chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Dyspnoea, Headache, Heart rate
Clinical narrative: back felt like truck hit entire back; headache; rapid heartbeat; SOB; leg weakness; legs feeling heavy; This is a spontaneous report from a contactable consumer (patient).   A 55-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EL9261 and Expire Date: 30Apr2021) in left arm via unspecified route of administration, on 08Feb2021 at 18:30, as single dose for covid-19 immunisation. The patient previously administered first dose on 18Jan2021 at 19:45 PM, (lot number: EL1284) in left arm. She did not administer any other vaccines in four weeks. Prior to and since vaccination, she was not diagnosed with Covid-19. Past drug and known allergies included Remicaid infusion, and had rapid heartbeat, sob, weakness. Medical history of patient included Crohns disease, Rheumatoid arthritis and Vit d deficiency. Other medications in two weeks were Tramadol, Cellcept (Mycophenolate), Gabapentin-ER, Vitamin D. The patient experienced rapid heartbeat, sob, leg weakness, legs feeling heavy on 08Feb2021 at 18:35, which lasted for 3 minutes. The next day on 09Feb2021, his back felt like truck hit entire back, still leg weakness, headache. The outcome of event was recovered for rapid heartbeat, sob, legs feeling heavy, leg weakness, headache, back pain. The patient did not receive any treatment for the events. The patient underwent lab tests which included heart rate with results as rapid on 08Feb2021.   Information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Limb discomfort
Clinical narrative: back felt like truck hit entire back; headache; rapid heartbeat; SOB; leg weakness; legs feeling heavy; This is a spontaneous report from a contactable consumer (patient).   A 55-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EL9261 and Expire Date: 30Apr2021) in left arm via unspecified route of administration, on 08Feb2021 at 18:30, as single dose for covid-19 immunisation. The patient previously administered first dose on 18Jan2021 at 19:45 PM, (lot number: EL1284) in left arm. She did not administer any other vaccines in four weeks. Prior to and since vaccination, she was not diagnosed with Covid-19. Past drug and known allergies included Remicaid infusion, and had rapid heartbeat, sob, weakness. Medical history of patient included Crohns disease, Rheumatoid arthritis and Vit d deficiency. Other medications in two weeks were Tramadol, Cellcept (Mycophenolate), Gabapentin-ER, Vitamin D. The patient experienced rapid heartbeat, sob, leg weakness, legs feeling heavy on 08Feb2021 at 18:35, which lasted for 3 minutes. The next day on 09Feb2021, his back felt like truck hit entire back, still leg weakness, headache. The outcome of event was recovered for rapid heartbeat, sob, legs feeling heavy, leg weakness, headache, back pain. The patient did not receive any treatment for the events. The patient underwent lab tests which included heart rate with results as rapid on 08Feb2021.   Information on the lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; she did not have any taste for two weeks; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EM9809; Expiration Date: Jun2021), via an unspecified route of administration, administered in left arm on 09Feb2021 (at the age of 74 years) as 1st single dose for COVID-19 immunization. Medical history included pulmonary fibrosis from 2015 and it was ongoing. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Feb2021, after vaccination the patient tested positive for COVID and she did not have any taste for two weeks in Feb2021 (date unspecified). The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 11Feb2021. The patient received antibody infusion as treatment for event on 12Feb2021 and she thought it was the monoclonal. The patient was scheduled to receive the second dose on 02Mar2021 and enquired if it was safe to take it or does she need to it put off until she has been COVID free for 3 months. On 28Feb2021, the patient recovered from events.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: stomach cramps; daily bouts of diarrhea; This is a spontaneous report from a contactable consumer (patient). This is one of two reports from same patient. A 65-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9261 and expiration date was not reported), via an unspecified route of administration, administered in Left arm on 21Jan2021 13:00 as single dose for covid-19 immunization. The patient received second dose of BNT162B2 (solution for injection: Lot number: EM9809), via an unspecified route of administration on 02Feb2021 at 01:15 pm on the left arm as a single dose for COVID-19 immunization. The patient medical history included osteoporosis, arthritis and allergies to crabmeat and wool. Concomitant medication included meloxicam 7.5 mg. The patient did not receive any vaccines 4 weeks prior to covid vaccination. The patient stated that, on 25Jan2021 (reported as 3 to 4 days after the first dose), she had 36 hours of stomach cramps, followed by ongoing daily bouts of diarrhoea. The patient stated that changes in diet did not help. The patient started to plan to call her doctor (today). The patient was not treated for the events. The outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: sore throat; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (Age:50; unit-unknown)  received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 28Feb2021 as unknown single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 01Mar2021, the patient experienced sore throat. Patient stated she received the pfizer covid 19 vaccine on Sunday, 28Feb2021. She reported a sore throat on Monday that has progressed. She wanted to know if she gets tested for covid, will the test come back postiive for the vaccine. The outcome of the events was unknown.   No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Vomiting
Clinical narrative: Vomiting; no energy; This is a spontaneous report from a contactable consumer (patient). A 64-years-old male patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 26Feb2021 11:00 as SINGLE DOSE for covid-19 immunisation. Medical history included cancer from an unknown date and unknown if ongoing and Patient had no known allergies. There were no concomitant medications. Patient had no other vaccine in four weeks and no other medications in two weeks. Patient had no covid prior vaccination and no covid tested post vaccination. On 27Feb2021 12:00 AM, the patient experienced vomiting and no energy. The outcome of the events was recovered on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Cluster headache, Confusional state, Mental fatigue, Migraine
Clinical narrative: mental exhaustion; Recurring cluster headaches; migraines; confusion; This is a spontaneous report from a contactable consumer (patient). A 30-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot: EN6202), via an unspecified route of administration, administered in Arm Right on 25Feb2021 14:45 (at the age of 30-years-old) as single dose for covid-19 immunisation. The patient's medical history included obesity and tree nuts. Patient was vaccinated at a hospital. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. The patient's concomitant medications included ibuprofen (MIDOL) and mepyramine maleate, pamabrom, paracetamol (PAMPRIN). On 25Feb2021 at 18:15, the patient experienced mental exhaustion, recurring cluster headaches, migraines and confusion. The outcome of the events was not recovered. The patient did not receive any treatment for the adverse events experienced by the patient.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Influenza like illness, Mobility decreased, Pyrexia
Clinical narrative: weakness; She got a little temperature; Woozy; symptoms of " a really bad flu"; can't get out of bed; This is a spontaneous report from a contactable other healthcare professional (patient) via medical information team. A female patient of an unspecified age (Age: 83; unit: Unknown) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced weakness, she got a little temperature, woozy, symptoms of a really bad flu. Husband of patient reported that his wife received the second dose of the Covid vaccine yesterday in which she is experiencing some weakness and a temperature. Patient got on the phone at this time to provide demographics and the rest of her symptoms she has been experiencing. Outbound disclaimer was provided during this time. Patient stated that she was experiencing symptoms of a really bad flu, no nausea and a headache. Patient states that she can't get out of bed. Patient states that her and her husband are elderly, and they have been seeing specialists and don't have a primary care physician. Reporter stated its Pfizer COVID-19 vaccination that they had yesterday. His wife is having a sort of, he doesn't know how you call it, she got a little temperature, she is feeling woozy today, the day after. He was wondering what you expect will be the end result, when did you think it might clear up. In response to further probing, reporter stated that not actually he wants to find out what is the prediction for of her condition. So, let him go and talk to them okay. The outcome of all events was unknown.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Somnolence
Clinical narrative: Stiffness (going to the elbow) in the left arm; Sleepy for 3 days; This is a spontaneous report from a contactable consumer or other non-HCP. This is one of two cases from same reporter. A 57-year-old non-pregnant female patient (at the age of 57-years) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Left Arm on 09Feb2021 02:15 PM as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive other vaccines 4 week prior to Pfizer vaccine. The patient had not diagnosed with COVID prior vaccination. And post vaccination, patient had not tested with covid. On 09Feb2021 04:00 PM, the patient experienced stiffness (going to the elbow) and sleepy for 3 days. No treatment was received for the events. The outcome of events was resolved approximately on unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain
Clinical narrative: sore throat; cough; This is a spontaneous report from a contactable Consumer. A 49-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 25Feb2021 as SINGLE DOSE for covid-19 immunisation. Medical history included mild covid-19. The patient's concomitant medications were not reported. On 01Mar2021 05:00, the patient experienced sore throat and cough. Patient reported to someone before speaking to you. She told me her name but patient forgot. They took all of the information from patient, she asked patient for the card that they gave her, but patient don't have it, it is in the car and her husband has it. Patient got the Pfizer shot on Thursday 25Feb2021. As of yesterday at 5am, she have had a sore throat, went away after couple of hours, have cough, no fever, no nausea, only have a cough. Patient asked whether these adverse effects from the vaccine because she usually baby sit her grandbaby, because she was not sure if it is a side effect or a cold. Maybe she caught it again, she had covid before, it wasn't like this, it was very mild. Upon follow-up on (02Mar2021), Patient reports that she took the Pfizer Inc, BioNTech COVID shot on Thursday, and now she had a really bad cough. Caller reports that she had no fever, no body aches, no nausea, so she was wondering if the cough could be a side effect of the vaccine. Coughing started yesterday early morning about 5am 01Mar2021. Patient had no other vaccines on the same day as her COVID vaccine. The outcome of sore throat was recovered and the outcome of cough was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Bowel movement irregularity, Chills, Defaecation urgency, Dysphonia, Feeling abnormal
Clinical narrative: urge to have a BM; left side of head had a funny sensation; Chills; hot flashes in my upper body; feels strange and voice has changed; feels strange and voice has changed; suddenly had to have a bowel movement; This is a spontaneous report from a contactable consumer or other non-HCP. A 76-years-old female patient (at the age of: 76-years) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6203; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in Left Arm on an unspecified date as 1st dose, single for covid-19 immunization. The patient Medical history was not reported. Concomitant medication included losartan potassium 50 mg once a day, ergocalciferol (VIT D) and calcium taken for an unspecified indication, start and stop date were not reported. No vaccination within four weeks prior to the first administration date of the suspect vaccine and No Family medical history relevant to ae and relevant tests. The patient experienced chills, hot flashes in my upper body, feels strange and voice has changed, and suddenly had to have a bowel movement on 02Mar2021, urge to have a bm and left side of head had a funny sensation on an unspecified date.  she got the first dose of the Pfizer Covid vaccine this morning around 08:00 AM, then the person who gave her the shot asked her what medication she takes and she told them, they did not say anything to her about it. States she took her medication for blood pressure around 09:30 AM at her regular time to take the medication, wants to know if it is okay Takes Losartan Potassium 50mg one time a day, states she took it with Vitamin D and Calcium. And States her voice is changed, she feels strange, states around 10:20 wanted to take bowel movement suddenly, could be a regular thing, states she feels some sort of hot flash sensations not bad, here and there and then feel chills. The patient underwent lab tests and procedures which included weight fluctuates between 144 and 145 on unspecified date. The outcome of the events feels strange, and voice has changed was not resolved and other events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Sensory disturbance, Weight
Clinical narrative: urge to have a BM; left side of head had a funny sensation; Chills; hot flashes in my upper body; feels strange and voice has changed; feels strange and voice has changed; suddenly had to have a bowel movement; This is a spontaneous report from a contactable consumer or other non-HCP. A 76-years-old female patient (at the age of: 76-years) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6203; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in Left Arm on an unspecified date as 1st dose, single for covid-19 immunization. The patient Medical history was not reported. Concomitant medication included losartan potassium 50 mg once a day, ergocalciferol (VIT D) and calcium taken for an unspecified indication, start and stop date were not reported. No vaccination within four weeks prior to the first administration date of the suspect vaccine and No Family medical history relevant to ae and relevant tests. The patient experienced chills, hot flashes in my upper body, feels strange and voice has changed, and suddenly had to have a bowel movement on 02Mar2021, urge to have a bm and left side of head had a funny sensation on an unspecified date.  she got the first dose of the Pfizer Covid vaccine this morning around 08:00 AM, then the person who gave her the shot asked her what medication she takes and she told them, they did not say anything to her about it. States she took her medication for blood pressure around 09:30 AM at her regular time to take the medication, wants to know if it is okay Takes Losartan Potassium 50mg one time a day, states she took it with Vitamin D and Calcium. And States her voice is changed, she feels strange, states around 10:20 wanted to take bowel movement suddenly, could be a regular thing, states she feels some sort of hot flash sensations not bad, here and there and then feel chills. The patient underwent lab tests and procedures which included weight fluctuates between 144 and 145 on unspecified date. The outcome of the events feels strange, and voice has changed was not resolved and other events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Heart rate, Heart rate increased, Insomnia, Pain in extremity
Clinical narrative: soreness on her arm/ sore arm; felt very cold; weird sensation which she can't fully explain. It was like electrical impulses all over her body started appearing and like her blood is running inside all over her body; heart rate went a little fast, recorded at 110-112; could not sleep; This is a spontaneous report from a contactable Nurse. A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 01Mar2021 (Batch/Lot Number: EN6205; Expiration Date: Jun2021) as 1st dose, single dose for covid-19 immunisation. Medical history included covid-19 from 27Nov2020 to an unknown date and aggressive fever. The patient's concomitant medications were not reported. The patient previously took albuterol, tylenol and mucinex for covid-19. The patient reported that she was fine after 1st dose of the Pfizer vaccine but experienced some soreness on her arm and took tylenol. When she got home, she felt very cold but did not have a fever and had a normal temperature. As she was laying down, she felt a weird sensation which she can't fully explain. It was like electrical impulses all over her body started appearing and like her blood is running inside all over her body. Her heart rate went a little fast, recorded at 110-112 while her normal is 100-110. She could not sleep because of this. She woke up today and mentioned that her symptoms are lessening, not as intense as they were last night, and there is a little improvement. She took Tylenol for her symptoms and did not go to work. She received the vaccine amidst having a previous COVID Diagnosis last thanksgiving, 27Nov2020 and stated that she may still have antibodies from her infection and that the vaccine might be interacting with it. She knew that the Pfizer vaccine was not tested in people with previous COVID Diagnosis and just followed the CDC's recommendation to get vaccinated after 90 days after the infection and inquired for information, Pfizer may have on these topics and if she should receive the 2nd dose on 22Mar2021. She had covid around thanksgiving being about 3 months ago, so she waited the 90 days to get the vaccine. She reported that since she was a covid patient, she was thinking is it because she had antibodies. She was checked 2 weeks in Feb2021 and she was positive for antibodies and wanted to know the relationship between antibodies and the vaccine. Therapeutic measures were taken as a result of soreness on her arm/ sore arm. The patient underwent lab tests and procedures which included heart rate: 110-112, heart rate went a little fast, recorded at 110-112 while her normal is 100-110, sars-cov-2 antibody test: positive on Feb2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Sensory disturbance
Clinical narrative: soreness on her arm/ sore arm; felt very cold; weird sensation which she can't fully explain. It was like electrical impulses all over her body started appearing and like her blood is running inside all over her body; heart rate went a little fast, recorded at 110-112; could not sleep; This is a spontaneous report from a contactable Nurse. A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 01Mar2021 (Batch/Lot Number: EN6205; Expiration Date: Jun2021) as 1st dose, single dose for covid-19 immunisation. Medical history included covid-19 from 27Nov2020 to an unknown date and aggressive fever. The patient's concomitant medications were not reported. The patient previously took albuterol, tylenol and mucinex for covid-19. The patient reported that she was fine after 1st dose of the Pfizer vaccine but experienced some soreness on her arm and took tylenol. When she got home, she felt very cold but did not have a fever and had a normal temperature. As she was laying down, she felt a weird sensation which she can't fully explain. It was like electrical impulses all over her body started appearing and like her blood is running inside all over her body. Her heart rate went a little fast, recorded at 110-112 while her normal is 100-110. She could not sleep because of this. She woke up today and mentioned that her symptoms are lessening, not as intense as they were last night, and there is a little improvement. She took Tylenol for her symptoms and did not go to work. She received the vaccine amidst having a previous COVID Diagnosis last thanksgiving, 27Nov2020 and stated that she may still have antibodies from her infection and that the vaccine might be interacting with it. She knew that the Pfizer vaccine was not tested in people with previous COVID Diagnosis and just followed the CDC's recommendation to get vaccinated after 90 days after the infection and inquired for information, Pfizer may have on these topics and if she should receive the 2nd dose on 22Mar2021. She had covid around thanksgiving being about 3 months ago, so she waited the 90 days to get the vaccine. She reported that since she was a covid patient, she was thinking is it because she had antibodies. She was checked 2 weeks in Feb2021 and she was positive for antibodies and wanted to know the relationship between antibodies and the vaccine. Therapeutic measures were taken as a result of soreness on her arm/ sore arm. The patient underwent lab tests and procedures which included heart rate: 110-112, heart rate went a little fast, recorded at 110-112 while her normal is 100-110, sars-cov-2 antibody test: positive on Feb2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Ear disorder, Headache, Paraesthesia oral
Clinical narrative: Tingling started around her mouth, went up her face, and in her head/tingling lips; Left ear is bothering her; Headache; Felt a rush go through her; This is a spontaneous report from a contactable consumer (patient) received via medical information team. A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: unknown), via an unspecified route of administration on 16Feb2021 as a single dose for COVID-19 immunization. The patient's medical history included intractable itching. The patient had a reaction to an epidural injection when she had a surgery 25 years ago. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced tingling started around her mouth, went up her face, and in her head/tingling lips, left ear is bothering her, headache, felt a rush go through her. As soon as she had the needle in her arm she felt a rush throughout her arm. She's also experiencing tingling in her mouth, around her lips, head and face. Before putting on her mask her lips start tingling in the outside only. Doesn't know if that should be expected or not. Everyone else she talked to has not had this experience. Tingling is periodic and not constant. Today, her lips are tingling and her left ear is bothering her. She would like to know if this has been reported before and if she should receive the second dose of the vaccine. The clinical outcome of the tingling started around her mouth, went up her face, and in her head/tingling lips, left ear is bothering her, headache, felt a rush go through her were unknown.   No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Myalgia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: test positive after 1st dose; little, slight muscle aches; pain at the injection site; This is a spontaneous report from a Non contactable Consumer. This Consumer reported for a male patient (husband) that:  A 72-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose Solution for injection, Lot number EL9264-A) via an unspecified route of administration, on 29Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient experienced SARS-CoV-1 test positive, muscle pain, vaccination site pain. The patient went into quarantine. Quarantine ended on 19Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 07Feb2021 and on 22Feb2021 sars-cov-2 test: negative. on an unspecified date with outcome of the events was unknown. The reporter stated that their quarantine is way over, and they have no symptoms or anything like that, and they were told to wait to get the second dose after a couple weeks, and it has been more than couple weeks that have gone by. They were told that they may have antibodies, and that they should wait 3 months until after they contracted COVID to get the second dose, which they would like to know if this is correct.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This is a spontaneous report from a contactable consumer (patient).  A 29-year- old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization.  Medical history and concomitant medications were not reported. One week after receiving the vaccine, the patient later experience fever and chills. It was reported that the chills that began at night and lasted until early afternoon (as reported). No treatment was received for the events. The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since the vaccination. The patient recovered from the events on unknown date. Patient thought it was not related to the vaccine.   No follow-up attempts are possible, information about lot/batch number cannot be obtained; Sender's Comments: Based on the information available and reported non-relatedness, contributory role of the suspect BNT162B2 can be excluded for pyrexia and chills. Since they could be concurrent condition.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Had pain before getting the vaccine but it's now getting worst; This is a spontaneous report from a contactable consumer or other non hcp. A 71-years-old elderly male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown) via an unspecified route of administration on an unspecified date at Single dose for COVID-19 immunization. The patient's Medical history included arthritis. She reported that her husband has stopped taking medications since 4 days now. They stopped taking a couple of mediations such as blood thinners, muscle relaxant and etc. The patient's concomitant medications were not reported. The patient was taking muscle relaxant to help with his pain related to arthritis. He also had pain before getting the vaccine but it's now getting worst because he hasn't taken his medication for a while. The outcome for the events was Unknown. Caller states that the pain her husband is experienced is not related to the vaccine. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Lip swelling
Clinical narrative: uncomfortable; my upper Right lip began to swell, slowly; This is a spontaneous report from a contactable consumer. A 63-years-old male patient received second dose BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: EN6203), via an unspecified route of administration, administered in Left arm on 04Mar2021 16:45 as 2nd dose, single dose; and previously took 1st dose of BNT162B2 for COVID-19 immunization. No covid prior vaccination and no known allergies. The patient medical history and concomitant medications were not reported. No vaccines within 4weeks. On 04Mar2021 17:00, 18 minutes after vaccination, patient upper Right lip began to swell, slowly. 30 minutes later when home it was very noticeable and uncomfortable. patient reported it was only point of concern. 6 hours later after 2 Tylenols, the swelling has decreased, Somewhat. No covid tested post vaccination. Patient reported no treatment was received. Patient was not recovered from events.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Nausea, Pyrexia
Clinical narrative: Vomiting; Nausea; Diarrhea; Headache; Chills; Fever; This is a spontaneous report from a contactable consumer (patient). A 42 years old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route, administered in Left arm on 04Mar2021 at 13:45 (at an age of 42 years during vaccination) as 1st dose, single dose for covid-19 immunisation. Medical history included known latex allergy. The patient had received other medications in two weeks prior to vaccination. The patient was not tested for covid prior to vaccination. Facility type vaccine was reported as Other. The patient had no other vaccine in four weeks to Covid-19 vaccination. On 04Mar2021 at 14:30, the patient experienced vomiting, nausea, diarrhea, headache, chills, fever. The patient was not tested for covid post to vaccination. The patient had not received any treatment medication for the resulted events. The outcome of the events was recovering.    No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; Nausea; Diarrhea; Headache; Chills; Fever; This is a spontaneous report from a contactable consumer (patient). A 42 years old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route, administered in Left arm on 04Mar2021 at 13:45 (at an age of 42 years during vaccination) as 1st dose, single dose for covid-19 immunisation. Medical history included known latex allergy. The patient had received other medications in two weeks prior to vaccination. The patient was not tested for covid prior to vaccination. Facility type vaccine was reported as Other. The patient had no other vaccine in four weeks to Covid-19 vaccination. On 04Mar2021 at 14:30, the patient experienced vomiting, nausea, diarrhea, headache, chills, fever. The patient was not tested for covid post to vaccination. The patient had not received any treatment medication for the resulted events. The outcome of the events was recovering.    No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pruritus, Throat irritation
Clinical narrative: dizziness; headache; Itching from head to toe including throat; Itching from head to toe including throat; This is a spontaneous report received from a non-contactable consumer (Patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 04Mar2021 14:00 (Batch/Lot Number: EN6199) as unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no known allergies, but he had other unspecified medical history. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. On 04Mar2021 14:00, the patient experienced dizziness, headache, itching from head to toe including throat. Patient received several rounds of Benadryl max dose to treat adverse events. No follow up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face, Urticaria
Clinical narrative: my lips swelled up severely; Facial swelling; I had giant itchy welts on legs and back and scalp; hives on back; This is a spontaneous report from a contactable other healthcare professional reported for herself. A 66-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER COVID-19 VACCINE, Batch number: Unknown), via an unspecified route in the right arm on 21Feb2021 at 09:00, as a single dose for covid-19 immunization (age at Vaccination was 66years). Medical history included chronic, osteopathic hives for more than 15 years ago. No known allergies reported. Concomitant medications taken in two weeks included Vitamin c (VITAMIN C [ASCORBIC ACID], curcuma longa (TURMERIC [CURCUMA LONGA], boswellia serrata (BOSWELLIA), ergocalciferol (VIT D) and cyanocobalamin (B12 [CYANOCOBALAMIN] (sublingual). Patient has not taken any other vaccine in four weeks. Since the vaccination, the patient had not been tested positive for COVID-19. On 22Feb2021 at 01:00, the next day, patient experienced hives on back, within 36 hours her lips swelled up severely, facial swelling and she had giant itchy welts on legs, back and scalp. Therapeutic treatment received as a result of the events included Benedryl, self-administered. Events assessed as non-serious by reporter. Reported that facial swelling subsided in about 6 hours, itchy welts come and go but are still present (11 days after the shot). Outcome of facial swelling was resolved and for all other events was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Pain, Pyrexia
Clinical narrative: Body aches/ achiness; Lethargy; Fever; This is a spontaneous report from a contactable other HCP. A 60-year-old male patient reported for himself that he received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration on 12Jan2021 08:30 in left arm as a second dose, single for COVID-19 immunization at public health clinic facility. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine) on an unspecified date for COVID-19 immunization. The patient did not receive any other vaccine within four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. The patient experienced body aches, achiness, lethargy and fever on 12Jan2021 at 11:00. The patient did not receive any treatment. The outcome of all events was recovered in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Trigeminal neuralgia
Clinical narrative: Trigeminal Neuralgia; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9267), via an unspecified route of administration in Arm Left on 24Feb2021 at 09:30(at the age of 43 years old) as 2nd dose, single dose for covid-19 immunisation at Health Clinic. Medical history was none. Known allergies was none. Other vaccine received in four weeks included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EM9810) via an unspecified route of administration in Arm Left on 03Feb2021 as first dose, single dose for covid-19 immunisation. Concomitant medication included lisdexamfetamine mesilate (VYVANSE) taken for an unspecified indication. The patient was not tested covid prior to vaccination. On 25Feb2021 at 20:00 the patient experienced trigeminal neuralgia. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Reporter reported as, "Doctor suspects a diagnosis of Trigeminal Neuralgia. Referred to a neurologist for confirmation and treatment plan". Therapeutic measures were taken as a result of trigeminal neuralgia. Treatment received as, medication to help with inflammation and pain. The patient was not tested for covid post vaccination. Outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site mass
Clinical narrative: Large lump at injection site; Large redness area almost half the top of arm; This is a spontaneous report from a contactable nurse (patient) or other Health Care Professional. A 69-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6203 and Expiry date: Unknown), via an unspecified route of administration in Arm Left, on 04Mar2021 at 12:00 PM (at the age of 69-years-old) as UNKNOWN, SINGLE for Covid-19 immunization. The patient medical history was not reported. The patient known allergies were not reported. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient did not receive other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 04Mar2021 at 16:00, the patient had experienced large lump at injection site, large redness area almost half the top of arm. The patient did not receive treatment for events. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Back pain, Fatigue, Glossodynia
Clinical narrative: Pain in arm and armpit; Pain in arm and armpit; Sore neck and jaw; Sore neck and jaw; Tongue very sensitive and still sensitive; Now I have a knot in my armpit that is very tender; Now I have a knot in my armpit that is very tender; Headache; tired; irritable; My back hurt for days; This is a spontaneous report from a contactable consumer (patient). A 48-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9266), via an unspecified route of administration, administered in arm right on 18Feb2021 at 16:30 (at an age of 48-years-old) as 2nd dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. She had known allergies and had other medical history. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318) via an unspecified route of administration, administered in arm right on 28Jan2021 at 16:15 as 1st dose, single dose for COVID-19 immunisation. She did not take other vaccine in four weeks. She had taken other medications in two weeks. Patient not had COVID prior vaccination and not had COVID tested post vaccination. On 18Feb2021 at 18:00, the patient experienced pain in arm and armpit, pain in arm and armpit, sore neck and jaw, sore neck and jaw, tongue very sensitive and still sensitive, now she had a knot in her armpit that is very tender that won't go away, headache, tired, irritable, her back hurt for days. The patient did not receive any treatment for the events. The clinical outcome of the pain in arm and armpit, pain in arm and armpit, sore neck and jaw, sore neck and jaw, tongue very sensitive and still sensitive, now she had a knot in her armpit that is very tender that won't go away, headache, tired, irritable, her back hurt for days were resolving.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Irritability, Neck pain, Pain in extremity, Pain in jaw
Clinical narrative: Pain in arm and armpit; Pain in arm and armpit; Sore neck and jaw; Sore neck and jaw; Tongue very sensitive and still sensitive; Now I have a knot in my armpit that is very tender; Now I have a knot in my armpit that is very tender; Headache; tired; irritable; My back hurt for days; This is a spontaneous report from a contactable consumer (patient). A 48-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9266), via an unspecified route of administration, administered in arm right on 18Feb2021 at 16:30 (at an age of 48-years-old) as 2nd dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. She had known allergies and had other medical history. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318) via an unspecified route of administration, administered in arm right on 28Jan2021 at 16:15 as 1st dose, single dose for COVID-19 immunisation. She did not take other vaccine in four weeks. She had taken other medications in two weeks. Patient not had COVID prior vaccination and not had COVID tested post vaccination. On 18Feb2021 at 18:00, the patient experienced pain in arm and armpit, pain in arm and armpit, sore neck and jaw, sore neck and jaw, tongue very sensitive and still sensitive, now she had a knot in her armpit that is very tender that won't go away, headache, tired, irritable, her back hurt for days. The patient did not receive any treatment for the events. The clinical outcome of the pain in arm and armpit, pain in arm and armpit, sore neck and jaw, sore neck and jaw, tongue very sensitive and still sensitive, now she had a knot in her armpit that is very tender that won't go away, headache, tired, irritable, her back hurt for days were resolving.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Pain in arm and armpit; Pain in arm and armpit; Sore neck and jaw; Sore neck and jaw; Tongue very sensitive and still sensitive; Now I have a knot in my armpit that is very tender; Now I have a knot in my armpit that is very tender; Headache; tired; irritable; My back hurt for days; This is a spontaneous report from a contactable consumer (patient). A 48-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9266), via an unspecified route of administration, administered in arm right on 18Feb2021 at 16:30 (at an age of 48-years-old) as 2nd dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. She had known allergies and had other medical history. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318) via an unspecified route of administration, administered in arm right on 28Jan2021 at 16:15 as 1st dose, single dose for COVID-19 immunisation. She did not take other vaccine in four weeks. She had taken other medications in two weeks. Patient not had COVID prior vaccination and not had COVID tested post vaccination. On 18Feb2021 at 18:00, the patient experienced pain in arm and armpit, pain in arm and armpit, sore neck and jaw, sore neck and jaw, tongue very sensitive and still sensitive, now she had a knot in her armpit that is very tender that won't go away, headache, tired, irritable, her back hurt for days. The patient did not receive any treatment for the events. The clinical outcome of the pain in arm and armpit, pain in arm and armpit, sore neck and jaw, sore neck and jaw, tongue very sensitive and still sensitive, now she had a knot in her armpit that is very tender that won't go away, headache, tired, irritable, her back hurt for days were resolving.  No follow-up attempts are possible. No further information is expected.