chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Influenza like illness
Clinical narrative: tired; brain fog; general flu like symptoms; This is a spontaneous report from a non-contactable other hcp (patient) via Pfizer sales representative. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not reported) as dose 1, single and on 04Feb2021 as dose 2, single both via an unspecified route of administration on an unspecified date for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date patient experienced tired, brain fog, general flu like symptoms following first dose of vaccine. On second dose she also had these same like symptoms. She received second dose on 04Feb and is symptom free as of today. The outcome of the events was recovered an unspecified date in Feb2021.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: episodes of light headiness; This is a spontaneous report from non-contactable Other-HCP via Pfizer Sales Representative.  A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot Number: Unknown), via unspecified route of administration, on an unspecified date as a dose 2, single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. On an unspecified date the patient experienced episodes of light headiness. It was reported that, patient experienced episodes of light headiness after second dose lasted less than 24 hours. The outcome for the reported event was resolved on an unspecified date.  No follow-up attempts are possible. Information on Batch number, Lot number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, SARS-CoV-2 test
Clinical narrative: Dizziness; This is a spontaneous report from a non-contactable other HCP via Pfizer sales representative. A patient of an unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration on an unspecified date as a dose 2, single for covid-19 immunization. Medical history included confirmed covid prior to beginning vaccine series and was not 90 days from original diagnosis. Concomitant medications were not reported. On an unspecified date, the patient (HCP) experienced some dizziness. The patient underwent lab tests and medical procedures which included SARS-CoV-2 test on an unspecified date, which showed result of confirmed covid. The clinical outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Limb discomfort, Muscle rigidity, Musculoskeletal stiffness, Pain
Clinical narrative: extreme body pain all over and in particular she is having trouble with her legs; extreme body pain all over and in particular she is having trouble with her legs; Her muscles are rigid and she can't even stretch them; Trouble walking; Her muscles are rigid and she can't even stretch them/leg stiffness; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- UNKNOWN) via an unspecified route of administration on 15Feb2021 as dose 2, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- UNKNOWN) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. She had side effects after second dose on 22Feb2021, 1 week (7 days) after the vaccine. Her muscles became rigid, had trouble walking, started sore all over and then legs got stiff and trouble walking, and she walked every day, all day everywhere normally on 22Feb2021. She was wondering, she had her second shot on the 15Feb2021 and she was fine with both shots but then 3 days ago she woke up with just extreme body pain all over and in particular she was having trouble with her legs and it was getting worse every day. It was like her muscles were so rigid and she could not even stretch them. She was wondering was this from the COVID vaccine or was there something else bizarre going on. She walked all day everywhere normally. She said she had somewhere to be if it only takes a minute or 2 she can do a report but if it is longer she would have to do it later. She had been holding several hours to get someone and now she has run out of time. She asked will she be talking to someone now about this. She asked was all of that going to take more than 4 to 5 minutes because she had to get where she was going. She said she will just call them back later. Her muscles became rid get, trouble walking, 22Feb2021 (also reported as 22Jan2021) started sore all over and then legs stiff and trouble walking and she walks everyday. She had not talked to her doctor. The outcome of all event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: feeling sick today; This is a spontaneous report from a female contactable consumer or other non hcp (parent) (patient's mother) reported for a male patient (in his 40s). A 4-decade-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 for covid-19 immunisation. On an unspecified date the patient experienced feeling sick today. Reporter stated that she was speaking with another agent and got disconnected from the call. She is a 76-year-old female calling to report side effects after receiving her second dose of the Pfizer COVID-19 vaccine yesterday. She states she did not receive any paperwork including the recipient fact sheet so she did not know what to expect. Since yesterday she has been experiencing: having pain at injection site it was very bad and could not raise my arm until today, fatigue, muscle pain, chills, lymph nodes in my neck are swollen, last night it was pretty bad, it took me until midday to feel a little bit better. Reporter also states that her son is in his 30's almost 40 and is feeling sick today, he has received his second dose as well. Reporter wanted to know if these symptoms were common after receiving the second dose of the Pfizer COVID-19 vaccine and how long these symptoms would last. Reporter also mentioned that when she was speaking to the agent prior to disconnection she was told that more people have reported side effects after the second dose than the first dose and would like to know if that information is true. Reporter wants to know how long she should wait before contacting her doctor about her side effects or what red flags she should be looking for after experiencing her side effects with the second dose of the Pfizer COVID-19 vaccine. Reporter wants to know if there are any contraindications regarding what she can or cannot eat after receiving the Pfizer COVID-19 vaccine. Outcome of the event was unknown.  Information of the Lot/Batch number has been requested  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 101.0
Sex: F
Vaccine: COVID19
Symptoms: Renal disorder
Clinical narrative: Kidneys problems; This is a spontaneous report from a contactable consumer. This contactable consumer reported for her grandmother. A 101-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 10Feb2021 (At the age of 101-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the patient experienced kidneys problems. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Breast mass
Clinical narrative: Lump on my breast parallel to the arm pit and it is not on the side where I was injected, it is on the oppesite side; This is a spontaneous report from a contactable consumer (patient).  A 76-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL926 and expiry date: not reported), via an unspecified route of administration on 03Feb2021 as dose 2, single (Age at vaccination: 76-year-old) for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL3247 and expiry date: May2021) via an unspecified route of administration on 13Jan2021 as dose 1, single (Age at vaccination: 76-year-old) for COVID-19 immunization. On 10Feb2021 (After receiving her 2nd dose of the COVID-19 vaccine), the patient has developed a lump in her breast parallel to the arm pit and it was not on the side where she was injected, it was on the opposite side. The patient believes it was a direct result of receiving the vaccine. The lump hasn't gone away, and it hasn't gone down terribly much but she thinks it's going down, but she can't tell (Patient was not sure). The patient did not receive any treatment for the event. Outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Muscle rigidity, Nasopharyngitis, Tremor
Clinical narrative: he feels wiped out; Shaking; Vomiting; rigidity in his upper body; he started getting cold and having chills; he started getting cold and having chills; This is a spontaneous report from a contactable consumer or other non hcp.   A 79-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6201 and expiry date was not reported), via an unspecified route of administration, on 24Feb2021 at 06:30 AM (age at vaccination: 79-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of COMIRNATY with lot no EL9261. On 24Feb2021, at 06:00, the patient started to feel cold and was having chills. He was never cold. By 9:30PM he started vomiting and he had rigidity in the upper part of his body it was almost like he was having a seizure but he was still talking to her and that lasted about an hour with the vomiting, shaking, and rigidity. She told him to take a hot shower, he couldn't stop shaking and he did take a hot shower then he got fully dressed and went to bed fully clothed to try and get warm. He had no fever but it was terrible and she said to him do you want to go to the hospital or take some Benadryl and he said no. She confirmed that, the next morning when he woke up, shaking vomiting and rigidity was gone but he felt wiped out. Outcome of the events shaking vomiting and rigidity was recovered on an unspecified date in 2021 and outcome of the events getting cold, having chills and feels wiped out was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: he feels wiped out; Shaking; Vomiting; rigidity in his upper body; he started getting cold and having chills; he started getting cold and having chills; This is a spontaneous report from a contactable consumer or other non hcp.   A 79-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6201 and expiry date was not reported), via an unspecified route of administration, on 24Feb2021 at 06:30 AM (age at vaccination: 79-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of COMIRNATY with lot no EL9261. On 24Feb2021, at 06:00, the patient started to feel cold and was having chills. He was never cold. By 9:30PM he started vomiting and he had rigidity in the upper part of his body it was almost like he was having a seizure but he was still talking to her and that lasted about an hour with the vomiting, shaking, and rigidity. She told him to take a hot shower, he couldn't stop shaking and he did take a hot shower then he got fully dressed and went to bed fully clothed to try and get warm. He had no fever but it was terrible and she said to him do you want to go to the hospital or take some Benadryl and he said no. She confirmed that, the next morning when he woke up, shaking vomiting and rigidity was gone but he felt wiped out. Outcome of the events shaking vomiting and rigidity was recovered on an unspecified date in 2021 and outcome of the events getting cold, having chills and feels wiped out was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred, Visual impairment
Clinical narrative: Really blurry eyes; she could not see anything; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6200, NDC number, expiry date was not reported) via an unspecified route of administration on 18Feb2021 in left arm as dose 1, single for covid-19 immunisation. The patient's medical history, concurrent conditions were reported as none and concomitant medications were not reported. On 21Feb2021, the patient experienced really blurry eyes; she could not see anything. Event was improving a little bit, but she still was not able to see well. She was not able to see herself in the mirror. She asked if really blurry eyes were a common side effect with Pfizer covid-19 vaccine. The outcome of both the events was resolving.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: Really blurry eyes; she could not see anything; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6200, NDC number, expiry date was not reported) via an unspecified route of administration on 18Feb2021 in left arm as dose 1, single for covid-19 immunisation. The patient's medical history, concurrent conditions were reported as none and concomitant medications were not reported. On 21Feb2021, the patient experienced really blurry eyes; she could not see anything. Event was improving a little bit, but she still was not able to see well. She was not able to see herself in the mirror. She asked if really blurry eyes were a common side effect with Pfizer covid-19 vaccine. The outcome of both the events was resolving.  No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: a little pain in his arm; This is a spontaneous report from a contactable consumer (Patient). A 72-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EM6198, Expiration date: 30Jun2021), via intramuscular, administered in arm Left on 23Feb2021 at 10:30 am or maybe 10:45 am (age at vaccination was 72 years) as dose 2, single for COVID-19 immunization in Hospital. Medical history not reported. Concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient explains he gets a flu vaccine every year the last one he had was sometime in late October 2020. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL9464, Expiration date: unknown) via intramuscular, administered in arm Left on 28Jan2021 (age at vaccination was 72 years) as dose 1, single for COVID-19 immunization and experienced feels like something inside, he was not normal, feel a little bit dizzy and he was just uncomfortable. In Feb2021, after second dose the patient experienced a little pain in his arm. With the second vaccine, patient did not feel anything but just a little bit of pain in his arm. He put a cold rag on his arm and it felt better within 20-25 minutes. The patient explained that he had the first COVID shot about 25 days ago and he feels like it was something inside. He clarifies for about a day or day and a half, he was not normal and it felt the same way as any flu shot. He thought it was normal to feel a little bit dizzy or feel a little "this". Attempted to clarify further what the caller meant by this statement and he explains he was just uncomfortable. He felt like there was something inside him for about a day or day and a half. He received the second vaccine on Tuesday, 23Feb2021. He explains he just had a little pain in his arm, but he didn't feel anything. His question is, is this unusual? All of his friends over 65 already received the second vaccine, and have something where they didn't feel well. However, he didn't feel anything, nothing. He wants to know is there some problem with the vaccine, was it not administered properly. His main question was does he have to do a test in 3 or 4 weeks to be sure of the COVID-19 vaccine and was there a scale that is used to measure full immunity or light immunity. Tp what degree does he have immunization. He knows the vaccine is supposed to be around 94 or 95% effective, but maybe he was in the 5% that was not. Asked how cautious he has to be. Therapeutic measures were taken as a result of a little pain in his arm. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: a little pain in his arm; This is a spontaneous report from a contactable consumer (Patient). A 72-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EM6198, Expiration date: 30Jun2021), via intramuscular, administered in arm Left on 23Feb2021 at 10:30 am or maybe 10:45 am (age at vaccination was 72 years) as dose 2, single for COVID-19 immunization in Hospital. Medical history not reported. Concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient explains he gets a flu vaccine every year the last one he had was sometime in late October 2020. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL9464, Expiration date: unknown) via intramuscular, administered in arm Left on 28Jan2021 (age at vaccination was 72 years) as dose 1, single for COVID-19 immunization and experienced feels like something inside, he was not normal, feel a little bit dizzy and he was just uncomfortable. In Feb2021, after second dose the patient experienced a little pain in his arm. With the second vaccine, patient did not feel anything but just a little bit of pain in his arm. He put a cold rag on his arm and it felt better within 20-25 minutes. The patient explained that he had the first COVID shot about 25 days ago and he feels like it was something inside. He clarifies for about a day or day and a half, he was not normal and it felt the same way as any flu shot. He thought it was normal to feel a little bit dizzy or feel a little "this". Attempted to clarify further what the caller meant by this statement and he explains he was just uncomfortable. He felt like there was something inside him for about a day or day and a half. He received the second vaccine on Tuesday, 23Feb2021. He explains he just had a little pain in his arm, but he didn't feel anything. His question is, is this unusual? All of his friends over 65 already received the second vaccine, and have something where they didn't feel well. However, he didn't feel anything, nothing. He wants to know is there some problem with the vaccine, was it not administered properly. His main question was does he have to do a test in 3 or 4 weeks to be sure of the COVID-19 vaccine and was there a scale that is used to measure full immunity or light immunity. Tp what degree does he have immunization. He knows the vaccine is supposed to be around 94 or 95% effective, but maybe he was in the 5% that was not. Asked how cautious he has to be. Therapeutic measures were taken as a result of a little pain in his arm. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort
Clinical narrative: experiencing full or pressure on her head; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer-sponsored program Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 23Feb2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date on Feb2021, the patient experienced full or pressure on her head and wanted to know if she could take Aleve because she didn't have Ibuprofen or Tylenol. The outcome of the event was unknown.   No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Illness, Nausea
Clinical narrative: feeling dizzy/lightheadedness; nauseous; got sick; This is a spontaneous report from a contactable consumer (patient).   A 63-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9262, Expiry date: not reported), via an unspecified route of administration on left arm on 23Feb2021 09:30 (at age of 63-years-old) as dose 2, single for covid-19 immunization at military facility. Medical history included ongoing cancer, heartburn and sick. The patient stated she had cancer and she had not been seen by her regular doctor. She saw her oncologist. Concomitant medication(s) included dexamethasone taken for sick from an unspecified start date and ongoing; omeprazole taken for heartburn from an unspecified start date and ongoing; talazoparib tosylate (TALZENNA) taken for cancer from an unspecified start date and ongoing. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL1283, Expiration Date: Not reported), via an unspecified route of administration on left arm on 02Feb2021 09:45 (at age of 63-years-old) as dose 1, single for covid-19 immunization and experienced vertigo which came on "all of a sudden" but resolved quickly. The patient had not received any other vaccine within 4 weeks. No additional vaccines administered on same date of the bnt162b2. No adverse events following prior vaccinations. Since receiving the second dose on an unspecified date in Feb2021, the patient reported dizziness, lightheadedness, and nausea. It was reported that since she got the shot she has been light headed and feeling dizzy. She does not know if it is part of the shot too. The patient got nauseous especially when she was about to eat dinner. The patient did not know if it was part of the shot too. It came out of the blue. She was sitting down and then all of a sudden it was like her head and world was tilted. It was like she was being shaken. This only lasted for like a minute. She got sick and threw up from this. Stated she is unsure if she recovered completely or recovered with lasting effects. Stated due to this event she was scared to get the second shot. She spent the rest of the day trying to take it easy. By the end of the day she was fine .This occurred about 7:30 AM. Of note, the patient was also being treated for cancer (not chemotherapy) but the patient stated that usually the pill did not bother the patient at all. The patient asked whether those symptoms be a result of vaccination, should the patient have waited longer before calling to see if symptoms would have resolved on their own. The events did not require visit to emergency room or physician office. The outcome of the events was not recovered. The outcome of got sick was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Tenderness on the vaccination site; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program COVAX US Support.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch/lot number was not reported) via an unspecified route of administration on 23Feb2021 as Dose 1, Single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On 23Feb2021, the patient experienced tenderness on the vaccination site. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: slight pain at injection site; This is a spontaneous report from a contactable consumer. This consumer reported for herself that,   A 52-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EL3247) (at the age of 52 years old), dose 1 via an unspecified route of administration, administered in arm right on 02Mar2021 09:30 as dose 1, single for covid-19 immunisation, workplace clinic. Medical history included drug hypersensitivity to penicillin from an unknown date and unknown if ongoing. Concomitant medication(s) included ascorbic acid (VIT C) taken for an unspecified indication, start and stop date were not reported; iron (IRON) taken for an unspecified indication, start and stop date were not reported; ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported. It was reported that on 02Mar2021 patient experienced slight pain at injection site. Treatment for the event was not received. Patient did not receive any other vaccines within four 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. The outcome for the event was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Extremely sick; This is a spontaneous report from a contactable consumer.    A 85-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown; Expiration Date: Unknown), via an unspecified route of administration on an unspecified date (age at vaccination 85 years) as dose number unknown, single for covid-19 immunization. Medical history and concomitant medications were not reported. It was unknown if patient was diagnosed with COVID-19, Prior to vaccination. It was unknown if patient has been tested for COVID-19, since the vaccination. On an unspecified date in Feb2021 patient was extremely sick.  Treatment received for adverse event was unknown. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Sore injection site; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in Right arm on 18Feb2021 16:30 at the age of 63-years-old as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma and seasonal allergy from an unknown date. The patient had no known allergies. Concomitant medications included lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported; simvastatin (SIMVASTIN) taken for an unspecified indication, start and stop date were not reported; omeprazole (OMEP [OMEPRAZOLE]) taken for an unspecified indication, start and stop date were not reported and unspecified seasonal allergy pill from an unspecified date received in two weeks of vaccination. The patient did not receive other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has been tested for COVID-19 post vaccination. On 19Feb2021, the patient experienced sore injection site. No treatment was received for adverse event. The patient underwent lab tests and procedures which included Nasal Swab (SARS-CoV-2 test): negative on 20Jan2021. Adverse event resulted in none of the above. The outcome of event was recovering.  Follow-up attempts completed. No further information expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness in left arm, site of administration; soreness in left arm, site of administration; This is a spontaneous report from a contactable consumer (patient herself).   A 44-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247, Expiration date: Unknown), via an unspecified route of administration in left arm on 02Mar2021 at 11:00 as dose 1, single (at the age of 44-years-old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient was not tested for COVID-19 post vaccination. The patient did not receive any other vaccine in four weeks of vaccination. The patient's known allergies were none. The patient medical history was not reported. The patient's concomitant medications included ibuprofen and fluticasone (FLONASE) taken for an unspecified indication, received within two weeks of vaccination. On 02Mar2021, the patient experienced soreness in left arm, site of administration. The patient was not received any treatment in response to the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: Sweating; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: EN5318, Expiration date was not reported), via an unspecified route of administration (administered on the right arm) on 05Feb2021 at 14:00 (at the age of 71-years-old) as dose 1, single for COVID-19 immunisation. Medical history included Parkinson's disease (patient thinks she was diagnosed 3 years ago). The patient's concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. On 06Feb2021, the patient experienced sweating. The outcome of the event was recovering.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Myalgia, Pain, Pain in extremity
Clinical narrative: My arm was hurting very badly, I couldn't even lift it or raise it up; Pain is more like very concentrated pain; If I lift it or reach out in front of me then there is like sharp shooting pain right in that same spot, I can tell like it is in my muscle; Pain is more like very concentrated pain; If I lift it or reach out in front of me then there is like sharp shooting pain right in that same spot, I can tell like it is in my muscle; On my first day, when I was just like I couldn't move it at all; I kept it moving all day that first day but it just kept getting worse and worse; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported, Expiry Date: unknown), via an unspecified route of administration on an unspecified date in Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The patient previously received Flu shot (Batch/Lot number was not reported, Expiry Date: unknown), via an unspecified route of administration on an unspecified date as an unspecified dose and experienced pain. On an unspecified date in Feb2021, the patient experienced her arm was hurting very badly, she could not even lift it or raise it up, pain is more like very concentrated pain, if she lift it or reach out in front of her then there is like sharp shooting pain right in that same spot, she can tell like it is in her muscle, on her first day, when she was just like she could not move it at all, she kept it moving all day that first day but it just kept getting worse and worse. The outcome of the events was unknown.  Follow-up attempts are completed. Information on lot and batch number has been requested. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tooth disorder
Clinical narrative: This is a spontaneous report from a contactable female consumer (patient). A female patient, of an unspecified age, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. On an unspecified date, patient had a dental procedure after receiving her 1st dose of vaccine. She was supposed to take steroid but now she wanted to know when she can take the steroid after she gets her 2nd dose. The outcome of the event: unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain on left arm; This is a spontaneous report from a contactable consumer. A 37-year-old male patient received first dose of bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EL3247), dose 1 via an un-specified route of administration, administered in Arm Left on 01Mar2021 11:45 as dose 1, single for covid-19 immunisation (at the age of 37-year-old). Medical history included None. 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 not received any other medications within 2 weeks of vaccination. On 01Mar2021 15:00 PM patient experienced pain on left arm. The treatment was not received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dental discomfort
Clinical narrative: will be given Novocaine for her dental crown; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) reported for herself that. A female patient of an unspecified age received BNT162B2 (formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported is to receive her second dose on 10Mar2021. That same day, she needs to go to her dentist and will be given Novocaine for her dental crown. The patient experienced will be given novocaine for her dental crown on an unspecified date. The clinical outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Vaccination site pain
Clinical narrative: Localized soreness at injection site after about 6 hours progressed to generalized aches, fatigue, and headache in 24 hours. Resolved in 48 hours.; aches; fatigue; headache; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EL3247, expiration date was not reported), via an unspecified route of administration, administered in right arm on 01Mar2021 09:15am (at the age of 38-years-old) as dose 2, single for covid-19 immunization at workplace clinic. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EL3247, expiration date was not reported), via an unspecified route of administration, administered in right arm on 10Feb2021 10:00 am (at the age of 38-years-old) as dose 1, single for covid-19 immunization at workplace clinic. The patient does not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications were received by the patient within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that on 01Mar2021 the patient experienced localized soreness at injection site after about 6 hours at 03:15 pm progressed to generalized aches, fatigue, and headache in 24 hours. No treatment was received for the adverse events. Resolved in 48 hours. The outcome of the events was recovered on 03Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Just typical injection site pain and fatigue; Just typical injection site pain and fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 53-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration, administered in left arm on 02Mar2021 09:00 AM (Lot number: EL3247, at the age of 53-year-old) as dose 1, single dose for COVID-19 immunization. The patient's medical history was not reported. No COVID prior to vaccination. No other vaccine administered in four weeks. The patient's concomitant medications in two weeks included secukinumab (COSENTYX) taken for an unspecified indication, start and stop date were not reported. On 02Mar2021 12:00 PM, the patient experienced just typical injection site pain and fatigue. Patient not tested for COVID post vaccination. No treatment received for the events. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 28-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE; formulation: solution for injection, Batch/Lot number: EL3248), dose 1 via an unspecified route of administration, administered in left arm on 01Mar2021 at 12:15 hours as dose 1, single (at the age of 28-years-old) for COVID-19 immunisation. The patient's medical history included anxiety. Concomitant medications included sertraline hydrochloride (ZOLOFT) received within 2 weeks of vaccination. The patient has no allergies to medications, food, or other products. 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 has not been tested for COVID-19. On 01Mar2021, the patient experienced diarrhea. The event was reported as non-serious and did not result in death/life threatening/caused/prolonged hospitalization/congenital anomaly/birth defect. The patient received no treatment for the adverse event. The patient confirmed that the date the patient experienced the reported event was on 01Mar2021 and reported the information on 03Mar2021. The clinical outcome for the event was not recovered. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Caller got sick after receiving the 1st dose; This is a spontaneous report from a Pfizer-sponsored program Pfizer Support. This is a spontaneous report from a contactable consumer (female) reported for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were unknown. On an unspecified date the patient experienced caller got sick after receiving the 1st dose. Patient wanted to be rescheduled since her second dose will be tomorrow. The outcome of the event was unknown. No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Condition aggravated, Dizziness, Headache, Pain in extremity
Clinical narrative: Headache; little sore arm; Dizziness; balance problems; the balance is getting worse; This is a spontaneous report from a contactable consumer (Patient) or other non-HCP.  A 73-year-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unspecified route of administration, on 23Feb2021 (Lot number was not reported, age at the time of vaccination was 73-year-old) as a dose 2, single for COVID-19 immunization. The relevant medical history included pacemaker, blood cholesterol and thyroid from an unspecified date. Concomitant medications included levothyroxine 0.05 mg, one before going to breakfast, taken for thyroid and terazosin hydrochloride (HYTRIN) 10mg, at night before going to sleep, taken for an unspecified indication. Previously, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via unspecified route of administration, on an unspecified date, as dose 1, single for COVID-19 immunization. On 23Feb2021 at 19:00, the patient experienced headache, little sore arm, dizziness, balance problems and the balance is getting worse. Consumer stated that he/she had the COVID about 4 months ago and was in the hospital for 9 days. He/she took our first shot 90 days later that and took our second shot on Tuesday, had every reaction mentioned on the paper; every side effect plus had one that was not going away which was balance problems and headache. Patient had a little sore arm, but the main thing was balance problem and feel like was falling over. He/she stated that the start date of experiencing the events was after taking the shot on Tuesday (23Feb2021). The problem started about 7 o clock in the night on 23Feb2021. When probed for the route of administration, stated upper arm into the muscle. Other medical conditions and concomitant medications included high blood pressure, had a pacemaker and took medication for cholesterol, things like that, took for his/her thyroid, took for his/her urinary something like that, took 20 different medications. When probed about still experiencing the event, he/she stated yes (not further clarified which events consumer was still experiencing). When probed about whether the event worsened improved or still persisting, patient stated the balance was getting worse, it came on later than other problems it has been last 3-4 days, it came on that night after the shot and had no muscle coordination and dizziness. When probed whether patient took any treatment for the events, he/she stated no. Patient took Tylenol. dose of Tylenol, stated 3 tablets, regular tablets every 6 hours and stopped it yesterday. Patient asked that how do find out this was the effect of shot. The clinical outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Sleep disorder
Clinical narrative: Chills; slept all day the day after dose; This is a spontaneous report from a contactable consumer. This consumer reported for a 73-Year-old female patient that who received bnt162b2 (BNT162B2) solution for injection, dose 2 (Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date (at the age of 73-years-old) as dose 1 single for covid-19 immunisation. Medical history included Crohn's disease from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Chills and slept all day the day after dose (but no fever), age: 73, date of birth: provided, slept all day the day after dose. Outcome of the events was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: International normalised ratio, International normalised ratio increased
Clinical narrative: INR was high; This is a spontaneous report from a Pfizer-sponsored program Support. A contactable male consumer (patient) reported that:  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 16Jan2021 as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. Medical history included heart problems and takes coumadin/ not clarified if patient had heart problems before or after covid vaccine. Concomitant medication was not reported. On 16Jan2021 patient received dose 1 of COVID-19 vaccine and week and half later tested and INR was high (Feb2021). HCP told to skip a pill. Again received dose 2 of COVID-19 vaccine and again tested with INR was high. The patient underwent lab tests and procedures which included international normalised ratio: high on Feb2021 and high on an unspecified date. The outcome of the event was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.