chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Pain in extremity
Clinical narrative: HEAVY ARM; PAIN OF LEFT ARM; NUMBNESS OF LEFT ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-SEP-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 SEP-2021, the patient experienced heavy arm. On SEP-2021, the patient experienced pain of left arm. On SEP-2021, the patient experienced numbness of left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heavy, pain of left arm, and numbness of left arm on 12-SEP-2021. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Injection site pain, Lip swelling, Malaise
Clinical narrative: SWELLING OF FACE; SWELLING OF TOP LIP/UPPER LIP; FEELING LIKE THERE IS A FEVER WITHOUT A FEVER (FEELING ICKY); MALAISE; MILD HEADACHE; WHEEZING IN BREATHING; HANDS WERE SWOLLEN/SWELLING OF HANDS; VERY LITTLE SORENESS ON THE INJECTION SITE/MILD SORENESS ON THE INJECTION SITE; 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 past medical history included: shingles, and concurrent conditions included: undifferentiated connective tissue disease, severe osteoarthritis, iodine allergy, alcohol user, non-smoker, and antibiotic allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of reporting. The patient was on an antiviral drug that patient cannot remember but given for shingles and had no history of drug abuse or illicit drug use. The patient reported that she had fillers on her face. The patient took pain medicine (an OTC). The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 and expiry: UNKNOWN) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination on left deltoid. No concomitant medications were reported. On 09-SEP-2021, the patient experienced very little soreness on the injection site/mild soreness on the injection site. On 11-SEP-2021, the patient experienced hands were swollen/swelling of hands and wheezing in breathing. On 12-SEP-2021, the patient experienced swelling of face, swelling of top lip/upper lip, feeling like there is a fever without a fever (feeling icky), malaise and mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from wheezing in breathing on 11-SEP-2021, and had not recovered from very little soreness on the injection site/mild soreness on the injection site, mild headache, malaise, feeling like there is a fever without a fever (feeling icky), hands were swollen/swelling of hands, swelling of face, and swelling of top lip/upper lip. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Swelling face, Wheezing
Clinical narrative: SWELLING OF FACE; SWELLING OF TOP LIP/UPPER LIP; FEELING LIKE THERE IS A FEVER WITHOUT A FEVER (FEELING ICKY); MALAISE; MILD HEADACHE; WHEEZING IN BREATHING; HANDS WERE SWOLLEN/SWELLING OF HANDS; VERY LITTLE SORENESS ON THE INJECTION SITE/MILD SORENESS ON THE INJECTION SITE; 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 past medical history included: shingles, and concurrent conditions included: undifferentiated connective tissue disease, severe osteoarthritis, iodine allergy, alcohol user, non-smoker, and antibiotic allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of reporting. The patient was on an antiviral drug that patient cannot remember but given for shingles and had no history of drug abuse or illicit drug use. The patient reported that she had fillers on her face. The patient took pain medicine (an OTC). The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 and expiry: UNKNOWN) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination on left deltoid. No concomitant medications were reported. On 09-SEP-2021, the patient experienced very little soreness on the injection site/mild soreness on the injection site. On 11-SEP-2021, the patient experienced hands were swollen/swelling of hands and wheezing in breathing. On 12-SEP-2021, the patient experienced swelling of face, swelling of top lip/upper lip, feeling like there is a fever without a fever (feeling icky), malaise and mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from wheezing in breathing on 11-SEP-2021, and had not recovered from very little soreness on the injection site/mild soreness on the injection site, mild headache, malaise, feeling like there is a fever without a fever (feeling icky), hands were swollen/swelling of hands, swelling of face, and swelling of top lip/upper lip. This report was non-serious.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Discoloured vomit, Headache, Nausea, Pain, Panic attack
Clinical narrative: VOMITING (BLACK IN COLOR); PANIC ATTACK; BODY ACHES; HEADACHE; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's past medical history included: stroke and concurrent conditions included: seasonal allergies, and panic attacks. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 10-SEP-2021 10:00 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, ademetionine, fluvoxamine, and loratadine. On 10-SEP-2021, the patient experienced panic attack. On 10-SEP-2021, the patient experienced body aches. On 10-SEP-2021, the patient experienced headache. On 10-SEP-2021, the patient experienced nausea. On 10-SEP-2021, the patient experienced fever. On 11-SEP-2021, the patient experienced vomiting (black in color). The action taken with covid-19 vaccine was not applicable. The patient had not recovered from vomiting (black in color), headache, body aches, nausea, and fever, and the outcome of panic attack was not reported. This report was non-serious.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: VOMITING (BLACK IN COLOR); PANIC ATTACK; BODY ACHES; HEADACHE; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's past medical history included: stroke and concurrent conditions included: seasonal allergies, and panic attacks. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 10-SEP-2021 10:00 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, ademetionine, fluvoxamine, and loratadine. On 10-SEP-2021, the patient experienced panic attack. On 10-SEP-2021, the patient experienced body aches. On 10-SEP-2021, the patient experienced headache. On 10-SEP-2021, the patient experienced nausea. On 10-SEP-2021, the patient experienced fever. On 11-SEP-2021, the patient experienced vomiting (black in color). The action taken with covid-19 vaccine was not applicable. The patient had not recovered from vomiting (black in color), headache, body aches, nausea, and fever, and the outcome of panic attack was not reported. This report was non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pyrexia
Clinical narrative: FEELING HOT; FEVER; This spontaneous report received from a parent concerned a 32 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-SEP-2021, the patient experienced feeling hot. On 10-SEP-2021, the patient experienced fever. The action taken with covid-19 vaccine was not applicable. The outcome of the fever and feeling hot was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Fatigue, Malaise, Pain, Pain assessment
Clinical narrative: HEART FLUTTERING; PAIN EVERYWHERE/ACHY FROM HEAD TO TOES; DID NOT FEEL GOOD; EXTREMELY TIRED; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight was 260 pounds, and height was 64 inches. The patient's past medical history included: liver transplant and blood clot. The patient experienced cellulitis when treated with levofloxacin (Lovenox), and oxycodone hydrochloride/paracetamol (Percocet). 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, 1 total, administered to left arm on 09-SEP-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, amlodipine besilate, bupropion hydrochloride, empagliflozin, ergocalciferol, ezetimibe, levothyroxine sodium, losartan, metoprolol, mycophenolate sodium, pioglitazone, calcium and tacrolimus. On 10-SEP-2021, the patient felt extremely tired and did not feel good. The patient went to bed around 9 pm and on 11-SEP-2021, she woke up at 4 am and felt like somebody beat her and she had pain everywhere, also her hair hurt. The patient was achy from head to toes, and her pain was over 10/10 on the pain scale. The patient took 2 Tylenols and felt no relief. On the same day, the patient felt like her heart was fluttering a couple of times. Laboratory data included: Pain scale (NR: not provided) pain over 10/10. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain everywhere/achy from head to toes, and heart fluttering, and the outcome of extremely tired and did not feel good was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210921278-COVID-19 VACCINE AD26.COV2.S- heart fluttering. 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: Headache, Lethargy, Malaise, Pain, Paraesthesia
Clinical narrative: FAIRLY SIGNIFICANT LETHARGY; BODY ACHES; HAVE NOT FELT WELL; DAILY HEADACHES; TINGLING IN VARIOUS REGIONS WHICH  STARTED ON THE RIGHT SIDE OF BODY AND MOVED TO BOTH FEET/LEGS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient reported that the patent was previously very healthy. 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 patient experienced fairly significant lethargy, body aches, have not felt well, daily headaches, and tingling in various regions which started on the right side of body and moved to both feet/legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, and the outcome of have not felt well, daily headaches, tingling in various regions which started on the right side of body and moved to both feet/legs and fairly significant lethargy was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Renal pain, Tinnitus
Clinical narrative: EXTREMELY PAINFUL PAIN IN BOTH KIDNEYS; RINGING IN EARS; SEVERE HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced extremely painful pain in both kidneys, ringing in ears, and severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extremely painful pain in both kidneys, and the outcome of severe headaches and ringing in ears was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chest pain, Chills, Diarrhoea, Panic attack
Clinical narrative: VERTIGO; CHEST PAIN; PANICKED AT 3 AM; THOUGHT WAS GOING TO DIE; CHILLS; VOMITING; DIARRHEA; FEVER; This spontaneous report received from a parent via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced vertigo, chest pain, panicked at 3 am, thought was going to die, chills, vomiting, diarrhea, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vomiting, diarrhea, chills, vertigo, chest pain, fever, panicked at 3 am and thought was going to die was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vertigo, Vomiting
Clinical narrative: VERTIGO; CHEST PAIN; PANICKED AT 3 AM; THOUGHT WAS GOING TO DIE; CHILLS; VOMITING; DIARRHEA; FEVER; This spontaneous report received from a parent via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced vertigo, chest pain, panicked at 3 am, thought was going to die, chills, vomiting, diarrhea, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vomiting, diarrhea, chills, vertigo, chest pain, fever, panicked at 3 am and thought was going to die was not reported. This report was non-serious.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Paraesthesia
Clinical narrative: JOINT PAIN ALL OVER; PINS AND NEEDLES SENSATION; This spontaneous report received from a patient concerned a 20 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: social alcohol user, and non smoker, and other pre-existing medical conditions included: The patient did not have any history of drug abuse or illicit drug use. The patient experienced anaphylaxis to flu vaccine at 6 months of age when treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 10-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-SEP-2021, the patient experienced pins and needles sensation. On 12-SEP-2021, the patient experienced joint pain all over. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pins and needles sensation on 11-SEP-2021, and had not recovered from joint pain all over. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site hypoaesthesia, Nausea, Paraesthesia
Clinical narrative: NAUSEA; INTERMITTENT TINGLING IN LEFT LEG; INJECTION LEFT ARM NUMBNESS WHICH MADE FEEL LIKE DEAD WEIGHT AND AFFECTED WHOLE HAND; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, and other pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 10-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-SEP-2021, the patient experienced injection left arm numbness which made feel like dead weight and affected whole hand. On 11-SEP-2021, the patient experienced nausea. On 11-SEP-2021, the patient experienced intermittent tingling in left leg. The action taken with covid-19 vaccine was not applicable. The patient recovered from nausea on 11-SEP-2021, had not recovered from intermittent tingling in left leg and injection left arm numbness which made feel like dead weight and affected whole hand. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: BODY ACHES; SEVERE CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: 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 patient experienced body aches, severe chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, severe chills, and fever. This report was non-serious. This case, from the same reporter is linked to 20210921477 and 20210921347.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Blood test, Headache, Pyrexia
Clinical narrative: A BASEBALL SIZE LUMP IN THE RIGHT ARM PIT; MILD HEADACHE; MILD FEVER; 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 concurrent conditions included: elevated bp, and other pre-existing medical conditions included: The patient does not have any known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 204B21A expiry: 11-DEC-2021) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. Concomitant medications included valsartan for elevated bp.  On 09-SEP-2021, the patient experienced mild headache. On 09-SEP-2021, the patient experienced mild fever. On 10-SEP-2021, the patient experienced a baseball size lump in the right arm pit. Laboratory data (dates unspecified) included: Blood test (NR: not provided) results not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild headache, and mild fever on 11-SEP-2021, and had not recovered from a baseball size lump in the right arm pit. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abnormal faeces, Lacrimal disorder, Skin odour abnormal, Urine odour abnormal
Clinical narrative: UNUSUAL ODOR PRESENT IN URINE; UNUSUAL ODOR PRESENT IN STOOLS; UNUSUAL ODOR PRESENT EVEN ON THE SKIN WHEN SHOWERED; UNUSUAL ORDER PRESENT IN OCULAR TEARS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 11-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-SEP-2021, the patient experienced unusual odor present in urine. On 12-SEP-2021, the patient experienced unusual odor present in stools. On 12-SEP-2021, the patient experienced unusual odor present even on the skin when showered. On 12-SEP-2021, the patient experienced unusual order present in ocular tears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unusual odor present in urine, unusual odor present in stools, unusual odor present even on the skin when showered and unusual order present in ocular tears was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Dizziness, Dyspnoea
Clinical narrative: SHORTNESS OF BREATH UPON ACTIVITY; UNABLE TO GO TO WORK CALLED OUT SICK; DIZZY ACTIVITY INTOLERANCE; WEAK; FATIGUE; SEVERE NIGHT SWEATS; BODY ACHE; SEVERE FEVER (101.7); SEVERE HEADACHE, WEAK PERSISTENT HEADACHE; RASH ON BOTH ARMS AND LEGS; CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 10-SEP-2021 12:20 for prophylactic vaccination. No concomitant medications were reported. On 10-SEP-2021, the patient experienced body ache. On 10-SEP-2021, the patient experienced rash on both arms and legs. On 10-SEP-2021, the patient experienced chills. On 10-SEP-2021, the patient experienced severe fever (101.7). On 10-SEP-2021, the patient experienced severe headache, weak persistent headache. Laboratory data included: Body temperature (NR: not provided). Treatment medications included: paracetamol. On 11-SEP-2021, the patient experienced severe night sweats. On 11-SEP-2021, the patient experienced fatigue. On 12-SEP-2021, the patient experienced shortness of breath upon activity. On 12-SEP-2021, the patient experienced unable to go to work called out sick. On 12-SEP-2021, the patient experienced dizzy activity intolerance. On 12-SEP-2021, the patient experienced weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe fever (101.7), rash on both arms and legs, chills, severe night sweats, unable to go to work called out sick, dizzy activity intolerance, weak, and shortness of breath upon activity, and the outcome of severe headache, weak persistent headache, body ache and fatigue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Illness, Night sweats, Pain
Clinical narrative: SHORTNESS OF BREATH UPON ACTIVITY; UNABLE TO GO TO WORK CALLED OUT SICK; DIZZY ACTIVITY INTOLERANCE; WEAK; FATIGUE; SEVERE NIGHT SWEATS; BODY ACHE; SEVERE FEVER (101.7); SEVERE HEADACHE, WEAK PERSISTENT HEADACHE; RASH ON BOTH ARMS AND LEGS; CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 10-SEP-2021 12:20 for prophylactic vaccination. No concomitant medications were reported. On 10-SEP-2021, the patient experienced body ache. On 10-SEP-2021, the patient experienced rash on both arms and legs. On 10-SEP-2021, the patient experienced chills. On 10-SEP-2021, the patient experienced severe fever (101.7). On 10-SEP-2021, the patient experienced severe headache, weak persistent headache. Laboratory data included: Body temperature (NR: not provided). Treatment medications included: paracetamol. On 11-SEP-2021, the patient experienced severe night sweats. On 11-SEP-2021, the patient experienced fatigue. On 12-SEP-2021, the patient experienced shortness of breath upon activity. On 12-SEP-2021, the patient experienced unable to go to work called out sick. On 12-SEP-2021, the patient experienced dizzy activity intolerance. On 12-SEP-2021, the patient experienced weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe fever (101.7), rash on both arms and legs, chills, severe night sweats, unable to go to work called out sick, dizzy activity intolerance, weak, and shortness of breath upon activity, and the outcome of severe headache, weak persistent headache, body ache and fatigue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: SHORTNESS OF BREATH UPON ACTIVITY; UNABLE TO GO TO WORK CALLED OUT SICK; DIZZY ACTIVITY INTOLERANCE; WEAK; FATIGUE; SEVERE NIGHT SWEATS; BODY ACHE; SEVERE FEVER (101.7); SEVERE HEADACHE, WEAK PERSISTENT HEADACHE; RASH ON BOTH ARMS AND LEGS; CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 10-SEP-2021 12:20 for prophylactic vaccination. No concomitant medications were reported. On 10-SEP-2021, the patient experienced body ache. On 10-SEP-2021, the patient experienced rash on both arms and legs. On 10-SEP-2021, the patient experienced chills. On 10-SEP-2021, the patient experienced severe fever (101.7). On 10-SEP-2021, the patient experienced severe headache, weak persistent headache. Laboratory data included: Body temperature (NR: not provided). Treatment medications included: paracetamol. On 11-SEP-2021, the patient experienced severe night sweats. On 11-SEP-2021, the patient experienced fatigue. On 12-SEP-2021, the patient experienced shortness of breath upon activity. On 12-SEP-2021, the patient experienced unable to go to work called out sick. On 12-SEP-2021, the patient experienced dizzy activity intolerance. On 12-SEP-2021, the patient experienced weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe fever (101.7), rash on both arms and legs, chills, severe night sweats, unable to go to work called out sick, dizzy activity intolerance, weak, and shortness of breath upon activity, and the outcome of severe headache, weak persistent headache, body ache and fatigue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Periorbital swelling, Sensitive skin, Skin irritation
Clinical narrative: SWELLING UNDERNEATH THE EYE; SKIN UNDER EYE IS LITTLE SENSITIVE; SKIN UNDER EYE IS IRRITATED; This spontaneous report received from a consumer concerned a 60 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included: dermal filler in cheeks. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 07-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-SEP-2021, the patient experienced swelling underneath the eye. On 12-SEP-2021, the patient experienced skin under eye is little sensitive. On 12-SEP-2021, the patient experienced skin under eye is irritated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling underneath the eye, skin under eye is irritated, and skin under eye is little sensitive. This report was non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Exposure during pregnancy, Magnetic resonance imaging, Ultrasound scan
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced drug allergy when treated with acetylsalicylic acid, and ibuprofen.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the patient experienced vaccine exposure during pregnancy. On 19-JUL-2021, Laboratory data included: MRI (NR: not provided) baby was diagnosed with a fetal stroke, and ultrasound scan (NR: not provided) baby was diagnosed with a fetal stroke. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccine exposure during pregnancy. This report was non-serious. This parent/child case is linked to 20210922547.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Foetal exposure during pregnancy, Magnetic resonance imaging head, Renal aplasia, Ultrasound head
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced drug allergy when treated with acetylsalicylic acid, and ibuprofen.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the patient experienced vaccine exposure during pregnancy. On 19-JUL-2021, Laboratory data included: MRI (NR: not provided) baby was diagnosed with a fetal stroke, and ultrasound scan (NR: not provided) baby was diagnosed with a fetal stroke. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccine exposure during pregnancy. This report was non-serious. This parent/child case is linked to 20210922547.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Taste disorder
Clinical narrative: SENSE OF TASTE GONE; STRANGE TASTE IN MOUTH; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis, non-alcohol use, non-smoker, lupus, high blood pressure, and high cholesterol, and other pre-existing medical conditions included: In youth tried several illicit drug usage, now has medical marijuana and vaporizes marijuana on an as needed bases. The patient was previously treated with memantine hydrochloride for high blood pressure, high cholesterol, omeprazole, ezetimibe, tramadol, folic acid, zinc; and experienced hives and swelling when treated with acetylsalicylic acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 10-SEP-2021 for prophylactic vaccination. Concomitant medications included hydroxychloroquine phosphate for lupus, and prednisone for rheumatoid arthritis. On 12-SEP-2021, the patient experienced sense of taste gone. On 12-SEP-2021, the patient experienced strange taste in mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sense of taste gone, and strange taste in mouth. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Injection site erythema, Injection site pain, Injection site swelling, Lethargy
Clinical narrative: LETHARGIC; WEAK; SHOT SIGHT PAIN; SEVERE MUSCLE CRAMPS ALL OVER BODY/COULD NOT TELL IF NERVES WERE ON FIRE OR IF MUSCLES HURT OR IF BONES WERE HURTING; WORST PAIN OF LIFE; SHOT SLIGHT REDNESS; SHOT SLIGHT SWELLING; STARTED RUNNING A FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 09-SEP-2021 09:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-SEP-2021, the patient experienced severe muscle cramps all over body/could not tell if nerves were on fire or if muscles hurt or if bones were hurting. On 09-SEP-2021, the patient experienced worst pain of life. On 09-SEP-2021, the patient experienced shot slight redness. On 09-SEP-2021, the patient experienced shot slight swelling. On 09-SEP-2021, the patient experienced started running a fever. On 09-SEP-2021, the patient experienced shot sight pain. Laboratory data included: Pain scale (NR: not provided) Exceed a 10 on the pain chart. On 10-SEP-2021, the patient experienced lethargic. On 10-SEP-2021, the patient experienced weak. The action taken with covid-19 vaccine was not applicable. The patient recovered from severe muscle cramps all over body/could not tell if nerves were on fire or if muscles hurt or if bones were hurting on 10-SEP-2021, and the outcome of shot sight pain, shot slight swelling, shot slight redness, started running a fever, weak, lethargic and worst pain of life was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms, Pain, Pain assessment, Pyrexia
Clinical narrative: LETHARGIC; WEAK; SHOT SIGHT PAIN; SEVERE MUSCLE CRAMPS ALL OVER BODY/COULD NOT TELL IF NERVES WERE ON FIRE OR IF MUSCLES HURT OR IF BONES WERE HURTING; WORST PAIN OF LIFE; SHOT SLIGHT REDNESS; SHOT SLIGHT SWELLING; STARTED RUNNING A FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 09-SEP-2021 09:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-SEP-2021, the patient experienced severe muscle cramps all over body/could not tell if nerves were on fire or if muscles hurt or if bones were hurting. On 09-SEP-2021, the patient experienced worst pain of life. On 09-SEP-2021, the patient experienced shot slight redness. On 09-SEP-2021, the patient experienced shot slight swelling. On 09-SEP-2021, the patient experienced started running a fever. On 09-SEP-2021, the patient experienced shot sight pain. Laboratory data included: Pain scale (NR: not provided) Exceed a 10 on the pain chart. On 10-SEP-2021, the patient experienced lethargic. On 10-SEP-2021, the patient experienced weak. The action taken with covid-19 vaccine was not applicable. The patient recovered from severe muscle cramps all over body/could not tell if nerves were on fire or if muscles hurt or if bones were hurting on 10-SEP-2021, and the outcome of shot sight pain, shot slight swelling, shot slight redness, started running a fever, weak, lethargic and worst pain of life was not reported. This report was non-serious.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Insomnia, Vision blurred
Clinical narrative: HEADACHE; NO SLEEP; BLURRY VISION; CHILLS; This spontaneous report received from a consumer concerned a 21 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known drug allergies, no known medical conditions and no known medication usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-SEP-2021, the patient experienced no sleep. On 11-SEP-2021, the patient experienced blurry vision. On 11-SEP-2021, the patient experienced chills. On 12-SEP-2021, the patient experienced headache. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from chills, no sleep, blurry vision, and headache. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: FEVER 101F; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, and high blood pressure, and other pre-existing medical conditions included: The patient has no known drug allergies. 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-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included insulin detemir for diabetes, metformin for diabetes, carvedilol for high blood pressure, and furosemide for high blood pressure.  On an unspecified date, the patient experienced fever 101f. Laboratory data (dates unspecified) included: SARS-CoV-2 test (NR: not provided) Unknown. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever 101f was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported,1 total, 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 patient experienced blood clots due to the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210921796-Covid-19 vaccine ad26.cov2.s- Blood clots. This event(s) is considered unassessable. The event(s) has an 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: F
Vaccine: COVID19
Symptoms: Headache, Heavy menstrual bleeding, Pain
Clinical narrative: INTENSE MENSTRUATION WITH BLOOD CLOTS; A LOT OF HEADACHES; BODY ACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 10-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-SEP-2021, the patient experienced body aches. On 10-SEP-2021, the patient experienced a lot of headaches. On 11-SEP-2021, the patient experienced intense menstruation with blood clots. The action taken with covid-19 vaccine was not applicable. The outcome of the a lot of headaches, body aches and intense menstruation with blood clots was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: ANXIETY (EXTREME SHORTNESS OF BREATH); This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no history of anxiety or of shortness of breath. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced anxiety (extreme shortness of breath). Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anxiety (extreme shortness of breath). This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Extra dose administered, Injection site pain, Malaise
Clinical narrative: MALAISE; CHILLS; INJECTION SITE SORENESS; LOW GRADE FEVER; RECEIVED TWO DOSES OF JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 30-MAR-2021, and dose was not reported, administered on 11-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-SEP-2021, the patient experienced received two doses of janssen covid-19 vaccine. On 11-SEP-2021, the patient experienced off label use. On an unspecified date, the patient experienced malaise, chills, injection site soreness, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low grade fever, malaise, chills, and injection site soreness, and the outcome of received two doses of janssen covid-19 vaccine and off label use was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Pyrexia
Clinical narrative: MALAISE; CHILLS; INJECTION SITE SORENESS; LOW GRADE FEVER; RECEIVED TWO DOSES OF JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 30-MAR-2021, and dose was not reported, administered on 11-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-SEP-2021, the patient experienced received two doses of janssen covid-19 vaccine. On 11-SEP-2021, the patient experienced off label use. On an unspecified date, the patient experienced malaise, chills, injection site soreness, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low grade fever, malaise, chills, and injection site soreness, and the outcome of received two doses of janssen covid-19 vaccine and off label use was not reported. This report was non-serious.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blindness transient, Blood pressure measurement, Fatigue, Vomiting
Clinical narrative: BLIND FOR 5 MINUTES/LOST VISION FOR ONE EYE FOR HALF A DAY; THROW UP; WEAK; TIRED; This spontaneous report received from a consumer (patient's grandmother) concerned a 21-year-old male patient of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient got an unspecified vaccine for the STD (sexually transmitted disease) when he was in his teens, and passed out and his blood pressure (BP) went down. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on an unspecified date in AUG-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 an unspecified date, in AUG-2021, soon after vaccination, the patient started to throw up and was blind for 5 minutes. On the same day of vaccination, he lost the vision for one eye for a half of the day. His girlfriend (nurse) stayed with him that night. On the next morning, he was weak and tired but his eye started to get better. It took 2 days for the patient to completely recover. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blind for 5 minutes/lost vision for one eye for half a day, throw up, weak, and tired on an unspecified date in AUG-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210921963-COVID-19 VACCINE AD26.COV2.S-Blind for 5 minutes/lost vision for one eye for half a day. 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).