chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Papilloma viral infection, Staphylococcal infection, Vaccination failure
Clinical narrative: Staph infection; had a lack of effect; HPV; This spontaneous report has been received from a consumer, who was the patient's mother, referring to a female patient of unknown age. Information about her pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions and allergies was not provided.  On an unknown date (reported also as "in the past"), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number and expiration date were not reported).  On an unknown date, the patient experienced human papillomavirus (HPV) (papilloma viral infection), so it was reported that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) had a lack of effect (vaccination failure). It was mentioned that the patient experienced a "staph" infection (staphylococcal infection), on an unknown date, after the shot, as well.   Information about treatment for the events, if any laboratory diagnostics were performed, or if the patient sought medical attention was not provided.  At the time of report, the patient had not recovered from the papilloma viral infection. The outcome of vaccination failure and staphylococcal infection was not provided.  The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and papilloma viral infection, and vaccination failure was considered related by the reporter. The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and staphylococcal infection was not provided.  Upon internal review, staphylococcal infection was determined to be a medically significant event.  This was one case of two from the same reporter.; Sender's Comments:  US-009507513-2105USA007264:
Sex: F
Vaccine: HPV9
Symptoms: Papilloma viral infection, Staphylococcal infection, Vaccination failure
Clinical narrative: The patients also experienced a Staph infection after the GARDASIL 9 shot as well; Vaccination failure; HPV; This spontaneous report has been received from a consumer, who was the patient's mother, referring to a female patient of unknown age. Information about her pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions and allergies was not provided.  On an unknown date (reported also as "in the past"), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number and expiration date were not reported).  On an unknown date, the patient experienced human papillomavirus (HPV) (papilloma viral infection), so it was reported that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) had a lack of effect (vaccination failure). It was mentioned that the patient experienced a "staph" infection (staphylococcal infection), on an unknown date, after the shot, as well.   Information about treatment for the events, if any laboratory diagnostics were performed, or if the patient sought medical attention was not provided.  At the time of report, the patient had not recovered from the papilloma viral infection. The outcome of vaccination failure and staphylococcal infection was not provided.  The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and papilloma viral infection, and vaccination failure was considered related by the reporter. The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and staphylococcal infection was not provided.  Upon internal review, staphylococcal infection was determined to be a medically significant event.  This was one case, of two from  the same reporter.; Sender's Comments:  US-009507513-2105USA007258:
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Precancerous cells present, Smear cervix abnormal
Clinical narrative: being diagnosed with "HPV pre-cancerous cells for cervical cancer"; being diagnosed with "HPV pre-cancerous cells for cervical cancer"; Information has been received from a 30 years old female patient (inconsistent information: age also reported as 32) via an agent, referring to herself. Information of concomitant medication and medical history was not reported. The patient had no drug reactions or allergies.  On an unknown date when the patient at 18 or 19 years old (inconsistency information: therapy start date also reported as 30 years old), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)(dose detail, frequency, route, lot# and expiration were unknown) for prophylaxis.         On an unknown date when the patient at 30 years old, the patient was diagnosed with "human papilloma virus (HPV) pre-cancerous cells for cervical cancer" (precancerous cells present and papilloma viral infection). The patient received treatment of a "leak was placed" and a present status of "negative with two normal pap smears". The outcome of the events was reported as recovered. The causality assessment between these events and suspect product was not provided by the reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shot and the booster, and got the shingles anyway /Suspected Vaccination failure; had the shot and the booster, and got the shingles anyway !; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine and Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received shot and the booster, and got the shingles anyway. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation for shingles infection and time to event onset was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: friends that got shingles after the shot/Suspected Vaccination failure; friends that got shingles after the shot; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received Shingles vaccine and friends that got shingles. The reporter reported that no guarantee that you will not get them again. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection and time to event onset was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site is red; Injection site is/swollen; This case was reported by a consumer via (Shingrix GSK and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th May 2021, the patient received Shingrix. In May 2021, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not reported. The patient got the Shingrix shot on the arm. After vaccination, the patient's arm around the injection site was red and swollen. The patient asked what he/she should do.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Computerised tomogram, Dizziness, Feeling of body temperature change, Hypoaesthesia
Clinical narrative: sepsis; Inflammatory; Faint; Cold; lightheaded; extreme pain; no movement in the right arm; Arm goes numb at night; shoulder pain; This case was reported by a lawyer and described the occurrence of sepsis in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The initial information received via Medical record on 27 May 2021: the patient received Shingrix vial Kit Pharmacy in the Right arm on 02 Oct 2019, one hour after the shot the arm was getting really sore, and was having a hard lifting or moving right arm. Lunch time he noticed that he was becoming faint, hot then cold, then lightheaded. He thought it was linked to a heart catheter he got implanted about 2 weeks ago, went to Medical Center and they took him right in. They could not get a pulse in the right arm or in finger, and sent him to hospital in ambulance. Now he has no movement in the right arm, extreme pain, at the hospital he was admitted, he got sepsis diagnosis after 3 days. Arm was still sore, and he got a cat scan, sonogram, and a bunch of other tests as well. Arm was currently sore, arm goes numb at night, no rash. They gave the shot all the way up in the shoulder not in muscle and doctors felt it might have penetrated tissue or the rotator cuff. He reported this to pharmacy and they reported it to staff and they asked if he was going to file a claim. They only gave diagnosis of Sepsis on shoulder, also had shoulder pain. He had copies of the shot lot number and all that information. On 21 Nov 2019, he had experienced inflammatory.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Inflammation, Laboratory test, Mobility decreased, Movement disorder
Clinical narrative: sepsis; Inflammatory; Faint; Cold; lightheaded; extreme pain; no movement in the right arm; Arm goes numb at night; shoulder pain; This case was reported by a lawyer and described the occurrence of sepsis in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The initial information received via Medical record on 27 May 2021: the patient received Shingrix vial Kit Pharmacy in the Right arm on 02 Oct 2019, one hour after the shot the arm was getting really sore, and was having a hard lifting or moving right arm. Lunch time he noticed that he was becoming faint, hot then cold, then lightheaded. He thought it was linked to a heart catheter he got implanted about 2 weeks ago, went to Medical Center and they took him right in. They could not get a pulse in the right arm or in finger, and sent him to hospital in ambulance. Now he has no movement in the right arm, extreme pain, at the hospital he was admitted, he got sepsis diagnosis after 3 days. Arm was still sore, and he got a cat scan, sonogram, and a bunch of other tests as well. Arm was currently sore, arm goes numb at night, no rash. They gave the shot all the way up in the shoulder not in muscle and doctors felt it might have penetrated tissue or the rotator cuff. He reported this to pharmacy and they reported it to staff and they asked if he was going to file a claim. They only gave diagnosis of Sepsis on shoulder, also had shoulder pain. He had copies of the shot lot number and all that information. On 21 Nov 2019, he had experienced inflammatory.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Sepsis, Ultrasound scan
Clinical narrative: sepsis; Inflammatory; Faint; Cold; lightheaded; extreme pain; no movement in the right arm; Arm goes numb at night; shoulder pain; This case was reported by a lawyer and described the occurrence of sepsis in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The initial information received via Medical record on 27 May 2021: the patient received Shingrix vial Kit Pharmacy in the Right arm on 02 Oct 2019, one hour after the shot the arm was getting really sore, and was having a hard lifting or moving right arm. Lunch time he noticed that he was becoming faint, hot then cold, then lightheaded. He thought it was linked to a heart catheter he got implanted about 2 weeks ago, went to Medical Center and they took him right in. They could not get a pulse in the right arm or in finger, and sent him to hospital in ambulance. Now he has no movement in the right arm, extreme pain, at the hospital he was admitted, he got sepsis diagnosis after 3 days. Arm was still sore, and he got a cat scan, sonogram, and a bunch of other tests as well. Arm was currently sore, arm goes numb at night, no rash. They gave the shot all the way up in the shoulder not in muscle and doctors felt it might have penetrated tissue or the rotator cuff. He reported this to pharmacy and they reported it to staff and they asked if he was going to file a claim. They only gave diagnosis of Sepsis on shoulder, also had shoulder pain. He had copies of the shot lot number and all that information. On 21 Nov 2019, he had experienced inflammatory.
Sex: U
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: GBS; This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The initial information received via Medical record on 27 May 2021: On 25 Jun 2020, the patient received Shingrix (unknown). On 02 Jul 2020, the patient experienced guillain barre syndrome. On an unknown date, the outcome of the guillain barre syndrome was unknown.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Paraesthesia
Clinical narrative: shingles; tingling sensation; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th February 2021, the patient received the 1st dose of Shingrix (intramuscular). On 28th April 2021, 78 days after receiving Shingrix, the patient experienced shingles and tingling sensation. On an unknown date, the outcome of the shingles was recovering/resolving and the outcome of the tingling sensation was not recovered/not resolved.   It was unknown if the reporter considered the shingles and tingling sensation to be related to Shingrix.  Additional details were provided as follows: The patient reported case for herself. The patient received Shingrix vaccine in the muscle, in the right deltoid at the pharmacy. The patient had shingles. The patient mentioned that the shingles were almost gone but she was still having tingling sensation. The patient did not have a lot number, expiration date and dose of the vaccine, she provided NDC (national drug code) number of Shingrix (NDC: 58160-0823-11) and mentioned the receipt said 10 pack of Shingrix.  The reporter did not consent to follow up. The reporter did not give a consent to follow up with healthcare professional.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose of shingrix on 5/27/2019 did not receive 2nd dose; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose of Shingrix on 27th May 2019, batch number-494PR, expiry date-13th September 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter enquired to restart series or one dose should be given. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose of Shingrix on 04Jan2020 and is late for the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 4th January 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 did not receive his 2nd Shingrix dose till the time of reporting, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: MAGNETS ARE STICKING TO ARM; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced magnets are sticking to arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of magnets are sticking to arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210603994.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose decreased
Clinical narrative: LOW BLOOD SUGAR BELOW 30 FOR THE PAST 2 WEEKS AFTER RECEIVING THE JANSSEN VACCINE; This spontaneous report received from a parent concerned a 24-year-old white and not Hispanic or Latino female. The patient's weight was 115 pounds, and height was 50 inches. The patient's concurrent conditions included diabetes type I, diabetic ketoacidosis, nonsmoker, nonalcoholic, developmentally delayed, cyclic vomiting, gastroparesis, hernia hiatal, esophagitis, acid reflux, Gastroesophageal reflux disease, and regular migranes. Patient had no known allergies. The patient had no drug abuse or illicit drug usage. Patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 23-JUN-2021) dose was not reported, 1 total administered on 18-MAY-2021 on left arm for prophylactic vaccination. Concomitant medications included insulin aspart for diabetic ketoacidosis.  On 16-MAY-2021 the patient was being admitted to hospital for diabetic ketoacidosis. After receiving vaccine patient started having very low blood sugar. Patient was on daily medications of Novolog Insulin using Pump with sensor for Keto acidosis. On 19-MAY-2021, the patient experienced low blood sugar below 30 for the past 2 weeks after receiving the janssen vaccine. Laboratory data (dates unspecified) included: Blood sugar decreased (NR: not provided) as below 30. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low blood sugar below 30 for the past 2 weeks after receiving the janssen vaccine. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210601568-COVID-19 VACCINE AD26.COV2.S- low blood sugar below 30 for the past 2 weeks after receiving the janssen vaccine. 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: CONMEDS-OTHER SUSPECT DRUGS, MEDICAL HISTORY.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient had no drug abuse or illicit drug usage. It was not reported if the patient consumed alcohol or smoke. 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 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. No concomitant medications were reported.  The patient donated blood 2 weeks ago, so 7 weeks after vaccination on  27-MAY-2021, the antibody test showed negative (coded as confirmed immunological vaccine failure). The retested today (as reported) on 01-JUN-2021, and was again negative. The patient was curious if she would get a different vaccine product or booster. The patient's daughter did not want her to visit as the patient have not seen granddaughter in over a year, since her daughter felt that the patient was unprotected.  On 27-MAY-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) Negative. On 01-JUN-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint (PQC).; Sender's Comments: V0: 20210602347-COVID-19 VACCINE AD26.COV2.S-CONFIRMED IMMUNOLOGICAL VACCINE FAILURE. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: ITCHY RASH; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's past medical history included Caesarean section and concurrent conditions included nephrotic syndrome, asthma, and penicillin allergy, and other pre-existing medical conditions included the patient is currently breast-feeding. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 31-MAY-2021 for prophylactic vaccination.  No concomitant medications were reported. On 31-MAY-2021, the subject experienced itchy rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of itchy rash was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included pcn allergy, alcohol user, and non-smoker, and other pre-existing medical conditions included the patient has no diagnostic data available. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21-JUN-2021) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-MAY-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Hypokinesia, Loss of personal independence in daily activities, Peripheral swelling, Testicular swelling
Clinical narrative: BILATERAL SWOLLEN LEGS FROM HIP TO FEET; SWOLLEN TESTICLES; DIFFICULTY AMBULATING UPSTAIRS; DIFFICULTY PUTTING ON SHOES; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's past medical history included open heart surgery, and aortic aneurysm. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. Concomitant medications included furosemide for heart surgery. On 04-MAY-2021, the subject experienced bilateral swollen legs from hip to feet. On 04-MAY-2021, the subject experienced swollen testicles. On 04-MAY-2021, the subject experienced difficulty ambulating upstairs. On 04-MAY-2021, the subject experienced difficulty putting on shoes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bilateral swollen legs from hip to feet, swollen testicles, difficulty ambulating upstairs, and difficulty putting on shoes. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: MAGNETS ARE STICKING TO ARM; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 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 subject experienced magnets are sticking to arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of magnets are sticking to arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210601258.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Vascular pain
Clinical narrative: SHARP PAIN FOR HALF SECOND IN VEINS ON WRIST, LEG; HEADACHE FOR 2 HOURS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced sharp pain for half second in veins on wrist, leg, and headache for 2 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sharp pain for half second in veins on wrist, leg, and headache for 2 hours. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: Pericarditis; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (Pericarditis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 23-Feb-2021, the patient experienced PERICARDITIS (Pericarditis) (seriousness criterion medically significant). The patient was treated with CLONIDINE for Symptomatic treatment, at an unspecified dose and frequency and MORPHINE for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PERICARDITIS (Pericarditis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter.  The patient had a pace maker put in on 23-Feb-2021 and had pericarditis the same day. About two weeks before Easter, the patient had pain every time she took a breath like she was going to have a heart attack.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship is unlikely.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship is unlikely.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Conductive deafness, Deafness neurosensory, Ear congestion, Ear discomfort
Clinical narrative: Conductive deafness; Ear discomfort; Paranasal sinus discomfort; Ear congestion; Hypoacusis; sensorineural hearing loss; This spontaneous case was reported by a health care professional and describes the occurrence of CONDUCTIVE DEAFNESS (Conductive deafness) and DEAFNESS NEUROSENSORY (sensorineural hearing loss) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included PREDNISONE, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), LEVOTHYROXINE SODIUM (SYNTHROID), ESTRADIOL (ESTRACE VAGINAL), PROGESTERONE, DEXLANSOPRAZOLE (DEXILANT) and ESTRADIOL (MENOSTAR) for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONDUCTIVE DEAFNESS (Conductive deafness) (seriousness criterion medically significant), EAR DISCOMFORT (Ear discomfort), PARANASAL SINUS DISCOMFORT (Paranasal sinus discomfort), EAR CONGESTION (Ear congestion), HYPOACUSIS (Hypoacusis) and DEAFNESS NEUROSENSORY (sensorineural hearing loss) (seriousness criterion medically significant). The patient was treated with NEOMYCIN at an unspecified dose and frequency; POLYMYXIN on 25-May-2021 at an unspecified dose and frequency; FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) (nasal) at an unspecified dose and frequency and PREDNISONE on 20-May-2021 at an unspecified dose and frequency. At the time of the report, CONDUCTIVE DEAFNESS (Conductive deafness), EAR DISCOMFORT (Ear discomfort), PARANASAL SINUS DISCOMFORT (Paranasal sinus discomfort), EAR CONGESTION (Ear congestion), HYPOACUSIS (Hypoacusis) and DEAFNESS NEUROSENSORY (sensorineural hearing loss) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: mixed sensory neuro/conductive hearing loss (abnormal) mixed sensory neuro/conductive hearing loss.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with the drug in response to events was not applicable.  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.   Symptoms were still ongoing and present at the time of this report; 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Paranasal sinus discomfort
Clinical narrative: Conductive deafness; Ear discomfort; Paranasal sinus discomfort; Ear congestion; Hypoacusis; sensorineural hearing loss; This spontaneous case was reported by a health care professional and describes the occurrence of CONDUCTIVE DEAFNESS (Conductive deafness) and DEAFNESS NEUROSENSORY (sensorineural hearing loss) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included PREDNISONE, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), LEVOTHYROXINE SODIUM (SYNTHROID), ESTRADIOL (ESTRACE VAGINAL), PROGESTERONE, DEXLANSOPRAZOLE (DEXILANT) and ESTRADIOL (MENOSTAR) for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONDUCTIVE DEAFNESS (Conductive deafness) (seriousness criterion medically significant), EAR DISCOMFORT (Ear discomfort), PARANASAL SINUS DISCOMFORT (Paranasal sinus discomfort), EAR CONGESTION (Ear congestion), HYPOACUSIS (Hypoacusis) and DEAFNESS NEUROSENSORY (sensorineural hearing loss) (seriousness criterion medically significant). The patient was treated with NEOMYCIN at an unspecified dose and frequency; POLYMYXIN on 25-May-2021 at an unspecified dose and frequency; FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) (nasal) at an unspecified dose and frequency and PREDNISONE on 20-May-2021 at an unspecified dose and frequency. At the time of the report, CONDUCTIVE DEAFNESS (Conductive deafness), EAR DISCOMFORT (Ear discomfort), PARANASAL SINUS DISCOMFORT (Paranasal sinus discomfort), EAR CONGESTION (Ear congestion), HYPOACUSIS (Hypoacusis) and DEAFNESS NEUROSENSORY (sensorineural hearing loss) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: mixed sensory neuro/conductive hearing loss (abnormal) mixed sensory neuro/conductive hearing loss.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with the drug in response to events was not applicable.  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.   Symptoms were still ongoing and present at the time of this report; 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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Diverticulitis, Malaise, Off label use
Clinical narrative: Felt seek; Diverticulitis exacerbation; Recommendations to defer the second vaccination from Physician; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-May-2021 and was forwarded to Moderna on 25-May-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIVERTICULITIS (Diverticulitis exacerbation) in a 59-year-old female 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.     Concomitant products included METFORMIN, ROSUVASTATIN, ATENOLOL, LANSOPRAZOLE (PREVACID), ALPRAZOLAM (XANAX), VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and DICYCLOMINE [DICYCLOVERINE] for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced OFF LABEL USE (Recommendations to defer the second vaccination from Physician). On 17-Apr-2021, the patient experienced DIVERTICULITIS (Diverticulitis exacerbation) (seriousness criterion medically significant). On 25-May-2021, the patient experienced MALAISE (Felt seek). At the time of the report, DIVERTICULITIS (Diverticulitis exacerbation) and MALAISE (Felt seek) had not resolved and OFF LABEL USE (Recommendations to defer the second vaccination from Physician) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that the patient was not hospitalized and had no surgery but received recommendations to defer the second vaccination from Physician. For now patient still had exacerbation and "felt seek" so asked to defer second vaccination presumably on 05Jun2021 which is out of recommended time frame. No treatment information was provided.  Company Comment : 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.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Product administered to patient of inappropriate age, Pyrexia, Seizure
Clinical narrative: Inappropriate age at vaccine administration; Fever; Chills; bodyache; Seizure; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-May-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) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (bodyache). On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). At the time of the report, SEIZURE (Seizure), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (bodyache) outcome was unknown. Not Provided          No concomitant medications were provided by the reporter.   No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events Seizure, Pyrexia, Chills, and Myalgia, a causal relationship cannot be excluded.  This report also refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # unknown, with no associated AEs.; 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 Seizure, Pyrexia, Chills, and Myalgia, a causal relationship cannot be excluded.  This report also refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # unknown, with no associated AEs.
Age: 49.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Cataract, Dialysis, Fatigue, Feeling abnormal, Feeling cold
Clinical narrative: Cataract; Dialysis; Feeling cold; Feeling hot; Feeling abnormal; Post procedural complication; Sleepiness; Fatigue/Tiredness; This spontaneous case was reported by a physician and describes the occurrence of CATARACT (Cataract) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to severe Crohn's disease).   In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced CATARACT (Cataract) (seriousness criterion medically significant), DIALYSIS (Dialysis), FEELING COLD (Feeling cold), FEELING HOT (Feeling hot), FEELING ABNORMAL (Feeling abnormal), POST PROCEDURAL COMPLICATION (Post procedural complication), SOMNOLENCE (Sleepiness) and FATIGUE (Fatigue/Tiredness). At the time of the report, CATARACT (Cataract), DIALYSIS (Dialysis), FEELING COLD (Feeling cold), SOMNOLENCE (Sleepiness) and FATIGUE (Fatigue/Tiredness) had not resolved, FEELING HOT (Feeling hot) had resolved, FEELING ABNORMAL (Feeling abnormal) was resolving and POST PROCEDURAL COMPLICATION (Post procedural complication) outcome was unknown.        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.   Concomitant product use was not reported.   Treatment information was not reported.  Company Comment: Very limited information regarding the events, Cataract, Dialysis, feeling cold, feeling hot, Feeling abnormal, Post procedural complication, Sleepiness, Fatigue has been provided at this time for an adult male patient who received mRNA-1273 on an unknown date. There is no patient information to further request for an additional information.; Sender's Comments: Very limited information regarding the events, Cataract, Dialysis, feeling cold, feeling hot, Feeling abnormal, Post procedural complication, Sleepiness, Fatigue has been provided at this time for an adult male patient who received mRNA-1273 on an unknown date. There is no patient information to further request for an additional information.
Age: 49.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Feeling hot, Post procedural complication, Somnolence
Clinical narrative: Cataract; Dialysis; Feeling cold; Feeling hot; Feeling abnormal; Post procedural complication; Sleepiness; Fatigue/Tiredness; This spontaneous case was reported by a physician and describes the occurrence of CATARACT (Cataract) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to severe Crohn's disease).   In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced CATARACT (Cataract) (seriousness criterion medically significant), DIALYSIS (Dialysis), FEELING COLD (Feeling cold), FEELING HOT (Feeling hot), FEELING ABNORMAL (Feeling abnormal), POST PROCEDURAL COMPLICATION (Post procedural complication), SOMNOLENCE (Sleepiness) and FATIGUE (Fatigue/Tiredness). At the time of the report, CATARACT (Cataract), DIALYSIS (Dialysis), FEELING COLD (Feeling cold), SOMNOLENCE (Sleepiness) and FATIGUE (Fatigue/Tiredness) had not resolved, FEELING HOT (Feeling hot) had resolved, FEELING ABNORMAL (Feeling abnormal) was resolving and POST PROCEDURAL COMPLICATION (Post procedural complication) outcome was unknown.        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.   Concomitant product use was not reported.   Treatment information was not reported.  Company Comment: Very limited information regarding the events, Cataract, Dialysis, feeling cold, feeling hot, Feeling abnormal, Post procedural complication, Sleepiness, Fatigue has been provided at this time for an adult male patient who received mRNA-1273 on an unknown date. There is no patient information to further request for an additional information.; Sender's Comments: Very limited information regarding the events, Cataract, Dialysis, feeling cold, feeling hot, Feeling abnormal, Post procedural complication, Sleepiness, Fatigue has been provided at this time for an adult male patient who received mRNA-1273 on an unknown date. There is no patient information to further request for an additional information.