chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: Anxiety/extreme amount of anxiety; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration in Jul2021 (Batch/Lot number was not reported) as dose number unknown, single for Covid-19 immunisation. The patient medical history and patient's concomitant medications were not reported. The patient experienced anxiety/extreme amount of anxiety on an unspecified date in Jul2021. Reporter states, she got the COVID vaccine and she had been experiencing  an extreme amount of anxiety.  Product details and pharmacy details could not be probed as the consumer was unwilling to complete the report. Hence limited information available over the call. NDC number and UPC number of COVID-19 vaccine was unknown. The outcome of event was unknown.   Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report from a contactable consumer. The reporter is a patient who was reporting her own experience with the Pfizer Covid-19 vaccine, along with other people reactions. This case is 3  of 4. This case is for the man.  A male patient of an unspecified age received BNT162B2 (unspecified Pfizer vaccine; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. No medical history and concomitant medications were reported. The patient previously received an unspecified COVID-19 vaccine on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced rash. The reporter mentioned that she did some research online. The second dose of Pfizer and reactions to the Pfizer vaccine and read about 2 people reactions, one is for a woman, and other is this report, about a man, and she does not know the location. It was in the newspaper that he had a rash. It might have been reversed but she does not remember their names. Reporter stated that it was public and was in the newspaper. The outcome of events was unknown.  Information about batch/Lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: slight chest tightness like little bit of chest pain like patient chest was still tight when patient breathe; slight chest tightness like little bit of chest pain like patient chest was still tight when patient breathe; This is a spontaneous report from a contactable consumer (patient). A patient received of unspecified age and gender received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number and expiration date were unknown), via an unspecified route of administration, on 15Jul2021 13:00, as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. Patient had the Pfizer Vaccine at 1 o'clock on 15Jul201 and experiencing like slight chest tightness like little bit of chest pain like patient chest was still tight when patient breathe if that make sense. Outcome of the events was not recovered.   Information about lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Magnetic resonance imaging, Pain in extremity, Smear cervix, Urine analysis
Clinical narrative: First Dose left arm pain at injection site; Given 05 Apr 2021 in the left arm in the muscle. That one was sore for a few days; This is a spontaneous report from a contactable consumer. This 59-year-old female consumer (patient) reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8737, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 05Apr2021 (at the age of 59 years) as DOSE 1,SINGLE for covid-19 immunization. Medical history included dizziness, thyroid disorder. Concomitant Products liothyronine sodium (CYTOMEL) taken for Underactive Thyroid since childhood. Vaccination facility was clinic type. list The patient did not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. It was reported that nothing happened with first shot. On 06Ap2021, after First Dose the patient experienced left arm pain at injection site. First shot was in the muscle and hurt/sore for a few days after. But after a few days, that went away. On 19Feb2021, she did an MRI with contrast. She had some issues with dizziness, so her ENT wanted to do it as a precaution just to see if there were any issues. Everything was negative, but her question was that she took the contrast in the arm and wondered if there was an interaction with the vaccine. She did not have a name, Lot or expiration of IV contrast used. She had a Pap smear on 29Mar2021. She did not specify any results and stated it was not relevant. Blood analysis with a company and urine analysis and blood workup. Everything was negative. On an unspecified date in Apr2021, the events were resolved.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: First Dose left arm pain at injection site; Given 05 Apr 2021 in the left arm in the muscle. That one was sore for a few days; This is a spontaneous report from a contactable consumer. This 59-year-old female consumer (patient) reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8737, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 05Apr2021 (at the age of 59 years) as DOSE 1,SINGLE for covid-19 immunization. Medical history included dizziness, thyroid disorder. Concomitant Products liothyronine sodium (CYTOMEL) taken for Underactive Thyroid since childhood. Vaccination facility was clinic type. list The patient did not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. It was reported that nothing happened with first shot. On 06Ap2021, after First Dose the patient experienced left arm pain at injection site. First shot was in the muscle and hurt/sore for a few days after. But after a few days, that went away. On 19Feb2021, she did an MRI with contrast. She had some issues with dizziness, so her ENT wanted to do it as a precaution just to see if there were any issues. Everything was negative, but her question was that she took the contrast in the arm and wondered if there was an interaction with the vaccine. She did not have a name, Lot or expiration of IV contrast used. She had a Pap smear on 29Mar2021. She did not specify any results and stated it was not relevant. Blood analysis with a company and urine analysis and blood workup. Everything was negative. On an unspecified date in Apr2021, the events were resolved.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: Since receiving the first dose Vaccine, has been experiencing extreme fatigue; The caller feels like she has been drinking.; Had a few headaches/ The caller gets dull headaches and they are persisting.; dizziness like feeling; This is a spontaneous report from a Pfizer-sponsored program. A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0185) (age at vaccination 55-year-old), dose 1 via an unspecified route of administration, administered in deltoid left on 22Jun2021 1at 0:45 as dose 1, single for covid-19 immunisation. The patient medical history (including any illness at time of vaccination) and concomitant medications were not reported. Patient did not known regarding family medical history relevant to AEs. Patient did not have additional vaccines administered on same date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the first administration date of the suspect vaccine. Patient did not experience any AE prior vaccinations. It was reported that, since receiving the first dose Vaccine, had been experiencing extreme fatigue. The caller feels like she had been drinking. Patient couldn't say exactly when this began. The patient states that she received the first dose Pfizer Covid 19 Vaccine on 22Jun2021, and this began in just a day or a couple of days after. The patient states the extreme fatigue had not gone away and was not good. The fatigue was moderate to severe and it was persisting. The fatigue kind of started like it ramped up if you know what the caller was saying. It was a bell shaped curve within a few days. The headaches began within a couple of days of receiving the first dose Pfizer Covid 19 Vaccine it seems like. The patient gets dull headaches and they were persisting. The patient states she went into the doctor office today, 15JUL2021 and was going to wait until next week to do some labs. The patient clarifies she just called the doctor's office today. Relevant Tests was reported as none. The reporter states that the Pfizer Covid 19 Vaccine was already drawn up that the patient received and asks was this bizarre? The outcome of event she has been drinking was unknown and for rest of the events was reported as Not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Dizziness
Clinical narrative: severe dizziness; her heart was not functioning; This is a spontaneous report from a contactable consumer (reported for herself). A 60-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included iron (IRON), zinc (ZINC), potassium (POTASSIUM) and blended ginger. On an unspecified date, patient experienced severe dizziness. Refused to go at first, eventually let him take the emergency room. She didn't want the ambulance to take me to the hospital. She was there for hours at midnight, her heart was not functioning transferred to (name withheld). States she has never been admitted to the hospital other than having her son who was 29Y. Before second dose started taking zinc, potassium and blended ginger trying to get her system together corona stuff in there. State takes iron. States received second dose of product with no adverse event. In the home and unemployed for a while. She was asking for aid for medical bills. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Condition aggravated, Peripheral swelling, Prothrombin time, Swelling face
Clinical narrative: it got more swollen/worse and it has been like that since/ face swelling; it got more swollen/worse and it has been like that since/ hand swelling; it got more swollen/worse and it has been like that since; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 24Feb2021 (at the age of 71-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (COVID Pfizer vaccine) on 02Feb2021 for covid-19 immunization and the next day she had little swelling in her face and hands and it kind of went away and came back and forth since she received it. It didn't go away really but it was just less. It came back before her second dose. She received the second dose of the vaccine on 24Feb2021, and it got more swollen/worse and it had been like that since. She was noticing the swelling in her veins ever since she had the shot. She had gone through blood tests, PT and everything (unknown results), her doctor was at a loss. They said they had not seen anyone who had events for this long. She stated it was going on since 5 months and it was affecting her. She had spent a bunch of money trying to figure out what was going on and she was getting no answers. She spoke with the CDC and they referred her to Pfizer. She stated she knew that there had been face swelling, but it supposedly goes away within a couple days. She wanted to know if anyone had experienced the events for this long. The outcome of all the events was not resolved.  Information on batch/lot number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Cold sweat, Headache, Hyperhidrosis, Insomnia
Clinical narrative: trouble sleeping; didn't feel very good; soreness in her arm; hurt like a regular kind of needle; hot and cold sweats; hot and cold sweats; headache; swelling; This is a spontaneous report from contactable consumer. A 53-years-old adult female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EW0176) via an unspecified route of administration, administered in left arm on 23May2021 at 17:30 as Dose 1,Single for COVID-19 immunization. The patient's medical history included ongoing factor v deficiency, COVID-19 in March 2020. The patient's concomitant medications were not reported. It was reported that, when patient got the first shot, patient did not felt very good after getting it and had the soreness in her arm, it did not really hurt at the injection site when they did it, it hurt like a regular kind of needle. The patient was getting hot and cold sweats after getting it and had a mild headache Patient did not felt good. She only probably slept 2 hours a night for the first whole week that time in Jun 2021 because her head was killing her and it wouldn't let her sleep. Trouble sleeping is still ongoing, its gotten better, it's improved, but its still not good. The patient underwent lab tests including Antibody test with No antibodies found in Oct 2020 and COVID-19 test resulted positive on an unspecified date. The outcome of headache was resolving and hot and cold sweats and trouble sleeping  was not resolved The outcome of events didn't feel very good, soreness in her arm, hurt like a regular kind of needle, swelling, chest pain and hot and cold sweats was unknown.  No further information was provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity, Paraesthesia, SARS-CoV-2 test, Swelling
Clinical narrative: trouble sleeping; didn't feel very good; soreness in her arm; hurt like a regular kind of needle; hot and cold sweats; hot and cold sweats; headache; swelling; This is a spontaneous report from contactable consumer. A 53-years-old adult female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EW0176) via an unspecified route of administration, administered in left arm on 23May2021 at 17:30 as Dose 1,Single for COVID-19 immunization. The patient's medical history included ongoing factor v deficiency, COVID-19 in March 2020. The patient's concomitant medications were not reported. It was reported that, when patient got the first shot, patient did not felt very good after getting it and had the soreness in her arm, it did not really hurt at the injection site when they did it, it hurt like a regular kind of needle. The patient was getting hot and cold sweats after getting it and had a mild headache Patient did not felt good. She only probably slept 2 hours a night for the first whole week that time in Jun 2021 because her head was killing her and it wouldn't let her sleep. Trouble sleeping is still ongoing, its gotten better, it's improved, but its still not good. The patient underwent lab tests including Antibody test with No antibodies found in Oct 2020 and COVID-19 test resulted positive on an unspecified date. The outcome of headache was resolving and hot and cold sweats and trouble sleeping  was not resolved The outcome of events didn't feel very good, soreness in her arm, hurt like a regular kind of needle, swelling, chest pain and hot and cold sweats was unknown.  No further information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: had two strokes; This is a spontaneous report from a Pfizer sponsored program. Received from a non-contactable consumer (patient's husband). A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had first vaccine and had two strokes and had to go to the hospital. Patient had stroke after first vaccine. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot; This is a spontaneous report from a contactable consumer. A 93-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, consumer stated that she found out that 2 other people she knew were having the same symptoms. Consumer clarified that they had a blood clot, stated that she did not ask them if they were having any other symptoms. Later, consumer stated that her neighbor who was 93 years old got a blood clot 3 days ago. The other person who got a blood clot was much younger and got it right after getting the vaccine. Consumer verified that these were the same 2 people she was talking about earlier and they both got the Pfizer Covid vaccine. The outcome of event was unknown. Information about Lot/Batch number has been requested
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Patient felt achy all over and had a headache; Patient felt achy all over and had a headache; This is a spontaneous report from a contactable consumer or other non hcp (patient). This report was received via a sales representative. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included RA (rheumatoid arthritis) from an unknown date and unknown if ongoing. Concomitant medications included methotrexate taken for an unspecified indication, start and stop date were not reported. The patient felt achy all over and had a headache on an unspecified date. Event took place after use of product. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clot; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, consumer stated that she found out that 2 other people she knew were having the same symptoms. Consumer clarified that they had a blood clot, stated that she didn't ask them if they were having any other symptoms. Later, consumer stated that her neighbor who was 93 years old got a blood clot 3 days ago. The other person who got a blood clot was much younger and got it right after getting the vaccine. Consumer verified that these were the same 2 people she was talking about earlier and they both got the Pfizer Covid vaccine. The outcome of event was unknown.  Information about Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness in the arm; This is a spontaneous report from a non-contactable consumer or other non hcp. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced soreness in the arm on an unspecified date. On an unspecified date it was reported, Caller stated "but the first shot doesn't protect you, right. Offered to place on additional hold to provide additional resources, but caller states "oh no I have to go now, thank you and caller disconnected. Response: Not provided, caller disconnected before response could be given. Caller was a consumer (declined to provide last name and phone number). Caller was inquiring about additional information regarding side effects of the Pfizer Covid-19. Caller states "I gotta talk to you, what happened was 07Jul2021 I got first dose, people I know got the first shot before me and said expect soreness in the arm. Alright that doesn't sound bad but my arm was excruciating, the pain was unbearable. Caller's questioned was that normal. Caller asked what about nausea, what does it say about that. Caller states "so I'll actually be throwing up". Caller asked "does this, listen carefully this was important, were any of the side effects related to your eyes, could it effect vision. Caller stated "because shortly after they gave me the vaccine, my vision was getting blurry, but I do have cataracts in both eyes. Could it make it blurry because I have cataracts" Caller states "here's my crucial question. I had the first shot and I'm going back for the second shot anytime after 28Jul2021. was it true--my pharmacist told me this--was it true that after the second dose your side effects are worse" Caller stated that means my nausea and my arm will be even worse. Caller stated but the first shot doesn't protect you, right. DSU: e-transmitting potential duplicate AE data captured. Response: Confirmed Pfizer Covid-19 vaccine. Provided disclaimers and spoke from the attached document. Also spoke from the EUA Prescribing Information on page 21 in Table 1 under pain at the injection site with reports of severe pain (LAB-# Revised: 25Jun2021). Referred caller to her HCP. Survey not offered due to caller disconnecting. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Diarrhoea
Clinical narrative: Severe abdominal cramping; I never had a stomach ache like this before; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (Pfizer COVID 19 Vaccine, solution for injection), via an unspecified route of administration on 13Jul2021 (Batch/Lot Number: EW0198) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 Batch/Lot Number: EW0217) on 22Jun2021 for covid-19 immunization; Not side effect. It was reported that, I am having, I had diarrhea yesterday (14Jul2021) and today (15Jul2021) and I am having severe abdominal cramping and I need to know if this is the side effect of this injection. Consumer was also informed about the role of Pfizer Drug Safety and requested to file a safety report, consumer stated, "It's going to take 10 minutes? I can't sit here for 10 minutes on the phone, I mean I have to go 'down' (voice not clear) this is bad. But if you can't transfer me, I will just call my doctor." LOT#: Consumer stated, "I never had a stomach ache like this before (15Jul2021), so the second dose was EW0198. The first one I had not side effect, the date here is (13Jul2021). The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Periorbital swelling, Pharyngeal swelling, Skin disorder
Clinical narrative: Swelling of the throat; Puffy eyes; My skin, my face and neck was like jelly; I get the allergic reaction to shot, Pfizer.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at dose number unknown, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced swelling of the throat, puffy eyes, my skin, my face and neck was like jelly, i get the allergic reaction to shot, pfizer. Reporter stated that, I was told to call this number and report. I get the allergic reaction to shot, Pfizer. Is this where we call to report an adverse reaction to the shot, Pfizer. Adverse reaction: Reporter stated that, swelling of the throat, puffy eye and my skin, my face and neck was like jelly. Outcome of the events was unknown.   Information about lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Vertigo
Clinical narrative: congested on right ear clogged; vertigo; This is a spontaneous report from a contactable physician. This Physician reported for the patient in response to HCP letter [sent to physician] via follow-up letter which included that: A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6208), via intramuscular route of administration in left arm on 12Mar2021 at 14:30 (at the age of 55-year-old) as dose 1, single for COVID-19 immunisation. Medical history included lichen planus from 27Oct2011 to an unknown date in 2012 (topical steroid for scalp- lichen planus on to of head.), auto immune from 27Oct2011 to an unknown date in 2012, alopecia from 27Oct2011 to an unknown date in 2012 (topical steroid for scalp- lichen planus on to of head. Hair loss). There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021, a week after from vaccination, the patient experienced congested on right ear clogged/ pressure/ felt like water in ear and vertigo. The outcome of the events was unknown at the time of reporting.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Tachycardia; This is a spontaneous report from a non-contactable consumer (patient). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 16Jan2021 (at age of 79-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included melanoma, high blood pressure, 2 Bad heart valves, aortic insufficiency, pancreatitis, brain tumor, stage 1 Bronchioloalveolar carcinoma/ stage 4 Bronchioloalveolar carcinoma, metastasis into both lungs, atrial fibrillation, hysterectomy, high triglycerides, thyroid obliterated, irregular heart beat, appendix removed, lung cancer surgery, benign meningioma surgery. Concomitant medication included erlotinib hydrochloride (TARCEVA) taken for an unspecified indication, start and stop date were not reported. The patient previously took synthroid and experienced drug hypersensitivity. The patient experienced tachycardia on an unspecified date. The outcome of the events was recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: it was feeling like a sensation in my leg, that wasn't there prior to the shot; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for himself). A 45-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0178), via an unspecified route of administration on 24May2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced it was feeling like a sensation in my leg, that wasn't there prior to the shot on an unspecified date in 2021. Patient stated, I got vaccinated on 24May2021, Okay, now the latest, the information that regards to the information so, right after I got my first vaccination, I held off. I held off because I wanted to find out what exactly was going on, give it a little time to see what was going on and that's what I did. So, now it's today and I want to get the second vaccine. It's almost a month and almost 6-7 weeks since I got my first vaccine. Will I be still be able to go and get vaccinated? Will I need a third dose? Well. I went to the pharmacy and they said to contact my doctor because they wasn't sure, If I had missed the window in regards to getting my first shot and my second shot and the time lapse, that has occurred. Okay. So, it's been 53, yeah it's been 2 months now, it's been a little under 7 weeks since I. Scheduled date for second shot: Patient stated, It was 3 weeks after the first shot. It was not an actual date. It was just 3 weeks from the day after first shot. Anatomical site for first vaccine: Patient stated, I really can't remember, to be honest with you. I want to say, may be it was my left, but I am not sure. May be it was my left but again I am not sure. I ended feeling, I wind up feeling something in my leg as well. I can't remember, what was it was on. I do remember, it was feeling like a sensation in my leg, that wasn't there prior to the shot. Outcome of the event was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Chills, Computerised tomogram, Dyspnoea
Clinical narrative: Chills; Fatigue; has trouble breathing; chest still hurts; has a lung issue now; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0164, Expiry date: not reported), via an unspecified route of administration, in Arm Left on 23Apr2021 at 10:00 (age at vaccination: 65-year-old) as dose 2, single for COVID-19 immunization. Medical history included diabetes mellitus from an unknown date and unknown if ongoing diagnosed maybe 7-10 years ago, blood pressure high from an unknown date and unknown if ongoing diagnosed about 5 years ago, thyroid problems from an unknown date and unknown if ongoing diagnosed about 15 years ago, COVID-19 in Nov2020 for two weeks, and she went to Emergency Room four times for it. She says that it took her 3 months to recover from that. Previously, the patient previously received BNT162B2 (Lot number: ER8733), administered in Left arm on 25Mar2021 at 10:00 for COVID-19 immunization. The patient had to wait four weeks between to get those COVID-19 vaccines, but she had no other vaccines the days she got the doses or recently prior to that time. Not started any new medications. The patient reported that side effects happened after her second shot, she started having chills the following day (24Apr2021) and then fatigue. She says after the second shot felt like she was getting the virus all over again, and she went to the emergency room on an unknown date in Apr2021 and there they did COVID-19 virus test (rapid) and result was negative and they said she didn't have it and to follow up with her PCP. And also they performed blood work and CT scan and her doctor said she didn't know what all to do, just to check out organs, which were ok and her heart was ok, it was pumping, but the CT scan saw something in the lungs. She went to the doctors and they said unfortunately they don't know too much about the virus. She waited two months to go back thinking it would be getting better. She has trouble breathing, and can do a little work but then she is done for the rest of day, it tires her out. Her chest still hurts and has a lung issue now, and will see a pulmonary doctor on the 28th. It is not constant, it comes and goes, it is not getting any better. She thought maybe it would be after 3 months like when she had the virus, and she would be ok now, but it has been longer than 3 months. They have done no treatment yet, until she sees the doctor. The patient visited emergency room and physician office visit due to all the events. The outcome of all events was not recovered.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Investigation, Lung disorder, SARS-CoV-2 test
Clinical narrative: Chills; Fatigue; has trouble breathing; chest still hurts; has a lung issue now; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0164, Expiry date: not reported), via an unspecified route of administration, in Arm Left on 23Apr2021 at 10:00 (age at vaccination: 65-year-old) as dose 2, single for COVID-19 immunization. Medical history included diabetes mellitus from an unknown date and unknown if ongoing diagnosed maybe 7-10 years ago, blood pressure high from an unknown date and unknown if ongoing diagnosed about 5 years ago, thyroid problems from an unknown date and unknown if ongoing diagnosed about 15 years ago, COVID-19 in Nov2020 for two weeks, and she went to Emergency Room four times for it. She says that it took her 3 months to recover from that. Previously, the patient previously received BNT162B2 (Lot number: ER8733), administered in Left arm on 25Mar2021 at 10:00 for COVID-19 immunization. The patient had to wait four weeks between to get those COVID-19 vaccines, but she had no other vaccines the days she got the doses or recently prior to that time. Not started any new medications. The patient reported that side effects happened after her second shot, she started having chills the following day (24Apr2021) and then fatigue. She says after the second shot felt like she was getting the virus all over again, and she went to the emergency room on an unknown date in Apr2021 and there they did COVID-19 virus test (rapid) and result was negative and they said she didn't have it and to follow up with her PCP. And also they performed blood work and CT scan and her doctor said she didn't know what all to do, just to check out organs, which were ok and her heart was ok, it was pumping, but the CT scan saw something in the lungs. She went to the doctors and they said unfortunately they don't know too much about the virus. She waited two months to go back thinking it would be getting better. She has trouble breathing, and can do a little work but then she is done for the rest of day, it tires her out. Her chest still hurts and has a lung issue now, and will see a pulmonary doctor on the 28th. It is not constant, it comes and goes, it is not getting any better. She thought maybe it would be after 3 months like when she had the virus, and she would be ok now, but it has been longer than 3 months. They have done no treatment yet, until she sees the doctor. The patient visited emergency room and physician office visit due to all the events. The outcome of all events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Myocarditis
Clinical narrative: myocarditis; had three miscarriages following the pfizer vaccine; became pregnant while taking bnt162b2; This is a spontaneous report from a contactable consumer from a Pfizer sponsored Program. This consumer reported for a female patient (wife's friend). A pregnant female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection batch/lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization. It was reported that, reporter stated that his wife's friend had three miscarriages following the Pfizer vaccine, the first one in the first trimester they could not find baby's heart beat. 2nd one had miscarriage a couple weeks after and then she conceived again and was in the hospital with myocarditis, her doctor said it was due to genetics and she lost the third one also. Reporter reports his wife's female friend had her first miscarriage, after the second vaccine and also reports that 82% of people, that got the vaccine experienced miscarriage and spontaneous abortion. Reporter states, his wife's friend had a total of 3 miscarriages and clarifies, that the first miscarriage occurred after both doses of the Pfizer Covid vaccine, reporter also states that she was also diagnosed with myocarditis and has spent hundreds of dollars on her medical bills. Reporter stated that this woman's doctor, said it was not caused from the vaccine, that it was genetic, and he did not report this to the VAERS website. The mother reported she became pregnant while taking BNT162B2. The reporter assessed the events as non-serious. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pruritus, Rash
Clinical narrative: had a rash on right leg by ankle that was itching and within a few days went up leg to arm and stomach; had a rash on right leg by ankle that was itching and within a few days went up leg to arm and stomach; little bumps, flaky bumps and they were filled with moisture; This is a spontaneous report from a contactable consumer, the patient.   A 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were unknown), via an unspecified route of administration, on 23Jun2021 (at the age of 73-year-old), as single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were unknown), via an unspecified route of administration, on 02Jun2021 (at the age of 73-year-old), as single dose, for COVID-19 immunization and no reaction after the first dose. Patient stated that, had no reaction after the first dose but after the second dose she had a rash on right leg by ankle that was itching and within a few days went up leg to arm and stomach, a little petroleum jelly and cortisone cream helped, but the jelly helped better with the itching. Patient was looking for treatment recommendations. The rash started, small, the size of a 50 cent piece on her right leg. Patient had little bumps, flaky bumps and they were filled with moisture. Patient came across papers of side effects which patient was experiencing, and for a minute patient didn't realize a rash started, it was small, the size of a 50 cent piece on her right leg; was started a week ago around 08Jul2021 or 09Jul2021 to it's ongoing on her arms. persisting Treatment - No, she didn't know what it was before she came across the report. She was thinking it was psoriasis at first, which she never gets. It started itching; was started around 06Jul2021 or 07Jul2021, it is still itching even though patient put the cream, petroleum jelly on it and put on hydrocortisone for itching. It started having little bumps, flaky bumps and they were filled with moisture. Patient can't say it was water and it has grown there and has spread to her left leg; was started around 06Jul2021 or 07Jul2021, it was just a dry patch that caught her attention because it started itching. Patient wants to know what she could do, what to put on it, and advice on what treatment. On the paper it says it was a non-severe reaction like hives, swelling of the face, rash. Patient clarified patient was not having hives or swelling of the face just a rash. Patient did not require emergency room and physician office visit for events. No AEs following prior vaccinations. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Skin swelling, Vaccination site infection, Vaccination site swelling
Clinical narrative: around the vaccine area there was swelling/Vaccination area was swollen; swelling has come down and now its puffy; They prescribed antibiotics because its infected. Very infected/Vaccination area was swollen for a month and after became infected; This is a spontaneous report from a contactable consumer. This male consumer (patient himself), a 36-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation was Solution for injection, Lot Number was EM9810), via an unspecified route on 21May2021 (age at vaccination was 36-year-old), as single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation was Solution for injection, Lot Number was not reported), dose 1 via an unspecified route on an unspecified date, as single dose for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed COVID-19. Prior to vaccination and Since the vaccination, the patient was not been tested for COVID-19. On 21May2021 the patient experienced around the vaccine area there was swelling/vaccination area was swollen, swelling has come down and now its puffy and They prescribed antibiotics because its infected. Very infected/vaccination area was swollen for a month and after became infected. The patient treatment received for the adverse event as antibiotics. The outcome of all events was not recovered.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Body temperature, Influenza like illness, Pain in extremity
Clinical narrative: Getting severe flu like symptoms; Started getting flu symptoms again were my joints ache and my fingers and everything; Anxiety attack; Running a temperature of about 102.9; She is running 4 degrees over what she supposed to be; Getting severe flu like symptoms; Started getting flu symptoms again were my joints ache and my fingers and everything; Getting severe flu like symptoms; Started getting flu symptoms again were my joints ache and my fingers and everything; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 14Jul2021 as dose 2, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose 1, single for COVID-19 immunization. Patient had this Pfizer vaccine the second dose the 14Jul2021 and two hours of doing great and then all of a sudden she started getting severe flu like symptoms and they were pretty severe. Today she woke up and felt pretty good and then after about 6 hours she started getting flu symptoms again with her joints ache and her fingers and everything and now she was monitoring her temperature, and then she had an anxiety attack and then right now she was running a temperature of about 102.9 and we were wondering is that how high temperature can be before it was dangerous. She was running 4 degrees over what she supposed to be, now are we able to tell her anything about that, she queried. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Getting severe flu like symptoms; Started getting flu symptoms again were my joints ache and my fingers and everything; Anxiety attack; Running a temperature of about 102.9; She is running 4 degrees over what she supposed to be; Getting severe flu like symptoms; Started getting flu symptoms again were my joints ache and my fingers and everything; Getting severe flu like symptoms; Started getting flu symptoms again were my joints ache and my fingers and everything; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 14Jul2021 as dose 2, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose 1, single for COVID-19 immunization. Patient had this Pfizer vaccine the second dose the 14Jul2021 and two hours of doing great and then all of a sudden she started getting severe flu like symptoms and they were pretty severe. Today she woke up and felt pretty good and then after about 6 hours she started getting flu symptoms again with her joints ache and her fingers and everything and now she was monitoring her temperature, and then she had an anxiety attack and then right now she was running a temperature of about 102.9 and we were wondering is that how high temperature can be before it was dangerous. She was running 4 degrees over what she supposed to be, now are we able to tell her anything about that, she queried. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain in extremity, Peripheral swelling
Clinical narrative: her arm was red; arm was red and swollen; hurting; hot; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for covid-19 immunisation. She stated about side effects in February, when she got her 2nd shot she was afraid that she got Moderna by mistake because her arm was red and swollen and hot and was still hurting. She stated that she also called because of an unusual side effect the first time. She thinks it was ridiculous that it took this long to follow up and she doesn't want to spend anymore time on it. The outcome of events was unknown.  Information about batch/Lot number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebral infarction, Death
Clinical narrative: death I63.9 - Cerebral infarction, unspecified