chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: back pain; This is a spontaneous report from a Pfizer Sponsored Program. A contactable male consumer reported for himself that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) at single dose for COVID-19 immunization on 08Jan2021. Relevant history and concomitant drugs were unknown. The patient got the vaccine yesterday and he had back pain on 09Jan2021. The patient asked if he could take Tylenol.  Outcome of event was unknown.  The information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle pain; This is a spontaneous report received from a contactable consumer (patient) from a Pfizer-sponsored program. A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The patient experienced muscle pain on an unspecified date. He was asking how long the muscle pain lasted. The outcome of the event was not recovered.  Information on the batch number and lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Parosmia
Clinical narrative: Has a very unpleasant taste and smell; Has a very unpleasant taste and smell; 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), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced a very unpleasant taste and smell on an unspecified date. The events were non-serious with outcome of unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site erythema, Vaccination site infection, Vaccination site warmth
Clinical narrative: Black and blue mark at the injection site, Bruising; Patch of warm red skin; Patch of warm red skin; Looks like a little bit of local infection; This is a spontaneous report from a contactable consumer (patient's husband). A 71-year-old female patient received the first dose of bnt162b2 (Pfizer BioNtech COVID-19 Vaccine) lot no: EL1283, via an unspecified route of administration on an unspecified date at a single dose for local vaccination roll out program. The patient's medical history and concomitant medications were not reported. The reporter was calling on behalf of his wife. She got the injection on Wednesday (unspecified date). On 06Jan2021, she has some bruising, some dark bruising and then a patch of warm red skin, black and blue mark at the injection site about half inches smaller in diameter. And then she has regular hot reddish patch around that. It looks like a little bit of local infection there, it appears like. Treatment not given at the time of report. For the causality, the reporter stated that events were definitely due the injection. The patient's weight was about 160 pounds on an unspecified date. Outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: after the patient got vaccinated his relative tested positive; after the patient got vaccinated his relative tested positive; This is a spontaneous report from a Pfizer-sponsored program . A contactable nurse (relative of the patient) reported for a patient of unspecified age and gender received the first dose of bnt162b2 (also reported as Pfizer Covid-19 Vaccine, lot no. and expiry date was not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The nurse called in because his relative got the 1st dose of vaccine but after the patient got vaccinated his relative tested positive on unspecified date. The nurse called in if the patient can take the 2nd dose of vaccine. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) but after the patient got vaccinated his relative tested positive on unspecified date.  The case will be reassessed should additional information become available.
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: back pain; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number), via an unspecified route of administration from an unspecified date at a single dose for an Covid-19 vaccination. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of bnt162b2 for Covid-19 vaccination. The patient wanted to know if he can take an over the counter drug like ibuprofen because he is experiencing severe back pain after taking the 2nd dose of Covid-19 Vaccine today. Outcome of the event was unknown.  Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: has swelling on the bottom of foot; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored Program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had swelling on the bottom of foot started on 09Jan2021. The patient asked if this could be caused by the vaccine. The outcome of the event was unknown. Reaction after first covid vaccine dose, on hold for 20 minutes, it went to VM.  Information about Lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Heart rate, Heart rate increased, Malaise
Clinical narrative: I have a fever; my current temperature is 102.6; Pulse is slightly high; I am not in the best of shape right now; Really tired; Hurting; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received  the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via an unspecified route of administration in Jan2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  In Jan2021, the patient had a fever,  her current temperature was 102.6; pulse was slightly high; patient not in the best of shape right now was kind of really tired and hurting. The patient's oxygen level was okay, checked it and it was around 96, 97 oxygen saturation. The patient further mentioned that the current temperature was real quick, patient was hoping to be around 100 but it spiked up as current temperature is 102.6. The outcome of the events was unknown.   Information on the lot/ batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Oxygen saturation, Pain, Pyrexia
Clinical narrative: I have a fever; my current temperature is 102.6; Pulse is slightly high; I am not in the best of shape right now; Really tired; Hurting; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received  the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via an unspecified route of administration in Jan2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  In Jan2021, the patient had a fever,  her current temperature was 102.6; pulse was slightly high; patient not in the best of shape right now was kind of really tired and hurting. The patient's oxygen level was okay, checked it and it was around 96, 97 oxygen saturation. The patient further mentioned that the current temperature was real quick, patient was hoping to be around 100 but it spiked up as current temperature is 102.6. The outcome of the events was unknown.   Information on the lot/ batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable Physician. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration on unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm on unspecified date. The outcome of the event sore arm was unknown.  Follow-up activities are possible, information on the batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Vaccination site vesicles
Clinical narrative: Blisters/One blister was kind of longer than the other at about 7mm; was given COVID-19 Vaccine too high and almost on the very top of the shoulder; This is a spontaneous report from a contactable other healthcare professional. A 43-year-old female patient received her second dose of bnt162b2 (BNT162B2 also reported COVID-19 Vaccine by Pfizer, lot EL1284, expiry 30Apr2021), intramuscularly on 08Jan2021 10:10 at 0.3 mL, single for Covid-19 immunisation since she was an essential worker. She had her first dose of vaccine on 21Dec2021 (lot EK5730, expiry date 31Mar2021) via IM route at 0.3ml single dose for Covid-19 immunisation. Medical history included seasonal allergy. The patient's concomitant medications were not reported. The patient reported that COVID Vaccine which was given on the very top of her shoulder on 08Jan2021. Because of the location of the injection, the patient experienced a cluster of blisters at the injection site on 09Jan2021 now reported as a big scab. One blister was kind of longer than the other at about 7mm's. She took ibuprofen and has been guarding her shoulder. The outcome of Vaccination site blister was recovering.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable nurse (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and patient's concomitant medications were not reported. The patient received his first dose on 22Dec2020 then, nine days later, on 31Dec2020, he tested positive for COVID. He is scheduled for his second dose on 12Jan2021. However, he is still out of work. He called to see if he could get his second dose a couple of days later or does it have to be exactly 3 weeks from the first shot and if it is okay to go a little longer. During the call, he stated he just wanted his question answered about the second shot, if can he wait a little longer. The outcome of the events was unknown.   Follow-up attempts are completed. The following information on the batch number has been requested.; Sender's Comments: A causal association between reported event and suspect BNT162B2 cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: Sick since took this vaccine; want to get rid of this sickness; Chills; Fever; Nausea; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that ever since receiving the vaccine last Tuesday, the patient had been sick and wanted to get rid of the sickness. Reportedly, the patient was "tired to be" (pending clarification) in sick." The patient had fever, nausea and chills. The outcome of the events was unknown.   No follow-up attempts are possible. Information on lot/batch cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Husband w/ Tingling tongue a few days after the first shot and it last about 2 weeks w/fluctuation in intensity; This is a spontaneous report from the Pfizer sponsored program, Pfizer RXPathways via a contactable consumer. A male patient (reporter's husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient experienced tingling tongue a few days after the first shot and it lasted about 2 weeks with fluctuation in intensity but decreased to almost non-existent yesterday. Reporter asked should the patient get the second shot and was this a sign of allergic reaction? Outcome of the event was resolving.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Extreme Fatigue; This is a spontaneous report from a non-contactable consumer (patient). This patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced extreme fatigue after first dose of Pfizer COVID vaccine. The outcome of event was unknown.  No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever; Chills; Headache; Body ache; This is a spontaneous report from contactable physician (patient) via Pfizer Sales Representative.   This 27-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on unknown date for COVID-19 immunization. No relevant medical history and concomitant medications were provided. On unknown date, the patient developed fever, chills, headache and body ache. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Hangover, Headache
Clinical narrative: Chills; headache; muscle ache; fatigue; Like a bad hangover; Feel crappy; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age (Age: 62, Unit: Unknown) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 date single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced chills, headache, muscle ache, fatigue, like a bad hangover, feel crappy. Outcome of events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Chills; headache; muscle ache; fatigue; Like a bad hangover; Feel crappy; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age (Age: 62, Unit: Unknown) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 date single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced chills, headache, muscle ache, fatigue, like a bad hangover, feel crappy. Outcome of events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Ocular discomfort
Clinical narrative: headache that would not go away, like her head would explode; pressure behind her eyes; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EJ685), intramuscular in her right arm on 06Jan2021 at a single dose for covid-19 immunisation. Medical history and concomitant medications were reported as none. On 06Jan2021, the patient experienced headache that would not go away, like her head would explode and pressure behind her eyes. Stated that both events started 30 minutes after the shot on 06Jan2021.Therapeutic measures were taken as a result of headache that would not go away, like her head would explode and pressure behind her eyes which included ibuprofen 800 and switched it out with TYLENOL. Outcome of the events headache that would not go away, like her head would explode and pressure behind her eyes was recovered on 09Jan2021.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pain
Clinical narrative: little fatigued; simply sore from the aches; muscle aches; shivering chills; This is a spontaneous report from contactable Physician (pediatrician, patient) via Pfizer Sales Representative. This male physician received second dose of BNT162B2 (the COVID vaccine) on 08Jan2021 at 1:00 PM for COVID-19 immunization. Medical history was had Covid in Aug2020 and he had zero symptoms. He has Graves' disease and microscopic colitis. Concomitant drug was not reported. Past drug was first dose of BNT162B2. He received his second dose of the COVID vaccine Jan 8th at 1:00 PM. At 2:30 AM on 09Jan2021 he woke with massive muscle aches and shivering chills. As of 8:00 AM on 09Jan2021 he is simply sore from the aches and a little fatigued. Event took place after use of product. Outcome of the event was unknown.  Information about Lot/Batch has been requested.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Got my Covid vaccine on the 20th and then I came back positive for Covid last week; Got my Covid vaccine on the 20th and then I came back positive for Covid last week; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on 20Dec2020 at a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  It was reported that the patient got the COVID vaccine on the 20th (20Dec2020) and then came back positive for COVID on an unspecified in Jan2021 (reported as last week), then tested negative on 08Jan2021 and was due for vaccine on 09Jan2021. It was asked if the patient will be able to get the vaccine. The outcome of the events was recovered on 08Jan2021.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: diagnosed with Covid; diagnosed with Covid; This is a spontaneous report from contactable other healthcare professional via a Pfizer sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date was not reported) via an unspecified route of administration on 04Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the vaccine on 04Jan2021 and was diagnosed with COVID on 07Jan2021. Outcome of the event was unknown.  Information about Lot/Batch number has been requested.; Sender's Comments: Although, BNT162B2 vaccine immunogenicity is not in full effect after short time (3 days in this case) from the first dose administration, a causal relationship between event "diagnosed with COVID" (coded to Drug ineffective / COVID-19) and BNT162B2 vaccine cannot be completely excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: was burning up; Sore arm; Throbbing headache; I was hot, I was cold; Fever; Chills; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old female patient received the second dose of BNT162B2 (BIONTECH COVID-19 VACCINE lot number: EK9231), via an unspecified route of administration, on 07Jan2021, at single dose, for COVID-19 immunization, in the hospital. Medical history included blood pressure high and high cholesterol. The patient reported "I just got my second Pfizer Vaccine (clarified as BioNTech Covid 19 vaccine) yesterday (07Jan2021) and I just wanted to call to report the side effects that I have because they told me you should specially after the second one. And I have had fever, headache, and chills. So, I just wanted to report this". When asked about the event start date, the patient stated, "I went to sleep, I got the shot yesterday morning on early (07Jan2021). And then I was fine except for the sore arm. And then I woke up in the night. I fell asleep fine; I woke up through the midnight and it was burning up. So, I took my temperature. So, I'd say about 3 am (08Jan2021)". When asked if the patient was still experiencing the events, the patient stated, "Little bit because I had also throbbing headache and I was hot, I was cold. I did take Tylenol (treatment) and I did think that it started to help a little bit. Because I did got, my fever has gone down." The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: body ache and chills; body ache and chills; This is a spontaneous report from a contactable consumer.   A female patient of an unspecified age received bnt162b2 (BNT162B2, Batch/lot # EK9231) at single dose on 06Jan2021 for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced body ache and chills on an unspecified date in Jan2021. No treatment received. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Chills, Feeling cold, Headache, Muscle spasms, Musculoskeletal chest pain
Clinical narrative: Fever is 100; Chills; Runny nose; Sneezing; I am hurting every where my ribs, my hand, my arms/she can't move her hands and her arm, and both of her arms hurt; Terrible headache; I am hurting every where my ribs, my hand, my arms; Having deep down spasm in my leg; I can't get warmed; My whole body hurts; This is a spontaneous report from a contactable nurse (patient) reported that a patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date then received the second dose on 07Jan2021 both via an unspecified route of administration at a single dose for COVID-19 immunization, and guselkumab (TREMFYA), via an unspecified route of administration from an unspecified date at an unknown dose and frequency for psoriasis. The patient's medical history and concomitant medications were not reported. It was reported that the patient received his/her second injection yesterday (07Jan2021). He/She was very sick today (08Jan2021). He/She have fever and chills, he/she still have a runny nose and sneezing, he/she can't move his/her hands and arm, and both of his/her arms hurt. He/She didn't go to work today. He/She can't move his/her hands, if he/she try to move his/her hands, his/her hand hurts, the bones in his/her arm hurts, both of his/her arms hurts, he/she just feel really bad today (08Jan2021). This is the worst, he/she have ever felt. He/She have a lot of bad symptoms and the last time he/she took the shot, he/she had same symptoms but they were not as much bad as they are now. He/She just thought that with the second vaccination he/she wouldn't get sick. He/She have been taking Ibuprofen every 6 hours. He/She can't get warm. But he/she knew he/she will get better but he/she just wanted to report this symptoms that he/she was having. He/She wanted to talk and get better but all he/she was saying is he/she have had single shot and he/she was really sick then and this is 10 times worse than that (first dose). His/Her whole body hurts, he/she have fever, chills. His/Her fever is 100. He/She have a terrible headache, he/she feel so bad right now. He/She wanted to let know that he/she was not feeling good and he/she was sure he/she will feel good by Monday but he/she just had some complications. He/She don't feel good, he/she was hurting everywhere his/her ribs, hand, arms. He/She was having deep down spasm in his/her leg and he/she have taken Aspirin (Intent: treatment) for that and he/she have been taking Ibuprofen (Intent: treatment) for his/her body ache and fever and he/she knew he/she was going to get better. He/She don't want to be wimpy but he/she don't feel good. The outcome of the events was not recovered.  Information about lot/batch has been requested.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Pain, Pain in extremity, Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: Fever is 100; Chills; Runny nose; Sneezing; I am hurting every where my ribs, my hand, my arms/she can't move her hands and her arm, and both of her arms hurt; Terrible headache; I am hurting every where my ribs, my hand, my arms; Having deep down spasm in my leg; I can't get warmed; My whole body hurts; This is a spontaneous report from a contactable nurse (patient) reported that a patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date then received the second dose on 07Jan2021 both via an unspecified route of administration at a single dose for COVID-19 immunization, and guselkumab (TREMFYA), via an unspecified route of administration from an unspecified date at an unknown dose and frequency for psoriasis. The patient's medical history and concomitant medications were not reported. It was reported that the patient received his/her second injection yesterday (07Jan2021). He/She was very sick today (08Jan2021). He/She have fever and chills, he/she still have a runny nose and sneezing, he/she can't move his/her hands and arm, and both of his/her arms hurt. He/She didn't go to work today. He/She can't move his/her hands, if he/she try to move his/her hands, his/her hand hurts, the bones in his/her arm hurts, both of his/her arms hurts, he/she just feel really bad today (08Jan2021). This is the worst, he/she have ever felt. He/She have a lot of bad symptoms and the last time he/she took the shot, he/she had same symptoms but they were not as much bad as they are now. He/She just thought that with the second vaccination he/she wouldn't get sick. He/She have been taking Ibuprofen every 6 hours. He/She can't get warm. But he/she knew he/she will get better but he/she just wanted to report this symptoms that he/she was having. He/She wanted to talk and get better but all he/she was saying is he/she have had single shot and he/she was really sick then and this is 10 times worse than that (first dose). His/Her whole body hurts, he/she have fever, chills. His/Her fever is 100. He/She have a terrible headache, he/she feel so bad right now. He/She wanted to let know that he/she was not feeling good and he/she was sure he/she will feel good by Monday but he/she just had some complications. He/She don't feel good, he/she was hurting everywhere his/her ribs, hand, arms. He/She was having deep down spasm in his/her leg and he/she have taken Aspirin (Intent: treatment) for that and he/she have been taking Ibuprofen (Intent: treatment) for his/her body ache and fever and he/she knew he/she was going to get better. He/She don't want to be wimpy but he/she don't feel good. The outcome of the events was not recovered.  Information about lot/batch has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: mild pain; This is a spontaneous report received from a contactable consumer (patient's sister). A 52-year-old female patient received the second dose of BNT162B2 (BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on 08Jan2021 13:15, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced mild pain on 08Jan2021 in the evening. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nasopharyngitis
Clinical narrative: Cold; I don't feel well; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A female patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 07Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.   In Jan2021, the patient was on the other line and the concern was regarding her cold, the patient actually had the vaccine the day before and she had a cold right now and she is quite sick, she is asking if she can be able took antibiotic (Unspecified Medication) and asking if it may interfere with vaccine shot?". The patient stated "I have no problem with the vaccine, I am not reporting anything wrong with the vaccine, I am merely asking whether I can take a antibiotic (Unspecified Medication) because I have a cold, which I had, so what's the answer for that?". "I don't want to answer any question, I don't feel well." The outcome of the events was unknown.  Information on the Lot/Batch number has been requested
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: his arm was real sore; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer sales representative, reported for himself that a male patient of unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date, at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient reported having first shot and said his arm was real sore. Event took place after use of product. Outcome of the event was unknown.   No follow-up attempts are possible; information about batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Hyperhidrosis, Pain
Clinical narrative: persisting body pain; profuse sweating; dizziness; headache; weakness; Stroke like soreness of the arms/crawling pain on right arm; This is a spontaneous report from a contactable other health care professional (patient). A patient of unspecified age and gender received first dose of BNT162B2, via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced persisting body pain, sweating, dizziness, headache, weakness, stroke like soreness of the arms/crawling pain on right arm on an unspecified date. Patient experienced crawling pain on right arm after 2 minutes that was injected the first dose. Patient had profuse sweating, dizziness and headache. After few hours, patient experienced weakness and persisting body pain. Stroke like soreness of the arms. Patient took ibuprofen (ADVIL). The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: persisting body pain; profuse sweating; dizziness; headache; weakness; Stroke like soreness of the arms/crawling pain on right arm; This is a spontaneous report from a contactable other health care professional (patient). A patient of unspecified age and gender received first dose of BNT162B2, via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced persisting body pain, sweating, dizziness, headache, weakness, stroke like soreness of the arms/crawling pain on right arm on an unspecified date. Patient experienced crawling pain on right arm after 2 minutes that was injected the first dose. Patient had profuse sweating, dizziness and headache. After few hours, patient experienced weakness and persisting body pain. Stroke like soreness of the arms. Patient took ibuprofen (ADVIL). The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Dizziness, Feeling abnormal, Headache
Clinical narrative: Cough; Headache; Dizzy; Nauseous; Low grade fever; Little Noxious, whole body aches completely aches my whole body like I have flu; Little Noxious, whole body aches completely aches my whole body like I have flu; Little Noxious, whole body aches completely aches my whole body like I have flu; This is a spontaneous report from a contactable nurse (patient).  A 61-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231 and expiration date 30Apr2021), via an unspecified route of administration on 07Jan2021 second dose at single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medication included lisinopril for blood pressure. The patient stated that she took her second dose on 07Jan2021 afternoon and today 08Jan2021 the patient feel really cough "ing" (not clarified), light headache, dizzy. I am having fever "99.4" (not clarified). The patient asked are not they not safe to take Tylenol, is it okay to take Motrin or just have to be Tylenol (treatment)." It was clarified that patient experienced Dizziness, headache, fever, a low grade fever and little Nauseous. Just my whole body aches completely aches my whole body like I have the flu." The patient was treated with Tylenol for the events.  The outcome of the events was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Nausea, Pain, Pyrexia
Clinical narrative: Cough; Headache; Dizzy; Nauseous; Low grade fever; Little Noxious, whole body aches completely aches my whole body like I have flu; Little Noxious, whole body aches completely aches my whole body like I have flu; Little Noxious, whole body aches completely aches my whole body like I have flu; This is a spontaneous report from a contactable nurse (patient).  A 61-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231 and expiration date 30Apr2021), via an unspecified route of administration on 07Jan2021 second dose at single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medication included lisinopril for blood pressure. The patient stated that she took her second dose on 07Jan2021 afternoon and today 08Jan2021 the patient feel really cough "ing" (not clarified), light headache, dizzy. I am having fever "99.4" (not clarified). The patient asked are not they not safe to take Tylenol, is it okay to take Motrin or just have to be Tylenol (treatment)." It was clarified that patient experienced Dizziness, headache, fever, a low grade fever and little Nauseous. Just my whole body aches completely aches my whole body like I have the flu." The patient was treated with Tylenol for the events.  The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Patient received 1st dose on 28Dec and presented symptoms on 05Jan; Patient received 1st dose on 28Dec and presented symptoms on 05Jan; This is a spontaneous report from a contactable pharmacist reporting for self via Pfizer field representative (Field Medical Director). A patient of unspecified age and gender received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry date not reported) on 28Dec2020 via an unspecified route of administration for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient presented COVID-19 symptoms on 05Jan2021. No lab tests reported. The outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 28Dec2020, and patient presented COVID-19 symptoms on 05Jan2021.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, patient's COVID-19 symptoms on 05Jan2021 likely represents a pre-existing infection prior to vaccine use.  Further information is needed for full medical assessment.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: side effects including hives; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received BNT162B2 on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Physician reported patient side effects including hives. The outcome of the event was unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: feeling a little queasy; This is a spontaneous report from a contactable consumer(patient's husband). A female patient of unspecified age received BNT162B2(lot number and expiration date not provided) via an unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter reported wife was feeling a little queasy after receiving a vaccine dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Pyrexia
Clinical narrative: she had fever; still felt weak; felt light tightness in her chest; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer reported a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number, expiration date not reported), via an unspecified route of administration on 04Jan2021 at a single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had her Covid vaccine first dose last Monday evening, on 04Jan2021. After getting the vaccine, she had fever in Jan2021. She felt better yesterday but still felt weak and felt light tightness in her chest in Jan2021. Outcome of the event of fever was recovering, while other events was unknown.  Information on lot/batch number was requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain in extremity, Product use issue
Clinical narrative: sore arm; Off label use; Drug use in unapproved population; This is a spontaneous report from a contactable a nurse reporting for herself and for her baby. This is the mother case. This 35-year-old female patient who was breastfeeding her 7-month-old infant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Dec2020 for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unknown date, the patient had sore arm with outcome of unknown. Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021025730 baby case
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: she had soreness in her arm; swelling in the arm; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that 9 days after she received the Pfizer COVID vaccine, she had soreness in her arm. The patient also said if it was common to have swelling in the arm. 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: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: fatigue; body aches; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received first dose of bnt162b2 (BNT162B2, lot # ELO142), via an unspecified route of administration on 09Jan2021 at single dose for covid-19 immunisation. Medical history included hypertension, diabetes and pacemaker. The patient's concomitant medications were not reported. The patient experienced fatigue and body aches on day of injection on 09Jan2021. The event outcome was unknown.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: mild runny nose; This is a spontaneous report from a contactable consumer (Patient).  A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at single dose for COVID-19 immunization.  Medical history included hypertension (HTN), diabetes and pacemaker.  The patient's concomitant medications were not reported. On 10Jan2021, after the use of the vaccine, the patient experienced mild runny nose (non-serious) with outcome of unknown.  Information on the Batch/Lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue
Clinical narrative: Metallic taste; Tired; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the vaccine and then 30 minutes after there is a metallic taste in patient's mouth, noticed that patient had a metallic taste in mouth and was just calling to see is this a normal reaction to the vaccine because patient didn't see it anywhere in the paperwork. Patient wanted to know if that is the normal side effect because it was not listed. Patient was also tired. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Hypokinesia, Malaise, Pain, Pain in extremity
Clinical narrative: Could not move arm at all; Painful arm; Really bad aches; didn't feel right; Headache; Marking on arm; it's weird; it's red, not inflamed or anything; it's probably like two quarters and has a little line/where the shot is; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration in the arm on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the COVID-19 vaccination, the first shot on Wednesday (06Jan2021). The patient had a very, like the patient had a marking on the arm, like it's weird where the shot was. It's red and it's not inflamed or anything. It's just very red filled, it's just concerning. The day the patient had on it was when the shot on Wednesday. Yesterday (07Jan2021), the patient could not move the patient's arm at all, had painful arm and the patient thought that was a flu shot before (could not be clarified). Then, the patient had really bad aches and just; the patient didn't feel right; and had headache. The patient took some Advil (Intent: Treatment) for the bad aches as it's said on the paperwork. The patient thought it works. Today (08Jan2021), the patient woke up and the patient's aches were gone, the patient's headache was gone but the patient still had just this mark on the arm, it's probably like two quarters and has a little line. It's very concerning to the patient. The patient was just worried, with some kind of a reaction to the shot. The patient had a nurse look at it where it was, and she didn't think it's major but the patient wanted to know if anybody else was having these issues. The outcome of the events "really bad aches" and "headache" was recovered on 08Jan2021; outcome of the event 'vaccination site erythema' was not recovered; and outcome of other events was unknown.  Information on the Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Could not move arm at all; Painful arm; Really bad aches; didn't feel right; Headache; Marking on arm; it's weird; it's red, not inflamed or anything; it's probably like two quarters and has a little line/where the shot is; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration in the arm on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the COVID-19 vaccination, the first shot on Wednesday (06Jan2021). The patient had a very, like the patient had a marking on the arm, like it's weird where the shot was. It's red and it's not inflamed or anything. It's just very red filled, it's just concerning. The day the patient had on it was when the shot on Wednesday. Yesterday (07Jan2021), the patient could not move the patient's arm at all, had painful arm and the patient thought that was a flu shot before (could not be clarified). Then, the patient had really bad aches and just; the patient didn't feel right; and had headache. The patient took some Advil (Intent: Treatment) for the bad aches as it's said on the paperwork. The patient thought it works. Today (08Jan2021), the patient woke up and the patient's aches were gone, the patient's headache was gone but the patient still had just this mark on the arm, it's probably like two quarters and has a little line. It's very concerning to the patient. The patient was just worried, with some kind of a reaction to the shot. The patient had a nurse look at it where it was, and she didn't think it's major but the patient wanted to know if anybody else was having these issues. The outcome of the events "really bad aches" and "headache" was recovered on 08Jan2021; outcome of the event 'vaccination site erythema' was not recovered; and outcome of other events was unknown.  Information on the Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, Tremor
Clinical narrative: He is having a fever of a 100.9; He is having really bad chills; He is just shaking up; This is a spontaneous report from contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: expiry date: unknown) via an unspecified route of administration, in Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine (COVID-19 Vaccine from Pfizer) yesterday. The patient's wife reported that the patient had fever of a 100.9, really bad chills, and was shaking up. Outcome of the events was unknown.  Information about lot/batch number has been requested.