chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site hypoaesthesia, Vaccination site paraesthesia
Clinical narrative: Tingling and numbness in the arm where injection occurred; Tingling and numbness in the arm where injection occurred; This is a spontaneous report from a contactable consumer reported for a female patient. A female patient of unspecified age (unknown if pregnant at the time of vaccination) received her first dose of bnt162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on 28Jan2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 28Jan2021, the patient had tingling and numbness in the arm where injection occurred. It was unknown if the patient received any other vaccines within four weeks prior to the Covid vaccine. It was unknown if the patient was diagnosed with Covid-19 prior to vaccination nor has the patient been tested for Covid-19 since the vaccination. Outcome was unknown for the events.  Information on the lot/batch number has been requested.  Follow-up (15Apr2021): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia
Clinical narrative: Muscle soreness onset in 6 h, lasting for 2 days, self-limiting unilateral left axillary lymphadenopathy onset on day 4, lasting for 3 days, self-limiting.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Pain, Pain in extremity
Clinical narrative: Second dose seemed to be placed higher than the first. Pain started roughly four hours later and I could not move my arm for 5 days at all without being in excruciating pain. I started stretching arm out and most of pain went away but I still cannot go to work and function normally without being in major pain, 9 days later.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams
Clinical narrative: Very vivid and bizarre dreams every night starting 4 nights ago. Also, deeper sleep but I wake up well rested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Skin induration
Clinical narrative: Injection is red and hard to touch.  Upper arm/shoulder is hard to touch as well.  ?Vaccine arm? without rash.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Vaginal haemorrhage
Clinical narrative: Heavy bleeding and extremely painful menstrual cramps during next menstrual cycle following second dose.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Influenza like illness, Tinnitus
Clinical narrative: Flu like symptom 24 hours after second shot then, not steady balance. Now, constant hissing sound.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Fatigue, Headache, Heart rate increased
Clinical narrative: For the first couple of days, I've been experienced some side effects, like pain in the arm I got shot, tiredness, headache, fatigue, rapid heart rate, muscle pain and nausea. Some of them were completely gone afterwards, but rapid heart rate, pain in the chest (both of them last for quite a while and don't seem to appear after any physical activity but at rest), shortness of breath even at rest, fatigue, sometimes nausea (that come and go pretty fast without any reason) are still with me after a week after the first shot. I don't feel like I'm able to do any workout also. I also have a slight cough too.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity
Clinical narrative: For the first couple of days, I've been experienced some side effects, like pain in the arm I got shot, tiredness, headache, fatigue, rapid heart rate, muscle pain and nausea. Some of them were completely gone afterwards, but rapid heart rate, pain in the chest (both of them last for quite a while and don't seem to appear after any physical activity but at rest), shortness of breath even at rest, fatigue, sometimes nausea (that come and go pretty fast without any reason) are still with me after a week after the first shot. I don't feel like I'm able to do any workout also. I also have a slight cough too.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: slight fever; Upon Follow up the case considered as valid as slight fever (event) reported.  This is a spontaneous report from a contactable Consumer (patient). A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Expiry date: Unknown) dose 1and dose 2 via unspecified route of administration on unspecified date in Feb2021 and Mar2021 respectively, both at single dose for COVID-19 Immunization. The patients medical history and concomitant medications were not reported. The patient experienced Slight fever on unspecified date. The outcome of the events was unknown.    Follow up (03Apr2021): Upon review of the Non-Serious Cases Line Listing report dated [03Apr2021], the following corrections have been made: [recode the event potentially exposed to COVID to no adverse effect and kindly delete the event scheduled to receive the first dose of the vaccine tomorrow'. Please make the case as invalid: this is a medical inquiry only and the patient had not received the vaccine yet].  Follow up (03Apr2021): New information received from Pfizer-sponsored program. A contactable consumer reported that includes: new event and month of vaccination.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Rash
Clinical narrative: Tenderness on the injection site; some aches and pains on her body; Can't get out of bed/she couldn't' stand up; Her arm was so sore/arm hurt a bit; Bone in body hurt and everyplace she has arthritis was worse; Bone in body hurt and everyplace she has arthritis was worse; Carpal tunnel reacted adversely; A prickly heat rash around her neck, down her chest between her breasts, it is ongoing and persisting; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via unspecified route of administration at arm left on 02Feb2021 08:00 AM at single dose for COVID-19 immunization. The patient's medical history included arthritis and she has had surgeries. Concomitant medication was not reported. The patient received her 1st dose of the Pfizer Covid vaccine on 02Feb2021 and said she was fine up until the night of the same day wherein she woke up from her sound sleep feeling absolutely in pain. Mentioned that the parts of her body where she had arthritis and her carpal tunnel acted up which she has never experienced before and said that she normally did not have problems like this. She also cannot get out of bed and said that her husband had to her help her out and she also had a rash. Currently, she was still experiencing tenderness on the injection site and some aches and pains on her body but not as bad as it previously was. The patient had bone in body hurt and everyplace she has arthritis was worse. The patient had the injection on 02Feb2021 at 8AM, and did ok with it, her arm hurt a bit, not bad, and that night she went to bed, and it was every bone in her body hurt and everyplace she has arthritis was worse, and her carpal tunnel reacted adversely, her arm was so sore, she can't believe it, now she has developed a rash. Her arm hurt that night, is a little tender now, it was not real red, just tender. Her husband had to help her out of bed, she could not stand up, she was not a baby, she has had surgeries, she responds well to that kind of thing, so this was unusual. Yesterday she was in bed all day, she did not get out of bed until 5PM. This all came on all of a sudden, she woke out of a sound sleep, she was totally terribly miserable. States her rash through lasted through yesterday, now she has developed a rash, a prickly heat rash around her neck, down her chest between her breasts, it is ongoing and persisting, but she is sure it will fade, she has had reactions to things before. No further details provided. She has not had any other tests or anything lately. No injections, none of that. Would like to know if she has to get her 2nd dose or not. The outcome of the events her arm was so sore/arm hurt a bit, bone in body hurt and everyplace she has arthritis was worse, Carpal tunnel reacted adversely was recovering/resolving. The outcome of the events rash, pain and cannot get out of bed/she could not stand up was unknown. The outcome of the events tenderness on the injection site was not recovered/not resolved.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Little soreness; This is a follow-up spontaneous report from a Pfizer-sponsored program. A 78-year-old contactable male consumer (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: 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. Patient experienced little soreness on the site where it has been injected. Patient took treatment as opioid (pain medication). Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Headache started after 26hr of vaccination and a low grade fever started with chills after 30hrsof 2nd dose.; chills followed by low grade fever; chills followed by low grade fever; This is a spontaneous report from a contactable consumer (reported on herself).  This 49-year-old female patient received second dose of BNT162B2 (COVID vaccine, solution for injection, lot number EL3247 expiry date: unknown) via an unspecified route of administration on in Left arm as a single dose on 09Feb2021 09:45 AM, for Covid-19 immunization. Medical history included asthma. She was allergic to Aspirin. Concomitant medications (within two weeks of vac-cine) included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (Advair), MONTELUKAST SODIUM (Singulair) and ESOMEPRAZOLE SODIUM (Nexium). She received first dose of BNT162B2 (COVID vaccine, solution for injection, lot number EL3247expiry date: unknown) via an unspecified route of administration on in Left arm as a single dose on 19Jan2021 10:00 AM, for Covid-19 immunization. She did not receive any other vaccine in four weeks of Covid-19 vaccine. On 10Feb2021 around 12: 45pm, in the afternoon, she experienced headache, but she did not think that this was related to vaccine and she continued with her routine on remaining of the day. After 6pm on 10Feb2021, she experienced chills followed by low grade fever. The patient did not receive any treatment for the events. The outcome of the events of headache and chills followed by low grade fever was recovering. The patient was not diagnosed with covid prior to vaccination and was not tested for covid post vaccination.   No further information was available.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Ear pain, Fatigue, Headache, Myalgia
Clinical narrative: only on my left side I had: muscle and joint pain; only on my left side I had: muscle and joint pain; earache; goopy eye; headache; exhaustion; pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 56-years-old non-pregnant female patient received bnt162b2 (Pfizer, Solution for injection, Lot Number: EL3302), dose 1 via an unspecified route of administration, administered in arm left on 13Jan2021 13:30 (at the time of 56-years-old) as single dose for covid-19 immunisation. Medical history included Von Willebrand's and history of lyme disease, allergies: Peanut and latex. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received vitamin supplements within 2 weeks of vaccination. Concomitant medication included vitamin supplements. After first shot in left arm, only on my left side I had: muscle and joint pain, earache, goopy eye, headache, exhaustion, and pain at injection site from 12 hours to 36 hours after shot administered on Jan2021. The patient received treatment as epipen on hand. Therapeutic measures were taken as a result of events. The outcome of events was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort, Vaccination site pain
Clinical narrative: only on my left side I had: muscle and joint pain; only on my left side I had: muscle and joint pain; earache; goopy eye; headache; exhaustion; pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 56-years-old non-pregnant female patient received bnt162b2 (Pfizer, Solution for injection, Lot Number: EL3302), dose 1 via an unspecified route of administration, administered in arm left on 13Jan2021 13:30 (at the time of 56-years-old) as single dose for covid-19 immunisation. Medical history included Von Willebrand's and history of lyme disease, allergies: Peanut and latex. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received vitamin supplements within 2 weeks of vaccination. Concomitant medication included vitamin supplements. After first shot in left arm, only on my left side I had: muscle and joint pain, earache, goopy eye, headache, exhaustion, and pain at injection site from 12 hours to 36 hours after shot administered on Jan2021. The patient received treatment as epipen on hand. Therapeutic measures were taken as a result of events. The outcome of events was unknown.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nausea, Vomiting
Clinical narrative: Nauseated and threw up and then later in the day the same thing happen to me. I nauseated and threw up; Nauseated and threw up and then later in the day the same thing happen to me. I nauseated and threw up; Tired; Muscle pain in my left thigh; This is a spontaneous report from a contactable consumer (the patient). A 83-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number- EN5318 and expiration date was not reported), via an unspecified route of administration, administered in right arm on 30Jan2021 (age at the vaccination 83-years-old) as single dose for covid-19 immunization. Medical history included rheumatoid arthritis. Concomitant medications include hydroxychloroquine, methotrexate. The patient received first shot on the 30Jan, and I was okay until 01Feb, and I woke, and I got nauseated and threw up and then later in the day the same thing happened to me. I nauseated and threw up and I had muscle pain in my left thigh. The next day, I was just extremely tired, and I didn't do any more throwing up because I do have Rheumatoid Arthritis and I was already compromised, I wonder should I take the 2nd shot which I due to have on 22Feb. Patient just took Tylenol for the pain in my leg and nothing else, I didn't want to start up again by taking something. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Heart rate, Heart rate increased, Muscle spasms
Clinical narrative: I had severe chills, fever and muscle cramps overnight. Was unable to get the temperature of the fever as it was hard to get up and move to get thermometer. However, after 6 - 7 hours, the fever broke; I had severe chills, fever and muscle cramps overnight. Was unable to get the temperature of the fever as it was hard to get up and move to get thermometer. However, after 6 - 7 hours, the fever broke; I had severe chills, fever and muscle cramps overnight. Was unable to get the temperature of the fever as it was hard to get up and move to get thermometer. However, after 6 - 7 hours, the fever broke; elevated heart rate; This is a spontaneous report from a contactable consumer (patient). A 35-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 15Feb2021 09:30 (Batch/Lot Number: EL3247) as SINGLE DOSE, dose 1 via an unspecified route of administration, administered in Arm Right on 25Jan2021 09:30 (Batch/Lot Number: EL3247) as SINGLE DOSE for covid-19 immunisation.  Medical history included was none. The patient had no known allergies. There were no concomitant medications. The patient did not receive other vaccine in four weeks and did not receive other medications in two weeks after receiving COVID vaccine. The patient had no history of COVID prior to vaccination and did not test post vaccination. The patient also stated that on 15Feb2021 at 10:00 PM, he had severe chills, fever and muscle cramps overnight. He was unable to get the temperature of the fever as it was hard to get up and move to get thermometer. However, after 6 - 7 hours (on 16Feb2021), the fever broke and returned to 97F. The patient stated that on 15Feb2021 at 10:15 AM, about 30-45 minutes after vaccination, he experienced elevated heart rate. His Apple Watch alerted him asking if he was working out, and upon checking his heart rate, it was oscillating between 85 - 110 BPM. After about an hour, his heart rate dropped back down. The patient did not receive any treatment for the events. The outcome of the events chills, fever and muscle cramps was recovered on unspecified date in 2021. The outcome of the event heart rate increased was recovering.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I had severe chills, fever and muscle cramps overnight. Was unable to get the temperature of the fever as it was hard to get up and move to get thermometer. However, after 6 - 7 hours, the fever broke; I had severe chills, fever and muscle cramps overnight. Was unable to get the temperature of the fever as it was hard to get up and move to get thermometer. However, after 6 - 7 hours, the fever broke; I had severe chills, fever and muscle cramps overnight. Was unable to get the temperature of the fever as it was hard to get up and move to get thermometer. However, after 6 - 7 hours, the fever broke; elevated heart rate; This is a spontaneous report from a contactable consumer (patient). A 35-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 15Feb2021 09:30 (Batch/Lot Number: EL3247) as SINGLE DOSE, dose 1 via an unspecified route of administration, administered in Arm Right on 25Jan2021 09:30 (Batch/Lot Number: EL3247) as SINGLE DOSE for covid-19 immunisation.  Medical history included was none. The patient had no known allergies. There were no concomitant medications. The patient did not receive other vaccine in four weeks and did not receive other medications in two weeks after receiving COVID vaccine. The patient had no history of COVID prior to vaccination and did not test post vaccination. The patient also stated that on 15Feb2021 at 10:00 PM, he had severe chills, fever and muscle cramps overnight. He was unable to get the temperature of the fever as it was hard to get up and move to get thermometer. However, after 6 - 7 hours (on 16Feb2021), the fever broke and returned to 97F. The patient stated that on 15Feb2021 at 10:15 AM, about 30-45 minutes after vaccination, he experienced elevated heart rate. His Apple Watch alerted him asking if he was working out, and upon checking his heart rate, it was oscillating between 85 - 110 BPM. After about an hour, his heart rate dropped back down. The patient did not receive any treatment for the events. The outcome of the events chills, fever and muscle cramps was recovered on unspecified date in 2021. The outcome of the event heart rate increased was recovering.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Investigation
Clinical narrative: shingles; This is a spontaneous report from a contactable Nurse (patient).   A 91-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 1 intramuscular, administered in Deltoid Left on 28Jan2021 15:00 as single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. On 30Jan2021, she began to see shingles starting under her breast, and it went into full blown shingles. She first noticed shingles barely under one breast, she noticed a little bit of a rash start and then it got worse and went all the way to her spine. It is kind of scabbing over now and she still has the deep pain. She did not have a problem with the itch, but she did have deep pain. She was not sure if it was coincidental. She was wondering if she should take the next shot. hcp gave her a medication, Valtrex, that he did not think would work since she was seen a week or two later after seeing the shingles and it should be taken when the shingles first starts. She took all of it. Patient does not think it was life threatening. she mentioned she had a problem with shakiness. Height was about 5'2", she shrunk. No prior vaccinations within 4 weeks and no AE prior vaccinations. The outcome of the event was recovering.      Information on lot/ batch number has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Fever; Chills; fatigue; This is a spontaneous report from a contactable consumer (patient himself). A 52-Year-old male patient received second dose of received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: Batch/Lot Number: EL3247; Expiration Date: unknown), via an unknown route on 16Feb2021 at 11:00 am in the left arm, as a SINGLE DOSE for COVID-19 immunization. The patient's medical history included marginally high blood pressure. Patient's concomitant medications included (medications in two weeks) lisinopril. The patient received first dose of BNT162B2, Solution for injection, Lot number: Batch/Lot Number: EL3247), via an unknown route on 26Jan2021 at 09:30 am in the left arm, as a SINGLE DOSE for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. On 16Feb2021 at around 10pm (on the same day of vaccination), the patient reported fatigue, fever, and chills. It was reported that, patient did not take any treatment medication for the events. The outcome of the events was resolving.
Sex: F
Vaccine: COVID19
Symptoms: Apathy, Arthralgia, Decreased appetite, Ear discomfort, Ear pain
Clinical narrative: pain on the back part of my shoulders. Excruciating, worst pain; she could sleep at all, she wasnt able to have food, she also had no motivation to do anything, not wanting to do anything, not wanting to leave her apartment; shooting pain on the right side into ear. It feels like her ear was being ripped off; shooting pain on the right side into ear. It feels like her ear was being ripped off; Lack of motivation; I had a terrible pain in my neck on both sides, I really couldn't move my neck; didn't have any appetite; body felt strange; This is a spontaneous report from a contactable consumer (patient). This 79-Year-old female consumer reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via unspecified route of administration, administered in Left arm on 04Feb2021 as a single dose for COVID-19 immunization. The patients past medical history and concomitant medications were not reported.  On Friday 05Feb2021, the patient felt like her body didn't feel good, like she was not tired or exhausted but just a strange feeling. Then following Saturday Sunday Monday and Tuesday she was okay. Then on Wednesday 10Feb2021 almost a week later, she got up with excruciating pain in the neck, she did not have a temperature, and she did not lose sense of taste or smell, as well as she had no appetite. She had no Appetit on Wednesday 10Feb2021, Thursday 11Feb2021 and then on Friday 12Feb2021 she finally ate. Every time she would move her body its like the entire neck, shoulder, and shoulder blades were in excruciating pain. She could sleep at all, she wasnt able to have food, she also had no motivation to do anything, not wanting to do anything, not wanting to leave her apartment. A week later then on Saturday and Sunday, on Sunday her neck hurt. Both Sunday and Monday last night she was in excruciating pain, that was in the neck and was trying to sleep. She could not turn from one side to the other, because of the shooting pain on the right side into ear. It felt like her ear was being ripped off. Today her ear felt strange, she could hear but soft and that part of neck on the right side was not the same. She had no Tylenol or anything because she did not want it to effect the vaccine. On an unspecified date, she had lack of motivation. Her second dose was scheduled for 25Feb2021. Caller asks could she get side effects at any point.  The patient was asking if her symptoms after her first dose were normal. The Clinical outcome for all the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Loss of personal independence in daily activities, Neck pain
Clinical narrative: pain on the back part of my shoulders. Excruciating, worst pain; she could sleep at all, she wasnt able to have food, she also had no motivation to do anything, not wanting to do anything, not wanting to leave her apartment; shooting pain on the right side into ear. It feels like her ear was being ripped off; shooting pain on the right side into ear. It feels like her ear was being ripped off; Lack of motivation; I had a terrible pain in my neck on both sides, I really couldn't move my neck; didn't have any appetite; body felt strange; This is a spontaneous report from a contactable consumer (patient). This 79-Year-old female consumer reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via unspecified route of administration, administered in Left arm on 04Feb2021 as a single dose for COVID-19 immunization. The patients past medical history and concomitant medications were not reported.  On Friday 05Feb2021, the patient felt like her body didn't feel good, like she was not tired or exhausted but just a strange feeling. Then following Saturday Sunday Monday and Tuesday she was okay. Then on Wednesday 10Feb2021 almost a week later, she got up with excruciating pain in the neck, she did not have a temperature, and she did not lose sense of taste or smell, as well as she had no appetite. She had no Appetit on Wednesday 10Feb2021, Thursday 11Feb2021 and then on Friday 12Feb2021 she finally ate. Every time she would move her body its like the entire neck, shoulder, and shoulder blades were in excruciating pain. She could sleep at all, she wasnt able to have food, she also had no motivation to do anything, not wanting to do anything, not wanting to leave her apartment. A week later then on Saturday and Sunday, on Sunday her neck hurt. Both Sunday and Monday last night she was in excruciating pain, that was in the neck and was trying to sleep. She could not turn from one side to the other, because of the shooting pain on the right side into ear. It felt like her ear was being ripped off. Today her ear felt strange, she could hear but soft and that part of neck on the right side was not the same. She had no Tylenol or anything because she did not want it to effect the vaccine. On an unspecified date, she had lack of motivation. Her second dose was scheduled for 25Feb2021. Caller asks could she get side effects at any point.  The patient was asking if her symptoms after her first dose were normal. The Clinical outcome for all the events was unknown.  Information about lot/batch number has been requested.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Feeling abnormal, Nasal discomfort, Pain in extremity, Throat irritation
Clinical narrative: Got a sensation in her nose, throat and upper chest like it was warm, and there was dryness; Got a sensation in her nose, throat and upper chest like it was warm, and there was dryness; Got a sensation in her nose, throat and upper chest like it was warm, and there was dryness; Lips felt funny; The arm that was a little sore; This is a spontaneous report from a contactable consumer (reporting herself). A 88-Years-old white female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9266, expiration date: 31 May 2021), via intramuscularly in left arm on 14Feb2021 at a dose of 0.3ml as a single dose for COVID-19 immunisation.  The patient's history included allergies to Penicillin, Cortisone, and she thinks also to Lidocaine, maybe. The patient did not have any NDC numbers, Lot numbers or expiry to provide for any of these products, as it was years ago. The patient did not receive any other medications. On 14Feb2021 about an hour after she got her vaccine; the patient had waited 40 minutes after getting the vaccine shot, and nothing happened, so she left, and while she was on her way home, she got a sensation in her nose, throat and upper chest like it was warm, and there was dryness. The patient previously used to get allergy shots because she was allergic to horse flies, and within 24 hours of being bitten, she would have hives the size of dinner plates. The patient went through allergy shots for 10 years and then she moved away and was no longer near water, so she did not think she needed the shots anymore. The patient had been getting the shots for 10 years, she would start to get where her lips felt funny and stuff after getting the shot, and her reaction to the COVID vaccine, felt similar to that, but it had dissipated within a half hour. This was probably respiratory and was not major, her nose did not close up, but it did get dry. The event resolved within an hour. The patient inquired with three physicians about if she should get the COVID vaccine, because she had an anaphylactic experience 40 years ago, before she was going to the allergist, and she had to go to the ER (emergency room), and they gave her whatever they did, Epinephrine or whatever it was, but that experience felt like she was being blown up like a straw was in her body. The patient inquired with these different physicians about told them about her experience from years ago, and what their suggestion would be, and they told the patient to go for it with getting the COVID vaccine, because it anything were to happen, it would be within 15 minutes of getting the shot, but the patient's was more than 15 minutes after getting it. The patient got the hives to the horse flies, it was usually within 24 hours. The patient did take an EPIPen with her when she went to get the COVID vaccine, because she was concerned she would have a reaction, but did not end up needing to use it. The outcome of the events was recovered.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Fatigue, Headache, Vaccination site pain
Clinical narrative: Headache; tiredness; Arm pain at injection site; Some left ear pain (4-5 quick pulsing feelings) approximately 30 mins after dose.; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247), via unspecified route of administration at arm left on 16Feb2021 02:45 PM at single dose for COVID-19 immunization. The patient's medical history included asthma. There was no COVID prior vaccination. The patient was not tested for COVID post vaccination. There were no known allergies. There were no other vaccines in four weeks. The patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via unspecified route of administration at arm left on 29Jan2021 09:00 AM at single dose for COVID-19 immunization. Concomitant medication included within two weeks was flecainide one time 2 weeks prior to second dose. On 16Feb2021 at 03:15 PM, the patient had some left ear pain (4-5 quick pulsing feelings) approximately 30 mins after dose. On 16Feb2021 at 08:45 PM, the patient had arm pain at injection site approximately 6 hours after dose that subsided by 24 hours after dose. On 17Feb2021 at 08:45, the patient had headache which started about 18 hours after dose and lasted for a few hours and on the same day the patient had general tiredness the day following dose. The patient did not receive any treatment for the events. The outcome of the events was recovered in 2021.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Back disorder, Rash, SARS-CoV-2 test
Clinical narrative: rash under armpits; it was my back went out; This is a spontaneous report from a contactable consumer. This 42-year-old  non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: Unknown), dose 1, administered in Arm Left on 05Feb2021 08:00 PM as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other vaccines within 4 weeks. On 05Feb2021, After going home and rest around 8 pm, the patient could not get out of sofa , her back went out and she had to crawl to bed and lay flat until Sunday. Then patient felt little better and then she had a rash under armpits.The patient underwent lab tests and procedures which included Nasal Swab: Positive on 18Feb2021. The patient did not receive any treatment for adverse event. The clinical outcome of the events was recovered.  Information on lot number/batch number has been requested.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Large red, itchy, warm patch right below injection sight.; Large red, itchy, warm patch right below injection sight; Large red, itchy, warm patch right below injection sight; This is a spontaneous report from a contactable consumer (patient).  A 68-years-old patient of an unknown gender received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN9581) administered in left arm via an unknown route of administration, on 14Feb2021 at 16:15 pm ((at the age of 68-years-old) as SINGLE DOSE for covid-19 immunization. Medical history included mixed connective tissue. The patient previously administered first dose of bnt162b2 (Lot number: EL1283) via unspecified route, administered in left arm on 24Jan2021 at 07:15am. There were no known allergies. Concomitant medications (other medications in two weeks) included Methotrexate, Hydroxychloroquine, Phenytoin, Prednisone. Prior to vaccination the patient was not tested for covid-19. Patient did not test COVID post vaccination. On 22Feb2021,  8 days after second dose, the patient experienced large red, itchy, warm patch right below injection sight about 3 inches in diameter. The patient did not receive any treatment for adverse events. The patient had no other vaccine in four weeks. The outcome of the events was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: injection site soreness, red rash, itching; injection site soreness, red rash, itching; Injection site soreness; This is a spontaneous report from a contactable Healthcare professional (Patient herself). A 62-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL9263, Expiration date: Not reported), via an unspecified route of administration on 16Feb2021 03:15 PM at a single dose at her left arm for COVID-19 immunisation. Medical history included high blood pressure. No allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Concomitant medications included losartan, tocopherol (VITAMIN E), ascorbic acid (VITAMIN C), cyanocobalamin (VITAMIN B12), estradiol (YUVAFEM) and replens iron, all received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced injection site soreness, red rash, itching on 18Feb2021. No treatment received for the adverse event. The patient had not been tested for COVID-19 since the vaccination. The outcome of events was not recovered.  Information about batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Pain
Clinical narrative: stomach ache/terrible stomach ache; pain; This is a spontaneous report from a contactable consumer (patient's husband). This is report 4 of 4 for the reporter's wife. A 68-year-old female patient (wife) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EN6201, Expiry Date: 30Jun2021), via an unspecified route of administration in left upper arm on 16Feb2021 at 3:45PM as single dose for COVID-19 immunization. Medical history included immune deficient and has additional issues and spinal surgical pain. Concomitant medication included oxycodone (XTAMPZA ER) at 18mg for spinal surgical pain. No additional vaccines administered on the same date of the Pfizer suspect. No prior vaccinations within 4 weeks. She does not get a lot of vaccines and this is something he has to get on her about. Reporter was concerned about his wife getting the second dose of the COVID Vaccine. She was due to get second shot on 09Mar2021. She was adamant about getting it. He was worried because she has more health issues. 24 hours later she got a terrible stomachache and pain which started in the afternoon of 18Feb2021. It lasted 3-4 days almost five days before it went away. The pain is gone now. It was low abdominal pain. It went away on 22Feb2021 (today as reported). His wife does not want to ask about her getting the 2nd dose. She would rather go in blind and not know anything. A visit to emergency room and physician's office was not required for events. The outcome of events was recovered on 22Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Myalgia
Clinical narrative: muscle aches all over my body; chills; Fatigue; a low grade fever of 99.8; headache; mild nausea; This is a spontaneous report from a contactable consumer (patient). A 23-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247), via an unspecified route of administration on 18Feb2021 14:45 as SINGLE DOSE in Arm Left for covid-19 immunization. Medical history included asthma and anemia. The patient previously took amoxicillin, ibuprofen and Advil and experienced known allergies. Historical vaccine included: the patient received first dose of bnt162b2 (Lot Number: EL3247), via an unspecified route of administration on 28Jan2021 10:15 as SINGLE DOSE in Arm Left for covid-19 immunization. Prior to the vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine in four weeks. Concomitant medications included: unspecified birth control medications. On 19Feb2021 at 5:30, the day after second dose of the COVID-19 vaccine, she experienced muscle aches all over my body, chills, fatigue, a low-grade fever of 99.8, a headache, and mild nausea. The patient did not receive any treatment for adverse events. Since the vaccination the patient had not been tested for COVID-19. The outcome of events was recovering.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: muscle aches all over my body; chills; Fatigue; a low grade fever of 99.8; headache; mild nausea; This is a spontaneous report from a contactable consumer (patient). A 23-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247), via an unspecified route of administration on 18Feb2021 14:45 as SINGLE DOSE in Arm Left for covid-19 immunization. Medical history included asthma and anemia. The patient previously took amoxicillin, ibuprofen and Advil and experienced known allergies. Historical vaccine included: the patient received first dose of bnt162b2 (Lot Number: EL3247), via an unspecified route of administration on 28Jan2021 10:15 as SINGLE DOSE in Arm Left for covid-19 immunization. Prior to the vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine in four weeks. Concomitant medications included: unspecified birth control medications. On 19Feb2021 at 5:30, the day after second dose of the COVID-19 vaccine, she experienced muscle aches all over my body, chills, fatigue, a low-grade fever of 99.8, a headache, and mild nausea. The patient did not receive any treatment for adverse events. Since the vaccination the patient had not been tested for COVID-19. The outcome of events was recovering.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever of 102.1; chills; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration in right arm on 17Feb2021 at 14:45 at single dose for COVID-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm on 27Jan2021 at 10:45 AM at single dose for COVID-19 immunization. Medical history included allergic to sulfa and penicillin. Concomitant medications included levothyroxine. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Feb2021 at 07:00, Patient had a fever of 102.1 and the chills on the next morning. Fever kept going down the next day and fine now. No treatment was received for the adverse events. The outcome of the events was recovered.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disorientation, Dyspnoea, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID/experiencing difficulty of breathing, disoriented a lot, feels horrible, 2 days ago experienced high fever, sore muscles, and headache/felt bad, 6 days after he felt pain and soreness; Breathing difficult; Disorientation; This is a spontaneous report from a Pfizer-sponsored program through a contactable consumers (one was patient), physician. A 67-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6201) via an unspecified route of administration on 16Feb2021 at single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. It was reported that patient got the 1st dose of the vaccine on 16Feb2021 and tested positive for COVID on 24Feb2021. He was experiencing difficulty of breathing, disoriented a lot, was suffering, and felt horrible in 2021. He says he was sorry he was so disoriented. He confirmed it was the Pfizer COVID 19 vaccine. patient stated 2 days ago he started experiencing high fever, sore muscles, and headache and 5 days later felt bad after vaccine shot. He says after 6 days from having the vaccine he felt pain and soreness and he called his administration health provider and they said for him to get a COVID test and on 24Feb2021 he tested positive for COVID. he was told to quarantine 10 days and take Tylenol, that was all they said. He was scheduled to get the second vaccine on 09Mar2021 at 12:30. The outcome for the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Dizziness, Heart rate, Heart rate irregular
Clinical narrative: A Fib; irregular heartbeat; dizziness; This is a spontaneous report received from a contactable consumer (patient) from Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not reported) via an unspecified route of administration on 16Feb2021, at a single dose for COVID-19 immunisation. The patient's medical history included pre-existing condition related to her heart. Concomitant medications was not reported. On 16Feb2021, the patient experienced an irregular heartbeat and dizziness after the 1st shot, she was not sure if that was related to the vaccine as she mentioned she has a pre-existing condition related to her heart. She wants to check if she can take the vaccine on 09Mar2021 since she has AFib after going to her heart doctor. The patient underwent lab tests and procedures which includes heartbeat irregular. Outcome of the events were reported as unknown.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Pyrexia
Clinical narrative: flu like symptoms; fever of 102 F; This is a spontaneous report from a contactable consumer or other non hcp.     A 46-years-old female patient received bnt162b2 (BNT162B2 Solution for injection), dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant was not reported. On Feb2021, The patient experienced flu like symptoms, fever of 102. Patient did not receive any treatment for events. The patient underwent lab tests and procedures which included body temperature: 102 Fahrenheit. The patient does not receive any vaccine prior to covid vaccine and post covid vaccination. The outcome of the events was unknown.   Information about Lot/Batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event following immunisation
Clinical narrative: had reaction after the second dose; This is a spontaneous report from a contactable Nurse (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Unknown); Expiry date: Unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had reaction after the second dose and she was wondering if she needed, that can she get another dose like they need to in future or was she considered allergic to it. Product details (asked that would be on the card they gave her), causality, treatment and other details were unknown (Limited information was available over the call).The outcome of event allergic reaction after immunization was unknown.  Follow up attempts were completed. No further information is expected.