chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Memory impairment
Clinical narrative: Second COVID shot canceled due to the weather/missed the second dose scheduled on 15Feb2021; He doesn't remember where he got the vaccine; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (father-in-law) that. A male patient of an unspecified age received (BNT162B2, formulation: Solution for injection, Lot Number: UNKNOWN), 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 was not reported. The patient experienced second covid shot cancelled due to the weather/missed the second dose scheduled on 15feb2021 on an unspecified date and he does not remember where he got the vaccine on an unspecified date. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No follow-up attempts are possible.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nasal congestion, Nasopharyngitis, Rhinorrhoea, Sinus headache
Clinical narrative: head cold; Sinus headache; Chills; Runny nose; congestion/ nose congested; This is a spontaneous report from a sponsored program. The contactable consumer (Patient) reported for herself. A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6198, Expiration date: unknown), via an unspecified route of administration, administered in Arm Left on 20Feb2021 16:00 (age at vaccination was 65 years) as dose 1, single for COVID-19 immunization. The patient's medical history included genital herpes from an unknown date and unknown if ongoing Verbatim: Genital herpes. Concomitant medication included ibuprofen taken for an unspecified indication, start and stop date were not reported. On Feb2021 the patient experienced chills, runny nose, congestion/ nose congested. On an unspecified date the patient experienced head cold. On 21Feb2021 the patient experienced sinus headache. Patient states that the literature was given but it doesn't list "don't take any medication" she didn't see anything like that. Caller states that she is so stressed, she had a splitting headache and took just 1 pill of 200mg Advil, then later that same day, she had the shot. Patient went to bed and had chills woke up with a head cold. It might have been on its way but she doesn't think its a side effect. The headache and clenching of teeth that caused jaw pain was prior to the first dose, she took the Advil for the headache and jaw pain at about 10-11AM same day. The Chills and head cold was on the same day starting around when she got into bed, she fell asleep woke up in the middle of the night with a runny nose, and her nose congested. The next day on 21Feb2021 she felt the sinus headache. At the moment, the ongoing symptoms are the runny nose, congestion, and the sinus in the head, but with all she was getting better. She was schedule for the second dose on 12Mar2021. Patient got genital herpes, she has had no outbreak for years, but she was having a slight outbreak because of all the stress, this recent outbreak began about 2 weeks ago. The patient underwent lab tests and procedures which included weight which showed 123lbs or 124lbs result on an unspecified date. The outcome of the events chills and head cold was unknown. The outcome of the events runny nose, congestion/ nose congested and sinus headache was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: head cold; Sinus headache; Chills; Runny nose; congestion/ nose congested; This is a spontaneous report from a sponsored program. The contactable consumer (Patient) reported for herself. A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6198, Expiration date: unknown), via an unspecified route of administration, administered in Arm Left on 20Feb2021 16:00 (age at vaccination was 65 years) as dose 1, single for COVID-19 immunization. The patient's medical history included genital herpes from an unknown date and unknown if ongoing Verbatim: Genital herpes. Concomitant medication included ibuprofen taken for an unspecified indication, start and stop date were not reported. On Feb2021 the patient experienced chills, runny nose, congestion/ nose congested. On an unspecified date the patient experienced head cold. On 21Feb2021 the patient experienced sinus headache. Patient states that the literature was given but it doesn't list "don't take any medication" she didn't see anything like that. Caller states that she is so stressed, she had a splitting headache and took just 1 pill of 200mg Advil, then later that same day, she had the shot. Patient went to bed and had chills woke up with a head cold. It might have been on its way but she doesn't think its a side effect. The headache and clenching of teeth that caused jaw pain was prior to the first dose, she took the Advil for the headache and jaw pain at about 10-11AM same day. The Chills and head cold was on the same day starting around when she got into bed, she fell asleep woke up in the middle of the night with a runny nose, and her nose congested. The next day on 21Feb2021 she felt the sinus headache. At the moment, the ongoing symptoms are the runny nose, congestion, and the sinus in the head, but with all she was getting better. She was schedule for the second dose on 12Mar2021. Patient got genital herpes, she has had no outbreak for years, but she was having a slight outbreak because of all the stress, this recent outbreak began about 2 weeks ago. The patient underwent lab tests and procedures which included weight which showed 123lbs or 124lbs result on an unspecified date. The outcome of the events chills and head cold was unknown. The outcome of the events runny nose, congestion/ nose congested and sinus headache was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Illness, Malaise, Pain
Clinical narrative: headache; achy; got pretty sick after getting the vaccine; did not feel good; This is a spontaneous report from a contactable consumer (patient spouse). A 68-year-old male patient (reporter's husband) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration on 09Feb2021 as dose 1, single for COVID-19 immunization. The patient's medical history included covid-19 in November for 2 weeks but did not have to go to the hospital and recovered (from Nov2020 to unspecified date in 2020). The patient's concomitant medications were not reported. Other products not provided. The reporter reported that patient got pretty sick after getting the vaccine and he did not feel good. Her husband had a headache and was achy for 2 days after the shot. She mentioned her husband's symptoms lasted a couple of days. She wanted to know if they should get their second scheduled dose of the vaccine. The outcome of events were resolved.  Follow-up activities were closed. No follow up attempt was made .
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Nausea, Pain in extremity
Clinical narrative: acid reflux; could not move her arm due to pain; Nauseous; This is a spontaneous report from a contactable consumer or other non hcp. A 79-years-old female patient received (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number: EN6200) via an unspecified route of administration, administered in Arm Left on 19Feb2021 12:45 pm (at the age of 79 years) as for covid-19 immunisation. The patient medical history was not reported.  The patient's concomitant medications were not reported. She gets the second dose of vaccine on 12Mar2021. she did have some slight reactions but she is also allergic to quite a few things. After first dose of vaccine, later that night she could not move her arm due to pain but soon after a day she can feel that she had a shot in her left arm, but she can move it and it doesn't hurt anymore. She states that pain in her arm wasn't that bad, but she has been nauseated ever since she got the vaccine every time she eats something on 19Feb2021, she had acid reflux and she doesn't know if it is aggravated on an unspecified date. The outcome of event could not move her arm due to pain was recovered on 22Feb2021 and the event Nauseous was recovering while other event was unknown.   Follow-up attempts completed. No further information expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy
Clinical narrative: joint issue; This is a spontaneous report from a contactable nurse (patient herself). A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL3249), dose 1 via an unspecified route of administration on 12Jan2021 (at the age of 40 years old) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient stated, on the first one she was taking Celebrex (treatment), the first vaccine and she stopped that shortly after that, that is why she stopped it on the January 21. It was treatment for like a joint issue. She stated she took 1 Ibuprofen when she needed it. On an unknown date in 2021, the patient experienced a joint issue. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection), dose 2 via an unspecified route of administration on 02Feb2021 (Batch/Lot Number: EL9264) as dose 2, single for covid-19 immunisation. For the causality, patient stated, she did not know. She thought it went right after because she was within 72 hours she thought after 24 hours right after the second one that she had and then it went away and came back like she said. Therapeutic measures were taken as a result of joint issue. Clinical outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: sore/arm is still sore/at the injection site; warm/hot/warm like hot/at the injection site; 2-3 inches diameter of redness/2-3 inches in diameter with it being red/at the injection site; puffed up a little/at the injection site; tinge of a headache; This is a spontaneous report from a contactable consumer. This 82-year-old female consumer(patient) reported that: An 82-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EN6198), via an unspecified route of administration as dose 2, single on 19Feb2021 (at the age of 82-year-old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: Unknown), via an unspecified route of administration as dose 1, single on 29Jan2021 (at the age of 82-year-old) for covid-19 immunisation and experienced sore arm that last a day, then it was fine. Patient had the second dose (as reported this past Friday), and her arm was still sore, warm like hot, and was maybe 2-3 inches in diameter with it being red on unspecified date. It was also puffed a little on unspecified date. The patient was wondering how long these symptoms will last at the injection site. On unspecified date, the patient had tinge of a headache. Patient had 2 friends and after their vaccine they had nothing. Patient have been put ice on it because it's warm. She asked whether she could continue to put ice of it. At the time of the report, the outcome of all events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: she had with the Shingrix and Pfizer-BioNTech Covid-19 Vaccine somehow made her hot flashes disappear.; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A female patient 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 an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included Hot flashes from an unknown date and unknown if ongoing (She said the she believes the reaction she had with the Shingrix and Pfizer-BioNTech Covid-19 Vaccine somehow made her hot flashes disappear). The patient's concomitant medications were not reported. On an unspecified date, the patient experienced she had with the shingrix and pfizer-biontech covid-19 vaccine somehow made her hot flashes disappear. It was reported a few days after receiving both the Shingrix and the Pfizer Covid vaccinations her hot flashes disappeared. She had moderate reactions to both vaccinations that lasted 12/36 hours respectively. The good part was that her hot flashes disappeared from the time the reactions began and they did not reappear for 1-3 days after symptoms disappeared. She said it would be great if one could find a correlation and eventually provide a permanent treatment for hot flashes. The patient said she sent an email to Pfizer and got a response. She said she believed the reaction she had with the Shingrix and Pfizer-BioNTech Covid-19 Vaccine somehow made her hot flashes disappear. With this, she said it would be great if Pfizer would develop a medication for hot flashes since there was no current cure for it yet. Serious was reported as no. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Felt achy; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single and second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced felt achy after getting the vaccine on an unspecified date. Her side effects were minimal. Patient received the second dose of the Covid-19 vaccine yesterday (on an unspecified date in 2021). Patient wanted to know, about the production of the Pfizer Covid-19 vaccine, and she would like more information. The clinical outcome of the event felt achy was unknown.  Information on the lot/batch number has been requested  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Limited soreness at injection site.; This is a spontaneous report from a contactable consumer. A 34-years-old male patient received bnt162b2 (BNT162B2,solution for injection,lot Number was EN6201), dose 1 via an unspecified route of administration, administered in Arm Left on 23Feb2021 10:45 as DOSE 1,SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 23Feb2021 17:00 the patient experienced limited soreness at injection site.The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The clinical outcome of the event was recovering.    Follow-up (21MAY2021): Follow-up attempts completed. No further information expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report from a contactable consumer (patient/herself). A 75-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EN6203; expiration date: unknown), at the age of 75, via an unspecified route of administration, on Feb 20, 2021, single dose, for COVID-19 immunization. No medical history or  concomitant medications reported. The patient called to tell about her headaches. On Feb 21, 2021, she had headaches on right-side of her head and she never has them. She does not even take aspirin. She had a mammogram on Saturday as well and everything went wonderful. Then on Sunday, Feb 21, 2021, she noticed she had a headache and she did not understand because she did not have headaches. She has had one every day since then. She even had one today on the right-side. They have stayed about the same. She can still do everything but since they are so rare for her, she notices them right away. They do not linger; they do not keep her from doing things; they were not blinding. They were just there. The only thing that concerned her was she had a mammogram Saturday (the appointment was at 9:00) and as soon as she finished the appointment, she hopped in the car and got the vaccine. She has been doing some reading and it does not seem like that was necessarily the smartest thing she did that day, but she did not know. She said the mammogram results came back good. The outcome of event not recovered. Follow-up (May 12, 2021): Follow-up attempts completed. No further information expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hiatus hernia, Injection site erythema, Injection site pain
Clinical narrative: muscle pain was in a site she had injured several times back prior to the vaccine; has been tired or last; hiatal hernia and this has made it worse; Chills; redness and pain at injection site; redness and pain at injection site; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 84-years-old female patient received bnt162b second dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number/Lot number was unknown), via an unspecified route of administration, administered in arm left on 22Feb2021 (Age at vaccination 84-years-old) as dose 2, single for covid-19 immunization. Medical history included chronic obstructive pulmonary disease, chronic bronchitis, breast cancer from an unknown date and unknown if ongoing. There were no concomitant medications. Patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number: not reported/Lot number: EL3247), via an unspecified route of administration, administered in arm left on 25Jan2021 (Age at vaccination 84-years-old) as dose 1, single for covid-19 immunization. On 22Feb2021, the patient experienced redness and pain at injection site. On 23Feb2021, the patient experienced chills. On 24Feb2021, the patient experienced hiatal hernia and this has made it worse. On an unspecified date the patient experienced muscle pain was in a site she had injured several times back prior to the vaccine, has been tired or last. Caller stated she was looking at the side effects, had the redness at injection site pain, only hurts if she lays down on it, tries to stay away from that, got the redness around it, somethings have gone away, had real bad chills last night, muscle pain was in a site she had injured several times back prior to the vaccine, hiatal hernia and this has made it worse, has been tired or last. The patient underwent lab tests and procedures which included weight was 150-154 lbs it goes up and down on an unspecified date. The clinical outcome of the events redness and pain at injection site, hiatal hernia and this has made it worse was not recovered. Chills was recovered on 23Feb2021. For the events muscle pain was in a site she had injured several times back prior to the vaccine, has been tired or last outcome was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Weight
Clinical narrative: muscle pain was in a site she had injured several times back prior to the vaccine; has been tired or last; hiatal hernia and this has made it worse; Chills; redness and pain at injection site; redness and pain at injection site; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 84-years-old female patient received bnt162b second dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number/Lot number was unknown), via an unspecified route of administration, administered in arm left on 22Feb2021 (Age at vaccination 84-years-old) as dose 2, single for covid-19 immunization. Medical history included chronic obstructive pulmonary disease, chronic bronchitis, breast cancer from an unknown date and unknown if ongoing. There were no concomitant medications. Patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number: not reported/Lot number: EL3247), via an unspecified route of administration, administered in arm left on 25Jan2021 (Age at vaccination 84-years-old) as dose 1, single for covid-19 immunization. On 22Feb2021, the patient experienced redness and pain at injection site. On 23Feb2021, the patient experienced chills. On 24Feb2021, the patient experienced hiatal hernia and this has made it worse. On an unspecified date the patient experienced muscle pain was in a site she had injured several times back prior to the vaccine, has been tired or last. Caller stated she was looking at the side effects, had the redness at injection site pain, only hurts if she lays down on it, tries to stay away from that, got the redness around it, somethings have gone away, had real bad chills last night, muscle pain was in a site she had injured several times back prior to the vaccine, hiatal hernia and this has made it worse, has been tired or last. The patient underwent lab tests and procedures which included weight was 150-154 lbs it goes up and down on an unspecified date. The clinical outcome of the events redness and pain at injection site, hiatal hernia and this has made it worse was not recovered. Chills was recovered on 23Feb2021. For the events muscle pain was in a site she had injured several times back prior to the vaccine, has been tired or last outcome was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: very tired; just slept like a log; This is a spontaneous report from a contactable consumer (patient) reporting for self.   A male patient of an unspecified age received BNT162B2 (BNT162B2, Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 16Feb2021 15:00 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced very tired on 16Feb2021 and just slept like a log on an unspecified date in 2021. It was stated as it was not that serious. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity
Clinical narrative: Sore arm; chills; headache; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date was not reported), via an unspecified route of administration on 22Feb2021 11:00 as dose number unknown, single for covid-19 immunization. The patient pregnant at time of vaccination was unknown. The facility the most recent COVID-19 vaccine was administered was workplace clinic. The patient medical history and concomitant medications were not reported. On 22Feb2021, the patient experienced sore arm, chills, headache. the patient received any other vaccines within 4 weeks prior to the COVID vaccine was unknown. The patient received any other medications within 2 weeks of vaccination was unknown. Prior to the vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not received treatment for the events. The clinical outcome of the events was recovered on an unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise
Clinical narrative: chills; Not feeling well/he just doesn't feel up to par; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 15Feb2021 (batch or lot number was not reported) as dose 1, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On unspecified date, the patient experienced chills but patient not sure if he had chills before the vaccine or after, not feeling well and he just doesn't feel up to par. Patient stated he got the shot first shot 15Feb. He confirms the Pfizer COVID 19 vaccine. He felt good for quite a while then he started getting chills. He may have had some chills before, but he is supposed to go up this morning to the drug store and have them run a test to see if had the COVID or if he doesn't have it. He asks will that test tell him if had the COVID or if this is a reaction from the shot. He hasn't had fever, he is not sure if he had chills before the vaccine or after but about week after had the vaccine, maybe a little less, he wasn't feeling really well, he just doesn't feel up to par. it just so happens he has a pacemaker and he was going to see his doctor for a check up on Thursday of this week and he told them he was not feeling well and they said okay they told him they were going to have him go into the (Specialty Pharmacy name) this morning and have them run a test to see if he has the COVID virus and he is wondering if that would tell if he had the COVID virus or if it's a reaction to the vaccine, he asks does call handler think they will be able to tell him that. He stated his main concern is he is going in week from next Monday for the second shot. He asks is there any chance that they will tell him not to get the second shot because he would be due to have the other shot so if he gets that he wants to know if he will have the same reactions or little bit less. He can't answer questions right now because he has to go have that test ran so he is short on time. Patient stated what he would like to know is when that test comes back it could be next Monday or Tuesday or it could be back this week but once they get the test back will they be able to tell if he had COVID or if it is reaction and then will they tell what to do the second one. No treatment received for the event Not feeling well/he just doesn't feel up to par. The outcome of the events was unknown.   Information about Lot/Batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer Sponsored Program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on 22Feb2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced headache on 23Feb2021. The outcome of the event was unknown. The patient was querying if he could take Advil for the event or not and if it would interfere with the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Vaccination site pain
Clinical narrative: headaches; fatigue; nausea; after first dose vaccination extreme soreness of injection sight; This is a spontaneous report from a contactable consumer (patient). A 30-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not reported) via an unspecified route of administration, administered in left arm on 24Feb2021 15:15 (at the age of 30-year-old) as a dose 1, single for COVID-19 immunisation. The patient medical history included asthma. The patient had no known allergy. Concomitant medications included budesonide (PULMICORT) and salbutamol sulfate (VENTOLIN HFA) taken for an unspecified indication on an unspecified date in two weeks. The patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for COVID-19 after vaccination. On 24Feb2021 at 22:15 about 7 hours after first dose vaccination, the patient experienced headaches, fatigue, nausea, and extreme soreness of injection sight. The patient took Tylenol for treatment of headache. Outcome of the events was unknown.  The lot and batch number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: drained; bad headache; This is a spontaneous report from a contactable consumer (patient). A 53-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 23Feb2021 at 14:00 (at the age of 53-years) as dose 2, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 02Feb2021 at 14:00 as dose 1, single for covid-19 immunization. On an unspecified date, the patient had experienced bad headache and drained. The patient did not receive any treatment for the events. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of the events was recovering at the time of report.   No follow-up attempts possible. No further information expected. Information on lot number cannot be obtained.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Severe Swelling at injection site; This is a spontaneous report from a contactable consumer (patient). A 51-years-old male patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 22Feb2021 as dose 1, single (at the age of 51-years-old) for COVID-19 immunisation. Medical history included COVID-19 (prior to vaccination) from an unknown date and unknown if ongoing. Patient had no other vaccine in four weeks. Patient had no concomitant medications/other medications in two weeks. On 23Feb2021, patient experienced severe swelling at injection site. Patient received no treatment for the event. Patient had not been tested for COVID-19, post vaccination. The outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vertigo
Clinical narrative: Buzzing in ears; vertigo; This is a spontaneous report from a contactable consumer (patient). A 70-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9266, Expiry date: unknown), via an unspecified route of administration in left arm on 17Feb2021 at 15:00 as dose 1, single for covid-19 immunisation at school/student health clinic. The patient was not pregnant at the time of vaccination. The patient's medical history included asthma, chronic obstructive pulmonary disease (COPD), drug hypersensitivity to Penicillin and sulfa. Concomitant medications included fluoxetine hydrochloride (FLUOXETINE ACCORD) 20 mg; budesonide, formoterol fumarate (SYMBICORT ASTRAZENECA) 160/4.5; salbutamol sulfate (PROAIR HFA); all were taken for an unknown indication in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Feb2021, Tuesday evening at 20:00, the patient experienced buzzing in ears and vertigo. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: body ache; This is a spontaneous report from a non-contactable consumer via a sales representative. A female patient of an unspecified age (Age: 84, Units: Unknown) 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 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced body ache. The reporter confirmed that reporter was the colleague the person who got the vaccine was a family member who was retired. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills
Clinical narrative: chills; Stomach discomfort; This is a spontaneous report from a non-contactable consumer or other non hcp. A adult male patient of unspecified age received bnt162b2 (Comirnaty, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. The patient previously received bnt162b2 (Batch/Lot number was not reported), via an unspecified route of administration on 07Jan2021 as DOSE 1, SINGLE for covid-19 immunization and had no reactions. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient received any other medications within 2 weeks of vaccination. The patient medical history and concomitant medications were not reported. No known allergies were reported. Report stated that the first shot was fine with no reactions. On an unspecified date, after second shot on the same evening, the patient woke up with chills and stomach discomfort. It did not last long and he felt at 50% the rest of the next day. The patient was fine at the time of the report. No treatment was received for the adverse events. It was unknown if the patient was diagnosed with Covid-19 prior to vaccination. Outcome of the events was recovered on an unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Food poisoning, Malaise
Clinical narrative: not feeling well; food poisoning; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of unspecified age received BNT162B2 (Pfizer- BioNTech COVID 19, solution for injection, Batch/ Lot number: unknown) via an unspecified route of administration on Feb2021 as DOSE 1, SINGLE for COVID-19 immunization. The patients medical history and concomitant medications were not reported. Patient reported that she received the Covid-19 vaccine first dose two weeks ago in Feb2021, she was supposed to get her second dose of Covid-19 vaccine but she was not feeling well she had food poisoning on Feb2021. The patient had concern, she got appointment for rescheduled for her second dose. It had been 3 weeks she just needed to know if she can reschedule this because she got food poisoning and she did not feel like going to all this. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm hurt; This is a spontaneous report from a non-contactable consumer (patient). A male 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 (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. The patient experienced arm hurt on an unspecified date. The outcome of event was unknown. The patient also received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunisation and experienced arm hurt, achy with a slight headache, tired and felt generally sick.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Pain, Vaccination site pain
Clinical narrative: he felt that his arm hurt a little worse than the first dose; achy; slight headache; tired; felt generally sick; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on an unspecified date (Batch/Lot number was not reported) for COVID-19 immunisation and the patient felt that his arm hurt. About 24 hours after receiving his second dose of the Pfizer COVID-19 vaccine (on an unspecified date), the patient felt that his arm hurt a little worse than the first dose, he was achy with a slight headache, tired, and felt generally sick. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: headache; muscle pain; This is a spontaneous report from a Pfizer sponsored program regulatory authority. A contactable consumer reported for a female patient (wife). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 22Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. On 22Feb2021, the patient experienced headache and muscle pain. The patient wants to know if the she can take Tylenol. The outcome of all events was unknown.    Follow-up attempts completed. No further information expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: mild headache; Fatigue; Muscle aches; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3246; Expiration Date: 30Apr2021), intramuscular, administered in arm left (biceps) on 08Jan2021 15:20 (age at vaccination 43-years-old) as dose 2, 30ug single for covid-19 immunisation. The medical history included COVID-19 from 01Jan2021 and unknown if ongoing. The concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EK5730, Expiry date: unknown), intramuscular, administered in arm left on 18Dec2020 (age at vaccination 43-years-old) as dose 1, single for covid-19 immunisation, tested positive for COVID on 01Jan2021 and experienced drug ineffective, sinus pressure, mild headache, red eyes, fatigue, and muscle aches. Reactions recurred on re-administration of product, after 12 hours after cessation of treatment. The patient experienced mild headache, fatigue, and muscle aches on an unspecified date in Jan2021. The outcome of the events were unknown.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Feeling abnormal, Pain in jaw, Vaccination site pain
Clinical narrative: dizzy/weird felling; metallic taste in mouth; slight soreness in jaw; sore arm at injections site; dizzy/weird felling; This is a spontaneous report from a contactable pharmacist (patient). A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. Medical history included previous allergic reactions with hives, exposure to insulation and exposure to roof shingles. The patient's concomitant medications were not reported. It was reported that patient experienced about 10 seconds of dizzy/weird feeling about 10 minutes after vaccination followed by metallic taste in mouth and slight soreness in jaw. About 8 hours later sore arm at injections site. Patient mentioned event took place after use of product. Outcome of all the events was unknown.   Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase, Blood creatine phosphokinase increased
Clinical narrative: elevated Kinase level reaction; This is a spontaneous report from a contactable pharmacist.  A male patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported, Pharmacist said that son took 1st dose of Covid vaccine and had an elevated Kinase level on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included blood creatine phosphokinase: elevated on. Information about lot/ batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: arm soreness; neck lymph node swelling; This is a spontaneous report from a contactable consumer (patient).  A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3246, Expiration Date: 21Apr2021), via an unspecified route of administration, administered in Deltoid Left on an unspecified date at 08:00 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EK5730, Expiration Date: 31Mar2021), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation and experienced arm soreness lasted for only 1 day. The patient experienced arm soreness, neck lymph node swelling lasting for only 1 day on an unspecified date. The outcome of events was recovered on an unspecified date.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Influenza like illness
Clinical narrative: flu-like symptoms; lost of appetite; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 22Feb2021 (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 flu-like symptoms, lost of appetite on an unspecified date. The outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Blood uric acid, C-reactive protein, Computerised tomogram, Fatigue
Clinical narrative: Left side of neck swollen lymph nodes; fatigue; This is a spontaneous report from a contactable other hcp.    A 53-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EL9261; Expiration Date: 31May2021), dose 2 intramuscular, administered in Arm Right on an unspecified date (Batch/Lot Number: EL9261; Expiration Date: 31May2021) as dose 2, single for covid-19 immunisation. Medical history included, sinusitis placed on Ceftin 500 mg BID (Twice a day)x21 days, otitis media, placed on Ceftin 500 mg BID (twice a day)x 21 days, thyroid mass patient was seeing endocrinologist but HCP is not sure patient has seen them since 2015 , hypothyroidism patient takes Synthroid , hypertension, sepsis. Patient has a niece with a haematological symptom, anxiety. Concomitant medication(s) included cefuroxime axetil (CEFTIN [CEFUROXIME AXETIL]) taken for sinusitis, otitis media; escitalopram oxalate (LEXAPRO) taken for anxiety, depression; estradiol (ESTRADIOL); hydroxyzine embonate (VISTARIL [HYDROXYZINE EMBONATE]; levothyroxine sodium (SYNTHROID) taken for hypothyroidism,; lisinopril (LISINOPRIL) taken for hypertension; vitamin d3 (VITAMIN D3) taken for vitamin d decreased; prednisone (PREDNISONE) taken for arthralgia, swelling, headache from 05Jan2021 to an unspecified stop date. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID.It was reported that, the patient experienced left side of neck swollen lymph nodes and fatigue on an unspecified date with outcome of recovered. The patient underwent lab tests and procedures which included antinuclear antibody: normal on 05Jan2021, blood uric acid: normal on 05Jan2021, computerised tomogram: normal on 08Jan2021, c-reactive protein: 5.0 on 05Jan2021 High, full blood count: normal on 05Jan2021, metabolic function test: normal on 05Jan2021, red blood cell sedimentation rate: 30 on 05Jan2021 High, rheumatoid factor: normal on 05Jan2021, vitamin d: 20 on 05Jan2021 Low. Therapeutic measures were taken as a result of left side of neck swollen lymph nodes (lymphadenopathy), fatigue (fatigue