chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Dry skin, Rash
Clinical narrative: Feet skin dry and my head dry also; Rash on my chest, back, arms, legs and hands; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 55-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0171) via an unspecified route of administration in left arm on 24Apr2021 at 09:00 AM as 2nd dose, single for COVID-19 immunization. Patient previously received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EP7533) via an unspecified route of administration in left arm on 04Apr2021 at 08:00 AM as 1st dose, single for COVID-19 immunization. Medical history included blood cholesterol and COVID 19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was diagnosed with COVID-19. On 29Apr2021 at 04:00 PM, patient experienced small red rashes only back after a week my hole chest, my back, legs, my arms get a really bad rash and my hands are very dry and my feet also and my head dry also. Can you contact me and let me know what can I do please. I been like this 30 days. Patient treated with Medroll 16 mg 2 a day. Since the vaccination, patient had not been tested for COVID-19. The outcome of the events was not recovered.    Information on Lot/Batch number was available. Additional information has been requested
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Sinus disorder, Sleep disorder
Clinical narrative: she is having sinuses; it happened at night time as soon as night comes, my nose are close; because there is no way I can't take sleep like that; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: ER8737) via an unspecified route of administration, administered in arm left on 26May2021 (at the age of 56 years) as 1st single dose for COVID-19 immunisation. Medical history included hyperactive sinus from 2007 about roundabout for a while. Patient stated no family medical history of sinuses. The patient's concomitant medications were not reported. On an unspecified date in May2021, last night the patient had sinused and she took Sudafed. Patient enquired if it was okay that she had Sudafed in the dose of Pfizer Vaccine will this interfere wanted to know more information about this situation. Patient wanted to know if this was gone a affect her vaccine in any way that she took Sudafed other day, because she was going to watch tonight and see what happens tonight, If she can take another one or not. Patient informed it happened at night time as soon as night comes, her nose are close. Patient know it's not from the vaccine, that's just something that happens. Patient just wanted to make sure it was okay with taking Sudafed because she read about taking any Ibuprofen or any Tylenol prior to take a shot. Patient was not able to take sleep like that, so that's why, she just wanted to make sure that's okay. Patient clarified she did not have any sinus at the time of vaccination, just that night and this was something that happened all the time, not all the time whenever feels up, it just happens every now or then it just happened that night. Patient informed that the second dose will be on 16Jun2021. As therapeutic measure patient took Sudafed pill orally night only as per needed. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Hypoaesthesia
Clinical narrative: My left leg, it started when I fell asleep during the night, it started to feel numb; Side of my ankle on the left side, my left leg ankle outside is numb and its numb over down to my foot; I got up and shook it of with my foot and so, everyday it is goes worse and worse; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ZW0173), dose 2 via an unspecified route of administration, administered in Arm Left on 29Apr2021 09:30 (at the age of 64-year-old) as 2nd dose, single dose for COVID-19 immunization. Medical history included diabetes. Concomitant medication included Naproxen taken for pain, a muscle relaxer; and dapagliflozin propanediol monohydrate, metformin hydrochloride (XIGDUO) taken for diabetes. The patient previously received first dose of BNT162B2 (Lot number: ER8729) in Arm Left on 06Apr2021 (1:30 in afternoon) for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient stated, "I would say around the 10th of this month, I was waking up with my left leg, it started when I fell asleep during the night, it started to feel numb, I got up and shook it with my foot and so, everyday it is goes worse and worse but I can't, side of my ankle on the left side, my left leg ankle outside is numb and its numb over down to my foot and I can't move my foot back so it's like my foot is numb and it stays that way and it has not gone away" on an unspecified date in May2021. When probed for time of vaccination again, the patient stated that "No, it's not but I remember on 29th, it was at, the first shot was on 1:30 in afternoon, you know the second shot was on 9:30, it was early, right after the open". No treatment received for the events. There was no investigation assessment and lab test. The outcome of event numbness in feet was not recovered and was unknown for other events.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Contusion, Musculoskeletal discomfort, Pruritus
Clinical narrative: trouble in the shoulder where they put the shot in; my back, my shoulder where they gave me the shot, it is like constantly pain like it is just like come and goes where in middle of the night I wake up; I have a bruise. Its been 4 week but I still have a bruise on my shoulder, my shoulder is hurting it. Its like my neck down my elbow; It is a rash or something itchy and its appear on me; It is a rash or something itchy and its appear on me; my back, my shoulder where they gave me the shot, it is like constantly pain like it is just like come and goes where in middle of the night I wake up; This is a spontaneous report from a contactable consumer, the patient. A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number,  number, UPC number and Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. About month ago, patient took the first Pfizer shot (further clarification was unknown hence captured as unspecified vaccine) and patient never had COVID yet. Patient was having so much trouble in the shoulder, where they put the shot in. Patient must back up or something because it's like all sudden his track or patient should always dumb the elbow just like. Patient didn't even think that the shot might be the problem but the back and shoulder where they gave the shot was constantly in pain (like it came and went). In middle of the night, patient woke up and it was just like drubbing, like a pinch nerve which patient thought that might be back was out. Patient went to chiropractor and realized about having a bruise. It had been 4 weeks, but patient still had a bruise on the shoulder where the needle was put in. Patient realized the shoulder was hurting. It's like neck down my elbow. Outcome of the event bruise was not recovered while of other events was unknown.  Follow-up attempts are needed. Further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: trouble in the shoulder where they put the shot in; my back, my shoulder where they gave me the shot, it is like constantly pain like it is just like come and goes where in middle of the night I wake up; I have a bruise. Its been 4 week but I still have a bruise on my shoulder, my shoulder is hurting it. Its like my neck down my elbow; It is a rash or something itchy and its appear on me; It is a rash or something itchy and its appear on me; my back, my shoulder where they gave me the shot, it is like constantly pain like it is just like come and goes where in middle of the night I wake up; This is a spontaneous report from a contactable consumer, the patient. A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number,  number, UPC number and Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. About month ago, patient took the first Pfizer shot (further clarification was unknown hence captured as unspecified vaccine) and patient never had COVID yet. Patient was having so much trouble in the shoulder, where they put the shot in. Patient must back up or something because it's like all sudden his track or patient should always dumb the elbow just like. Patient didn't even think that the shot might be the problem but the back and shoulder where they gave the shot was constantly in pain (like it came and went). In middle of the night, patient woke up and it was just like drubbing, like a pinch nerve which patient thought that might be back was out. Patient went to chiropractor and realized about having a bruise. It had been 4 weeks, but patient still had a bruise on the shoulder where the needle was put in. Patient realized the shoulder was hurting. It's like neck down my elbow. Outcome of the event bruise was not recovered while of other events was unknown.  Follow-up attempts are needed. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Rash
Clinical narrative: serious side effects like breathing problems and rashes; serious side effects like breathing problems and rashes; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as a single Dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, after first dose patient experianced serious side effects like breathing problems and rashes. She was due to take her second dose after a week. She wanted to talk to someone about the side effects that she had. The outcome for the events was Unknown.  Information about lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypoaesthesia, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: redness in left arm; swelling in left arm; itching in left arm; numbness from shoulder down to 2 fingers but mainly had the numbness in her upper arm; hives around both wrists and joints and knees; This is a spontaneous report received from a contactable consumer (patient husband) via a Pfizer sponsored Programme. A 38-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8731, Expiration date: Unknown) via an intramuscular route, administered in left shoulder (left arm) on 04May2021 at 8:15 (at the age of 38-year-old) at a single dose for covid-19 immunization at public health department. Patient medical history included seasonal allergies, illness at time of vaccination was overweight. Patient had reactions to flu shots in the past, not hives but her immune system gets ramped up; just like the normal side effects being a little bit more for her and had like a natural allergic reaction and she had a reaction to cat hair. Concomitant medications were not reported. Patient had no history of previous immunization with the Pfizer vaccine. The patient did not receive additional vaccines on same date of the Pfizer Suspect. The patient did not receive prior vaccinations within 4 weeks. On 04May2021, after got shot the patient experienced redness, swelling, itching in the left arm. She also experienced numbness from her shoulder all the way down to two of her fingers, but mainly had the numbness in her upper arm. These symptoms were what she initially got and then it evolved over the 12-24 hours after receiving the shot, patient was developed with hives around both wrists and joints and knees. Patient received Benadryl as a treatment for the events. The events did not result in emergency or physician room. She did not have any problems of breathing or anything like that. Patient was consulted by doctor and stated no reason to have blood work or tests or anything. She had the numbness for about 24 hours and the hives resolved after about 48 hours. The outcome of events numbness from her shoulder all the way down to two of her fingers, but mainly had the numbness in her upper arm, hives around both wrists and joints and knees was recovered on an unspecified date in May2021, and the rest of the events was unknown. Reporter wants to know how patient will be authorized to get the second shot.  Follow-up attempts are needed. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: I woke up my whole bed and my clothes were sweaty, my bed was sweaty; This is a spontaneous report from a contactable consumer (patient). A 71-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection,Lot Number: EW0179 and Expiry date: Unknown), via an unspecified route of administration on an unspecified date as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient stated that he just had the shot on the 25May2021 and the last night, the first night after he got the shot on the "26th" (further not clarified) he did the same thing. The patient stated that when he was sleeping and he was awake and had sweating so much in his bed and had protective pad underneath his sheet and it was soaked wet. He woke up his whole bed and his clothes were sweaty, his bed was sweaty and second night the same thing happened. The outcome of event was unknown.  Information on the lot/ batch number has been requested.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: patient started it thing really bad and it will not stop; This is a spontaneous report received from a contactable consumer (patient) reported that 19-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), first dose (lot number: Ew0151) and second dose (lot number: Er8731) both via an unspecified route of administration in right arm on unknown date in 2021 (at the age of 19 years) as a single dose for COVID-19 immunisation. The patient medical history was not reported. Patient was not pregnant at time of vaccination. Concomitant medications included fluoxetine. Patient has taken birth control medications in two weeks and has not taken any other medications in four weeks. Patient previously took lactose and had allergies. It was reported that on 22May2021, the patient started it thing really bad and it will not stop and this event resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19, has not received any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Body height decreased, Decreased immune responsiveness, Hypersensitivity, Rash
Clinical narrative: Rash on aqueduct of both eyes/Both eyes have a rough rash under them/rash lower down to where aqueduct and passing eye entering cheek area; allergic reaction that is not going away; lowered her immune system; she might be shrinking; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EP6955, Expiration date was not reported), via intramuscular route of administration, administered in left arm on 26Mar2021 as 2ND DOSE, SINGLE DOSE (at the age of 64-years-old) for COVID-19 immunization. Medical history included compromised immune status, obesity, respiratory illness and allergies to pollen (from an unknown date and unknown if ongoing). Patient had ongoing genetic/chromosomal abnormalities, ongoing endocrine abnormalities (including diabetes) and ongoing asthma (born with it). Patient did not have any asthma attack. Concomitant medications included ibuprofen (occasionally) and vitamins not otherwise specified (NOS) taken for an unspecified indication (start and stop date were not reported). Patient previously received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN6204, NDC number and Expiration date: unknown), via intramuscular route of administration in left arm on 05Mar2021 at 15:00 hours, as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had an allergic reaction that was not going away. Patient reported that this started after the vaccine. Patient thought Pfizer COVID vaccine had lowered her immune system. When patient got up in the morning, she had a rash in aqueduct of both eyes (lower down to where aqueduct passing eye entering cheek area) which could be felt on touching. It started a month ago on 28Apr2021 after second dose. Both eyes had a rough rash under them. Patient noticed it when she washed her face in the morning (did not have an exact time). Patient was not using any harsh products and face wash was same as before and the moisturizer was just extra virgin olive oil because she did not want to use any chemicals. She waited patiently for it to subside but it was not going away. Patient stated she might be shrinking and said it occurred after she received the vaccine. She was going to have a checkup on 08Jun2021, and blood work done. Outcome of the event rash in aqueduct of both eyes was not recovered while of other events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: He broke out in a rash that is itching; This is a spontaneous report from a contactable consumer (patient's wife). A 62-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number unspecified, expiration date unspecified), dose 2 via an unspecified route of administration, administered in arm left on 25May2021 as 2nd dose, single for covid-19 immunization. Medical history included Blood pressure and AFib. Concomitant medication included losartan (50 mg) taken for blood pressure and tenecteplase (ELAXIM). On 26May2021, the patient broke out in a rash that was itching and reported as worsened. patient Just had normal meal, he never had been allergic to anything. The outcome of the event was not recovered.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A sore arm; This is a spontaneous report received from a Pfizer sponsored program from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/lot number and expiry date were not provided), unspecified dose via an unspecified route of administration on an unspecified date, as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore arm for a couple of days and the key was to be well hydrated beforehand. The outcome of event was unknown.  Information about Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Rash
Clinical narrative: allergic reaction/I had broke out after my second shot, 'its a rash'/it's been spread over my body, its there and it itch real bad; allergic reaction/I had broke out after my second shot, 'its a rash'/it's been spread over my body, its there and it itch real bad; allergic reaction/I had broke out after my second shot, 'its a rash'/it's been spread over my body, its there and it itch real bad; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received second dose of BNT162B2 (FIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported, NDC number, UPC number and Expiry Date were unknown), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (FIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. Patient reported that patient experienced, allergic reaction; Had broke out after second shot, it's been spread over body, it itch real bad; Spreading over body, had a rash and it's spread on body on an unspecified date. Patient stated that, was trying to see what have to do to get the rash out of my body, from the shot?". Also stated that what need to do after shot would give me cream or something." Patient added, that is going to the ER. Seriousness of the events was not reported. The outcome of the events was unknown.  Information about Lot/Batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Flatulence, Pain in extremity, SARS-CoV-2 antibody test
Clinical narrative: First dose: gas; sore arm; This is a spontaneous report received from a contactable Nurse (patient). This 70-year-old (same age at vaccination) female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, lot: EM9809) via an unspecified route of administration on 22Feb2021 at 11:30 AM in left arm as single dose to prevent Covid 19 virus. Medical history reported was parkinsons disease, chronic lymphocytic leukemia, sleep apnea, chronic fatigue, hypothyroidism, all ongoing. She has not had any changes to her medications. She has taken the same medications for years. Concomitant medication reported was immunoglobulin g human (IGG) ongoing Infusion, every 4 weeks. Patient does have a slight allergy to Miralax. She vomited when she took it. She had the Miralax in 2012 when she broke her hip, she was at a rehab hospital. The hospital didn't have any prunes, so they gave her Miralax twice. She reported she has no immunity because of her cancer, and she was hoping she can still receive the Covid 19 vaccine booster if needed. She received her IgG infusion on the days after she received her first and second Covid 19 vaccine. She's been getting IgG for 15 years. The patient experienced gas after first dose of vaccine on an unspecified date.it was reported She did fine with the first Covid 19 vaccine other than some gas. She reported she was a very young and very active. She mentioned to have maybe a sore arm on an unspecified date. The patient underwent investigations on an unspecified date included, blood work, Electromyographic Nerve Test with unspecified result and units and COVID-19 antibody test with negative result. Outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, SARS-CoV-2 test
Clinical narrative: Low grade fever that finally broke 5/29/2021; Been very fatigued; This is a spontaneous report from a contactable consumer (patient herself). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Er8732) via an unspecified route of administration, administered in left arm on 30Mar2021 12:00 as single dose for COVID-19 immunization. Medical history included asthma, mild depression, aneurysm, food allergy (milk, eggs ragweed newly discovered), penicillin allergy. Patient was not pregnant at time of vaccination. No covid prior vaccination. Concomitant medications included montelukast, zingiber officinale (GINGER), diphenhydramine hydrochloride (BENADRYL) and trisleep. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: En6203) administered in left arm as single dose for COVID-19 immunization for which the patient had experienced events of anemia and monocytosis. It was reported that in Mar2021 the patient experienced low grade fever that finally broke 5/29/2021, been very fatigued. The patient had not tested positive prior to vaccination, later on since the vaccination, the patient underwent lab tests and procedures which included Nasal Swab test which was negative on an unspecified date. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of low-grade fever and fatigued as iron pills were taken by patient. The outcome of events was unknown  Follow-up attempts are needed. further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Contusion, Malaise, Myalgia
Clinical narrative: Weakness/she was too weak to get up; Feels like there is a bruise behind her eyes; Achy muscles; Does not feel well: all she wants to do is sleep.; Temperature after second vaccine, most recent is 102 degrees; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCIN, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date and second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCIN, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in May2021 (reported as yesterday) both as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient does not feel well: all she wants to do is sleep, feels like there was a bruise behind her eyes, achy muscles, weakness. On 28May2021, at 3 am, her temperature was 100.1 degrees, at 10 am, her temperature was 101 degrees, and a later (reported as half hour ago), her temperature was 102 degrees (after second dose). Patient stated she had the same symptoms after the first vaccine, but then they went away. Patient ate broth and crackers. Patient took an Extra Strength Tylenol (Expiration, May2024), one 500 mg pill and a couple of hours prior, she took two Ibuprofen (lot number, expiration date unknown, stated bottle was in the other room and she was too weak to get up) for her achy muscles. Stated neither medication has been effective in improving her symptoms. Patient stated that she had every symptom, that was mentioned in important safety information guide. Patient was recommended go to a local Urgent Care if her symptoms become more concerned. Outcome for the event Fever was not recovered and for rest of the events was unknown.  Follow up needed; Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Weakness/she was too weak to get up; Feels like there is a bruise behind her eyes; Achy muscles; Does not feel well: all she wants to do is sleep.; Temperature after second vaccine, most recent is 102 degrees; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCIN, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date and second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCIN, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in May2021 (reported as yesterday) both as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient does not feel well: all she wants to do is sleep, feels like there was a bruise behind her eyes, achy muscles, weakness. On 28May2021, at 3 am, her temperature was 100.1 degrees, at 10 am, her temperature was 101 degrees, and a later (reported as half hour ago), her temperature was 102 degrees (after second dose). Patient stated she had the same symptoms after the first vaccine, but then they went away. Patient ate broth and crackers. Patient took an Extra Strength Tylenol (Expiration, May2024), one 500 mg pill and a couple of hours prior, she took two Ibuprofen (lot number, expiration date unknown, stated bottle was in the other room and she was too weak to get up) for her achy muscles. Stated neither medication has been effective in improving her symptoms. Patient stated that she had every symptom, that was mentioned in important safety information guide. Patient was recommended go to a local Urgent Care if her symptoms become more concerned. Outcome for the event Fever was not recovered and for rest of the events was unknown.  Follow up needed; Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Headache, Malaise
Clinical narrative: Headache; Woozy feeling; feeling like you have been drinking the alcohol; Feeling of unwell; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date: not reported) via an unspecified route of administration on 28May2021 at 3:00 as UNKNOWN, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that I just had Pfizer vaccine yesterday (28May2021) at 3 and I pretty much felt okay yesterday (28May2021) but today (29May2021) I was feeling very strange and I knew all of this is side effects. The one I had maybe like was a little bit of headache. I thought I should hydrate more and I did try to do that but the weirdest feeling was like a woozy feeling like it just came and went. It was kind of a feeling like you have been drinking the alcohol and all. That's a weird feeling I was getting that concerned me. I was really concerned about that. And I know that the symptoms are the feeling of unwell. So, it feels really strange to me. When the patient was asked for medical help, the patient reported that I mean, it's not severe enough. I was just resting in my bed right now. I did not drive anywhere because I thought it would not be a good idea. I just thought it was a good idea to tell you what was going on. I know we were supposed to contact the pharmacy, but the pharmacy was closed right now where I had the vaccine. I do not know, I just thought I would tell someone what is going on because I was concerned. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Heart rate, Heart rate increased, Magnetic resonance imaging heart, Oedema
Clinical narrative: Sinus tachycardia; Edema; I had a 'tremor' and both of my legs; My heart rate has been a 140 ever since then; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: I38731) via an unspecified route of administration, administered in right arm on 21May2021 (at the age of 44 years old) as a single dose for COVID-19 immunization. Medical history included Long COVID, cardiac arrest (twice), bilateral pulmonary embolism, four upper extremity DVT (deep vein thrombosis), blood clot from an unknown date and unknown if ongoing. No family medical history of adverse effect. Concomitant medication included apixaban (ELIQUIS) 2.5 mg tablet in the morning and night to prevent blood clot, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW6955) dose 1 via an unspecified route of administration on 28Apr2021 as 1st dose, single dose for COVID-19 immunization and it made her sick. The patient reported that she had a vaccine reaction that just needed to report. The patient had long COVID, tested positive in January. The patient waited for 90 days before she could be vaccinated for her first vaccine. The patient got her 2nd vaccine on 21May2021 4:30 in the evening and her heart rate had been 140 ever since then. She had a tremor and both of her legs. She went to cardiologist and doctor told to call and let Pfizer know about tachycardia. The patient stated that she woke up Saturday morning 22May2021 with tachycardia. He had done an EKG (electrocardiogram). It was just normal sinus tachycardia, there was no arrhythmia, heart rate was 68 to 78. The patient reported that it was the side effect of the vaccine. The patient stated that her cardiologist said there was nothing that can be done. The doctor told her to wear compression stroking for the edema which she had done since she follow him and her heart rate was coming down and it was down to like 120's now but doctor told her that it will eventually come down on its own, there was a medication and there was nothing to do. The doctor did have her on a heart monitor, so he can watch her rhythm and heart rate but stated there was a medication. The patient underwent lab tests and procedures which included electrocardiogram: normal on 28May2021 Normal sinus Tachycardia, heart rate: 140 on 28May2021, Cardiac magnetic resonance imaging: unknown on 28May2021. The clinical outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus tachycardia, Tremor
Clinical narrative: Sinus tachycardia; Edema; I had a 'tremor' and both of my legs; My heart rate has been a 140 ever since then; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: I38731) via an unspecified route of administration, administered in right arm on 21May2021 (at the age of 44 years old) as a single dose for COVID-19 immunization. Medical history included Long COVID, cardiac arrest (twice), bilateral pulmonary embolism, four upper extremity DVT (deep vein thrombosis), blood clot from an unknown date and unknown if ongoing. No family medical history of adverse effect. Concomitant medication included apixaban (ELIQUIS) 2.5 mg tablet in the morning and night to prevent blood clot, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW6955) dose 1 via an unspecified route of administration on 28Apr2021 as 1st dose, single dose for COVID-19 immunization and it made her sick. The patient reported that she had a vaccine reaction that just needed to report. The patient had long COVID, tested positive in January. The patient waited for 90 days before she could be vaccinated for her first vaccine. The patient got her 2nd vaccine on 21May2021 4:30 in the evening and her heart rate had been 140 ever since then. She had a tremor and both of her legs. She went to cardiologist and doctor told to call and let Pfizer know about tachycardia. The patient stated that she woke up Saturday morning 22May2021 with tachycardia. He had done an EKG (electrocardiogram). It was just normal sinus tachycardia, there was no arrhythmia, heart rate was 68 to 78. The patient reported that it was the side effect of the vaccine. The patient stated that her cardiologist said there was nothing that can be done. The doctor told her to wear compression stroking for the edema which she had done since she follow him and her heart rate was coming down and it was down to like 120's now but doctor told her that it will eventually come down on its own, there was a medication and there was nothing to do. The doctor did have her on a heart monitor, so he can watch her rhythm and heart rate but stated there was a medication. The patient underwent lab tests and procedures which included electrocardiogram: normal on 28May2021 Normal sinus Tachycardia, heart rate: 140 on 28May2021, Cardiac magnetic resonance imaging: unknown on 28May2021. The clinical outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Myalgia, Nervous system disorder, Neurological symptom
Clinical narrative: Having strange neurologic reaction; Burning sensation; Tingling; Sore Muscle; Sore Joint; Nervous sensation inside my body all the way from neck to my toe; Feeling like a nerve storm going on; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE DOSE and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date the patient had having strange neurologic reaction, burning sensation, tingling, sore muscle, sore joint and nervous sensation inside my body all the way from neck to my toe; Feeling like a nerve storm going on. It was reported that patient received second vaccine shot on Wednesday and patient had very strange neurologic reaction, burning sensation, tingling, sore muscle, sore joint and just a nervous sensation inside body all the way from neck to my toe feeling like a nerve storm going on. It was reported that patient thought it started with the first shot and amplified (not clarified) with the second shot. patient need to get some immediate help (treatment). Reporter seriousness for events was Unspecified. The outcome of events was unknown.   Information about lot/batch number has been be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Having strange neurologic reaction; Burning sensation; Tingling; Sore Muscle; Sore Joint; Nervous sensation inside my body all the way from neck to my toe; Feeling like a nerve storm going on; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE DOSE and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date the patient had having strange neurologic reaction, burning sensation, tingling, sore muscle, sore joint and nervous sensation inside my body all the way from neck to my toe; Feeling like a nerve storm going on. It was reported that patient received second vaccine shot on Wednesday and patient had very strange neurologic reaction, burning sensation, tingling, sore muscle, sore joint and just a nervous sensation inside body all the way from neck to my toe feeling like a nerve storm going on. It was reported that patient thought it started with the first shot and amplified (not clarified) with the second shot. patient need to get some immediate help (treatment). Reporter seriousness for events was Unspecified. The outcome of events was unknown.   Information about lot/batch number has been be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Positive Covid after vaccine; Positive Covid after vaccine; This is a spontaneous report from a contactable other hcp. A patient of unspecified age and gender received BNT162b2 (COMIRNATY, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unknown date in Jan2021 as unknown, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced positive covid after vaccine. In an ongoing clinical trial the Pfizer BioNTech covid-19 vaccine has been shown to prevent covid-19 following two doses given to 3 weeks apart the duration of protection against covid-19 is currently unknown. When asked about risk of Pfizer biotech covid-19 vaccine, stated side effects that have been reported with pfizer biontech covid-19 vaccine includes: injection site pain, tiredness, headache, muscle pain , chills, joint pain, fever, injection site swelling, injection site redness, nausea, feeling unwell, swollen lymph nodes (lymphadenopathy). There is a remote chance that the pfizer biontech covid-19 vaccine could cause a severe allergic reaction. a severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of pfizer biontech covid-19 vaccine. Signs of a serious allergic reactions can include difficulty breathing, swelling of the face and throat, fast heartbeat, a bad rash all over the body, dizziness and weakness, this may not be all the possible side effects of pfizer biontech covid-19 vaccine serious and unexpected side-effects may occur. Pfizer biontech covid-19 vaccine is still being studied in clinical trials. The outcome of event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event COVID -19 and the suspect drug  BNT162b2  cannot be excluded. The case will be reassessed once new information is available
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Pruritus
Clinical narrative: both hands started itching; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 29Mar2021 12:00 (Batch/Lot Number: ER8732, NDC 59267-1000-1) as, 0.3 ML SINGLE DOSE for covid-19 immunisation. The patient had no family medical history. Medical history included breast cancer from Sep2006; she completed 6 rounds of chemo and 37 days of radiation and finished in Aug2007; she had right mastectomy on 13Oct2006; she had 3 surgeries in 3 weeks and had 27 lymph nodes removed. Concomitant medication(s) included carvedilol (COREG) taken for arrhythmia (has been taking 14 years) start and stop date were not reported; lisinopril (LISINOPRIL) taken for blood pressure abnormal (has been taking 14 years) start and stop date were not reported. The patient previously took herceptin on Dec2006 and experienced cardiac failure congestive (she had heart damage from chemo and radiation, she had a reaction to Herceptin. They stopped it, stated she had congestive heart failure from it, but it did reverse and she still has that tagged on her. Caller stated she didn't die from breast cancer, but that's her history. Stated she previously had echos done monthly between chemo that was every 3 weeks to check the ejection fraction. Ejection fraction at some point started showing she was in trouble and he called the oncologists and said the Herceptin was done. Confirms she was told she had congestive heart failure, heart damage, but it was reversed now); Tylenol was like a big pain med for her, but it puts her to sleep; Aleve gave her hives and this occurred when it first came out, but she was not sure when that was. Caller stated both hands started itching at some point the evening of 29Mar2021, beginning around midnight, between midnight and 5 am on 30Mar2021. The patient didinot receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Caller describes as kind of itch that is internally itching and cant scratch, it was inside of her itching. Caller stated it fully resolved by the time she woke up on 30Mar2021. The ouctome of th event was recovered on 30Mar2021. No treatment was received for the event.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: throwing up every 10 minutes; diarrhea; This is a spontaneous report from a contactable consumer (patient wife). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 26May2021 (Batch/Lot number was not reported), as unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that patient took the Pfizer Covid vaccine. Reporter stated that her husband had not stopped throwing up since three o'clock this morning (28May2021) and had diarrhea on an unspecified date in May2021. She wanted to know how to get him to stop throwing up, that patient was throwing up every 10 minutes. Seriousness of the event was not reported. Outcome of the events was unknown.  Communication: Caller was encouraged to reach out to her husbands healthcare provider, urgent care or emergency room for medical advice. Caller declines to provide further information and disconnects the call. No further information provided or obtained.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.