chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had both doses of the COVID-19 vaccination, a couple weeks after, the patient tested positive for COVID-19; had both doses of the COVID-19 vaccination, a couple weeks after, the patient tested positive for COVID-19; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A female patient of an unspecified age started received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE); both via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had both doses of the COVID-19 vaccination, a couple weeks after, the patient tested positive for COVID-19 on unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Got positive reading after her vaccination.; Got positive reading after her vaccination.; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients (herself and her husband). This is first (wife) of two reports. A female patient of an unspecified age received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that got positive reading after her vaccination on an unspecified date. She added that her husband got a bad covid outbreak after first dose and the location closed. The patient underwent lab tests and procedures which included covid-19 reading (sars-cov-2 test) was positive on an unspecified date. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: mild arm pain; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were unknown), via an unspecified route of administration on 20Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced mild arm pain on an unspecified date. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a sponsored program. A non-contactable consumer (patient) reported that a female patient of unspecified age received first dose of BNT162B2, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously took dupilumab (DUPIXENT). The patient took dupilumab the day before the covid vaccine. She was concerned if it worked, is she can get the second dose. She experienced a headache after covid vaccine. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, SARS-CoV-2 test
Clinical narrative: Loss of taste; Loss of smell; she tested positive- 5/tested positive for COVID-19; This is a spontaneous report from a sponsored Program. A contactable female consumer (patient) reported that a 37-years-old female patient received bnt162b2 (BNT162B2; Batch/lot number: EL1284) first dose, intramuscular on 11Jan2021 between 9-9:30 a.m at SINGLE DOSE at Right upper arm for covid-19 immunisation.  The patient medical history was not reported. Prior Vaccinations (within 4 weeks) was None. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None.  The patient's concomitant medications were not reported.  The patient experienced she tested positive- 5/tested positive for covid-19 on 18Jan2021 with outcome of unknown, loss of taste on 18Jan2021 02:00 with outcome of recovered on 23Jan2021, loss of smell on 18Jan2021 02:00 with outcome of recovered 23Jan2021.  The patient underwent lab tests and procedures which included sars-cov-2 test (COVID-19 Rapid Test): positive on 18Jan2021, sars-cov-2 test (COVID-19 Test): inconclusive on 29Jan2021.  The action taken in response to the event(s) for bnt162b2 was not applicable. Caller was scheduled today for the 2nd dose of Pfizer vaccine. However, 2 weeks ago she tested positive- 5 days after the 1st dose of the vaccine. Today, she had no symptoms for over a week and she didn't know yet if she was still positive for COVID or not. Caller was asking if she can take the 2nd dose today or if she needed to wait for days/weeks before taking it. On 11Jan2021, the caller received her first dose of COVID-19. On 18Jan2021, the caller tested positive for COVID-19. She was symptom free after 5 days. She was scheduled to receive her second dose at 12:00pm today. She stated she has been getting conflicting information. She wanted to know can she receive the second vaccine? Since 23Jan2021, she has been symptom free. She mentioned she filled out a questionnaire online about and she did respond that she tested positive after receiving the first dose, but she never heard anything back. Caller stated she noticed probably around 2 am in the morning on 18Jan, she had that feeling in my throat where she was losing her sense of smell and taste. She woke up that morning around 8am, and these senses were completely gone. Caller stated it was the only symptom she had. She confirmed she had a COVID-19 Rapid test done on 18Jan2021. She actually went and got tested again on Friday, 29Jan2021, to see if she still had COVID. However, the person doing the test must not have done it right. The person only swabbed one nostril and the test came back inconclusive as of yesterday. The events not require a visit to Emergency Room and Physician Office.   No further information was provided or obtained.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Myalgia, Neck pain
Clinical narrative: he had a problem with his heart; neck pain/his neck on the left side, when he turn his head to the left side it hurts; muscle pain is from neck down to upper shoulder; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. On 28Jan2021, patient experienced neck pain; further reported as his neck on the left side, when he turn his head to the left side hurts and patient also experienced muscle pain from his neck down to the upper shoulder. It was also reported that the patient had a problem with his heart on an unspecified date. Outcome of events was unknown.   Information on the lot/batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Rash, Vaccination site warmth
Clinical narrative: Rash on my chest; I guess the rash joined one another on my chest, inside my legs and both my upper arms; Cough; My left arm where I got the shot that arm, it was feverish, it was very hot; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of BNT162B2, lot no. EL9262, via an unspecified route of administration (left arm) on 24Jan2021 at a single dose for COVID-19 immunization at a hospital facility. They gave her a dose that was recommended. Medical history and concomitant medications were not reported. The patient reported a reaction that she had to her first vaccine. It was Pfizer BioNTech COVID-19 Vaccine EUA and she had that on 24Jan2021 and she had a little cough the following day (25Jan2021) which she did not have before and then she didn't recover from the cough but she woke up on the 27th with a little bit of rash on her chest and she just kind of ignored it but within four hours she had not just a rash, she had she guessed the rash joined one another on her chest, inside her legs and both her upper arms. She started taking Benadryl and it took about 125 mg of the Benadryl over 30 hours before she was able to get rid of the rash. It happened three days later at her house. She treated herself with Benadryl. She was not experiencing any kind of breathing problems or anything that she was alarmed about. She only took Benadryl 25 mg when she first saw it because the rash was not severe but within four hours even after she took the 25 mg, the rash became very severe and her left arm where she got the shot that arm, it was feverish, it was very hot on Jan2021. She didn't know next step with her second dose. She felt like rash was severe. Her rash took over 30 hours and taking 125mg Benadryl to get rid of it. So, she didn't know how to prepare or what to expect. She was due to get it on 14Feb. The patient recovered from rash generalized on Jan2021, not recovered from cough, while outcome of other event was unknown.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Discomfort, Heart rate, Heart rate increased
Clinical narrative: discomfort; did not sleep a wink last night; Nauseous; blood pressure elevated/139/94; heart rate elevated/His heart rate is currently 139; This is a spontaneous report from a contactable consumer (patient). A 56 -year-old male patient received his  first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9264), intramuscular (on left arm) on 28Jan2021 12:30 (at the age of 56 -years-old), single dose for COVID-19 immunization. No relevant medical history. The patient's concomitant medications were not reported. Patient is calling about the first dose of the Pfizer covid19 vaccine which he received on Thursday. Yesterday, he started getting nauseous, it is terrible and very strong. The nausea has been continuous since yesterday. His blood pressure and heart rate is pretty elevated. Declines any treatment. The nausea was bad yesterday and stayed bad, he did not sleep a wink last night. His last blood pressure taken about 10 minutes ago was 139/94. His blood pressure is normally 125 over 65 or 70. His heart rate is currently 139. His heart rate and blood pressure became elevated yesterday. States it might have to do with how much discomfort he is in. When querying other medications and medical conditions, he reports nothing out of the ordinary. The outcome of the events sleep disorder and discomfort was unknown, other events was not recovered. No Prior Vaccinations (within 4 weeks).No AE(s) following prior vaccinations.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Sleep disorder
Clinical narrative: discomfort; did not sleep a wink last night; Nauseous; blood pressure elevated/139/94; heart rate elevated/His heart rate is currently 139; This is a spontaneous report from a contactable consumer (patient). A 56 -year-old male patient received his  first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9264), intramuscular (on left arm) on 28Jan2021 12:30 (at the age of 56 -years-old), single dose for COVID-19 immunization. No relevant medical history. The patient's concomitant medications were not reported. Patient is calling about the first dose of the Pfizer covid19 vaccine which he received on Thursday. Yesterday, he started getting nauseous, it is terrible and very strong. The nausea has been continuous since yesterday. His blood pressure and heart rate is pretty elevated. Declines any treatment. The nausea was bad yesterday and stayed bad, he did not sleep a wink last night. His last blood pressure taken about 10 minutes ago was 139/94. His blood pressure is normally 125 over 65 or 70. His heart rate is currently 139. His heart rate and blood pressure became elevated yesterday. States it might have to do with how much discomfort he is in. When querying other medications and medical conditions, he reports nothing out of the ordinary. The outcome of the events sleep disorder and discomfort was unknown, other events was not recovered. No Prior Vaccinations (within 4 weeks).No AE(s) following prior vaccinations.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first single dose of BNT162B2 (Solution for injection, lot number: EL9263, exp date not reported), via an unspecified route of administration (anatomical location: arm left) on 02Feb2021 11:00 as treatment first dose (COVID-19 immunisation). Vaccination Facility Type: at the mall. Vaccine was not administered at military facility. Medical history included diabetes type 1, from late 30s or 40s; and she had a stroke when she was 53 years old. Family history included sister with type 1 diabetes, other sister with hypogammaglobulin anemia. Concomitant medication included ongoing oral ramipril taking since she was 53 because she had a stroke as blood thinner. The patient had no prior vaccinations within 4 weeks. She thought she got Moderna but they sent her home with Pfizer paper. Asking how can she know which vaccine she had? Then states now she sees the name Pfizer on her vaccine card. Mentions that she had some dizziness in the last half hour on 02Feb2021. She was scheduled to receive the next dose of the vaccine 23Feb2021. No investigation assessment performed. The outcome of dizziness was recovering (ongoing at the time of reporting).
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose, Dizziness
Clinical narrative: Dizziness; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first single dose of BNT162B2 (Solution for injection, lot number: EL9263, exp date not reported), via an unspecified route of administration (anatomical location: arm left) on 02Feb2021 11:00 as treatment first dose (COVID-19 immunisation). Vaccination Facility Type: at the mall. Vaccine was not administered at military facility. Medical history included diabetes type 1, from late 30s or 40s; and she had a stroke when she was 53 years old. Family history included sister with type 1 diabetes, other sister with hypogammaglobulin anemia. Concomitant medication included ongoing oral ramipril taking since she was 53 because she had a stroke as blood thinner. The patient had no prior vaccinations within 4 weeks. She thought she got Moderna but they sent her home with Pfizer paper. Asking how can she know which vaccine she had? Then states now she sees the name Pfizer on her vaccine card. Mentions that she had some dizziness in the last half hour on 02Feb2021. She was scheduled to receive the next dose of the vaccine 23Feb2021. No investigation assessment performed. The outcome of dizziness was recovering (ongoing at the time of reporting).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use, Vaccination site mass, Vaccination site pruritus
Clinical narrative: I got the first shot on 24Jan2021 and I got the second dose on 31Jan2021; I got the first shot on 24Jan2021 and I got the second dose on 31Jan2021; Have a lump on my arm and it's very itchy/lump where they give me the shot; Have a lump on my arm and it's very itchy/lump where they give me the shot; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 31Jan2021 at a single dose on arm for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient received the first dose of BNT162B2 for COVID-19 immunisation on 24Jan2021. Consumer stated, "I took my second Covid shot on Sunday (31Jan2021) and I have a lump where they give me the shot. I have a lump on my arm and it's very itchy. So that's what I wanted to know that is why I have been hold for an hour to find out how you can assist me. I am asking you what you can do for me. I don't think you understand me. I have been holding an hour because my arm has a lump where I got the shot. Are they supposed to give the first shot and second shot in the same arm?" Event start date was reported as "Yesterday, 01Feb2021." The patient did not receive treatment for the events. The outcome of the events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: his arm was just sore for a day; This is a spontaneous report from a contactable healthcare professional (patient). A male patient of an unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiration date were not provided) solution for injection, via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he received the first dose of the COVID vaccine on 21Jan2021 (12 days ago). He stated that he was fine, his arm was just sore for a day on an unspecified date in 2021. The outcome of the event was recovered on an unspecified date in 2021.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise
Clinical narrative: Chills; Very tired; just don't feel well; Headache; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration on 2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced chills, very tired, just don't feel well all on 2021 with outcome of unknown and headache on 2021 with outcome of not recovered. The patient stated, "I am having some I think they are side effects, I had my injection for the vaccine (Clarified as COVID 19 vaccine Pfizer) Thursday last Thursday and I was wondering, I didn't had any side effect right away but I am having chills, no fever, very tired, just don't feel well, I didn't know (incomplete sentence), I read the list that's on the list headache but it still be 5 days later." On paraphrasing concern, patient stated, "Yeah, the chills are the worst more than the headache that is my question."  Information about lot/batch number has been requested.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: When she got the first dose it hurt a little, but didn't hardly feel anything.; This is a spontaneous report from a contactable consumer (patient).  A 90-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot: Either EX3246 or EL3246) via an unspecified route of administration left arm, at the age of 90-year-old, on 07Jan2021 around 13:30-14:00, single dose, for covid-19 immunisation.  Medical history included glaucoma and drip down her nose and sinus.  The patient's concomitant medications were not reported. In Jan2021, when she got the first dose, it hurt a little but didn't hardly feel anything. Outcome of the event was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Dyspnoea, Feeling hot
Clinical narrative: could taste metal in my mouth; get over heated and breathing slightly difficult; get over heated and breathing slightly difficult; This is a spontaneous report from a contactable consumer reported for herself. A 73-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer; lot number: EL8982) via an unspecified route of administration at left arm on 16Feb2021 at 01:15 PM at a single dose for COVID-19 immunization. Medical history included allergies to medications, food, or other products: dairy and pineapple. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer; lot number: EL8982) at left arm on 29Jan2021 at 01:15 PM for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included acetylsalicylic acid (BABY ASPIRIN) and vitamin D nos. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was other. As soon as the nurse started to administer the shot the patient could taste metal in her mouth. Within minutes she started to get over heated and breathing slightly difficult. She opened all the windows in the car and reminded herself that she was breathing and could blow the horn at any time. Difficulty breathing lasted minutes but the overheating about 20 minutes. Once she cooled down all symptoms disappeared. Adverse event start date was reported as on 16Feb2021 at 01:15 PM. The events were reported as non-serious. No treatment received for events. The outcome of events was resolved on 16Feb2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Chills, Headache, Neck pain
Clinical narrative: Fever at 102.2; chills; stomach cramping; sore neck; sore at site of injection; minor headache; runny nose; This is a spontaneous report from a contactable consumer reported for self. This 37-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EN 5318) at single dose on 16Feb2021 10:00 for COVID-19 immunisation. The first dose was on 26Jan2021 at 11:00 AM (Lot#: EN5318) in left arm. Medical history was not reported. Allergies to medications, food, or other products was none known. Concomitant medication included vitamin D. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient had fever at 102.2 and chills, stomach cramping, sore neck, sore at site of injection, minor headache and runny nose on 17Feb2021 12:00 AM. There was no treatment received for the adverse event. This was a non-serious report. The events did not result in death, not life threatening, not caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. Patient was recovering from the events.   No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, Vaccination site pain
Clinical narrative: Fever at 102.2; chills; stomach cramping; sore neck; sore at site of injection; minor headache; runny nose; This is a spontaneous report from a contactable consumer reported for self. This 37-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EN 5318) at single dose on 16Feb2021 10:00 for COVID-19 immunisation. The first dose was on 26Jan2021 at 11:00 AM (Lot#: EN5318) in left arm. Medical history was not reported. Allergies to medications, food, or other products was none known. Concomitant medication included vitamin D. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient had fever at 102.2 and chills, stomach cramping, sore neck, sore at site of injection, minor headache and runny nose on 17Feb2021 12:00 AM. There was no treatment received for the adverse event. This was a non-serious report. The events did not result in death, not life threatening, not caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. Patient was recovering from the events.   No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was sore for a day; This 66- year-old female patient contactable consumer (reported for herself) received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 13Feb2021 at 10:00 AM (at the age of 66-years-old) as a single dose for COVID-19 immunization, in left arm. The facility where COVID-19 vaccine was administered was at a Hospital. She has had no other vaccines on the same day or in the past 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history included: Thyroid problem. Concomitant medication included: Synthroid 88mcg, Synthroid 75mcg, Ibandronate. On 13Feb2021 at 5:00PM, the patient reported that her arm was sore for a day. The clinical outcome of the event arm sore was recovered. It was reported that since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Really Big Headache; This is a spontaneous report from a contactable other health professional. A 19-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (batch/lot is unknown: Not available/provided to reporter at the time of report completion) via an unspecified route of administration on 16Feb2021 at single dose for COVID-19 immunization. Medical history included Covid-19. Prior to vaccination, the patient was diagnosed with COVID-19. No known allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient experienced really big headache on 17Feb2021. Event did not result in Emergency Room Visit or Physician Office Visit. No treatment received for the adverse event. The event was considered non-serious per reporter. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Balance disorder, Body temperature, Chest discomfort
Clinical narrative: extremely weak; right shoulder pain; temp started rising & by 2PM it was up to 102.4; legs were like jelly; felt unsteady & like I would fall; felt so bad/felt awful/talking about end of life wishes; no appetite; chest tightness; This is a spontaneous report from a contactable other health care professional reported for herself. A 58-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not available), via an unspecified route of administration on 09Feb2021 16:30 (at the age of 58-year-old) at single dose in left arm for covid-19 immunization. Medical history included Heart Failure, Sarcoidosis, Asthma, Obesity and Covid from Apr2020 to an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. Concomitant medications the patient received within 2 weeks of vaccination included prednisone, carvedilol (COREG), spironolactone (ALDACTONE), hydrochlorothiazide, lisinopril (LISINOPRIL/HCTZ). The day of injection on 09Feb2021 at 16:30 PM that same night 8 pm the patient started experiencing some chest tightness. Since the patient live in country when she left work(hospital). At that point she took 50mg of P.O. benadryl (diphenhydramine). So the patient just took time and hung around town. She went to family dollar then publix. She felt better at 9 pm so and went home. The next morning (on 10Feb2021 her legs were like jelly when she woke up to go to bathroom. She felt unsteady and like she would fall. Next thing she just felt so bad and no appetite so she ate nothing that day. Her temp started rising and by 2PM on 10Feb2021 it was up to 102.4, the patient felt so awful then the feeling of doom set in so she was talking about end of life wishes. She had Covid back in Apr2020 and it was like reliving it again. On 11Feb2021 she felt better but had to call out low grade 99.4 only she was able to eat some but extremely weak and right shoulder pain (moderate). Friday (on 12Feb2021) she went to work but still felt weak. She felt better over the weekend (Feb2021). Here we were 17Feb2021 and still not completely there but 90% better. The adverse events result in doctor or other healthcare professional office/clinic visit. No treatment received for other adverse event. The patient underwent lab tests and procedures which included body temperature: 102.4 on 10Feb2021, body temperature: 99.4 on 11Feb2021, Nasal Swab Covid-19/SARS: negative on 16Feb2021. The outcome of the events was reported as recovered in Feb2021.  Information on the lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Feeling abnormal, Limb discomfort, Pyrexia, SARS-CoV-2 test
Clinical narrative: extremely weak; right shoulder pain; temp started rising & by 2PM it was up to 102.4; legs were like jelly; felt unsteady & like I would fall; felt so bad/felt awful/talking about end of life wishes; no appetite; chest tightness; This is a spontaneous report from a contactable other health care professional reported for herself. A 58-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not available), via an unspecified route of administration on 09Feb2021 16:30 (at the age of 58-year-old) at single dose in left arm for covid-19 immunization. Medical history included Heart Failure, Sarcoidosis, Asthma, Obesity and Covid from Apr2020 to an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. Concomitant medications the patient received within 2 weeks of vaccination included prednisone, carvedilol (COREG), spironolactone (ALDACTONE), hydrochlorothiazide, lisinopril (LISINOPRIL/HCTZ). The day of injection on 09Feb2021 at 16:30 PM that same night 8 pm the patient started experiencing some chest tightness. Since the patient live in country when she left work(hospital). At that point she took 50mg of P.O. benadryl (diphenhydramine). So the patient just took time and hung around town. She went to family dollar then publix. She felt better at 9 pm so and went home. The next morning (on 10Feb2021 her legs were like jelly when she woke up to go to bathroom. She felt unsteady and like she would fall. Next thing she just felt so bad and no appetite so she ate nothing that day. Her temp started rising and by 2PM on 10Feb2021 it was up to 102.4, the patient felt so awful then the feeling of doom set in so she was talking about end of life wishes. She had Covid back in Apr2020 and it was like reliving it again. On 11Feb2021 she felt better but had to call out low grade 99.4 only she was able to eat some but extremely weak and right shoulder pain (moderate). Friday (on 12Feb2021) she went to work but still felt weak. She felt better over the weekend (Feb2021). Here we were 17Feb2021 and still not completely there but 90% better. The adverse events result in doctor or other healthcare professional office/clinic visit. No treatment received for other adverse event. The patient underwent lab tests and procedures which included body temperature: 102.4 on 10Feb2021, body temperature: 99.4 on 11Feb2021, Nasal Swab Covid-19/SARS: negative on 16Feb2021. The outcome of the events was reported as recovered in Feb2021.  Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Nausea
Clinical narrative: Fever 100.7; chills; headache; nausea; injection site pain redness & swelling; injection site pain redness & swelling; injection site pain redness & swelling; exhaustion; This is a spontaneous report from a contactable 65 reporting for herself. A 65-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN6201/expiration date: not provided), via an unspecified route of administration, on 12Feb2021 at 11:00 (at the age of 65 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included Hashimoto's hypothyroidism. The patient has allergies to halibut and sea kelp. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL8982/expiration date: not provided), via an unspecified route of administration, on 22Jan2021 at 03:30 PM (at the age of 65 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levothyroxine sodium (SYNTHROID), rosuvistatin, acetylsalicylic acid (ASPIRIN), probiotic, and vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Feb2021 at 23:00, the patient experienced fever 100.7, chills, headache, nausea, injection site pain redness and swelling, and exhaustion. The events did not require hospitalization. The outcome of the events fever 100.7, chills, headache, nausea, injection site pain redness and swelling, and exhaustion was recovering. Since the vaccination, the patient had not been tested for COVID-19.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Fever 100.7; chills; headache; nausea; injection site pain redness & swelling; injection site pain redness & swelling; injection site pain redness & swelling; exhaustion; This is a spontaneous report from a contactable 65 reporting for herself. A 65-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN6201/expiration date: not provided), via an unspecified route of administration, on 12Feb2021 at 11:00 (at the age of 65 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included Hashimoto's hypothyroidism. The patient has allergies to halibut and sea kelp. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL8982/expiration date: not provided), via an unspecified route of administration, on 22Jan2021 at 03:30 PM (at the age of 65 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levothyroxine sodium (SYNTHROID), rosuvistatin, acetylsalicylic acid (ASPIRIN), probiotic, and vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Feb2021 at 23:00, the patient experienced fever 100.7, chills, headache, nausea, injection site pain redness and swelling, and exhaustion. The events did not require hospitalization. The outcome of the events fever 100.7, chills, headache, nausea, injection site pain redness and swelling, and exhaustion was recovering. Since the vaccination, the patient had not been tested for COVID-19.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Dyspnoea, Pruritus
Clinical narrative: Deep itching; dry cough in lungs; chest tightness, heaviness; shortness of breath for 4 days after; This is a spontaneous report from a contactable consumer reported for himself that a 42-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at Left arm on 25Jan2021 12:00 at single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Hospital. Medical history included Seasonal allergies, various surgeries. Concomitant medication included levocetirizine dihydrochloride (LEVOCETIRIZIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Deep itching dry cough in lungs and chest tightness, heaviness, shortness of breath for 4 days after, events start date provided as 07Feb2021 04:00 PM. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered. The patient received the second dose of BNT162 on 13Feb2021 11:30 AM via an unspecified route of administration at Right arm for covid-19 immunization.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Nausea
Clinical narrative: Nausea; tiredness; headache; injection site tenderness; feeling unwell; chills; fever waves; This is a spontaneous report from a contactable consumer reported for self. This 52-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 16Feb2021 11:00 AM in left arm for COVID-19 immunization. Medical history included HBP (Blood pressure high); thyroid issues; obesity; known_allergies: seasonal allergies; covid-19. Concomitant medications the patient received within 2 weeks of vaccination included levothyroxine, losartan, HCTZ, vitamin D NOS, paracetamol (TYLENOL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced nausea, tiredness, headache, injection site tenderness, feeling unwell, chills/fever waves on 16Feb202112:00 PM. There was no treatment received for the adverse event. This was a non-serious report. The events did not result in death, not life threatening, not caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. The outcome of events was unknown.   Information on the lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Nausea; tiredness; headache; injection site tenderness; feeling unwell; chills; fever waves; This is a spontaneous report from a contactable consumer reported for self. This 52-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 16Feb2021 11:00 AM in left arm for COVID-19 immunization. Medical history included HBP (Blood pressure high); thyroid issues; obesity; known_allergies: seasonal allergies; covid-19. Concomitant medications the patient received within 2 weeks of vaccination included levothyroxine, losartan, HCTZ, vitamin D NOS, paracetamol (TYLENOL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced nausea, tiredness, headache, injection site tenderness, feeling unwell, chills/fever waves on 16Feb202112:00 PM. There was no treatment received for the adverse event. This was a non-serious report. The events did not result in death, not life threatening, not caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. The outcome of events was unknown.   Information on the lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mammogram, Ultrasound scan
Clinical narrative: enlarge lymph node under left armpit detected in sonogram. Not visual to eye or felt with manual examination; This is a spontaneous report from a contactable consumer reported for herself. A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT# EL9262), via an unspecified route of administration in left arm on 03Feb2021 at second single dose for covid-19 immunisation. Medical history included high blood pressure, hypothyroidism, low vitamin D, breast cancer survivor since Jan2018. No allergies to medications, food, or other products. Patient was not pregnant at the time of vaccination. The patient previously took bnt162b2 (LOT# EL1284) in left arm on 13Jan2021 at first single dose for covid-19 immunisation. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was receiving yearly mammogram and sonogram for breast cancer survivor since Jan2018. Enlarge lymph node under left armpit was detected in sonogram. Not visual to eye or felt with manual examination. Event was considered as non-serious. It was unknown whether treatment was received. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Alanine aminotransferase abnormal, International normalised ratio, International normalised ratio increased
Clinical narrative: Alt is at 148; my INR level went from 2.9 to 4.3; This is a spontaneous report from a contactable consumer, the patient. This 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose  1, single dose via an unspecified route of administration in the left arm on 15Feb2021 at 12:00 PM (at the age of 65-years-old ) for COVID-19 vaccination. Relevant medical history included asthma and chronic blood clot in heart. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included amiodarone and warfarin. On 16Feb2021 at 15:00 the patient experienced alanine aminotransferase (ALT) at 148 and international normalized ratio (INR) went from 2.9 to 4.3. The events were reported as non-serious and required a doctor or other healthcare professional office/clinic visit. Treatment received for events alanine aminotransferase (ALT) at 148 and international normalized ratio (INR) went from 2.9 to 4.3 included reducing dosage of warfarin still working on the liver. The clinical outcome of alanine aminotransferase (ALT) at 148 and international normalized ratio (INR) went from 2.9 to 4.3 was unknown. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Dysphagia, Dysphonia, Sensation of foreign body
Clinical narrative: hoarse voice; felt like she had a big lump in her throat; difficulty swallowing; Allergic reaction; This is a spontaneous report from a contactable consumer (patient's daughter) received via Medical Information Team.  An 85-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265), via an unspecified route of administration on 04Feb2021 (at the age of 85 years) at single dose for COVID-19 immunisation.  The patient medical history included allergic to different medications.  The patient's concomitant medications were not reported.  It was reported that on 04Feb2021, the patient an hour after the vaccine developed a hoarse voice and two hours later felt like she had a big lump in her throat and had difficulty swallowing, their healthcare provider said he didn't believe it was an allergic reaction and was leaving it up to her if she wants to get it or not. The reporter stated her mother is allergic to different medications and those allergic reactions started the same way this did. The patient outcome of the events was unknown.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nausea, Pain, Pyrexia
Clinical narrative: body aches; headache; nausea; a low-grade fever; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) via an unspecified route of administration on 16Feb2021 12:30 at single dose on left arm for covid-19 immunisation. The medical history was none. Historical Vaccine included first dose of of bnt162b2 (lot number: EL3247) on 26Jan2021 12:30 at single dose on left arm for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included vitamin D, and ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE). The patient experienced body aches, headache, nausea and a low-grade fever on 17Feb2021. About 12 hours after the second dose, the patient started to have body aches, a headache, and nausea. This lasted for about 18 hours. At about 24 hours post-shot, she took her temperature and had a low-grade fever. She took 400 mg of ibuprofen at about 24 hours post-shot and that helped ease the side effects. By 30 hours post-shot, she was able to return to normal activies. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered on 17Feb2021.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. This consumer reported that a 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 31-years, via an unspecified route of administration on 04Feb2021 at single dose for COVID-19 immunisation. Medical history included anxiety. Concomitant medication included venlafaxine hydrochloride (EFFEXOR) for anxiety. Patient stated that she started to show symptoms of COVID-19 on 10Feb2021 and tested positive for COVID-19 on 11Feb2021 and her quarantine is going to be over this weekend on 21Feb2021 and scheduled to get a second dose on 25Feb2021 (Thursday) and wondering if it is recommended that she gets the 2nd dose next week since had a positive COVID-19 test. No treatment received. Outcome of the event was unknown.   Information on the lot/batch number has been requested.