chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise
Clinical narrative: Feeling very tired; Fall sick; Headache; This is a spontaneous report from a contactable healthcare professional (patient). A 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247; Expiration date was not reported) on the left arm on 17Feb2021 (10:30) as dose 1, single, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any vaccines within four weeks prior to the vaccination. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the left arm on 26Jan2021 (10:30) for COVID-19 immunization. On 17Feb2021 (13:00), the patient was feeling very tired; fall sick; and had headache. The patient did not receive any treatment for the reported events. The outcome of the events was recovered on an unspecified date in 2021 for headache; and was not recovered for all the other events.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pain
Clinical narrative: Flu-like symptoms; Aches; Chills; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247; Expiration date was not reported) on the left arm on 16Feb2021 (11:30) as dose 2, single, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. The patient's medical history and concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247; Expiration date was not reported) on 26Jan2021 (11:30) (when the patient was 35 years old), intramuscular on the left arm for COVID-19 immunization. On 16Feb2021 (23:00), the patient had flu-like symptoms, aches and chills. The patient did not receive any treatment for the reported events. The outcome for the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity, SARS-CoV-2 test
Clinical narrative: sore arm; fatigues; chills; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration on 16Feb2021 (at the age of 31 years old) as dose 1, single for COVID-19 immunisation. The patient has no medical history. The patient has never had COVID prior to vaccination. The patient is not pregnant at the time of vaccination. The patient's concomitant medications were not reported. No other vaccine was given in four weeks. The patient experienced sore arm, fatigues and chills on 17Feb2021. No treatment was given in response to the events. The patient underwent lab tests and procedures which included COVID test (post vaccination) via Nasal swab on 09Feb2021 which was negative. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm sour; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN4201; Expiration date was not reported) on 16Feb2021 (12:00) as dose number unknown, single, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 17Feb2021, the patient's arm was sore ("arm sour"). The patient did not receive any treatment for the event. The outcome of the event was not recovered. The patient did not have COVID-19 prior to the vaccination, and was not tested post-vaccination.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; fatigue; This is a spontaneous report from a contactable consumer (patient) via Covid-19 Adverse Event Self-Reporting Solution. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 16Feb2021 12:00 (lot number: El3247; expiry date: unknown) at the age of 55-years-old, as dose 1, single, for Covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient was not taking concomitant medications. The vaccine was administered in a workplace clinic. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient has not been tested for COVID-19 since vaccination. On 17Feb2021 at 08:00, the patient experienced sore arm and fatigue. The patient did not receive treatment for the events. The patient recovered from the events on unspecified date.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chill after injection; This is a spontaneous report from a contactable consumer (patient) via Covid-19 Adverse Event Self-Reporting Solution (COVAES). A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 15Feb2021 12:30 (lot number: EL3247; expiry date: unknown) at the age of 36-years-old, as dose 2, single, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown if the patient had known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Jan2021 at 08:00 AM (lot number: EL3247; expiry date: unknown) at the age of 36-years old, as dose 1, single, in left arm for Covid-19 immunisation. The vaccine was administered in a workplace clinic. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient has not been tested for COVID-19 since vaccination. The patient experienced chill after injection on 15Feb2021 at 12:30. The patient did not receive treatment for the event. The patient recovered from the event on unspecified date.    No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: after her first dose she had swollen glands; This is a spontaneous report from a Pfizer-sponsored program  Support. A contactable female consumer (patient) reported for herself that, A female patient of an unspecified age received 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 as a DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. After her first dose, she had swollen glands on an unspecified date. It was reported that, the patient already got her first dose. Her second dose was scheduled for tomorrow (date unspecified). The patient wanted to confirm if she could take Tylenol or Advil. Outcome of the event was unknown.  Information on the batch/lot number has been requested. Follow-up attempts completed. No further information expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Gastrointestinal disorder, Gastrooesophageal reflux disease
Clinical narrative: Feeling very unwell; Nauseous; Diarrhea; Bad stomach pains; My arms hurt around my peck muscles; Experiencing acid reflux; Lightheadedness; GI symptoms; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A 34-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9810), via an unspecified route of administration, administered in Arm Left on 14Feb2021 14:00 (at the age of 34-years-old) as dose 1, single for COVID-19 immunisation. Medical history included psoriatic arthropathy from an unknown date and unknown if ongoing , covid-19 from Nov2020 to an unknown date. Concomitant medications included amoxicillin (AMOXICILLIN) taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. In pharmacy or drug store patient received vaccine facility. Since the vaccine on day 3, On 15Feb2021 13:00 I have been extremely nauseous, diarrhea, bad stomach pains. I did call my doctor but she said there was not anything to do. I wanted to know if what I am experiencing was normal because it does not seem to be getting any better. I am still feeling nauseous and have diarrhea. Also, my arms hurt around my peck muscles. I am not sure if I should get the second dose. Caller had Covid back in Nov of 2020 and reported feeling very unwell on unknown date. She received her first Covid vaccination on 14Feb2021. The day after receiving the vaccination she reported experiencing acid reflux and lightheadedness which are still continuing. She was due for the second vaccination soon and wanted to know if she should get it. She was seen by her physician yesterday for ongoing GI symptoms and physician recommended treatment for acid reflux. No treatment was received for the events. Patient visited Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 03Feb2021. The outcome of the event malaise was reported as unknown and while for other events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb injury, Malaise, Nausea, SARS-CoV-2 test
Clinical narrative: Feeling very unwell; Nauseous; Diarrhea; Bad stomach pains; My arms hurt around my peck muscles; Experiencing acid reflux; Lightheadedness; GI symptoms; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A 34-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9810), via an unspecified route of administration, administered in Arm Left on 14Feb2021 14:00 (at the age of 34-years-old) as dose 1, single for COVID-19 immunisation. Medical history included psoriatic arthropathy from an unknown date and unknown if ongoing , covid-19 from Nov2020 to an unknown date. Concomitant medications included amoxicillin (AMOXICILLIN) taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. In pharmacy or drug store patient received vaccine facility. Since the vaccine on day 3, On 15Feb2021 13:00 I have been extremely nauseous, diarrhea, bad stomach pains. I did call my doctor but she said there was not anything to do. I wanted to know if what I am experiencing was normal because it does not seem to be getting any better. I am still feeling nauseous and have diarrhea. Also, my arms hurt around my peck muscles. I am not sure if I should get the second dose. Caller had Covid back in Nov of 2020 and reported feeling very unwell on unknown date. She received her first Covid vaccination on 14Feb2021. The day after receiving the vaccination she reported experiencing acid reflux and lightheadedness which are still continuing. She was due for the second vaccination soon and wanted to know if she should get it. She was seen by her physician yesterday for ongoing GI symptoms and physician recommended treatment for acid reflux. No treatment was received for the events. Patient visited Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 03Feb2021. The outcome of the event malaise was reported as unknown and while for other events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dizziness, Gastrooesophageal reflux disease, Nausea
Clinical narrative: Feeling very unwell; Nauseous; Diarrhea; Bad stomach pains; My arms hurt around my peck muscles; Experiencing acid reflux; Lightheadedness; GI symptoms; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A 34-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9810), via an unspecified route of administration, administered in Arm Left on 14Feb2021 14:00 (at the age of 34-years-old) as dose 1, single for COVID-19 immunisation. Medical history included psoriatic arthropathy from an unknown date and unknown if ongoing , covid-19 from Nov2020 to an unknown date. Concomitant medications included amoxicillin (AMOXICILLIN) taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. In pharmacy or drug store patient received vaccine facility. Since the vaccine on day 3, On 15Feb2021 13:00 I have been extremely nauseous, diarrhea, bad stomach pains. I did call my doctor but she said there was not anything to do. I wanted to know if what I am experiencing was normal because it does not seem to be getting any better. I am still feeling nauseous and have diarrhea. Also, my arms hurt around my peck muscles. I am not sure if I should get the second dose. Caller had Covid back in Nov of 2020 and reported feeling very unwell on unknown date. She received her first Covid vaccination on 14Feb2021. The day after receiving the vaccination she reported experiencing acid reflux and lightheadedness which are still continuing. She was due for the second vaccination soon and wanted to know if she should get it. She was seen by her physician yesterday for ongoing GI symptoms and physician recommended treatment for acid reflux. No treatment was received for the events. Patient visited Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 03Feb2021. The outcome of the event malaise was reported as unknown and while for other events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Nausea
Clinical narrative: headache; Fatigue; nausea; malaise; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect via a contactable consumer (patient himself). An unspecified aged male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Patient medical history and concomitant drugs were not reported. Patient stated that on an unspecified date after first dose of vaccine he experienced Headache, Fatigue, nausea and malaise and for which he took Tylenol. Outcome of events was unknown.  Information about lot/ batch number has been requested. Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Vomiting
Clinical narrative: He is lethargic and is vomiting.; He is lethargic and is vomiting.; This is a spontaneous report from a contactable consumer (patient's wife) from a Pfizer-sponsored program. A male patient of an unknown age received second dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: unknown) via an unspecified route of administration on 12Feb2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported. It was reported that caller's husband had his second COVID shot last 12Feb2021. He was lethargic and was vomiting. The outcome of the events was unknown.    Information about lot/batch number has been requested. Follow-up attempts are completed. No further information was expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dysgeusia, Headache, Pyrexia, Rash
Clinical narrative: metallic taste in his mouth; soreness in [his] arm /the injection site was a little sore as; rash on his chest and down [his] arms a little bit; headaches; fever; This is a spontaneous report from a contactable consumer. This (Age: 59; Unit: Unknown) male consumer (patient) reported.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 08Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included flu vaccine. It was reported that the patient stated that after receiving the first dose of the Pfizer-BioNTech COVID-19 vaccine on 08Feb2021 (last Monday), the patient stated an hour after the shot, that the patient had a metallic taste in [his] mouth that lasted between 1-2 hours on 08Feb2021. The patient added he also had soreness in [his] arm on 08Feb2021. The patient specified nine days after the vaccination, the patient developed a rash on his chest and down [his] arms a little bit on an unspecified date in Feb2021. The patient also experienced headaches and a fever on an unspecified date in Feb2021. The patient explained that the headaches lasted for three days, and now it was a dull headache. The patient specified the fever started on the Wednesday night and lasted all the way through last night. The patient mentioned he checked his temperature that day and it was normal. The patient asked these were the side effects of the vaccine. The patient underwent lab tests and procedures which included body temperature: normal on 19Feb2021 (he checked his temperature today). Outcome of the events metallic taste in his mouth and soreness in [his] arm /the injection site was a little sore as, was reported as Recovered on an unspecified date, Outcome of the event rash on his chest and down [his] arms a little bit, fever was reported as recovering and outcome of the event headache was reported as not recovered at this time of the report.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: metallic taste in his mouth; soreness in [his] arm /the injection site was a little sore as; rash on his chest and down [his] arms a little bit; headaches; fever; This is a spontaneous report from a contactable consumer. This (Age: 59; Unit: Unknown) male consumer (patient) reported.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 08Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included flu vaccine. It was reported that the patient stated that after receiving the first dose of the Pfizer-BioNTech COVID-19 vaccine on 08Feb2021 (last Monday), the patient stated an hour after the shot, that the patient had a metallic taste in [his] mouth that lasted between 1-2 hours on 08Feb2021. The patient added he also had soreness in [his] arm on 08Feb2021. The patient specified nine days after the vaccination, the patient developed a rash on his chest and down [his] arms a little bit on an unspecified date in Feb2021. The patient also experienced headaches and a fever on an unspecified date in Feb2021. The patient explained that the headaches lasted for three days, and now it was a dull headache. The patient specified the fever started on the Wednesday night and lasted all the way through last night. The patient mentioned he checked his temperature that day and it was normal. The patient asked these were the side effects of the vaccine. The patient underwent lab tests and procedures which included body temperature: normal on 19Feb2021 (he checked his temperature today). Outcome of the events metallic taste in his mouth and soreness in [his] arm /the injection site was a little sore as, was reported as Recovered on an unspecified date, Outcome of the event rash on his chest and down [his] arms a little bit, fever was reported as recovering and outcome of the event headache was reported as not recovered at this time of the report.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Oropharyngeal pain
Clinical narrative: colds and sore throat now; colds and sore throat now; This is a spontaneous report from a contactable consumer via Pfizer sponsored program Covax Support. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, 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. On an unspecified date, the patient had colds and sore throat and asked if they need to reschedule the second dose on 17Feb. The outcome of the events were unknown.   Follow-up attempts completed. No further information expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Back pain, Chills, Dysgeusia
Clinical narrative: is just not feeling well; has a weird taste in her mouth, like metal or bitterness; joints and muscles started hurting; raspberry red tongue and it was swollen; raspberry red tongue and it was swollen; cheeks were irritated; bumps on inside of top and bottom lips; uvula was swollen; throat was swollen; hard time swallowing; joints and muscles started hurting; eyes were puffy; chills; felt a little sick to her stomach; back hurts; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 16Feb2021 as single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Caller states that within about 15 minutes after receiving the vaccine on 16Feb2021, patient had a raspberry red tongue and it was swollen, cheeks were irritated, bumps on inside of top and bottom lips, uvula was swollen and almost touching her tongue, throat was swollen and had a hard time swallowing, joints and muscles started hurting, eyes were puffy. She states that she has also experienced muscle aches, joint aches, chills, felt a little sick to her stomach but nothing really bad with the chills and that her back hurts. Caller also reported that Patient was just not feeling well and had a weird taste in her mouth, like metal or bitterness. She went to see her doctor early Wednesday morning for these side effects and she was told to take claritin. Since beginning this treatment recommendation her symptoms have improved a lot. She wants to know how long these symptoms are going to last for because she does not feel well. Event were reported as non-serious. The clinical outcome of the events is just not feeling well and Taste metallic was unknown and all the other events outcome was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Enlarged uvula, Erythema, Lip swelling, Malaise
Clinical narrative: is just not feeling well; has a weird taste in her mouth, like metal or bitterness; joints and muscles started hurting; raspberry red tongue and it was swollen; raspberry red tongue and it was swollen; cheeks were irritated; bumps on inside of top and bottom lips; uvula was swollen; throat was swollen; hard time swallowing; joints and muscles started hurting; eyes were puffy; chills; felt a little sick to her stomach; back hurts; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 16Feb2021 as single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Caller states that within about 15 minutes after receiving the vaccine on 16Feb2021, patient had a raspberry red tongue and it was swollen, cheeks were irritated, bumps on inside of top and bottom lips, uvula was swollen and almost touching her tongue, throat was swollen and had a hard time swallowing, joints and muscles started hurting, eyes were puffy. She states that she has also experienced muscle aches, joint aches, chills, felt a little sick to her stomach but nothing really bad with the chills and that her back hurts. Caller also reported that Patient was just not feeling well and had a weird taste in her mouth, like metal or bitterness. She went to see her doctor early Wednesday morning for these side effects and she was told to take claritin. Since beginning this treatment recommendation her symptoms have improved a lot. She wants to know how long these symptoms are going to last for because she does not feel well. Event were reported as non-serious. The clinical outcome of the events is just not feeling well and Taste metallic was unknown and all the other events outcome was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Periorbital swelling, Pharyngeal swelling, Swollen tongue, Tongue erythema
Clinical narrative: is just not feeling well; has a weird taste in her mouth, like metal or bitterness; joints and muscles started hurting; raspberry red tongue and it was swollen; raspberry red tongue and it was swollen; cheeks were irritated; bumps on inside of top and bottom lips; uvula was swollen; throat was swollen; hard time swallowing; joints and muscles started hurting; eyes were puffy; chills; felt a little sick to her stomach; back hurts; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 16Feb2021 as single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Caller states that within about 15 minutes after receiving the vaccine on 16Feb2021, patient had a raspberry red tongue and it was swollen, cheeks were irritated, bumps on inside of top and bottom lips, uvula was swollen and almost touching her tongue, throat was swollen and had a hard time swallowing, joints and muscles started hurting, eyes were puffy. She states that she has also experienced muscle aches, joint aches, chills, felt a little sick to her stomach but nothing really bad with the chills and that her back hurts. Caller also reported that Patient was just not feeling well and had a weird taste in her mouth, like metal or bitterness. She went to see her doctor early Wednesday morning for these side effects and she was told to take claritin. Since beginning this treatment recommendation her symptoms have improved a lot. She wants to know how long these symptoms are going to last for because she does not feel well. Event were reported as non-serious. The clinical outcome of the events is just not feeling well and Taste metallic was unknown and all the other events outcome was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: diarrhea; bad bowel; This is a spontaneous report from a contactable consumer or other non-health care professional reported for a patient (son) and report received from a Pfizer sponsored program. A 40-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on 12Feb2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced diarrhea and had a bad bowel for 3 days on an unspecified date. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 12Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included constipation from an unknown date and unknown if ongoing Caller described herself as an advantage in having diarrhoea because she is normally constipated. The patient's concomitant medications were not reported.The patient experienced diarrhoea on an unspecified date. The outcome of the event diarrhoea was unknown.  Information about the Lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: experiencing a toothache; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a patient (daughter) that a female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on 18Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that reporters daughter had a scheduled 1st dose this Thursday 18Feb2021, and was experiencing a toothache on an unspecified date. Reporter was asking if Augmentin (antibiotic) from her doctor can affect the vaccine. Outcome of the event was unknown.   Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood cholesterol abnormal
Clinical narrative: had the vaccine on 09Feb2021 and had taken Praluent injection for her cholesterol and wants to know if it will not affect the vaccine; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient (wife) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 09Feb2021 as dose 1, single for COVID-19 immunisation And patient also received alirocumab (PRALUENT, formulation: injection), via an unspecified route of administration from unknown date at unknown dose for cholesterol. The patient medical history and concomitant medications were not reported. The patient had the vaccine on 09Feb2021 and had taken praluent injection for her cholesterol and wants to know if it will not affect the vaccine. On an unspecified date, the patient underwent lab tests and procedures which cholesterol results were Had taken Praluent injection for her cholesterol and wants to know if it will not affect the vaccine. Therapeutic measures were taken as a result of had the vaccine on 09Feb2021 and had taken praluent injection for her cholesterol and wants to know if it will not affect the vaccine. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: headache; body ache; fever; Chills; This is a spontaneous report from a contactable consumer. A 63-year-old female patient received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 18Feb2021 (Batch/Lot Number: EL3247) as SINGLE DOSE for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient received initial  dose of BNT162B2 on 28Jan2021 (Lot number=EL3247, Administration time=09:45 A.M, Administrator route=Intramuscular at Left arm). The patient experienced Headache, body ache, fever and chills on 18Feb2021 at 21:00. The patient underwent lab tests and procedures which included body temperature: 101 on 18Feb2021. The outcome of the events was recovered.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain
Clinical narrative: Chills; aching; severe headache; nausea; This is a spontaneous report from a Pfizer-sponsored program and contactable consumer. A 50-years-old male patient 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 14Feb2021 at 08:45 (at the age of 50-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included weight increased (Just Heavy weight) from an unknown date and unknown if ongoing. No concomitant medication was reported. Other products, patient History and investigation assessment reported as no. History and Investigations: No. Patient received 2nd dose of COVID vaccine Sunday morning on 15Feb2021 at 8:45AM, the patient experienced minor symptoms pain, chills and aches. Has not taken anything for pain but would like to know if patient can take something such as Tylenol or Advil. Patient did not have any underlying conditions. Since midnight has had many of the common symptoms such as nausea, aching, chills and severe headache. Wants to know if he can take a Tylenol. Patient needs the Tylenol. Did not want to do anything that was advised against. The outcome of the events were unknown.   Follow-up attempts completed. No further information expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Sluggishness
Clinical narrative: Dizziness/dizzy; Real weak; Feeling sluggish; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's wife) reported for a 71-year-old patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date (at age of 71-years-old) as DOSE 1, SINGLE for COVID-19 immunization. No medical history and concomitant medications were reported. Reporter was calling on behalf of her husband. He has been having some issues since he got his first vaccine, a week or 2 after of first dose he started feeling sluggish was real weak and was now dizzy on an unspecified date. Stated last Thursday he went and got this second dose of the vaccine, still dizzy. Wanted to know if this was something he should be concerned about, where should he go from here. Caller was encouraged to reach out to his healthcare provider for medical advice. Caller stated they need to go so she could call her husband's doctor. The outcome of al events was unknown.  Information about batch/lot number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arm hurts; This is a spontaneous report from a Pfizer-sponsored program regulatory authority SUPPORT from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated her arm hurt on an unspecified date with outcome of unknown. She was asking what she can do for the pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: after the 1st dose of the vaccine, she experienced pain in the arms; 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, Formulation: Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, the caller was scheduled the 2nd dose of the vaccine tomorrow, on an unspecified date and was asked whether she needed to do a signing up just like the 1st dose before, after providing the information that she needed to call the facility, the caller gave information that, after the 1st dose of the vaccine, she experienced pain in the arms on an unspecified date. The outcome of the event was unknown.  Information about lot/ batch number has been requested. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Neurological symptom, Paraesthesia
Clinical narrative: Neurological feelings in legs and feet; tingling feelings; This is a spontaneous report from a contactable consumer (patient) and from Pfizer. A female patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced neurological feelings in legs and feet 3 or 4 days and tingly feelings. The outcome of the events was unknown.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: Flu; This is a spontaneous report from a Pfizer sponsored program COVAX US Support. A contactable female consumer reported that, a female patient of unspecified age received first dose of BNT162B2 (Pfizer COVD-19 Vaccine, formulation: Solution for injection, batch/lot number: unknown) via an unspecified route of administration on 13Feb2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had the first dose of vaccine and currently experiencing Flu. Outcome of the event was not recovered.  Information about lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain, Pyrexia
Clinical narrative: 'excessively' sick; Chills; fever; aches and pain in her whole body.; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9267), via an unspecified route of administration on 18Feb2021 (at the age of 60-years-old) as dose 1, single for COVID-19 immunization. Medical history included COVID-19 from Oct2020; diabetes, high blood pressure, and a heart disease from an unknown date and unknown if ongoing. The patient had unspecified concomitant medication. On 19Feb2021, the patient experienced chills, fever, aches and pain in her whole body. She wanted to know if this was normal, if she should expect the same reaction or worse for the second dose, and if the previous COVID-19 could have caused the reaction she experienced. She needed to know if she was going to be excessively sick as she was after the first shot if she got the second shot. Therapeutic measures taken as a result of the events included ibuprofen and acetaminophen. Outcome of the events was unknown.   No follow-up attempts are possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Full blood count abnormal
Clinical narrative: scheduled by her Physician for blood work on Friday; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced scheduled by her physician for blood work on Friday. The patient underwent lab tests and procedures which included blood count: abnormal on unspecified date. The outcome of the event blood count abnormal was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Nausea, Pain, Vaccination site erythema
Clinical narrative: Nausea; some aches; swelling and redness on the site; swelling and redness on the site; tiredness; not feeling well; This is spontaneous report from Pfizer-sponsored program from a contactable consumer (patient). A 90-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date on an unspecified date on Thursday 10:30 AM as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine includes BNT162B2 on an unspecified date for COVID-19 immunization and experienced no adverse event. On an unspecified date, after the second dose, the patient experienced Nausea, some aches, a little bit of swelling and redness on the site, tiredness and not feeling well. Outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Nausea; some aches; swelling and redness on the site; swelling and redness on the site; tiredness; not feeling well; This is spontaneous report from Pfizer-sponsored program from a contactable consumer (patient). A 90-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date on an unspecified date on Thursday 10:30 AM as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine includes BNT162B2 on an unspecified date for COVID-19 immunization and experienced no adverse event. On an unspecified date, after the second dose, the patient experienced Nausea, some aches, a little bit of swelling and redness on the site, tiredness and not feeling well. Outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Influenza like illness, Tremor
Clinical narrative: her hands started to shake; flu like symptoms; sense of smell and taste "went backwards"; sense of smell and taste "went backwards"; This is a spontaneous report from a contactable nurse.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 18Feb2021 (Batch/Lot Number: EM9809) as dose 1, single for COVID-19 immunisation.  Medical history included COVID-19 on 15Jan2021 and 5 days later she lost her sense of smell and taste, in which a week ago, got it back.  The patient's concomitant medications were not reported.  The patient experienced after a half hour her hands started to shake, in which she took some deep breaths and got over that. She stated that she had flu like symptoms and took Tylenol and today is the best day she has had since receiving the vaccine. She reported that her sense of smell and taste "went backwards and it's not as keen." She asked, "Does this happen to people who have had Covid such as regression of senses in smell and taste? "When should I expect it to come back like before?" Caller asked who is stating that it is ok to receive the vaccine if you've had Covid. The outcome of the events was recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 11Feb2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache on Feb2021 with outcome of unknown. Patient was asking if he can take Tylenol because he experienced a headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at injection site after receiving 1st dose of the vaccine; This is a spontaneous report from a Pfizer-sponsored program, COVAX US Support via medical information team. A contactable consumer (patient) reported that a male patient of an unspecified age (age: 82; unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history was not reported. Concomitant medications included ongoing acetylsalicylic acid (ASPRIN) and blood thinners. On an unspecified date, patient experienced pain at injection site after receiving 1st dose of the vaccine should not have blood thinners and asprin wanted to know if he should hold off until after he receives the 2nd dose. Patient received the first dose of the Covid vaccine and read that it is not recommended to take aspirin or any blood thinner while receiving the covid vaccine. He was on blood thinners and aspirin regularly, in which he asks if he needs to stop them before receiving the second dose. He asked if the blood thinners reduced the efficacy of the vaccine. He has not experienced any bleeding or bruising. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.