chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenitis
Clinical narrative: Severe inflammation and pain in left axillary lymphs; Severe inflammation and pain in left axillary lymphs; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient (not pregnant at the time of vaccination) received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: unknown, via unspecified route, in left arm on 21Apr2021 15:30 (at 47-years age) 1ST DOSE SINGLE for covid-19 immunisation. The patient's medical history included Migraines, past drug advil. The patient's concomitant medications included vitamin D, zinc, magnesio in within 2 weeks of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received other medications in 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Apr2021 the patient had experienced severe inflammation and pain in left axillary lymphs. The outcome of the event was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Pain in extremity
Clinical narrative: She was unable to work due to the pain; Pain in thigh, calf, hamstring of both the legs. It comes and goes away. It improves when I sleep but worsen when I sit and work. It started as thigh pain during my periods and then became calf and hamstring pain.; This is a spontaneous report from a contactable consumer. A 30-years-old female, non-pregnant, patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration, administered in left arm on 27Mar2021 15:00 (Batch/Lot Number: ER8730) as single dose for COVID-19 immunization. Medical history included arthritis from an unknown date and unknown if ongoing, hip pain in Jan2021, resolved by taking vitamin D3 tablets by "NatureMade" 2000IU and milk. The patient's concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with COVID-19, since the vaccination the patient has not been tested for COVID-19. On 14Apr2021 13:00 the patient started experiencing pain in thigh, calf, hamstring of both the legs. It comes and goes away. It improves during sleep but worsen when the patient sits and works. It started as thigh pain during the patient's periods and then became calf and hamstring pain. The patient reported that it surely has altered something in her body. She is a software engineer and most of the time she needs to work on her laptop. She took Pfizer vaccine to save herself from COVID-19 instead this vaccine is crippling her and she was unable to work due to the pain. As a result of the event the patient scheduled an appointment with orthopedic. It was also reported that the patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, at Pharmacy or Drug Store, on 24Apr2021 at 2:30 pm (Batch/lot number: EW0170). At the time of the report the event had not resolved yet.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Fatigue, Myalgia, SARS-CoV-2 test
Clinical narrative: I did a rapid test it came back positive. I did a PCR test also, but I am waiting for the result.; chills; muscle pain; mostly fatigue; This is a spontaneous report received from Medical Information and a contactable male consumer (patient). A 40-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and Expiration date not reported), via an unspecified route of administration on 22Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Monday, 26Apr2021 the patient started feeling symptoms included fatigue, muscle Soreness, that were pretty light. On 27Apr2021, they got worst, the patient had muscle pain and mostly fatigue and in the night, the patient started having chills that are persisting on 28Apr2021. The patient underwent lab tests and diagnosis which include a rapid covid test that came back positive and also got a PCR test but results will not be back for about 48 hours. The outcome of all the events was reported as unknown.  Information about lot/batch number has been requested.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Fall
Clinical narrative: STROKE; FELL DOWN; This spontaneous report received from a health care professional (patient's wife) concerned a 54 year old male of Hispanic or Latino other race. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, diabetes, and high cholesterol. The patient had no known allergies and was non smoker.  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, administered on 16-MAR-2021 at 16:00 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. After vaccination, later on that evening her husband mentioned that he did not feel too good. He took a Tylenol and then went to bed. At around 3:00 that evening his wife woke up to go to the bathroom and noticed her husband was awake. When she asked he responded that he thought he might have suffered a stroke. On unspecified date he experienced fell down and unable to move the right side of his body. On 17-MAR-2021 at around 5:00 that morning, she took him to the emergency room (ER). There the ER department performed a computerized tomography (CAT) scan and confirmed that he indeed had a stroke and decided to transfer him to another hospital. On 22-MAR-2021, he was then discharged. He was hospitalized for 5 days. A few days later on 24 or 25-MAR-2021 she took him to her Doctor Of Medicine (MD.) where they had him do rehab which consisted of daily walking. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke, and the outcome of fell down was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210515350-Covid-19 vaccine ad26.cov2.s- A 54- year- old male of Hispanic or Latino other race presents with Stroke. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: DIZZY; MASSIVE HEADACHE/WORST HEADACHE ONLY ON RIGHT SIDE OF THE HEAD; This spontaneous report received from a consumer by a Business partner   was received on 07-MAY-2021 and concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced dizzy. On 2021, the subject experienced massive headache/worst headache only on right side of the head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the massive headache/worst headache only on right side of the head and dizzy was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non serious.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a health care professional concerned a male of unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 14-MAY-2021. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 25-MAY-2021) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the patient experienced confirmed immunological vaccine failure.  On MAY-2021, Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) Negative with a level of 5.87 when <12 is considered negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000179590.; Sender's Comments: V0: 20210523786-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Muscle spasms
Clinical narrative: DIZZINESS; LEG CRAMPS/BAD CHARLEY HORSE; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A,and expiry: 23-JUN-2021) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced dizziness. On 13-MAY-2021, the subject experienced leg cramps/bad charley horse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from leg cramps/bad charley horse, and had not recovered from dizziness. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a 60-year-old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry date : Unknown) dose was not reported, 1 total administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 20-APR-2021, the patient had negative quantitative antibody test (spike protein test) (confirmed immunological vaccine failure). Laboratory data included: Semi Quantitative spike protein Antibody test (NR: not provided) as Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. . The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210457869.; Sender's Comments: V0:20210525044 covid-19 vaccine ad26.cov2.s - Confirmed immunological vaccine failure.This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically:SPECIAL SITUATIONS
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Fatigue, Pain, Pain assessment
Clinical narrative: ABDOMINAL PAIN; SORENESS; TIREDNESS; This spontaneous report received from a patient concerned a 36 year old male. The patient's weight was 190 pounds, and height was 175 centimeters. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no pertinent medical history. the patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, Laboratory data included: Pain scale (NR: not provided) 4/10 (unit not reported). On 03-MAY-2021, the subject experienced abdominal pain. On 03-MAY-2021, the subject experienced soreness. On 03-MAY-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness, and tiredness on 06-MAY-2021, and had not recovered from abdominal pain. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Headache, Nausea, Pyrexia
Clinical narrative: SHAKING; FELT LIKE WHEN HE HAD COVID BACK IN OCTOBER WHERE HE WAS HOPITALIZED; VERY LOW ENERGY LEVEL; NAUSEA; FEVER; HEADACHE; 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 past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced shaking, felt like when he had covid back in october where he was hopitalized, very low energy level, nausea, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shaking, nausea, fever, headache, very low energy level and felt like when he had covid back in october where he was hopitalized was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: SHAKING; FELT LIKE WHEN HE HAD COVID BACK IN OCTOBER WHERE HE WAS HOPITALIZED; VERY LOW ENERGY LEVEL; NAUSEA; FEVER; HEADACHE; 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 past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced shaking, felt like when he had covid back in october where he was hopitalized, very low energy level, nausea, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shaking, nausea, fever, headache, very low energy level and felt like when he had covid back in october where he was hopitalized was not reported. This report was non-serious.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dizziness, Dysphonia, Oropharyngeal pain, Sneezing
Clinical narrative: DIZZINESS; COUGH; SNEEZING; SORE THROAT; SOME HOARSEN; This spontaneous report received from a patient concerned an 83 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced sore throat. On 15-MAY-2021, the subject experienced some hoarsen. On an unspecified date, the subject experienced dizziness, cough, and sneezing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore throat, and the outcome of dizziness, cough, sneezing and some hoarsen was not reported. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: DIZZINESS; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 11-MAY-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Dizziness, Nausea, Pain
Clinical narrative: STOMACH CRAMPING; NAUSEA; VERY SLEEPY; ACHY EVERYWHERE; SORE ARM; CHILLS; DIZZINESS; HEART RACING; FEVER; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced dizziness. On MAY-2021, the subject experienced heart racing. On MAY-2021, the subject experienced fever. On 11-MAY-2021, the subject experienced very sleepy. On 11-MAY-2021, the subject experienced achy everywhere. On 11-MAY-2021, the subject experienced sore arm. On 11-MAY-2021, the subject experienced chills. On 14-MAY-2021, the subject experienced stomach cramping. On 14-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very sleepy on 15-MAY-2021, and dizziness, heart racing, nausea, and fever on MAY-2021, and had not recovered from achy everywhere, chills, stomach cramping, and sore arm. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Palpitations, Pyrexia, Somnolence
Clinical narrative: STOMACH CRAMPING; NAUSEA; VERY SLEEPY; ACHY EVERYWHERE; SORE ARM; CHILLS; DIZZINESS; HEART RACING; FEVER; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced dizziness. On MAY-2021, the subject experienced heart racing. On MAY-2021, the subject experienced fever. On 11-MAY-2021, the subject experienced very sleepy. On 11-MAY-2021, the subject experienced achy everywhere. On 11-MAY-2021, the subject experienced sore arm. On 11-MAY-2021, the subject experienced chills. On 14-MAY-2021, the subject experienced stomach cramping. On 14-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very sleepy on 15-MAY-2021, and dizziness, heart racing, nausea, and fever on MAY-2021, and had not recovered from achy everywhere, chills, stomach cramping, and sore arm. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: DIZZINESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dizziness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: ARM HURTING FOR A WEEK; FEVER; NAUSEOUS; MAJOR HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced arm hurting for a week, fever, nauseous, and major headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, nauseous, and major headache, and had not recovered from arm hurting for a week. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: UNSPECIFIED ADVERSE EVENTS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced unspecified adverse events. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unspecified adverse events. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: Arm of injection feels really hot,arm turned red,arm swelled; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (Arm of injection feels really hot,arm turned red,arm swelled) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CELLULITIS (Arm of injection feels really hot,arm turned red,arm swelled) (seriousness criterion medically significant). At the time of the report, CELLULITIS (Arm of injection feels really hot,arm turned red,arm swelled) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reporter. Patient also experienced pain. No treatments were reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Eye swelling, Feeding disorder, Loss of consciousness, Migraine
Clinical narrative: Massive vertigo attack; Severe migraine; can't go anywhere; pain medication wasn't working at all; Pain; couldn't eat anything down; eye was so swollen; Passed out right after the injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out right after the injection) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out right after the injection) (seriousness criterion medically significant). On an unknown date, the patient experienced VERTIGO (Massive vertigo attack), MIGRAINE (Severe migraine), MOBILITY DECREASED (can't go anywhere), DRUG INEFFECTIVE (pain medication wasn't working at all), PAIN (Pain), FEEDING DISORDER (couldn't eat anything down) and EYE SWELLING (eye was so swollen). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out right after the injection), VERTIGO (Massive vertigo attack), MIGRAINE (Severe migraine), MOBILITY DECREASED (can't go anywhere), DRUG INEFFECTIVE (pain medication wasn't working at all), PAIN (Pain), FEEDING DISORDER (couldn't eat anything down) and EYE SWELLING (eye was so swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant list is provided.  Treatment information was not provided.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain, Vertigo
Clinical narrative: Massive vertigo attack; Severe migraine; can't go anywhere; pain medication wasn't working at all; Pain; couldn't eat anything down; eye was so swollen; Passed out right after the injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out right after the injection) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out right after the injection) (seriousness criterion medically significant). On an unknown date, the patient experienced VERTIGO (Massive vertigo attack), MIGRAINE (Severe migraine), MOBILITY DECREASED (can't go anywhere), DRUG INEFFECTIVE (pain medication wasn't working at all), PAIN (Pain), FEEDING DISORDER (couldn't eat anything down) and EYE SWELLING (eye was so swollen). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out right after the injection), VERTIGO (Massive vertigo attack), MIGRAINE (Severe migraine), MOBILITY DECREASED (can't go anywhere), DRUG INEFFECTIVE (pain medication wasn't working at all), PAIN (Pain), FEEDING DISORDER (couldn't eat anything down) and EYE SWELLING (eye was so swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant list is provided.  Treatment information was not provided.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Carcinoembryonic antigen increased
Clinical narrative: CEA level increased; This spontaneous case was reported by a consumer and describes the occurrence of CARCINOEMBRYONIC ANTIGEN INCREASED (CEA level increased) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     Concurrent medical conditions included Colon cancer.   On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced CARCINOEMBRYONIC ANTIGEN INCREASED (CEA level increased) (seriousness criterion medically significant). At the time of the report, CARCINOEMBRYONIC ANTIGEN INCREASED (CEA level increased) outcome was unknown.            patient was on concomitant medications they were not reported.  No treatment information was provided  Company comment: Based on current available information and the temporal association between product use and the start date of the event a causal relationship is unlikely.   This case was linked to MODERNATX, INC.-MOD-2021-106630 (E2B Linked Report).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event a causal relationship is unlikely. MODERNATX, INC.-MOD-2021-106630:WIFE CASE
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Epigastric Pain and Diarrhea. She could not work for 2 weeks; Epigastric Pain and Diarrhea. She could not work for 2 weeks; This is a spontaneous report received from a contactable physician. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), on unspecified date in Apr2021 as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter stated that patient received the first dose of the Pfizer COVID vaccine 3 weeks before the present report (Apr2021) and 36 hours later she had epigastric pain and diarrhea. She could not work for 2 weeks and reporter wanted to know data on risk of having it again for the second dose. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nocturnal dyspnoea
Clinical narrative: Shortness of breath at night followed by severe headache - every night after vaccine; headache; This is spontaneous report from contactable consumer (patient).  A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, in Arm Left on 22Apr2021 11:15 (Batch/Lot Number: Er8735) as single dose for covid-19 immunisation at Pharmacy or Drug Store. The patient medical history was not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Ew0150) on 01Apr2021 04:30 PM (at 33 years old) in left arm for covid-19 immunisation. Concomitant medications included iron (IRON) taken for an unspecified indication, start and stop date were not reported and vitamin supplements. The patient experienced shortness of breath at night followed by severe headache - every night after vaccine on 22Apr2021 20:00 with outcome of not recovered. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, Vaccination site rash
Clinical narrative: Bilateral rash on upper arms. The rash was most pronounced on the left arm (site of my 2 vaccinations). The rash appeared just short of a week after my first injection.; Bilateral rash on upper arms. The rash was most pronounced on the left arm (site of my 2 vaccinations). The rash appeared just short of a week after my first injection.; This is a spontaneous report from a contactable consumer.  A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left in Mar2021 (Batch/Lot Number: ER8730) as 1st dose, single for covid-19 immunization. The patient's medical history included hay fever; severe case of chicken pox at age 14 from an unknown date and unknown if ongoing. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) and fluticasone propionate (FLONASE ALLERGY RELIEF) taken for an unspecified indication, start and stop date were not reported. The patient previously took nickel, cherry fruit. The patient experienced bilateral rash on upper arms. the rash was most pronounced on the left arm (site of my 2 vaccinations). the rash appeared just short of a week after my first injection on 31Mar2021 07:00. It was further reported as bilateral rash on upper arms. The rash was most pronounced on the left arm (site of my 2 vaccinations). The rash appeared just short of a week after my first injection.  It faded somewhat over the 3 weeks leading up to my final vaccination on April 14. The rash became more apparent a week following the 2nd dose and continues at the present moment. The area was approximately 10 inches along the inside of the left arm and is half that length on the right arm. The rash was slightly raised. Patient applied  lotion as needed to help with the itching but the rash remains. Telehealth appointment on May 1 (yesterday) resulted in prescriptions for hydrocortisone cream for the rash and a 7-day supply of Cephalexin. The outcome of the event was not recovered. Patient has was not diagnosed with COVID-19 prior to vaccination and the patient has not tested for COVID-19 since the vaccination.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Pruritus, Rash papular
Clinical narrative: Bilateral rash on upper arms. The rash was most pronounced on the left arm (site of my 2 vaccinations). The rash appeared just short of a week after my first injection.; Bilateral rash on upper arms. The rash was most pronounced on the left arm (site of my 2 vaccinations). The rash appeared just short of a week after my first injection.; This is a spontaneous report from a contactable consumer.  A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left in Mar2021 (Batch/Lot Number: ER8730) as 1st dose, single for covid-19 immunization. The patient's medical history included hay fever; severe case of chicken pox at age 14 from an unknown date and unknown if ongoing. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) and fluticasone propionate (FLONASE ALLERGY RELIEF) taken for an unspecified indication, start and stop date were not reported. The patient previously took nickel, cherry fruit. The patient experienced bilateral rash on upper arms. the rash was most pronounced on the left arm (site of my 2 vaccinations). the rash appeared just short of a week after my first injection on 31Mar2021 07:00. It was further reported as bilateral rash on upper arms. The rash was most pronounced on the left arm (site of my 2 vaccinations). The rash appeared just short of a week after my first injection.  It faded somewhat over the 3 weeks leading up to my final vaccination on April 14. The rash became more apparent a week following the 2nd dose and continues at the present moment. The area was approximately 10 inches along the inside of the left arm and is half that length on the right arm. The rash was slightly raised. Patient applied  lotion as needed to help with the itching but the rash remains. Telehealth appointment on May 1 (yesterday) resulted in prescriptions for hydrocortisone cream for the rash and a 7-day supply of Cephalexin. The outcome of the event was not recovered. Patient has was not diagnosed with COVID-19 prior to vaccination and the patient has not tested for COVID-19 since the vaccination.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, Vaccination site rash
Clinical narrative: itching; bilateral rash on upper arms; more apparent a week following the 2nd dose; rash is slightly raised; bilateral rash on upper arms; more apparent a week following the 2nd dose; rash is slightly raised; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose, via an unspecified route of administration, administered in left arm on 14Apr2021 16:30 (Lot Number: EW0162) (at age 57 years old) as single dose for covid-19 immunisation. Medical history included known allergies to nickel and fresh cherries, hay fever, and severe case of chicken pox at age 14. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Concomitant medications included fluticasone propionate (FLONASE) and diphenhydramine hydrochloride (BENADRYL) both taken for unspecified indications, start and stop date were not reported. The patient previously received the first dose of bnt162b2 administered in left arm in Mar2021 16:30 (lot no: ER8730) at age 57 years old for COVID-19 immunization and experienced rash., The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Mar2021, the patient experienced bilateral rash on upper arms. The rash was most pronounced on the left arm (site of his 2 vaccinations). The rash appeared just short of a week after his first injection. It faded somewhat over the 3 weeks leading up to her final vaccination on 14Apr2021. The rash became more apparent a week following the 2nd dose (Apr2021) and continued at the present moment. The area is approximately 10 inches along the inside of the left arm and is half that length on the right arm. The rash is slightly raised. He applied lotion as needed to help with the itching but the rash remains. Telehealth appointment on 01May2021 (yesterday) resulted in prescriptions for hydrocortisone cream for the rash and a 7-day supply of cephalexin. The event was reported as non-serious. The patient had not recovered from the event rash; while for itching was unknown.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Pruritus, Rash papular
Clinical narrative: itching; bilateral rash on upper arms; more apparent a week following the 2nd dose; rash is slightly raised; bilateral rash on upper arms; more apparent a week following the 2nd dose; rash is slightly raised; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose, via an unspecified route of administration, administered in left arm on 14Apr2021 16:30 (Lot Number: EW0162) (at age 57 years old) as single dose for covid-19 immunisation. Medical history included known allergies to nickel and fresh cherries, hay fever, and severe case of chicken pox at age 14. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Concomitant medications included fluticasone propionate (FLONASE) and diphenhydramine hydrochloride (BENADRYL) both taken for unspecified indications, start and stop date were not reported. The patient previously received the first dose of bnt162b2 administered in left arm in Mar2021 16:30 (lot no: ER8730) at age 57 years old for COVID-19 immunization and experienced rash., The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Mar2021, the patient experienced bilateral rash on upper arms. The rash was most pronounced on the left arm (site of his 2 vaccinations). The rash appeared just short of a week after his first injection. It faded somewhat over the 3 weeks leading up to her final vaccination on 14Apr2021. The rash became more apparent a week following the 2nd dose (Apr2021) and continued at the present moment. The area is approximately 10 inches along the inside of the left arm and is half that length on the right arm. The rash is slightly raised. He applied lotion as needed to help with the itching but the rash remains. Telehealth appointment on 01May2021 (yesterday) resulted in prescriptions for hydrocortisone cream for the rash and a 7-day supply of cephalexin. The event was reported as non-serious. The patient had not recovered from the event rash; while for itching was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Pain in extremity
Clinical narrative: Arm pain after dose 1 from 6-30 hours afterward; Missed period; This is a spontaneous report from a contactable consumer (patient).   A 38-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm right on 09Apr2021 13:15 (Batch/Lot Number: EW0151) as single dose at the age of 38-year-old for COVID-19 immunisation, administered at hospital.  The patient medical history was not reported. The concomitant medications within 2 weeks of vaccination includes: birth control. The patient was not pregnant. The patient had not received other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. In Apr2012 the patient experienced arm pain after dose 1 from 6-30 hours afterward and missed period (scheduled to get 23Apr-25Apr) on an unspecified date. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Eye swelling, Skin exfoliation
Clinical narrative: Eye swelling and eye skin peeling under eye. To now completely raw and irritated.; Eye swelling and eye skin peeling under eye. To now completely raw and irritated.; Eye swelling and eye skin peeling under eye. To now completely raw and irritated.; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration in left arm on 18Mar2021 (at the age of 24-years-old) as unknown, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was a reported as other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and since vaccination, patient was not tested for COVID-19. Medical history included undifferentiated connective tissue disease, Celiac and known allergies: wheat. Concomitant medications included methotrexate; prednisone; sertraline hydrochloride (ZOLOFT) and birth control. The patient previously took tramadol and experienced allergy. The reported events were eye swelling and eye skin peeling under eye. To now completely raw and irritated, all on 19Mar2021. The patient considered as serious due to disabling/incapacitating but did not result in death, non-life threatening, did not cause/prolong hospitalization and no congenital anomaly/birth defect. The events resulted to doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. Treatment for the events included steroid cream and benedryl. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Dizziness, Malaise, Myalgia
Clinical narrative: Dizziness; Nausea/gets lot of nauseous; Weakness/she feels like weak; Vomiting; Her muscle still sore; fever; Feeling unwell; This is a spontaneous report from a contactable consumer who reported for her/his mother. A 49-year-old female (non-pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arrm on 30Apr2021 17:30 (Batch/Lot number was not reported) as single dose (at 49 years old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 30Apr2021, the patient experienced dizziness, nausea/gets lot of nauseous, weakness/she feels like weak, vomiting, her muscle still sore, fever, feeling unwell. Dizziness, nausea, weakness, vomiting, myalgia were worsened. The outcome of all events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Dizziness; Nausea/gets lot of nauseous; Weakness/she feels like weak; Vomiting; Her muscle still sore; fever; Feeling unwell; This is a spontaneous report from a contactable consumer who reported for her/his mother. A 49-year-old female (non-pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arrm on 30Apr2021 17:30 (Batch/Lot number was not reported) as single dose (at 49 years old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 30Apr2021, the patient experienced dizziness, nausea/gets lot of nauseous, weakness/she feels like weak, vomiting, her muscle still sore, fever, feeling unwell. Dizziness, nausea, weakness, vomiting, myalgia were worsened. The outcome of all events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: PE lower lobs of my lung; diagnosis of sever DVT left leg (ankle to groin); This is a spontaneous report from a contactable consumer reported for himself. A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL9262) dose 1 via an unspecified route of administration, administered in left arm on 28Jan2021 12:45 PM (74-year-old at vaccination) at a single dose for COVID-19 immunisation. Medical history was not reported. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. On Friday, 29Jan2021, the day after his 1st shot he began having pain in the lower left leg. Adverse event start date was on 29Jan2021 11:00 AM. The pain intensified through Sunday. On Thursday 02Feb2021 went to emergency room (ER) Confirmed diagnosis of sever deep vein thrombosis (DVT) left leg (ankle to groin) and pulmonary embolism (PE) lower lobs of his lung; on 04Feb2021. Now on apixaban (ELIQUIS) for 6 months. The adverse event result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Treatment received for the adverse event included apixaban. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not resolved.  Information on batch/lot number has been requested.