not resolved.   It was unknown if the reporter considered the movement disorder and pain 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. The patient was still crippled up at the time of reporting. The patient could not make a fist with right or left hand and had excruciating pain. The patient had all the symptoms of rheumatoid arthritis but had been tested and had not rheumatoid arthritis. The same symptoms were equal to that of heavy metal poisoning which he/she was tested for and there was no sign of the poisoning. The patient stated that, what the heck did the shingles vaccination do for him/her. The patient filed a complaint with the CDC and had not heard back from anyone till the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; I get them; Have had 3 shingle shots; 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 and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient received 3 doses of Shingles vaccine, which led to extra dose administered. After receiving Shingles vaccine, the patient got shingles. The patient stated that Shingles vaccine did not help. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation of shingles were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; Rash; Hurting; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and pain. The patient was treated with acetic acid (White Vinegar). On an unknown date, the outcome of the vaccination failure, shingles, rash and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, rash and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter's mother. The age at vaccination was not reported. Couple of months after receiving Shingles vaccine, the patient got shingles. The reporter stated that spray rash with white vinegar and it really did make it stopped hurting. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory confirmation were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: I had two shots and had 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.   The patient's past medical history included shingles (had in 1978). Concurrent medical conditions included diabetes.   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 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 and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had 2 Shingles shots and had shingles twice, in 1978 and at the time of reporting. The patient said watch your stress level and diet especially if you had diabetes. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
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 age at vaccination was not reported. The reporter stated that, he/she knew someone who got Shingles vaccine and also got 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, 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 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 patient had reported for him/herself. The age at vaccination was not reported. The patient received Shingles vaccine quite a few years ago from the date of reporting. After receiving Shingles vaccine, the patient still got shingles recently and probably the worst and longest episode yet till the time of reporting. 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: M
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, 1 month 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 wife. The age at vaccination was not reported. A month after receiving Shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization 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 patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got 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: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; flare ups; 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.  The patient's past medical history included shingles.   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 patient had reported for him/herself. The age at vaccination was not reported. The patient had more flare ups of shingles since he/she got Shingles vaccine than he/she ever had before. The patient regretted getting Shingles vaccine. 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: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Got worst case of shingles which lasted for MONTHS; This case was reported by a consumer via interactive digital media  and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the 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. The patient received Shingles vaccine on the advice of her medical professional. A couple of weeks after receiving Shingles vaccine, the patient had worst case of shingles she would ever had which lasted for months. The patient had trouble with shingles. The patient advised the reporter not to get the Shingles vaccine. The reporter took her advice. The reporter stated that, without looking, he/she would take bets this was encouraging folks to get the Shingles vaccine.
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 an unspecified number of patients 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 age at vaccination was not applicable. The reporter stated that, he/she knew of people who after receiving Shingles vaccine, still got 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.
Age: 77.0
Sex: F
Vaccine: UNK
Symptoms: Back pain, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Muscle aches, (neck & lower back), headache, nausea, extreme fatigue, hives
Age: 77.0
Sex: F
Vaccine: UNK
Symptoms: Neck pain, Urticaria
Clinical narrative: Muscle aches, (neck & lower back), headache, nausea, extreme fatigue, hives
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Late-
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Headache-Mild
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Presyncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Additional Details: vasovagal symptoms post injection
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Eye swelling, Injection site erythema, Injection site pruritus, Mouth swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: patient came into the pharmacy and stated that she have adverse reactions (rashes,swelling and pruritus) from the 3rd COVID shot administered on 09/01/2021.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Swelling face, Swollen tongue
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: patient came into the pharmacy and stated that she have adverse reactions (rashes,swelling and pruritus) from the 3rd COVID shot administered on 09/01/2021.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Tachycardia
Clinical narrative: Systemic: Hypertension-Medium, Systemic: Tachycardia-Medium
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Confusional state, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Severe
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Lethargy, Syncope, Tremor
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Severe
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Severe
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Seizure, Tremor
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Additional Details: Patient got his first Dose of Moderna COvid 19 vaccine. He was waiting in the waiting areas after the vaccine and had a seizure with profuse sweating. 911 was called but patient came back to senses and both caregiver and patient declined ambulatory service. Patient informed RPH that he had notting to eat since morning. The vaccine was provided around 5pm
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Medium, Additional Details: violent shaking for short term, fell towards floor from seat position, father caught before hitting floor. blood pressure checked was in normal limits
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash vesicular
Clinical narrative: Vesicular rash all over each extremity
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: Per patient, she experienced a red/pink rash on arm around injection site.  Arm is rock hard, painful, and warm to touch.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: I had intense dizziness that started about 24 hours after getting both Pfizer vaccines. This persisted for a day or two after the vaccine. It went away after around day 2.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: Systemic: Headache-Severe, Additional Details: Patient stated she experienced a migraine for 1 week after the administration of her first vaccination. She said she took Tylenol, but the migraine still persisted.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint injury, Paraesthesia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Injection site bruising, Tachycardia
Clinical narrative: Site: Bruising at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Tachycardia-Mild
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dry mouth, Dysphagia, Heart rate increased, Hypoaesthesia
Clinical narrative: 1. Face went numb  2. Trouble swallowing ( feels like something is in throat) 3. Every time I work out neck and jaw muscles cramp 4. Suddenly developed TMD ( went to dermatologist to confirm) 3. Symptoms have been constant 4 months  4. Severe dry mouth  5. Fast heart rate  6. Anxiety.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Temporomandibular joint syndrome, Trismus
Clinical narrative: 1. Face went numb  2. Trouble swallowing ( feels like something is in throat) 3. Every time I work out neck and jaw muscles cramp 4. Suddenly developed TMD ( went to dermatologist to confirm) 3. Symptoms have been constant 4 months  4. Severe dry mouth  5. Fast heart rate  6. Anxiety.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site paraesthesia, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: about 10 minutes after vaccine, patient alerted pharmacist that she feels tingling on her injection site and her left arm. After addtitional 15 minutes under observation, patient tingling condition is the same. vital signs : 97.5 BP 110/80 HR 73. Patient was adviced to monitor her condtion and seek medical help worsening. I called her today 3 times. patient did not answer phone.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Myocardial infarction, Tremor
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Shakiness-Mild, Additional Details: Pt came into pharamcy and told me a few weeks later about how his second vaccaine was due and reported AE to me. Pt expereinced chest tightness and pain. he went to ER and they told him he had been diagnosted with "mini heart attack". Pt was told to F/U with PCP. I talked to pateint and told him not to get naother dose until PCP or caridologist appoitnment is made. Shared a few providers in the area and recomended going closer to get the best care. Pt seems to have recoved event
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Very tired and extremely sore arm, shoulder and neck starting at injection site.  This was dose #3 due to immunocompromised health.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Lip swelling, Rash
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: Patient States her lips got swollen when she got her 3rd covid pfizer vaccine. Patient also mentioned that she had the same lip swelling reaction from either her 1st or 2nd vaccine but decided not to report because symptoms went away. When asked to specify which dose, she could not recall.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute myeloid leukaemia, Biopsy bone marrow abnormal, Blast cells, Bone marrow failure, Caesarean section
Clinical narrative: Pregnancy history: G2P1001. Patient had the Pfizer COVID vaccine on 8/6/21 at 33 3/7 weeks gestation (EDD 9/21/21). Presented 8/15/21 at 34 5/7 weeks gestation with preterm labor. CBC with differential found to have significant abnormalities. Twins were delivered via C-section. Twin A birth weight 5lb 2.5oz and twin B birth weight 6lb 1.4oz. Oncology consulted and bone marrow biopsy diagnosed patient with AML. Induction chemotherapy with 7+3 given 8/17-8/23/21 with resulting pancytopenia necessitating daily blood/platelet transfusions. On 9/1/21, had a catastrophic intracranial hemorrhage and patient died on 9/2/21.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chemotherapy, Death, Exposure during pregnancy, Full blood count, Haemorrhage intracranial
Clinical narrative: Pregnancy history: G2P1001. Patient had the Pfizer COVID vaccine on 8/6/21 at 33 3/7 weeks gestation (EDD 9/21/21). Presented 8/15/21 at 34 5/7 weeks gestation with preterm labor. CBC with differential found to have significant abnormalities. Twins were delivered via C-section. Twin A birth weight 5lb 2.5oz and twin B birth weight 6lb 1.4oz. Oncology consulted and bone marrow biopsy diagnosed patient with AML. Induction chemotherapy with 7+3 given 8/17-8/23/21 with resulting pancytopenia necessitating daily blood/platelet transfusions. On 9/1/21, had a catastrophic intracranial hemorrhage and patient died on 9/2/21.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myelosuppression, Neutrophil count decreased, Pancytopenia, Platelet count decreased, Platelet transfusion
Clinical narrative: Pregnancy history: G2P1001. Patient had the Pfizer COVID vaccine on 8/6/21 at 33 3/7 weeks gestation (EDD 9/21/21). Presented 8/15/21 at 34 5/7 weeks gestation with preterm labor. CBC with differential found to have significant abnormalities. Twins were delivered via C-section. Twin A birth weight 5lb 2.5oz and twin B birth weight 6lb 1.4oz. Oncology consulted and bone marrow biopsy diagnosed patient with AML. Induction chemotherapy with 7+3 given 8/17-8/23/21 with resulting pancytopenia necessitating daily blood/platelet transfusions. On 9/1/21, had a catastrophic intracranial hemorrhage and patient died on 9/2/21.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Premature labour, Transfusion, Twin pregnancy, White blood cell count increased
Clinical narrative: Pregnancy history: G2P1001. Patient had the Pfizer COVID vaccine on 8/6/21 at 33 3/7 weeks gestation (EDD 9/21/21). Presented 8/15/21 at 34 5/7 weeks gestation with preterm labor. CBC with differential found to have significant abnormalities. Twins were delivered via C-section. Twin A birth weight 5lb 2.5oz and twin B birth weight 6lb 1.4oz. Oncology consulted and bone marrow biopsy diagnosed patient with AML. Induction chemotherapy with 7+3 given 8/17-8/23/21 with resulting pancytopenia necessitating daily blood/platelet transfusions. On 9/1/21, had a catastrophic intracranial hemorrhage and patient died on 9/2/21.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Abdominal pain lower, Acute myeloid leukaemia, Anticoagulant therapy, Back pain
Clinical narrative: Pregnancy history: G2P1001. Patient had the Pfizer COVID vaccine on 8/6/21 at 33 3/7 weeks gestation (EDD 9/21/21). Presented 8/15/21 at 34 5/7 weeks gestation with preterm labor. CBC with differential found to have significant abnormalities. Twins were delivered via C-section. Twin A birth weight 5lb 2.5oz and twin B birth weight 6lb 1.4oz. Oncology consulted and bone marrow biopsy diagnosed patient with AML. Induction chemotherapy with 7+3 given 8/17-8/23/21 with resulting pancytopenia necessitating daily blood/platelet transfusions. On 9/1/21, had a catastrophic intracranial hemorrhage and patient died on 9/2/21.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy bone marrow, Blood fibrinogen, Blood smear test, Calcium ionised, Chromosomal analysis
Clinical narrative: Pregnancy history: G2P1001. Patient had the Pfizer COVID vaccine on 8/6/21 at 33 3/7 weeks gestation (EDD 9/21/21). Presented 8/15/21 at 34 5/7 weeks gestation with preterm labor. CBC with differential found to have significant abnormalities. Twins were delivered via C-section. Twin A birth weight 5lb 2.5oz and twin B birth weight 6lb 1.4oz. Oncology consulted and bone marrow biopsy diagnosed patient with AML. Induction chemotherapy with 7+3 given 8/17-8/23/21 with resulting pancytopenia necessitating daily blood/platelet transfusions. On 9/1/21, had a catastrophic intracranial hemorrhage and patient died on 9/2/21.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Exposure during pregnancy, Fatigue, Fibrin D dimer, Full blood count, Immunophenotyping
Clinical narrative: Pregnancy history: G2P1001. Patient had the Pfizer COVID vaccine on 8/6/21 at 33 3/7 weeks gestation (EDD 9/21/21). Presented 8/15/21 at 34 5/7 weeks gestation with preterm labor. CBC with differential found to have significant abnormalities. Twins were delivered via C-section. Twin A birth weight 5lb 2.5oz and twin B birth weight 6lb 1.4oz. Oncology consulted and bone marrow biopsy diagnosed patient with AML. Induction chemotherapy with 7+3 given 8/17-8/23/21 with resulting pancytopenia necessitating daily blood/platelet transfusions. On 9/1/21, had a catastrophic intracranial hemorrhage and patient died on 9/2/21.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: International normalised ratio, Laboratory test, Metabolic function test, Neutrophil count normal, Platelet count decreased
Clinical narrative: Pregnancy history: G2P1001. Patient had the Pfizer COVID vaccine on 8/6/21 at 33 3/7 weeks gestation (EDD 9/21/21). Presented 8/15/21 at 34 5/7 weeks gestation with preterm labor. CBC with differential found to have significant abnormalities. Twins were delivered via C-section. Twin A birth weight 5lb 2.5oz and twin B birth weight 6lb 1.4oz. Oncology consulted and bone marrow biopsy diagnosed patient with AML. Induction chemotherapy with 7+3 given 8/17-8/23/21 with resulting pancytopenia necessitating daily blood/platelet transfusions. On 9/1/21, had a catastrophic intracranial hemorrhage and patient died on 9/2/21.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Premature labour, Prothrombin time
Clinical narrative: Pregnancy history: G2P1001. Patient had the Pfizer COVID vaccine on 8/6/21 at 33 3/7 weeks gestation (EDD 9/21/21). Presented 8/15/21 at 34 5/7 weeks gestation with preterm labor. CBC with differential found to have significant abnormalities. Twins were delivered via C-section. Twin A birth weight 5lb 2.5oz and twin B birth weight 6lb 1.4oz. Oncology consulted and bone marrow biopsy diagnosed patient with AML. Induction chemotherapy with 7+3 given 8/17-8/23/21 with resulting pancytopenia necessitating daily blood/platelet transfusions. On 9/1/21, had a catastrophic intracranial hemorrhage and patient died on 9/2/21.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Dyspnoea, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Laryngitis
Clinical narrative: acute laryngitis with loss of voice
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Nausea, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Irregular breathing, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting/Unresponsive-Severe, Systemic: Irregular breathing-Severe, Additional Details: Paramedics were called and patient transported to hospital. Later released and patient seemed to have recovered.
Age: 45.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: pt complained of a rash that started the day after the shot and was still a problem on date of reporting.  itchy, raised, red at area of injection
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Mouth swelling, Swelling face, Swollen tongue
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Facial swelling occurred 24 hours post injection.  Patient stated that previous dermal fillers could be the likely cause.  Patient went to urgent care and provided steroid injection and oral steroid therapy.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Basedow's disease, Cardiac disorder, Cardiac failure, Cardiac failure congestive, Echocardiogram
Clinical narrative: Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Severe decrease in heart rate and CHF-Severe, Additional Details: The patient states that he has Graves Disease.  After receiving the COVID vaccine he states that his heart rate dropped dangerously low, he was hospitalized and had cardiac problems and developed heart failure.  He is now out of the hospital, but is still recovering and is requiring monitoring and echocardiograms to asses his heart function.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate decreased
Clinical narrative: Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Severe decrease in heart rate and CHF-Severe, Additional Details: The patient states that he has Graves Disease.  After receiving the COVID vaccine he states that his heart rate dropped dangerously low, he was hospitalized and had cardiac problems and developed heart failure.  He is now out of the hospital, but is still recovering and is requiring monitoring and echocardiograms to asses his heart function.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium