chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock, Hypersensitivity
Clinical narrative: Anaphylactic shock; severe allergic reaction/felt tonge swell; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock) and HYPERSENSITIVITY (severe allergic reaction/felt tonge swell) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016A21A and 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Sleep disorder, High cholesterol, MS, Shellfish allergy (anaphylactic shock), Iodine allergy (anaphylactic shock) and Allergy NOS (allergy to "many things"). Concomitant products included ATORVASTATIN for High cholesterol, GLATIRAMER ACETATE (GLATOPA) for Multiple sclerosis, VANEX for Sleep disorder, DULOXETINE HYDROCHLORIDE (CYMBALTA), ACETYLSALICYLIC ACID (BABY ASPIRIN), BACLOFEN, VITAMIN D3 and FISH OIL (OMEGA 3 FISH OILS) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021 at 2:05 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERSENSITIVITY (severe allergic reaction/felt tonge swell) (seriousness criteria hospitalization and life threatening). On 01-Apr-2021 at 4:05 PM, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criteria hospitalization and life threatening). The patient was hospitalized from 01-Apr-2021 to 02-Apr-2021 due to ANAPHYLACTIC SHOCK and HYPERSENSITIVITY. On 01-Apr-2021, ANAPHYLACTIC SHOCK (Anaphylactic shock) and HYPERSENSITIVITY (severe allergic reaction/felt tonge swell) had resolved.            Symptoms of anaphylactic shock included couldn't breath, throat closed, and face was all red and puffy.   Treatment for the events included epinephrine, intravenous steroids and diphenhydramine hydrochloride, and "other stuff" at hospital.  Based on the current available information and temporal association between the use of the product and the onset date of the reported event of anaphylactic shock, a causal relationship cannot be excluded.  Patient's underlying multiple allergies may have been contributory.   This case was linked to MOD-2021-066604 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event of anaphylactic shock, a causal relationship cannot be excluded.  Patient's underlying multiple allergies may have been contributory.
Sex: F
Vaccine: COVID19
Symptoms: Muscle swelling, Peripheral swelling
Clinical narrative: legs swelled; leg muscles swelled up; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (legs swelled) and MUSCLE SWELLING (leg muscles swelled up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (legs swelled) (seriousness criterion hospitalization) and MUSCLE SWELLING (leg muscles swelled up) (seriousness criterion hospitalization). At the time of the report, PERIPHERAL SWELLING (legs swelled) and MUSCLE SWELLING (leg muscles swelled up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported a female patient had received Moderna's COVID-19 vaccination and her legs and leg muscles swelled up and she was hospitalized for two days. The reporter also stated that she was a "runner" and had strong leg muscles.  Limited information regarding these events has been provided at this time and a causal relationship cannot be excluded; Sender's Comments: Limited information regarding these events has been provided at this time and a causal relationship cannot be excluded
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: was hospitalized with multiple blood clots; This spontaneous case was reported by a physician and describes the occurrence of THROMBOSIS (was hospitalized with multiple blood clots) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included Surgery (on his shoulder.) on 12-Mar-2021.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced THROMBOSIS (was hospitalized with multiple blood clots) (seriousness criterion hospitalization). At the time of the report, THROMBOSIS (was hospitalized with multiple blood clots) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported.  Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event of thrombosis, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Choking, Dysphagia, Oropharyngeal discomfort, Pharyngeal swelling, Swelling face
Clinical narrative: Felt like she was choking after 1st dose; Felt like couldn't swallow after 1st dose; Felt like throat was swollen after 1st dose; Couldn't drink after 1st dose; Face swelling after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of CHOKING (Felt like she was choking after 1st dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history. ). Concomitant products included THYROID (ARMOUR THYROID) and CELECOXIB (CELEBREX) for an unknown indication.    On 06-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 CHOKING (Felt like she was choking after 1st dose) (seriousness criterion medically significant), DYSPHAGIA (Felt like couldn't swallow after 1st dose), PHARYNGEAL SWELLING (Felt like throat was swollen after 1st dose), OROPHARYNGEAL DISCOMFORT (Couldn't drink after 1st dose) and SWELLING FACE (Face swelling after 1st dose). At the time of the report, CHOKING (Felt like she was choking after 1st dose), DYSPHAGIA (Felt like couldn't swallow after 1st dose), PHARYNGEAL SWELLING (Felt like throat was swollen after 1st dose), OROPHARYNGEAL DISCOMFORT (Couldn't drink after 1st dose) and SWELLING FACE (Face swelling after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included-Benadryl and Antihistamine.   Limited information regarding these events has been provided at this time and a causal relationship cannot be excluded   Reporter did not allow further contact; Sender's Comments: Limited information regarding these events has been provided at this time and a causal relationship cannot be excluded
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count decreased
Clinical narrative: platelets dropped to 3000; This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT DECREASED (platelets dropped to 3000) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (Patient takes "cancer medication"). Concomitant products included OSIMERTINIB MESILATE (TAGRISSO) and APIXABAN (ELIQUIS) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PLATELET COUNT DECREASED (platelets dropped to 3000) (seriousness criterion hospitalization prolonged). The patient was hospitalized from 15-Mar-2021 to 24-Mar-2021 due to PLATELET COUNT DECREASED. At the time of the report, PLATELET COUNT DECREASED (platelets dropped to 3000) outcome was unknown. Not Provided          Treatment of this event was not provided.  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.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Dry mouth, Dysgeusia, Facial paralysis
Clinical narrative: left arm is tingling numb; droopy face; headache; nausea; left arm began bothering her and it was aching; vibration of the feet; left arm is tingling numb; sharp chest pain; dry mouth; metallic taste in mouth; dizzy; right hand got weak; prickly itch everywhere, and was on her chest and under neck; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (droopy face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced VIBRATORY SENSE INCREASED (vibration of the feet), VACCINATION SITE ANAESTHESIA (left arm is tingling numb), CHEST PAIN (sharp chest pain), DRY MOUTH (dry mouth), DYSGEUSIA (metallic taste in mouth), DIZZINESS (dizzy), MUSCULAR WEAKNESS (right hand got weak), PARAESTHESIA (prickly itch everywhere, and was on her chest and under neck), NAUSEA (nausea) and VACCINATION SITE PAIN (left arm began bothering her and it was aching). On an unknown date, the patient experienced FACIAL PARALYSIS (droopy face) (seriousness criterion medically significant), VACCINATION SITE PARAESTHESIA (left arm is tingling numb) and HEADACHE (headache). At the time of the report, FACIAL PARALYSIS (droopy face), VIBRATORY SENSE INCREASED (vibration of the feet), VACCINATION SITE PARAESTHESIA (left arm is tingling numb), VACCINATION SITE ANAESTHESIA (left arm is tingling numb), CHEST PAIN (sharp chest pain), DRY MOUTH (dry mouth), DYSGEUSIA (metallic taste in mouth), DIZZINESS (dizzy), MUSCULAR WEAKNESS (right hand got weak), PARAESTHESIA (prickly itch everywhere, and was on her chest and under neck), HEADACHE (headache), NAUSEA (nausea) and VACCINATION SITE PAIN (left arm began bothering her and it was aching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications were not provided.Treatment information were not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, 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 events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscular weakness, Nausea, Paraesthesia, Vaccination site anaesthesia
Clinical narrative: left arm is tingling numb; droopy face; headache; nausea; left arm began bothering her and it was aching; vibration of the feet; left arm is tingling numb; sharp chest pain; dry mouth; metallic taste in mouth; dizzy; right hand got weak; prickly itch everywhere, and was on her chest and under neck; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (droopy face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced VIBRATORY SENSE INCREASED (vibration of the feet), VACCINATION SITE ANAESTHESIA (left arm is tingling numb), CHEST PAIN (sharp chest pain), DRY MOUTH (dry mouth), DYSGEUSIA (metallic taste in mouth), DIZZINESS (dizzy), MUSCULAR WEAKNESS (right hand got weak), PARAESTHESIA (prickly itch everywhere, and was on her chest and under neck), NAUSEA (nausea) and VACCINATION SITE PAIN (left arm began bothering her and it was aching). On an unknown date, the patient experienced FACIAL PARALYSIS (droopy face) (seriousness criterion medically significant), VACCINATION SITE PARAESTHESIA (left arm is tingling numb) and HEADACHE (headache). At the time of the report, FACIAL PARALYSIS (droopy face), VIBRATORY SENSE INCREASED (vibration of the feet), VACCINATION SITE PARAESTHESIA (left arm is tingling numb), VACCINATION SITE ANAESTHESIA (left arm is tingling numb), CHEST PAIN (sharp chest pain), DRY MOUTH (dry mouth), DYSGEUSIA (metallic taste in mouth), DIZZINESS (dizzy), MUSCULAR WEAKNESS (right hand got weak), PARAESTHESIA (prickly itch everywhere, and was on her chest and under neck), HEADACHE (headache), NAUSEA (nausea) and VACCINATION SITE PAIN (left arm began bothering her and it was aching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications were not provided.Treatment information were not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, 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 events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site paraesthesia, Vibratory sense increased
Clinical narrative: left arm is tingling numb; droopy face; headache; nausea; left arm began bothering her and it was aching; vibration of the feet; left arm is tingling numb; sharp chest pain; dry mouth; metallic taste in mouth; dizzy; right hand got weak; prickly itch everywhere, and was on her chest and under neck; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (droopy face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced VIBRATORY SENSE INCREASED (vibration of the feet), VACCINATION SITE ANAESTHESIA (left arm is tingling numb), CHEST PAIN (sharp chest pain), DRY MOUTH (dry mouth), DYSGEUSIA (metallic taste in mouth), DIZZINESS (dizzy), MUSCULAR WEAKNESS (right hand got weak), PARAESTHESIA (prickly itch everywhere, and was on her chest and under neck), NAUSEA (nausea) and VACCINATION SITE PAIN (left arm began bothering her and it was aching). On an unknown date, the patient experienced FACIAL PARALYSIS (droopy face) (seriousness criterion medically significant), VACCINATION SITE PARAESTHESIA (left arm is tingling numb) and HEADACHE (headache). At the time of the report, FACIAL PARALYSIS (droopy face), VIBRATORY SENSE INCREASED (vibration of the feet), VACCINATION SITE PARAESTHESIA (left arm is tingling numb), VACCINATION SITE ANAESTHESIA (left arm is tingling numb), CHEST PAIN (sharp chest pain), DRY MOUTH (dry mouth), DYSGEUSIA (metallic taste in mouth), DIZZINESS (dizzy), MUSCULAR WEAKNESS (right hand got weak), PARAESTHESIA (prickly itch everywhere, and was on her chest and under neck), HEADACHE (headache), NAUSEA (nausea) and VACCINATION SITE PAIN (left arm began bothering her and it was aching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications were not provided.Treatment information were not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, 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 events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Influenza like illness, Loss of consciousness, Palpitations, Tinnitus
Clinical narrative: Flu-like symptoms; light Headedness; Ears ringing; Passing out; Heart pounding; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passing out) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Asthma and Shellfish allergy.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passing out) (seriousness criterion medically significant), PALPITATIONS (Heart pounding) and TINNITUS (Ears ringing). On 27-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms) and DIZZINESS (light Headedness). On 26-Mar-2021, LOSS OF CONSCIOUSNESS (Passing out), PALPITATIONS (Heart pounding) and TINNITUS (Ears ringing) had resolved. On 28-Mar-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms) had resolved. On 31-Mar-2021, DIZZINESS (light Headedness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, 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 events, a causal relationship cannot be excluded.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Haematoma, Pain in extremity, Peripheral swelling
Clinical narrative: very much like a blood clot; R leg swelling; very hematoma; big red patch; warm sensation in the the leg; pain that he never had; normal pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (very much like a blood clot) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (normal pain in the injection site). On 04-Apr-2021, the patient experienced THROMBOSIS (very much like a blood clot) (seriousness criterion medically significant), PERIPHERAL SWELLING (R leg swelling), HAEMATOMA (very hematoma), ERYTHEMA (big red patch), FEELING HOT (warm sensation in the the leg) and PAIN IN EXTREMITY (pain that he never had). At the time of the report, THROMBOSIS (very much like a blood clot), PERIPHERAL SWELLING (R leg swelling), HAEMATOMA (very hematoma), ERYTHEMA (big red patch), FEELING HOT (warm sensation in the the leg), PAIN IN EXTREMITY (pain that he never had) and VACCINATION SITE PAIN (normal pain in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis, Vaccination site pain
Clinical narrative: very much like a blood clot; R leg swelling; very hematoma; big red patch; warm sensation in the the leg; pain that he never had; normal pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (very much like a blood clot) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (normal pain in the injection site). On 04-Apr-2021, the patient experienced THROMBOSIS (very much like a blood clot) (seriousness criterion medically significant), PERIPHERAL SWELLING (R leg swelling), HAEMATOMA (very hematoma), ERYTHEMA (big red patch), FEELING HOT (warm sensation in the the leg) and PAIN IN EXTREMITY (pain that he never had). At the time of the report, THROMBOSIS (very much like a blood clot), PERIPHERAL SWELLING (R leg swelling), HAEMATOMA (very hematoma), ERYTHEMA (big red patch), FEELING HOT (warm sensation in the the leg), PAIN IN EXTREMITY (pain that he never had) and VACCINATION SITE PAIN (normal pain in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Cellulitis, Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: Cellulitis; Tenderness in lower axillar on the left side; Firmness at the injection site; Swelling at the injection site; Redness at the injection site; This spontaneous case was reported by a physician and describes the occurrence of CELLULITIS (Cellulitis) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant), AXILLARY PAIN (Tenderness in lower axillar on the left side), VACCINATION SITE INDURATION (Firmness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, CELLULITIS (Cellulitis), VACCINATION SITE INDURATION (Firmness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown and AXILLARY PAIN (Tenderness in lower axillar on the left side) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment information was not provided.  Concomitant medications were not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Breast pain
Clinical narrative: A couple of years ago a titanium chip was injected into my left breast to help mark/locate a cyst. Last week, after my vaccine, I experienced pinching/stabbing pain around area of titanium chip.; This is a spontaneous report from a contactable consumer. This 62-year-old patient of unspecified gender received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 02Mar2021 at 16:30 (at the age of 62-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included a titanium chip injected into left breast to help mark/locate a cyst on an unspecified date a couple of years ago, type 2 diabetes, psoriasis, and depression. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination the patient had not been diagnosed with COVID-19. Concomitant medications included metformin and glyburide from unknown dates for unknown indications. The patient previously received sulfa antibiotics from an unknown date for an unknown indication and experienced allergy. The patient had an allergy to pineapple. On an unspecified date "last week" after receiving BNT162B2 the patient experienced pinching/stabbing around the area of the titanium chip. It gradually lessened and by day 7 post vaccine it seemed to have stopped. There was no swelling, redness, or rash. The event was reported as non-serious. The patient was not hospitalized for the event. The patient did not receive any treatment for the event. The outcome of pinching/stabbing around the area of the titanium chip was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: My right arm was very swollen, painful to touch; My right arm was very swollen, painful to touch; fever; numbness in top of neck near shot area for days; This is a spontaneous report from a contactable consumer (patient). This 64-year-old female patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EN6202; expiration date: Jun2021) via an unspecified route of administration in Mar2021 at 08:30 as a single dose in the right arm for COVID-19 immunization. Medical history included high blood pressure. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccine. The patient's concomitant medications were not reported. The patient previously received sulfa from an unspecified date for an unspecified indication and experienced allergy.  In Mar2021 at 08:30 the patient experienced right arm was very swollen, painful to touch, fever, and numbness in top of neck near shot area for days. The patient did not receive any treatment for the events. The outcomes of right arm was very swollen, painful to touch, fever, and numbness in top of neck near shot area for days were recovered with lasting effects. It was also reported that since the vaccine, the patient had not been tested for COVID-19.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vulvovaginal mycotic infection
Clinical narrative: Vaginal yeast infection; This is a spontaneous report received from contactable consumer, the patient. A 54-year-old adult [non-pregnant] female received the first dose of BNT162B2 (solution for injection; batch/lot and expiry information not provided) as a single dose via an unspecified route in the left arm on 09Mar2021 at 15:45 (at 54-years-old), for COVID-19 immunization. Relevant medical history included neuropathy and depression. The patient denied any allergies to medications, food, or other products. Concomitant medications included gabapentin and bupropion. The patient was not diagnosed with COVID prior to the vaccine and was not pregnant at the time of vaccination. Additionally, the patient denied receiving any other vaccines within four weeks prior to this vaccine. On 09Mar2021 at 20:00 the patient began to experience a vaginal yeast infection. The patient reported that she went to the doctor or other healthcare professional office or clinic for the event. The patient has not been tested for COVID since receiving the vaccine. It was unknown if the event was treated. The outcome of the vaginal yeast infection was not recovered.   The lot number for the vaccine, BNT162b2, was provided as unknown and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Very Dizzy the morning after shot; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: 6199) via an unspecified route of administration in the right arm on 09Mar2021 at 12:00 (at the age of 37-years-old) as a single dose for COVID-19 immunization. The patient's medical history included breast cancer. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant therapy included radiation treatment for breast cancer. On 10Mar2021 at 06:00, the patient was very dizzy the morning after shot. The patient was in radiation treatment for breast cancer. The patient stated that she never felt dizzy from this treatment. The patient did not receive treatment for very dizzy. The clinical outcome of very dizzy was recovering. Since the vaccination, the patient has not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hot flush, Sluggishness
Clinical narrative: chills; hot flashes; Mild headache; sluggish; This is a spontaneous report from a contactable consumer. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 2, via an unspecified route of administration, on 09Mar2021 (Lot Number: EN6204) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. She previously received first dose of BNT162b2, via an unspecified route of administration, on 16Feb2021 (Lot Number: EL9267) for COVID-19 immunization. On 10Mar2021 at 10:00 the patient experienced chills around 18 hours after second dose. Then hot flashes. No fever. Mild headache and sluggish. The consumer reported the events were non-serious, were not life-threatening, were not disabling/incapacitating, and did not involve hospitalization or death. No treatment was received for the events. The clinical outcome of chills, hot flashes, mild headache, and sluggish was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Had stomach pains since then; This is a spontaneous report received from contactable consumer, the patient. A male patient of unspecified age received the first dose of BNT162B2 (solution for injection; batch/lot and expiry information not provided) as a single dose via an unspecified route on 08Mar2021, for COVID-19 immunization. There was no medical history, concomitant medications or past drug history reported. The patient reported that he received his first dose of the COVID vaccine on 08Mar2021 and as soon as he got in his car, he had stomach pains. The consumer inquired if this was a side effect of the vaccine. The outcome of the stomach pains was not recovered.  The consumer reported that he was unsure if the stomach pains were related to the COVID vaccine or not.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Malaise, Pain, Pain in extremity, Pyrexia
Clinical narrative: upper arm was sore; body aches; Low grade fever; he was warm; just didn't feel good the next day; This is a spontaneous report received from a contactable consumer (patient's wife). A 73-year-old-male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6204) via an unspecified route of administration in the right arm on 05Mar2021 at 12:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history or concomitant medications. The patient had no vaccinations in the 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number EL9269) intramuscularly in the right arm on 12Feb2021 (at the age of 73-years-old) for COVID-19 immunisation. It was reported that the patient's upper arm was sore, he had body aches, a low-grade fever, was feeling warm, and just didn't feel good the next day on 06Mar2021. The following day, 07Mar2021, the patient felt fine and had recovered completely. The clinical outcomes of upper arm was sore, he had body aches, a low-grade fever, was feeling warm, and just didn't feel good the next day were recovered on 07Mar2021.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Headache, Lymphadenopathy, Nausea
Clinical narrative: terrible headache; Nausea; Body aches; lymph node is bothersome; Stated that she had the vaccine on Sunday and had Covid all over again on Monday.; Fever of 101; Chills; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 07Mar2021 (at the age of 68-years-old) as a single dose for COVID-19 immunization. Medical history included COVID-19 in Oct2020 for which she was not hospitalized but pretty sick. Concomitant medications were not reported. On Sunday (07Mar2021), the patient experienced ran a 101 fever and chills. The patient "had COVID-19 all over again" on Monday (08Mar2021). She had no sore throat or lymph node problems. Today (10Mar2021) the patient woke up at 03:00 with chills, terrible headache, nausea, body aches, and lymph node bothersome. The patient wanted to know if with the second dose she could expect similar. The outcomes of fever, chills, COVID-19, headache, nausea, body aches, and lymph node bothersome were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: terrible headache; Nausea; Body aches; lymph node is bothersome; Stated that she had the vaccine on Sunday and had Covid all over again on Monday.; Fever of 101; Chills; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 07Mar2021 (at the age of 68-years-old) as a single dose for COVID-19 immunization. Medical history included COVID-19 in Oct2020 for which she was not hospitalized but pretty sick. Concomitant medications were not reported. On Sunday (07Mar2021), the patient experienced ran a 101 fever and chills. The patient "had COVID-19 all over again" on Monday (08Mar2021). She had no sore throat or lymph node problems. Today (10Mar2021) the patient woke up at 03:00 with chills, terrible headache, nausea, body aches, and lymph node bothersome. The patient wanted to know if with the second dose she could expect similar. The outcomes of fever, chills, COVID-19, headache, nausea, body aches, and lymph node bothersome were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea/I took the first shot of the Pfizer on Friday (05March2021) and I had diarrhea for the next three days; This is a spontaneous report from a contactable consumer, the patient. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 05Mar2021 as a single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient reported, "I took the first shot of the Pfizer on Friday, 05Mar2021 and I had diarrhea for the next three days (from Mar2021). I have to take another shot I am afraid I am going to get it again." The outcome of the event was unknown. Outcome of the event, diarrhea was unknown.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Feeling of tightness in throat
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Chills, body aches
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Confusional state, Headache, Malaise, Nausea
Clinical narrative: feeling sick/general malaise; severe arthritis; headache; some confusion; some nausea; This is a spontaneous report from a contactable consumer, the patient. This 71-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6201) via an unspecified route, administered in the left arm on 28Feb2021 at 03:15 (at the age of 71-years-old) as a single dose for COVID-19 immunization. The patient's medical history included migraine, arthritis, Meibomian gland dysfunction, and rosacea. The patient had known allergies which were not further specified. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications the patient received within 2 weeks of vaccination were not specified. In Feb2021, the patient was feeling sick since receiving the second vaccine, and it's been 10 days. The patient experienced general malaise, severe arthritis, headache, some confusion and some nausea. The patient stated common side effects, but they seemed to be lasting a long time. The clinical outcomes of feeling sick/general malaise, severe arthritis, headache, confusion and nausea were not recovered. Since the vaccination, the patient has not been tested for COVID-19.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Small red lump at injection site a week after injection. Lump spread and became hot and sensitive  to the touch. Followed by fever and vomiting the next day.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Small red lump at injection site a week after injection. Lump spread and became hot and sensitive  to the touch. Followed by fever and vomiting the next day.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Flushing, Hyperhidrosis, Nausea
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Incoherent, Mobility decreased
Clinical narrative: PATIENT STATED THAT APPROXIMATELY 26 HOURS AFTER HIS INJECTION HE WAS INCOHERENT, FELL, AND COULD NOT MOVE. ADVERSE EVENT LASTED 24 HOURS.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dissociation, Disturbance in attention, Feeling abnormal, Impaired driving ability, Lymph node pain
Clinical narrative: I got an itchy rash on my right leg within the first 15 minutes, staff at the site tried to get me to belief it was from anxiety. The redness subsided though bumps remained when they let me go home. I also felt a bit "detached" on the drive home and really had to concentrate on my driving. Once home, I still felt odd but went about my day. About four hours later, I realized I was scratching my stomach and chest while watching TV. Upon raising my shirt, I saw a bright red rash on the top part of my belly that extended underneath both breasts and to the area directly over my heart, and up my left side into my left armpit. All of these areas were very itchy. I put Hydrocortisone cream on them, which helped reduce the itching quite quickly. I then took half a Benadryl tablet. When I awoke the next morning, the areas that had been bright red now had dark red dots but did not itch. However, I had lines of a bright red, itchy rash on both thighs near my groin. I again applied Hydrocortisone cream and took Benadryl, which helped abate the symptoms. Lymph nodes in my left armpit were quite sore as well, so I took ibuprofen.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: I got an itchy rash on my right leg within the first 15 minutes, staff at the site tried to get me to belief it was from anxiety. The redness subsided though bumps remained when they let me go home. I also felt a bit "detached" on the drive home and really had to concentrate on my driving. Once home, I still felt odd but went about my day. About four hours later, I realized I was scratching my stomach and chest while watching TV. Upon raising my shirt, I saw a bright red rash on the top part of my belly that extended underneath both breasts and to the area directly over my heart, and up my left side into my left armpit. All of these areas were very itchy. I put Hydrocortisone cream on them, which helped reduce the itching quite quickly. I then took half a Benadryl tablet. When I awoke the next morning, the areas that had been bright red now had dark red dots but did not itch. However, I had lines of a bright red, itchy rash on both thighs near my groin. I again applied Hydrocortisone cream and took Benadryl, which helped abate the symptoms. Lymph nodes in my left armpit were quite sore as well, so I took ibuprofen.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Headache, extreme fatigue, nausea, dizziness, joint pain
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Nausea, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itching and bumps started half an hour after injection.  They lasted for about 18 hours and were all over.  Started with left side of my neck then right leg, stomach, back and both arms
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Headache, Pain
Clinical narrative: Body aches; Headache; severe abdominal cramping; diarrhea; This is a spontaneous report from a non-contactable nurse, the patient. A non-pregnant adult female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in the right arm on 16Feb2021 08:45 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (Batch/Lot number was not reported) via an unspecified route of administration in left arm on an unspecified date 15:00 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to BNT162b2. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced body aches, headache, severe abdominal cramping and diarrhea on 17Feb2021 04:00. The patient did not receive treatment for the events. The outcome of events, body aches, headache, severe abdominal cramping and diarrhea, was recovered on an unspecified date.   No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Catatonia, Staring, Unresponsive to stimuli, Vital signs measurement
Clinical narrative: Within 5 minutes of receiving the vaccine patient's blood pressure bottomed out and he became catatonic (like state). He was not responding to his wife or I calling his name. He was not able to move his body and just kept staring down/ off into the distance. He would come in and out as time went on he was slowing coming back to us as his BP started to elevate. He was not having trouble breathing/ we did not use any medication. Paramedics were called since patient was not responding. They evaluated him in the rescue. result of patient unknown at this time were not available to follow up when phoned on Sunday
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Nausea, Pyrexia, Vomiting
Clinical narrative: nausea and vomiting, diarrhea, fever, and chills. No treatment - sleep/time.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: PATIENT HAD RECEIVED ONE DOSE OF PFIZER ON 12/28/2020. PATIENT WAS UNAWARE OF THE NAME AND TYPE OF THE VACCINE SHE RECEIVED . ON 3/14/2021 SHE SIGNED UP FOR MODERNA 1ST DOSE. THE ERROR WAS NOTICED ON 4/11/21 WHEN SHE CAME FOR SECOND DOSE MODERNA WHILE LOGIN HER 2ND DOSE ON DELVAX. WE CONTACTED PATIENT AND SHE ADMIT THAT SHE DID RECEIVE PFIZER BUT DIDNT KNOW IT WAS COVID-19 VACCINE.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Mobility decreased, Product administered at inappropriate site, Red blood cell sedimentation rate normal, X-ray
Clinical narrative: The person was not injected at the correct site for an IM injection it was injected to high on the shoulder, closer  to the acromion. Pt is having issues is moving his arm.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Fall, Loss of consciousness, Syncope
Clinical narrative: Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Weakness-Severe, Additional Details: THis event happened approximately 30 sec after receiving the Janssen COVID-19 Vaccine. Patient was brought to the ER by firemen due to in and out consciousness. Patient was with boyfriend who caught her as she was falling. Patient did not hit her head. She did state that she has passed out in the pass once after receiving a vaccine, but not regularly. She states she does not have a fear of needles when asked by fireman.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Myalgia
Clinical narrative: sore muscle pain; dizziness; This is a spontaneous report from a contactable consumer (patient's wife). The consumer reported similar events for two patients, this is the second of two reports. A male patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID-19 MRA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 08Mar2021 at 08:00, the patient experienced sore muscle and dizziness. The patient's wife knew that sore muscle pain was normal but 3 days after the vaccine and dizziness continued. The outcomes of sore muscle pain and dizziness were not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021285441 same reporter/drug/event, different patients
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Low grade fever, body aches
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever chills body aches nausea headache. For 36 hours after injection