chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Electrocardiogram
Clinical narrative: AFIB; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: ER8730), via an unspecified route of administration, administered in the left arm on 25Mar2021 17:45 as SINGLE DOSE for covid-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing , atrial fibrillation (AFIB) from an unknown date and unknown if ongoing, surgery from an unknown date and unknown if ongoing, ablasion completed in 15Apr for AFIB. The patient had no allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included acetylsalicylic acid (ASPRIN) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (CARTIA [ACETYLSALICYLIC ACID]) taken for an unspecified indication, start and stop date were not reported; ubidecarenone (COQ10 [UBIDECARENONE]) taken for an unspecified indication, start and stop date were not reported; omega-3-acid ethyl ester (LOVAZA) taken for an unspecified indication, start and stop date were not reported; ramipril (RAMIPRIL) taken for an unspecified indication, start and stop date were not reported. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. The patient had an ablasion completed in 15Apr2021 for AFIB and had no symptoms since. On 02Apr2021, he had a routine electrocardiogram (EKG) and it showed AFIB was back. He had no symptoms prior. The onset date of afib was reported as 02Apr2021 at 09:00. There was an emergency room (ER) or physician office visits. The patient underwent lab tests and procedures which included electrocardiogram: afib was back on 02Apr2021. Therapeutic measures taken as a result of afib included dronedarone hydrochloride. The outcome of afib. was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Muscle twitching, Neuralgia, Pain
Clinical narrative: passed out; black out; tense nerve feelings/nerve twitching; tense nerve feelings/nerve twitching; typical body aches or pain; This is a spontaneous report from a contactable consumer (patient). This 35- year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EN6208), via an unspecified route of administration, on 12Apr2021 at 09:30 am (at the age of 35-years-old) as a single dose for COVID-19 vaccination, in left arm. The facility where COVID-19 vaccine was administered was a hospital. No known allergies. Patient has no relevant medical history. States: I live a healthy lifestyle diet, exercise, proper rest. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 10:00 am, the patient stated: I passed out and or blacked out on my drive home from the hospital. I was careful to follow the 15minute wait period before I left the hospital and was ok at that point. I had tense nerve feelings came over me as it grew so strong, I was forced to try and get my car on an off ramp to leave the highway I was on. I thankfully did not get any real injuries to my body as I spun and landed on the side of the road in the grass area. However, this experience was horrifying to say the least. I had a delayed reaction to this vaccine, other than this one incident, I really only had the typical body aches or pain for 24 hours and a bit of nerve twitching. I will not mark this as a risk of death, because it was my driving a car that risked my safety not the vaccine, however, the vaccine did cause the black out. The clinical outcome of the events was recovered. The patient was not tested for COVID-19 after the vaccination.  Information about the Lot/batch number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Nausea
Clinical narrative: right sided numbness; severe headache; nausea; This is a spontaneous report from a contactable nurse, reporting for herself. A 22-year-old non-pregnant female patient received the first dose of the bnt162b2 (BNT162B2; Lot Number: EK4176), via an unspecified route of administration in the left arm on 15Jan2021 at 09:00 at a single dose for covid-19 immunization. The patient received the immunization in a hospital. Medical history included Ehlers-Danlos, allergic asthma, and fracture. Concomitant medication included drospirenone/ethinylestradiol (NIKKI) for birth control. There were no other vaccines given in four weeks. The patient previously took tramadol (MANUFACTURER UNKNOWN) and experienced allergies. On 28Jan2021 at 11:00, the patient experienced right sided numbness, severe headache, and nausea, which were serious for disability. Therapeutic measures were taken as a result of the events. The patient was treated in the emergency room and sent home with TIA protocol to follow with neurologist. There was no COVID prior or post vaccination. The clinical outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information currently available the causal association between the reported events right sided numbness, severe headache, and nausea and the usage of the vaccine BNT162B2 cannot be excluded but also the contributory role of the concomitant medications/medical history of the patient need to be taken into consideration. The case will be reassessed should the additional information be available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Parkinson's disease
Clinical narrative: suspected Parkinson disease; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's second dose is due on 16Apr2021. A day before her second dose she will undergo a nuclear scan for suspected Parkinson disease. It is a dots nuclear medicine scan that will inject radioactive tracer in her system. Asking if this will counteract with the vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Nausea
Clinical narrative: Body aches, fever up to 102.6°, chills, bad headache, tiredness, nausea, loss of appetite   Using ice and taking Tylenol every 4 hours
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Body aches, fever up to 102.6°, chills, bad headache, tiredness, nausea, loss of appetite   Using ice and taking Tylenol every 4 hours
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, X-ray
Clinical narrative: serious pain on his left leg; This is a spontaneous report received from a contactable consumer, the patient. A 52-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as a single dose (at the age of 52 years-old) for COVID-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on an unknown date (Batch/Lot number was not reported) for COVID-19 immunisation.  The patient experienced serious pain on his left leg on an unknown date in Mar2021 after the second dose of bnt162b2.  The patient underwent lab tests and procedures which included x-ray on an unknown date: which showed x-ray hasn't had any improvement. The clinical outcome of the event serious pain on his left leg was unknown.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiovascular symptom
Clinical narrative: Feeling symptoms of myocarditis since the second shot.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: Feeling symptoms of myocarditis since the second shot.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Facial pain, Paraesthesia oral, Rash, Toothache
Clinical narrative: 4/24/21  1:05pm first dose Pfizer vaccine  1:10pm huge allergic reaction, felt like pre-anaphylaxis, like I was going to die  1:13pm took 2 Benadryl 25mg  5:30pm took 1 Benadryl 25 mg Loose stools all day, stayed home as Benadryl was working 4/25/21  12:30am took 1 Benadryl 25mg (weird feeling in my tongue)  1:25pm took 1 Benadryl 25mg for pain in my cheekbones & teeth and rash on both cheeks below eyes  1:58pm took 1 Benadryl 25mg   "    " 2:19pm took 1 Benadryl 25mg   "    " 2:49pm checked into hospital emergency room as allergic reaction would not subside 4:30pm got IV with Benadryl 25mg, Methylprednisolone & Pepcid (throat felt strange) 7:26pm discharged from ER 4/26/21 Medrol 24g 4/27 Medrol 20g
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Dizziness, Injection site erythema, Injection site induration
Clinical narrative: Experiencing what is being described as ?Covid Arm?. Redness at injection site, hard lump, feverish to touch, painful. My arm feels like dead weight and there?s a white hot burning sensation in my shoulder joint. Nausea, dizziness and light headed feeling that comes and goes.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pain, Injection site warmth, Limb discomfort, Nausea
Clinical narrative: Experiencing what is being described as ?Covid Arm?. Redness at injection site, hard lump, feverish to touch, painful. My arm feels like dead weight and there?s a white hot burning sensation in my shoulder joint. Nausea, dizziness and light headed feeling that comes and goes.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Continuing Tinnitus from date of vaccination
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: Worsening of preexisting tinnitus
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Fatigue, Headache, Myalgia
Clinical narrative: 1. Got 1st shot Modena on left arm on January 17, 2021, usual headache sore muscle and tired for a day. 2. Blood pressure shot up  to 159 accidentally when visit dental office on January 27, 2021 3. Got 2nd shot Modena on left arm on February 16, 2021, usual sore muscle, better than after 1st shot. 4. Blood pressure continue to shot up to 169 when visit up night guard on Feb 24, 2021 5. Visit primary Dr, blood pressure continued to be as high as 159. 6. On April 23, 2021, while visit dental office, blood pressure shot up to 179/75 causing personnel alarm and advise to talk to PCP. 7. Checking Blood pressure daily at home using portable wrist cuff:  upper number measurement ranged from  140 to 197 in the last week as I checked daily, morning, noon and evening.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever since injection of vaccine. 100 degrees. lasting  8+ days.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache
Clinical narrative: Had joint pain, fatigue and headache . Started about 8 hours after vaccine and continued through the following day. About 24 hours
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Audiogram, Tinnitus
Clinical narrative: Tinnitus in both ears (ringing sound) that started a few days after vaccination and hasn't reduced in volume since
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Miliaria, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: Pain sore arm for about 48 hrs. Light headache for about 24 hours. Weekend after big sore lump in underarm. Exactly a week later, tonight my arm is hot and itchy. Has big lump looks like big bug bite. Feel prickly and hot and slightly headache/nauseous.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin warm
Clinical narrative: Pain sore arm for about 48 hrs. Light headache for about 24 hours. Weekend after big sore lump in underarm. Exactly a week later, tonight my arm is hot and itchy. Has big lump looks like big bug bite. Feel prickly and hot and slightly headache/nauseous.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood test, Fatigue, Gait disturbance, Hypoaesthesia
Clinical narrative: Numbness in hands, feet and legs. Numbness caused inconsistent issue with gait pattern. Unable to feel sensation of hot, cold or amount of pressure, particularly in lower leg, primarily my left leg. Constant pain in back of neck and mid-spine area. Severe fatigue mixed with numbness causing an inability to walk for a short time. The fatigue continues and tingling numbness is frequently onset without any reason. Many symptoms have subsided with sporadic tingling and numbness remaining.and persistent fatigue
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Neck pain, Paraesthesia
Clinical narrative: Numbness in hands, feet and legs. Numbness caused inconsistent issue with gait pattern. Unable to feel sensation of hot, cold or amount of pressure, particularly in lower leg, primarily my left leg. Constant pain in back of neck and mid-spine area. Severe fatigue mixed with numbness causing an inability to walk for a short time. The fatigue continues and tingling numbness is frequently onset without any reason. Many symptoms have subsided with sporadic tingling and numbness remaining.and persistent fatigue
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: Allergic reaction, moderate throat tightening within 15 minutes of vaccination with no prior history of allergic response to vaccines or any medications. Patient treated under regional allergic reaction protocol by EMS as a mild allergic reaction, patient received IV, IV Diphenhydramine, and ambulance transport to ED for evaluation/observation.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling, Pruritus, Throat irritation
Clinical narrative: Allergic reaction, moderate throat tightening within 15 minutes of vaccination with no prior history of allergic response to vaccines or any medications. Patient treated under regional allergic reaction protocol by EMS as a mild allergic reaction, patient received IV, IV Diphenhydramine, and ambulance transport to ED for evaluation/observation.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Nodule, Pain, Pruritus, Rash
Clinical narrative: Red/discolored skin about 2-3 inches in diameter. Painful with and without touching within 24 hours of 2nd dose. Lump formed below redness. The lump and redness/rash became itchy about 72 hours after injection with continued soreness and tenderness.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Tenderness
Clinical narrative: Red/discolored skin about 2-3 inches in diameter. Painful with and without touching within 24 hours of 2nd dose. Lump formed below redness. The lump and redness/rash became itchy about 72 hours after injection with continued soreness and tenderness.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: DVT; PE; This is a spontaneous report from a contactable physician. A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the left arm, on 28Jan2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension (HTN) and fibroids. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medication included amlodipine besilate (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the right arm, on 07Jan2021 (at the age of 42-years-old) for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced deep vein thrombosis (DVT) and pulmonary embolism (PE) on 29Jan2021, which caused hospitalization for 5 days from an unspecified date to an unspecified date. Therapeutic measures were taken as a result of the events, which included direct oral anticoagulants (DOAC). The clinical outcome of DVT and PE was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of Deepvein thrombosis,pulmonary embolism cannot be excluded.But also consider relevant medical history of hypertension and fibroids tendency to form blood clots and concomitant medications also have possible contributory role. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site pain, Pain
Clinical narrative: Large, painful red circle at injection site, fatigue, body ache
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Sudden hearing loss
Clinical narrative: Sudden Hearing Loss; 1st dose 16Mar2021, 2nd dose 22Mar2021; This is a spontaneous report from a contactable consumer (patient) reported that a 73-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 22Mar2021 10:30 (at the age of 73-years-old) as a single dose for covid-19 immunisation. The patient medical history included diabetes from an unknown date. The patient had no covid-19 prior vaccination. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in left arm on 16Mar2021 2:30 PM (at the age of 73-years-old) for covid-19 immunization. The patient experienced sudden hearing loss on 08Apr2021 17:00 with outcome of unknown. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not received any treatment for the event. The outcome of the event was unknown. Not covid-19 tested post vaccination.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Drug ineffective, Dyspnoea, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: Pulmonary embolism; Shortness of breath; she tested positive for Covid; she tested positive for Covid; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 52 years of age), dose 1 via an unspecified route of administration on 20Mar2021 12:00 (Batch/Lot Number: ER8727; Expiration Date: 31Jul2021) as a single dose for COVID-19 immunisation. Medical history included allergies wherein she mentioned that her allergies were acting up so she took Tylenol 500mg, 1 pill; and insomnia. Concomitant medications included paracetamol (TYLENOL) taken for hypersensitivity; cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC DUO) taken for hypersensitivity, start and stop date were not reported; and dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol (NYQUIL) taken for insomnia (it helps her sleep at night), start and stop date were not reported. It was reported that the patient already received 1st dose of the Pfizer-BioNTech Covid-19 Vaccine and was scheduled to receive the 2nd dose on 17Apr2021. Yesterday, she tested positive for Covid and got hospitalized. She said she got discharged today and is now on medication which includes a blood thinner. She wanted to know if she needed to reschedule her 2nd dose, and how. It was clarified that the patient had Covid test on 12Apr2021 with Positive result. She mentioned that she was reading paperwork and it said something about to let her vaccination provider know about medical conditions, allergies, bleeding or if she take blood thinners. She stated that she was prescribed blood thinners yesterday evening and she was going to be taking them for 3-6 months. She questioned if it was going to affect if she takes the shot on Saturday. She added that she will be on the blood thinner 5-6 days by then. She stated that she was tested for Covid in the hospital that she went in with shortness of breath and they did the test yesterday. She had shortness of breath Saturday (09Apr2021) and she went to the ER on 12Apr2021 and was admitted and was released 13Apr2021. She stated that she was diagnosed from being discharged with blood clots and she is now on a blood thinner and a steroid pill for inflammation. She clarified that she was diagnosed on 12Apr2021 with pulmonary embolism and was put on ELIQUIS and will take it for the 1st 7 days, 2 tablets twice a day and they are 5mg each and then she will take 1 tablet twice a day until she follows up with her primary doctor and will either stop taking it at 3 months or 6 months. She will also be taking Dexamethasone 2mg tablet taking 3 tablets once a day for 8 days. She stated that they did a C scan to identify blood clots. There was no other vaccine administered on the same date the Pfizer vaccine was given. The outcome of events was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Pulmonary embolism; Shortness of breath; she tested positive for Covid; she tested positive for Covid; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 52 years of age), dose 1 via an unspecified route of administration on 20Mar2021 12:00 (Batch/Lot Number: ER8727; Expiration Date: 31Jul2021) as a single dose for COVID-19 immunisation. Medical history included allergies wherein she mentioned that her allergies were acting up so she took Tylenol 500mg, 1 pill; and insomnia. Concomitant medications included paracetamol (TYLENOL) taken for hypersensitivity; cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC DUO) taken for hypersensitivity, start and stop date were not reported; and dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol (NYQUIL) taken for insomnia (it helps her sleep at night), start and stop date were not reported. It was reported that the patient already received 1st dose of the Pfizer-BioNTech Covid-19 Vaccine and was scheduled to receive the 2nd dose on 17Apr2021. Yesterday, she tested positive for Covid and got hospitalized. She said she got discharged today and is now on medication which includes a blood thinner. She wanted to know if she needed to reschedule her 2nd dose, and how. It was clarified that the patient had Covid test on 12Apr2021 with Positive result. She mentioned that she was reading paperwork and it said something about to let her vaccination provider know about medical conditions, allergies, bleeding or if she take blood thinners. She stated that she was prescribed blood thinners yesterday evening and she was going to be taking them for 3-6 months. She questioned if it was going to affect if she takes the shot on Saturday. She added that she will be on the blood thinner 5-6 days by then. She stated that she was tested for Covid in the hospital that she went in with shortness of breath and they did the test yesterday. She had shortness of breath Saturday (09Apr2021) and she went to the ER on 12Apr2021 and was admitted and was released 13Apr2021. She stated that she was diagnosed from being discharged with blood clots and she is now on a blood thinner and a steroid pill for inflammation. She clarified that she was diagnosed on 12Apr2021 with pulmonary embolism and was put on ELIQUIS and will take it for the 1st 7 days, 2 tablets twice a day and they are 5mg each and then she will take 1 tablet twice a day until she follows up with her primary doctor and will either stop taking it at 3 months or 6 months. She will also be taking Dexamethasone 2mg tablet taking 3 tablets once a day for 8 days. She stated that they did a C scan to identify blood clots. There was no other vaccine administered on the same date the Pfizer vaccine was given. The outcome of events was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Muscle spasms
Clinical narrative: thought she was having a stroke; severe cramp in her left leg below the knee to her toes and it is extremely painful; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in the right arm on 09Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included ongoing blood pressure high diagnosed about 7-8 years ago. The patient's concomitant medications were not reported. The patient got her first dose of the Pfizer Covid vaccine on 09Apr2021. On Saturday, 10Apr2021, she got this severe cramp in her left leg below the knee to her toes and it is extremely painful and thought she was having stroke. She stated that she was treating with a warm cloth and was going to go to the emergency room; rubbing down in case there is a blood clot. She wanted to know if this could be from the vaccine. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Acne, Chills, Cough, Fatigue, Feeling hot
Clinical narrative: she still has to walk with a cane; chills; pimples came out on her mouth; couldn't even walk; had body aches; felt tired; her arm was hurting; Her arm was hurting, she felt a hard, hot spot, it lasted 3 days; Her arm was hurting, she felt a hard, hot spot, it lasted 3 days; coughing; This is a spontaneous report from a contactable consumer via the medical information team. A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm on 01Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included diabetic and the patient was allergic to certain medicines. The patient's concomitant medications were not reported. On 02Apr2021, the patient arm was hurting, she felt a hard, hot spot, it lasted for 3 days but went away. in the evening, the patient started coughing. On 04Apr2021 in the afternoon, the patient had body aches, couldn't even walk. She wasn't feeling like that before the vaccine. Then she started having chills, pimples came out on her mouth but they were already dried up. The patient was getting better, the cough was worse at night but not bad enough to go to the hospital. The cough was better with remedies. She gets tired when walking but the worst part was already over. For now, the patient still has to walk with a cane, but she did not have any problems before the vaccine. The outcome of the events "her arm was hurting", "Her arm was hurting, she felt a hard, hot spot, it lasted 3 days", had body aches, chills, pimples came out on her mouth was recovered  Information about Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Pain, Vaccination site mass, Vaccination site pain, Walking aid user
Clinical narrative: she still has to walk with a cane; chills; pimples came out on her mouth; couldn't even walk; had body aches; felt tired; her arm was hurting; Her arm was hurting, she felt a hard, hot spot, it lasted 3 days; Her arm was hurting, she felt a hard, hot spot, it lasted 3 days; coughing; This is a spontaneous report from a contactable consumer via the medical information team. A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm on 01Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included diabetic and the patient was allergic to certain medicines. The patient's concomitant medications were not reported. On 02Apr2021, the patient arm was hurting, she felt a hard, hot spot, it lasted for 3 days but went away. in the evening, the patient started coughing. On 04Apr2021 in the afternoon, the patient had body aches, couldn't even walk. She wasn't feeling like that before the vaccine. Then she started having chills, pimples came out on her mouth but they were already dried up. The patient was getting better, the cough was worse at night but not bad enough to go to the hospital. The cough was better with remedies. She gets tired when walking but the worst part was already over. For now, the patient still has to walk with a cane, but she did not have any problems before the vaccine. The outcome of the events "her arm was hurting", "Her arm was hurting, she felt a hard, hot spot, it lasted 3 days", had body aches, chills, pimples came out on her mouth was recovered  Information about Batch/Lot number has been requested.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Cyanosis, Dyspnoea, Pallor, SARS-CoV-2 test
Clinical narrative: Asthma triggered throughout the day in shorter spans of time; hard time inhaling air, shortness of breath; blue lips; pale; This is a spontaneous report from a contactable consumer (patient). A 23-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 23-years-old via an unspecified route of administration, administered in arm left on 10Apr2021 10:15 (Batch/Lot Number: EP7533) as single dose for covid-19 immunisation.  Medical history included asthma and eczema from an unknown date and unknown if ongoing. Concomitant medications included albuterol sulfate and loratadine, pseudoephedrine sulfate (CLARITIN-D); all taken for an unspecified indication, start and stop date were not reported. The patient reported that his asthma triggered throughout the day in shorter spans of time, hard time inhaling air, shortness of breath on 11Apr2021 11:00; emergency Albuterol Sulfate inhaler not working to help, had to go to ER where they gave steroids for his lungs and breathing and out him in oxygen. He was told that he had blue lips and was pale on 11Apr2021 11:00. He was in ER for 4-6 hrs then hospitalized for one day to monitor and gave medicine. Then he was advised to go to the doctor and get referral for pulmonologist for asthma. Basically all of Sunday, his asthma would get triggered few hours then got short within every 30 min then every 5 min and inhaler stopped working to help the situation. Diagnosed with asthma since kid but had no serious issues prior to vaccination, only after vaccination. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. The patient was hospitalized due to the events for 1 day. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 11Apr2021. Therapeutic measures were taken as a result of the events which included treatment with Steroid, IV Fluids, Albuterol, Advent, oxygen tank. The patient was recovering from the events.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Head injury, Joint injury, Loss of consciousness
Clinical narrative: Passed out; felt dizy; hit my head and injured my ankle; fallen; hit my head and injured my ankle; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, administered in Arm Right at the age of 26-year-old, on 12Apr2021 10:30, as SINGLE DOSE for covid-19 immunisation.  Medical history was not reported. The patient's concomitant medications were not reported. The patient did not receive vaccine in four weeks nor was the patient tested for COVID post vaccination. On 12Apr2021 at 11:00, the patient felt dizzy and then the patient passed out. When the patient woke 3 minutes later, he had fallen and hit his head and injured his ankle. The patient was taken by the ambulance to the local ER and was released later that day as his vitals had returned to normal. Therapeutic measures taken in response to the events included IV fluids. They advised that the patient reach out to see if he can receive my second shot on 03May202. Outcome of the events was recovering at the time of the report.  Information about lot/batch number has been requested.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Vital signs measurement
Clinical narrative: Passed out; felt dizy; hit my head and injured my ankle; fallen; hit my head and injured my ankle; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, administered in Arm Right at the age of 26-year-old, on 12Apr2021 10:30, as SINGLE DOSE for covid-19 immunisation.  Medical history was not reported. The patient's concomitant medications were not reported. The patient did not receive vaccine in four weeks nor was the patient tested for COVID post vaccination. On 12Apr2021 at 11:00, the patient felt dizzy and then the patient passed out. When the patient woke 3 minutes later, he had fallen and hit his head and injured his ankle. The patient was taken by the ambulance to the local ER and was released later that day as his vitals had returned to normal. Therapeutic measures taken in response to the events included IV fluids. They advised that the patient reach out to see if he can receive my second shot on 03May202. Outcome of the events was recovering at the time of the report.  Information about lot/batch number has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Fatigue, Hyperhidrosis, Myocardial infarction
Clinical narrative: dry heaves; chest pain; heart attack; Sweats and chills the next morning; Sweats and chills the next morning; tiredness; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 29Mar2021 17:45 (Batch/Lot Number: EP1534) as SINGLE DOSE for covid-19 immunization.  Medical history reported as "none before this event".  Patient previously received the first dose of BNT162B2 (lot number: EN6203) on 08Mar2021 17:45 in the left arm for covid-19 immunization. The patient's concomitant medications were not reported. The patient experienced sweats and chills the next morning, tiredness, then went to dry heaves and chest pain after 2:30 PM -- on 30Mar2021 all these side effects started from early morning and at 5:30 went to ER and was told he was having a heart attack. The patient underwent lab tests and procedures on 30Mar2021, which included Covid (sars-cov-2) test with negative results.  The outcome of events was reported as "not recovered". Therapeutic measures were taken as a result of the events includes angiogram and stent on right side of heart. The events were considered as serious since events involved inpatient hospitalization and persistent or significant disability or incapacity.  No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Retching, SARS-CoV-2 test
Clinical narrative: dry heaves; chest pain; heart attack; Sweats and chills the next morning; Sweats and chills the next morning; tiredness; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 29Mar2021 17:45 (Batch/Lot Number: EP1534) as SINGLE DOSE for covid-19 immunization.  Medical history reported as "none before this event".  Patient previously received the first dose of BNT162B2 (lot number: EN6203) on 08Mar2021 17:45 in the left arm for covid-19 immunization. The patient's concomitant medications were not reported. The patient experienced sweats and chills the next morning, tiredness, then went to dry heaves and chest pain after 2:30 PM -- on 30Mar2021 all these side effects started from early morning and at 5:30 went to ER and was told he was having a heart attack. The patient underwent lab tests and procedures on 30Mar2021, which included Covid (sars-cov-2) test with negative results.  The outcome of events was reported as "not recovered". Therapeutic measures were taken as a result of the events includes angiogram and stent on right side of heart. The events were considered as serious since events involved inpatient hospitalization and persistent or significant disability or incapacity.  No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Sinusitis
Clinical narrative: sinus infection; got colds; This is a spontaneous report from a 19-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on 17Mar2021 (at the age of 19-years-old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The patient's mother stated that the patient ended up getting a sinus infection in 2021 and was currently on antibiotics and steroids. The patient also got colds in 2021 and was prescribed by her doctor to take steroids which will end on 14Apr2021. The patient was advised by her doctor not to take the second dose while taking steroids. Her second dose was scheduled on 17Apr2021. The outcome of the events sinus infection and cold was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Road traffic accident
Clinical narrative: developed rashes from neck down to her feet; car accident; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 09Apr2021 as a single dose for COVID-19 IMMUNIZATION. Co-suspect included muscle relaxant. Relevant medical history and concomitant medication were not provided. On 11Apr2021, the patient experienced a car accident and was prescribed a muscle relaxant. On 13Apr2021, the patient experienced developed rashes from neck down to her feet. The patient was asking if this was vaccine related or from the muscle relaxant that she took. Treatment received for the event car accident included a muscle relaxant. The outcome of the events car accident and rash was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Developed blood clot in right leg (behind knee); This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration, administered in Arm Left first dose on 26Feb2021 11:15 at single dose for covid-19 immunisation. The patient's medical history included Developed blood clots after twin c section. The patient has been off blood thinners for 2.5 years. The patient was not pregnant at time of vaccination. The patient's concomitant medications included venlafaxine hydrochloride (EFFEXOR) and vitamin d [vitamin d nos]. On 17Mar2021, the patient Developed blood clot in right leg (behind knee). The patient was put on blood thinners as treatment. The events cause the patient emergency room visit and physician office visit. The outcome of the event was recovering.  Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Lethargy, Limb discomfort, Palpitations, SARS-CoV-2 test
Clinical narrative: Nearly fainting; vertigo like symptoms; lightheaded; lethargic; blurred vision; shaky; heart palpitations; limbs feel heavy; This is a spontaneous report from a contactable consumer (patient). A 35-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ep 6955) via an unspecified route of administration, administered on the right arm on 26Mar2021 15:30 at a single dose for COVID-19 immunization. Medical history included anxiety, depression; and known allergies: penicillin and gluten. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and sertraline hydrochloride (ZOLOFT). The patient previously took amoxicillin and diflucan and experienced allergies. On 30Mar2021 22:00, the patient experienced nearly fainting, vertigo like symptoms, lightheaded, lethargic, blurred vision, shaky, heart palpitations and limbs feel heavy. The event resulted to a doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for the events for 1 day. Treatment was received for the events which included medication, heart monitor, MRI, MRA, MRV, CT scan. COVID test post vaccination included nasal swab on 01Apr2021: negative. Patient was not pregnant. The facility where the vaccine was administered was in a school or student health clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Tremor, Vertigo, Vision blurred
Clinical narrative: Nearly fainting; vertigo like symptoms; lightheaded; lethargic; blurred vision; shaky; heart palpitations; limbs feel heavy; This is a spontaneous report from a contactable consumer (patient). A 35-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ep 6955) via an unspecified route of administration, administered on the right arm on 26Mar2021 15:30 at a single dose for COVID-19 immunization. Medical history included anxiety, depression; and known allergies: penicillin and gluten. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and sertraline hydrochloride (ZOLOFT). The patient previously took amoxicillin and diflucan and experienced allergies. On 30Mar2021 22:00, the patient experienced nearly fainting, vertigo like symptoms, lightheaded, lethargic, blurred vision, shaky, heart palpitations and limbs feel heavy. The event resulted to a doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for the events for 1 day. Treatment was received for the events which included medication, heart monitor, MRI, MRA, MRV, CT scan. COVID test post vaccination included nasal swab on 01Apr2021: negative. Patient was not pregnant. The facility where the vaccine was administered was in a school or student health clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Super heavy period/bleeding through an overnight pad every 2-3 hours; This is a spontaneous report from a contactable consumer (patient) reported that a 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0153), via an unspecified route of administration, administered in arm left on 08Apr2021 14:45 (at the age of 40-years-old) as a single dose for covid-19 immunisation. The vaccine was administered at the Pharmacy/drug store. The patient was not pregnant at the time of vaccination. The patient medical history included low progesterone and low thyroid both from an unknown date. The patient did not had covid-19 prior vaccination. The patient's concomitant medications were not reported. On 10Apr2021, the patient had super heavy period. She was bleeding through an overnight pad every 2-3 hours. They were supposed to last between 10-12 hours. This lasted for almost 2 days, unfortunately if was during the weekend or she would have sought medical help from her doctor. The patient did not received any treatment for the reported event. Not covid-19 tested post vaccination. The outcome of the event was recovered on 12Apr2021.