chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Heart rate increased, Paraesthesia oral
Clinical narrative: HEART BEATS FAST; TONGUE HAD A PRICKLY FEELING; BAD CHILLS; FATIGUE; 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 past medical history included lymph nodes removed, and concurrent conditions included cancer, congestive heart failure, and heart beats fast. 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 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, the subject experienced heart beats fast. On 02-APR-2021, the subject experienced tongue had a prickly feeling. On 02-APR-2021, the subject experienced bad chills. On 02-APR-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad chills on 03-APR-2021, and had not recovered from tongue had a prickly feeling, heart beats fast, and fatigue. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus
Clinical narrative: INJECTION SITE ITCHING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced injection site itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injection site itching was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Arthralgia, Asthenia, Chills, Dyspnoea
Clinical narrative: RAPID GASPING BREATHS; SHAKES; CHILLS; WEAKNESS; NAUSEA; SPEECH LOSS/ COULD NOT TALK; FEVER; JOINT ACHES IN KNEES AND SHOULDERS; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid, and concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies. patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Janssen1808978, expiry: UNKNWON) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced speech loss/ could not talk. On APR-2021, the subject experienced joint aches in knees and shoulders. On APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced rapid gasping breaths. On 09-APR-2021, the subject experienced shakes. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced weakness. On 09-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from speech loss/ could not talk, rapid gasping breaths, shakes, and chills on APR-2021, was recovering from nausea, had not recovered from weakness, and fever, and the outcome of joint aches in knees and shoulders was not reported. 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: Nausea, Pyrexia, Tremor
Clinical narrative: RAPID GASPING BREATHS; SHAKES; CHILLS; WEAKNESS; NAUSEA; SPEECH LOSS/ COULD NOT TALK; FEVER; JOINT ACHES IN KNEES AND SHOULDERS; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid, and concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies. patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Janssen1808978, expiry: UNKNWON) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced speech loss/ could not talk. On APR-2021, the subject experienced joint aches in knees and shoulders. On APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced rapid gasping breaths. On 09-APR-2021, the subject experienced shakes. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced weakness. On 09-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from speech loss/ could not talk, rapid gasping breaths, shakes, and chills on APR-2021, was recovering from nausea, had not recovered from weakness, and fever, and the outcome of joint aches in knees and shoulders was not reported. 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: Chills
Clinical narrative: CHILLS; This spontaneous report received from a patient concerned a 36 year old male. The patient's weight was 190 pounds, and height was 74 inches. The patient's concurrent conditions included no alcohol, and non smoker, and other pre-existing medical conditions included no known allergies no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042a1a, and batch number: 042A1A expiry: 21-JUN-2021) dose was not reported, administered on 09-APR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021 21:00, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 10-APR-2021 03:00. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: SORE ARM; CHILLS; This spontaneous report received from a consumer concerned a 30 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced sore arm. On 06-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 08-APR-2021, and was recovering from sore arm. This report was non-serious.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood pressure normal, Body temperature, Chills, Fatigue
Clinical narrative: SLEEPY; BP NORMAL; BAD CHILLS AND RIGOURS; FATIGUE; FEVER; This spontaneous report received from a parent concerned a 20 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthmatic, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced sleepy. On 06-APR-2021, the subject experienced bp normal. On 06-APR-2021, the subject experienced bad chills and rigours. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced fever. Laboratory data included: Blood pressure (NR: not provided) 130/84, Body temperature (NR: not provided) 103 F, and Oxygen saturation (NR: not provided) 100 %. On 06-APR-2021 23:00, treatment medications included: paracetamol. On 07-APR-2021 04:00, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleepy, bad chills and rigours, and fatigue on 09-APR-2021, and bp normal, and the outcome of fever was not reported. This report was non-serious. This case, from the same reporter is linked to 20210420331.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation, Pyrexia, Somnolence
Clinical narrative: SLEEPY; BP NORMAL; BAD CHILLS AND RIGOURS; FATIGUE; FEVER; This spontaneous report received from a parent concerned a 20 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthmatic, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced sleepy. On 06-APR-2021, the subject experienced bp normal. On 06-APR-2021, the subject experienced bad chills and rigours. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced fever. Laboratory data included: Blood pressure (NR: not provided) 130/84, Body temperature (NR: not provided) 103 F, and Oxygen saturation (NR: not provided) 100 %. On 06-APR-2021 23:00, treatment medications included: paracetamol. On 07-APR-2021 04:00, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleepy, bad chills and rigours, and fatigue on 09-APR-2021, and bp normal, and the outcome of fever was not reported. This report was non-serious. This case, from the same reporter is linked to 20210420331.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Vomiting
Clinical narrative: VOMITING; LIGHT-HEADED; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced vomiting, light-headed, headache, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, nausea, vomiting and light-headed was not reported. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Pain in extremity, Somnolence
Clinical narrative: PASSED OUT; LIGHT HEADED; VERY SLEEPY; ARM PAIN; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 043A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 07-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the patient was very sleepy and experienced arm pain. On 08-APR-2021, the patient passed out in shower and felt light headed, he awoke in shower with no known duration and with no injuries The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out, and the outcome of light headed, arm pain and very sleepy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210420738-covid-19 vaccine ad26.cov2.s -Passed out. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: ARM AND SHOULDER PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced arm and shoulder pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm and shoulder pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any drug abuse, illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 to Right Deltoid for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021 07:00, the subject experienced chills. On 10-APR-2021 07:00, the subject experienced fever. On 10-APR-2021 07:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, and headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood blister, Contusion, Rash, Vision blurred
Clinical narrative: BLISTER ON OPPOSITE ARM OF INJECTION WITH PURPLE POOLING BLOOD UNDERNEATH/WIDE AREA OF NEEDLE STICK LOOKING DOTS OF BLOOD; BRUISING ON OPPOSITE ARM OF INJECTION; RASH ON OPPOSITE ARM OF INJECTION; BLURRING OF VISION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced blurring of vision. On 09-APR-2021, the subject experienced rash on opposite arm of injection. On 09-APR-2021, the subject experienced blister on opposite arm of injection with purple pooling blood underneath/wide area of needle stick looking dots of blood. On 09-APR-2021, the subject experienced bruising on opposite arm of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blurring of vision, rash on opposite arm of injection, blister on opposite arm of injection with purple pooling blood underneath/wide area of needle stick looking dots of blood, and bruising on opposite arm of injection. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Disorientation, Dyspnoea
Clinical narrative: UPSET STOMACH; SOME LOOSE STOOLS; ARM ACHED; CHILLS; HEADACHE BECAME AGONIZING AND POUNDING; TROUBLE BREATHING; TROUBLE FALLING ASLEEP; FACE FELT SWOLLEN; FELT DISORIENTED; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hormone replacement therapy. 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 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 09-APR-2021, the subject experienced trouble breathing. On 09-APR-2021, the subject experienced trouble falling asleep. On 09-APR-2021, the subject experienced face felt swollen. On 09-APR-2021, the subject experienced felt disoriented. On 09-APR-2021, the subject experienced arm ached. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced headache became agonizing and pounding. On 10-APR-2021, the subject experienced upset stomach. On 10-APR-2021, the subject experienced some loose stools. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm ached, and headache became agonizing and pounding, and the outcome of chills, trouble falling asleep, face felt swollen, trouble breathing, upset stomach, some loose stools and felt disoriented was not reported. This report was non-serious.; Sender's Comments: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Initial insomnia, Pain in extremity, Swelling face
Clinical narrative: UPSET STOMACH; SOME LOOSE STOOLS; ARM ACHED; CHILLS; HEADACHE BECAME AGONIZING AND POUNDING; TROUBLE BREATHING; TROUBLE FALLING ASLEEP; FACE FELT SWOLLEN; FELT DISORIENTED; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hormone replacement therapy. 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 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 09-APR-2021, the subject experienced trouble breathing. On 09-APR-2021, the subject experienced trouble falling asleep. On 09-APR-2021, the subject experienced face felt swollen. On 09-APR-2021, the subject experienced felt disoriented. On 09-APR-2021, the subject experienced arm ached. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced headache became agonizing and pounding. On 10-APR-2021, the subject experienced upset stomach. On 10-APR-2021, the subject experienced some loose stools. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm ached, and headache became agonizing and pounding, and the outcome of chills, trouble falling asleep, face felt swollen, trouble breathing, upset stomach, some loose stools and felt disoriented was not reported. This report was non-serious.; Sender's Comments: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Headache
Clinical narrative: DIZZINESS; TROUBLE BREATHING; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 dizziness, trouble breathing, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, trouble breathing and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Heart rate increased, Pyrexia
Clinical narrative: INCREASED HEART RATE; DIZZINESS; FATIGUE; FEVER; This spontaneous report received from a patient concerned a 28 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced increased heart rate. On 08-APR-2021, the subject experienced dizziness. On 08-APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dizziness, and increased heart rate, and had not recovered from fever, and fatigue. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Headache, Impaired work ability
Clinical narrative: SORE THROAT; DRY COUGH; PAIN IN THE BACK AROUND THE RIBS; UNABLE TO WORK; CHILLS; EXTREMELY TIRED; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced sore throat, dry cough, pain in the back around the ribs, unable to work, chills, extremely tired, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, sore throat, dry cough, pain in the back around the ribs, extremely tired, headache and unable to work was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Oropharyngeal pain
Clinical narrative: SORE THROAT; DRY COUGH; PAIN IN THE BACK AROUND THE RIBS; UNABLE TO WORK; CHILLS; EXTREMELY TIRED; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced sore throat, dry cough, pain in the back around the ribs, unable to work, chills, extremely tired, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, sore throat, dry cough, pain in the back around the ribs, extremely tired, headache and unable to work was not reported. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Bruxism, Chest discomfort, Chills, Contusion, Dizziness
Clinical narrative: HEAVINESS ON THE CHEST; WHEEZING; SQUEEZE SOUND OUT AND COARSE VOICE; ARM HURT; ARM BRUISED; COULD NOT FOCUS; HEAD FELT LIKE A THOUSAND POUND  (BUT NOT A POUNDING HEADACHE); SWEATING AND DRENCHED; COULD NOT GET WARM; OOZY; TEETH CLENCHING; TINGLING PAIN; COULD NOT STAND UP (HUNCHED  OVER) FOR MOVING; HORRIFIC CHILLS; SHOOTING PAIN ON THE INJECTION  SIDE; FEVERISH; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included severe asthmatic, hashimoto disease, polycystic ovaries, egg allergy, soy allergy, onion and garlic allergy, shellfish and molluscs allergy, tropical fish allergy, and sensitive to gluten. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced could not get warm. On 08-APR-2021, the subject experienced oozy. On 08-APR-2021, the subject experienced teeth clenching. On 08-APR-2021, the subject experienced tingling pain. On 08-APR-2021, the subject experienced could not stand up (hunched over) for moving. On 08-APR-2021, the subject experienced horrific chills. On 08-APR-2021, the subject experienced shooting pain on the injection side. On 08-APR-2021, the subject experienced feverish. On 09-APR-2021, the subject experienced could not focus. On 09-APR-2021, the subject experienced head felt like a thousand pound (but not a pounding headache). On 09-APR-2021, the subject experienced sweating and drenched. On 09-APR-2021, the subject experienced arm bruised. On 09-APR-2021, the subject experienced arm hurt. On 10-APR-2021, the subject experienced heaviness on the chest. On 10-APR-2021, the subject experienced wheezing. On 10-APR-2021, the subject experienced squeeze sound out and coarse voice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from oozy, horrific chills, and feverish on 10-APR-2021, and could not stand up (hunched over) for moving, and shooting pain on the injection side on 09-APR-2021, was recovering from could not get warm, head felt like a thousand pound (but not a pounding headache), sweating and drenched, and could not focus, had not recovered from wheezing, arm hurt, heaviness on the chest, and arm bruised, and the outcome of tingling pain, teeth clenching and squeeze sound out and coarse voice was not reported. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Dysstasia, Feeling cold, Head discomfort, Hyperhidrosis
Clinical narrative: HEAVINESS ON THE CHEST; WHEEZING; SQUEEZE SOUND OUT AND COARSE VOICE; ARM HURT; ARM BRUISED; COULD NOT FOCUS; HEAD FELT LIKE A THOUSAND POUND  (BUT NOT A POUNDING HEADACHE); SWEATING AND DRENCHED; COULD NOT GET WARM; OOZY; TEETH CLENCHING; TINGLING PAIN; COULD NOT STAND UP (HUNCHED  OVER) FOR MOVING; HORRIFIC CHILLS; SHOOTING PAIN ON THE INJECTION  SIDE; FEVERISH; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included severe asthmatic, hashimoto disease, polycystic ovaries, egg allergy, soy allergy, onion and garlic allergy, shellfish and molluscs allergy, tropical fish allergy, and sensitive to gluten. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced could not get warm. On 08-APR-2021, the subject experienced oozy. On 08-APR-2021, the subject experienced teeth clenching. On 08-APR-2021, the subject experienced tingling pain. On 08-APR-2021, the subject experienced could not stand up (hunched over) for moving. On 08-APR-2021, the subject experienced horrific chills. On 08-APR-2021, the subject experienced shooting pain on the injection side. On 08-APR-2021, the subject experienced feverish. On 09-APR-2021, the subject experienced could not focus. On 09-APR-2021, the subject experienced head felt like a thousand pound (but not a pounding headache). On 09-APR-2021, the subject experienced sweating and drenched. On 09-APR-2021, the subject experienced arm bruised. On 09-APR-2021, the subject experienced arm hurt. On 10-APR-2021, the subject experienced heaviness on the chest. On 10-APR-2021, the subject experienced wheezing. On 10-APR-2021, the subject experienced squeeze sound out and coarse voice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from oozy, horrific chills, and feverish on 10-APR-2021, and could not stand up (hunched over) for moving, and shooting pain on the injection side on 09-APR-2021, was recovering from could not get warm, head felt like a thousand pound (but not a pounding headache), sweating and drenched, and could not focus, had not recovered from wheezing, arm hurt, heaviness on the chest, and arm bruised, and the outcome of tingling pain, teeth clenching and squeeze sound out and coarse voice was not reported. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site paraesthesia, Pain in extremity, Pyrexia, Vision blurred
Clinical narrative: HEAVINESS ON THE CHEST; WHEEZING; SQUEEZE SOUND OUT AND COARSE VOICE; ARM HURT; ARM BRUISED; COULD NOT FOCUS; HEAD FELT LIKE A THOUSAND POUND  (BUT NOT A POUNDING HEADACHE); SWEATING AND DRENCHED; COULD NOT GET WARM; OOZY; TEETH CLENCHING; TINGLING PAIN; COULD NOT STAND UP (HUNCHED  OVER) FOR MOVING; HORRIFIC CHILLS; SHOOTING PAIN ON THE INJECTION  SIDE; FEVERISH; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included severe asthmatic, hashimoto disease, polycystic ovaries, egg allergy, soy allergy, onion and garlic allergy, shellfish and molluscs allergy, tropical fish allergy, and sensitive to gluten. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced could not get warm. On 08-APR-2021, the subject experienced oozy. On 08-APR-2021, the subject experienced teeth clenching. On 08-APR-2021, the subject experienced tingling pain. On 08-APR-2021, the subject experienced could not stand up (hunched over) for moving. On 08-APR-2021, the subject experienced horrific chills. On 08-APR-2021, the subject experienced shooting pain on the injection side. On 08-APR-2021, the subject experienced feverish. On 09-APR-2021, the subject experienced could not focus. On 09-APR-2021, the subject experienced head felt like a thousand pound (but not a pounding headache). On 09-APR-2021, the subject experienced sweating and drenched. On 09-APR-2021, the subject experienced arm bruised. On 09-APR-2021, the subject experienced arm hurt. On 10-APR-2021, the subject experienced heaviness on the chest. On 10-APR-2021, the subject experienced wheezing. On 10-APR-2021, the subject experienced squeeze sound out and coarse voice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from oozy, horrific chills, and feverish on 10-APR-2021, and could not stand up (hunched over) for moving, and shooting pain on the injection side on 09-APR-2021, was recovering from could not get warm, head felt like a thousand pound (but not a pounding headache), sweating and drenched, and could not focus, had not recovered from wheezing, arm hurt, heaviness on the chest, and arm bruised, and the outcome of tingling pain, teeth clenching and squeeze sound out and coarse voice was not reported. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: HEAVINESS ON THE CHEST; WHEEZING; SQUEEZE SOUND OUT AND COARSE VOICE; ARM HURT; ARM BRUISED; COULD NOT FOCUS; HEAD FELT LIKE A THOUSAND POUND  (BUT NOT A POUNDING HEADACHE); SWEATING AND DRENCHED; COULD NOT GET WARM; OOZY; TEETH CLENCHING; TINGLING PAIN; COULD NOT STAND UP (HUNCHED  OVER) FOR MOVING; HORRIFIC CHILLS; SHOOTING PAIN ON THE INJECTION  SIDE; FEVERISH; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included severe asthmatic, hashimoto disease, polycystic ovaries, egg allergy, soy allergy, onion and garlic allergy, shellfish and molluscs allergy, tropical fish allergy, and sensitive to gluten. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced could not get warm. On 08-APR-2021, the subject experienced oozy. On 08-APR-2021, the subject experienced teeth clenching. On 08-APR-2021, the subject experienced tingling pain. On 08-APR-2021, the subject experienced could not stand up (hunched over) for moving. On 08-APR-2021, the subject experienced horrific chills. On 08-APR-2021, the subject experienced shooting pain on the injection side. On 08-APR-2021, the subject experienced feverish. On 09-APR-2021, the subject experienced could not focus. On 09-APR-2021, the subject experienced head felt like a thousand pound (but not a pounding headache). On 09-APR-2021, the subject experienced sweating and drenched. On 09-APR-2021, the subject experienced arm bruised. On 09-APR-2021, the subject experienced arm hurt. On 10-APR-2021, the subject experienced heaviness on the chest. On 10-APR-2021, the subject experienced wheezing. On 10-APR-2021, the subject experienced squeeze sound out and coarse voice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from oozy, horrific chills, and feverish on 10-APR-2021, and could not stand up (hunched over) for moving, and shooting pain on the injection side on 09-APR-2021, was recovering from could not get warm, head felt like a thousand pound (but not a pounding headache), sweating and drenched, and could not focus, had not recovered from wheezing, arm hurt, heaviness on the chest, and arm bruised, and the outcome of tingling pain, teeth clenching and squeeze sound out and coarse voice was not reported. This report was non-serious.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling hot, Nasopharyngitis, Pain in extremity
Clinical narrative: MINOR COLD; SORE ARM; FATIGUE; CHILLS; FEELING HOT; This spontaneous report received from a consumer concerned a 21 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced feeling hot. On 10-APR-2021, the subject experienced chills. On an unspecified date, the subject experienced minor cold, sore arm, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling hot, and chills on 11-APR-2021, and minor cold, and had not recovered from sore arm, and fatigue. This report was non-serious. This case, from the same reporter is linked to 20210421646.
Sex: U
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: FAINTING; This spontaneous report received from a pharmacist via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) frequency 1 total, dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 11-APR-2021, the patient experienced fainting after the vaccine was administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fainting was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210420923-COVID-19 VACCINE AD26.COV2.S-fainting. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Injection site swelling, Injection site warmth, Neck pain
Clinical narrative: INJECTION SITE WARMTH; PAIN/UNABLE TO BEND THE NECK DUE TO PAIN; TIREDNESS/VERY TIRED; SORE/TERRIBLE SORE ON INJECTION SITE; INJECTION SITE SWOLLEN; This spontaneous report received from a consumer concerned a 43 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol use, and other pre-existing medical conditions included the patient had no known allergies and had no drug abuse or illicit drug usage. The patient was not pregnant at the time of vaccination. 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 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced injection site warmth. On 07-APR-2021, the subject experienced pain/unable to bend the neck due to pain. On 07-APR-2021, the subject experienced tiredness/very tired. On 07-APR-2021, the subject experienced sore/terrible sore on injection site. On 07-APR-2021, the subject experienced injection site swollen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiredness/very tired, and sore/terrible sore on injection site, and the outcome of pain/unable to bend the neck due to pain, injection site warmth and injection site swollen was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Nausea, Pain
Clinical narrative: TIRED; PAIN AT THE INJECTION SITE; SEVERE BODY ACHES; UNCONTROLLABLE SHAKING; NAUSEA; HEADACHE; HIGH FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced severe body aches. On 07-APR-2021, the subject experienced uncontrollable shaking. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced high fever. On 07-APR-2021, the subject experienced pain at the injection site. On 09-APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from high fever, severe body aches, and pain at the injection site, had not recovered from tired, and the outcome of uncontrollable shaking, nausea and headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: TIRED; PAIN AT THE INJECTION SITE; SEVERE BODY ACHES; UNCONTROLLABLE SHAKING; NAUSEA; HEADACHE; HIGH FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced severe body aches. On 07-APR-2021, the subject experienced uncontrollable shaking. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced high fever. On 07-APR-2021, the subject experienced pain at the injection site. On 09-APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from high fever, severe body aches, and pain at the injection site, had not recovered from tired, and the outcome of uncontrollable shaking, nausea and headache was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Fatigue
Clinical narrative: LEFT CHEST PAIN; FELT VERY TIRED; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced felt very tired. On 09-APR-2021 02:00, the subject experienced left chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left chest pain, and felt very tired. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Injection site pain, Myalgia
Clinical narrative: DIZZINESS, LIGHT HEADED, FEELING FAINT; CHILLS; INJECTION SITE PAIN AND SORENESS; HEADACHE; MUSCLE ACHES; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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 dizziness, light headed, feeling faint, chills, injection site pain and soreness, headache, muscle aches, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site pain and soreness, headache, muscle aches, nausea, chills and dizziness, light headed, feeling faint was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: DIZZINESS, LIGHT HEADED, FEELING FAINT; CHILLS; INJECTION SITE PAIN AND SORENESS; HEADACHE; MUSCLE ACHES; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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 dizziness, light headed, feeling faint, chills, injection site pain and soreness, headache, muscle aches, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site pain and soreness, headache, muscle aches, nausea, chills and dizziness, light headed, feeling faint was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nail discolouration
Clinical narrative: NAILS TURNED ORANGE; This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced nails turned orange. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nails turned orange. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FATIGUE; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 04-APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210427380 and 20210421641.
Sex: U
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: FAINTING; This spontaneous report received from a consumer via a company representative concerned multiple patients.  The patient's weight, height and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) frequency one total, dose was not reported, administered on 07-APR-2021 for prophylactic vaccination.. No concomitant medications were reported. The batch number was not reported. Per procedure, no follow-up will be requested for this case. The consumer reported about the article which said that multiple people on 07-APR-2021 experienced fainting after receiving the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainting on unspecified date in APR-2021. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210420898.; Sender's Comments: V0: 20210421103-covid-19 vaccine ad26.cov2.s-fainting. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Paraesthesia, Pyrexia
Clinical narrative: TINGLING  ALL OVER HER BODY; BODY TURNED RED AT SOME TIME; CHILLS; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced tingling all over her body, body turned red at some time, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, chills, and tingling all over her body, and the outcome of body turned red at some time was not reported. This report was non-serious.