chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: blacked out 10 seconds after receiving the vaccine; He has lost 10 pounds; huge appetite; feels horrible; he is weak and exhausted; he is weak and exhausted; anxiety; he struggles through everyday of his life; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 23 year-old male patient received bnt162b2 (BNT162B2), administration date Jun2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset Jun2021, outcome "unknown", described as "blacked out 10 seconds after receiving the vaccine"; WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "He has lost 10 pounds"; INCREASED APPETITE (non-serious) with onset 2021, outcome "unknown", described as "huge appetite"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "feels horrible"; ASTHENIA (non-serious), FATIGUE (non-serious) all with onset 2021, outcome "unknown" and all described as "he is weak and exhausted"; ANXIETY (non-serious) with onset 2021, outcome "unknown", described as "anxiety"; GENERAL PHYSICAL HEALTH DETERIORATION (non-serious) with onset 2021, outcome "unknown", described as "he struggles through everyday of his life". The events "blacked out 10 seconds after receiving the vaccine", "he has lost 10 pounds", "huge appetite", "feels horrible", "he is weak and exhausted", "he is weak and exhausted" and "anxiety" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: colonoscopy: (Dec2021) normal; computerised tomogram: (Dec2021) normal; endoscopy: (Nov2021) normal; magnetic resonance imaging: (unspecified date) normal; scan brain: (unspecified date) normal; weight: (unspecified date) lost 10. The patients body systems and the symptoms vary all the time. The patient watched everything and put in the mouth and felt so horrible. The patient had been to many doctors and specialists. The patient had been registered to see an infectious disease doctor. It had been 6 months and the patient felt the same. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Autoimmune disorder, Biopsy skin, Chills, Lichen planus, Pain
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Apr2021 (Lot number: EW0151) at the age of 26 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "cholecystectomy" (unspecified if ongoing); "tonsillectomy" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3. Past drug history included: Bactrim for lip itch, notes: Bactrim - lip itch is the result. Vaccination history included: Bnt162b2 (Product=COVID 19, Brand=Pfizer,, Lot number=ER2613,, Lot unknown=False,, Administration date=21Mar2021,, Administration time=08:45 AM,, Dose number=1,, Vaccine location=Left arm), administration date: 21Mar2021, when the patient was 26 years old, for immunisation, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 11Apr2021, outcome "not recovered", described as "sore arm"; PAIN (non-serious) with onset 11Apr2021, outcome "not recovered", described as "body aches"; CHILLS (non-serious) with onset 11Apr2021, outcome "not recovered", described as "chill"; LICHEN PLANUS (non-serious) with onset 06Jun2021 12:00, outcome "not recovered", described as "Lichen planus". The events "sore arm", "body aches", "chill" and "lichen planus" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, pain, chills, lichen planus. Additional information: The patient was taking Women's multivitamins in two weeks. The patient also signed up for vaccine side effects - reporting symptoms and incorrectly selected no side effects because she thought that her lesions were yeast induced. On around 06Jun2021 she developed an itchy lesion on inner thigh believed to resemble yeast or bacterial infections. She treated this with over the counter topical yeast medications, 3 weeks later she developed lesions on both breasts also resembling what she believed was yeast and attempted to treat it the same way, but it did not go away. After developing more lesions on her back, legs, breast, arms she decided to visit a dermatologist 23Jul2021, She had a punch biopsy completed using samples from her arm and back. These samples came back as lichen Planus on 04Aug2021. It's now aggressively widespread and not responding to treatment.  AE resulted in visit to dermatologist and received treatment of topical Steroids and Oral Steroids. The patient did not have covid prior vaccination and was not covid tested post vaccination. No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Skin lesion
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Apr2021 (Lot number: EW0151) at the age of 26 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "cholecystectomy" (unspecified if ongoing); "tonsillectomy" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3. Past drug history included: Bactrim for lip itch, notes: Bactrim - lip itch is the result. Vaccination history included: Bnt162b2 (Product=COVID 19, Brand=Pfizer,, Lot number=ER2613,, Lot unknown=False,, Administration date=21Mar2021,, Administration time=08:45 AM,, Dose number=1,, Vaccine location=Left arm), administration date: 21Mar2021, when the patient was 26 years old, for immunisation, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 11Apr2021, outcome "not recovered", described as "sore arm"; PAIN (non-serious) with onset 11Apr2021, outcome "not recovered", described as "body aches"; CHILLS (non-serious) with onset 11Apr2021, outcome "not recovered", described as "chill"; LICHEN PLANUS (non-serious) with onset 06Jun2021 12:00, outcome "not recovered", described as "Lichen planus". The events "sore arm", "body aches", "chill" and "lichen planus" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, pain, chills, lichen planus. Additional information: The patient was taking Women's multivitamins in two weeks. The patient also signed up for vaccine side effects - reporting symptoms and incorrectly selected no side effects because she thought that her lesions were yeast induced. On around 06Jun2021 she developed an itchy lesion on inner thigh believed to resemble yeast or bacterial infections. She treated this with over the counter topical yeast medications, 3 weeks later she developed lesions on both breasts also resembling what she believed was yeast and attempted to treat it the same way, but it did not go away. After developing more lesions on her back, legs, breast, arms she decided to visit a dermatologist 23Jul2021, She had a punch biopsy completed using samples from her arm and back. These samples came back as lichen Planus on 04Aug2021. It's now aggressively widespread and not responding to treatment.  AE resulted in visit to dermatologist and received treatment of topical Steroids and Oral Steroids. The patient did not have covid prior vaccination and was not covid tested post vaccination. No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy, Chills, Lichen planus, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Apr2021 (Lot number: EW0151) at the age of 26 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "cholecystectomy" (unspecified if ongoing); "tonsillectomy" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3. Past drug history included: Bactrim for lip itch, notes: Bactrim - lip itch is the result. Vaccination history included: Bnt162b2 (Product=COVID 19, Brand=Pfizer,, Lot number=ER2613,, Lot unknown=False,, Administration date=21Mar2021,, Administration time=08:45 AM,, Dose number=1,, Vaccine location=Left arm), administration date: 21Mar2021, when the patient was 26 years old, for immunisation, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 11Apr2021, outcome "not recovered", described as "sore arm"; PAIN (non-serious) with onset 11Apr2021, outcome "not recovered", described as "body aches"; CHILLS (non-serious) with onset 11Apr2021, outcome "not recovered", described as "chill"; LICHEN PLANUS (non-serious) with onset 06Jun2021 12:00, outcome "not recovered", described as "Lichen planus". The events "sore arm", "body aches", "chill" and "lichen planus" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, pain, chills, lichen planus. Additional information: The patient was taking Women's multivitamins in two weeks. The patient also signed up for vaccine side effects - reporting symptoms and incorrectly selected no side effects because she thought that her lesions were yeast induced. On around 06Jun2021 she developed an itchy lesion on inner thigh believed to resemble yeast or bacterial infections. She treated this with over the counter topical yeast medications, 3 weeks later she developed lesions on both breasts also resembling what she believed was yeast and attempted to treat it the same way, but it did not go away. After developing more lesions on her back, legs, breast, arms she decided to visit a dermatologist 23Jul2021, She had a punch biopsy completed using samples from her arm and back. These samples came back as lichen Planus on 04Aug2021. It's now aggressively widespread and not responding to treatment.  AE resulted in visit to dermatologist and received treatment of topical Steroids and Oral Steroids. The patient did not have covid prior vaccination and was not covid tested post vaccination. No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 27 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no illness at the time of vaccination, no adverse event after any previous vaccination (s), no history of allergy to vaccine, drug, food, no pre-existing acute illness 30 days prior to vaccination and no allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, expiry: 21-SEP-2021) 0.5 ml, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210955823, 20211246471, 20211246474, 20211246559, 20211246432, 20211246539, 20211246471, 20211246517 and 20211246439.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 27 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no illness at the time of vaccination, no adverse event after any previous vaccination (s), no history of allergy to vaccine, drug, food, no pre-existing acute illness 30 days prior to vaccination and no allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, expiry: 21-SEP-2021) 0.5 ml, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210955823, 20211246471, 20211246474, 20211246559, 20211246432, 20211246539, 20211246471, 20211246517 and 20211246439.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE (NO ASSOCIATED ADVERSE REACTION); This spontaneous report received from a health care professional concerned a 37 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no Illness at the time of vaccination, no history of allergy to vaccine, drug, or food, no hospitalization in last 30 day and no Pre-existing acute illness 30 days prior to vaccination. The patient does not have allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A and expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 11:20 for prophylactic vaccination.  No concomitant medications were reported.  On 22-SEP-2021, the patient experienced administration of expired vaccine (no associated adverse reaction). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine (no associated adverse reaction) was not reported. This report was non-serious. This case, from the same reporter is linked to 20211246517, 20211137983, 20211137862, 20210955494, 20211246488, 20211246559, 20211246474, 20211245708, 20210955823, 20211246539 and 20211246471.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED DOSE OF VACCINE; This spontaneous report received from a health care professional concerned a 60 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no illness at the time of vaccination, had no past history of similar event, had no history of allergy to vaccine, drug or food, had no pre-existing acute illness 30 days prior to vaccination and had no history of hospitalization in last 30 days, with any cause. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, and expiry: 21-SEP-2021) .5 ml, administered on 22-SEP-2021 14:01 for prophylactic vaccination. No concomitant medications were reported.  On 22-SEP-2021, the patient experienced administered expired dose of vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired dose of vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211246488, 20211246559, 20210955494, 20210955823, 20211246471, 20211246474, 20211245708 and 20211246539.  .
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Dizziness, Hypersensitivity
Clinical narrative: weakness; dizziness; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 07Mar2021 (Batch/Lot number: unknown) as dose 1 single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious) with onset 08Mar2021, outcome "unknown", described as "weakness"; DIZZINESS (non-serious) with onset 08Mar2021, outcome "unknown", described as "dizziness".  Additional information: the patient called to say that he got the 1st dose of Covid 19 vaccine yesterday (07Mar21) and today he's experiencing weakness and dizziness.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: weakness; dizziness; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 07Mar2021 (Batch/Lot number: unknown) as dose 1 single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious) with onset 08Mar2021, outcome "unknown", described as "weakness"; DIZZINESS (non-serious) with onset 08Mar2021, outcome "unknown", described as "dizziness".  Additional information: the patient called to say that he got the 1st dose of Covid 19 vaccine yesterday (07Mar21) and today he's experiencing weakness and dizziness.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thrombosis, Ultrasound Doppler abnormal
Clinical narrative: BLOOD CLOT; MUSCLE PULLED LIKE SENSATION ON EACH OUTER SIDE OF TORSO, BELOW CLAVICLE, ACROSS CHEST,HIGH ON THE CHEST, SAME SENSATION LEFT SIDE TO RIGHT SIDE; This spontaneous report received from a patient concerned a 72-year-old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included cigarette smoker (as a teenager, stopped at 18 years old) and concurrent conditions included non-alcohol user, and other pre-existing medical conditions included patient did not have drug abuse or illicit drug usage. The patient was allergic to cipro and benadryl, The patient was not pregnant at the time of report.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1), (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: unknown) dose was not reported, 1 total, administered on 10-MAR-2021 for prophylactic vaccination. Then, there was a blood clot, which was almost 8 months prior to this report (dose number in series 1). No concomitant medications were reported. Non-company suspect vaccine included: BNT 162 (form of admin and route of admin were not reported, batch number: FH8028 expiry: unknown) dose was not reported, administered on 17-NOV-2021 for prophylactic vaccination (Dose number in series 2). First week after Pfizer vaccine, the patient was fine. In NOV-2021 (in second week), on an unspecified date, the patient experienced odd things like muscle pulled like sensation on each outer side of torso, below clavicle, across chest, high on the chest, same sensation left side to right side. She woke up and could not walk on their right calf. 10 days after taking the Pfizer shot on 27-NOV-2021, the patient was diagnosed with a blood clot. Treatment medications (dates unspecified) included Xarelto (rivaroxaban) for blood clot prescribed by doctor (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot and muscle pulled like sensation on each outer side of torso, below clavicle, across chest, high on the chest, same sensation left side to right side was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211239219-covid-19 vaccine ad26.cov2.s-blood clot . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Muscle strain, Thrombosis
Clinical narrative: BLOOD CLOT; MUSCLE PULLED LIKE SENSATION ON EACH OUTER SIDE OF TORSO, BELOW CLAVICLE, ACROSS CHEST,HIGH ON THE CHEST, SAME SENSATION LEFT SIDE TO RIGHT SIDE; This spontaneous report received from a patient concerned a 72-year-old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included cigarette smoker (as a teenager, stopped at 18 years old) and concurrent conditions included non-alcohol user, and other pre-existing medical conditions included patient did not have drug abuse or illicit drug usage. The patient was allergic to cipro and benadryl, The patient was not pregnant at the time of report.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1), (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: unknown) dose was not reported, 1 total, administered on 10-MAR-2021 for prophylactic vaccination. Then, there was a blood clot, which was almost 8 months prior to this report (dose number in series 1). No concomitant medications were reported. Non-company suspect vaccine included: BNT 162 (form of admin and route of admin were not reported, batch number: FH8028 expiry: unknown) dose was not reported, administered on 17-NOV-2021 for prophylactic vaccination (Dose number in series 2). First week after Pfizer vaccine, the patient was fine. In NOV-2021 (in second week), on an unspecified date, the patient experienced odd things like muscle pulled like sensation on each outer side of torso, below clavicle, across chest, high on the chest, same sensation left side to right side. She woke up and could not walk on their right calf. 10 days after taking the Pfizer shot on 27-NOV-2021, the patient was diagnosed with a blood clot. Treatment medications (dates unspecified) included Xarelto (rivaroxaban) for blood clot prescribed by doctor (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot and muscle pulled like sensation on each outer side of torso, below clavicle, across chest, high on the chest, same sensation left side to right side was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211239219-covid-19 vaccine ad26.cov2.s-blood clot . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Injection site pain, Myalgia
Clinical narrative: Just a sore arm; feeling Fatigued/Tiredness; joint pain; muscle pain; Lack of concentration; Sore muscles and bones; i had joint pain and muscle pain all over especially in the spine; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 13:45 (Batch/Lot number: unknown) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EWO176, Location of injection: Arm Left, Vaccine Administration Time: 11:45 AM), administration date: 20Apr2021, when the patient was 29 years old, for COVID-19 Immunization, reaction(s): "Dose 1:07Apr2021;Dose 2:20Apr2021"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EWO153, Location of injection: Arm Left, Vaccine Administration Time: 11:45 AM), administration date: 07Apr2021, when the patient was 29 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 13:45, outcome "unknown", described as "booster"; PAIN IN EXTREMITY (non-serious) with onset 09Dec2021 20:00, outcome "not recovered", described as "Just a sore arm"; FATIGUE (non-serious) with onset 09Dec2021 20:00, outcome "not recovered", described as "feeling Fatigued/Tiredness"; ARTHRALGIA (non-serious) with onset 09Dec2021 20:00, outcome "not recovered", described as "joint pain"; MYALGIA (non-serious) with onset 09Dec2021 20:00, outcome "not recovered", described as "muscle pain"; DISTURBANCE IN ATTENTION (non-serious) with onset 09Dec2021 20:00, outcome "not recovered", described as "Lack of concentration"; BONE PAIN (non-serious) with onset 09Dec2021 20:00, outcome "not recovered", described as "Sore muscles and bones"; SPINAL PAIN (non-serious) with onset 09Dec2021 20:00, outcome "not recovered", described as "i had joint pain and muscle pain all over especially in the spine". Therapeutic measures were not taken as a result of pain in extremity, fatigue, arthralgia, myalgia, disturbance in attention, bone pain, spinal pain.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received any other medications within 2 weeks of vaccination: Ibuprofen Over Counter. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. No known allergies and other medical history.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Bone pain, Disturbance in attention, Fatigue, Immunisation
Clinical narrative: Just a sore arm; feeling Fatigued/Tiredness; joint pain; muscle pain; Lack of concentration; Sore muscles and bones; i had joint pain and muscle pain all over especially in the spine; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 13:45 (Batch/Lot number: unknown) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EWO176, Location of injection: Arm Left, Vaccine Administration Time: 11:45 AM), administration date: 20Apr2021, when the patient was 29 years old, for COVID-19 Immunization, reaction(s): "Dose 1:07Apr2021;Dose 2:20Apr2021"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EWO153, Location of injection: Arm Left, Vaccine Administration Time: 11:45 AM), administration date: 07Apr2021, when the patient was 29 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 13:45, outcome "unknown", described as "booster"; PAIN IN EXTREMITY (non-serious) with onset 09Dec2021 20:00, outcome "not recovered", described as "Just a sore arm"; FATIGUE (non-serious) with onset 09Dec2021 20:00, outcome "not recovered", described as "feeling Fatigued/Tiredness"; ARTHRALGIA (non-serious) with onset 09Dec2021 20:00, outcome "not recovered", described as "joint pain"; MYALGIA (non-serious) with onset 09Dec2021 20:00, outcome "not recovered", described as "muscle pain"; DISTURBANCE IN ATTENTION (non-serious) with onset 09Dec2021 20:00, outcome "not recovered", described as "Lack of concentration"; BONE PAIN (non-serious) with onset 09Dec2021 20:00, outcome "not recovered", described as "Sore muscles and bones"; SPINAL PAIN (non-serious) with onset 09Dec2021 20:00, outcome "not recovered", described as "i had joint pain and muscle pain all over especially in the spine". Therapeutic measures were not taken as a result of pain in extremity, fatigue, arthralgia, myalgia, disturbance in attention, bone pain, spinal pain.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received any other medications within 2 weeks of vaccination: Ibuprofen Over Counter. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. No known allergies and other medical history.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pain in extremity, Spinal pain
Clinical narrative: Just a sore arm; feeling Fatigued/Tiredness; joint pain; muscle pain; Lack of concentration; Sore muscles and bones; i had joint pain and muscle pain all over especially in the spine; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 13:45 (Batch/Lot number: unknown) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EWO176, Location of injection: Arm Left, Vaccine Administration Time: 11:45 AM), administration date: 20Apr2021, when the patient was 29 years old, for COVID-19 Immunization, reaction(s): "Dose 1:07Apr2021;Dose 2:20Apr2021"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EWO153, Location of injection: Arm Left, Vaccine Administration Time: 11:45 AM), administration date: 07Apr2021, when the patient was 29 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 13:45, outcome "unknown", described as "booster"; PAIN IN EXTREMITY (non-serious) with onset 09Dec2021 20:00, outcome "not recovered", described as "Just a sore arm"; FATIGUE (non-serious) with onset 09Dec2021 20:00, outcome "not recovered", described as "feeling Fatigued/Tiredness"; ARTHRALGIA (non-serious) with onset 09Dec2021 20:00, outcome "not recovered", described as "joint pain"; MYALGIA (non-serious) with onset 09Dec2021 20:00, outcome "not recovered", described as "muscle pain"; DISTURBANCE IN ATTENTION (non-serious) with onset 09Dec2021 20:00, outcome "not recovered", described as "Lack of concentration"; BONE PAIN (non-serious) with onset 09Dec2021 20:00, outcome "not recovered", described as "Sore muscles and bones"; SPINAL PAIN (non-serious) with onset 09Dec2021 20:00, outcome "not recovered", described as "i had joint pain and muscle pain all over especially in the spine". Therapeutic measures were not taken as a result of pain in extremity, fatigue, arthralgia, myalgia, disturbance in attention, bone pain, spinal pain.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received any other medications within 2 weeks of vaccination: Ibuprofen Over Counter. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. No known allergies and other medical history.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Alanine aminotransferase increased, Alpha-1 antitrypsin deficiency, Ammonia normal, Anion gap
Clinical narrative: Dx with Autoimmune hepatitis 3 months (November) after receiving vaccine. Unsure if this was present before as some report of icterus in same month as vaccine.  Then dx with severe necrotizing myositis 4 months (December 21) after starting vaccine series despite tx of AIH.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Antimitochondrial antibody, Antinuclear antibody, Aspartate aminotransferase increased, Bilirubin conjugated increased, Biopsy liver
Clinical narrative: Dx with Autoimmune hepatitis 3 months (November) after receiving vaccine. Unsure if this was present before as some report of icterus in same month as vaccine.  Then dx with severe necrotizing myositis 4 months (December 21) after starting vaccine series despite tx of AIH.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood albumin decreased, Blood alkaline phosphatase increased, Blood bilirubin increased, Blood calcium, Blood chloride decreased
Clinical narrative: Dx with Autoimmune hepatitis 3 months (November) after receiving vaccine. Unsure if this was present before as some report of icterus in same month as vaccine.  Then dx with severe necrotizing myositis 4 months (December 21) after starting vaccine series despite tx of AIH.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood cholesterol normal, Blood creatinine increased, Blood glucose, Blood lactic acid increased, Blood potassium normal
Clinical narrative: Dx with Autoimmune hepatitis 3 months (November) after receiving vaccine. Unsure if this was present before as some report of icterus in same month as vaccine.  Then dx with severe necrotizing myositis 4 months (December 21) after starting vaccine series despite tx of AIH.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood sodium decreased, Blood triglycerides, Blood urea normal, Carbon dioxide decreased, Ceruloplasmin
Clinical narrative: Dx with Autoimmune hepatitis 3 months (November) after receiving vaccine. Unsure if this was present before as some report of icterus in same month as vaccine.  Then dx with severe necrotizing myositis 4 months (December 21) after starting vaccine series despite tx of AIH.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chills, Eye colour change, Full blood count normal, Gene mutation identification test positive, Glomerular filtration rate decreased
Clinical narrative: Dx with Autoimmune hepatitis 3 months (November) after receiving vaccine. Unsure if this was present before as some report of icterus in same month as vaccine.  Then dx with severe necrotizing myositis 4 months (December 21) after starting vaccine series despite tx of AIH.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Haematocrit normal, Haemoglobin normal, Hepatic steatosis, Hepatitis viral test, High density lipoprotein decreased
Clinical narrative: Dx with Autoimmune hepatitis 3 months (November) after receiving vaccine. Unsure if this was present before as some report of icterus in same month as vaccine.  Then dx with severe necrotizing myositis 4 months (December 21) after starting vaccine series despite tx of AIH.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: International normalised ratio increased, Lipase normal, Liver function test increased, Low density lipoprotein normal, Mean cell haemoglobin concentration decreased
Clinical narrative: Dx with Autoimmune hepatitis 3 months (November) after receiving vaccine. Unsure if this was present before as some report of icterus in same month as vaccine.  Then dx with severe necrotizing myositis 4 months (December 21) after starting vaccine series despite tx of AIH.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Nausea, Non-high-density lipoprotein cholesterol, Platelet count decreased, Portogram, Protein total decreased
Clinical narrative: Dx with Autoimmune hepatitis 3 months (November) after receiving vaccine. Unsure if this was present before as some report of icterus in same month as vaccine.  Then dx with severe necrotizing myositis 4 months (December 21) after starting vaccine series despite tx of AIH.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Prothrombin time, Smooth muscle antibody, Ultrasound abdomen normal, White blood cell count increased
Clinical narrative: Dx with Autoimmune hepatitis 3 months (November) after receiving vaccine. Unsure if this was present before as some report of icterus in same month as vaccine.  Then dx with severe necrotizing myositis 4 months (December 21) after starting vaccine series despite tx of AIH.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Autoimmune hepatitis, Biopsy muscle abnormal, Lipids increased, Metabolic disorder, Necrotising myositis
Clinical narrative: Dx with Autoimmune hepatitis 3 months (November) after receiving vaccine. Unsure if this was present before as some report of icterus in same month as vaccine.  Then dx with severe necrotizing myositis 4 months (December 21) after starting vaccine series despite tx of AIH.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Chest pain, Coagulation test, Full blood count, Laboratory test
Clinical narrative: Admitted to ER with significant chest pain 4 days after vaccination. ER administered Toradol which relieved chest pain. High sensitivity troponin test revealed levels at 3461ng/L at 5 AM on 12/15/2021. Admitted to the Hospital the morning of 12/15. Levels continued to climb to 6353.5ng/L at 8:35 PM on 12/15 before coming down to 5068.7ng/L at 3:57 AM on 12/16/2021.  Remained in the hospital on a heart monitor until 12/17/2021 at 12 PM. Discharged with instructions to self-limit activity and with a heart monitor for two weeks.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, SARS-CoV-2 test
Clinical narrative: Admitted to ER with significant chest pain 4 days after vaccination. ER administered Toradol which relieved chest pain. High sensitivity troponin test revealed levels at 3461ng/L at 5 AM on 12/15/2021. Admitted to the Hospital the morning of 12/15. Levels continued to climb to 6353.5ng/L at 8:35 PM on 12/15 before coming down to 5068.7ng/L at 3:57 AM on 12/16/2021.  Remained in the hospital on a heart monitor until 12/17/2021 at 12 PM. Discharged with instructions to self-limit activity and with a heart monitor for two weeks.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac monitoring, Chest pain, Troponin I increased
Clinical narrative: Admitted to ER with significant chest pain 4 days after vaccination. ER administered Toradol which relieved chest pain. High sensitivity troponin test revealed levels at 3461ng/L at 5 AM on 12/15/2021. Admitted to the Hospital the morning of 12/15. Levels continued to climb to 6353.5ng/L at 8:35 PM on 12/15 before coming down to 5068.7ng/L at 3:57 AM on 12/16/2021.  Remained in the hospital on a heart monitor until 12/17/2021 at 12 PM. Discharged with instructions to self-limit activity and with a heart monitor for two weeks.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Adverse event, Intervertebral discitis, Peripheral artery thrombosis
Clinical narrative: DISCITIS; BLOOD CLOT IN FEMORAL ARTERY; BAD SIDE EFFECT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2. s (suspension for injection, route of admin, and batch number were not reported) dose was not reported,1 total, administered in MAR-2021 for prophylactic vaccination (dose number in series 1). On an unspecified date in MAR-2021, the patient experienced bad side effect. On an unspecified date after initial vaccination, the patient experienced blood clot in femoral artery, and discitis. The patient clarified that discitis was infections of discs in back (dose number in series 1). The outcome of the blood clot in femoral artery, discitis and bad side effect was unknown. The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported) dose not reported, 1 total administrated, start therapy date were not reported for prophylactic vaccination as a booster dose (dose number in series 2). The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient reported of experiencing again same bad side effect, blood clot in femoral artery, and discitis (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot in femoral artery, discitis and bad side effect was unknown. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20211235699 (Dose number in series 1).; Sender's Comments: V0-20211233462-covid-19 vaccine ad26.cov2.s-Discitis, Blood clot in femoral artery. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Adverse drug reaction, Intervertebral discitis, Peripheral artery thrombosis
Clinical narrative: DISCITIS; BLOOD CLOT IN FEMORAL ARTERY; BAD SIDE EFFECT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2. s (suspension for injection, route of admin, and batch number were not reported) dose was not reported,1 total, administered in MAR-2021 for prophylactic vaccination (dose number in series 1). On an unspecified date in MAR-2021, the patient experienced bad side effect. On an unspecified date after initial vaccination, the patient experienced blood clot in femoral artery, and discitis. The patient clarified that discitis was infections of discs in back (dose number in series 1). The outcome of the blood clot in femoral artery, discitis and bad side effect was unknown. The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported) dose not reported, 1 total administrated, start therapy date were not reported for prophylactic vaccination as a booster dose (dose number in series 2). The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient reported of experiencing again same bad side effect, blood clot in femoral artery, and discitis (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot in femoral artery, discitis and bad side effect was unknown. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20211235699 (Dose number in series 1).; Sender's Comments: V0-20211233462-covid-19 vaccine ad26.cov2.s-Discitis, Blood clot in femoral artery. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Pharyngeal swelling, Throat irritation
Clinical narrative: I was not expecting any immediate adverse symptoms, given that my first two doses of Moderna only produced mild flu like symptoms after more than 24 hours. Five minutes after taking the shot I began feeling a bit lightheaded and like they were waves of heat going through my body. I continued grocery shopping at the Safeway to dispense the shot, but eventually told my brother that I was feeling bad enough that I needed to go talk to the pharmacist about what I was feeling. As I was walking back to the pharmacy counter, I began noticing what felt like a growing ball in the back of my throat. I described my symptoms to them and they said they would like me to sit and watch  me. I asked for water as it was becoming difficult to swallow. As the feeling grew stronger, I asked for the epipen wanting to make sure I would not get to the point of restricted breathing, and administered a dose. I had never had an anaphylactic reaction to anything before, but my younger brother has a severe allergy and I was familiar with the procedure. The pharmacist called the EMS unbeknownst to me and they convinced me to go to the emergency room. I was administered intravenous Benadryl and then more epinephrine after I mentioned it was beginning to feel like my tongue was too big for my mouth. After arriving at the hospital about 40 minutes later, I was feeling pretty fine and any noticeable swelling had abated but they kept me for observation for 4 hours. The only remark was that my uvula had stuck to the side of my throat, which may have increased a sensation of an anaphylactic response. I am not 100% confident that this was not a more mild response heightened by the power of suggestion to be completely honest. Though I will say that I had not read about any issues with tongue or throat swelling before I began experiencing it. No further issues have occurred.