chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electromyogram, Fatigue, Hypoaesthesia, Immediate post-injection reaction, Insomnia
Clinical narrative: Immediately after the injection I had pinching needles in my tongue which went away after a while within a few hours I had heaviness and numbness and tingling in both arms. and that night I started with heaviness in my lower legs and a feeling that I couldn't fully feel my lower legs, and tingling and numbness around my toes and top of my foot. It felt like someone was squeezing my toes. I had the vaccine about 4 months ago but I still have the symptoms. It is not as intense but I still have them. I have been to two neurological doctors. I called my primary care doctor immediately after my vaccine and they did an EMG test where they said it was a mild Gillian Barre response. I also have fatigue and insomnia.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Limb discomfort, Paraesthesia
Clinical narrative: Immediately after the injection I had pinching needles in my tongue which went away after a while within a few hours I had heaviness and numbness and tingling in both arms. and that night I started with heaviness in my lower legs and a feeling that I couldn't fully feel my lower legs, and tingling and numbness around my toes and top of my foot. It felt like someone was squeezing my toes. I had the vaccine about 4 months ago but I still have the symptoms. It is not as intense but I still have them. I have been to two neurological doctors. I called my primary care doctor immediately after my vaccine and they did an EMG test where they said it was a mild Gillian Barre response. I also have fatigue and insomnia.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site reaction, Rash
Clinical narrative: arm was hurting again; Rash erythematous; shot area red; arm was sore and painful; developed rashes; Cellulitis; This case was received via VAERS (Reference number: 0991329) on 11-May-2021 and was forwarded to Moderna on 11-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of CELLULITIS (Cellulitis) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product VITAMIN D [VITAMIN D NOS] for an unknown indication.    Concurrent medical conditions included Blood pressure high and Obesity. Concomitant products included ATENOLOL, TRIAMTERENE, HYDROCHLOROTHIAZIDE, LEVONORGESTREL (MIRENA), VITAMIN B [VITAMIN B NOS] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 16-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started VITAMIN D [VITAMIN D NOS] (unknown route) at an unspecified dose. On 25-Jan-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant). On 26-Jan-2021, the patient experienced INJECTION SITE REACTION (arm was hurting again), RASH ERYTHEMATOUS (Rash erythematous), INJECTION SITE ERYTHEMA (shot area red), INJECTION SITE PAIN (arm was sore and painful) and RASH (developed rashes). At the time of the report, CELLULITIS (Cellulitis), INJECTION SITE REACTION (arm was hurting again), RASH ERYTHEMATOUS (Rash erythematous), INJECTION SITE ERYTHEMA (shot area red), INJECTION SITE PAIN (arm was sore and painful) and RASH (developed rashes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Symptom Text : Received the Moderna vaccine (shot 1) on 1/16/21 and developed cellulitis on 1/25/21. The day after shot area red and arm was sore and painful. Went away the following day. On 1/24/21 noticed patient's arm was hurting again it wasn't until 1/25/21 that the big red rash area was seen at shot site and grewup my arm and her hands developed rashes.  No treatment information was provided.  Company Comment: 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: 43.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Rash erythematous
Clinical narrative: arm was hurting again; Rash erythematous; shot area red; arm was sore and painful; developed rashes; Cellulitis; This case was received via VAERS (Reference number: 0991329) on 11-May-2021 and was forwarded to Moderna on 11-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of CELLULITIS (Cellulitis) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product VITAMIN D [VITAMIN D NOS] for an unknown indication.    Concurrent medical conditions included Blood pressure high and Obesity. Concomitant products included ATENOLOL, TRIAMTERENE, HYDROCHLOROTHIAZIDE, LEVONORGESTREL (MIRENA), VITAMIN B [VITAMIN B NOS] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 16-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started VITAMIN D [VITAMIN D NOS] (unknown route) at an unspecified dose. On 25-Jan-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant). On 26-Jan-2021, the patient experienced INJECTION SITE REACTION (arm was hurting again), RASH ERYTHEMATOUS (Rash erythematous), INJECTION SITE ERYTHEMA (shot area red), INJECTION SITE PAIN (arm was sore and painful) and RASH (developed rashes). At the time of the report, CELLULITIS (Cellulitis), INJECTION SITE REACTION (arm was hurting again), RASH ERYTHEMATOUS (Rash erythematous), INJECTION SITE ERYTHEMA (shot area red), INJECTION SITE PAIN (arm was sore and painful) and RASH (developed rashes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Symptom Text : Received the Moderna vaccine (shot 1) on 1/16/21 and developed cellulitis on 1/25/21. The day after shot area red and arm was sore and painful. Went away the following day. On 1/24/21 noticed patient's arm was hurting again it wasn't until 1/25/21 that the big red rash area was seen at shot site and grewup my arm and her hands developed rashes.  No treatment information was provided.  Company Comment: 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: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Palpitations, Paraesthesia, Sinus arrhythmia
Clinical narrative: tachycardia; sinus arrhythmia; heart palpitations; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in the right arm on 06Feb2021 16:00 (04:00 PM) (Batch/Lot Number: EL9267) at the age of 40-years-old as unknown, single dose for COVID-19 immunization at a workplace clinic. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient had no medical history and no known allergies. Concomitant medications included daily multi-vitamin and an iron supplement, both taken for unspecified indications, start and stop date were not reported (reported as other medications in two weeks). The patient had heart palpitations beginning 08Feb2021 at 08:00 AM, then had an ECG with a sinus arrhythmia present on 10Feb2021, and then went to emergency room (ER) on 19Feb2021 for severe tachycardia. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive treatment for the events. The patient was tested for COVID post vaccination which was a nasal swab (PCR) with a negative result on 10Feb2021. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Palpitations, SARS-CoV-2 test, Sinus arrhythmia, Tachycardia
Clinical narrative: tachycardia; sinus arrhythmia; heart palpitations; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in the right arm on 06Feb2021 16:00 (04:00 PM) (Batch/Lot Number: EL9267) at the age of 40-years-old as unknown, single dose for COVID-19 immunization at a workplace clinic. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient had no medical history and no known allergies. Concomitant medications included daily multi-vitamin and an iron supplement, both taken for unspecified indications, start and stop date were not reported (reported as other medications in two weeks). The patient had heart palpitations beginning 08Feb2021 at 08:00 AM, then had an ECG with a sinus arrhythmia present on 10Feb2021, and then went to emergency room (ER) on 19Feb2021 for severe tachycardia. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive treatment for the events. The patient was tested for COVID post vaccination which was a nasal swab (PCR) with a negative result on 10Feb2021. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Pruritus
Clinical narrative: itchy sensations all over body; tingling, prickly, itchy sensations all over body; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 16Feb2021 09:00 (Batch/Lot Number: EM9809) as SINGLE DOSE for covid-19 immunisation. Medical history included Hashimoto's thyroiditis.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported; tocopherol (VITAMIN E) taken for an unspecified indication, start and stop date were not reported; vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported; ascorbic acid (VITAMIN C ASC ACID) taken for an unspecified indication, start and stop date were not reported; probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported; zinc taken for an unspecified indication, start and stop date were not reported; calcium taken for an unspecified indication, start and stop date were not reported.  The patient previously took Atovaquone / Proguanil, trimethoprim, acyclovir, bactrim, nitrofurantoin and cipro and had allergies. On 16Feb2021 18:00, patient experienced tingling, prickly, itchy sensations all over body with no visible rash started within 8-9 hours after injection and have persisted now for 5 days after injection; the sensations move around, have worsened as day proceeds; "I had the same reaction to Atovaquone/ Proguanil (malarone) 3 years ago", she added. The outcome of events was not recovered. Patient did not received any treatment for the events.   Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Pruritus
Clinical narrative: itchy sensations all over body; tingling, prickly, itchy sensations all over body; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 16Feb2021 09:00 (Batch/Lot Number: EM9809) as SINGLE DOSE for covid-19 immunisation. Medical history included Hashimoto's thyroiditis.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported; tocopherol (VITAMIN E) taken for an unspecified indication, start and stop date were not reported; vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported; ascorbic acid (VITAMIN C ASC ACID) taken for an unspecified indication, start and stop date were not reported; probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported; zinc taken for an unspecified indication, start and stop date were not reported; calcium taken for an unspecified indication, start and stop date were not reported.  The patient previously took Atovaquone / Proguanil, trimethoprim, acyclovir, bactrim, nitrofurantoin and cipro and had allergies. On 16Feb2021 18:00, patient experienced tingling, prickly, itchy sensations all over body with no visible rash started within 8-9 hours after injection and have persisted now for 5 days after injection; the sensations move around, have worsened as day proceeds; "I had the same reaction to Atovaquone/ Proguanil (malarone) 3 years ago", she added. The outcome of events was not recovered. Patient did not received any treatment for the events.   Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Pain, Pyrexia
Clinical narrative: felt feverish (though temp was 97.3) more sluggish amd more brain fog than before injection (like I was getting a cold or flu). Symptoms less apparent today; felt feverish (though temp was 97.3) more sluggish amd more brain fog than before injection (like I was getting a cold or flu). Symptoms less apparent today; felt feverish (though temp was 97.3) more sluggish amd more brain fog than before injection (like I was getting a cold or flu). Symptoms less apparent today; felt feverish (though temp was 97.3) more sluggish amd more brain fog than before injection (like I was getting a cold or flu). Symptoms less apparent today; felt feverish (though temp was 97.3) more sluggish amd more brain fog than before injection (like I was getting a cold or flu). Symptoms less apparent today; felt feverish (though temp was 97.3) more sluggish amd more brain fog than before injection (like I was getting a cold or flu). Symptoms less apparent today; This is a spontaneous report from a contactable consumer (patient).  A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 73-years-old), administered in Arm Left on 19Feb2021 13:30 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. Medical history included Obstructive Sleep Apnea, ongoing sluggishness, ongoing brain fog, and COVID-19 ("If COVID prior vaccination: Yes"). Concomitant medications included armodafinil and doxepin hcl both taken for unspecified indications, start and stop dates were not reported. About 19 hours after injection (on 20Feb2021, 09:00 AM) felt feverish (though temp was 97.3), more sluggish and more "brain fog" than before injection ("like I was getting a cold or flu"). Symptoms less apparent today. No treatment received for the events. The patient underwent lab tests and procedures which included body temperature: 97.3 on 20Feb2021. The outcome of the events was Recovering/Resolving.  Facility type vaccine was Public Health Clinic/Veterans Administration facility. No other vaccine in four weeks. Not COVID tested post vaccination.  Information on the lot/batch number has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Condition aggravated, Feeling abnormal, Influenza like illness, Nasopharyngitis
Clinical narrative: felt feverish (though temp was 97.3) more sluggish amd more brain fog than before injection (like I was getting a cold or flu). Symptoms less apparent today; felt feverish (though temp was 97.3) more sluggish amd more brain fog than before injection (like I was getting a cold or flu). Symptoms less apparent today; felt feverish (though temp was 97.3) more sluggish amd more brain fog than before injection (like I was getting a cold or flu). Symptoms less apparent today; felt feverish (though temp was 97.3) more sluggish amd more brain fog than before injection (like I was getting a cold or flu). Symptoms less apparent today; felt feverish (though temp was 97.3) more sluggish amd more brain fog than before injection (like I was getting a cold or flu). Symptoms less apparent today; felt feverish (though temp was 97.3) more sluggish amd more brain fog than before injection (like I was getting a cold or flu). Symptoms less apparent today; This is a spontaneous report from a contactable consumer (patient).  A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 73-years-old), administered in Arm Left on 19Feb2021 13:30 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. Medical history included Obstructive Sleep Apnea, ongoing sluggishness, ongoing brain fog, and COVID-19 ("If COVID prior vaccination: Yes"). Concomitant medications included armodafinil and doxepin hcl both taken for unspecified indications, start and stop dates were not reported. About 19 hours after injection (on 20Feb2021, 09:00 AM) felt feverish (though temp was 97.3), more sluggish and more "brain fog" than before injection ("like I was getting a cold or flu"). Symptoms less apparent today. No treatment received for the events. The patient underwent lab tests and procedures which included body temperature: 97.3 on 20Feb2021. The outcome of the events was Recovering/Resolving.  Facility type vaccine was Public Health Clinic/Veterans Administration facility. No other vaccine in four weeks. Not COVID tested post vaccination.  Information on the lot/batch number has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Sluggishness
Clinical narrative: felt feverish (though temp was 97.3) more sluggish amd more brain fog than before injection (like I was getting a cold or flu). Symptoms less apparent today; felt feverish (though temp was 97.3) more sluggish amd more brain fog than before injection (like I was getting a cold or flu). Symptoms less apparent today; felt feverish (though temp was 97.3) more sluggish amd more brain fog than before injection (like I was getting a cold or flu). Symptoms less apparent today; felt feverish (though temp was 97.3) more sluggish amd more brain fog than before injection (like I was getting a cold or flu). Symptoms less apparent today; felt feverish (though temp was 97.3) more sluggish amd more brain fog than before injection (like I was getting a cold or flu). Symptoms less apparent today; felt feverish (though temp was 97.3) more sluggish amd more brain fog than before injection (like I was getting a cold or flu). Symptoms less apparent today; This is a spontaneous report from a contactable consumer (patient).  A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 73-years-old), administered in Arm Left on 19Feb2021 13:30 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. Medical history included Obstructive Sleep Apnea, ongoing sluggishness, ongoing brain fog, and COVID-19 ("If COVID prior vaccination: Yes"). Concomitant medications included armodafinil and doxepin hcl both taken for unspecified indications, start and stop dates were not reported. About 19 hours after injection (on 20Feb2021, 09:00 AM) felt feverish (though temp was 97.3), more sluggish and more "brain fog" than before injection ("like I was getting a cold or flu"). Symptoms less apparent today. No treatment received for the events. The patient underwent lab tests and procedures which included body temperature: 97.3 on 20Feb2021. The outcome of the events was Recovering/Resolving.  Facility type vaccine was Public Health Clinic/Veterans Administration facility. No other vaccine in four weeks. Not COVID tested post vaccination.  Information on the lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Pain, Pruritus, Rash, Rash vesicular
Clinical narrative: Developed a blister that itched on inside of left forearm 10 hours after injection/some blisters on right inside forearm/blister on  couple on trunk and chest and back of left leg; This is a spontaneous report from a contactable consumer (patient). A 63-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200), via an unspecified route of administration, administered in left arm on 23Feb2021 (at the age of 63-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication(s) included vitamin d, 1500mg; niacinamide 1000mg. On 24Feb2021 14:00, the patient developed a blister that itched on inside of left forearm 10 hours after injection/some blisters on right inside forearm/blister on couple on trunk and chest and back of left leg. The patient did not receive any treatment. Outcome of event was not recovered.  No follow-up attempts are needed. No further Information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister
Clinical narrative: Developed a blister that itched on inside of left forearm 10 hours after injection/some blisters on right inside forearm/blister on  couple on trunk and chest and back of left leg; This is a spontaneous report from a contactable consumer (patient). A 63-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200), via an unspecified route of administration, administered in left arm on 23Feb2021 (at the age of 63-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication(s) included vitamin d, 1500mg; niacinamide 1000mg. On 24Feb2021 14:00, the patient developed a blister that itched on inside of left forearm 10 hours after injection/some blisters on right inside forearm/blister on couple on trunk and chest and back of left leg. The patient did not receive any treatment. Outcome of event was not recovered.  No follow-up attempts are needed. No further Information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Paraesthesia oral, Pharyngeal swelling, Swollen tongue
Clinical narrative: Patient had an ED visit and/or hospitalization within 6 weeks of receiving COVID vaccine.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Nail disorder, Pain in extremity, Throat tightness
Clinical narrative: Patient had an ED visit and/or hospitalization within 6 weeks of receiving COVID vaccine.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Patient had an ED visit and/or hospitalization within 6 weeks of receiving COVID vaccine.
Age: 98.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arteriosclerosis
Clinical narrative: She did not have an adverse event following the vaccine. Died on February 24 2021
Age: 98.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: She did not have an adverse event following the vaccine. Died on February 24 2021
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Glossodynia, Limb discomfort, Sleep disorder
Clinical narrative: mouth ulcer under tongue; Tip of tongue felt like it was dipped in hot sauce; Chills; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 66-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6205) on 12Mar2021 at 11:15 am via an unspecified route in the left arm (at the age of 66-years-old) as a single dose for Covid-19 immunization. Medical history included osteoporosis, high cholesterol, penicillin and sulfamethoxazole, trimethoprim (BACTRIM) allergy, CT contrast allergy (Contrast media allergy), and shellfish allergy. Concomitant medications were none. The patient did not receive any other vaccines within four weeks before the COVID vaccine. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Historical history reported that the patient took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9266) via an unspecified route in the left arm on 19Feb2021 at 11:15 AM for Covid-19 immunization. The patient experienced chills and fatigue on 13Mar2021 and on second day tip of tongue felt like the tip of the tongue was dipped in hot sauce on 14Mar2021. The patient was better but developed a mouth ulcer under the tongue on 15Mar2021. On day 4, the patient had several mouth ulcers and the patient still had them on day 5. Therapeutic measures were not mentioned for the adverse events. The patient had not recovered from the events at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Mouth ulceration, Tongue discomfort
Clinical narrative: mouth ulcer under tongue; Tip of tongue felt like it was dipped in hot sauce; Chills; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 66-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6205) on 12Mar2021 at 11:15 am via an unspecified route in the left arm (at the age of 66-years-old) as a single dose for Covid-19 immunization. Medical history included osteoporosis, high cholesterol, penicillin and sulfamethoxazole, trimethoprim (BACTRIM) allergy, CT contrast allergy (Contrast media allergy), and shellfish allergy. Concomitant medications were none. The patient did not receive any other vaccines within four weeks before the COVID vaccine. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Historical history reported that the patient took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9266) via an unspecified route in the left arm on 19Feb2021 at 11:15 AM for Covid-19 immunization. The patient experienced chills and fatigue on 13Mar2021 and on second day tip of tongue felt like the tip of the tongue was dipped in hot sauce on 14Mar2021. The patient was better but developed a mouth ulcer under the tongue on 15Mar2021. On day 4, the patient had several mouth ulcers and the patient still had them on day 5. Therapeutic measures were not mentioned for the adverse events. The patient had not recovered from the events at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash pruritic
Clinical narrative: Rash began to break out on my right wrist on March 11 mid day. 12Mar this rash broke out on my lower forearm. 13Mar it spread to my right leg above the knee and the right side of my penis. 14Mar behind my right ear and on the right side of my neck.; Rash began to break out on my right wrist on March 11 mid day. 12Mar this rash broke out on my lower forearm. 13Mar it spread to my right leg above the knee and the right side of my penis. 14Mar behind my right ear and on the right side of my neck.; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6199) via an unspecified route of administration in the left arm on 10Mar2021 at 11:15 (at the age of 71-years-old) as single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included Sertraline 15 mg (MANUFACTURER UNKNOWN), Multi Vitamin (MANUFACTURER UNKNOWN), Vitamin D (MANUFACTURER UNKNOWN) and Vitam (MANUFACTURER UNKNOWN) for unknown indications from an unknown date to unknown date, unknown if ongoing. Allergies to medications, food, or other products reported as None. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Mar2021 at 1:00 PM, the patient experienced break out of rash on his right wrist; on 12Mar2021, the rash broke out on his lower forearm; on 13Mar2021, the rash spread to his right leg above the knee and the right side of penis. On 14Mar2021, patient experienced rashes behind his right ear and on the right side of his neck. No therapeutic measures were reported for events. The clinical outcome of the generalized rash and penile rash was not recovered. No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Penile rash, Rash
Clinical narrative: Rash began to break out on my right wrist on March 11 mid day. 12Mar this rash broke out on my lower forearm. 13Mar it spread to my right leg above the knee and the right side of my penis. 14Mar behind my right ear and on the right side of my neck.; Rash began to break out on my right wrist on March 11 mid day. 12Mar this rash broke out on my lower forearm. 13Mar it spread to my right leg above the knee and the right side of my penis. 14Mar behind my right ear and on the right side of my neck.; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6199) via an unspecified route of administration in the left arm on 10Mar2021 at 11:15 (at the age of 71-years-old) as single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included Sertraline 15 mg (MANUFACTURER UNKNOWN), Multi Vitamin (MANUFACTURER UNKNOWN), Vitamin D (MANUFACTURER UNKNOWN) and Vitam (MANUFACTURER UNKNOWN) for unknown indications from an unknown date to unknown date, unknown if ongoing. Allergies to medications, food, or other products reported as None. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Mar2021 at 1:00 PM, the patient experienced break out of rash on his right wrist; on 12Mar2021, the rash broke out on his lower forearm; on 13Mar2021, the rash spread to his right leg above the knee and the right side of penis. On 14Mar2021, patient experienced rashes behind his right ear and on the right side of his neck. No therapeutic measures were reported for events. The clinical outcome of the generalized rash and penile rash was not recovered. No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Diarrhoea, Pyrexia, Tremor, Vomiting
Clinical narrative: Chills; fever; shaking; Diarrhea; vomiting; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non pregnant female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no. EN6208) via an unspecified route of administration in the right arm on 12Mar2021(at the age of 60 years old as a single dose for COVID-19 immunisation. The patient's medical history not reported. Concomitant medications for an unknown indication. The patient did not have any allergies to medications, foods or other products.  The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and not been tested for COVID-19.  On12Mar2021 The patient was experienced diarrhea and vomiting 15 hours after the vaccination which continued for 12 hours. The patient also experienced chills, shaking and fever that climbed to 102.7 from 24 to 48 hours after the vaccination. The patient also reported that it took another 48 hours for the fever to end. The patient did not undergo any lab tests and procedures. The patient had not received any treatment for the events Diarrhea, vomiting, chills and shaking were recovering and the event fever was recovered at the time of report. No follow-up attempts are needed. No further information is expected
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry eye, Eye irritation, Eye swelling, Urticaria
Clinical narrative: Swollen eyes; Both eyes are dry and feel burning; Both eyes are dry and feel burning; Hives on both eyes; This is a spontaneous report from a contactable consumer, the patient.  A 36-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6206) via an unspecified route of administration in the left arm on 15Mar2021 at 09:00 (at the age of 36-years-old) as a single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Allergies to medications, food, or other products reported to Shrimp/seafood (mild). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 15Mar2021 at 19:00, patient experienced hives on both eye. The patient also experienced swollen eyes on16Mar2021 at 08:00 which was followed by dry eyes and burning of the eyes. Therapeutic measures were taken as a result of adverse event and included self-treatment with Benadryl and Allegra. The clinical outcome of the events were reported as recovered with sequelae. No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry throat, Glossodynia, Headache, Pharyngeal paraesthesia, Throat irritation
Clinical narrative: Immediately felt like the way far back of my tongue was stung by something or pricked with a needle; Ask for a headache on the left side only.; now my throat feels tingly; Itchy throat; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), as first dose via an unspecified route of administration, in left arm on 16Mar2021 at 11:00 AM (at the age of 44-years-old) as single dose for COVID-19 immunization. The patient's medical history included asthma. Allergies to medications, food, or other products was included Gluten and sulpha drugs. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021, the patient experienced immediately felt like the way far back of her tongue was stung by something or pricked with a needle and now her throat felt tingly and scratchy. Asked for a headache on the left side only. The patient did not receive any treatment for the reported events. The clinical outcome of tongue was stung, throat felt tingly, throat felt scratchy and headache on the left side were unresolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Glossodynia, Headache, Pharyngeal paraesthesia, Throat irritation
Clinical narrative: Immediately felt like the way far back of my tongue was stung by something or pricked with a needle; Ask for a headache on the left side only.; now my throat feels tingly; Itchy throat; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), as first dose via an unspecified route of administration, in left arm on 16Mar2021 at 11:00 AM (at the age of 44-years-old) as single dose for COVID-19 immunization. The patient's medical history included asthma. Allergies to medications, food, or other products was included Gluten and sulpha drugs. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021, the patient experienced immediately felt like the way far back of her tongue was stung by something or pricked with a needle and now her throat felt tingly and scratchy. Asked for a headache on the left side only. The patient did not receive any treatment for the reported events. The clinical outcome of tongue was stung, throat felt tingly, throat felt scratchy and headache on the left side were unresolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Heart rate increased, Paraesthesia, Tremor
Clinical narrative: strong tingling in the fingers; Dizziness; fast heartbeat; tremors; This is a spontaneous report from a contactable non health care professional. A 45 Year(s) old patient of unspecified gender has received BNT162B2{COVID-19 MRNA VACCINE BIONTECH} [batch/lot number# EN6207], via unspecified route to left arm on 16Mar2021 09:45 AM {age at vaccination 45 years} for covid 19 vaccination . Medical history was unknown. Concomitant medication(s) was unknown. The patient experienced Dizziness, fast heartbeat, strong tingling in the fingers and tremors on 16Mar2021 at unspecified time. The patient had not undergone lab tests and procedures. The patient had not been diagnosed with covid 19 before and after vaccination. The patient allergies included seasonal allergies, egg allergy and penicillin allergy. No therapeutic measures were taken as a result of Dizziness, fast heartbeat, strong tingling in the fingers and tremors. The patient recovered from the events 2 hrs after vaccine on 16Mar2021. No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: STERILE WATER WAS USE AS THE DILUENT INSTEAD OF NACL; This is a spontaneous report from a contactable Pharmacist. A 47-year-old male patient received BNT162B2(PFIZER-BIOTECH COVID-19 mRNA vaccine), via intramuscular route of administration in the right arm on 05Feb2021at 02:00 PM (at the age of 47-years-old) as single dose for COVID 19 Immunisation. Prior to vaccination the patient did not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and he did not receive any other vaccines within 2 weeks post vaccination, Medical history and Concomitant medications were not reported. The patient experienced sterile water was used as the diluent instead of NACL on 05Feb2021. No treatment was received for adverse event. Clinical outcome of the event sterile water was used as the diluent instead of NACL was resolved. The lot number EL1283 for the vaccine. No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product preparation error
Clinical narrative: STERILE WATER WAS USE AS THE DILUENT INSTEAD OF NACL; This is a spontaneous report from a contactable Pharmacist. A 47-year-old male patient received BNT162B2(PFIZER-BIOTECH COVID-19 mRNA vaccine), via intramuscular route of administration in the right arm on 05Feb2021at 02:00 PM (at the age of 47-years-old) as single dose for COVID 19 Immunisation. Prior to vaccination the patient did not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and he did not receive any other vaccines within 2 weeks post vaccination, Medical history and Concomitant medications were not reported. The patient experienced sterile water was used as the diluent instead of NACL on 05Feb2021. No treatment was received for adverse event. Clinical outcome of the event sterile water was used as the diluent instead of NACL was resolved. The lot number EL1283 for the vaccine. No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Anxiety, Throat irritation, Throat tightness
Clinical narrative: Chest tightness; Dizzy; Breathing difficult; Throat tightness; Hives on vaccinated arm; This is a spontaneous report from contactable consumer, the patient. A 30-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Lot Number: EN6201), via an unspecified route of administration in the left arm on 13Mar2021 at 10:45 am as a single dose for COVID-19 immunisation. The patient's medical history included ovarian cysts and irritable bowel syndrome (IBS). The patient was allergic to Gluten, dairy, bees, methocarbamol (manufacturer unknown), Dilaudid(manufacturer unknown). The concomitant medication included birth control contraceptives (Manufacturer unknown), Gastrozyme (Manufacturer unknown), Beta TCP (Manufacturer unknown), Phosphatidyl choline (Manufacturer unknown) for an unknown indication. On 13Mar2021, at 11:00 am the patient experienced dizzy (after 15 minutes of vaccination), hives on the vaccinated arm (after another 15 minutes), chest and throat tightness (after 30 minutes as per reported). The patient experienced breathing difficulties on 16Mar2021 at unknown time. Therapeutic measure were taken as a result of dizzy, hives on the vaccinated arm, chest and throat tightness, breathing difficulties treated with Benadryl, Pepcid, prednisone.The clinical outcomes of the dizzy, hives on vaccination arm, breathing difficulty, chest and throat tightness were not recovered. No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactoid reaction, Dizziness, Urticaria
Clinical narrative: Chest tightness; Dizzy; Breathing difficult; Throat tightness; Hives on vaccinated arm; This is a spontaneous report from contactable consumer, the patient. A 30-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Lot Number: EN6201), via an unspecified route of administration in the left arm on 13Mar2021 at 10:45 am as a single dose for COVID-19 immunisation. The patient's medical history included ovarian cysts and irritable bowel syndrome (IBS). The patient was allergic to Gluten, dairy, bees, methocarbamol (manufacturer unknown), Dilaudid(manufacturer unknown). The concomitant medication included birth control contraceptives (Manufacturer unknown), Gastrozyme (Manufacturer unknown), Beta TCP (Manufacturer unknown), Phosphatidyl choline (Manufacturer unknown) for an unknown indication. On 13Mar2021, at 11:00 am the patient experienced dizzy (after 15 minutes of vaccination), hives on the vaccinated arm (after another 15 minutes), chest and throat tightness (after 30 minutes as per reported). The patient experienced breathing difficulties on 16Mar2021 at unknown time. Therapeutic measure were taken as a result of dizzy, hives on the vaccinated arm, chest and throat tightness, breathing difficulties treated with Benadryl, Pepcid, prednisone.The clinical outcomes of the dizzy, hives on vaccination arm, breathing difficulty, chest and throat tightness were not recovered. No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Injection site urticaria, Throat tightness
Clinical narrative: Chest tightness; Dizzy; Breathing difficult; Throat tightness; Hives on vaccinated arm; This is a spontaneous report from contactable consumer, the patient. A 30-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Lot Number: EN6201), via an unspecified route of administration in the left arm on 13Mar2021 at 10:45 am as a single dose for COVID-19 immunisation. The patient's medical history included ovarian cysts and irritable bowel syndrome (IBS). The patient was allergic to Gluten, dairy, bees, methocarbamol (manufacturer unknown), Dilaudid(manufacturer unknown). The concomitant medication included birth control contraceptives (Manufacturer unknown), Gastrozyme (Manufacturer unknown), Beta TCP (Manufacturer unknown), Phosphatidyl choline (Manufacturer unknown) for an unknown indication. On 13Mar2021, at 11:00 am the patient experienced dizzy (after 15 minutes of vaccination), hives on the vaccinated arm (after another 15 minutes), chest and throat tightness (after 30 minutes as per reported). The patient experienced breathing difficulties on 16Mar2021 at unknown time. Therapeutic measure were taken as a result of dizzy, hives on the vaccinated arm, chest and throat tightness, breathing difficulties treated with Benadryl, Pepcid, prednisone.The clinical outcomes of the dizzy, hives on vaccination arm, breathing difficulty, chest and throat tightness were not recovered. No follow-up attempts are needed. No further information is expected.