chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Chills, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: ACHE; CHILLS; SORE ARM; SLIGHTLY KICKING MY BUTT; This spontaneous report received from a patient via a company representative 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 was not reported, administered on 11-JUN-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 12-JUN-2021, the subject experienced ache. On 12-JUN-2021, the subject experienced chills. On 12-JUN-2021, the subject experienced sore arm. On 12-JUN-2021, the subject experienced slightly kicking my butt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the ache, sore arm, chills and slightly kicking my butt was not reported. This report was non-serious.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Confusional state, Cough, Dyspnoea, Headache
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a 20 year old male. 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: 1821288, and expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 14:25 for prophylactic vaccination. No concomitant medications were reported. On 10-JUN-2021, the subject experienced headache. On 11-JUN-2021, the subject experienced could not think, confused. On 11-JUN-2021, the subject experienced vomit. On 11-JUN-2021, the subject experienced cough. On 11-JUN-2021, the subject experienced lack of air. On 11-JUN-2021, the subject experienced heavy sweating. On 11-JUN-2021, the subject experienced extreme pain in his legs (described as the worst of any workout he has ever done in his life). On 11-JUN-2021, the subject experienced chills. On 11-JUN-2021, the subject experienced fever. Treatment medications (dates unspecified) included: salbutamol. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not think, confused, vomit, cough, lack of air, heavy sweating, extreme pain in his legs (described as the worst of any workout he has ever done in his life), chills, fever, and headache on 12-JUN-2021. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a 20 year old male. 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: 1821288, and expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 14:25 for prophylactic vaccination. No concomitant medications were reported. On 10-JUN-2021, the subject experienced headache. On 11-JUN-2021, the subject experienced could not think, confused. On 11-JUN-2021, the subject experienced vomit. On 11-JUN-2021, the subject experienced cough. On 11-JUN-2021, the subject experienced lack of air. On 11-JUN-2021, the subject experienced heavy sweating. On 11-JUN-2021, the subject experienced extreme pain in his legs (described as the worst of any workout he has ever done in his life). On 11-JUN-2021, the subject experienced chills. On 11-JUN-2021, the subject experienced fever. Treatment medications (dates unspecified) included: salbutamol. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not think, confused, vomit, cough, lack of air, heavy sweating, extreme pain in his legs (described as the worst of any workout he has ever done in his life), chills, fever, and headache on 12-JUN-2021. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: LIGHT FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 12-JUN-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 12-JUN-2021, the subject experienced light fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of light fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Oxygen saturation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; 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 concurrent conditions included chronic obstructive pulmonary disease (COPD). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 1 total, dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 12-MAY-2021 or 13-MAY-2021, the patient had contact with COVID-19 and was tested positive on 18-MAY-2021 (suspected clinical vaccination failure and suspected covid-19 infection). The patient never had fever. The patient had few chills, runny nose and body aches. It was reported that COVID-19 had never affected the patient's lungs. The patient had oxygen at home and used as needed and monitored her levels on a daily basis. The patient had stayed hydrated, took Tylenol (paracetamol) daily, double doses of Vitamin D (ergocalciferol), Vitamin C (ascorbic acid,), Elderberry (sambucus nigra) and zinc. The patient had not visited hospital. On 27-MAY-2021, the patient tested negative for COVID-19. The patient was still working to get strength back.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000182683. 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: V0:20210628624- 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: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Therapy non-responder
Clinical narrative: This spontaneous report received from a patient concerned a male of unspecified age, race and ethnic origin. 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 and expiry: 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. On 12-JUNE-2021, the patient took a blood test to check that he had generated antibodies and the result was the following: Immunoglobulin G (IgG) antibodies: 0.018 Negative - 0.018 index (S/C) [Assay results were reported as an index value of the ratio of specimen to calibrator absorbance (S/C or S/CO)], Immunoglobulin M (IgM) antibodies: 1.17 Positive - 1.17 index (S / C) Given this result, the antibodies that protect against the virus had not been generated after 60 days of application of the vaccine (confirmed immunological vaccine failure). 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: 90000182752. The suspected product quality complaint has been confirmed to be non-voided based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210628716-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccine failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Malaise, Musculoskeletal discomfort, Nausea
Clinical narrative: STOMACH PAIN; BACK DISCOMFORT; NAUSEA; MALAISE; 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 was not reported, administered on 08-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-JUN-2021, the subject experienced malaise. On 12-JUN-2021, the subject experienced stomach pain. On 12-JUN-2021, the subject experienced back discomfort. On 12-JUN-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, stomach pain, and back discomfort, and the outcome of malaise was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous report received from a pharmacist 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, intramuscular, batch number: 204A21A, and expiry: 11-JUN-2021) .5 ml, administered on 12-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, the subject experienced expired vaccine used. On 12-JUN-2021, the subject experienced incorrect product storage. The outcome of the expired vaccine used and incorrect product storage was not reported. This report was non-serious.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Pain in extremity, Skin haemorrhage
Clinical narrative: This spontaneous report received from a patient concerned a 77 year old female. The patient's weight was 160 pounds, and height was 62 inches. The patient's concurrent conditions included hypertension, depression, allergy to cat dander ( sneezing, watering eyes), no alcohol use, and non-smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient experienced dryness of mouth (drug allergy) when treated with codeine. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced right and left arm soreness two to three days after the shot. On JUN-2021, the subject experienced headache. On JUN-2021, the subject experienced redness at injection site. On 10-JUN-2021, the subject experienced bleeding spots under the skin on right arm. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The outcome of the bleeding spots under the skin on right arm, headache, right and left arm soreness two to three days after the shot and redness at injection site was not reported. This report was non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: MAGNETS STUCK TO INJECTION SITE; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, expiry: 18-AUG-2021) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-MAY-2021, the subject experienced magnets stuck to injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from magnets stuck to injection site. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Heavy menstrual bleeding, Pyrexia
Clinical narrative: MENSTRUAL CYCLE LASTED 10 DAYS; FEVER; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no illness at the time of vaccination, no known allergies. with the existing information. in the past 14 days, patient had not been in close contact with anyone who tested positive for covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A, and expiry: JUN-2021) .5 ml, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, Laboratory data included: Body temperature (NR: not provided) 97.5 F. On 13-MAY-2021, the subject experienced fever. On JUN-2021, the subject experienced menstrual cycle lasted 10 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and the outcome of menstrual cycle lasted 10 days was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Vision blurred
Clinical narrative: EXTREMELY ITCHY EYES; BLURRED VISION; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 04-JUN-2021, the subject experienced extremely itchy eyes. On 04-JUN-2021, the subject experienced blurred vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from extremely itchy eyes, and blurred vision. This report was non-serious.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTERED VACCINE AT ROOM TEMPERATURE FOR 4 HOURS; VACCINE STORED OUTSIDE OF THE RECOMMENDED STORAGE CONDITIONS; This spontaneous report received from a health care professional concerned a 65 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies and no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A expiry: 07-AUG-2021) dose was not reported, administered on 14-JUN-2021 13:36 for prophylactic vaccination. No concomitant medications were reported.  On 14-JUN-2021, the subject experienced administered vaccine at room temperature for 4 hours. On 14-JUN-2021, the subject experienced vaccine stored outside of the recommended storage conditions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered vaccine at room temperature for 4 hours and vaccine stored outside of the recommended storage conditions was not reported. This report was non-serious. This case, from the same reporter is linked to 20210630313.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: VACCINE ERROR ADMINISTERED 10 MINUTES PAST 6 HOURS OF 1ST PUNCTURE; 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 vaccine error administered 10 minutes past 6 hours of 1st puncture. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine error administered 10 minutes past 6 hours of 1st puncture was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, a month after vaccination, the patient donated blood and found out he still did not have the antibodies (confirmed immunological vaccine failure), then after a month again he donated blood and did not have the antibody or antigen in blood. Laboratory data included: Antibody test (NR: not provided) Negative. On JUN-2021, Laboratory data included: 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).; Sender's Comments: V0: 20210630149-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.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: BLOOD GLUCOSE STABILIZATION/UNEXPECTED THERAPEUTIC BENEFIT; This spontaneous report received from a consumer concerned a 75 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. Concomitant medications included insulin aspart for type 2 diabetes, insulin degludec for type 2 diabetes, liraglutide for type 2 diabetes, and metformin for type 2 diabetes. On JUN-2021, the subject experienced blood glucose stabilization/unexpected therapeutic benefit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood glucose stabilization/unexpected therapeutic benefit was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: LEFT OUT OF FRIDGE BEYOND 6 HOURS; This spontaneous report received from a pharmacist 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, intramuscular, batch number: 1821288, expiry: 01-AUG-2021) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced left out of fridge beyond 6 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of left out of fridge beyond 6 hours was not reported. This report was non-serious. This case, from the same reporter is linked to 20210619240.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Pain
Clinical narrative: CHILLS; HEADACHES; FEVER; FATIGUE; BODY ACHES; LOSS OF APPETITE; SORE ARM; This spontaneous report received from a parent concerned an 18 year old male. 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: 206A21A expiry: UNKNOWN) dose was not reported, administered on 12-JUN-2021 17:45 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, the subject experienced sore arm. On 13-JUN-2021, the subject experienced body aches. On 13-JUN-2021, the subject experienced loss of appetite. On 13-JUN-2021, the subject experienced chills. On 13-JUN-2021, the subject experienced headaches. On 13-JUN-2021, the subject experienced fever. On 13-JUN-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm, and the outcome of chills, fever, headaches, body aches, loss of appetite and fatigue was not reported. This report was non-serious.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: CHILLS; HEADACHES; FEVER; FATIGUE; BODY ACHES; LOSS OF APPETITE; SORE ARM; This spontaneous report received from a parent concerned an 18 year old male. 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: 206A21A expiry: UNKNOWN) dose was not reported, administered on 12-JUN-2021 17:45 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, the subject experienced sore arm. On 13-JUN-2021, the subject experienced body aches. On 13-JUN-2021, the subject experienced loss of appetite. On 13-JUN-2021, the subject experienced chills. On 13-JUN-2021, the subject experienced headaches. On 13-JUN-2021, the subject experienced fever. On 13-JUN-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm, and the outcome of chills, fever, headaches, body aches, loss of appetite and fatigue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On JUN-2021, treatment medications included: paracetamol. On 12-JUN-2021, the subject experienced body aches. On 12-JUN-2021, the subject experienced chills. On 12-JUN-2021, the subject experienced fever. On 12-JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, chills, headache, and body aches. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: HIGH BLOOD PRESSURE/BLOOD PRESSURE OUT OF WHACK; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient not had any drug abuse / illicit drug use. the patient did not drink caffeine and had no high sodium. the patient had no change in his life. 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 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 165-180 (unit not reported), 140-165 (unit not reported). On MAR-2021, treatment medications included: metoprolol. On 24-MAR-2021, the subject experienced high blood pressure/blood pressure out of whack. On 15-JUN-2021, Laboratory data included: Blood pressure (NR: not provided) 165-180 (unit not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from high blood pressure/blood pressure out of whack. This report was non-serious.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: MUSCLE TWITCH IN BOTH ARMS; This spontaneous report received from a parent concerned a 25 year old male. 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: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced muscle twitch in both arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle twitch in both arms on 2021. This report was non-serious.
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: RECEIVED A VACCINE OUTSIDE OF 6 HOUR WINDOW; This spontaneous report received from a health care professional concerned a 47 year old of unspecified 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: 202A21A, expiry: 07-AUG-2021) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUN-2021, the subject experienced received a vaccine outside of 6 hour window. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received a vaccine outside of 6 hour window was not reported. This report was non-serious.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 65 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 14-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-JUN-2021, the subject experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Peripheral swelling
Clinical narrative: ARM SWELLED UP; BRUISES AROUND AREA PUNCTURED TURNED BLACK AND BLUE; This spontaneous report received from a parent concerned a male 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced arm swelled up, and bruises around area punctured turned black and blue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm swelled up and bruises around area punctured turned black and blue was not reported. This report was non-serious. This parent/child case is linked to 20210555169.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Tinnitus
Clinical narrative: Ringing/pain in both ears, nasal drip
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Shoulder injury related to vaccine administration
Clinical narrative: SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION.  LEFT SHOULDER PAIN POST COVID VACCINE ADMINISTRATION.  EXAM IS NORMAL BUT APPEARS INJECTION WAS PLACED INTHE INSERTION OF THE DELTOID OR POSSIBLY SUBACROMIAL SPACE VICE THE DELTOID MUSCLE BELLY BASED ON PHYSICAL EXAM AND SUBJECTIVE COMPLAINT.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Itchy, painfully, swollen and hard patch  at injection site   Started on the night of June 16th
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; FEVER; A LOT OF FATIGUE; This spontaneous report received from a patient via a company representative 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 body aches, chills, fever, and a lot of fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, body aches and a lot of fatigue was not reported. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Headache, Hypoaesthesia, Limb discomfort
Clinical narrative: BONES HURTING SEVERELY ALL OVER THE HIPS KNEES ANKLES RIBS ARMS AND BACK; TINGLING IN RIGHT ARM; NUMBNESS IN RIGHT ARM; BODY ACHES LIKE THE FLU; LIPS TINGLING BUT NOT SWOLLEN  HAPPENED ONLY ONCE FOR HALF HOUR; SQUEEZING LIKE PRESSURE ON RIGHT ARM FELT LIKE RUBBER AROUND BANDS ARMS AND BLOCKING CIRCULATION; JOINT PAIN; HEADACHE ON RIGHT TOP SIDE OF HEAD; FEVER TEMP HIGHEST 104.1F TO  RANGE OF 102F; MUSCLE PAIN; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient not tested positive for covid, not aware that has had covid before, ended up in emergency room last fall due to non covid virus. The patient experienced got sick like in vomiting when treated with hydromorphone hydrochloride, and morphine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-JUN-2021, the subject experienced bones hurting severely all over the hips knees ankles ribs arms and back. On 15-JUN-2021, the subject experienced tingling in right arm. On 15-JUN-2021, the subject experienced numbness in right arm. On 15-JUN-2021, the subject experienced body aches like the flu. On 15-JUN-2021, the subject experienced lips tingling but not swollen happened only once for half hour. On 15-JUN-2021, the subject experienced squeezing like pressure on right arm felt like rubber around bands arms and blocking circulation. On 15-JUN-2021, the subject experienced joint pain. On 15-JUN-2021, the subject experienced headache on right top side of head. On 15-JUN-2021, the subject experienced fever temp highest 104.1f to range of 102f. On 15-JUN-2021, the subject experienced muscle pain. Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lips tingling but not swollen happened only once for half hour on 15-JUN-2021, and was recovering from tingling in right arm, squeezing like pressure on right arm felt like rubber around bands arms and blocking circulation, numbness in right arm, fever temp highest 104.1f to range of 102f, body aches like the flu, headache on right top side of head, muscle pain, joint pain, and bones hurting severely all over the hips knees ankles ribs arms and back. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Paraesthesia, Paraesthesia oral, Pyrexia
Clinical narrative: BONES HURTING SEVERELY ALL OVER THE HIPS KNEES ANKLES RIBS ARMS AND BACK; TINGLING IN RIGHT ARM; NUMBNESS IN RIGHT ARM; BODY ACHES LIKE THE FLU; LIPS TINGLING BUT NOT SWOLLEN  HAPPENED ONLY ONCE FOR HALF HOUR; SQUEEZING LIKE PRESSURE ON RIGHT ARM FELT LIKE RUBBER AROUND BANDS ARMS AND BLOCKING CIRCULATION; JOINT PAIN; HEADACHE ON RIGHT TOP SIDE OF HEAD; FEVER TEMP HIGHEST 104.1F TO  RANGE OF 102F; MUSCLE PAIN; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient not tested positive for covid, not aware that has had covid before, ended up in emergency room last fall due to non covid virus. The patient experienced got sick like in vomiting when treated with hydromorphone hydrochloride, and morphine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-JUN-2021, the subject experienced bones hurting severely all over the hips knees ankles ribs arms and back. On 15-JUN-2021, the subject experienced tingling in right arm. On 15-JUN-2021, the subject experienced numbness in right arm. On 15-JUN-2021, the subject experienced body aches like the flu. On 15-JUN-2021, the subject experienced lips tingling but not swollen happened only once for half hour. On 15-JUN-2021, the subject experienced squeezing like pressure on right arm felt like rubber around bands arms and blocking circulation. On 15-JUN-2021, the subject experienced joint pain. On 15-JUN-2021, the subject experienced headache on right top side of head. On 15-JUN-2021, the subject experienced fever temp highest 104.1f to range of 102f. On 15-JUN-2021, the subject experienced muscle pain. Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lips tingling but not swollen happened only once for half hour on 15-JUN-2021, and was recovering from tingling in right arm, squeezing like pressure on right arm felt like rubber around bands arms and blocking circulation, numbness in right arm, fever temp highest 104.1f to range of 102f, body aches like the flu, headache on right top side of head, muscle pain, joint pain, and bones hurting severely all over the hips knees ankles ribs arms and back. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular, Influenza like illness, Urticaria, Vaccination site pain
Clinical narrative: Irregular heartbeat; Hives on cheeks, ring finger and on different parts of the body; Hives like "bombs"; Regular "flu-like" symptoms; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE IRREGULAR (Irregular heartbeat) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001BZ18A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to chemicals NOS (Allergy to yellow hair dye 5) and Allergy to chemicals NOS (Allergy to yellow hair dye 6).    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced URTICARIA (Hives like "bombs"), INFLUENZA LIKE ILLNESS (Regular "flu-like" symptoms) and VACCINATION SITE PAIN (Pain at the injection site). On 12-Apr-2021, the patient experienced URTICARIA (Hives on cheeks, ring finger and on different parts of the body). On 22-Apr-2021, the patient experienced HEART RATE IRREGULAR (Irregular heartbeat) (seriousness criterion hospitalization). The patient was hospitalized on 22-Apr-2021 due to HEART RATE IRREGULAR. At the time of the report, HEART RATE IRREGULAR (Irregular heartbeat), URTICARIA (Hives on cheeks, ring finger and on different parts of the body), INFLUENZA LIKE ILLNESS (Regular "flu-like" symptoms) and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown and URTICARIA (Hives like "bombs") had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took ice and other natural things as treatment for non-serious events.  On 22-Apr-2021, patient got hospitalized for irregular heartbeat and went in ambulance. She said irregular heartbeat may be due to stress. As doctor suggested she didn't take 2nd shot.  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.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up TCR form was received on 04-May-2021. Patient had new events and was hospitalized.; 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Insomnia, Malaise, Pain, Vaccination site movement impairment
Clinical narrative: excruciating pain/vaccine symptoms hurt 20 times more; cannot sleep or do anything; cannot lift a piece of paper; completely disabled right now and cannot go to work; vaccine rash (large patch); cannot go to work/ can not do anything; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (excruciating pain/vaccine symptoms hurt 20 times more), INSOMNIA (cannot sleep or do anything), VACCINATION SITE MOVEMENT IMPAIRMENT (cannot lift a piece of paper), MALAISE (completely disabled right now and cannot go to work), VACCINATION SITE RASH (vaccine rash (large patch)) and IMPAIRED WORK ABILITY (cannot go to work/ can not do anything) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 028A21A) for COVID-19 vaccination.     The patient's past medical history included Arthritis and Knee surgery NOS.   On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (excruciating pain/vaccine symptoms hurt 20 times more) (seriousness criterion disability), INSOMNIA (cannot sleep or do anything) (seriousness criterion disability), VACCINATION SITE MOVEMENT IMPAIRMENT (cannot lift a piece of paper) (seriousness criterion disability), MALAISE (completely disabled right now and cannot go to work) (seriousness criterion disability), VACCINATION SITE RASH (vaccine rash (large patch)) (seriousness criterion disability) and IMPAIRED WORK ABILITY (cannot go to work/ can not do anything) (seriousness criterion disability). At the time of the report, PAIN (excruciating pain/vaccine symptoms hurt 20 times more), INSOMNIA (cannot sleep or do anything), VACCINATION SITE MOVEMENT IMPAIRMENT (cannot lift a piece of paper), MALAISE (completely disabled right now and cannot go to work), VACCINATION SITE RASH (vaccine rash (large patch)) and IMPAIRED WORK ABILITY (cannot go to work/ can not do anything) outcome was unknown.            Concomitant product use was not provided.  Symptoms started 7 days after the shot and lasted 2.5-3 weeks.  Patient wanted to knowif could take paracetamol to treat symptoms. The vaccine symptoms hurt 20 times more.  Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to -MOD-2021-072900 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: TCR - reporter/patient name obtained.; 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. -MOD-2021-072900:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: excruciating pain/vaccine symptoms hurt 20 times more; cannot sleep or do anything; cannot lift a piece of paper; completely disabled right now and cannot go to work; vaccine rash (large patch); cannot go to work/ can not do anything; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (excruciating pain/vaccine symptoms hurt 20 times more), INSOMNIA (cannot sleep or do anything), VACCINATION SITE MOVEMENT IMPAIRMENT (cannot lift a piece of paper), MALAISE (completely disabled right now and cannot go to work), VACCINATION SITE RASH (vaccine rash (large patch)) and IMPAIRED WORK ABILITY (cannot go to work/ can not do anything) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 028A21A) for COVID-19 vaccination.     The patient's past medical history included Arthritis and Knee surgery NOS.   On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (excruciating pain/vaccine symptoms hurt 20 times more) (seriousness criterion disability), INSOMNIA (cannot sleep or do anything) (seriousness criterion disability), VACCINATION SITE MOVEMENT IMPAIRMENT (cannot lift a piece of paper) (seriousness criterion disability), MALAISE (completely disabled right now and cannot go to work) (seriousness criterion disability), VACCINATION SITE RASH (vaccine rash (large patch)) (seriousness criterion disability) and IMPAIRED WORK ABILITY (cannot go to work/ can not do anything) (seriousness criterion disability). At the time of the report, PAIN (excruciating pain/vaccine symptoms hurt 20 times more), INSOMNIA (cannot sleep or do anything), VACCINATION SITE MOVEMENT IMPAIRMENT (cannot lift a piece of paper), MALAISE (completely disabled right now and cannot go to work), VACCINATION SITE RASH (vaccine rash (large patch)) and IMPAIRED WORK ABILITY (cannot go to work/ can not do anything) outcome was unknown.            Concomitant product use was not provided.  Symptoms started 7 days after the shot and lasted 2.5-3 weeks.  Patient wanted to knowif could take paracetamol to treat symptoms. The vaccine symptoms hurt 20 times more.  Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to -MOD-2021-072900 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: TCR - reporter/patient name obtained.; 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. -MOD-2021-072900:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Prostatomegaly, Urinary retention
Clinical narrative: Prostate swelling; Unable to urinate/Zero flow/ haven't urinated since May 31st; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY RETENTION (Unable to urinate/Zero flow/ haven't urinated since May 31st) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder. Concomitant products included LIOTHYRONINE and LEVOTHYROXINE for Thyroid disorder.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced URINARY RETENTION (Unable to urinate/Zero flow/ haven't urinated since May 31st) (seriousness criterion medically significant). On an unknown date, the patient experienced PROSTATOMEGALY (Prostate swelling). The patient was treated with TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, URINARY RETENTION (Unable to urinate/Zero flow/ haven't urinated since May 31st) and PROSTATOMEGALY (Prostate swelling) had not resolved.            Treatment included pain medications. The patient went to the hospital and got a catheter inserted.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow up received added a new event.; 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. Further information has been requested