chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd Shingrix vaccine administered 4 weeks after 1st Shingrix vaccine.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number BA5GK, expiry date 4th November 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 5th May 2021, the patient received the 2nd dose of Shingrix. On 5th May 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: Pharmacist reported 2nd Shingrix vaccine administered 4 weeks after 1st Shingrix vaccine which led to shortening of vaccination schedule. The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: soreness / at the injection site; swelling / at the injection site; redness / at the injection site; "baseball sized" knot at the injection site; first dose of Shingrix on 10/2/2020; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 2nd October 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site erythema, injection site mass and incomplete course of vaccination. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and injection site mass were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and injection site mass to be related to Shingrix.  Additional details were provided as follows: This case was reported by pharmacist on behalf of the patient. The age at vaccination was not applicable for 2nd dose. The patient received 1st dose of Shingrix in right deltoid and experienced redness, swelling, soreness, and a baseball sized knot at the injection site.  The reporter was unaware of how long after receiving the 1st dose that these symptoms began and lasted. Reporter stated all symptoms had resolved. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on 27Feb2020 and has not received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 27th February 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received first dose and missed 2nd dose. Till the time of reporting, the patient did not receive the 2nd dose of the vaccine, which led to incomplete course of vaccination. VAERS details reported for 1st dose of shingrix. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis
Clinical narrative: Had severe shoulder pain after the first dose; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included frozen shoulder and hashimoto's disease.   On 13th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 6 months after receiving Shingrix, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was not recovered/not resolved.   It was unknown if the reporter considered the shoulder pain to be related to Shingrix.  Additional details were provided as follow: The case was reported by the patient herself. Concomitant products included Steroid Injection. The patient received 1st dose of Shingrix in right deltoid, more than 6 months before the date of reporting and experienced severe shoulder pain.  Till the time of reporting, the patient did not receive 2nd dose. No primary care physician information given. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: First / on 11-3-2020 / scheduled / second / on 5-24-2021, 21 days late / due to Covid-19; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 3rd November 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The patient had reported for herself. The age at vaccination was not applicable for this report. The patient received 1st dose and scheduled to receive her second Shingrix dose on 24th May 2021, 21 days late. The patient scheduled the second dose later due to Covid-19 and her availability to receive the second Shingrix vaccine. The patient confirmed that she did not ever got Covid-19 infection. The reporter did not consent to follow-up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient was given the second dose / reconstituted with sterile water; Patient was given the second dose / reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number P2J7E, expiry date unknown) for prophylaxis.   On 17th May 2021, the patient received the 2nd dose of Shingrix. On 17th May 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix reconstituted with sterile water instead of the ASO1B approved diluent,which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Reconstituted Shingrix lyophilized powder with sterile water / and administered to a patient; Reconstituted Shingrix lyophilized powder with sterile water / and administered to a patient; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th May 2021, the patient received Shingrix. On 14th May 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was captured as an adult as per vaccine indication. The patient was administered reconstituted Shingrix lyophilized powder with sterile water instead of with the adjuvant suspension component (AS01b), which led to wrong solution used for drug reconstitution and inappropriate dose of vaccine administered. The reporter was unable to provide any vaccine or patient details at the time of reporting. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose received 2 years ago / delayed second dose of shingrix / asymptomatic; This case was reported by a pharmacist via call center representative 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 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of shingrix which led to Incomplete course of vaccination. The reporter inquired about what to do in terms of delayed 2nd dose of shingrix whether to restart or continue the series and when. The reporter was unwilling to share patient information and simply wanted to know what to do in these types of situation, would not want to be contacted about adverse event. The reporter did not consent to follow up.
Age: 28.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received dose 1 of Twinrix on 11/18/2020 and 2nd dose on 01/20/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 28-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HAB (Twinrix).   On 20th January 2021, the patient received the 2nd dose of Twinrix. On an unknown date, the patient started Twinrix Pre-Filled Syringe Device. On 20th January 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received 1st dose of Twinrix on 18th November 2020. The patient received 2nd dose twinrix more than recommended interval, which led to lengthening of vaccination schedule. The reporter wanted to know when the patient could receive 3rd dose.  The batch number and expiration date were asked but were not available.  No further clarifications were performed. The reporter did not consent to follow-up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 INFECTION (FLU LIKE SYMPTOMS/COUGH); This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 06-MAY-2021, the subject experienced covid-19 infection (flu like symptoms/cough).  Laboratory data included: COVID-19 virus test (NR: not provided) Positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine  was not applicable. The outcome of covid-19 infection (flu like symptoms/cough) was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Echocardiogram, Hypoaesthesia, Laboratory test, Venous occlusion
Clinical narrative: CARDIAC ARREST (SEVER CHEST PAIN); CLOGGED VEIN; LEFT ARM GOES TO SLEEP; This spontaneous report received from a patient concerned a 62 year old white male. The patient's past medical history included blood clot, heart attack, lump in leg, and stents in main arteries, and concurrent conditions included heavy smoker, and heart issues.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808025, expiry: UNKNOWN) dose was not reported, 1 total administered on 12-MAR-2021 to left arm as prophylactic vaccination. The patient was previously treated with clopidogrel bisulfate for blood clot.  On an unspecified date in 2021, Laboratory data included: Echocardiogram (NR: not provided) unknown, and Lab test (full workup)(NR: not provided) unknown. On an unspecified date in Mar-2021, a week later vaccination, the patient experienced that left arm went to sleep which felt worse next day, on 25-APR-2021, patient experienced severe pain in chest, called ambulance and was taken to hospital. On same day patient was hospitalized. Patient went to full cardiac arrest twice same day. It was stated that vein that was 60 percent good earlier was 100 percent clogged (clogged vein) in one month after getting the vaccine. They tried to put stent in, clear vein out, and put piece of metal and expanded it, to make alley way for blood flow. Patient stated that patient would not take Plavix this time. According to patient, stent was reacting with Plavix, and decided to take something different. They did same job twice. It was stated that patient was discharged on 05-May-2021 from hospital. On 12-MAY-2021, patient went to consult the health care professional to make sure everything was okay. The patient gave lot number 1808025, then stated that, patient thinks it is 180, and then either 5 or 8, and next it was either D or 0, and then after the space it is 25.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cardiac arrest (sever chest pain), left arm goes to sleep and clogged vein was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210523134-COVID-19 VACCINE AD26.COV2.S-CARDIAC ARREST (SEVERE CHEST PAIN), CLOGGED VEIN. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Carotid artery occlusion, Cerebrovascular accident, Computerised tomogram, Echocardiogram, Laboratory test
Clinical narrative: STROKE; RIGHT CAROTID ARTERY BLOCKAGE; This spontaneous report received from a patient concerned a 62-year-old white female, ethnicity unspecified. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, hypertension, hyperlipidemia, and allergy to latex, and other pre-existing medical conditions included allergy to Provaxin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 06-JUN-2021) dose was not reported, 1 in total administered on 06-APR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported.  On 28-APR-2021, the patient experienced stroke. On 10-MAY-2021, the patient was hospitalized. On 11-MAY-2021, the patient was discharged. On an unspecified date, the patient experienced right carotid artery blockage (60 percent). Laboratory data included: CT scan (NR: not provided) stroke, Echocardiogram (NR: not provided) stroke, Laboratory test (NR: not provided) stroke, and MRI (NR: not provided) stroke The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke, and the outcome of right carotid artery blockage was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210523342-covid-19 vaccine ad26.cov2.s -stroke, right carotid artery blockage. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging
Clinical narrative: STROKE; RIGHT CAROTID ARTERY BLOCKAGE; This spontaneous report received from a patient concerned a 62-year-old white female, ethnicity unspecified. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, hypertension, hyperlipidemia, and allergy to latex, and other pre-existing medical conditions included allergy to Provaxin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 06-JUN-2021) dose was not reported, 1 in total administered on 06-APR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported.  On 28-APR-2021, the patient experienced stroke. On 10-MAY-2021, the patient was hospitalized. On 11-MAY-2021, the patient was discharged. On an unspecified date, the patient experienced right carotid artery blockage (60 percent). Laboratory data included: CT scan (NR: not provided) stroke, Echocardiogram (NR: not provided) stroke, Laboratory test (NR: not provided) stroke, and MRI (NR: not provided) stroke The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke, and the outcome of right carotid artery blockage was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210523342-covid-19 vaccine ad26.cov2.s -stroke, right carotid artery blockage. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock
Clinical narrative: ANAPHYLACTIC SHOCK; This spontaneous report received from a company representative concerned a 22 year old female. The patient's height, and weight were not reported. The patient's past medical history included anaphylactic reaction with unknown cause. The patient had no known allergies. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry date were Unknown) dose was not reported, 1 total, administered on 11-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 11-MAY-2021, the patient experienced anaphylactic shock, and was hospitalized and given high dose of steroids to manage adverse reaction. Patient was discharged on the same day (11-MAY-2021). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from anaphylactic shock. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210523394-COVID-19 VACCINE AD26.COV2.S-Anaphylactic shock. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer (company representative) concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total administered on 2021(about three months prior to this report) for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in 2021, after vaccination, the patient got coronavirus infection a month ago prior to this report for two weeks (suspected clinical vaccination failure).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection on 2021, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint-90000179462. The suspected product quality complaint has been confirmed to be not voided (meet PQC criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210523713-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective
Clinical narrative: WASN'T SATISFIED WITH EFFICACY RATE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient wasn't satisfied with the efficacy rate of covid-19 vaccine ad26.cov2.s , On 26-APR-2021,patient scheduled to get the first dose of Pfizer-BioNTech vaccine.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of wasn't satisfied with efficacy rate was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210524437-Covid-19 vaccine ad26.cov2.s-Wasn't Satisfied with Efficacy rate.. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Gastric disorder, Hair disorder, Irritability, Loss of consciousness, Nerve injury
Clinical narrative: ARM FROM SHOULDER TO PINKY FINGER HURTS IF SOMETHING  TOUCHES IT; FEELS IRRITATED; FEELS LIKE NERVE DAMAGE; FEELS LIKE THE HAIR ON ARMS HURT; PASSED OUT TWICE; SUNBURN LIKE FEELING IN VACCINE INJECTION ARM WITH NO REDNESS OR RASH; SEVERE STOMACH ISSUES FOR A  WEEK; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient donated blood and passed out twice.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  4 days later, the patient donated blood and for the first time ever, passed out twice. The patient had severe stomach issues for about a week but that have resolved. The patient's arm that she received the vaccine in, felt like a sunburn- no redness, rash or swelling. The patient's arm didn't hurt unless something is touching it.  It was not hot to the touch but felt very strange and very sensitive from her shoulder all the way to the tip of her pinky finger on the outer portion of arm. It was very sensitive even when washing the hands. The patient mentioned that it felt like nerves have been damaged. It felt like hair on arm hurt. It fell irritated. The caller mentioned that her daughter got the vaccine the same day and experienced the same thing but didn't last as long-maybe a couple of days and it was gone. On an unspecified date, the patient felt like passed out twice, sunburn but no redness, no rash and it started from the shoulder to pinky finger (coded as sunburn like feeling in vaccine injection arm with no redness or rash), arm from shoulder to pinky finger hurts if something touches it, feels irritated, feels like nerve damage and feels like the hair on arms hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe stomach issues for a week on MAY-2021, and the outcome of passed out twice, sunburn like feeling in vaccine injection arm with no redness or rash, arm from shoulder to pinky finger hurts if something touches it, feels irritated, feels like nerve damage and feels like the hair on arms hurt was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210531194.; Sender's Comments: V0:20210525585-covid-19 vaccine ad26.cov2.s-Passed out twice. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Skin burning sensation
Clinical narrative: ARM FROM SHOULDER TO PINKY FINGER HURTS IF SOMETHING  TOUCHES IT; FEELS IRRITATED; FEELS LIKE NERVE DAMAGE; FEELS LIKE THE HAIR ON ARMS HURT; PASSED OUT TWICE; SUNBURN LIKE FEELING IN VACCINE INJECTION ARM WITH NO REDNESS OR RASH; SEVERE STOMACH ISSUES FOR A  WEEK; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient donated blood and passed out twice.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  4 days later, the patient donated blood and for the first time ever, passed out twice. The patient had severe stomach issues for about a week but that have resolved. The patient's arm that she received the vaccine in, felt like a sunburn- no redness, rash or swelling. The patient's arm didn't hurt unless something is touching it.  It was not hot to the touch but felt very strange and very sensitive from her shoulder all the way to the tip of her pinky finger on the outer portion of arm. It was very sensitive even when washing the hands. The patient mentioned that it felt like nerves have been damaged. It felt like hair on arm hurt. It fell irritated. The caller mentioned that her daughter got the vaccine the same day and experienced the same thing but didn't last as long-maybe a couple of days and it was gone. On an unspecified date, the patient felt like passed out twice, sunburn but no redness, no rash and it started from the shoulder to pinky finger (coded as sunburn like feeling in vaccine injection arm with no redness or rash), arm from shoulder to pinky finger hurts if something touches it, feels irritated, feels like nerve damage and feels like the hair on arms hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe stomach issues for a week on MAY-2021, and the outcome of passed out twice, sunburn like feeling in vaccine injection arm with no redness or rash, arm from shoulder to pinky finger hurts if something touches it, feels irritated, feels like nerve damage and feels like the hair on arms hurt was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210531194.; Sender's Comments: V0:20210525585-covid-19 vaccine ad26.cov2.s-Passed out twice. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINATION FAILURE; This spontaneous report received from a 57 year old male patient. The patient's weight was 70 kilograms and height was 64 inches. The patient's concurrent conditions included penicillin allergy (PCN). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported 1 in total administered in left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 11-MAY-2021, Laboratory data included: COVID-19 antibody test was negative and the patient reported suspected immunological vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000179796.; Sender's Comments: V0: 20210530196-Covid-19 vaccine ad26.cov2.s- Suspected immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Musculoskeletal chest pain, Skin discolouration, Skin haemorrhage
Clinical narrative: UPPER CHEST WAS BLACK AND BLUE; CHEST TENDER TO THE TOUCH; CHEST HAD LIKE BROKEN BLOOD VESSELS; CHEST WAS TIGHT; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included veins burning, vomiting, redness, burning sensation, swelling, sick, faint, and anaphylactic reaction, and concurrent conditions included multiple sclerosis, non alcoholic, non smoker, sulfa allergy, and steroid allergy, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. Patient was not pregnant at the time of vaccination. Patient had red light therapy as well. The patient experienced drug allergy when treated with teriflunomide, influenza vaccine, interferon, prednisone, cimetidine, and glatiramer acetate. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. Concomitant medications included atorvastatin for drug used for unknown indication, losartan for drug used for unknown indication, and ibuprofen. On 28-APR-2021, the subject experienced chest was tight. On 14-MAY-2021, the subject experienced upper chest was black and blue. On 14-MAY-2021, the subject experienced chest tender to the touch. On 14-MAY-2021, the subject experienced chest had like broken blood vessels. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from upper chest was black and blue, chest was tight, chest tender to the touch, and chest had like broken blood vessels. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood immunoglobulin M decreased, Chest X-ray, Chest discomfort, Contusion, Dehydration
Clinical narrative: UPPER CHEST WAS BLACK AND BLUE; CHEST TENDER TO THE TOUCH; CHEST HAD LIKE BROKEN BLOOD VESSELS; CHEST WAS TIGHT; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included veins burning, vomiting, redness, burning sensation, swelling, sick, faint, and anaphylactic reaction, and concurrent conditions included multiple sclerosis, non alcoholic, non smoker, sulfa allergy, and steroid allergy, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. Patient was not pregnant at the time of vaccination. Patient had red light therapy as well. The patient experienced drug allergy when treated with teriflunomide, influenza vaccine, interferon, prednisone, cimetidine, and glatiramer acetate. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. Concomitant medications included atorvastatin for drug used for unknown indication, losartan for drug used for unknown indication, and ibuprofen. On 28-APR-2021, the subject experienced chest was tight. On 14-MAY-2021, the subject experienced upper chest was black and blue. On 14-MAY-2021, the subject experienced chest tender to the touch. On 14-MAY-2021, the subject experienced chest had like broken blood vessels. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from upper chest was black and blue, chest was tight, chest tender to the touch, and chest had like broken blood vessels. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Hypertension, Laboratory test abnormal, Platelet count decreased
Clinical narrative: UPPER CHEST WAS BLACK AND BLUE; CHEST TENDER TO THE TOUCH; CHEST HAD LIKE BROKEN BLOOD VESSELS; CHEST WAS TIGHT; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included veins burning, vomiting, redness, burning sensation, swelling, sick, faint, and anaphylactic reaction, and concurrent conditions included multiple sclerosis, non alcoholic, non smoker, sulfa allergy, and steroid allergy, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. Patient was not pregnant at the time of vaccination. Patient had red light therapy as well. The patient experienced drug allergy when treated with teriflunomide, influenza vaccine, interferon, prednisone, cimetidine, and glatiramer acetate. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. Concomitant medications included atorvastatin for drug used for unknown indication, losartan for drug used for unknown indication, and ibuprofen. On 28-APR-2021, the subject experienced chest was tight. On 14-MAY-2021, the subject experienced upper chest was black and blue. On 14-MAY-2021, the subject experienced chest tender to the touch. On 14-MAY-2021, the subject experienced chest had like broken blood vessels. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from upper chest was black and blue, chest was tight, chest tender to the touch, and chest had like broken blood vessels. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Medication error, Product storage error
Clinical narrative: MEDICATION ERROR; INCORRECT STORAGE OF VACCINE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced medication error. On 13-MAY-2021, the subject experienced incorrect storage of vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of the medication error and incorrect storage of vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: UNSPECIFIED ADVERSE REACTION; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes.The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included mrna 1273. On 2021, the subject experienced unspecified adverse reaction. The action taken with covid-19 vaccine  was not applicable. The outcome of unspecified adverse reaction was not reported. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Chills, Extraocular muscle paresis, Nausea, Paraesthesia
Clinical narrative: That evening high fever, chills  nausea and then few days later Bell?s palsy, face is tingling, eye won?t shut and speech hindered.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Speech disorder
Clinical narrative: That evening high fever, chills  nausea and then few days later Bell?s palsy, face is tingling, eye won?t shut and speech hindered.
Sex: U
Vaccine: COVID19
Symptoms: Vein disorder
Clinical narrative: VEINS APPEARING ON BODY/ ON THIGHS/ LOWER PARTS OF LEGS/ ON SHOULDER/ ON BOTH GROINS; This spontaneous report received from a patient . The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced veins appearing on body/ on thighs/ lower parts of legs/ on shoulder/ on both groins. The action taken with covid-19 vaccine  was not applicable. The outcome of veins appearing on body/ on thighs/ lower parts of legs/ on shoulder/ on both groins was not reported. This report was non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head normal, Computerised tomogram neck, Echocardiogram normal, Headache, Intensive care
Clinical narrative: -Abrupt      _______ , Nausea, Vomiting, Posterior Headache -Emergency Room Visit -Received tPA, which resolved symptoms -ICU admission for 2 nights
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, Nausea, Vomiting
Clinical narrative: -Abrupt      _______ , Nausea, Vomiting, Posterior Headache -Emergency Room Visit -Received tPA, which resolved symptoms -ICU admission for 2 nights
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chapped lips, Dry skin, Dyspnoea, Lip erythema, Lip exfoliation
Clinical narrative: Burning of mouth, lips, difficulty breathing.  Lips swelled, cracked and peeled.  Inside of mouth no longer burning ,   Swelling in lips has gone down, they have been peeling for days.  Lips are red, still sore, but I'm hoping they are done peeling. I really don't feel I can handle another shot of this vaccine.   I think I may have to cancel the second shot.  I don't know what is it it, everyone keeps telling me it has no penicillin or sulfa drugs in it, but the symptoms are the same.  The only difference is my hands haven't cracked and peeled along with my lips and mouth.  I've had these problems since last tuesday night and am taking Benadryl trying to get some relief from it still.  Please let me know if you have any solutions to prevent this.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Lip pain, Lip swelling, Oral discomfort, Skin disorder
Clinical narrative: Burning of mouth, lips, difficulty breathing.  Lips swelled, cracked and peeled.  Inside of mouth no longer burning ,   Swelling in lips has gone down, they have been peeling for days.  Lips are red, still sore, but I'm hoping they are done peeling. I really don't feel I can handle another shot of this vaccine.   I think I may have to cancel the second shot.  I don't know what is it it, everyone keeps telling me it has no penicillin or sulfa drugs in it, but the symptoms are the same.  The only difference is my hands haven't cracked and peeled along with my lips and mouth.  I've had these problems since last tuesday night and am taking Benadryl trying to get some relief from it still.  Please let me know if you have any solutions to prevent this.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: My menstrual cycle has been consistent (occurring every month) and there have been no changes for the past 10 years. One week before the 1st Moderna COVID-19 vaccine date, my period arrived like normal. Exactly one week after taking the first dose, I received my period once again (twice in 1 month). This is very abnormal. There were no other factors affecting my lifestyle. I believe the vaccine has contributed to my abnormal period and this should be made aware to all volunteers prior to receiving their vaccine.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nasal congestion, Nasal dryness, Throat irritation
Clinical narrative: Dry nose Scratchy throat Chills Very tired Stuffy nose
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper
Clinical narrative: PAIN IN THE LOWER RIGHT SIDE STOMACH; SWOLLEN STOMACH; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1820095, expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced pain in the lower right side stomach, and swollen stomach. The action taken with covid-19 vaccine  was not applicable. The outcome of the pain in the lower right side stomach and swollen stomach was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Pain, Pain in extremity, Sleep disorder
Clinical narrative: My arm still hurts almost 5 months later. I have shooting pains up to my shoulder and down my arm when I try to straighten it out. I wake up in pain every morning. I cant sleep on it. I do not have full range of motion.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Fever exceeding 100°F even after taking tylenol, body aches, running nose, bedridden for over 20hrs up to now. Symptoms have still not subsided at time of report.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: -Hives almost immediately after receiving vaccine -Swollen, red, raised circle around injection site, about the size of my palm, started 1-2 days after injection, lasted 2-3 days -pain at injection site for at least 2 weeks afterwards -fatigue, chills, headache, malaise starting the day after the vaccine and lasting 2-3 days
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Malaise, Urticaria
Clinical narrative: -Hives almost immediately after receiving vaccine -Swollen, red, raised circle around injection site, about the size of my palm, started 1-2 days after injection, lasted 2-3 days -pain at injection site for at least 2 weeks afterwards -fatigue, chills, headache, malaise starting the day after the vaccine and lasting 2-3 days
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests normal, Tinnitus
Clinical narrative: I started noticing a hissing sound in my left ear. Initially noticed it was on and off  since ~4/25. However, it persisted and especially noticeable at night since ~5/4. I tried using Debrox and visited ENT on 5/10. ENT Dr. cleaned wax but "tinnitus" persisted.   I have no history of tinnutus and audiology test is also normal.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Neuralgia, Pain in extremity, Rash, Sciatic nerve neuropathy
Clinical narrative: Shingles: pain in the right left along sciatic nerve. Rash on right buttocks, and on right ankle. Still occurring, it has been 8 days since the pain in my right leg began.