chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain
Clinical narrative: Lot of pain in my neck and in my shoulder; Lot of pain in my neck and in my shoulder; This is a Spontaneous report from a Contactable consumer (patient). A 62-years-old female patient received the first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: FE3360) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history included diabetic. Concomitant medication included Gabapentin, Benazepril, Omeprazole DR and Vitamin D3. Consumer stated, I hope you could help me. I got my vaccine on Thursday, I believe at 3:30 PM. Last night, I started to get a lot of pain in my neck and in my shoulder. Is that a side effect. The patient received treatment with just took Tylenol and Ibuprofen, it was 800 mg of Ibuprofen and Tylenol is only 325 mg. The patient still experiencing events: Consumer stated, Yes, I still have pain but not like the last time. I still have pain in my neck and shoulder. The outcome of the events was recovering.    Follow-up attempts are completed. No further information was expected.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL1283) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced diarrhea on an unspecified date. It was reported Consumer stated, No, I had a shot and I have had diarrhea since I have had it and I was wondering do I need to take the other one or would it be best I do not take the other shot. Well, I was wanting to watch this program on TV. I had been waiting a long time. The reason why I called was to find out if I should have the other shot as I have had diarrhea. The outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Pain
Clinical narrative: I felt sick like the flu and it lasted for about four days; It was like headache and aching like I had the flu; It was like headache and aching like I had the flu; This is a spontaneous report received from a contactable Consumer (Patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection and batch no/lot number: EL9263) via an unspecified route of administration on 29Jan2021 04:00 in the morning (at the age of 77-years-old) as single dose for COVID-19 immunization. The patient medical history was reported as hypothyroid. Concomitant medications included levothyroxine. Patient experienced I felt sick like the flu and it lasted for about four days and It was like headache and aching like I had the flu in 2021. It was reported that, Consumer stated I had vaccination, I thought I was supposed to call and just report any adverse effects from the vaccination. I had the vaccination on the Friday night of 29Jan (not clarified) and about 4:00 in the morning, I felt sick like the flu and it lasted for about four days. That's pretty much it, it was like headache and aching like I had the flu. Treatment: Consumer stated, No, once I got out, I felt like it has got better and it felt just like flu and I thought, well at least it doesn't feel as bad as the real thing is (not clarified further). No, I didn't, I think I might have taken some Tylenol. The outcome of the event I felt sick like the flu and it lasted for about four days was recovered on an unspecified date in 2021.while other was unknown.   Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Severe rash broke out; Numerous red dots all over the surface area of her back; she reported severe itchiness for 2-4 days; This is a spontaneous report from a contactable consumer. A 73-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 10Feb2021 14:30 (Batch/Lot Number: EN6201) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 16Feb2021 08:00, the patient experienced severe rash broke out, numerous red dots all over the surface area of her back, and she reported severe itchiness for 2-4 days. Therapeutic measures were taken as a result of the events (Benadryl tablets (oral) & hydrocortisone cream). The outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vaccination site pain
Clinical narrative: Caller reported being very tired/fatigue, achiness, and injection site pain that went on for about a week or so after receiving the first dose; Caller reported being very tired/fatigue, achiness, and injection site pain that went on for about a week or so after receiving the first dose; Caller reported being very tired/fatigue, achiness, and injection site pain that went on for about a week or so after receiving the first dose; This is a spontaneous report from a contactable consumer (patient) via medical information team. An 81 unspecified unit female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, 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 were not reported. It was reported that "upon answering the call and initiating the greeting, consumer was talking on another phone to another female, in which I overheard a possible report of an experienced side effect for the COVID vaccine. Female on the other phone stated, "Neither did I. I felt the shot on the first day." Consumer then realized that agent was on the line. Caller reported being very tired/fatigue, achiness, and injection site pain that went on for about a week or so after receiving the first dose. Caller states that she was unable to go out for almost a week. Caller asked, how do I know that I really got the shot? Do most people have a reaction the second time and by not getting one is that ok. Stating that she kept calling every day and gave them all the information. Caller asked if Pfizer's Covid vaccine was stored in the freezer? Caller states, when it was out of the freezer, I assume it has a life of it was own and it was perfectly fine to give. Caller reports not seeing any freezers at her vaccination center in the mall. Caller states, I had no problems, very pleased with all that happened, and I feel much better hearing from you". 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.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood magnesium, Blood thyroid stimulating hormone, Dizziness, Full blood count, Vitamin B12
Clinical narrative: Extreme dizziness; This is a spontaneous report from a contactable consumer. A 36-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation (at the age of 36-year-old). The patient medical history was not reported. Concomitant medication(s) included buspirone (BUSPIRONE) 15 mg, one tablet twice a day and fluoxetine hydrochloride (PROZAC) 60 mg taken for an unspecified indication. On an unspecified date, since her last injection the patient experienced extreme dizziness. On 09Feb2021, the patient underwent lab tests and procedures which included magnesium: normal, Thyroid Panel: normal, CBC: normal, B12: normal. The patient taken Meclizine, Zofran. The outcome of event was unknown.  Follow-up attempts completed. No further information expected.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 95-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# not reported), at the age of 95, via an unspecified route of administration on Feb 22, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On Feb 22, 2021, patient experienced itching, which was real bad. She wanted to know what she needs to do about it and if she can use prednisolone ointment for it. The outcome of the event: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Body aches; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 08Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 administered on an unspecified date for COVID-19 immunization. On an unspecified date the patient experienced body aches. It was reported by the patient that "patient and patient's husband had their second vaccine on Monday, last Monday, a week ago, 8Feb2021 (later confirmed). And they neither had any problems with the first one. And with the second one, the patient had few body aches." The clinical outcome of the event was unknown.   Follow-up attempts completed. No further information expected.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Illness, Pain, Pain in extremity
Clinical narrative: Sore arm; Very fatigued; Loss of appetite; White blood cells were elevated; white blood count was high; Sick; Bad aches; This is a spontaneous report from a contactable consumer. A 92-year-old male patient (husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 08Feb2021 (at the age of 92-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history included diabetes, high blood pressure, high cholesterol. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization and stated that, they neither had any problems with the first one. It was reported that, this was the first case out of the 2 cases. This was the case where caller (patient's wife) was reported for husband (patient). Stated that, the caller just had a question. Stated that, she could not seem to be getting answer about their COVID-19 vaccine. Stated that, the caller and her husband had their second vaccine on Monday, last Monday, a week ago, on 08Feb2021 (later confirmed). Stated that, they neither had any problems with the first one and with the second one, the caller had few body aches but the patient did not, except the sore arm. Stated that, now her question was, the patient started to get sick on 13Feb2021, Saturday and he has been sick for 3 days. He was at work, he was not that bad but he was very fatigued and has loss of appetite and stated that, what the caller was wondering was and one of the things, the caller wanted to ask-on Wednesday, he got bad aches on 10Feb2021 and he had lab work that he does every 6 months and they called him on Friday and told him that his white blood cells were elevated and he told them that he has had the vaccine and they said that it can happen, you know when you have the vaccine. Stated that, what the caller wanted to know was that, it took too long for him to get side effects from the second vaccine. Stated that, he had on Monday and he stated, getting sick on Saturday. Stated that, the caller did not have LOT# and expiration date. Stated that, the patient took the vaccine on Wednesday and his white blood count was high and they told him that it could be from the vaccine. The caller was provided with the contact# for Pfizer Medical Information. Treatment was not received for the events. On 10Feb2021, the patient underwent lab tests and procedures which included white blood cells (white blood cell count), resulted as elevated/high. The outcome of the events for sick was recovered on an unspecified date in 2021 while for the other events was unknown.  No follow up attempts are possible, information about lot/batch number cannot be obtained.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count increased
Clinical narrative: Sore arm; Very fatigued; Loss of appetite; White blood cells were elevated; white blood count was high; Sick; Bad aches; This is a spontaneous report from a contactable consumer. A 92-year-old male patient (husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 08Feb2021 (at the age of 92-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history included diabetes, high blood pressure, high cholesterol. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization and stated that, they neither had any problems with the first one. It was reported that, this was the first case out of the 2 cases. This was the case where caller (patient's wife) was reported for husband (patient). Stated that, the caller just had a question. Stated that, she could not seem to be getting answer about their COVID-19 vaccine. Stated that, the caller and her husband had their second vaccine on Monday, last Monday, a week ago, on 08Feb2021 (later confirmed). Stated that, they neither had any problems with the first one and with the second one, the caller had few body aches but the patient did not, except the sore arm. Stated that, now her question was, the patient started to get sick on 13Feb2021, Saturday and he has been sick for 3 days. He was at work, he was not that bad but he was very fatigued and has loss of appetite and stated that, what the caller was wondering was and one of the things, the caller wanted to ask-on Wednesday, he got bad aches on 10Feb2021 and he had lab work that he does every 6 months and they called him on Friday and told him that his white blood cells were elevated and he told them that he has had the vaccine and they said that it can happen, you know when you have the vaccine. Stated that, what the caller wanted to know was that, it took too long for him to get side effects from the second vaccine. Stated that, he had on Monday and he stated, getting sick on Saturday. Stated that, the caller did not have LOT# and expiration date. Stated that, the patient took the vaccine on Wednesday and his white blood count was high and they told him that it could be from the vaccine. The caller was provided with the contact# for Pfizer Medical Information. Treatment was not received for the events. On 10Feb2021, the patient underwent lab tests and procedures which included white blood cells (white blood cell count), resulted as elevated/high. The outcome of the events for sick was recovered on an unspecified date in 2021 while for the other events was unknown.  No follow up attempts are possible, information about lot/batch number cannot be obtained.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: persistent headaches; bouts of extreme fatigue; This is a spontaneous report from a non-contactable other health care professional (patient). A 25-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 04Feb2021 (Batch/Lot Number: EL3247) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included Known allergies: dairy, shellfish, SULFA, gluten. There were no concomitant medications. The patient received first dose of BNT162B2 on 14Jan2021 (at 24-years-old) for COVID-19 immunisation (product=COVID 19, Brand=Pfizer, Lot number= EL1283, Lot unknown=False, Administrator route: Intramuscular, Vaccine location= Left arm, Dose number=1). On 14Feb2021, the patient experienced persistent headache, bouts of extreme fatigue. The patient did not receive treatment for the events. The outcome of the events was recovering. The patient did not have COVID prior vaccination, and was not COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; fever; This is a spontaneous report from a contactable consumer reporting on behalf of the patient. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Feb2021 at 11:30 am (Lot Number: EN6198; Expiration Date: 30Jun2021; at the age of 78 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the 1st dose of the COVID vaccine on 23Feb2021 at around 11:30 am. An hour after he got home from getting the vaccine on 23Feb2021, the patient experienced chills and fever. Symptoms were treated with Tylenol. The reporter would like to know how fast the side effects from the COVID vaccine can appear and would like to know how long the side effects could last. The patient has not yet recovered from the events. The events were assessed as non-serious.   No follow-up attempts are possible; information about batch number was already obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Pain
Clinical narrative: Itching at injection site; Feeling "achy"; This is a spontaneous report from a contactable other healthcare professional. A 55 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 22Jan2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 10Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reports no missed doses. Prior to start of therapy thyroid nodules. After start confirmed diagnosis of hashimoto disease with increased thyroid nodules. Received both coronavirus vaccines: 22Jan2021 and 10Feb2021 with itching at injection site, feeling "achy" which resolved with aspirin. Unsure if feeling achy from vaccine or significant change in weather. Leg cramps resolved after prescription of coq10 supplement with a statin for cholesterol.  Therapeutic measures were taken as a result of this with Xeljanz XR 11mg daily oral route for Rheumatoid Arthritis taken From 01Oct2020 to current.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: runny nose; This is a spontaneous report received from a contactable consumer via Pfizer-sponsored program. A 78-year-old male patient (husband) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 29Jan2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, patient experienced runny nose. Reporter stated that this week her husband was plowing the snow and his nose was running (stated that runny nose started at the beginning of the week probably Tuesday) and wanted to know could he go and get the second dose of the vaccine on Friday (19Feb2021). Reporter stated that she had been giving him Tylenol, that he did not have a fever. The event was assessed as non-serious. Therapeutic measures were taken as a result of runny nose. The clinical outcome of event was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Energy increased
Clinical narrative: her energy was up after the second dose, but that seems to have worn off as of yesterday; This is a spontaneous report from a contactable consumer (parent). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a Dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a Dose 1, single for COVID-19 immunization. she had "a tad after the first dose. She mentioned that her energy was up after the second dose, but that seems to have worn off as of yesterday." The outcome of the event was recovering.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information was expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Pain in extremity
Clinical narrative: joint swelling in the second finger of left hand; pain in the second finger of left hand; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 73-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in Arm Left on 06Feb2021 16:00 (at the age of 73 years), (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation at clinic. Medical history included high blood pressure from an unknown date and unknown if ongoing. Concomitant medications included amlodipine taken for blood pressure abnormal from an unspecified start date and ongoing; lisinopril taken for blood pressure abnormal from an unspecified start date and ongoing. On 11Feb2021 the patient experienced joint swelling in the second finger of left hand, pain in the second finger of left hand. The events resulted in visit to Physician Office. The clinical outcome of the events joint swelling in the second finger of left hand was recovering, pain in the second finger of left hand was not recovered at the time of report.  Follow-up attempts completed. No further information expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination site swelling
Clinical narrative: slight chills; soreness at the injection site; This is a spontaneous report from a contactable consumer female patient(daughter) reported that. A 47-years-old female patient received bnt162b2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 13Feb2021 (Batch/Lot Number: EL9266; Expiration Date: 31May2021) as DOSE 2 SINGLE for covid-19 immunization (Age at vaccination 47 years). The patient medical history and concomitant medications were not reported. The patient past vaccine took first dose 23Jan2021. Caller is calling about the Pfizer COVID vaccine. He says on Saturday, his wife, his daughter and his self-went to get their second shot. Caller says he and his daughter experienced mild side effects. They experience slight chills and soreness at the injection site on an unspecified date. His wife experienced tremendous side effects, her arm was bothering her a lot, she had fever until Monday up to 103 and diarrhea. She had chills nausea fatigue.The fever stopped today she no longer has fever, but she is still experiencing dizziness and fatigue. She woke up dizzy this morning, she is tired today, she had diarrhea twice again today, but the dizziness is bothering her the most. She also has loss of appetite; she does not want to eat. She wants to know why she is dizzy all these days later. Dizziness started this morning she was very dizzy. It went away for a while she ate lunch, she forced lunch down, but she is still dizzy now. She was drinking water because her husband thought she was dehydrating herself. She ate a piece of chocolate and sat down incase her sugar was dropping. She had diarrhea starting Saturday and she had the feeling yesterday, but she didn't go then today she went twice. Her chills were Saturday, Sunday, and now she is done with the chills and the fever. That went away yesterday. Now she just has the tiredness and the dizziness. The tiredness she can handle but she can't stand buy herself she gets dizzy when she is walking. The event outcome was unknown.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Muscle cramps; This is a spontaneous report from a contactable consumer (patient). This consumer reported for self that: A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported, expiration date: 06Feb), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced muscle cramps on an unspecified date. The outcome of the event was reported as unknown.  Information about Batch/Lot number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: Elevated BP; This is a spontaneous report from a contactable consumer reported that. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 06Feb2021 (Batch/Lot number was not reported) as DOSE 1 SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported.  The caller explains her neighbor had the same reaction and her blood pressure was elevated as well. She states they got their vaccines on the same day on an unspecified date. The patient underwent lab tests and procedures which included blood pressure measurement: elevated on an unspecified date. The event outcome was unknown.  No further details were provided or obtained.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: cheeks to be swelling; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration on 12Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. Relevant medical history includes allergic to sulfa and has little back pain that that is "coming and going". The patient's concomitant medication included an Argan cream. Reporter's mom (patient) received the Pfizer-BioNTech COVID-19 Vaccine first dose 11 days ago (12Feb2021). Patient experienced her cheeks to be swelling; 'underneath the cheek it has a dimple' on an unspecified date in Feb2021. Patient took Benadryl, the swelling went back down but not all the way. Reporter was seeking guidance on what to do with the swelling. Reporter also mentioned that Patient started a new Argan cream on her face before getting the vaccine and asking if it would be possible that this caused the swelling. Reporter also asked if somebody takes a blood thinner, is there a different vaccine for them; like a blood thinner shot. Reporter also wanted to know if patient could take the second shot. The outcome of the event was recovering at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Vaccination site pain
Clinical narrative: slight chills; soreness at the injection site; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received second dose of bnt162b2 (Pfizer COVID 19 vaccine, Solution for injection, Batch/lot number: EL9266, Expiry date: 31May2021) via an unspecified route on 13Feb2021 (age at vaccination: 73-year-old), 0.3ml as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer COVID 19 vaccine, Solution for injection, Batch/lot number: EL9262, Expiry date: 31May2021) via an unspecified route on an unspecified date (age at vaccination: 73-year-old), as a single dose for covid-19 immunization. Patient says on Saturday, his wife, his daughter and his self-went to get their second shot. On an unknown date, patient experienced slight chills and soreness at the injection site. The clinical outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nasopharyngitis, Pain, Vomiting
Clinical narrative: her husband was freezing last night; her husband threw-up 1 or 2 times; her husband has muscle aches allover; her husband has body aches allover; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 15Feb2021 (Batch/Lot number and Expiry date was not reported) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the patient experienced her husband was freezing last night, her husband threw-up 1 or 2 times, her husband has muscle aches allover and her husband has body aches allover. Reported that she and her husband got their second COVID-19 Vaccines shots yesterday. She said she was fine, but her husband was freezing last night, and threw-up 1 or 2 times. She said her husband has muscle and body aches allover, so she gave him 2 Tylenol PM this morning. The reporter asked if her husband is going to be all right. It was advised that Pfizer does not give medical advice, and if she thinks her husband needs medical attention to call his doctor, or if emergent to go to an emergency room. The reporter stated she thinks she read to give Tylenol if a person hurts after getting the COVID-19 Vaccine. She said her husband is achy allover, so she thinks the Tylenol PM will help, and her husband will sleep for a while. The reporter stated that she used to work at a nursing home. No further details provided. The reporter was unwilling to complete the report. The clinical outcome of the events was unknown.  No follow-up attempts are possible. Information about batch/ lot number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue extreme/tired; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as dose 1, single, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had fatigue extreme/tired/extremely fatigued. The outcome of the event was unknown.  Information about lot/batch number cannot be obtained. No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment, Vitreous floaters
Clinical narrative: Vision temporarily impaired morning after vaccination for about 1 hour saw floater "hole" when looked at objects; Vision temporarily impaired morning after vaccination for about 1 hour saw floater "hole" when looked at objects; This is a spontaneous report from a contactable Consumer or Non-healthcare Professional reporting for a patient. A 44-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 11Feb2021 at the age of 44-years-old as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive other vaccine in four weeks of vaccination. The patient did not receive other medications in two weeks of vaccination. It was unknown if the patient was diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. On 12Feb2021, the patient experienced Vision temporarily impaired morning after vaccination for about 1 hour and Saw floater "hole" when looked at objects. No treatment was received for adverse events. Adverse events resulted in none of the above. The outcome of events was recovered on 12Feb2021.  Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy; This is a spontaneous report from a contactable consumer (patient's wife). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 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 got the COVID-19 shot on Tuesday (unspecified date) and he is complaining of being dizzy on an unspecified date. She stated that her husband had called in sick for two days in a row. She was wondering how long this side effect is expected to last. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Body height decreased, Fatigue, Headache, Limb discomfort
Clinical narrative: She may have shrunk a little; Arm soreness at injection site; Extreme tiredness; Headache; Nausea; General unwell feeling; Didn't feel steady on her legs; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported, patient was 74-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 08Feb2021 at 10:00 as DOSE 2, SINGLE for covid-19 immunisation. Medical history reported as none. There were no concomitant medications. Historical vaccine included Flu Shot for immunization on an unspecified date and experienced mild sore arm; first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration, administered in Arm Left on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. It was reported that reporter attempted to clarify which lot number was for the second dose of COVID-19 Vaccine. Provided two lot numbers from her patient card of EM9810 and EL3249. Caller was unable to determine which lot number coincided with her second COVID-19 Vaccine. No additional vaccines administered on same date of Pfizer suspect; no prior vaccinations received within 4 weeks. On 09Feb2021, the patient experienced arm soreness at injection site, extreme tiredness, headache, nausea, general unwell feeling, didn't feel steady on her legs, on an unspecified date, the patient experienced she may have shrunk a little. Reported that arm soreness at injection site was mild pain, extreme tiredness only lasted a day to a day and a half, mild nausea made her not want to eat. Didn't feel steady on her legs as she did not have wobble legs, just didn't feel steady. Had no fever and no joint pain. The patient underwent lab tests and procedures which included body height which resulted as she may have shrunk a little. Patient received treatment for headache with aspirin and it took care of the headache immediately. The outcomes of events (Arm soreness at injection site, Headache, Nausea, Didn't feel steady on her legs) were recovered on an unspecified date in Feb2021, the outcomes of events (Extreme tiredness, General unwell feeling) were recovering, the outcome of event (She may have shrunk a little) was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Vaccination site pain
Clinical narrative: She may have shrunk a little; Arm soreness at injection site; Extreme tiredness; Headache; Nausea; General unwell feeling; Didn't feel steady on her legs; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported, patient was 74-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 08Feb2021 at 10:00 as DOSE 2, SINGLE for covid-19 immunisation. Medical history reported as none. There were no concomitant medications. Historical vaccine included Flu Shot for immunization on an unspecified date and experienced mild sore arm; first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration, administered in Arm Left on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. It was reported that reporter attempted to clarify which lot number was for the second dose of COVID-19 Vaccine. Provided two lot numbers from her patient card of EM9810 and EL3249. Caller was unable to determine which lot number coincided with her second COVID-19 Vaccine. No additional vaccines administered on same date of Pfizer suspect; no prior vaccinations received within 4 weeks. On 09Feb2021, the patient experienced arm soreness at injection site, extreme tiredness, headache, nausea, general unwell feeling, didn't feel steady on her legs, on an unspecified date, the patient experienced she may have shrunk a little. Reported that arm soreness at injection site was mild pain, extreme tiredness only lasted a day to a day and a half, mild nausea made her not want to eat. Didn't feel steady on her legs as she did not have wobble legs, just didn't feel steady. Had no fever and no joint pain. The patient underwent lab tests and procedures which included body height which resulted as she may have shrunk a little. Patient received treatment for headache with aspirin and it took care of the headache immediately. The outcomes of events (Arm soreness at injection site, Headache, Nausea, Didn't feel steady on her legs) were recovered on an unspecified date in Feb2021, the outcomes of events (Extreme tiredness, General unwell feeling) were recovering, the outcome of event (She may have shrunk a little) was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site was sore; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as dose 1, single, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient's injection site was sore. The outcome of the event was unknown.  Information on Lot/batch number cannot be obtained. No follow-up attempts are possible. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: she had quivers in her arm, in the front of her neck where her thyroid used to be, in her lips; This is a spontaneous report from a contactable consumer (patient's husband). A 78-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number, NDC number, expiry date was not reported) via an unspecified route of administration on 12Feb2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine) on an unspecified date for covid-19 immunization. The patient experienced quivers in her arm where she got the covid-19 vaccine, in the front of her neck where her thyroid used to be and in her lips on an unknown date in Feb2021. Investigation assessment was not reported. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Occasional chills and aches; Occasional chills and aches; This is a spontaneous report from a contactable consumer. A 37-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 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 for COVID-19 immunization. The patient medical and concomitant medication history were reported. The patient experienced occasional chills and aches on an unspecified date. The outcome of the events were unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: still feels achy/Her body still hurts; This is a spontaneous report from a contactable consumer (patient). This female consumer of an unspecified age received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 08Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes BNT162B2 dose 1 on an unspecified date. On an unspecified date in 2021 patient experienced still feels achy/her body still hurts. The caller reported that the first time she had the covid-19 vaccine she had side effects. Caller asked, do some people have lingering side effects? She said that it might not be related. She has also heard that her doctor had effects for like 2 weeks. She has heard that some people have lingering effects. She would like information on this. The caller declined to complete a safety report and requested to be transferred to USMI to have her questions addressed. Caller declined to provide an email. The outcome of event was recovering.  Information on the lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza like illness, Malaise, Myalgia, Pain
Clinical narrative: Flu like symptoms / like the flu; Muscle ache; feeling lousy; felt bad / feeling bad; body aches; This is a spontaneous report from a contactable consumer (parent). This consumer reported similar events for two patients. This is the 1st of two reports. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on 16Feb2021 at 12:30 (at the age of 44-years-old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on 26Jan2021 at 09:00 (at the age of 44-years-old) for COVID-19 immunisation. On an unspecified date in Feb2021, the patient experienced flu like symptoms / like the flu, muscle ache, feeling lousy, felt bad / feeling bad, and body aches. It was reported that the patient has been on the couch and had to call out of work. 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021170713 Different patient, same reporter and product and similar events.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Caller states they experienced a sore arm for a few days; slight pressure headache; her husband had fatigue; This is a spontaneous report from a contactable Nurse. This Nurse reported for patient (Husband). A 71-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), dose 2 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 previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown) on an unspecified date for COVID-19 immunization. The caller reported that she and her husband received the second dose of the vaccine 4 weeks from the first dose of the vaccine. Caller also stated she and her husband had normal reactions to the vaccine. The "caller states they experienced a sore arm for a few days" and a "slight pressure headache" on an unspecified date. The caller stated, "her husband had fatigue" on an unspecified date. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.