chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: I received the first Covid-19 Moderna dose at roughly 8:47 a.m. After waiting 15 minutes I continued with my normal routine. I took (2) Tylenol anticipating symptoms from the vaccine. I finished my workday and got off around 4:00 p.m. Got home and ate dinner around 5:00 p.m. I did a light workout with the Nintendo Switch Adventure Fit game for 30 minutes. At 8:00 p.m. I began to feel adverse effects. I was reading to the boys when I felt a general all-around weird feeling that almost made want to stop reading. As I kept reading, I found it at times difficult to figure out words. Which slowed down my usual reading speed. I read for 30-45 minutes and this would happen intermittently. After done reading I proceeded to tell my husband about my day and dreams. So sure, of what I was about to say but would suddenly forget. Regaining my thoughts, I would finish my story but would then suddenly forget again. I would also start tasks, like putting my dirty clothes in the hamper, but then lose focus on that task. Thinking maybe I just needed a good night?s sleep, I went to bed. Through out the night I just felt waves uneasiness. I would fall asleep but then wake back up again feeling weird. My hands were shaking, possible response to fear of the effects. I seemed to focus on my heart beat every now then making me think I might have experienced a slight rapid heart rate. I would also feel a weird intermittent fuzzy feeling that would rush from the back of my head to the front of my head. It was almost like a warning that I was going to feel bad again. Eventually, not knowing the time, I fell asleep. The next morning, I woke up at approximately 6:00 a.m. I felt fatigued mentally and physically, had a mild headache, slight fuzzy headed, slight dizziness, slight nausea and had a sore arm. I took (2) Tylenol around 9:00 a.m and decided to report my symptoms to my PCPs office and made an appointment with an available ARNP. I took (2) Tylenol again at 6:00 p.m. I felt almost back to my normal self the third day after my vaccination.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vascular injury
Clinical narrative: None stated.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site bruising, Injection site erythema, Injection site mass
Clinical narrative: A rash developed  all around the injection site which had been bruised since the shot. It was red raised bumps that was itchy and painful. There were large lumps under the skin. I woke up the next day with a severe headache and extreme fatigue.   The  second day after the rash first appears the symptoms subsided but the rash is still present.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling, Rash erythematous
Clinical narrative: A rash developed  all around the injection site which had been bruised since the shot. It was red raised bumps that was itchy and painful. There were large lumps under the skin. I woke up the next day with a severe headache and extreme fatigue.   The  second day after the rash first appears the symptoms subsided but the rash is still present.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular
Clinical narrative: A rash developed  all around the injection site which had been bruised since the shot. It was red raised bumps that was itchy and painful. There were large lumps under the skin. I woke up the next day with a severe headache and extreme fatigue.   The  second day after the rash first appears the symptoms subsided but the rash is still present.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: Deep venous thrombosis, pt was treated with blood thinners at Hospital emergency room and is being followed up by pt's primary care provider.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Injection site pain
Clinical narrative: Left arm where shot was given is tinder/sore - started soon after vaccine was given and continuing at time of this report.  Explosive diarrhea - starting after eating around 11pm , continuation unknown at this point.  Just took anti-diarrhea medicine to help symptoms.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Echocardiogram normal, Electrocardiogram ST segment elevation, Troponin increased
Clinical narrative: Chest pain approximately 12 hours after 2nd dose of Pfizer covid vaccine.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis per patient's mother
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: Seven days after receiving the second dose of the Pfizer/BioNTech COVID-19 vaccine, I began to experience ringing in my ears, and the ringing has continued ever since.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Immediate post-injection reaction, Lymphadenopathy, Menstrual disorder
Clinical narrative: immediately after the vaccine my arm and hand were itchy and hot. later that night i had normal cold symptoms which i expected. everyday after that i have experienced severe headaches. i wake up everyday with a pounding headache. my arm is still sore. Most  concerning is the fact that i have started menstrating again. i have and IUD and havent bleed in 6 months. now iam. my glands are swollen under my jaw as well. These symptoms are still current 7 days after the vaccine.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain in extremity, Pruritus
Clinical narrative: immediately after the vaccine my arm and hand were itchy and hot. later that night i had normal cold symptoms which i expected. everyday after that i have experienced severe headaches. i wake up everyday with a pounding headache. my arm is still sore. Most  concerning is the fact that i have started menstrating again. i have and IUD and havent bleed in 6 months. now iam. my glands are swollen under my jaw as well. These symptoms are still current 7 days after the vaccine.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Malaise, Mobility decreased, Pain
Clinical narrative: After having my second dosage on Thursday (06/03/2021) at 4:30pm I was feeling ok until Friday (06/04/2021) morning I was really achy and could not get out of bed because my whole body was hurting. I was experiencing pain in my joints and could not bend my fingers from either hand. I was having slight fevers on and off.  The pain in my joints and aches in my body continued through Sunday evening 06/06/2021. On Monday 06/07/2021 I was still achy but was able to be more mobile and was almost back to my normal state of being. On Tuesday 06/08/2021 At 9:30pm I went to take a shower and started feeling like I was beginning to feel unwell. I started to feel light headed and  like I was going to faint so I sat down. I went to lay down for about 15min and started to feel better by 10:30pm.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: After having my second dosage on Thursday (06/03/2021) at 4:30pm I was feeling ok until Friday (06/04/2021) morning I was really achy and could not get out of bed because my whole body was hurting. I was experiencing pain in my joints and could not bend my fingers from either hand. I was having slight fevers on and off.  The pain in my joints and aches in my body continued through Sunday evening 06/06/2021. On Monday 06/07/2021 I was still achy but was able to be more mobile and was almost back to my normal state of being. On Tuesday 06/08/2021 At 9:30pm I went to take a shower and started feeling like I was beginning to feel unwell. I started to feel light headed and  like I was going to faint so I sat down. I went to lay down for about 15min and started to feel better by 10:30pm.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Magnetic resonance imaging, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Aching pain (not sharp pain) under foot, specifically under arch of left foot.  Only on left foot and not on right foot.  Pain also has sporadically some tingling and burning sensation.  Pain is chronic and doesn't subside and has lasted for over 3 months now.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray limb normal
Clinical narrative: Aching pain (not sharp pain) under foot, specifically under arch of left foot.  Only on left foot and not on right foot.  Pain also has sporadically some tingling and burning sensation.  Pain is chronic and doesn't subside and has lasted for over 3 months now.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pruritus
Clinical narrative: extreme tiredness; headaches; muscular pains; body itch; This is a spontaneous report from a contactable consumer (patient). A 46-year-old non-pregnant female patient received bnt162b2 (Lot Number: EN6205), dose 2 via an unspecified route of administration, administered in right arm on 04Mar2021 (at the age of 46 years old) as single dose for covid-19 immunization. The patient previously received bnt162b2 (Lot Number: EL9264), dose 1 via an unspecified route of administration, administered in left arm on 11Feb2021 at 09:30 AM as single dose for covid-19 immunization. The patient's medical history reported as no. The patient had no other vaccine in four weeks and no other concomitant medications in two weeks. The patient experienced extreme tiredness, headaches, muscular pains, body itch on 06Mar2021. No treatment for the events. The patient had not COVID prior vaccination and did not have COVID tested post vaccination. The outcome of events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Pyrexia
Clinical narrative: diarrhea; Fever; chills; headache; fatigue; This is a spontaneous report from a non-contactable consumer (patient) reported for herself. A 47-year-old non-pregnant female patient received bnt162b2 (Pfizer COVID 19 vaccine, Lot number was not reported), dose 1 via an unspecified route of administration, administered in left arm on 05Mar2021 18:00 (at the age of 47 years old) as single dose for covid-19 immunization. The patient had no medical history and known allergies. The patient had no other vaccine in four weeks. Concomitant medications in two weeks included rosuvastatin calcium (CRESTOR). The patient experienced fever, diarrhea, chills, headache, and fatigue on 07Mar2021 at 12:00 AM. The patient had not COVID prior vaccination and did not have COVID tested post vaccination. No treatment for events. The outcome of events was recovering.   No follow-up attempts are possible. No further information is expected. The information about lot number and expiration date cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Starting my mensural cycles again after 5 months into menopause after 1st vaccine; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EW0161), via an unspecified route of administration in arm left on 13Apr2021 as a single dose for COVID-19 immunisation. The patient had no relevant medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient was not tested for COVID-19. On an unspecified date in 2021, patient started mensural cycles again after 5 months into menopause after 1st vaccine. No treatment was given for the event. The case was considered as non serious. The outcome of the event was reported as not recovered.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: She is now positive for HPV; This spontaneous report was received from a physician, concerning a female patient of unknown age. No information was provided regarding the patient's pertinent medical history, concomitant medications and previous drug reactions or allergies.  On an unspecified date reported as "years ago", the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) by intramuscular (IM) route as human papilloma virus (HPV) vaccination (dose, frequency, anatomical location, vaccination scheme, lot number and expiration date were no reported).  In 2021 reported as "now", the patient was positive for HPV. According to the physician, the patient was probably positive with one of the strains that the 4 valent vaccine did not cover.  At the time of the report, the outcome of human papilloma virus test positive was unknown.  Causality assessment was not provided by the reporter.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; the vaccine was administered while out of recommended range; This spontaneous report was received from a registered nurse referring to a 6 months old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.                  On 15-MAY-2021, the patient was administered with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (2 ml, strength was not reported, valid lot # 1694410, expiration date 19-DEC-2021) orally for prophylaxis while out of recommended range. The vaccine administered experienced a temperature excursion of 89 Fahrenheit, with time frame 24 hours. There was no previous temperature excursion. A digital data logger was involved.  No additional adverse event was reported.
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: No additional adverse events reported; Caller is a medical assistant inquiring on next steps regarding a patient who received their first dose of GARDASIL 9 when they were 18 years old and now in their 30s. Caller reports that the patient believes they received their first dose in 2003.; This spontaneous report was received from a medical assistant referring to a currently 30-years-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not provided.  In approximately 2003, at the age of 18-years-old, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (formulation, exact dose, route of administration, vaccination scheme frequency, and anatomical location were not reported; lot number and expiration date were unknown). The patient did not receive any of the subsequent doses in the series and the reporter wanted to know what would be next steps with this patient (inappropriate schedule of product administration). No adverse events were reported.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/ PQC reported at this time.; Nurse called in to report a temperature excursion that took place on 3/9/2022. Caller reported vaccines have been administered to patients. Caller reported this patient received ROTATEQ, not PEDVAX HIB.; This spontaneous report was received from a licensed vocational nurse and refers to a 2-months-old patient of unknown gender. No information was provided regarding the patient's medical history, concomitant medications, past drug reactions or allergies.  On 09-MAR-2021, the product rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number 1742460 and expiration date 16-NOV-2021) had a temperature excursion (product storage error). It was stated that the vaccine reached a temperature of 9 degree Celsius. This excursion had a time frame reported of 30 minutes.   On 15-MAR-2021, this improper storage vaccine was administered to the patient (concentration, dose number and vaccination scheme frequency were not provided) orally for prophylaxis.  No previous excursions were reported, and information was provided via data logger. No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA007015: US-009507513-2105USA006749: US-009507513-2105USA007032: US-009507513-2105USA007003:
Sex: F
Vaccine: HPV4
Symptoms: Ill-defined disorder
Clinical narrative: Patient experiencing the same current unknown symptoms that she experienced when she was administered GARDASIL at the age of 10 or 11; This spontaneous report Was received from a physician and refers to a female patient of unknown age.  The patient's concurrent conditions, medical history, concomitant medications, drugs reactions or allegies were not provided.   Merck Employee reported that provider drove her daughter, of current unknown age, to see an herbalist due to daughter experiencing unknown symptoms. Merck employee was unable to provide onset date of when symptoms occurred. Provider stated that upon the herbalist assessment, which consist of electrodes and electrical waves throughout the body, the herbalist asked provider if the daughter ever received quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL). Provider informed Herbalist that she did and that the symptoms the daughter is experiencing now, she also experienced around the time she receivedquadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) at the age of 10 or 11. Merck employee was unable to provide date of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) administration. Merck employee stated that provider was now concerned about the ingredients in quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL)  from herbalist perspective. Merck employee also reports that provider stated that the herbalist commented that quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL)  causes infertility. Merck employee stated that provider responded by saying she know patients that she administered quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL)  to that have had two to three babies. The outcome of ill defined disorder was not reported.   The causal relationship between ill-defined disorder and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) was not provided.; Sender's Comments:  2106USA000509:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller stated the ROTATEQ that underwent a temperature excursion was administered to 9 patients; This spontaneous report was received from a medical assitant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 21-MAY-2021, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) orally, lot number 1707306, expiration date 26-DEC-2021 (dosage regimen was not provided) for prophylaxis. No adverse event was reported.      The vaccine underwent a temperature excursion as follows: between 36 degrees Farhrenheit (°F) and 46°F with an average of 46.9°F for 30 minutes. The call was due to digital data logger. There were no previous tempreature excursion.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller stated the ROTATEQ that underwent a temperature excursion was administered to 9 patients; This spontaneous report was received from a medical assitant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 14-MAY-2021, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) orally, lot number 1707306, expiration date 26-DEC-2021 (dosage regimen was not provided) for prophylaxis. No adverse event was reported.      The vaccine underwent a temperature excursion as follows: between 36 degrees Farhrenheit (°F) and 46°F with an average of 46.9°F for 30 minutes. The call was due to digital data logger. There were no previous tempreature excursion.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller stated the ROTATEQ that underwent a temperature excursion was administered to 9 patients; This spontaneous report was received from a medical assitant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 12-MAY-2021, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) orally, lot number 1707306, expiration date 26-DEC-2021 (dosage regimen was not provided) for prophylaxis. No adverse event was reported.      The vaccine underwent a temperature excursion as follows: between 36 degrees Farhrenheit (°F) and 46°F with an average of 46.9°F for 30 minutes. The call was due to digital data logger. There were no previous tempreature excursion.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller stated the ROTATEQ that underwent a temperature excursion was administered to 9 patients; This spontaneous report was received from a medical assitant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 28-MAY-2021, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) orally, lot number 1707306, expiration date 26-DEC-2021 (dosage regimen was not provided) for prophylaxis. No adverse event was reported.      The vaccine underwent a temperature excursion as follows: between 36 degrees Farhrenheit (°F) and 46°F with an average of 46.9°F for 30 minutes. The call was due to digital data logger. There were no previous tempreature excursion.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: a patient received an expired MMR II; This spontaneous report was received from a medical assistant referring to a female patient of unknown age. The patient's concurrent conditions, medical history, and concomitant medications were not reported.   On 02-JUN-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # S010704 with an expiration date on 08-APR-2021) for prophylaxis (expired product administered).  Strength, dose, anatomical location, and route of administration were not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received from a lawyer and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On or about 19-OCT-2017, patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not reported) vaccine for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, patient suffered herpes zoster. As a result of these symptoms, patient was seen and treated by medical providers and is still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patients also experience mental and emotional distress due to resulting physical limitations and seriousness of Patients' condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patients sustained severe and permanent personal injuries. Further, as a tragic consequence of company's wrongful conduct, patients suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of company's conduct, patients have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster was reported as not recovered. The reporter considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 11-year-old patient of an unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-MAY-2021, the patient was vaccinated with dose of improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1687292, expiration date 25-AUG-2022, 0.5 milliliter (anatomical location and route of administration were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion above 47 degrees Fahrenheit (F) (46.9 F) for 84 hours 30 minutes 0 seconds. Data logger was not involved. There were no previous excursions reported. No additional adverse events were 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: 1687292; expirationdate: 25-AUG-2022; 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: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE; PROQUAD that underwent a temperature excursion was administered to two patients; This spontaneous report has been received from a healthcare business professional referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history, and drug reactions/allergies were not reported.  On 25-MAY-2021, the patient was vaccinated with the improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) for prophylaxis (lot # T028298, expiration date 16-FEB-2022 (strength, dose,  route of administration and anatomical location were not reported), which underwent a temperature excursion at 6.96 Fahrenheit (F) for 15 min (product storage error temperature too high). The temperature excursion was detected by a data logger. There was no previous temperature excursion. No additional adverse event or information was reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA006420:
Sex: F
Vaccine: COVID19, UNK
Symptoms: Thrombosis
Clinical narrative: Patient stated that she has blood clots in her legs due to COVID vaccine; This is a solicited report from a non-Pfizer sponsored program, received from a contactable consumer, based on information received by Pfizer.  This 38-year-old female patient was involved in a patient support program. The patient (patient ID: redacted) received apixaban. The report describes a case of thrombosis (Patient stated that she has blood clots in her legs due to COVID vaccine). Co-suspect products included COVID-19 vaccine for an unknown indication. On an unknown date, the patient started apixaban (unknown route), (unspecified dose and frequency). On an unknown date, the patient experienced thrombosis (seriousness criterion medically significant). The action taken with apixaban (unknown) was unknown. At the time of the report, thrombosis outcome was unknown. The patient received apixaban for unknown indication. The patient reported that she had blood clot in her legs due to COVID vaccine. For apixaban (unknown), the reporter considered thrombosis to be not related. Further follow up was not possible, as no further information was available.  The reporter's assessment of the causal relationship of the event with the suspect product COVID-19 vaccine was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.; Sender's Comments: BMS Medical Evaluation Comment: This patient had thrombosis after receiving apixaban study therapy. Patient also got vaccinated for COVID-19. Based on the limited information available regarding the therapy details, event onset date, action taken with the suspect and outcome of the event, it cannot be ascertained with the reasonable possibility that the apixaban could have contributed to the event thrombosis.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dermatitis bullous, Erythema, Heart rate, Hypertension
Clinical narrative: Dermatitis bullous; Erythema; Peripheral swelling; Pruritus; Somnolence; Hypertension; This case was received via FDA VAERS on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of DERMATITIS BULLOUS (Dermatitis bullous) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced DERMATITIS BULLOUS (Dermatitis bullous) (seriousness criterion medically significant), ERYTHEMA (Erythema), PERIPHERAL SWELLING (Peripheral swelling), PRURITUS (Pruritus), SOMNOLENCE (Somnolence) and HYPERTENSION (Hypertension). At the time of the report, DERMATITIS BULLOUS (Dermatitis bullous), ERYTHEMA (Erythema), PERIPHERAL SWELLING (Peripheral swelling), PRURITUS (Pruritus), SOMNOLENCE (Somnolence) and HYPERTENSION (Hypertension) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Blood pressure measurement (120-80): 140/105 (High) BP 140/105mmHg and 155/81 (High) 155/81mmHg. On 29-Mar-2021, Heart rate: 80 (normal) 80 bpm and 82 (normal) pulse 82 bpm. On 29-Mar-2021, Oxygen saturation: 98 % (normal) SpO2 98% and 96 % (normal) SpO2 96%.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had red rash and swelling on both arms, mildly itchy. Extended below shot injection site to finger tips. Increased itching under left arm as well as mild itchy on torso. Alert and oriented. No concomitant medication information was provided. No treatment medication information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation, Peripheral swelling, Pruritus, Somnolence
Clinical narrative: Dermatitis bullous; Erythema; Peripheral swelling; Pruritus; Somnolence; Hypertension; This case was received via FDA VAERS on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of DERMATITIS BULLOUS (Dermatitis bullous) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced DERMATITIS BULLOUS (Dermatitis bullous) (seriousness criterion medically significant), ERYTHEMA (Erythema), PERIPHERAL SWELLING (Peripheral swelling), PRURITUS (Pruritus), SOMNOLENCE (Somnolence) and HYPERTENSION (Hypertension). At the time of the report, DERMATITIS BULLOUS (Dermatitis bullous), ERYTHEMA (Erythema), PERIPHERAL SWELLING (Peripheral swelling), PRURITUS (Pruritus), SOMNOLENCE (Somnolence) and HYPERTENSION (Hypertension) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Blood pressure measurement (120-80): 140/105 (High) BP 140/105mmHg and 155/81 (High) 155/81mmHg. On 29-Mar-2021, Heart rate: 80 (normal) 80 bpm and 82 (normal) pulse 82 bpm. On 29-Mar-2021, Oxygen saturation: 98 % (normal) SpO2 98% and 96 % (normal) SpO2 96%.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had red rash and swelling on both arms, mildly itchy. Extended below shot injection site to finger tips. Increased itching under left arm as well as mild itchy on torso. Alert and oriented. No concomitant medication information was provided. No treatment medication information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis, COVID-19, SARS-CoV-2 test
Clinical narrative: Appendicitis; COVID-19; This case was received via FDA VAERS on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of APPENDICITIS (Appendicitis) and COVID-19 (COVID-19) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 02-Apr-2021, the patient experienced APPENDICITIS (Appendicitis) (seriousness criterion medically significant) and COVID-19 (COVID-19) (seriousness criterion medically significant). The patient was treated with Surgery (appendectomy) for Appendicitis. At the time of the report, APPENDICITIS (Appendicitis) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, SARS-CoV-2 test: positive (Positive) The result was positive..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information provided. The patient was tested before having an appendectomy.; Sender's Comments: Based on the mechanism of action of mRNA 1273, event Covid 19 is unlikely related to the Vaccine.Very limited information regarding the event Appendicitis have been provided at this time. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Palpitations, Tinnitus
Clinical narrative: Condition aggravated; Palpitations; Tinnitus; This case was received on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of CONDITION AGGRAVATED (Condition aggravated), PALPITATIONS (Palpitations) and TINNITUS (Tinnitus) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Asthma and Allergy NOS. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and LOSARTAN for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced CONDITION AGGRAVATED (Condition aggravated) (seriousness criterion disability), PALPITATIONS (Palpitations) (seriousness criterion disability) and TINNITUS (Tinnitus) (seriousness criterion disability). At the time of the report, CONDITION AGGRAVATED (Condition aggravated), PALPITATIONS (Palpitations) and TINNITUS (Tinnitus) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Immediately upon receiving injection, the patient's heart began racing, and what had been a relatively quite ringing in his ears for the past year or two, also immediately became 2-3x louder (maybe even more), where it had remained ever since (nearly 2 months). The heart rate settled down within a few second, but the ringing persisted, and continued. Before the vaccine, the ringing was a very high pitched, constant tone, like the high pitched tone he used to hear on an airplane sometimes, but it was so quiet that he only noticed when he would wake up in the morning or at other random times when everything around him was very quiet. Since the vaccine, however, it became loud enough that it was impossible not to notice it constantly; not so loud that he could not hear other things around him or people talking, but definitely loud enough that it was unmistakably there and could at times be a real distraction to focus and even conversation.  Treatment medications were not reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Injection site pain
Clinical narrative: Can shingles vaccine cause pain in area of injection; Can shingles vaccine cause/shivering; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain and shivering. On an unknown date, the outcome of the injection site pain and shivering were unknown.   It was unknown if the reporter considered the injection site pain and shivering to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient reported and enquired if the administration of Shingles vaccine could lead to pain in the area of injection and shivering.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I had them got a shot and them 2 more times; This case was reported by a consumer via 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 shingles.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received a shot of Shingles vaccine and experienced shingles. The Follow up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: I got the shingles!!!; Painful; This case was reported by a consumer via 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, several days after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by the patient. The patient got the Shingle shot and in a couple of days got the shingles and it was painful.
Sex: U
Vaccine: VARZOS
Symptoms: Ageusia, Headache, Pain in extremity
Clinical narrative: going to get a COVID test today; sore arm; headache; cannot taste my foods/ Sweet and salty especially./it seems to be just affecting my taste; This case was reported by a consumer and described the occurrence of suspected covid-19 in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included viral infection, taste loss and loss of smell (Viral infection).   On 3rd June 2021, the patient received the 1st dose of Shingrix. On 4th June 2021, 1 days after receiving Shingrix, the patient experienced suspected covid-19, pain in arm, headache and taste loss. On an unknown date, the outcome of the suspected covid-19, pain in arm, headache and taste loss were unknown.   It was unknown if the reporter considered the suspected covid-19, pain in arm, headache and taste loss to be related to Shingrix.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received 1st dose of Shingrix vaccine and experienced common side effects of headache, sore arm and also discovered that could not taste foods sweet and salty especially.  The patient had previously lost his/her taste and smell with a viral infection October 2019, prior to COVID but this was improving and at this point it was limited to wine tasting bad. The patient Smells and tastes were both affected at that time and right now it seems to be just affecting taste. The patient was vaccinated fully for COVID, but going to get a COVID test today. The patient wanted to know this is related to the vaccine or not. The reporter consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shingles right after we got vaccinated/suspected vaccination failure; got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure 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 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 and age group were not reported. The case was reported by the patient's wife. The reporter said that her husband got shingles right after they got vaccinated. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratoy test confirming shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: arm was useless for a week / pain in each arm; This case was reported by a consumer via media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not reported. The reporter mentioned that, he/she was not expected the amount of pain he/she experienced after getting each shot. The patient's arm was useless for a week. The reporter mentioned that, Shingles vaccine did not make him/her sick but he/she was not expected the pain in each arm, but he/she did not regret it at all. The reporter mentioned that, he/she would do it over a hundred times plus before getting shingles. The follow-up would not be possible, as no contact details were available. For the tolerability of 2nd dose, refer case US2021AMR122245 reported for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR122245:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: What if it has been more than 6 months after my first Shingrix vaccine?; This case was reported by a consumer via interactive digital media  and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not applicable for this report. Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.  The reporter enquired what if it was more than 6 months after his or her first Shingrix vaccine. The follow up was not required.