chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: shortness of breath; tightness in throat; sore throat; chills; cough; fatigue; runny nose; chest congestion; This is a spontaneous report from a contactable other healthcare professional (patient). A 72-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EZ9262, via an unspecified route of administration, in arm left on 06Feb2021 at 09:30 (at 72-years age), as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: 1284, 72-years-old at the time of vaccination), via an unspecified route of administration, in arm left on 16Jan2021 as single for covid-19 immunisation and experienced redness and swelling at injection site no other side effects. On 07Feb2021 the patient underwent blood test, chest X-RAY and electrocardiogram which resulted normal. On 07Feb2021, the patient experienced shortness of breath, tightness in throat, sore throat, chills, cough, fatigue, runny nose. Adverse events required visit to emergency room. On an unknown date in Feb2021 she experienced chest congestion. Patient took cough medicine for mucus and chest congestion vicks on chest and heat pad and did not receive any treatment for all other events. Outcome was unknown for chest congestion and was resolved with sequel on 09Feb2021 for all other events.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Paraesthesia, Swelling
Clinical narrative: got tingling after the vaccine; got "covid arm"-redness about 2 inch in the diameter, swelling like she just got a shot; got "covid arm"-redness about 2 inch in the diameter, swelling like she just got a shot; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received first dose of bnt162b2 ( PFIZER-BIOTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported) via an unspecified route of administration on 17Feb2021 as Dose 1,Single for COVID-19 immunization. No medical history and no concomitant medications were reported.She said she had breast cancer and can use only one arm for shots and she read on the CDC site that the arm needs to be rotated for the second dose.The reported stated she received Pfizer covid vaccine first dose on the 17th Feb and experienced the tingling in the lips and her tongue then it went away. 11 days later she experienced it again and got "covid arm" redness about 2 inch in the diameter, swelling like she just got a shot.She said her sister also got tingling after the vaccine. Reporter wanted to know should she get the second dose or not. The outcome for the event was reported as unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Paraesthesia, Throat tightness
Clinical narrative: my throat started to feel tight; Tingling (pin prick) sensation on forehead, down nose and upper lip area; little lightheaded; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), dose 1 via unspecified route administration on 06Mar2021 (at 11:30 AM) as dose 1, single in left arm for covid-19 immunization (at the age of 45years). Patient was not diagnosed with COVID-19 prior to the COVID vaccine and since the vaccination. Patient did not receive other vaccine within four weeks prior to the COVID vaccine. The patient medical history included Known allergies: latex. The patient's concomitant medications were not reported. The patient had not taken any treatment for reported events. The patient experienced tingling (pin prick) sensation on forehead, down nose and upper lip area, little lightheaded and my throat started to feel tight on 06Mar2021 (at 11:45 AM). The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Fatigue, Malaise, Pain in extremity
Clinical narrative: Arm was a little more sore; Little swelling (arm); Small lump at injection; Tiredness; Feeling unwell; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program.   The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 06Apr2021, this case now contains all required information to be considered valid.  A 67-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the right arm, on 18Mar2021 at 09:40 (Batch/Lot Number: EN6204), at the age of 67 years old, as 2nd single dose, for COVID-19 immunisation. The patient had no prior vaccination within 4 weeks. Medical history included, lymphoma, ongoing type 2 diabetes mellitus, ongoing muscle spasticity, ongoing acidreflux/gastrooesophageal reflux disease (GERD), edema, and ongoing high blood pressure. Concomitant medications included ongoing insulin glargine (LANTUS) for type 2 diabetes mellitus, ongoing metformin for type 2 diabetes mellitus, ongoing baclofen for muscle spasticity, ongoing pantoprazole for acid reflux/GERD, furosemide for oedema, ongoing lisinopril for high blood pressure, ongoing metoprolol for high blood pressure, ongoing apixaban (ELIQUIS) as blood thinner, ongoing calcium/ colecalciferol (CALCIUM PLUS VITAMIN D), ongoing unspecified multivitamins, and ongoing paracetamol (TYLENOL extra strength, not taken a day before shots and a day after shots). It was also reported that insulin glargine, metformin, baclofen, pantoprazole, furosemide, lisinopril, metoprolol, and apixaban were also given to prevent congestive heart failure (as reported). Past drug history included intramuscular administration in the right arm of the 1st dose of BNT162b2 (Batch/Lot Number: EN6201), on 27Feb2021 at 09:50 AM, at the age of 66 years old. On 18Mar2021 the patient performed a blood test for a CT Scan done on 23Mar2021 due to lymphoma surveillance. After the administration of the 2nd dose of BNT162b2, on 18Mar2021, the patient's arm was a little more sore with respect to the first shot, and additionally it had a little swelling with a small lump at injection. The patient additionally described tiredness and feeling unwell. The events were reported as non-serious, and no treatment was needed. The patient recovered within approximately 4 days.  No follow-up attempts are possible; no further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site mass
Clinical narrative: Arm was a little more sore; Little swelling (arm); Small lump at injection; Tiredness; Feeling unwell; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program.   The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 06Apr2021, this case now contains all required information to be considered valid.  A 67-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the right arm, on 18Mar2021 at 09:40 (Batch/Lot Number: EN6204), at the age of 67 years old, as 2nd single dose, for COVID-19 immunisation. The patient had no prior vaccination within 4 weeks. Medical history included, lymphoma, ongoing type 2 diabetes mellitus, ongoing muscle spasticity, ongoing acidreflux/gastrooesophageal reflux disease (GERD), edema, and ongoing high blood pressure. Concomitant medications included ongoing insulin glargine (LANTUS) for type 2 diabetes mellitus, ongoing metformin for type 2 diabetes mellitus, ongoing baclofen for muscle spasticity, ongoing pantoprazole for acid reflux/GERD, furosemide for oedema, ongoing lisinopril for high blood pressure, ongoing metoprolol for high blood pressure, ongoing apixaban (ELIQUIS) as blood thinner, ongoing calcium/ colecalciferol (CALCIUM PLUS VITAMIN D), ongoing unspecified multivitamins, and ongoing paracetamol (TYLENOL extra strength, not taken a day before shots and a day after shots). It was also reported that insulin glargine, metformin, baclofen, pantoprazole, furosemide, lisinopril, metoprolol, and apixaban were also given to prevent congestive heart failure (as reported). Past drug history included intramuscular administration in the right arm of the 1st dose of BNT162b2 (Batch/Lot Number: EN6201), on 27Feb2021 at 09:50 AM, at the age of 66 years old. On 18Mar2021 the patient performed a blood test for a CT Scan done on 23Mar2021 due to lymphoma surveillance. After the administration of the 2nd dose of BNT162b2, on 18Mar2021, the patient's arm was a little more sore with respect to the first shot, and additionally it had a little swelling with a small lump at injection. The patient additionally described tiredness and feeling unwell. The events were reported as non-serious, and no treatment was needed. The patient recovered within approximately 4 days.  No follow-up attempts are possible; no further information expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Nausea, Paraesthesia, Pruritus
Clinical narrative: Within 20 minutes of injection my right arm became tingly; my torso, back, both arms and neck were red, itchy with a raised rash.; my torso, back, both arms and neck were red, itchy with a raised rash.; my torso, back, both arms and neck were red, itchy with a raised rash.; extremely tired; nauseous; This is a spontaneous report from a contactable Consumer. A 53-years-old (Adult 18-64Years) non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, administered in right arm on 05Mar2021 (at the age of 53-years-old) as a single dose for covid-19 immunization. The patient medical history included asthma, allergies, cardiomyopathy, history of anaphylaxis. The patient concomitant medications were not reported. The patient had allergies with latex, penicillin, shellfish. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, administered in right arm on 12Feb2021 at 13:15 (at the age of 53-years-old) as a single dose for covid-19 immunization. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Mar2021 at 13:45, it was reported, "within 20 minutes of injection my right arm became tingly then within 2 hours my torso, back, both arms and neck were red, itchy with a raised rash. That evening I became extremely tired that lasted for 4 entire days. I was also nauseous for 4 days. On the fourth day the nausea was gone, the fatigue was somewhat better, but the rash is still as bad as when it began. I have been taking Benadryl with little relief". Therapeutic measures were taken as a result of pruritus and rash popular. The patient did not receive any other treatment. Outcome of the event was recovering, at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular
Clinical narrative: Within 20 minutes of injection my right arm became tingly; my torso, back, both arms and neck were red, itchy with a raised rash.; my torso, back, both arms and neck were red, itchy with a raised rash.; my torso, back, both arms and neck were red, itchy with a raised rash.; extremely tired; nauseous; This is a spontaneous report from a contactable Consumer. A 53-years-old (Adult 18-64Years) non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, administered in right arm on 05Mar2021 (at the age of 53-years-old) as a single dose for covid-19 immunization. The patient medical history included asthma, allergies, cardiomyopathy, history of anaphylaxis. The patient concomitant medications were not reported. The patient had allergies with latex, penicillin, shellfish. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, administered in right arm on 12Feb2021 at 13:15 (at the age of 53-years-old) as a single dose for covid-19 immunization. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Mar2021 at 13:45, it was reported, "within 20 minutes of injection my right arm became tingly then within 2 hours my torso, back, both arms and neck were red, itchy with a raised rash. That evening I became extremely tired that lasted for 4 entire days. I was also nauseous for 4 days. On the fourth day the nausea was gone, the fatigue was somewhat better, but the rash is still as bad as when it began. I have been taking Benadryl with little relief". Therapeutic measures were taken as a result of pruritus and rash popular. The patient did not receive any other treatment. Outcome of the event was recovering, at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Paraesthesia oral, Tongue discomfort
Clinical narrative: Tingling in my tongue and lower lip; It is like if you put pepper on your tongue, I am feeling it from the tip of tongue to the sides of my tongue like from the tip you go towards you jawline; It is like burning and it started out as tingling; It feels like it is there and there is something wrong; This is a spontaneous report from a contactable nurse. This 76-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EL9265, expiration date was not reported), intramuscularly in right upper arm on 02Mar2021 (age at the time of vaccination was 76-years-old) as single dose for COVID-19 immunization. The patient took the shot at 11.30 yesterday morning, got the shot at around 11:10 AM, the patient was asked to wait for 15 minutes and the patient waited for 25 minutes. The patient's medical history included high blood pressure and it was controlled and taking high blood pressure medication, anxiety. The patient's concomitant medications included the patient take Synthroid and Levothyroxine because the patient had thyroid gland removed years ago (not clarified further) and Sertraline, which was Zoloft (not clarified if consumer was taking Zoloft or Sertraline, hence not captured in tab), 50 mg for anxiety. On an unknown date, the patient would reduce it to a burning, yesterday it was more pronounced, and it continued all night, so the patient didn't sleep flat. The patient was not sure if it will get to anaphylactic or anything, it was like put pepper on tongue, that was best description that the patient can give, it was like if put pepper on tongue, the patient felt it from the tip of tongue to the sides of my tongue like from the tip go towards the jawline and it was not under whole tongue, it was right around it and it was like burning and it started out as tingling and sometimes, it does like it did today morning (on the day of reporting), but it was not a severe tingling but it was felt like it was there and there was something wrong (not clarified appropriately further, hence ongoing not checked). The patient did not received any treatment and was just ready to go hospital if the patient had to just in case but there was nothing. The patient had no breathing problem and nothing at all. The outcome of the event was not resolved. The patient was hesitated to get the second dose. The patient just wanted to report the side effect that did not see in the list and all of the literature.   No follow up attempts are possible. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Poor quality sleep
Clinical narrative: She noticed some shortness of breath upon exertion, especially after her walk; I am not sleeping well, but I  don't sleep well anyway and don't think it's related to the vaccine.; This is a spontaneous report from a contactable consumer (patient). A 83-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm right on 28Feb2021 at 13:20 (at the age of 82-years-old) (Batch/Lot Number: GN6202) as DOSE 1, SINGLE for covid-19 immunization. Vaccination facility type was Physician Office. Vaccine was not administered at Facility. The patient's medical history was not reported. Concomitant medications included a lot of unspecified pills. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Patient had no other vaccines on the same day as the suspect product. Prior Vaccinations (within 4 weeks) was none. Patient stated after her first vaccine dose, over last 5 days on an unspecified date in Mar2021, she noticed some shortness of breath upon exertion, especially after her walk, she wanted to know if it was normal because it only occurred during exertion. Patient also stated that other than that I haven't had any side effects, I am not sleeping well, but I don't sleep well anyway and don't think it's related to the vaccine, she also stated her second dose was scheduled on the 24th day instead of 21st day. Patient stated that she was prescribed an inhaler by her doctor a couple years ago, but she never used it before, but she tried using it yesterday but she did not know if it helped or not, since she only felt the shortness of breath when she was doing a brisk walk. The patient would call doctor will call she would probably just tell me to take my inhaler.Caller states that she noticed that when she takes her 30 minute, daily walks, she is getting some shortness of breath. Caller states that she got her Pfizer COVID vaccine shot, a week and a half ago, and she is wondering if that could be a side effect of the product, or if it is a symptom of COVID. The events did not result in emergency room/ physician office visit. The patient was not admitted to hospital due to events. Relevant test reported as none. Therapeutic measures were taken as a result of she noticed some shortness of breath upon exertion, especially after her walk (dyspnoea exertional). The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: pins and needles and tingling down her left arm and into left breast area; This is a spontaneous report from a contactable consumer or other non health care professional (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in arm left on an unspecified date as single dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported), 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 an unspecified date, patient stated, it just feels like pins and needles and tingling down her left arm and into left breast area and she wants to know if that is normal and how long will that last. it seems like that is what it came from, but it happened after the vaccination and she is still experiencing it five weeks later. The outcome of event was not resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Blood pressure measurement, Blood pressure systolic, Blood test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) reported for herself. A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/lot number: EN6198, expiration date: Unknown) via an intramuscular route in left deltoid on 24Feb2021 at 09:51 (age at vaccination: 73-year-old), as a single dose for covid-19 immunization (reason: hadn't seen her grandson in over a year). Medical history included low cholesterol and diabetes. Concomitant medications included ramipril 5 mg once per day for blood pressure and diabetes. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no adverse events following prior vaccinations. None, previous immunization with the Pfizer vaccine considered as suspect. When she went to get the vaccine, she was fine. They made her sit for 20 minutes. After receiving the vaccine on 24Feb2021, she sat down for about maybe 30 minutes and when she got up, she noticed she had lightheaded/dizziness. she said she thinks she needed to go to the doctor. She went to doctor that was inside the center, they took her blood pressure, and it was at 172. The doctor was saying she was anxious and that she will be fine. She sat there for a while. After about 15-20 minutes, she thought she's fine, so she got up, and the doctor asked her, if she was sure. Her husband and she walked around to get some air. She thought the dizziness was going to go away, but it's been a week. Up unto this day, she still got dizzy, like a light headedness. She wanted to know if it was going to go away and how long was this going to last. Her blood pressure was consistent sometimes it went to 130-140. Her second COVID 19 vaccine was scheduled for 17Mar2021. The patient underwent lab test and procedure which included blood drawn (blood test unspecified) when she went to the doctor yesterday, she didn't have any results yet and she checked it this morning her blood pressure and it was 128/69. She also went to ophthalmologist to make sure it wasn't her eyes and that was fine. She had not gone to the ED just the doctor because it wasn't really that bad. She's concerned if she's walking down the street. The clinical outcome of the event dizzy was not recovered, high blood pressure was recovered on 24Feb2021 and anxious was unknown. No follow-up attempts are possible; Information about lot/batch number cannot been obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) reported for herself. A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/lot number: EN6198, expiration date: Unknown) via an intramuscular route in left deltoid on 24Feb2021 at 09:51 (age at vaccination: 73-year-old), as a single dose for covid-19 immunization (reason: hadn't seen her grandson in over a year). Medical history included low cholesterol and diabetes. Concomitant medications included ramipril 5 mg once per day for blood pressure and diabetes. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no adverse events following prior vaccinations. None, previous immunization with the Pfizer vaccine considered as suspect. When she went to get the vaccine, she was fine. They made her sit for 20 minutes. After receiving the vaccine on 24Feb2021, she sat down for about maybe 30 minutes and when she got up, she noticed she had lightheaded/dizziness. she said she thinks she needed to go to the doctor. She went to doctor that was inside the center, they took her blood pressure, and it was at 172. The doctor was saying she was anxious and that she will be fine. She sat there for a while. After about 15-20 minutes, she thought she's fine, so she got up, and the doctor asked her, if she was sure. Her husband and she walked around to get some air. She thought the dizziness was going to go away, but it's been a week. Up unto this day, she still got dizzy, like a light headedness. She wanted to know if it was going to go away and how long was this going to last. Her blood pressure was consistent sometimes it went to 130-140. Her second COVID 19 vaccine was scheduled for 17Mar2021. The patient underwent lab test and procedure which included blood drawn (blood test unspecified) when she went to the doctor yesterday, she didn't have any results yet and she checked it this morning her blood pressure and it was 128/69. She also went to ophthalmologist to make sure it wasn't her eyes and that was fine. She had not gone to the ED just the doctor because it wasn't really that bad. She's concerned if she's walking down the street. The clinical outcome of the event dizzy was not recovered, high blood pressure was recovered on 24Feb2021 and anxious was unknown. No follow-up attempts are possible; Information about lot/batch number cannot been obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Gait disturbance, Headache, Hypoaesthesia, Lymph node pain
Clinical narrative: Tingling/paraesthesia/paraesthesia in leg,foot/paraesthesia in arm, hand; numbness; fever; chills; severe headache; swelling painful lymphnodes on neck; swelling painful lymphnodes on neck; stumbling/Trouble walking; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 52-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration, administered in Left arm on 02Mar2021 at 13:15 (at the age of 52 years) as Dose number Unknown, Single for COVID-19 immunization.The patient's medical history included environmental pollen and some fruit, nuts and soy along with Severe allergies and asthma, Cranial nerve palsy after viral cold and Trigeminus neuralgia. Patient's Concomitant medications were not reported. Patient did not receive any other vaccines within 2 or 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination.1 hour after injection, on 02Mar2021 at 14:30, the patient experienced Tingling, numbness and paraesthesia in leg, foot, arm and hand on left side of body. Followed by fever, chills, severe headache and swelling painful lymph nodes on neck.1 week after vaccination, no improvement on numbness in leg and foot but spreading over to right side as well. Trouble walking and stumbling at times.AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.No treatment received.The outcome of the events was not recovered.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Paraesthesia, Pyrexia
Clinical narrative: Tingling/paraesthesia/paraesthesia in leg,foot/paraesthesia in arm, hand; numbness; fever; chills; severe headache; swelling painful lymphnodes on neck; swelling painful lymphnodes on neck; stumbling/Trouble walking; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 52-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration, administered in Left arm on 02Mar2021 at 13:15 (at the age of 52 years) as Dose number Unknown, Single for COVID-19 immunization.The patient's medical history included environmental pollen and some fruit, nuts and soy along with Severe allergies and asthma, Cranial nerve palsy after viral cold and Trigeminus neuralgia. Patient's Concomitant medications were not reported. Patient did not receive any other vaccines within 2 or 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination.1 hour after injection, on 02Mar2021 at 14:30, the patient experienced Tingling, numbness and paraesthesia in leg, foot, arm and hand on left side of body. Followed by fever, chills, severe headache and swelling painful lymph nodes on neck.1 week after vaccination, no improvement on numbness in leg and foot but spreading over to right side as well. Trouble walking and stumbling at times.AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.No treatment received.The outcome of the events was not recovered.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Tooth disorder
Clinical narrative: My teeth feel weird today.Will this happen in 3 weeks when I get the second vaccination; My lips tingled each am, except today.; This is a spontaneous report from a contactable consumer (patient). A 70-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6206, Expiry date not reported) via unspecified route of administration administered in left arm on 04Mar2021 at 10:15 (at age of 70-year-old) as dose 1, single for COVID-19 Immunization. Patient medical history includes autoimmune diseases, graves disease, Lupus, RA (Rheumatoid arthritis), Sjogren and know allergies included quinine, sulfa, paxil, wellbutrin. Patient concomitant medications were not reported. Prior to the vaccination, the patient did not receive any other vaccines within four weeks and was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID. On 05Mar2021, patient experienced lips tingled each am, except today. This occurs each am the day after since she got vaccinated and also her teeth feel weird today (08Mar2021). Patient wanted to know will this happen in 3 weeks when she get the second vaccination. Patient did not receive any treatment for events. The outcome of events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Pyrexia, Upper respiratory tract infection
Clinical narrative: Flu like symptoms; Low grade fever; Came down with an upper respiratory infection at the same time as the flu like symptoms.; This is a spontaneous report from a contactable consumer (patient). A 70-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number: EN6200) via an unspecified route of administration in right arm on 27Feb2021 at 10:45 (at the age of 70-year-old) as a single dose for COVID-19 immunisation at other facility. The patient had no medical history and no known allergies. 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 other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination, patient was not tested for covid-19. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on unspecified date (at the age of 70-year-old) as a single dose for COVID-19 immunisation at other facility. On 28Feb2021, the patient experienced Flu like symptoms that started 24 hours after the second dose, this lasted for five days and patient had low grade fever lasted about 48 hours and came down with an upper respiratory infection at the same time as the flu like symptoms. Patient did not receive any treatment for the events. The outcome of events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Peripheral swelling, Skin mass
Clinical narrative: Arm swollen; black and blue bruise; small lump under the skin; This is a spontaneous report from a contactable (patient). A 59-year-old non-pregnant female patient received first dose BNT162B2 (solution for injection, Batch/Lot number and expiry date was not reported, age at vaccination: 59-year-old), via an unspecified route of administration, in Arm Left on 03Mar2021 02:30 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included ginkgo biloba leaf (GINKO BILOBA [GINKGO BILOBA LEAF]) and vitamins. The patient previously had codeine, dilaudid, and morphine allergies. On 03Mar2021 03:00, the patient experienced arm swollen, black and blue bruise and small lump under the skin. The patient did not receive any corrective treatment. The patient did not receive any other vaccine in four weeks. The patient was not tested positive for covid prior and post vaccination. The outcome of events was recovered.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Dyspnoea, Paraesthesia, Tremor
Clinical narrative: tingling/shaking; tingling/shaking; short of breath; chills ("shaky"); Vaccine-Related Anxiety(include misc mentalhealth)/Mood is anxious; This is a spontaneous report from a non-contactable Other Health Professional. A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6206), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that During her 15-minute waiting period after the injection, the patient began to experience tingling/shaking, short of breath. She denied rash, hives, welts, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. Patient complains of chills ("shaky") and shortness of breath Mood and Affect: Mood is anxious. Treatment included: water, snacks and Pepcid Follow up response to treatment. It was reported that Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) patient observed in the bay for approx. 15 minutes. Patient greatly improved with treatments above. Patient encouraged to eat 30 minutes prior to next vaccine. She reports that she is appreciative of her care today. F/up with pcp as needed. The outcome of events was unknown whereas Vaccine-Related Anxiety (include misc mentalhealth)/Mood anxious was recovering.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Paraesthesia oral
Clinical narrative: patient experienced dizziness and she could not open her eyes due to her vision kept on spinning; tingling lips and tongue; This is a spontaneous report from a contactable consumer (patient). A female patient of an age 76 (units not provided) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 06Mar2021 10:00, as single dose, for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 06Mar2021 at 10:15, 15 minutes later after vaccination, the patient experienced tingling lips and tongue and was able to manage while in the facility. On the same day, at 7 pm (at 19:00), the patient experienced dizziness and she could not open her eyes due to her vision kept on spinning. She wanted to know if it was safe for her to get the 2nd shot. The outcome of events was unknown.  No follow up attempts are possible, information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Dyspnoea, Oxygen saturation
Clinical narrative: feeling trouble breathing, like a feeling of not being able to breathe; This is a spontaneous report from a contactable consumer, the patient. A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6199; Batch no: not reported), via an unspecified route of administration on 07Mar2021 (age at vaccination: 66 years) as dose 1, single for covid-19 immunization. Medical history included Bleeding Ulcers from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient stated that, after receiving the first dose of the Pfizer-BioNtech Covid-19 vaccine on Sunday 07Mar2021, as soon as she got home she started feeling trouble breathing, like a feeling of not being able to breathe, she had to take a deep breath every ten minutes or so. She told that she was breathing okay but just got the sensation that she could not breathe. She waited, but the feeling was still continuing today and it was not going away at all. Last night she went to Urgent Care and they took a chest X-ray, her lungs were clear, her oxygen rate was 99, but she had the feeling as if she cannot breathe. Reportedly, her HCP would try with Benadryl to see if it makes this symptom go away and if not they would try with steroid. She stated that, this happened to her once with a generic reflux medicine like Nexium or Prevacid (further not clarified hence captured as Unspecified medications). It was like 5-6 years ago and the exact generic drug that she took was one of the 'oprazole' but she did not know which one exactly. She wanted to know if this was a contraindication for the vaccine and if someone else has reported this and if this symptom will disappear. The patient underwent lab tests and procedures which included blood test (blood drawn) 2 weeks ago with unknown result and took a chest X-ray, her lungs were clear, her oxygen rate was 99. No Investigation Assessment provided. The outcome of the event was assessed as not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Neoplasm skin, Pruritus
Clinical narrative: a lump under skin about size of a half-dollar and it is very itchy; a lump under skin about size of a half-dollar and it is very itchy; Skin in red is area; This is a spontaneous report from a contactable consume (patient). A 65-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6202), via an unspecified route of administration in right arm on 04Mar2021 at 14:00 (at the age of 65-year-old) as single for covid-19 immunisation. The patient's medical history included multi-level, bilateral foramina stenosis. The patient had known allergies to sulfa drugs, penicillin, reflex, codeine. Concomitant medications receive in two weeks included gabapentin for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 12Mar2021, at 06:00 AM, 8 days later she has a lump under skin about size of a half-dollar and it is very itchy. Skin in red is area. The patient did not receive any treatments for the events. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Localised infection, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: normal reactions like sore arm; on the 6th day after the first shot I developed a terrible sore throat which lasted for 5 days; This is a spontaneous report from a contactable consumer or other non hcp.   A 62-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 15Feb2021 12:00 (Batch/Lot Number: EN6208) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included methimazole (METHIMAZOLE) taken for an unspecified indication, start and stop date were not reported; propranolol (PROPRANOLOL) taken for an unspecified indication, start and stop date were not reported; pantoprazole (PANTOPRAZOLE) taken for an unspecified indication, start and stop date were not reported; famotidine (FAMOTIDINE) taken for an unspecified indication, start and stop date were not reported.  On 21Feb2021 (6th day) after the first dose, the patient experienced normal reactions like sore arm on the 6th day after the first shot she developed a terrible sore throat which lasted for 5 days. The PCP sent for a Covid test. On 26Feb2021, sars-cov-2 test: negative was negative. The sore throat disappeared as abruptly as it started while the outcome of the event localised infection was unknown. The action taken in response to the event(s) for bnt162b2 was not applicable.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Felt tingling on neck, shoulder and head; This is a spontaneous report from a non-contactable consumer (patient's mother) via Pfizer sales representative. An adult female patient (unknown if patient was pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. Vaccine facility type was unknown. The patient's medical history and concomitant medications were unknown. Known allergies reported as unknown. Other vaccine in four weeks was Unknown. It was unknown if covid tested prior or post vaccination. On 07Mar2021, two days after getting injection, patient felt tingling on neck, shoulder and head, was not sure if it had anything to do with the vaccine. Patient was not treated for the event. The event did not result in emergency room/ physician office visit. The outcome of the event was not recovered.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: numbness/tingling feeling in mouth; a sore ear; numbness/tingling feeling in mouth; This is a spontaneous report from a non-contactable consumer (Patient). A 42-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6204), via an unspecified route of administration on 03Mar2021 at 08:30 as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included estradiol (ESTRADIOL) 1 mg taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine in four weeks and had no covid prior vaccination. On 04Mar2021 at 08:00, 24 hours after vaccine felt a sore ear and numbness/tingling feeling in mouth. None of these symptoms required medical attention but she thought with this being a new vaccine it would be helpful to report all side effects. Patient did not received treatment for event. Patient was not tested for covid post vaccination. The outcome for the events was reported as resolving.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Hypoaesthesia oral, Paraesthesia oral, Pyrexia
Clinical narrative: lips began to tingle and numb; lips began to tingle and numb; spiked a fever 2 degrees over my normal; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), dose 1 via an unspecified route of administration, administered in arm left on 08Mar2021 at 15:15 as dose 1, single for COVID-19 immunisation. Medical history included T2 diabetic, hypertension and had known allergies to sulfa drugs. Concomitant medications included ramipril and tadalafil, taken for an unspecified indication, start and stop date were not reported (medications received in two weeks). No other vaccine received in four weeks. The patient did not have COVID prior vaccination and was not COVID tested post vaccination. On 11Mar2021 at 12:00, 3 days after injection, lips began to tingle and numb, like after Novocaine wears off. Now 12 hours later (as reported), still not right. Also spiked a fever 2 degrees over his normal about six hours into the event. The patient did not receive treatment for the reported events. The outcome of the events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Chills, Dyspnoea, Feeling abnormal
Clinical narrative: My arm is sore; my arm was sore, it is still sore; I wasn't feeling right, my breath was not right/shortness of breath; Chills; I wasn't feeling right, my breath was not right; temperature was 101; This is a spontaneous report from a contactable Consumer (patient). A 59-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6208) via an unspecified route of administration in left arm on 11Mar2021 as single dose for covid-19 immunization. The medical history included acid reflux. The concomitant medication included Pantoprazole taken for acid reflux (40 mg, Once every other day for acid reflux) and Patient had been taking it from past 3 years. In Mar2021, the patient experienced that his arm was sore and it was still sore, patient wasn't feeling right, his breath was not right, shortness of breath, don't feel good, went to the bathroom a lot and chills. Patient further explained his arm was just a little sore other stuff went away. It was also reported, that was all until last Monday, after Monday I still have sore arm, my arm is still sore but I don't have shortness of breath anymore. patient is supposed to go back on the 2nd of Apr for his shot. Patient reported that he took some Tylenol and NyQuil for the chills and all. The patient underwent lab test of blood test and diabetes check-up and temperature was 101, SWAB test and it was positive 22Feb2021. The outcome of the event arm was sore was not recovered, wasn't feeling right, breath was not right, chills was recovered.   No follow-up attempt are needed. No further information expected.