chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Chills, Dyspnoea, Muscular weakness
Clinical narrative: Pain of lower extremities; SHORTNESS OF BREATH; WEAKNESS OF THE UPPER ARMS; WEAKNESS OF LEGS; Chills; Fever; VIBRATION SENSE ON BOTH LEGS; Chest tightness; STIFFNESS/TIGHTNESS OF LEGS; This spontaneous report received from a consumer concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and no any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced vibration sense on both legs. On 09-MAR-2021, the subject experienced chest tightness. On 09-MAR-2021, the subject experienced stiffness/tightness of legs. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.1 F. On 16-MAR-2021, the subject experienced weakness of legs. On 23-MAR-2021, the subject experienced weakness of the upper arms. On 04-APR-2021, the subject experienced shortness of breath. On an unspecified date, the subject experienced pain of lower extremities. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest tightness, chills, and fever on 10-MAR-2021, and had not recovered from vibration sense on both legs, shortness of breath, weakness of legs, weakness of the upper arms, stiffness/tightness of legs, and pain of lower extremities. 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity, Pyrexia, Sensory disturbance
Clinical narrative: Pain of lower extremities; SHORTNESS OF BREATH; WEAKNESS OF THE UPPER ARMS; WEAKNESS OF LEGS; Chills; Fever; VIBRATION SENSE ON BOTH LEGS; Chest tightness; STIFFNESS/TIGHTNESS OF LEGS; This spontaneous report received from a consumer concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and no any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced vibration sense on both legs. On 09-MAR-2021, the subject experienced chest tightness. On 09-MAR-2021, the subject experienced stiffness/tightness of legs. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.1 F. On 16-MAR-2021, the subject experienced weakness of legs. On 23-MAR-2021, the subject experienced weakness of the upper arms. On 04-APR-2021, the subject experienced shortness of breath. On an unspecified date, the subject experienced pain of lower extremities. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest tightness, chills, and fever on 10-MAR-2021, and had not recovered from vibration sense on both legs, shortness of breath, weakness of legs, weakness of the upper arms, stiffness/tightness of legs, and pain of lower extremities. 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: F
Vaccine: COVID19
Symptoms: Ehlers-Danlos syndrome
Clinical narrative: MASSIVE EDS FLARE,INTENSE FULL BODY PAIN,SUBLUXING; This spontaneous report received from a patient via a company representative 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 04-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 APR-2021, the patient experienced massive EDS (Ehlers-Danlos syndrome) flare, intense full body pain, and everything is subluxing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the massive EDS flare, intense full body pain and subluxing was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210409435-Covid-19 vaccine ad26.cov2.s-Ehlers-Danlos syndrome. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: POSITIVE COVID TEST; This spontaneous report received from a patient concerned a 28 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, batch number: 1802070, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced positive covid test. Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of positive covid test was not reported. 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Lymphadenopathy, Pruritus, Urticaria
Clinical narrative: ITCHING ALL OVER BODY; SWOLLEN LYMPH NODES; FLUSHING; HIVES ALL OVER BODY; HEADACHE; This spontaneous report received from a patient concerned a 56 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: 1805018, expiry: UNKNOWN) dose was not reported, 1 total, administered on 24-MAR-2021 to left arm, for prophylactic vaccination. Concomitant medications included montelukast for asthma. On 25-MAR-2021, the subject experienced itching all over body. On 25-MAR-2021, the subject experienced swollen lymph nodes. On 25-MAR-2021, the subject experienced flushing. On 25-MAR-2021, the subject experienced hives all over body. On 25-MAR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: montelukast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 2021, had not recovered from hives all over body, itching all over body, and swollen lymph nodes, and the outcome of flushing was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Oral discomfort
Clinical narrative: BURNING MOUTH; 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, 1 total, administered on MAR-2021 on an unspecified anatomical site for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced burning mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning mouth. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: LEFT LEG NUMBNESS; LEFT FOOT FEELING OF WEIGHTLESSNESS; LEFT ARM AND HAND TINGLING; TONGUE NUMBNESS; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included psoriasis, and non smoker. The patient was previously treated with apremilast for psoriasis; and experienced hives and local inflammatory response when treated with progesterone. 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 05-APR-2021 10:00 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced left arm and hand tingling. On 05-APR-2021, the subject experienced tongue numbness. On 05-APR-2021 11:45, the subject experienced left leg numbness. On 05-APR-2021 11:45, the subject experienced left foot feeling of weightlessness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left leg numbness, left foot feeling of weightlessness, and tongue numbness on 05-APR-2021, and was recovering from left arm and hand tingling. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM IS A LITTLE SORE; 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 04-APR-2021 on an unspecified anatomical site for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced arm is a little sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm is a little sore was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dreamy state, Fatigue, Injection site pain, Limb discomfort, Malaise
Clinical narrative: DREAMY STATE; MUSCLE FELT HEAVIER/FELT LIKE HUGE WEIGHT; NIGHT STRESS; LEGS FEEL STIFF; LEG SORENESS; NOT FEELING WELL; APPLICATION SITE SORENESS; NAUSEA; TIREDNESS/SLUGGISH; 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 was not reported, 1 total administered on 08-MAR-2021 05:30 on left arm for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included calcium chloride/glucose/magnesium chloride/potassium chloride/sodium chloride/sodium lactate for hydration.  On 08-MAR-2021, the patient experienced dreamy state, muscle felt heavier/felt like huge weight, night stress, legs feel stiff, leg soreness, not feeling well, application site soreness, nausea and tiredness/sluggish. On 09-MAR-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from leg soreness, application site soreness, and tiredness/sluggish, and had not recovered from nausea, dreamy state, muscle felt heavier/felt like huge weight, legs feel stiff, not feeling well, and night stress. 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: Musculoskeletal stiffness, Nausea, Pain in extremity, Stress
Clinical narrative: DREAMY STATE; MUSCLE FELT HEAVIER/FELT LIKE HUGE WEIGHT; NIGHT STRESS; LEGS FEEL STIFF; LEG SORENESS; NOT FEELING WELL; APPLICATION SITE SORENESS; NAUSEA; TIREDNESS/SLUGGISH; 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 was not reported, 1 total administered on 08-MAR-2021 05:30 on left arm for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included calcium chloride/glucose/magnesium chloride/potassium chloride/sodium chloride/sodium lactate for hydration.  On 08-MAR-2021, the patient experienced dreamy state, muscle felt heavier/felt like huge weight, night stress, legs feel stiff, leg soreness, not feeling well, application site soreness, nausea and tiredness/sluggish. On 09-MAR-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from leg soreness, application site soreness, and tiredness/sluggish, and had not recovered from nausea, dreamy state, muscle felt heavier/felt like huge weight, legs feel stiff, not feeling well, and night stress. 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: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Gait disturbance, Pain, Pyrexia
Clinical narrative: MILD FEVER; FEELING OF DEATH; BODY ACHES; HARD TO WALK; This spontaneous report received from a patient concerned a 24 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included no known drug allergies .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 05-APR-2021 12:30 to Left Arm as prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced feeling of death. On 05-APR-2021, the subject experienced body aches. On 05-APR-2021, the subject experienced hard to walk. Laboratory data included: Body temperature (NR: not provided) 104 F. Treatment medications included: ibuprofen. On 05-APR-2021 19:30, the subject experienced mild fever. Laboratory data included: Body temperature (NR: not provided) 100-102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, hard to walk, and mild fever, and the outcome of feeling of death was not reported. 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: Fatigue, Headache, Influenza like illness
Clinical narrative: FLU LIKE SYMPTOMS; INTENSE FATIGUE; MILD 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 not reported) 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 flu like symptoms, intense fatigue, and mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the intense fatigue, flu like symptoms and mild headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210412169.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Illness, Influenza like illness, Malaise
Clinical narrative: STOMACH ACHE; FLU-LIKE SYMPTOMS; SICKNESS; NOT FEELING WELL; HEADACHE; This spontaneous report received from a patient 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 admin not reported, batch number: Unk) dose was not reported, administered on 05-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 an unspecified date, the subject experienced stomach ache, flu-like symptoms, sickness, not feeling well, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the not feeling well, stomach ache, flu-like symptoms, sickness and headache was not reported. This report was non-serious.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Influenza, Injection site pain, Loss of consciousness
Clinical narrative: SYNCOPE/PASSED OUT FOR A COUPLE OF HOURS; SEVERELY DEHYDRATED; FLU; INJECTION SITE WAS SORE; This spontaneous report received from a pharmacist concerned a 44 year old  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, and expiry: 06-JUN-2021) dose was not reported, frequency 1 total administered on 02-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the patient was severely dehydrated a couple of hours after receiving the vaccine, syncope/passed out for a couple of hours (unsure how long), and injection site was sore. On same day, it felt like the patient had the flu, which was described as chills, fever and the patient's throat being sore at the same time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope/passed out for a couple of hours, severely dehydrated, injection site was sore, and felt like patient had the flu on 04-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210411188-covid-19 vaccine ad26.cov2. s-syncope/passed out, severely dehydrated. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Depression, Injection site pain
Clinical narrative: INTENSE DEPRESSIVE FEELINGS; STOMACH CRAMPS; STOMACH BLOATING; SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 63 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included drug titration. 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 05-APR-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included diazepam. On 06-APR-2021, the subject experienced intense depressive feelings. On 06-APR-2021, the subject experienced stomach cramps. On 06-APR-2021, the subject experienced stomach bloating. On 06-APR-2021, the subject experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from intense depressive feelings, stomach cramps, stomach bloating, and soreness at injection site. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Malaise, Pain
Clinical narrative: 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 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced body aches. On 03-APR-2021, the subject experienced arm pain. On 03-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced general unwell. On 03-APR-2021, the subject experienced fever 101 F. On 03-APR-2021, the subject experienced headaches. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, general unwell, fever 101f, and headaches on 04-APR-2021, and arm pain on 03-APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: 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 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced body aches. On 03-APR-2021, the subject experienced arm pain. On 03-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced general unwell. On 03-APR-2021, the subject experienced fever 101 F. On 03-APR-2021, the subject experienced headaches. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, general unwell, fever 101f, and headaches on 04-APR-2021, and arm pain on 03-APR-2021. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: HEADACHE; TIRED; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 57 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: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 in left Arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced tired. On 06-APR-2021, the subject experienced muscle aches. On 06-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, tired, muscle aches and fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: VACCINE EXPOSURE VIA BREAST FEEDING; This spontaneous report received from a parent concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, transmammary, expiry: UNKNOWN) 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 vaccine exposure via breast feeding. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine exposure via breast feeding was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Exposure during pregnancy, Headache, Nausea, Pyrexia
Clinical narrative: 38 WEEKS PREGNANT AND WHEN GOT THE SHOT; BAD CHILLS/TEETH CHATTERING; NAUSEA; HEADACHE; FEVER; This spontaneous pregnancy report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. It was not reported whether the patient had been pregnant before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin) 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 38 weeks pregnant and when got the shot, bad chills/teeth chattering, nausea, headache, and fever. The date of the subject's last menstrual period and expected delivery date were not reported. The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad chills/teeth chattering, nausea, and headache, had not recovered from 38 weeks pregnant and when got the shot, and the outcome of fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Influenza, Nausea, Pyrexia
Clinical narrative: FEELING COLD; FELT BAD LIKE FLU; VOMITING; NAUSEA; HEADACHE; LOW GRADE FEVER; This spontaneous report received from a consumer concerned a 40 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, alcohol user, and non-smoker.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: not reported) dose was not reported, administered on 05-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced feeling cold. On 06-APR-2021, the subject experienced felt bad like flu. On 06-APR-2021, the subject experienced vomiting. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, headache, low grade fever, vomiting, felt bad like flu, and feeling cold. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: FEELING COLD; FELT BAD LIKE FLU; VOMITING; NAUSEA; HEADACHE; LOW GRADE FEVER; This spontaneous report received from a consumer concerned a 40 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, alcohol user, and non-smoker.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: not reported) dose was not reported, administered on 05-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced feeling cold. On 06-APR-2021, the subject experienced felt bad like flu. On 06-APR-2021, the subject experienced vomiting. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, headache, low grade fever, vomiting, felt bad like flu, and feeling cold. This report was non-serious.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Accidental exposure to product, Incorrect dose administered, Needle issue, Syringe issue
Clinical narrative: PARTIAL DOSE ADMINISTERED; LIQUID LEAKING OUT OF THE SYRINGE, NEEDLE; LIQUID LEAKING OUT OF THE SYRINGE, NEEDLE; LIQUID LEAKING OUT OF ARM; This spontaneous report received from a pharmacist concerned a 67 year old of unspecified 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: 042A21A, expiry: not reported) dose was not reported, administered on 06-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced partial dose administered. On 06-APR-2021, the subject experienced liquid leaking out of the syringe, needle. On 06-APR-2021, the subject experienced liquid leaking out of the syringe, needle. On 06-APR-2021, the subject experienced liquid leaking out of arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the partial dose administered, liquid leaking out of the syringe, needle, liquid leaking out of the syringe, needle and liquid leaking out of arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: LOSS SENSE OF SMELL; This spontaneous report received from a consumer 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 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced loss sense of smell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of loss sense of smell was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: NOSE DRIP; 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced nose drip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of nose drip was not reported. This report was non-serious. This case, from the same reporter is linked to 20210414424.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; This spontaneous report received from a patient concerned a 48 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: 1808980 expiry: not reported) dose was not reported, administered on 06-APR-2021 at 13:00 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021 12:00, the subject experienced chills. On 07-APR-2021 12:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and chills. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Accidental exposure to product, Underdose
Clinical narrative: DRIPPED DOWN TO ELBOW; POSSIBLE UNDERDOSE; 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: not reported) dose was not reported, administered to left arm on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced possible underdose. On 06-APR-2021, the subject experienced dripped down to elbow. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the possible underdose and dripped down to elbow was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: ACHES AND PAINS; CHILLS; LOW GRADE 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) dose was not reported, administered on 05-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 aches and pains. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) 100.3-100.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, aches and pains and low grade fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Product dispensing error, Underdose
Clinical narrative: PULLING 0.5ML X 6 DOSES FROM ONE  VIAL, INSTEAD OF 5 DOSES; PULLING 0.5ML X 6 DOSES FROM ONE  VIAL, INSTEAD OF 5 DOSES; This spontaneous report received from a vaccine facility concerned patients of unspecified number, age and sex. The patient's weight, height, and medical history were not reported. The patients 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 lot number was not reported. The company was unable to perform follow up to request batch number. No concomitant medications were reported. On an unspecified date, the vaccine providers were pulling 0.5mL x 6 doses from one vial instead of the indicated of 5 doses from the vaccine vial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pulling 0.5ml x 6 doses from one vial, instead of 5 doses was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: PLATELETS DECREASED; This spontaneous report received from a consumer concerned of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune deficiency.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose,1 total, start therapy date were not reported 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. Laboratory test was recommended by her doctor due to her autoimmune deficiency.  On an unspecified date, the patient did quarterly blood test for platelet count which showed poor platelets numbers (platelets decreased), however retest was performed for possible test error and poor numbers. Retest showed the worse results and doctor requested patient to proceed to an emergency room. Patient was hospitalized (date unspecified) for a week with hourly blood test to daily test. Patient was discharged from hospital at the end of week with weekly test checks. Laboratory data (dates unspecified) included: Platelet count as Low/Poor numbers and platelet count second test showed worse result. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from platelets decreased. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210411605-covid-19 vaccine ad26.cov2.s-platelets decreased. 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: MEDICAL HISTORY
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: EAR NOISES AFTER THREE DAYS OF VACCINATION; 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: Unk) dose was not reported, administered on 05-APR-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 APR-2021, the subject experienced ear noises after three days of vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ear noises after three days of vaccination. This report was non-serious.
Age: 29.0
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Hypertension, Oxygen saturation, Palpitations
Clinical narrative: ELEVATED BLOOD PRESSURE; HEART PALPITATIONS; SHAKINESS; DROWSINESS; This spontaneous report received from a health care professional concerned a 29 years old of unspecified 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: 042A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 06-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, five minutes after vaccination the patient experienced elevated blood pressure, heart palpitations, shakiness and drowsiness. On 06-APR-2021, Laboratory data included: Blood pressure (NR: not provided) 230/116 mmHg, Oxygen saturation (NR: not provided) Normal, and Pulse rate (NR: not provided) Normal. Blood pressure did go down eventually. Patient was rushed to the hospital/Emergency room on 06-APR-2021. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient was recovering from elevated blood pressure and heart palpitations, and the outcome of shakiness and drowsiness was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: COVID-19 VACCINE AD26.COV2.S -elevated blood pressure, heart palpitations, shakiness and drowsiness. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 29.0
Sex: U
Vaccine: COVID19
Symptoms: Somnolence, Tremor
Clinical narrative: ELEVATED BLOOD PRESSURE; HEART PALPITATIONS; SHAKINESS; DROWSINESS; This spontaneous report received from a health care professional concerned a 29 years old of unspecified 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: 042A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 06-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, five minutes after vaccination the patient experienced elevated blood pressure, heart palpitations, shakiness and drowsiness. On 06-APR-2021, Laboratory data included: Blood pressure (NR: not provided) 230/116 mmHg, Oxygen saturation (NR: not provided) Normal, and Pulse rate (NR: not provided) Normal. Blood pressure did go down eventually. Patient was rushed to the hospital/Emergency room on 06-APR-2021. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient was recovering from elevated blood pressure and heart palpitations, and the outcome of shakiness and drowsiness was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: COVID-19 VACCINE AD26.COV2.S -elevated blood pressure, heart palpitations, shakiness and drowsiness. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain in extremity, Vomiting
Clinical narrative: CHILLS; HEADACHE; NAUSEA; VOMITING; SORE ARM; This spontaneous report received from a consumer 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 left arm on 05-APR-2021 13:45 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up as the patient denied consent for follow-up. No concomitant medications were reported. On 05-APR-2021, the subject experienced sore arm. On 05-APR-2021 11:00, the subject experienced vomiting. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, was recovering from sore arm, and had not recovered from chills, headache, and nausea. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: General symptom
Clinical narrative: MILD SYMPTOMS; This spontaneous report received from a health care professional concerned multiple patients. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A 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 mild symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild symptoms was not reported. This report was non-serious.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Pain in extremity
Clinical narrative: BODY HOT; SORE/PAINFUL ARM; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 63 year old of unspecified 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: 042A21A, expiry: not reported) dose was not reported, administered on 05-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced body hot. On 05-APR-2021, the subject experienced sore/painful arm. On 05-APR-2021, the subject experienced severe headache. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body hot on 06-APR-2021, and had not recovered from severe headache, and sore/painful arm. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; FEVER; This spontaneous report received from 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 and the company is unable to perform follow-up to request batch/lot no) dose was not reported, administered on 06-APR-2021 15:40 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, Laboratory data included: Body temperature (NR: not provided) 101.3 (units unspecified). On 07-APR-2021 02:00, the subject experienced body aches. On 07-APR-2021 02:00, the subject experienced chills. On 07-APR-2021 02:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills and body aches was not reported. This report was non-serious.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: FEVER; HEADACHE; CHILLS; 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 penicillin allergy, non smoker, and alcoholic.  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 at 13:00 on left arm for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100.4 F. On 06-APR-2021 18:45, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, and chills. This report was non-serious.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Body temperature, Facial pain, Pyrexia
Clinical narrative: LEFT SIDE FACE PAIN; BLISTERS ON THE FACE; FEVER; This spontaneous report received from a consumer concerned a 28-year-old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy.  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 03-APR-2021 in left deltoid for prophylactic vaccination. Concomitant medications included benzylpenicillin. On 03-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 38 C. On 05-APR-2021, the subject experienced left side face pain. On 05-APR-2021, the subject experienced blisters on the face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 04-APR-2021, and had not recovered from left side face pain, and blisters on the face. This report was non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: DEEP , SHARP BILATERAL BACK PAIN; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's past medical history included previous accident causing herniated discs ( unknown when ).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 06-APR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 06-APR-2021, the subject experienced deep, sharp bilateral back pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from deep , sharp bilateral back pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Panic attack
Clinical narrative: PANIC ATTACK; This spontaneous report received from a consumer 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, 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 panic attack. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of panic attack was not reported. This report was non-serious. This case, from the same reporter is linked to 20210410701.