chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No other AE reported; administered GARDASIL 9 during a temperature excursion; This spontaneous report was received from a medical assistant and refers to a 14-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-FEB-2021, the hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) vaccines experienced the temperature excursion of 11 degrees Celsius for 10 hours.    On 02-MAR-2021, the patient was vaccinated with improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter, lot # T007035, expiration date 01-MAY-2022 (route of administration and anatomical location were not provided) for prophylaxis. The vaccine was administered by the certified and trained medical assistant and was paid for with  Vaccines for Children (VFC) funds. There was no previous temperature excursion. Digital data logger was involved. The vaccine was not available for return/evaluation. There was no other adverse event reported. At the time of reporting, the patient had not experienced cellulitis, erythema or swelling at the site of the injection.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007035; expirationdate: 01-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Medical Assistant; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA001535: US-009507513-2103USA001532: US-009507513-2103USA001526:
Age: 72.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 77-year-old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 04-APR-2016, the patient was vaccinated by a pharmacist with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event was not reported. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse events; VAQTA was administered to 1 patient/ temperature excusrion/ excurions occured on 3/24/2021; This spontaneous report was received from a medical assistance and refers to a patient of unknown age and gender.     In the morning on 25-MAR-2021, the patient was vaccinated with an improperly stored one dose of hepatitis a vaccine, inactivated (VAQTA) lot # T020442 has been verified to be a valid lot number, expiration date reported as 26-JAN-2022 for prophylaxis (exact dose, strength, route of administration and anatomical location were not reported). The temperature excursion was 34.65 degrees Fahrenheit (F) for 30 minutes. There were no previous excursions reported. The digital data logger was involved. No adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T020442; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: HIBV, MMR
Symptoms: Seizure
Clinical narrative: she started having seizures / still currently gets seizures; This spontaneous report as received from a patient's mother refers to a currently 28-year-old female patient. Her concurrent conditions included hypothyroidism. The patient's concomitant therapies included methsuximide (CELONTIN), levetiracetam(KEPPRA) and "Selbatol". There was no information regarding her medical history. The patient had none drug reactions or allergies.  On an unknown date, the patient was was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (dose, route of administration, indication, lot # and expiration date were not reported) for prophylaxis, without any reactions.  On 21-APR-1994, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot# 1603W has been verified to be not valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (dose, route of administration and expiration date were not reported) for vaccination. On the same date, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (dose, route of administration, indication, lot # and expiration date were not reported) for prophylaxis.  On 01-MAY-1994, the patient started having seizures. She still currently got seizures and was taking seizure medications. The patient did not have seizures prior to taking the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). The patient sought medical attention on an unknown date. The reporter stated that she reported this in the past (initial version was not found).  The outcome of seizure was reported as not recovered. The causality assessment between the events and the suspect therapies was not provided.  Upon internal review, the event of seizures was determined to be medically significant.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: swelling, warmth and redness from shoulder to elbow of left arm; swelling, warmth and redness from shoulder to elbow of left arm; swelling, warmth and redness from shoulder to elbow of left arm; This spontaneous report was received from a 66-year-old non-pregnant female patient, who was referring to herself. She has no pertinent medical history and no drug reactions/allergies.  On 18-NOV-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection, 0.5 milliliter, intramuscularly (strength, lot number and expiry date were not reported) for prophylaxis. Concomitant vaccinations included flu shot given on the same day.   On an unspecified date in November 2020 (approximately 5 hours after receiving the suspect vaccine), the patient experienced swelling, warmth and redness from shoulder to elbow of left arm. The events lasted for several days. No treatment was given to the patient. No lab diagnostics/tests were performed. The patient did not seek medical attention. On an unknown date (reported as couple of days after), the patient recovered from the events.  The relatedness between the events and the suspected vaccine was not reported.
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No additional AEs; a patient who is currently 9 weeks pregnant was administered MMR II/the patient is currently 9 weeks pregnant and was more than likely pregnant at the time of MMR II administration; This spontaneous prospective pregnancy report as received from a registered nurse refers to a 29-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date in February 2021, the pregnant patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. At the time of the report, the patient was 9 weeks pregnant, the pregnancy outcome was pending and the fetal outcome was unknown.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: Rotateq was given after the temperature excursion; This spontaneous report was received from a nursing assistant and refers to a patient of an unknown age and gender. There was no information about the patient's concomitant therapies, concurrent conditions or medical history provided.  On 30-MAR-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1660998, expiration date 03-MAY-2021, 2 milliliter, orally (anatomical location was not provided) for prophylaxis. The administered vaccine experienced the temperature excursion of 8.8 degree Celsius (C) for 6 minutes. Data logger was not involved. There were no previous excursions reported.
Age: 44.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: MMR II was administered to a patient past the expiration date; This spontaneous report was received from a pharmacist and refers to a 44-year-old patient of an unknown gender. There was no information about the patient's concomitant therapies, concurrent conditions or medical history provided.  On 29-MAR-2021, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), rHA, lot # R036582, expiration date 17-DEC-2020 (anatomical location and route of administration were not provided) for prophylaxis.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I took first shot and broke out worst then when I had them. Don't care about getting it again.; This case was reported by a consumer and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional information was provided as follows: The age at vaccination was not reported but was captured as adult as per vaccine indication. The patient broke out worst then when had Shingles. The patient did not care about getting the vaccine again. The patient stated it as a bad experience.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: shingles / from spine to navel from shoulder blade to navel / milder case / on left side; occassionall nerve pain; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles from spine to navel from shoulder blade to navel on right side for the 1st and 2nd time).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles and nerve pain. On an unknown date, the outcome of the shingles and nerve pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles and nerve pain to be related to Shingles vaccine.  Additional information was provided as follows: The age at vaccination was not reported but was captured as adult as per vaccine indication. The patient got shingles twice from spine to navel from shoulder blade to navel on right side. Post vaccination, the patient had milder shingles on left side. It was for the third time the patient got the shingles. For the first time patient had it on left side of neck. The patient stated that shingles still lingers without rash, in occasional nerve pain. The patient was shying away from the second dose.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Headache, Myalgia, Neck pain
Clinical narrative: Loss of appetite; Fatigue; Headache / headaches are intense / occur when going from a sitting to a standing position /  headaches are more constant at night and concentrated at the back of the neck and head; headaches are more constant at night and concentrated at the back of the neck and head; muscle soreness; Arm soreness; This case was reported by a consumer via call center representative and described the occurrence of muscle soreness in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on an unknown date).   In March 2021, the patient received the 2nd dose of Shingrix. In March 2021, 1 day after receiving Shingrix, the patient experienced muscle soreness, pain in arm, appetite lost, fatigue, headache and neck pain. On an unknown date, the outcome of the muscle soreness, appetite lost, fatigue, headache and neck pain were not recovered/not resolved and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the muscle soreness, pain in arm, appetite lost, fatigue, headache and neck pain to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient herself. The patient received second dose of Shingrix in left arm, 16 days ago from reporting day. The patient continued to experience residual side effects including headache, fatigue, muscle soreness, lack of appetite. On an unknown date, less than 3 weeks after vaccination, the patient also reported experiencing arm soreness, which went away after 3 days. The fatigue, headache, muscle soreness, and lack of appetite began the day after receiving second dose. The patient reported symptoms have gotten worse overtime. The headaches were intense and usually occur when going from a sitting to a standing position. The reporter reported headaches would subside when they begin walking around. The headaches were more constant at night and concentrated at the back of the neck and head. The reporter did not consent to follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Loss of appetite; Fatigue; Headache / headaches are intense / occur when going from a sitting to a standing position /  headaches are more constant at night and concentrated at the back of the neck and head; headaches are more constant at night and concentrated at the back of the neck and head; muscle soreness; Arm soreness; This case was reported by a consumer via call center representative and described the occurrence of muscle soreness in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on an unknown date).   In March 2021, the patient received the 2nd dose of Shingrix. In March 2021, 1 day after receiving Shingrix, the patient experienced muscle soreness, pain in arm, appetite lost, fatigue, headache and neck pain. On an unknown date, the outcome of the muscle soreness, appetite lost, fatigue, headache and neck pain were not recovered/not resolved and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the muscle soreness, pain in arm, appetite lost, fatigue, headache and neck pain to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient herself. The patient received second dose of Shingrix in left arm, 16 days ago from reporting day. The patient continued to experience residual side effects including headache, fatigue, muscle soreness, lack of appetite. On an unknown date, less than 3 weeks after vaccination, the patient also reported experiencing arm soreness, which went away after 3 days. The fatigue, headache, muscle soreness, and lack of appetite began the day after receiving second dose. The patient reported symptoms have gotten worse overtime. The headaches were intense and usually occur when going from a sitting to a standing position. The reporter reported headaches would subside when they begin walking around. The headaches were more constant at night and concentrated at the back of the neck and head. The reporter did not consent to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Palpitations, Pharyngeal swelling
Clinical narrative: SWOLLEN THROAT; HEART RACING; HEADACHE; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight was 220 kilograms, and height was 54 inches. The patient's past medical history included hormone replacement therapy, and concurrent conditions included thyroid disorder, anxiety, depression, arthritis, non smoker, and no alcohol use, and other pre-existing medical conditions included the patient had no known allergies or history of drug abuse or illicit drug usage. The patient received COVID-19 vaccine AD26.COV2.S (suspension for injection, intramuscular, batch number: Unknown) dose not reported, on 04-MAR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. It was reported that the patient was on unspecified hormone replacement therapy medication, thyroid medication, a blood thinner ,antianxiety and antidepressant medications, pre diabetes medications, and arthritis medication. On 04-MAR-2021, the subject experienced swollen throat and heart racing and was admitted to emergency room. On 04-MAR-2021, the subject also experienced headache. No further information provided. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 04-MAR-2021, and had not recovered from swollen throat, and heart racing. The reporter assessed the events as related to COVID-19 vaccine AD26.COV2.S This report was serious (Hospitalization Caused / Prolonged) for swollen throat and heart racing.; Sender's Comments: Swollen throat, headache and heart racing . This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship. There are no other factors more likely to be associated with the event(s) than the drug.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: CHEST TIGHTNESS; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 40 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pollen allergy, alcohol use (socially), no smoking, and  no drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022) dose was not reported, administered on 06-MAR-2021;11:00 am, into left arm, for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021, the patient experienced chest tightness and shortness of breath. Patient complained of chest tightness which began approx. 2 min after injection.  Patient also stated that he had to breathe slowly and "not heavy", and felt short of breath. The dose of covid-19 vaccine ad26.cov2.s was not changed. The patient had not recovered from chest tightness, and shortness of breath. This report was serious (Other Medically Important Condition).; Sender's Comments: Chest tightness, and shortness of breath. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are no other factors more likely to be associated with the event(s) than the drug.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Respiratory rate decreased
Clinical narrative: CHEST TIGHTNESS; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 40 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pollen allergy, alcohol use (socially), no smoking, and  no drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022) dose was not reported, administered on 06-MAR-2021;11:00 am, into left arm, for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021, the patient experienced chest tightness and shortness of breath. Patient complained of chest tightness which began approx. 2 min after injection.  Patient also stated that he had to breathe slowly and "not heavy", and felt short of breath. The dose of covid-19 vaccine ad26.cov2.s was not changed. The patient had not recovered from chest tightness, and shortness of breath. This report was serious (Other Medically Important Condition).; Sender's Comments: Chest tightness, and shortness of breath. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are no other factors more likely to be associated with the event(s) than the drug.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Pyrexia, Tremor, Vomiting
Clinical narrative: VOMITING; SEVERE SHAKING; HIGH HEART RATE; FEVER OVER 100.2; This spontaneous report received from a health care professional . The patient's weight, height, and medical history were not reported. It was not asked if the patient had any allergies. It was unknown if the patient consume alcohol, smoke and if there was any drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 05-MAR-2021; 04.45 pm, vaccination site not reported, for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On 06-MAR-2021, the patient experienced vomiting, severe shaking, high heart rate, and fever over 100.2. Patient was given injection around 4.45 pm on 05-MAR-2021 and adverse events of severe shaking, fever over 100.2, high heart rate and vomiting started about 45 minutes ago. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, severe shaking, and fever over 100.2, and the outcome of high heart rate was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: Vomiting, severe shaking, high heart rate, and fever over 100.2.. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship. There are no other factors more likely to be associated with the event(s) than the drug.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Respiratory rate increased, SARS-CoV-2 test
Clinical narrative: INCREASED HEART RATE; BREATHING INCREASE; This spontaneous report received from a patient concerned an 85 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, intramuscular, batch number: Unknown) dose was not reported, administered on 05-MAR-2021; 08:40 am, into left arm, for covid-19 prevention. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-MAR-2021, the patient experienced increased heart rate and breathing increase. Patient had covid screening a couple of days ago and it was negative. Patient reported that she got the shot at about 20 minutes to 9 am today and was fine till after dinner around 1:30 and her heart rate increased by 10 beats per minute (bpm) and she had increased breathing. Patient wanted to know if that was a bad reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased heart rate, and breathing increase on 05-MAR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: Increased heart rate, and breathing increase. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are no other factors more likely to be associated with the event(s) than the drug.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Respiratory rate increased, SARS-CoV-2 test negative
Clinical narrative: INCREASED HEART RATE; BREATHING INCREASE; This spontaneous report received from a patient concerned an 85 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, intramuscular, batch number: Unknown) dose was not reported, administered on 05-MAR-2021; 08:40 am, into left arm, for covid-19 prevention. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-MAR-2021, the patient experienced increased heart rate and breathing increase. Patient had covid screening a couple of days ago and it was negative. Patient reported that she got the shot at about 20 minutes to 9 am today and was fine till after dinner around 1:30 and her heart rate increased by 10 beats per minute (bpm) and she had increased breathing. Patient wanted to know if that was a bad reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased heart rate, and breathing increase on 05-MAR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: Increased heart rate, and breathing increase. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are no other factors more likely to be associated with the event(s) than the drug.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; 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, intramuscular, batch number: Unknown) dose was not reported, administered on 06-MAR-2021, vaccination site was not reported, for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On 06-MAR-2021, the patient experienced fever. Patient reported that she received the covid vaccination last night around midnight. Next morning patient started to have a fever. Patient was referred to seek medical advice from health care practitioner as patient asked what she should take for fever, as health care practitioner know her medical history. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was serious (Other Medically Important Condition).; Sender's Comments: Pyrexia. This event(s) is labeled and is therefore considered potentially related.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Feeling abnormal, Heart rate increased
Clinical narrative: DIFFICULTY BREATHING; FAST HEARTBEAT; DIZZINESS; WEAKNESS; WEIRD FEELING; 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, intramuscular, batch number: Unknown) dose was not reported, administered on 06-MAR-2021 to Left Arm for covid-19 vaccination. No concomitant medications were reported.  On 06-MAR-2021 (at night), the patient experienced difficulty breathing, fast heartbeat, dizziness, weakness, and weird feeling. Symptoms have not worsened or improved since onset. The patient stated that "he doesn't feel that bad, but feels weird, like he is in the water." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from difficulty breathing, fast heartbeat, dizziness, weakness, and weird feeling (outcome also reported as unknown). This report was serious (Other Medically Important Condition).; Sender's Comments: Difficulty breathing, fast heartbeat, dizziness, weakness, and weird feeling. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are no other factors more likely to be associated with the event(s) than the drug.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Pyrexia
Clinical narrative: FEVER; HEART RATE INCREASED; 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 and batch number: Unknown) dose was not reported, administered on 05-MAR-2021 12:00 for prophylactic vaccination. No concomitant medications were reported.  On 05-MAR-2021, the patient experienced fever and heart rate increased. Her heart rate was115 beats per minute even at rest. Treatment medications included paracetamol for fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and heart rate increased was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: Fever and heart rate increased. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship. There are no other factors more likely to be associated with the event(s) than the drug.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature fluctuation, Chills, Dizziness, Loss of consciousness, Sensitive skin
Clinical narrative: PASSED OUT; LIGHT HEADED; SHIVERING; HARD TIME REGULATING ITS TEMPERATURE; SENSITIVE SKIN; This spontaneous report received from a female of unspecified age reporting on self via social media. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced sensitive skin.  On an unspecified date, the patient stated that the side effects for her were bad but short lived, got light headed and passed out in her kitchen, if she felt light headed, sat or lay down so she could not fall, her body also had a hard time regulating its temperature (temperature regulation disorder). The patient was shivering uncontrollably for about an hour, and then overheated very quickly under all blankets. On 11-MAR-2021 the patient mentioned that her skin feel sensitive, otherwise she was fine. She got the shot yesterday. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headed, was recovering from shivering, and sensitive skin, the outcome of passed out and temperature regulation disorder was not reported. The reporter considered the causality between JNJ-78436735, and light headed, shivering, sensitive skin, passed out and temperature regulation disorder as related. Company causality between JNJ-78436735, and light headed, shivering, sensitive skin, passed out and temperature regulation disorder was possible This report was serious (Other Medically Important Condition).; Sender's Comments: 20210322217-JANSSEN COVID-19 VACCINE-Passed out. This event   is considered unassessable. The event has a compatible/suggestive   temporal relationship, is unlabeled, and has unknown scientific   plausibility. There is no information on any other factors potentially   associated with the event.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Loss of consciousness, Sensitive skin, Temperature regulation disorder
Clinical narrative: PASSED OUT; LIGHT HEADED; SHIVERING; HARD TIME REGULATING ITS TEMPERATURE; SENSITIVE SKIN; This spontaneous report received from a female of unspecified age reporting on self via social media. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced sensitive skin.  On an unspecified date, the patient stated that the side effects for her were bad but short lived, got light headed and passed out in her kitchen, if she felt light headed, sat or lay down so she could not fall, her body also had a hard time regulating its temperature (temperature regulation disorder). The patient was shivering uncontrollably for about an hour, and then overheated very quickly under all blankets. On 11-MAR-2021 the patient mentioned that her skin feel sensitive, otherwise she was fine. She got the shot yesterday. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headed, was recovering from shivering, and sensitive skin, the outcome of passed out and temperature regulation disorder was not reported. The reporter considered the causality between JNJ-78436735, and light headed, shivering, sensitive skin, passed out and temperature regulation disorder as related. Company causality between JNJ-78436735, and light headed, shivering, sensitive skin, passed out and temperature regulation disorder was possible This report was serious (Other Medically Important Condition).; Sender's Comments: 20210322217-JANSSEN COVID-19 VACCINE-Passed out. This event   is considered unassessable. The event has a compatible/suggestive   temporal relationship, is unlabeled, and has unknown scientific   plausibility. There is no information on any other factors potentially   associated with the event.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Influenza like illness, Seizure
Clinical narrative: SEIZURE; FLU LIKE SYMPTOMS (CHILLS, HIGH TEMPERATURE, FEELS HOT,STUFFY NOSE); This spontaneous report received from a consumer concerned a 67 year old female. 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: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. Batch number was not reported has been requested No concomitant medications were reported. No concomitant medications were reported.  On MAR-2021,On an unspecified date, the patient experienced seizure, shaking, chills, high temperature, feels hot, and stuffy nose. patient daughter report she was suffering from seizure symptoms include extremely stiff ,extreme dizziness, shaking, and eyes rolling in back of head, also reported her mother did not lost consciousness and has been coherent .Daughter stated symptoms seem almost like a stroke ,upon follow call she clarify about seizure which is subsided. seizure occurred 3 times over past 5 days prior to call (first night of vaccine, next morning, and reporting day.) Daughter also reported mother had flu-like symptoms for the first 3 days after vaccine, including chills, high temperature, feels hot, and stuffy nose, but these have resolved. Daughter reports mother has not had symptoms like these prior to vaccine. she also report pharmacist who gave vaccine is aware of symptoms. patient body temperature was high, patient not performed covid 19 test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms ( chills, high temperature, feels hot ,stuffy nose.), and the outcome of seizure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: v0: 20210322863-Covid-19 Vaccine Ad26.Cov2.S-Seizure. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Feeling hot, Gaze palsy, Influenza like illness
Clinical narrative: SEIZURE; FLU LIKE SYMPTOMS (CHILLS, HIGH TEMPERATURE, FEELS HOT,STUFFY NOSE); This spontaneous report received from a consumer concerned a 67 year old female. 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: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. Batch number was not reported has been requested No concomitant medications were reported. No concomitant medications were reported.  On MAR-2021,On an unspecified date, the patient experienced seizure, shaking, chills, high temperature, feels hot, and stuffy nose. patient daughter report she was suffering from seizure symptoms include extremely stiff ,extreme dizziness, shaking, and eyes rolling in back of head, also reported her mother did not lost consciousness and has been coherent .Daughter stated symptoms seem almost like a stroke ,upon follow call she clarify about seizure which is subsided. seizure occurred 3 times over past 5 days prior to call (first night of vaccine, next morning, and reporting day.) Daughter also reported mother had flu-like symptoms for the first 3 days after vaccine, including chills, high temperature, feels hot, and stuffy nose, but these have resolved. Daughter reports mother has not had symptoms like these prior to vaccine. she also report pharmacist who gave vaccine is aware of symptoms. patient body temperature was high, patient not performed covid 19 test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms ( chills, high temperature, feels hot ,stuffy nose.), and the outcome of seizure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: v0: 20210322863-Covid-19 Vaccine Ad26.Cov2.S-Seizure. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal stiffness, Nasal congestion, Pyrexia, Seizure, Tremor
Clinical narrative: SEIZURE; FLU LIKE SYMPTOMS (CHILLS, HIGH TEMPERATURE, FEELS HOT,STUFFY NOSE); This spontaneous report received from a consumer concerned a 67 year old female. 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: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. Batch number was not reported has been requested No concomitant medications were reported. No concomitant medications were reported.  On MAR-2021,On an unspecified date, the patient experienced seizure, shaking, chills, high temperature, feels hot, and stuffy nose. patient daughter report she was suffering from seizure symptoms include extremely stiff ,extreme dizziness, shaking, and eyes rolling in back of head, also reported her mother did not lost consciousness and has been coherent .Daughter stated symptoms seem almost like a stroke ,upon follow call she clarify about seizure which is subsided. seizure occurred 3 times over past 5 days prior to call (first night of vaccine, next morning, and reporting day.) Daughter also reported mother had flu-like symptoms for the first 3 days after vaccine, including chills, high temperature, feels hot, and stuffy nose, but these have resolved. Daughter reports mother has not had symptoms like these prior to vaccine. she also report pharmacist who gave vaccine is aware of symptoms. patient body temperature was high, patient not performed covid 19 test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms ( chills, high temperature, feels hot ,stuffy nose.), and the outcome of seizure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: v0: 20210322863-Covid-19 Vaccine Ad26.Cov2.S-Seizure. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction, Feminisation acquired
Clinical narrative: UNABLE TO ACHIEVE OR MAINTAIN AN ERECTION; FEMINIZATION; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received JNJ78436735 (Ad26.COV2.S)(suspension for injection, intramuscular, and batch number: UNKNOWN expiry: UNKNOWN) 0.5 ml, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in MAR-2021, the patient was unable to achieve or maintain an erection as well as feminization (making him 5'3" and giving him small hands). The action taken with JNJ78436735 (Ad26.COV2.S) was not applicable. The outcome of the unable to achieve or maintain an erection and feminization was not reported. This report was serious (Other Medically Important Condition).  Version created to amend previously reported information on 11-MAR-2021. Upon review, the following information was amended: outcome was updated from possible to not reported in narrative. Null flavor unknown selected for batch no.; Sender's Comments: v1: Version created to amend outcome in narrative. 20210324270-Covid-19 vaccine ad26.cov2.s-Erectile dysfunction. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: U
Vaccine: COVID19
Symptoms: Hypotension, Loss of consciousness, Syncope
Clinical narrative: FAINTING; LOSS OF CONSCIOUSNESS; HYPOTENSION; This spontaneous report received from a health care professional concerned multiple patients. Initial information was processed along with the additional information received on 17-MAR-2021. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The nurse reported on 11-MAR-2021. two patients had hypotensive episodes and fainted in clinic. On 11-MAR-2021, the patients experienced loss of consciousness. On an unspecified date, the patients had fainted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the loss of consciousness, hypotension and fainting was not reported. The reporter provided causality between covid-19 vaccine ad26.cov2.s and loss of consciousness, hypotension, fainting was possible. This report was serious (Other Medically Important Condition).; Reporter's Comments: This case contains multiple patients.; Sender's Comments: V0: 20210324277- Covid-19 vaccine ad26.cov2.S- loss of consciousness, hypotension, fainting. This events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, Fatigue, Flank pain, Loss of personal independence in daily activities
Clinical narrative: FELT BILATERAL LUNG CONGESTION; BILATERAL SIDE PAIN; VOMITING; DIFFICULTY BREATHING; PAIN WHEN BREATHS; FEVER OF 100 F; FATIGUE; MISSED WORK TODAY; LEFT ARM PAIN; This spontaneous report received from a patient concerned a 52 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, intramuscular, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-MAR-2021 (mentioned as yesterday), the symptoms of the patient started, and he missed work today (loss of personal independence in daily activities) and left arm pain (painful L arm) because he was not feeling well. The reporter advised him to contact his primary care provider, but he said he called and they are not able to see him without an appointment also advised him to seek medical attention by going to the emergency room. The patient agrees to go to the Emergency Room. On 11-MAR-2021, the patient experienced bilateral side pain (flank pain), vomiting, felt bilateral lung congestion (lung congestion), difficulty breathing, fever of 100 F, fatigue, pain when breaths (painful respiration).  Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever of 100 f, had not recovered from bilateral side pain, left arm pain, fatigue, vomiting, difficulty breathing, feels bilateral lung congestion, and pain when breaths, and the outcome of missed work today was not reported. The reporter considered the causality between Covid-19 vaccine ad26.cov2.s and event bilateral side pain, left arm pain, fatigue, vomiting, difficulty breathing, feels bilateral lung congestion, pain when breaths, fever of 100 f and missed work today as possible. Company causality between Covid-19 vaccine ad26.cov2.s  and event bilateral side pain, left arm pain, fatigue, vomiting, difficulty breathing, feels bilateral lung congestion, pain when breaths, fever of 100 f and of missed work today as possible.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210325415- Covid-19 vaccine ad26.cov2.S- bilateral lung congestion. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.