chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Headache; my back was hurting; going on the second week my back still hurt; was very tired so I just  stayed like that for 3 days; right behind my ear;  where your lymph nodes are its swollen; This is a spontaneous report from a contactable other hcp. A 56-years-old patient of an unspecified gender received bnt162b2 (BNT162B2) formulation solution for injection, dose 1 (Lot number was not reported) via an unspecified route of administration at arm on 12Jul2021 (at the age of 56-years-old) as a single dose for covid-19 immunisation. Medical history included from an unknown date and unknown if ongoing. There were no concomitant medications. On 12Jul2021 got my first dose of the Pfizer Covid vaccine and that night nurse had a horrible headache, nurse back was hurting, and nurse was very tired so nurse just stayed like that for 3 days now then this was going on the second week nurse back still hurt patient still had a headache and had right behind patient ear you know where your lymph nodes are its swollen, should patient be concern about the second shot.   Information on lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: That evening I experienced severe dizziness, similar to vertigo. I have never had vertigo prior to this. I felt like I was falling forward. It has not gone away since. I do not have it all the time, m; That evening I experienced severe dizziness, similar to vertigo. I have never had vertigo prior to this. I felt like I was falling forward. It has not gone away since. I do not have it all the time, m; This is a spontaneous report from a contactable consumer or other non hcp for herself. A 63-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 08Jun2021 10:00 (Batch/Lot Number: EW0177) as dose 1, single (age at vaccination 63-year-old) for covid-19 immunisation. Medical history included Hypoactive Thyroid from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. patient did not receive other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. No known allergies. The dose 2 was taken on 29Jun2021. The patient experienced that evening i experienced severe dizziness, similar to vertigo. i have never had vertigo prior to this. i felt like i was falling forward. it has not gone away since. i do not have it all the time, mostly when I am laying down on 08Jun2021 19:00 with outcome of not recovered. The treatment was not received for events. The outcome for all events was not recovered.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Feeling abnormal
Clinical narrative: Cough; Feeling under the weather; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated, "What I was trying to find out. I tried as they say make a long story short here. I just got the shot (Unspecified Shot) a couple days ago. It was not really (incomplete sentence), it was to do with the shot or not? So, this was the question. I was not feeling under the weather before I got the shot, but I started to have little bit of cough since then and my daughter has not feeling well also (Further clarification was unknown if daughter had the shot or not, hence split case was not made). She finds out that the young lady she works with her family were in (state), so we were in area that had a high number of cases, her family had contracted the virus (Further clarification was unknown), so meaning that my daughter was exposed, my daughter was exposed probably a week or so, with my daughter was going to get a couple of rapid tests to make sure she was positive or negative. Now I had someone tell me, I understood that this shot did not had the live virus in it, I understood that already, just to tell you, I know that part, but this was the question someone (incomplete sentence), I did not know if this was true that was why I was calling Pfizer. Someone told my daughter because that I had my first shot a couple days ago that I might, (incomplete sentence) if I tested right now (distorted voice) even if it was 'far'. My question to you, was that true, should I go ahead and take a test anyway to see if it tests positive or should I be sure it may be nothing. I did have a shot couple of days ago." The clinical outcome of the events was unknown at the time of report.  Information about Batch/lot number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: 11 days after a ringing and vibrating in her ear; This is a spontaneous report from a contactable consumer (patient herself). A 63-years-old female patient received second dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 63-years-old) as single dose for COVID-19 immunisation. Patient previously received first dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), 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. On an unspecified date, patient experienced 11 days after a ringing and vibrating in her ear. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Poor quality product administered, Product preparation error, Product preparation issue
Clinical narrative: Runny nose; Headache; Left arm hurting; The co-worker said that she "diluted it with sterile water" but caller said "she didn't think it was diluted and that she saw what the co-worker gave her".; The co-worker said that she "diluted it with sterile water" but caller said "she didn't think it was diluted and that she saw what the co-worker gave her".; The co-worker said that she "diluted it with sterile water" but caller said "she didn't think it was diluted and that she saw what the co-worker gave her".; This is a spontaneous report from a Pfizer sponsored program. A contactable 34-year-old female consumer (patient) reported for herself.  A 34-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 22Jul2021 (at the age of 34-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes Indigestion and allergy from an unspecified onset and unknown ongoing and concomitant medications includes Protonix [OMEPRAZOLE] and Acrivastine (BENADRYL ALLERGY RELIEF). On 22Jul2021, patient received first dose of the Pfizer COVID-19 vaccine and patient doesn't think it was diluted at all, Caller said she was given 0.1milliliter of whatever was drawn up. Caller mentioned that after she was given the vaccine, the co-worker said that she diluted it with sterile water, but caller said she didn't think it was diluted and that she saw what the co-worker gave her. It was brought to the caller's attention that the vaccine was supposed to be diluted, and before the shot was administered, the co-worker said you're not supposed to dilute it. Caller mentioned that the "co-worker gave 2 doses of the vial, and caller knows it was supposed to be 6 doses in a vial, and the co-worker had no dosages left and caller was wondering where are the other doses of the vial" Caller wanted to know information on being given an undiluted dose of the vaccine, on whether it is effective. Caller wanted to know what she was supposed to do if the Pfizer BioNTech COVID-19 vaccine dose given to her was diluted with sterile water. On 23Jul2021 patient experienced left arm hurting, on 24Jul2021 patient experienced runny nose and headache. No other vaccines taken within four weeks prior to the first administration date of the suspect vaccine. The outcome of the event Runny nose and headache was recovered on 26Jul2021 and pain in extremity was recovered on 27Jul2021.  No follow-up attempts possible. No further information expected.  Follow-up (PRD/SRD (09Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Runny nose; Headache; Left arm hurting; The co-worker said that she "diluted it with sterile water" but caller said "she didn't think it was diluted and that she saw what the co-worker gave her".; The co-worker said that she "diluted it with sterile water" but caller said "she didn't think it was diluted and that she saw what the co-worker gave her".; The co-worker said that she "diluted it with sterile water" but caller said "she didn't think it was diluted and that she saw what the co-worker gave her".; This is a spontaneous report from a Pfizer sponsored program. A contactable 34-year-old female consumer (patient) reported for herself.  A 34-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 22Jul2021 (at the age of 34-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes Indigestion and allergy from an unspecified onset and unknown ongoing and concomitant medications includes Protonix [OMEPRAZOLE] and Acrivastine (BENADRYL ALLERGY RELIEF). On 22Jul2021, patient received first dose of the Pfizer COVID-19 vaccine and patient doesn't think it was diluted at all, Caller said she was given 0.1milliliter of whatever was drawn up. Caller mentioned that after she was given the vaccine, the co-worker said that she diluted it with sterile water, but caller said she didn't think it was diluted and that she saw what the co-worker gave her. It was brought to the caller's attention that the vaccine was supposed to be diluted, and before the shot was administered, the co-worker said you're not supposed to dilute it. Caller mentioned that the "co-worker gave 2 doses of the vial, and caller knows it was supposed to be 6 doses in a vial, and the co-worker had no dosages left and caller was wondering where are the other doses of the vial" Caller wanted to know information on being given an undiluted dose of the vaccine, on whether it is effective. Caller wanted to know what she was supposed to do if the Pfizer BioNTech COVID-19 vaccine dose given to her was diluted with sterile water. On 23Jul2021 patient experienced left arm hurting, on 24Jul2021 patient experienced runny nose and headache. No other vaccines taken within four weeks prior to the first administration date of the suspect vaccine. The outcome of the event Runny nose and headache was recovered on 26Jul2021 and pain in extremity was recovered on 27Jul2021.  No follow-up attempts possible. No further information expected.  Follow-up (PRD/SRD (09Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Diarrhoea, Dyspnoea
Clinical narrative: Shortness of breath; back pain; Chest pain; Diahhrea; This is a spontaneous report from a contactable consumer (patient).   A 34-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number were not provided, Expiration date were not provided), via an unspecified route of administration, administered in Arm Left on 26Jul2021 13:00 (at the age of 34-years-old) as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medication was not reported. No Prior to vaccination, was the patient diagnosed with COVID-19. On 28Jul2021, the patient experienced shortness of breath, back pain and chest pain, diarrhoea. The patient not received treatment. The outcome of the events was recovering.   No Follow-up attempts are possible. No information is expected further.
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Eye swelling, Throat irritation
Clinical narrative: Her eyes are like swelling up; She has like an itchy throat; Her right ear is like a little bit closed up; This is a spontaneous report from a contactable consumer. A female patient (reporter's sister) received unknown number dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8731; Expiration date: 31Jul2021) via an unspecified route of administration on an unspecified date in 2021 as single dose for COVID-19 immunization. Medical history, concomitant conditions or past drug history of the patient were not reported. On an unspecified date in 2021, patient experienced a reaction, her eyes were like swelling up and then she has like an itchy throat and her right ear was like a little bit closed up." Reporter was not sure if patient should go to the ER (Emergency Room) now. Reporter asked, "Should we go to the Emergency Room or is this like a very normal thing." Outcome of the events were unknown.  As reporter was not willing to proceed the call. Product details (NDC# and UPC#), Pharmacy details and treatment could not be probed over the call. Limited information available over the call and appropriate response could not be provided.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash papular
Clinical narrative: Extreme itching with raised red bumps (pimple sizes like) all over the body, mostly in the back. Red bumps leaks out clear yellow liquid; Extreme itching with raised red bumps (pimple sizes like) all over the body, mostly in the back. Red bumps leaks out clear yellow liquid; This is a spontaneous report from a contactable consumer or other non hcp. A 54-years-old male patient received Second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0151) via an intramuscular route of administration in Arm Left on 03May2021 11:20 (age at vaccination 54years old) as single dose and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: ER8736) via an intramuscular route of administration in Arm Left on 05Apr2021 11:00 (age at vaccination 54years old) as single dose for covid-19 immunisation. Medical history included from an unknown date and unknown if ongoing. The patient did not have known allergies. Prior to vaccination, the patient was diagnosed with COVID-19 reported as unknown. The patient did not receive any other vaccines within 4 weeks and Other medications in two weeks prior to the COVID vaccine. There were no concomitant medications. Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced extreme itching with raised red bumps (pimple sizes like) all over the body, mostly in the back red bumps leaks out clear yellow liquid on 15Apr2021. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was not recovered. Therapeutic measures were taken as a result of extreme itching with raised red bumps (pimple sizes like) all over the body, mostly in the back. red bumps leak out clear yellow liquid.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: the first shot I did I had no side effect sore arm that was it; This is a spontaneous report from a contactable consumer(Patient herself). A 36-year-old female received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration as SINGLE DOSE for covid-19 immunisation. Patient medical history includes celiac disease and concomitant medications include Claritin-D, Iron supplement, Products B-12, vitamin D. Patient had sore arm. The outcome of the event was unknown.  Follow up attempts are completed, no other information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Ear infection
Clinical narrative: constant ear infection; This is a spontaneous report from a contactable consumer (Parent). A 12-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Right Arm on 16Jun2021 for COVID-19 immunization (The patient age at the vaccination is 12-years-old). The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccination included BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not eported), dose 1 via an unspecified route of administration, at unknown anatomical location on unknown date for COVID-19 immunization.Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient  did not diagnosed with COVID-19. Since the vaccination, the patient not tested for COVID-19. The patient experienced constant ear infection on 21Jun2021. Antibiotics were taken as a result of constant ear infection. Outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus
Clinical narrative: Redness in my chest, in my arm, between the shoulder and on my ear; I feel like warm/ it is like getting hot/ My body getting hot; I also feel itching; This is a spontaneous report from a contactable reporter (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: not reported, Expiry Date: Unknown), dose 1 via an unspecified route of administration on 26Jul2021 as a DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that, on 30Jul2021 had redness in my chest, in my arm, between the shoulder and on my ear, I feel like warm/ it is like getting hot/ my body getting hot and I also feel itching. Reporter stated, "I did get the vaccine on Monday this week, I was fine until today that is Friday, so I have like redness in my chest, in my arm, between the shoulder and on my ear, it is like getting hot and my body getting hot, so I feel like warm, and I also feel itching." It was the Pfizer, the first shot yeah. Reporter stated, "No, 'just want to know what's going on' (incomplete sentence), yeah yeah." Reporter stated, "What I am going to do 'this is what I want to understand, what medicine should I take or what I am going to do?" Reporter seriousness for the events were unspecified. Outcome of all the events were unknown.  Comment: Reporter type could not be probed hence captured as reporter or other non-health profession in tab.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Mouth swelling, Urine analysis
Clinical narrative: mouth swollen up; This is a spontaneous report from a contactable consumer or other non-hcp (patient himself). A 33-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration in Arm Left on 22Jul2021 (Lot Number: EW0198) as dose 1, single for COVID-19 immunisation. Medical history was he had previously been on a regimen of blood thinners several months ago. The patient's concomitant medications were none. The patient experienced mouth swollen up on 22Jul2021. Patient's mouth was swollen up, more along the line of the jaw, it was swollen up to the size of maybe a small cherry, and it keeps going up, sometimes it was all the way and he can still see the area in his mouth where it's swollen up. He was calling because it's been longer than a week, the swelling was still there, he kind of has no feeling, he can feel the part of the mouth, but has no feeling where the swelling was, and it literally started maybe about 30 minutes after the shot. It's worse because he doesn't have feeling on that side, there's nothing there, it actually feels kind of hard as well. The patient underwent lab tests and procedures which included blood test: ok, urine analysis: ok. The outcome of the event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: she did get some redness; This is a spontaneous report from a contactable consumer. This consumer (patient's daughter) reported for a 91-year-old female patient (reporter's mother) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient's daughter reported she had taken the Pfizer vaccine. She did get some redness and she got from the vaccine but nothing like she had got on an unspecified date. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Having a small amount of diarrhea; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 35-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on 26Jul2021 13:30 as dose 1, single (age at vaccination: 35 years) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date Jul2021, it was reported that it was not serious as of now but after a week of taking that shot, I am noticing that I am having a small amount of diarrhea. They did not gave me the lot number, they told me that this was my first dose and then they said the second dose would be on the 16Aug (not clarified). Consumer stated that I started these symptoms like on Saturday morning, that was only as I took the Pfizer. It was stated that see your vaccination card when you get the first dose then you get the vaccine card that tell you when to return for your second dose of Pfizer Vaccine Covid-19, bring your vaccination card and the attention information that if you require visit the website or call the cell phone number provided, my first vaccine it was fine. The clinical outcome of the event was unknown.    Information on the Lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: a big lump of hives or rash that is itchy; a big lump of hives or rash that is itchy; a big lump of hives or rash that is itchy; This is a spontaneous report from a contactable consumer. A 55-Year-old male received first dose of bnt162b2 (BNT162B2, Formulation: Solution for Injection, Batch/Lot Number were not reported) via 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. After getting the 1st dose of the vaccine the reporters husband experienced a big lump of hives or rash that is itchy. Talked to a Pharmacist, advised them not to get the second dose. While his primary care physician asked them to call Pfizer to ask how to remedy this. Reporter said that her husband did not do anything different and that he had this after get-ting the vaccine. The reporter on the line calling about the Pfizer Vaccine, clarified to be the COVID Vaccine. On 19Jul2021 she called to report her husband had a bad reaction to the vaccine. It has been four weeks now and her husband is still having these bad reactions. It has not subsided. The patient requested for medical information. The outcome of the events was not recovered.  Information about Lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Condition aggravated, Pruritus, Rash
Clinical narrative: rash all over the back and stomach; rash all over the back and stomach was reported as worsened; itching around the arm and down; pain in the chest and a heavy feeling; pain in the chest and a heavy feeling; I am also under stress.; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0198, Expiration Date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 23Jul2021 14:00 (at the age of 41-year-old) as dose 2, single for COVID-19 immunization. The patient medical history was none reported. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Solution for injection, Lot Number: EW0185; Expiration Date: Unknown), administered in Left Arm on 02Jul2021 (at the age of 41-year-old) for COVID-19 immunization. Facility where COVID-19 vaccine was administered at Pharmacy. Patient Vaccination was not administered at Military Facility. Patient any additional vaccines administered on same date of the Pfizer Suspect was none reported. The patient received any other vaccines within 4 weeks prior to the COVID vaccine was none reported. Patient experienced adverse events prior vaccinations was none reported. Patient family medical history relevant to adverse events was none reported. Patient experienced rash all over the back and stomach was reported as worsened on an unspecified date in 2021. Patient stated received the second dose on 23Jul2021. A week later she started experiencing rash all over the back and stomach (30Jul2021) and noticed some itching around the arm and down (2021). Patient noticed once in a while a pain in the chest and a heavy feeling (2021). I could take breaths. I could also take deep breaths. I was also under stress (2021). Patient stated she was uncertain if she was having a side effect. She had the second vaccine a week ago this past Friday; for the last three days or so she has had a weird rash all over her stomach and back. Patient stated the rash began 30Jul2021, Friday. Stated it was getting worse. It was on her stomach and back, mentions that it was not on her bottom. Patient denied any other medical conditions, medications, labs, testing, or treatments relevant to report. Patient stated she was planning on calling her doctor once she spoke with someone at Pfizer. Verified she was calling to see if this was a side effect from the Covid Vaccine. Patient was not visited emergency room and physician office. There was no investigation assessment. Patient relevant tests were none reported. The clinical outcome of event was rash all over the back and stomach was not recovered and for another events outcome was unknown.  Follow-up activities closed. Batch/lot number available for [vaccine/BNT162B2].
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Stress
Clinical narrative: rash all over the back and stomach; rash all over the back and stomach was reported as worsened; itching around the arm and down; pain in the chest and a heavy feeling; pain in the chest and a heavy feeling; I am also under stress.; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0198, Expiration Date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 23Jul2021 14:00 (at the age of 41-year-old) as dose 2, single for COVID-19 immunization. The patient medical history was none reported. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Solution for injection, Lot Number: EW0185; Expiration Date: Unknown), administered in Left Arm on 02Jul2021 (at the age of 41-year-old) for COVID-19 immunization. Facility where COVID-19 vaccine was administered at Pharmacy. Patient Vaccination was not administered at Military Facility. Patient any additional vaccines administered on same date of the Pfizer Suspect was none reported. The patient received any other vaccines within 4 weeks prior to the COVID vaccine was none reported. Patient experienced adverse events prior vaccinations was none reported. Patient family medical history relevant to adverse events was none reported. Patient experienced rash all over the back and stomach was reported as worsened on an unspecified date in 2021. Patient stated received the second dose on 23Jul2021. A week later she started experiencing rash all over the back and stomach (30Jul2021) and noticed some itching around the arm and down (2021). Patient noticed once in a while a pain in the chest and a heavy feeling (2021). I could take breaths. I could also take deep breaths. I was also under stress (2021). Patient stated she was uncertain if she was having a side effect. She had the second vaccine a week ago this past Friday; for the last three days or so she has had a weird rash all over her stomach and back. Patient stated the rash began 30Jul2021, Friday. Stated it was getting worse. It was on her stomach and back, mentions that it was not on her bottom. Patient denied any other medical conditions, medications, labs, testing, or treatments relevant to report. Patient stated she was planning on calling her doctor once she spoke with someone at Pfizer. Verified she was calling to see if this was a side effect from the Covid Vaccine. Patient was not visited emergency room and physician office. There was no investigation assessment. Patient relevant tests were none reported. The clinical outcome of event was rash all over the back and stomach was not recovered and for another events outcome was unknown.  Follow-up activities closed. Batch/lot number available for [vaccine/BNT162B2].
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: little tired after the 1st dose; This is a non-serious spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable 40-year-old male consumer (patient) reported. A 40-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the vaccine series over 6 months ago, completed the series in Feb2021. The patient was a little tired after the 1st dose but fine after 2nd dose, on an unspecified date. Outcome of the event was unknown. Information about batch/lot number has been requested.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: swelling underneath the armpit towards the shoulder where they gave the shot; This is a spontaneous report from a contactable consumer. A 58-years-old male 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 31Jul2021 (at the age of 58-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Reason for no lot number: of COVID Vaccine: caller unwilling to complete the report. The patient medical and concomitant medication history were reported. Other product, patient history and investigation assessment were not provided. Patient had the vaccine 2 days ago and got a swelling underneath the armpit towards the shoulder where they gave the shot. Patient wants to know if this was normal. 2nd dose schedule on 28August2021. The outcome of the event was unknown.   The lot number was not provided. Information on lot number has been requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired for a few days; This is a spontaneous report from a contactable Pharmacist reported for a female 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. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced tired for a few days. Caller is looking for information on any neurological side effects that can be caused by the Pfizer COVID-19 vaccine. He states his brother sent him a 29 minute long video of this doctor claiming that you are going to be a cripple after receiving the vaccine, caller sates in theory that could happen, but it would be so rare, this guy is just trying to scare everyone into not getting the vaccine and that is the last thing we need is for people not to receive the vaccine. He states he and wife had received the vaccine and he had a sore arm, and she was tired for a few days but nothing more than that. The clinical outcome of the event was unknown.  Information about lot/ Batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fluid retention, Gastrointestinal disorder, Seasonal allergy, Swelling face, Weight
Clinical narrative: This is a non-serious spontaneous report from a Pfizer-sponsored Program COVAX US Support. A contactable 58-year-old female consumer (patient) reported for herself. A 58-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (at the age of 58-years-old) as a single dose for covid-19 immunization. Medical history included ongoing food allergy food sensitivities to nuts, corn, sesame and eggs, ongoing gluten sensitivity, ongoing vitamin d deficiency in vitamin D, ongoing iron deficiency deficient in iron. The patient experienced experienced facial swelling, body weight gain and "retained water". This happened within a week and now at three weeks the symptoms have started to fade. She had leaky gut, seasonal allergies. Outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Weight increased
Clinical narrative: This is a non-serious spontaneous report from a Pfizer-sponsored Program COVAX US Support. A contactable 58-year-old female consumer (patient) reported for herself. A 58-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (at the age of 58-years-old) as a single dose for covid-19 immunization. Medical history included ongoing food allergy food sensitivities to nuts, corn, sesame and eggs, ongoing gluten sensitivity, ongoing vitamin d deficiency in vitamin D, ongoing iron deficiency deficient in iron. The patient experienced experienced facial swelling, body weight gain and "retained water". This happened within a week and now at three weeks the symptoms have started to fade. She had leaky gut, seasonal allergies. Outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Chapped lips, Lip blister, Lip dry, Lip swelling
Clinical narrative: Lip swelling; Blistering of lips; Dry/ chapped; Dry/ chapped; This is a spontaneous report from a contactable consumer or other non hcp. consumer reporting similar events under the same suspect product(s) for 2 patients. This consumer reported for male patient (reporters brother). A 57-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 19Jan2021 11:00 (Batch/Lot Number: EK9231) as dose 2, single for covid-19 immunisation. Medical history included hypothy. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for hypothyroidism from 2008 and ongoing. The patient received first dose of bnt162b2 on 29Dec2020 at 11:00 (Anatomical site if injection: Arm, Intramuscular, Batch/Lot number: EL1284) for covid-19 immunisation. The patient did not receive any Prior vaccinations. On an unknown date the patient experienced lip swelling, blistering of lips and dry/ chapped. It was reported that Horrible swelling and blistering of lips lasted 3 months. Now no longer swollen but constantly dry/ chapped. The outcome of all the events was unknown. Follow-up attempts are completed. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202100985958
Sex: U
Vaccine: COVID19
Symptoms: Lip blister, Lip dry, Lip swelling
Clinical narrative: lip swelling; blistering of lips; dry / chapped; This is a spontaneous report from a contactable consumer or other non-HCP.   This consumer reporting for multiple patients. This case was reported for best friends that:  A patient of unspecified age and gender 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 (Age of vaccination: Unknown) for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced lip swelling, blistering of lips and dry or chapped. The outcome of all events was unknown. Follow-up (08Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  No follow-up attempts are possible. Information about lot/batch no cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100985957
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Hypoacusis
Clinical narrative: She mentioned that she is unable to go back to the facility for her 2nd dose due to an issue with hearing.; She mentioned that she is unable to go back to the facility for her 2nd dose due to an issue with hearing.; This is a spontaneous report from a contactable consumer or other non hcp from a Pfizer.  A female patient of an unspecified age received bnt162b2 (BNT162B2,Formulation:Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 17Apr2021 as Dose 1, Single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that she was unable to go back to the facility for her second dose due to an issue with hearing on an unspecified date in 2021. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Illness
Clinical narrative: getting loose stools after each dose; got really sick; This is a spontaneous report from a contactable consumer (patient), from a Pfizer sponsored program. A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 28Jul2021 (at the age of 61-years-old) as dose 2, single for covid-19 immunization. The patient medical history included COVID-19 illness from Mar2021 (She also mentioned that she had the COVID-19 illness back in Mar). Concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization and experienced getting loose stools after each dose. It was reported that, the patient is a teacher who received her second dose of the Pfizer COVID-19 vaccine last Wednesday 28Jul2021 and got really sick. She is feeling better. She also mentioned that she had the COVID-19 illness back in Mar2021. She is required to do a baseline COVID-19 test before she goes back to work. She would like to know how soon should she be tested or how long should she wait. She has just taken the 2nd dose on 28Jul2021. She has mentioned getting loose stools after each dose. The outcome of the event got really sick was recovering and outcome was unknown for other event.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Malaise, Nausea, SARS-CoV-2 test
Clinical narrative: Unwell; dizzy; Nauseous; This is a spontaneous report from a contactable consumer. This 50-year-old female consumer (patient) reported in response to Non-HCP letter sent that included that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunization. Patient's Medical History included left kidney removed donated (living donor) (05Nov2018-ongoing), appendectomy (1989) and gallbladder removal (2000). The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown dose as dose 1, single for COVID-19 immunization and experienced nausea, was dizzy and fuzzy. It was mentioned that prior vaccinations and concomitant drugs were reported as none. Within first minutes she felt dizzy, nauseous and unwell. The patient received tylenol for treatment. Her second shot was worse than first and recovery was faster. On 01Feb2021, PCR was performed for which result was negative. On an unknown dates PCR was performed three times for which results were negative. The event of nausea was not recovered. The events malaise and dizziness were recovering. Information on lot/batch number had been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Fatigue, Headache, Nausea, Pain
Clinical narrative: Extreme Fatigue; Headache; Nausea; Body Ache; Cold Sweats; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via intramuscular route of administration (age at vaccination 53-year) in left arm (deltoid) on 19Jun2021 at 02:20 PM as dose 2, single for COVID-19 immunization. Medical history reported none. There were no concomitant medications. Historical vaccine includes first dose of BNT162B2 received via Intramuscular route of administration in Left arm (deltoid) on 08May2021 at 02:00 PM for COVID-19 immunization; after first dose the patient experienced extremely tired/extreme fatigue, headaches, nausea, flu-like symptoms, body aches, felt less tired but still not back to normal. Reported facility type was pharmacy or drug store. Prior vaccination with in 4weeks was reported none. On 25Jun2021 the patient experienced extreme fatigue, headache, nausea, body ache, cold sweats. As reported her side effects came in 2-3days periods, then went away for 3-4days and came back again, 2 times with first and twice with second vaccine. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 29May2021. Patient received no treatment for the adverse events. The seriousness of the events was reported as non-serious. The clinical outcome of the events was resolved on 27Jun2021.   Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Extreme Fatigue; Headache; Nausea; Body Ache; Cold Sweats; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via intramuscular route of administration (age at vaccination 53-year) in left arm (deltoid) on 19Jun2021 at 02:20 PM as dose 2, single for COVID-19 immunization. Medical history reported none. There were no concomitant medications. Historical vaccine includes first dose of BNT162B2 received via Intramuscular route of administration in Left arm (deltoid) on 08May2021 at 02:00 PM for COVID-19 immunization; after first dose the patient experienced extremely tired/extreme fatigue, headaches, nausea, flu-like symptoms, body aches, felt less tired but still not back to normal. Reported facility type was pharmacy or drug store. Prior vaccination with in 4weeks was reported none. On 25Jun2021 the patient experienced extreme fatigue, headache, nausea, body ache, cold sweats. As reported her side effects came in 2-3days periods, then went away for 3-4days and came back again, 2 times with first and twice with second vaccine. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 29May2021. Patient received no treatment for the adverse events. The seriousness of the events was reported as non-serious. The clinical outcome of the events was resolved on 27Jun2021.   Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received 2nd dose of bnt162b2 (Pfizer Covid 19 vaccine,Batch/Lot number was not reported), via an unspecified route of administration on 01Aug2021 as Dose 2,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced fever on 02Aug2021.Therapeutic measures were taken as a result of fever.The caller stated that after giving her daughter Tylenol,after two hours the fever goes back up.Caller was asking what should be given to her daughter now.The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.