chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site mass, Vaccination site warmth
Clinical narrative: about 3 hours later I had this big knot over from my injection its about 2 inches long and it's like a big roll; this knot came up from the injection site and it's real hot and its real hard and its real red; this knot came up from the injection site and it's real hot and its real hard and its real red; this knot came up from the injection site and it's real hot and its real hard and its real red; This is a spontaneous report from a contactable consumer, the patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 2 via an unspecified route of administration on 17Mar2021 10:30 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), dose 1 via an unspecified route of administration on 24Feb2021 as a single dose for covid-19 immunization. On 17Mar2021, the patient experienced "about 3 hours later I had this big knot over from my injection its about 2 inches long and it's like a big roll it's about happening and it's big rod and this knot came up from the injection site and it's real hot and its real hard and its real red". Outcome of the event was unknown. No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Memory impairment
Clinical narrative: Memory problems with me and my husband. Can not remember words and places normally not a problem; This is a spontaneous report from a contactable consumer (spouse). A 72-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown), dose 1 via an unspecified route of administration on 10Feb2021 12:00 PM on Arm Left as dose 1, single; and then BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown), dose 2 via an unspecified route of administration on 13Mar2021 on Arm Left as dose 2, single for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Allergies to medications, food, or other products was Codeine. No prior vaccination done. List of any other medications the patient received within 2 weeks of vaccination reported as yes. Prior to vaccination, was the patient was not diagnosed with COVID. Since the vaccination, the patient was been tested for COVID-19. On an unspecified date in Feb2021. the patient reported, Memory problems with her and her husband. Cannot remember words and places normally not a problem. They were not really concerned but curious if this is in fact due to the vaccines. It appears to have started happening shortly after first vaccine and continued to be worse after the second vaccine. No treatment received for the adverse event. The patient underwent lab tests and procedures which included covid-19 negative on 05Mar2021. The outcome of the event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021318689 similar report from same reporter
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Nausea
Clinical narrative: very exhausted after this vaccine; shortness of breath; Headache; Nausea; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6207, Expiry date not reported) via unspecified route of administration on 17Mar2021 (at age of 74-years-old) as dose 1, single for COVID-19 Immunisation. Medical history included stroke and blood thinner. Concomitant medications included apixaban (ELIQUIS) used for blood thinner. Consumer stated, had my vaccine on the 17Mar2021 and that day I was just very exhausted after this vaccine but then that night I had shortness of breath, a headache and nausea and that lasted for 5 days. Now today was the first day, the patient feel back to normal again after 5 days and was kind of afraid to get my second shot. Patient enquired was that it will okay or what are, will it just dissipate like the other one. The outcome of all events was recovered on 22Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash macular, Urticaria
Clinical narrative: that look like hives; red pimples and hives like thing; On her stomach; little red lumps over her body or belly/red pimples/On her stomach; It looks like shingles; This is a spontaneous report from a contactable consumer or other non hcp (patient's husband). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6206), via an unspecified route of administration on 15Mar2021 as dose 2, single for covid-19 immunization (vaccinated at 68 years of age). The patient medical history and concomitant medications were not reported. The patient experienced that look like hives; red pimples and hives like thing; on her stomach, little red lumps over her body or belly/red pimples/on her stomach, it looks like shingles on an unspecified date in Mar2021. Reporter's wife got the second dose on 15Mar2021. About 1 week later, she got hives on her stomach. Reporter asked if it was a side effect of the vaccine. Reporter stated, his wife and he, they got the second dose of Pfizer Covid vaccine last week and his wife yesterday started to break out it was not hives but they were little red lumps over her body or belly. She had gone to the doctor but the doctor didn't know, the doctor didn't have experience with Pfizer vaccine and what he want to find was, was that a side effect that had been reported. Reporter stated, it was just basically around the belly, around the thigh. It looks like shingles, but the doctor said it wasn't shingles, but he didn't know what it was. The Pfizer thing was new, and the side effect was new so he don't know. Reporter stated, he doesn't know what her body weight was. Reporter stated, the doctor gave her some cream to put on the red spots, the things have popped up. Therapeutic measures were taken as a result of events which includes cream. The outcome for all events was unknown.   No follow-up attempts are needed, Information on lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Slight nausea, headaches; Slight nausea, headaches; my arm hurting but the shortness of breath bothered; my arm hurting but the shortness of breath bothered; fatigue; This is a spontaneous report received from a Pfizer Pfizer from a contactable consumer (patient). A 70-year-old female patient received bnt162b2 (BNT162B2, solution for injection; batch/lot number not reported), via an unspecified route of administration, on an unspecified date, as Dose 1, single for COVID-19 immunization. Medical history included melanoma. The patient's concomitant medications were not reported. Phone call received from the patient and during the call, the patient stated, "I'm in excellent health. I went to get the first Pfizer vaccine'. On an unspecified date, she stated that she received first dose of vaccine 4 weeks ago and had a horrible reaction. she had everything, slight nausea, headaches which did not bother her, and she did not care about her arm hurting but the shortness of breath bothered her, and it was the fatigue that bothered her beyond anything I had ever experienced before. After 3 days, it took her two days to recover from the reaction. Now last week, she was supposed to get the 2nd shot and quite frankly she chickened out. So, she made the appointment for this week and she was supposed to go this afternoon. She asked, there was anything she could do to lessen the reaction and she was scared of this vaccine. She had Melanoma and stated that she has never had an experience like this. Caller stated that her primary provider informed her, she might have to get Johnson and Johnson vaccine for second dose. The outcome of all the events was resolved.  Note: The patient's date of birth and patient's gender, were not provided during the call.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Lymphadenopathy
Clinical narrative: Ball under armpit; Ball under armpit; This is a spontaneous report from a contactable consumer or other non-HCP (patient's girlfriend). A 20-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration in Arm Left on 15Mar2021 09:30 (age at the time of vaccination 19-years-old), as a single dose for COVID-9 immunization. The patient's medical history and concomitant medication were not reported. No prior vaccinations within 4 weeks. On 16Mar2021, the patient experienced Ball under armpit. Patient did not received treatment for adverse event. Caller wanted to see if it was swollen lymph nodes. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arthritis, Dyspnoea, Pain
Clinical narrative: shortness of breath; I have been more pain than I was before I got the shot; arthritis on my leg; 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, lot number: ZL7PHD, Expiration date was not reported), via an unspecified route of administration, on 04Mar2021 as dose 1, single for covid-19 immunization. The patient medical history included that patient have been more pain than was before patient  got the shot and ongoing arthritis (Cortisone shot for arthritis). Concomitant medications was not reported. On an unspecified date, consumer stated, "I received my vaccine on 4th (04Mar2021) of this month and on the 8th (08Mar2021) I got a cortisone shot for my arthritis on my leg and I have been reached, I have been shortness of breath and also on my leg when I got the cortisone shot I called the doctor and told to call me back. I have been more pain than I was before I got the shot. So, consumer wanted to know is these side effects due to vaccine. Consumer stated, "It do not have no number. It is a number here ZL7PHD. Is that the number I do not have it and wanted to know that he could take 2nd shot on 25th. This was all I have, I do not know. I just want to know what the side effects is when I take the shot". Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension
Clinical narrative: Abdomen may be swollen; This is a spontaneous report from a contactable consumer (patient).   A 59-years-old female patient received first dose of  bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EP7534, expiry date: not reported) via an unspecified route of administration on 16Mar2021 (at the age of 59-years old) as dose 1,single for covid-19 immunisation. Medical history included  Low thyroid, Restrictive lung disease. The patient was not taking any treatment for the condition reportedly. Concomitant medication included levothyroxine sodium (TIROSINT) taken for hypothyroidism. On an unspecified date, the patient experienced abdomen may be swollen.  The patient had never felt this way before and it happened since the patient had the first dose. Therapeutic measures were taken as a result of the event with Advil, 200 mg. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Body mass index, Vaccination site mass, Vaccination site pain, Vaccination site warmth
Clinical narrative: golf ball sized lump at injection site; golf ball sized lump at the injection site. it is warm and tender to the touch.; golf ball sized lump at the injection site. it is warm and tender to the touch.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot Number: unknown) via an unspecified route of administration on 17Mar2021 at 13:00 (at the age of 40-year-old), as a single dose for COVID-19 immunization. Medical history included diabetes, liver disorder and covid-19. Concomitant medications were not reported. The patient was diagnosed with COVID-19 prior to vaccination. The patient had not tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. It's unknown whether the patient had any allergies. On 17Mar2021, the patient experienced golf ball sized lump at the injection site, warm and tender to the touch. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not received treatment for the reported events. The patient underwent lab test and procedure which included BMI with unknown result. The clinical outcome of the events vaccination site lump, vaccination site warmth and vaccination site tenderness were not resolved at the time of this report.   No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: 9 days after the vaccine, the injection site swelling; Injection site redness; injection site warmth; This is a spontaneous report from a contactable consumer (patient). A 30-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EN6207/EN6206, Expiry Date: Unknown) via an unspecified route of administration in left arm on 18Mar2021 at 19:30 (at the age of 30-year-old) as dose 1, single for COVID-19 vaccination. Medical history included asthma, COVID-19 and ADHD. Concomitant medications received within 2 weeks of vaccination included dexamfetamine saccharate, amfetamine sulfate, amfetamine aspartate (ADDERALL) for unknown indication on an unknown date, levocetirizine dihydrochloride (XYZAL) for unknown indication on an unknown date. Allergic to medications included CECLOR (MANUFACTURER UNKNOWN), BACTRIM (MANUFACTURER UNKNOWN) and AUGMENTIN (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 00:00, 9 days after the vaccination, the injection site swelling surface area had increased from the size of a golf ball. It was still red and still warm to the touch. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of vaccination site swelling, vaccination site erythema, vaccination site warmth was not recovered.   No follow up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient's address added and Past drug event Augmentin was coded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Tremor
Clinical narrative: lightheadedness; shaking; This is a spontaneous report from non-contactable other healthcare professional. A 35-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution for injection; Lot number: EN6205) via unspecified route of administration on 22Mar2021 (at the age of 35-years-old) as second dose, single for COVID-19 immunisation. Medical history included hypoglycemia from and unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously received first dose of PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution for injection; Lot number: unknown) via unspecified route of administration on unknown date as a single dose for COVID-19 immunisation. On 22Mar2021, during her fifteen minutes waiting period of injection, the patient began to experience light-headedness and shaking. The patient denied rash, difficulty breathing, difficulty swallowing, wheezing, itching and facial swelling. The patient complained of dizziness. Treatment included: water. The patient's follow up response towards treatment was good. The patient was escorted out of the facility and denied symptoms while ambulating out. The patient discharged and was stable to go home and follow up with primary care physician. Treatment was taken for the event which included with water. The clinical outcome of the light-headedness and shaking was resolved on 22Mar2021.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: VAERS Block was updated from Block 17 to Block 13 and also Block 10 ticked for SD BNT162B2. Treatment included: water added in the narrative.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Limb injury, Skin discolouration
Clinical narrative: she has developed chills; her fingers were turning blue.; her fingers were turning blue.; This is a spontaneous report from a contactable consumer and from a Pfizer sponsored program COVAX US support. This 76-year-old (age at vaccination) female consumer (patient) reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number; EN6207, expiration date; 31Jul2021, Pfizer COVID 19 vaccine manufacturer; Unspecified, NDC number; unknown) via an unspecified route of administration on 17Mar2021 at 10:30 at left arm as dose 2, single for covid-19 immunisation. Vaccination facility was Health and Wellness Center. Patient's medical history included blood pressure high, high cholesterol, knee replacement from Jul2020 to unspecified, heart problems, breast cancer (dates unspecified). Patient mentions predating treatment with the Pfizer COVID 19 vaccine, she had knee replacement surgery in Jul2020 and Nov2020 and had a COVID 19 test done before each time. Both the COVID 19 test from Jul2020 and Nov2020 were negative. Family History included mother heart problems; sister breast cancer; daughter breast cancer; father cancer. Relevant tests included two COVID-19 tests both negative on Jul2020 and Nov2020. Historical vaccine included first dose of BNT162B2, lot number: EN6199, on 24Feb2021 at 10:30 am in left arm for covid-19 immunisation. Concomitant medications were not reported. Prior vaccinations (within 4 weeks) were reported as none. Consumer had the first dose of the Pfizer COVID-19 vaccine on 24Feb2021 and had no reaction after. Consumer got the second dose on 17Mar2021. On 24Mar2021, she has developed chills and her fingers were turning blue on 24Mar2021 to ongoing. Reporter seriousness for the events was unspecified. The AEs did not require a visit to emergency room or physician's office. Consumer wanted to know if that is an adverse events associated with the vaccine and if those are adverse events that would go away. She also would want to know if she should go to the ER for it. Consumer states she has received both of the vaccines. Last week on 17Mar2021 she got the second dose. Then on 24Mar2021 she noticed chills; and her hands and fingers turned blue. They are still that way today. She didn't know if she should call Pfizer or call the wellness center. She is asking if this will go away or should she go to the ER? Clarifies she received the first dose of the Pfizer COVID 19 vaccine on 24Feb2021 at 1030 am in the left arm and had no reaction. Then she had the second dose on 17Mar2021 at 1030 am in the left arm. Patient does not see NDC on her vaccination card. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dehydration, Diarrhoea, Dizziness, Functional gastrointestinal disorder
Clinical narrative: Digestive issue; Loose stool; Dehydration; Dizziness; weight lost; Head ache; Chills; Whole body ache; This is a spontaneous report from a non-contactable consumer (patient, self-reporting). A 63-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: Er2613 and expiration date was not reported) via an unspecified route of administration in the left arm on 22Mar2021 at 14:45 (at the age of 63-years-old) as a dose 1, single for COVID-19 immunisation. Medical history included unspecified immunity deficiency (bad immune system), the patient was allergic to dairy (milk allergy) and codeine. Other medications that the patient received within two weeks of vaccination included magnesium, vitamin b-12(MANUFACTURER, K2 with D3, vit C and better bitters. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 26Mar2021, the patient experienced headache, chills, whole body ache, digestive issue, loose stool, dehydration, dizziness and weight loss and it was day four only very slight improvement. The patient underwent lab test procedures weight and result was lost on 26Mar2021. The clinical outcome of indigestion, loose stools, dehydration, dizziness, weight loss, headache, chills and general body pain was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Patient's "Age at Vaccination/Units" captured as "63 years" per vaccination date=22Mar2021 and DoB.  2. For History "allergies: Dairy": Coding updated from "Dairy intolerance" to "Milk allergy" per MedDRA.  3. For History "Bad immune system": Coding updated from "Unspecified immunity deficiency" to "Immune system disorder".  4. For "Past Drug Event": Reaction Coding updated from "Allergy" to "Drug allergy".  5. "weight" captured as Lab Data with Result "lost" and Test Date "26Mar2021".  6. No Drug Code for Con-Med "B-12" and "VIT C", coded out in Product tab.  7. Con-Med "K2 with D3" coded in tab as "D3 +K2".  8. For event "Digestive issue": Please review if need update the Coding from "Indigestion" to "Functional gastrointestinal disorder" per MedDRA.  9. Initial information need review: List of any other medications the patient received within 2 weeks of vaccination: Magnesium, B-12, K2 with D3, Vit C, Better Bitters
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Weight, Weight decreased
Clinical narrative: Digestive issue; Loose stool; Dehydration; Dizziness; weight lost; Head ache; Chills; Whole body ache; This is a spontaneous report from a non-contactable consumer (patient, self-reporting). A 63-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: Er2613 and expiration date was not reported) via an unspecified route of administration in the left arm on 22Mar2021 at 14:45 (at the age of 63-years-old) as a dose 1, single for COVID-19 immunisation. Medical history included unspecified immunity deficiency (bad immune system), the patient was allergic to dairy (milk allergy) and codeine. Other medications that the patient received within two weeks of vaccination included magnesium, vitamin b-12(MANUFACTURER, K2 with D3, vit C and better bitters. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 26Mar2021, the patient experienced headache, chills, whole body ache, digestive issue, loose stool, dehydration, dizziness and weight loss and it was day four only very slight improvement. The patient underwent lab test procedures weight and result was lost on 26Mar2021. The clinical outcome of indigestion, loose stools, dehydration, dizziness, weight loss, headache, chills and general body pain was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Patient's "Age at Vaccination/Units" captured as "63 years" per vaccination date=22Mar2021 and DoB.  2. For History "allergies: Dairy": Coding updated from "Dairy intolerance" to "Milk allergy" per MedDRA.  3. For History "Bad immune system": Coding updated from "Unspecified immunity deficiency" to "Immune system disorder".  4. For "Past Drug Event": Reaction Coding updated from "Allergy" to "Drug allergy".  5. "weight" captured as Lab Data with Result "lost" and Test Date "26Mar2021".  6. No Drug Code for Con-Med "B-12" and "VIT C", coded out in Product tab.  7. Con-Med "K2 with D3" coded in tab as "D3 +K2".  8. For event "Digestive issue": Please review if need update the Coding from "Indigestion" to "Functional gastrointestinal disorder" per MedDRA.  9. Initial information need review: List of any other medications the patient received within 2 weeks of vaccination: Magnesium, B-12, K2 with D3, Vit C, Better Bitters
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rashes on arm; itchiness on arm; This is a spontaneous report from a non-contactable consumer. A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via an unspecified route of administration in the arm on 20Mar2021 (at the age of 42-years-old), as asingle dose for COVID-19 immunisation. Medical history of the patient included diabetes. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021, after 9 days of vaccination, the patient developed rashes and itchiness on arm where vaccine was administered. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if the patient had received any treatment for the events. The clinical outcome of the events rashes and itchiness on arm were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Vaccination Facility Country  added, Narrative "This is a spontaneous report from a contactable consumer" updated to "This is a spontaneous report from a non-contactable consumer"; Final sentence updated to " No follow-up attempts are possible. No further information is expected".
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Hyperhidrosis, Nausea, Panic attack
Clinical narrative: Dizziness; Sweating; Shortness of breath; Nausea; Panic attack; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 27-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, in left arm on 30Mar2021 15:00 (Lot Number: ER8734), at the age of 27 years, as single dose for COVID-19 immunisation. The patient medical history was not reported. No known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. Patient did not receive any other medications in two weeks. On 30Mar2021 15:00, the patient experienced dizziness, sweating, shortness of breath, nausea and panic attack. The events were considered as non-serious. The events were not received treatment. The outcome of all the events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal mass, Pigmentation disorder
Clinical narrative: upper abdominal swelling after getting the first dose; mottling on abdomen after getting the first dose; abdomen was kind of lumpy after getting the first dose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3248), dose 1, via an intramuscular route, administered in Arm Left on 03Mar2021 (61-years- at the time of vaccination), as dose 1, single for covid-19 immunization. Medical history included Type 2 Diabetes from 2018 and ongoing. Concomitant medication included valsartan taken for high blood pressure from 2018 and ongoing; hydrochlorothiazide taken for Blood pressure high from 2017 and ongoing; aspirin [acetylsalicylic acid] taken for prophylaxis from 2015 and ongoing; vitamin d nos taken for Vitamin D low from 2016 and ongoing; calcium carbonate taken for absorption of Vitamin D from 2019 and ongoing. On 04Mar2021, the patient experienced, upper abdominal swelling after getting the first dose, mottling on abdomen after getting the first dose and abdomen was kind of lumpy after getting the first dose. Outcome of the event abdomen was kind of lumpy after getting the first dose was unknown, other events was recovered on 08Mar2021.  Additional Context: Caller received the second dose of the Covid-19 vaccine. She is reporting that she experienced side effects. She received the second dose on 23Mar2021. Caller is a Pfizer employee reporting on herself. Caller states she had a lot of the common ones other people have reported. She experienced foggy feeling, was flushed, jaw ache, headache, sore neck, eye pain, low grade fever, chills, muscle aches and fatigue. She started feeling foggy 15 minutes later after getting the vaccine. She received the first dose on 03Mar2021. Lot: EL3248. NDC is not provided. The card doesn't indicate the expiry but there is a date of Apr2021 on the card. Caller assumes this is the expiry. It was given intramuscular in the left arm. She adds that after the first dose she had upper abdominal swelling. This lasted for 4 days. She saw her doctor for this. Her abdomen was also mottled and kind of lumpy for lack of a better word.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia
Clinical narrative: muscle around elbow is tender and painful.; difficult to straighten; This is a spontaneous report from a contactable nurse. A non-pregnant female patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Batch/Lot Number: unknown), via an unspecified route of administration on an unknown date in Mar2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history and concomitant medications were not reported. Prior to the vaccination, it was unknown that the patient was diagnosed with COVID-19. Since the vaccination, it was unknown that the patient had been tested for COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021, the patient muscle around the elbow was tender, painful and difficult to straighten (muscle stiffness). It was unknown that the patient received any treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained  Amendment: This follow-up report is being submitted to amend previously reported information: Patient's country, vaccination facility country, best doctor or health care professional information were added and event onset date for AE "Difficult to straighten" was added in events tab.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Diarrhoea, Fatigue, Pyrexia
Clinical narrative: Diarrhea; Fever of roughly 38.5C; Mild tiredness; Loss of appetite; Mild injections site tenderness; This is a spontaneous report received from a contactable consumer, the patient. A 20-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8732) via an unspecified route of administrated on 26Mar2021 at 17:45 (at the age of 20-years-old) as a DOSE 1, SINGLE for COVID-19 immunisation. Medical history included COVID-19 from Dec2020 to unknown date. Concomitant medications were not reported. The patient had no known allergies to medications, food or other products. The patient did not received any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination the patient was diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. On 27March2021 at 15:00 the patient experienced Fever of roughly 38.5C, mild tiredness, loss of appetite and mild injections site tenderness and at 15:45 after 22 hours of the first dose of vaccine, the patient experienced diarrhea. All foods consumed within the timeframe were unassociated with incidents of diarrhea in the past, though not frequently consumed. These included rye and mushroom soup, neither of which are associated with allergies or intolerances. The patient stated that this was not to say that there was a definitive connection with the first dose of the vaccine, but a correlation was present. The patient did not received any treatment for the reported events. The patient underwent lab tests or procedure, which include body temperature on 27Mar2021 and tested with a temperature of 38.5C. The clinical outcome of the events diarrhea, fever, mild tiredness, loss of appetite and mild injections site tenderness were recovering.   No follow-up attempts are needed. No further information expected.  Amendment: This follow-up report is being submitted to amend previously reported information: The date for Lab data captured as: 27Mar2021, Narrative 'The patient underwent lab tests or procedure, which include body temperature on an unknown date and tested with a temperature of 38.5C' update as 'The patient underwent lab tests or procedure, which include body temperature on 27Mar2021 and tested with a temperature of 38.5C' and Dose description was updated in narrative.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Diarrhea; Fever of roughly 38.5C; Mild tiredness; Loss of appetite; Mild injections site tenderness; This is a spontaneous report received from a contactable consumer, the patient. A 20-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8732) via an unspecified route of administrated on 26Mar2021 at 17:45 (at the age of 20-years-old) as a DOSE 1, SINGLE for COVID-19 immunisation. Medical history included COVID-19 from Dec2020 to unknown date. Concomitant medications were not reported. The patient had no known allergies to medications, food or other products. The patient did not received any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination the patient was diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. On 27March2021 at 15:00 the patient experienced Fever of roughly 38.5C, mild tiredness, loss of appetite and mild injections site tenderness and at 15:45 after 22 hours of the first dose of vaccine, the patient experienced diarrhea. All foods consumed within the timeframe were unassociated with incidents of diarrhea in the past, though not frequently consumed. These included rye and mushroom soup, neither of which are associated with allergies or intolerances. The patient stated that this was not to say that there was a definitive connection with the first dose of the vaccine, but a correlation was present. The patient did not received any treatment for the reported events. The patient underwent lab tests or procedure, which include body temperature on 27Mar2021 and tested with a temperature of 38.5C. The clinical outcome of the events diarrhea, fever, mild tiredness, loss of appetite and mild injections site tenderness were recovering.   No follow-up attempts are needed. No further information expected.  Amendment: This follow-up report is being submitted to amend previously reported information: The date for Lab data captured as: 27Mar2021, Narrative 'The patient underwent lab tests or procedure, which include body temperature on an unknown date and tested with a temperature of 38.5C' update as 'The patient underwent lab tests or procedure, which include body temperature on 27Mar2021 and tested with a temperature of 38.5C' and Dose description was updated in narrative.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Lethargy, Pain, Vaccination site pain
Clinical narrative: Body aches (across entire body); Chills; Sore arm where injected; Lethargy/ need to sleep; This is a spontaneous report from a contactable consumer. A 47-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN) on 29Mar2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. It is unknown, if the patient received any other vaccines within four weeks prior to the COVID-19 vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN) on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it is unknown if the patient got tested for COVID-19.  On 30Mar2021 at 06:00, the patient experienced body aches (across entire body), chills, sore arm where injected and lethargy/ need to sleep. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of body aches, chills, sore arm and lethargy.  The clinical outcome of the events body aches, chills, sore arm where injected and lethargy was recovered on an unknown date in Mar2021.  No follow-up attempts are needed; information about lot/ batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: reporter reported for brother, patient name removed from reporter tab, and reporter address detail removed from patient tab.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash macular
Clinical narrative: Rash on legs and arms mainly; Noticed some spots on arms; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: Unknown), via an unspecified route of administration on 20Mar2021 at 13:30 (at the age of 47-year-old), as dose 1, single in left arm for COVID-19 immunisation. The patient's medical history was not reported. Patient had no known allergies. Concomitant medications received within 2 weeks of vaccination included bupropion hydrochloride (WELLBUTRIN); vilazodone hydrochloride (VIIBRYD); and amfetamine aspartate, amfetamine sulfate, dexamefetamine saccharate and dexamefetamine sulfate (ADDERALL); taken for unspecified indications, start and stop dates were not reported. It was reported that the patient was getting COVID test if possible. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Mar2021, 6 days, 10 hours and 30 minutes after the administration of first dose of vaccine, the patient experienced rash on legs and arms and mainly noticed some spots on arms (spot-like rash) in the evening and really spread on Tuesday and today (day of the report). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The patient had no COVID prior vaccination and unknown whether the patient was tested COVID post vaccination. The clinical outcome of the event rash on legs and arms and spots on arms was not resolved at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: "Relevant Med History: None" removed since not clearly reported this in source.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: fatigue; nausea; This is a spontaneous report from a non-contactable consumer. A 74-years-old male patient received a dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on an unknown date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Medical history and concomitant medication were not reported. It was unknown whether the patient has received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if prior to vaccination, the patient was diagnosed with COVID-19. It was unknown since the vaccination, if the patient had COVID-19 test. On an unknown patient experienced fatigue and some nausea for 2 days and was back to normal. It was unknown whether the patient received any treatment for the adverse events. The clinical outcome of the events was recovered on unspecified date (reported as back to normal).   No follow-up attempts are possible; information about lot number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Primary reporter name was added. VAERS Primary reporter Addl Qualification updated as patient per source. Patient's first name updated. The outcome of events was updated as recovered per source.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Intermenstrual bleeding, Lymphadenopathy
Clinical narrative: Breakthrough bleeding while on birth control; Daughter also had swollen lymph nodes, under her arm; Exposure to Sars-CoV-2 at work; This is a spontaneous report from a contactable consumer (patient mother). A female patient of an age 27 (unspecified age units) received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE, second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Patient concomitant medications included unspecified birth control pills; start date and stop date were not reported. This report was not related to a study or programme. Reason for no lot number of Covid-19 vaccine was stated as Caller unwilling to complete the report. The patient experienced breakthrough bleeding while on birth control, also had swollen lymph nodes, under her arm, exposure to sars-cov-2 at work on an unspecified date. Caller reported that patient received the Pfizer-Biontech Covid19 vaccine. Then, 2 weeks afterward, she had breakthrough bleeding, even though she was taking birth control pills. Daughter also had swollen lymph nodes, under her arm. In response, reporter was informed that no information was available from the clinical trials regarding effects on menstruation. Lymphadenopathy was a commonly reported AE. Caller reports that patient was a pharmacist and fully vaccinated with the Pfizer-Biontech Covid19 vaccine, recently had an exposure to Sars-CoV-2 at work. All the technicians that she worked with got Sars-CoV-2, and since she was vaccinated, she did not get it. Caller stated that was good news, it must work. In response, provided efficacy data from the fact sheet. Caller stated that patient had both doses of the Covid-19 vaccine. And was on birth control and experienced breakthrough bleeding, swollen lymph nodes. When caller was asked if she would be willing to complete a safety report on the patient, the caller replied that it was up to the patient to report her experience. Caller reported that the patient was a pharmacist, and she did not want to impede on her privacy. Caller reported that the patient went to the doctor for the lymph node thing and the patient's physician instructed the patient to just put a warm compress on her lymph nodes and that the swelling was just from irritation. Caller reported that her physician when told of the patients swollen lymph nodes said, "no we are seeing that". The events were reported as not serious. Clinical outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Muscle fatigue, Pyrexia, Somnolence
Clinical narrative: Woke up with strong shivers, hard jawquivering; 103 degree fever; extreme muscle fatigue; Slept a full day; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old non pregnant female patient received the unknown dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA vaccine, lot no: unknown) via unspecified route of administration on 27Mar2021 at 14:30 (at the age of 23-years-old) as a Dose number Unknown, Single for COVID-19 immunization. The medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Mar2021, at 03:00, the patient had woken up with strong shivers, hard jaw quivering, 103-degree fever, extreme muscle fatigue and had slept a full day. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as the result of adverse events. The patient underwent lab tests and procedures that included Body temperature of 103 degree. The clinical outcome of the events shivers, hard jaw quivering, fever, muscle fatigue and sleepy were recovered/resolved on an unknown date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Vaccination Facility Country added; 2. 103 degree fever added as lab data.