chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Nausea, Pyrexia
Clinical narrative: fever 100.6 degrees; Nausea; Chills; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 67-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9809) via an unspecified route of administration, administered in arm left on 25Feb2021 13:00 (at the age of 67-year-old) at dose 2, single for covid-19 immunisation. Medical history included IBS (Verbatim: IBS). Reported she has a history of IBS, but she does not think the IBS was relevant to what she was experiencing now. No further details provided. Concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9264) via intramuscular route of administration, administered in arm right on 04Feb2021 (at the age of 67-year-old) at dose 1, single for covid-19 immunisation. On 26Feb2021 the patient experienced fever 100.6 degrees, nausea, chills. Reported she received her second Pfizer COVID-19 Vaccine yesterday, and now is running a 100.6 degree fever. She said she had all the symptoms listed for the COVID-19 Vaccine. Reporter asked if she can take Tylenol, or should she just leave her symptoms alone. Reporter stated she did not want to mess up the effectiveness of the COVID-19 Vaccine by taking Tylenol if she was not supposed to. Reporter was advised she would be transferred to Pfizer Medical Information for further assistance with her question. Reported her husband had received his second COVID-19 Vaccine dose at the same time she received hers, and her husband was fine. No further details provided. Reported she received her second Pfizer COVID-19 Vaccine yesterday, and now is running a 100.6 degree fever. Reported her symptoms occurred approximately 12 hours after she received her second COVID-19 Vaccine (between 1:00AM-2:00AM on 26Feb2021). She said she had all the symptoms listed with the COVID-19 Vaccine information, specifically stating nausea, chills, and fever. Reported she received her first COVID-19 Vaccine on 04Feb2021, providing Pfizer Lot Number: EL9264. She said her first dose of the COVID-19 Vaccine was administered in her right arm. She said there was no NDC or Expiration Date listed on her COVID-19 Vaccination card. The patient underwent lab tests and procedures which included body temperature: 100.6 degrees on 26Feb2021. Events did not require a visit to emergency room, physician Office. Outcome of the events was not resolved.  No follow up attempts are possible. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Body temperature, Chills, Dizziness
Clinical narrative: low-grade fever; chills; he's very weak; shouldn't walk; headache/pain headache; swollen lymph nodes; tiredness; flu-like symptoms; fast heart rate; dizziness; feeling unwell; nausea; This is a spontaneous report from a contactable consumer. A 33-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot Number: EN5318), dose 2 via an unspecified route of administration on 25Feb2021 10:30 as DOSE 2, SINGLE for covid-19 immunisation (at the age of 33 years). Medical history included, deafness Diagnosed at birth and wisdom Teeth issues from an unknown date and unknown if ongoing. Concomitant medications included amoxicillin (AMOXICILLIN) taken for tooth impacted, start and stop date were not reported; ibuprofen (MOTRIN [IBUPROFEN]), codeine phosphate, paracetamol (TYLENOL WITH CODEINE) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 on 04Feb2021 for covid-19 immunisation. He received no other vaccines on the same day at the covid vaccine, or even in the 4 weeks prior. Consumer reported that my son, who's hearing impaired, received his 2nd dose of the Pfizer COVID 19 vaccine yesterday. On 26Feb2021 this morning he has low-grade fever and chills, he's very weak and shouldn't walk. He has a headache, swollen lymph nodes, and tiredness. He has flu-like symptoms. Caller states that she is calling on the phone on behalf of her son. She is calling about the Pfizer BIONTECH covid vaccine. Her son had the second covid shot and he woke up this morning with a fever of 101, fast heart rate, dizziness, feeling unwell, nausea, pain headache, tiredness. Caller states that they are now up at clinic to be treated. Caller states that she has notified Pfizer of all about side effects, and she needs to know what to do next. Caller was informed that Pfizer could not provide and specific medical treatment or medical advice. All symptoms started this morning at 8:30AM, he woke up feeling this way. Caller explains that he was on an antibiotic because of an impacted wisdom tooth, it was Amoxicillin, it was prescribed a few days after the first dose, like within a day or too, caller states that she does not know if that's related, or if it's purely circumstantial as he has had this issue before. He was also prescribed Motrin which he took. He was given a prescription for Tylenol 3 with codeine but not fill that prescription. She has not Lot for Amoxicillin, the bottle is at home. The patient underwent lab tests and procedures which included blood test: unknown on 26Feb2021, body temperature: 101 on 26Feb2021, body temperature: 99.7 fahrenheit on 26Feb2021, heart rate: 130 on 26Feb2021. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Gait inability, Headache, Heart rate, Heart rate increased
Clinical narrative: low-grade fever; chills; he's very weak; shouldn't walk; headache/pain headache; swollen lymph nodes; tiredness; flu-like symptoms; fast heart rate; dizziness; feeling unwell; nausea; This is a spontaneous report from a contactable consumer. A 33-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot Number: EN5318), dose 2 via an unspecified route of administration on 25Feb2021 10:30 as DOSE 2, SINGLE for covid-19 immunisation (at the age of 33 years). Medical history included, deafness Diagnosed at birth and wisdom Teeth issues from an unknown date and unknown if ongoing. Concomitant medications included amoxicillin (AMOXICILLIN) taken for tooth impacted, start and stop date were not reported; ibuprofen (MOTRIN [IBUPROFEN]), codeine phosphate, paracetamol (TYLENOL WITH CODEINE) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 on 04Feb2021 for covid-19 immunisation. He received no other vaccines on the same day at the covid vaccine, or even in the 4 weeks prior. Consumer reported that my son, who's hearing impaired, received his 2nd dose of the Pfizer COVID 19 vaccine yesterday. On 26Feb2021 this morning he has low-grade fever and chills, he's very weak and shouldn't walk. He has a headache, swollen lymph nodes, and tiredness. He has flu-like symptoms. Caller states that she is calling on the phone on behalf of her son. She is calling about the Pfizer BIONTECH covid vaccine. Her son had the second covid shot and he woke up this morning with a fever of 101, fast heart rate, dizziness, feeling unwell, nausea, pain headache, tiredness. Caller states that they are now up at clinic to be treated. Caller states that she has notified Pfizer of all about side effects, and she needs to know what to do next. Caller was informed that Pfizer could not provide and specific medical treatment or medical advice. All symptoms started this morning at 8:30AM, he woke up feeling this way. Caller explains that he was on an antibiotic because of an impacted wisdom tooth, it was Amoxicillin, it was prescribed a few days after the first dose, like within a day or too, caller states that she does not know if that's related, or if it's purely circumstantial as he has had this issue before. He was also prescribed Motrin which he took. He was given a prescription for Tylenol 3 with codeine but not fill that prescription. She has not Lot for Amoxicillin, the bottle is at home. The patient underwent lab tests and procedures which included blood test: unknown on 26Feb2021, body temperature: 101 on 26Feb2021, body temperature: 99.7 fahrenheit on 26Feb2021, heart rate: 130 on 26Feb2021. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Lymphadenopathy, Malaise, Nausea, Pyrexia
Clinical narrative: low-grade fever; chills; he's very weak; shouldn't walk; headache/pain headache; swollen lymph nodes; tiredness; flu-like symptoms; fast heart rate; dizziness; feeling unwell; nausea; This is a spontaneous report from a contactable consumer. A 33-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot Number: EN5318), dose 2 via an unspecified route of administration on 25Feb2021 10:30 as DOSE 2, SINGLE for covid-19 immunisation (at the age of 33 years). Medical history included, deafness Diagnosed at birth and wisdom Teeth issues from an unknown date and unknown if ongoing. Concomitant medications included amoxicillin (AMOXICILLIN) taken for tooth impacted, start and stop date were not reported; ibuprofen (MOTRIN [IBUPROFEN]), codeine phosphate, paracetamol (TYLENOL WITH CODEINE) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 on 04Feb2021 for covid-19 immunisation. He received no other vaccines on the same day at the covid vaccine, or even in the 4 weeks prior. Consumer reported that my son, who's hearing impaired, received his 2nd dose of the Pfizer COVID 19 vaccine yesterday. On 26Feb2021 this morning he has low-grade fever and chills, he's very weak and shouldn't walk. He has a headache, swollen lymph nodes, and tiredness. He has flu-like symptoms. Caller states that she is calling on the phone on behalf of her son. She is calling about the Pfizer BIONTECH covid vaccine. Her son had the second covid shot and he woke up this morning with a fever of 101, fast heart rate, dizziness, feeling unwell, nausea, pain headache, tiredness. Caller states that they are now up at clinic to be treated. Caller states that she has notified Pfizer of all about side effects, and she needs to know what to do next. Caller was informed that Pfizer could not provide and specific medical treatment or medical advice. All symptoms started this morning at 8:30AM, he woke up feeling this way. Caller explains that he was on an antibiotic because of an impacted wisdom tooth, it was Amoxicillin, it was prescribed a few days after the first dose, like within a day or too, caller states that she does not know if that's related, or if it's purely circumstantial as he has had this issue before. He was also prescribed Motrin which he took. He was given a prescription for Tylenol 3 with codeine but not fill that prescription. She has not Lot for Amoxicillin, the bottle is at home. The patient underwent lab tests and procedures which included blood test: unknown on 26Feb2021, body temperature: 101 on 26Feb2021, body temperature: 99.7 fahrenheit on 26Feb2021, heart rate: 130 on 26Feb2021. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Lethargy, Neck pain, Pain in extremity
Clinical narrative: fever of 102degrees F; lethargic; sore arm, shoulder, neck; sore arm, shoulder, neck; sore arm, shoulder, neck; This is a spontaneous report from a contactable consumer. A 80-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 25Feb2021 14:00 (at the age of 80 years old) as dose 1, single for COVID-19 immunisation at public health facility. The patient medical history and concomitant medications were not reported. The patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced fever of 102degrees f, lethargic, sore arm, shoulder, neck on 26Feb2021 07:00. Reported as, "fever of 102degrees F, lethargic, sore arm, shoulder, neck; took aspirin and fever came down to 98.4 degrees F". Patient received aspirin as treatment. Since the vaccination, the patient did not tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: 102 fahrenheit on 26Feb2021, body temperature: 98.4 fahrenheit on 2021. Outcome of all the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever of 102degrees F; lethargic; sore arm, shoulder, neck; sore arm, shoulder, neck; sore arm, shoulder, neck; This is a spontaneous report from a contactable consumer. A 80-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 25Feb2021 14:00 (at the age of 80 years old) as dose 1, single for COVID-19 immunisation at public health facility. The patient medical history and concomitant medications were not reported. The patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced fever of 102degrees f, lethargic, sore arm, shoulder, neck on 26Feb2021 07:00. Reported as, "fever of 102degrees F, lethargic, sore arm, shoulder, neck; took aspirin and fever came down to 98.4 degrees F". Patient received aspirin as treatment. Since the vaccination, the patient did not tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: 102 fahrenheit on 26Feb2021, body temperature: 98.4 fahrenheit on 2021. Outcome of all the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: experiencing a fever; This is a spontaneous report from a Pfizer sponsored program. A non-contactable female consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. It was mentioned that, patient received 2nd dose 1 month ago and recently started experiencing a fever and patient was wondering if this was normal. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Fever; Fatigue; Muscle pain/Weakness; Muscle pain/Weakness; Sore arm; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient).  A 36-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in arm left on 05Feb2021 14:30 (at the age of 36 years) as dose 2, single for covid-19 immunisation at workplace clinic. The patient medical history was reported as none. Concomitant medications included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication from Sep2018 and ongoing; probiotics (PROBIOTICS) taken for an unspecified indication from 16Jan2021 and ongoing; lecithin (LECITHIN) taken for an unspecified indication from Jun2019 and ongoing. It was reported that, the patient followed standard vaccine schedule only vaccine taken in the past year was flu shot. Also she has previously received Hep A/B combo shot and multiple previous Flu vaccinations over the course of the previous decades. There were no AE following prior vaccinations. There were no additional vaccines administered on same date of the Pfizer suspect. On 05Feb2021 18:30 the patient experienced sore arm. On 06Feb2021, the patient experienced fever (at 10:00), muscle pain, weakness and fatigue (at 7:00). It was reported that, no relevant tests were done, no culture was performed, there were no predisposing factors and no antipyretic was used. It was reported that the vaccine was not administered at military facility. The Adverse events did not require any visits to the emergency room or physician office. The patient did not receive any treatment for the events. Patient was not admitted to the hospital due to the events. The outcome of the events was recovered in on an unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Eating disorder, Feeling abnormal, Flatulence
Clinical narrative: upset feeling digestive tract/jumping and feel gurgling; not eating right/eating little; headaches; loose phlegm in back of throat; nausea; sneezing; she has had a runny nose so she has been getting very little sleep; she has had a runny nose so she has been getting very little sleep; very unsteady the whole week; noise and mucous in the back of throat; gas and bubbling; she has all the gas and bubbling and swelling; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 87-years-old female patient received BNT162B2 (PFIZER-BIONTECH EUA COVID-19 VACCINE, solution for injection, Lot number: EN5318, expiration date: May2021) via unknown route of administration on 19Feb2021 at 14:00, dose 1, single (age at vaccination: 87 years) in her arm for COVID-19 immunisation. Medical history included small intestinal bacterial overgrowth (SIBO) (she has been taking supplements to keep it under control and having fermented foods), endometrial cancer, right lung lobectomy, total hysterectomy, high potassium, edema, Mohs surgery (surgery done to her forehead recently) and blood pressure. The concomitant medication included losartan for blood pressure. Patient reported that she got the first injection a week ago today, on 19Feb at 02:00PM. She said she had no problems until Sunday and through the rest of the week. She says today is the first day she almost feels as good as she felt before getting the vaccine. She reported she has had issues in Feb2021 with upset feeling digestive tract, and not eating right (eating little), she has had nausea slightly though she never did upchuck. Patient also reported she has had headaches, sneezing, and loose phlegm in back of her throat. She said she has been gargling for that at night. She reported that she has had a runny nose so she has been getting very little sleep, she has had noise and mucous in the back of throat and noise in her digestive tract. She says she has problems with her small intestine bacteria overgrowth, also called SIBO, for which she has been taking supplements to keep it under control and having fermented foods, she puts her hand on her stomach and can feel it jumping and feel gurgling, she has been very unsteady the whole week. She says she is sorry that she took the vaccine since her immune system is totally compromised, over the years she has had 4-5 bouts of cancer, and her intestines has more bad bacteria than good bacteria, she has all the gas and bubbling and swelling because of that. The outcome of the events upset feeling digestive tract, not eating right/eating little, headache, loose phlegm in back of throat was resolving and outcome for rest of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Nausea, Oropharyngeal discomfort, Productive cough
Clinical narrative: upset feeling digestive tract/jumping and feel gurgling; not eating right/eating little; headaches; loose phlegm in back of throat; nausea; sneezing; she has had a runny nose so she has been getting very little sleep; she has had a runny nose so she has been getting very little sleep; very unsteady the whole week; noise and mucous in the back of throat; gas and bubbling; she has all the gas and bubbling and swelling; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 87-years-old female patient received BNT162B2 (PFIZER-BIONTECH EUA COVID-19 VACCINE, solution for injection, Lot number: EN5318, expiration date: May2021) via unknown route of administration on 19Feb2021 at 14:00, dose 1, single (age at vaccination: 87 years) in her arm for COVID-19 immunisation. Medical history included small intestinal bacterial overgrowth (SIBO) (she has been taking supplements to keep it under control and having fermented foods), endometrial cancer, right lung lobectomy, total hysterectomy, high potassium, edema, Mohs surgery (surgery done to her forehead recently) and blood pressure. The concomitant medication included losartan for blood pressure. Patient reported that she got the first injection a week ago today, on 19Feb at 02:00PM. She said she had no problems until Sunday and through the rest of the week. She says today is the first day she almost feels as good as she felt before getting the vaccine. She reported she has had issues in Feb2021 with upset feeling digestive tract, and not eating right (eating little), she has had nausea slightly though she never did upchuck. Patient also reported she has had headaches, sneezing, and loose phlegm in back of her throat. She said she has been gargling for that at night. She reported that she has had a runny nose so she has been getting very little sleep, she has had noise and mucous in the back of throat and noise in her digestive tract. She says she has problems with her small intestine bacteria overgrowth, also called SIBO, for which she has been taking supplements to keep it under control and having fermented foods, she puts her hand on her stomach and can feel it jumping and feel gurgling, she has been very unsteady the whole week. She says she is sorry that she took the vaccine since her immune system is totally compromised, over the years she has had 4-5 bouts of cancer, and her intestines has more bad bacteria than good bacteria, she has all the gas and bubbling and swelling because of that. The outcome of the events upset feeling digestive tract, not eating right/eating little, headache, loose phlegm in back of throat was resolving and outcome for rest of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: upset feeling digestive tract/jumping and feel gurgling; not eating right/eating little; headaches; loose phlegm in back of throat; nausea; sneezing; she has had a runny nose so she has been getting very little sleep; she has had a runny nose so she has been getting very little sleep; very unsteady the whole week; noise and mucous in the back of throat; gas and bubbling; she has all the gas and bubbling and swelling; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 87-years-old female patient received BNT162B2 (PFIZER-BIONTECH EUA COVID-19 VACCINE, solution for injection, Lot number: EN5318, expiration date: May2021) via unknown route of administration on 19Feb2021 at 14:00, dose 1, single (age at vaccination: 87 years) in her arm for COVID-19 immunisation. Medical history included small intestinal bacterial overgrowth (SIBO) (she has been taking supplements to keep it under control and having fermented foods), endometrial cancer, right lung lobectomy, total hysterectomy, high potassium, edema, Mohs surgery (surgery done to her forehead recently) and blood pressure. The concomitant medication included losartan for blood pressure. Patient reported that she got the first injection a week ago today, on 19Feb at 02:00PM. She said she had no problems until Sunday and through the rest of the week. She says today is the first day she almost feels as good as she felt before getting the vaccine. She reported she has had issues in Feb2021 with upset feeling digestive tract, and not eating right (eating little), she has had nausea slightly though she never did upchuck. Patient also reported she has had headaches, sneezing, and loose phlegm in back of her throat. She said she has been gargling for that at night. She reported that she has had a runny nose so she has been getting very little sleep, she has had noise and mucous in the back of throat and noise in her digestive tract. She says she has problems with her small intestine bacteria overgrowth, also called SIBO, for which she has been taking supplements to keep it under control and having fermented foods, she puts her hand on her stomach and can feel it jumping and feel gurgling, she has been very unsteady the whole week. She says she is sorry that she took the vaccine since her immune system is totally compromised, over the years she has had 4-5 bouts of cancer, and her intestines has more bad bacteria than good bacteria, she has all the gas and bubbling and swelling because of that. The outcome of the events upset feeling digestive tract, not eating right/eating little, headache, loose phlegm in back of throat was resolving and outcome for rest of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: woke up had a mild fever of 99.9 degrees; This is a spontaneous report from a contactable other healthcare professional (patient). A 53-year-old male patient received second dose of bnt162b2 (BNT162B2; Solution for injection; Lot Number: UNKNOWN), via an unspecified route of administration, administered in left arm as dose 2, single on 25Feb2021 11:45 AM (at the age of 53-year-old) for covid-19 immunisation. Patient had no known allergies and medical history. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (COMIRNATY; Solution for injection; Lot Number: UNKNOWN), via unspecified route of administration, administered in left arm as dose 1, single on 04Feb2021 10:30 AM (at the age of 53-year-old) for covid-19 immunisation. Both doses were taken at workplace clinic. No other vaccine in four weeks administered and no other medications took in two weeks. The patient experienced woke up had a mild fever of 99.9 degrees on 26Feb2021 05:30 AM in the morning. Lab tests and procedures which included body temperature: 99.9 centigrade on 26Feb2021. Patient received no treatment for the event. Patient had no COVID prior to vaccination and post vaccination not tested for COVID. At the time of this report, outcome of the events was recovered on 26Feb2021.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Rash
Clinical narrative: Fever; chills; aches; rash; This is a spontaneous report from a contactable consumer (patient). A 23-years-old female non pregnant patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9265) dose 1, administered in Left arm on 29Jan2021 12:00 PM as single for covid-19 immunisation and bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6021), dose 2 via an unspecified route of administration, administered in Left arm on 20Feb2021 12:30 PM (at the age of 23-year-old) as single for covid-19 immunisation. Medical history included asthma and food allergy (Pineapple) from an unknown date and unknown if ongoing. Concomitant medications included escitalopram (ESCITALOPRAM), minocycline (MINOCYCLINE) and ethinylestradiol, etonogestrel (NUVARING) taken for an unspecified indication, start and stop date were not reported. Prior vaccinatopn patient was not has covid and Post vaccination covid test was not performed. On 21Feb2021, 06:00 AM the patient experienced fever, chills, aches and rash. No treatment was received. Outcome of the events were resolving.    Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: he was taking 80 mg of Aspirin continuously for his heart since he was not advised not to take it; sore arm; This is a spontaneous report from a contactable consumer (patient).   A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1, via an unspecified route of administration on 28Jan2021 (age at vaccination 72 years) at 1 st dose single for covid-19 immunisation and dose 2, via an unspecified route of administration on 22Feb2021 (age at vaccination 72 years) at 2 nd dose single for covid-19 immunisation. The patient medical history included blood thinning (he says during that time he was taking 81 mg aspirin nightly for his heart, for blood thinning, which he has done for years.) and his heart. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN) from an unspecified date at 81 mg daily for blood thinning and for his heart. The patient stated that, during the time the first and second doses of the vaccine were administered to him on 28Jan2021 and 22Feb2021, respectively, he was taking 81 mg of Aspirin continuously nightly for his heart and for blood thinning which he has done for years and he was wondering if it has affected the efficacy of the vaccine. He denied to having any bruising or bleeding problems and just experienced a sore arm. The patient was not told to take Aspirin while taking the vaccine, then he was told by someone he talked to as it can reduce efficacy for vaccine. The patient said he has had no reactions to drugs. Since he was not advised to take it but now, he stopped after hearing he should not take the medication when getting the vaccine as it can reduce efficacy for vaccine. The patient discontinued his medication for 3 days. The patient wanted to know if taking the Aspirin 80 mg for his heart during the two doses of the Covid-19 vaccine may affect the efficacy of the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Neuralgia
Clinical narrative: sporadic muscle nerve pain in my left arm and left leg for a few days following the injection; sporadic muscle nerve pain in my left arm and left leg for a few days following the injection; headaches; This is a spontaneous report from a contactable health care professional (patient). A 46-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL1284), via intramuscular in arm left on 08Jan2021 at 08:00 AM (at the age of 46-year-old) as a dose 1, single for COVID-19 immunization. The patient's medical history included known allergies: walnuts. The patient's concomitant medications within 2 weeks of vaccination included ibuprofen (ADVIL), taken for toothache and amoxicillin, taken for toothache. It was reported that, the patient was not pregnant at time of vaccination. 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, has the patient been tested for COVID-19 was reported as no. On an unspecified date in 2021, after the 1st dose, the patient had sporadic muscle nerve pain in her left arm and left leg for a few days following the injection. Stated that, the patient also experienced headaches during that time. The reporter considered the events as non-serious. Treatment was not received for the events. The outcome of the events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever 101 24 hrs post injection; This is a spontaneous report from a contactable consumer (Patient). A 47-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: el3247, patient was 47-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Right on 24Feb2021 at 02:00 PM as DOSE 2, SINGLE for covid-19 immunisation. Medical history included migraine, penicillin allergy. Concomitant medication(s) included nicotinic acid (NIASPAN) taken within 2 weeks of vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: el3247), on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. 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 was not tested for COVID-19. On 25Feb2021 at 06:30, the patient experienced fever 101 24 hrs. post injection. No seriousness criteria were reported. Patient received treatment for event with Naproxen. On 25Feb2021 at 06:30, the patient underwent lab test and procedure which included fever resulted as 101. The outcome of event was recovered on an unspecified date in 2021.  No follow up needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: fever; chills; body aches; This is a spontaneous report from a contactable consumer or other non-Health Care Professional.A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration on 17Feb2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced fever, chills, body aches. The outcome of events was recovered.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Lymphadenopathy
Clinical narrative: Mild diarrhea 24 hrs after injection; Left arm shoulder/rotor cuff extreme pain; Swollen lymph nodes in neck 3 hrs after injection; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6198), via an unspecified route of administration on 24Feb2021 at 16:30 (at the age of 61-year-old), as dose 1, single in right arm for COVID-19 immunization at Public health department. The patient's medical history included allergies to hornet venom and molds. Patient's past drugs included prednisone, xarelto, levofloxacin and lanolin; and experienced allergies. Concomitant medication within 2 weeks of vaccination included Balloon, tramadol, acetaminophen, vitamin B-12 (CYANOCOBALAMIN); all taken for unspecified indications, start and stop dates were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Feb2021 at 04:30, 12 hours after vaccine, the patient experienced left arm shoulder/rotor cuff extreme pain. This was opposite to the injection arm. On 25Feb2021 at 16:30, 24 hrs after vaccination, the patient experienced mild diarrhea. On 24Feb2021 at 19:30, 3 hours after vaccination, the patient experienced swollen lymph nodes in neck. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment with Nabumetone 500mg for inflammation and Tramadol 50mg. It was reported as unknown if patient had COVID prior vaccination and patient was not tested COVID post vaccination. The clinical outcome of all the events was not resolved.  Follow-up attempts completed. No further information expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Lip swelling, Peripheral swelling, Scan
Clinical narrative: lips and the right side of his face and his right side fingers became numb and swollen; lips and the right side of his face and his right side fingers became numb and swollen/numbness to his hand went up to his shoulder and his arm; lips and the right side of his face and his right side fingers became numb and swollen; lips and the right side of his face and his right side fingers became numb and swollen; lips and the right side of his face and his right side fingers became numb and swollen/ hand became so swollen; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiry date: Unknown), via an unspecified route of administration on 02Feb2021 (at the age of 72-years-old) as dose 1, single for COVID-19 immunization. Medical history was not reported. The patient concomitant medication which includes Fish oil and Vitamin D3, both taken for an unspecified indication, start and stop date were not reported. On an unspecified date in Feb2021, reported as 7 days later (not specified exact date), patient was sitting in his room when his lips and the right side of his face and his right side fingers became numb and swollen, reported as all on the right side. Patient stated that 30 minutes later after washing his hands and walking the symptoms went away. And this happened again another 3 days later, on an unspecified date in Feb2021, the right side of his face, his lips and right fingers became swollen and numb, and 1 hour later again it went away. After 2 days, on an unspecified date in Feb2021, while sitting on the couch, same thing, face lips and hands, swollen on the right side, patient wash his hands, exercise and walk. It happened 4th time, on an unspecified date in Feb2021, the numbness to his hand went up to his shoulder and his arm and hand became so swollen that patient could not move his hand to his body. Then they came fast and 2 hours later and it was gone again. Patient reported that he went to the ER, had an IV and a scan, x-ray with unknown results, the doctor said it may be a stroke but then not a stroke it was likely a reaction or allergy. Patient stated that he never had this before and he only take fish oil and vitamin D3 over the counter. Patient also reported that he cancelled the second dose that was due to on Tuesday. The outcome of the events was unknown.   No follow-up attempts are possible. Information about Lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling face, X-ray
Clinical narrative: lips and the right side of his face and his right side fingers became numb and swollen; lips and the right side of his face and his right side fingers became numb and swollen/numbness to his hand went up to his shoulder and his arm; lips and the right side of his face and his right side fingers became numb and swollen; lips and the right side of his face and his right side fingers became numb and swollen; lips and the right side of his face and his right side fingers became numb and swollen/ hand became so swollen; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiry date: Unknown), via an unspecified route of administration on 02Feb2021 (at the age of 72-years-old) as dose 1, single for COVID-19 immunization. Medical history was not reported. The patient concomitant medication which includes Fish oil and Vitamin D3, both taken for an unspecified indication, start and stop date were not reported. On an unspecified date in Feb2021, reported as 7 days later (not specified exact date), patient was sitting in his room when his lips and the right side of his face and his right side fingers became numb and swollen, reported as all on the right side. Patient stated that 30 minutes later after washing his hands and walking the symptoms went away. And this happened again another 3 days later, on an unspecified date in Feb2021, the right side of his face, his lips and right fingers became swollen and numb, and 1 hour later again it went away. After 2 days, on an unspecified date in Feb2021, while sitting on the couch, same thing, face lips and hands, swollen on the right side, patient wash his hands, exercise and walk. It happened 4th time, on an unspecified date in Feb2021, the numbness to his hand went up to his shoulder and his arm and hand became so swollen that patient could not move his hand to his body. Then they came fast and 2 hours later and it was gone again. Patient reported that he went to the ER, had an IV and a scan, x-ray with unknown results, the doctor said it may be a stroke but then not a stroke it was likely a reaction or allergy. Patient stated that he never had this before and he only take fish oil and vitamin D3 over the counter. Patient also reported that he cancelled the second dose that was due to on Tuesday. The outcome of the events was unknown.   No follow-up attempts are possible. Information about Lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: fever of 101.0; Chills; Body aches; Extremely tired; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for himself). A 36-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL 3247), via an unspecified route of administration, administered in arm left on 25Feb2021 at 13:00 (01:00 PM) (at the age of 36-year-old) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Patient had no allergies to medications, food, or other products. The patient concomitant medication included rosuvastatin calcium (CRESTOR) at a dose of 20 mg daily taken for an unspecified indication, start and stop date were not reported. 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. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in arm left on 04Feb2021 at 01:00 PM as dose 1, single for COVID-19 immunization. On 26Feb2021 at 09:00 AM, the patient experienced fever of 101.0, chills, body aches, extremely tired. The patient underwent lab tests and procedures which included fever was 101.0 on 26Feb2021. AE: Body aches and run down <12 hours from injection. 18 hours after, fever of 101.0 and chills. Extremely tired and body aches also continuing. Query response received and confirmed (the patient) confirmed the adverse events on 26Feb2021 and submitted the report on the 27Feb2021. The patient did not receive treatment for the events. Outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Fever; Chills; Body ache/sore after days; Fatigue; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 23-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3248; Expiration Date: 30Apr2021), via an unspecified route of administration (at the age of 23-years), administered in deltoid left on an unspecified date at 11:00 as dose 2, single for COVID-19 immunization. Medical history included , thyroid cancer, hashimotos sip, complete thyroidectomy onset(diagnosed) 10Jul20219 to stop date 05Sep2019 and COVID-19 from an unknown date and unknown if ongoing. The historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EK5730; Expiration Date: 31Mar2021), via an unspecified route of administration (at the age of 23-years), administered on 21Dec2201 at 13:30 as dose 1, single for COVID-19 immunization and experienced positive for Covid-19. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication from 05Sep2019 and ongoing. On 21Jan2021, the patient experienced fever, chills, body ache/sore after days and fatigue. The adverse events did not resulted in emergency room and physician office visit. The facility type was reported as hospital. The clinical outcome of the events was reported as unknown.  Follow-up attempts completed. No further information expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Fever; Nauseous; Headache; This is a spontaneous report from a contactable consumer. This consumer reported for a 57-Year-old female patient (wife) that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on 20Feb2021(at the age of 57 years) as dose 2, single for covid-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD). There were no concomitant medications. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization and she was okay with the first dose. No investigation assessment was reported. Reporter's wife had her second dose on 20Feb2021, obviously of the Pfizer vaccine and she was okay with the first dose, but the second dose she had experienced like the side effects like fever and like nauseous, and also had headache. Patient woke up with events on 21Feb2021 (morning), so they won't know the outcome of events until later on that day. So, he wanted to know if there was anything he could give her to kind of lessen the side effects. Reporter stated that they could talk to her, if they need to. The patient received no treatment for the events. The outcome of all events was not recovered.  Follow-up attempts completed. No further information expected.