chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: feeling discomfotable at the injection site; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer, the female patient of an unspecified age received BNT162B2 (Comirnaty) via an unspecified route of administration on 05Feb2021 (Batch/Lot number: UNKNOWN) as single dose for covid-19 immunisation. The patient medical history and concomitant medication was not reported. The patient had the vaccine this morning and was feeling discomfortable at the injection site on an unspecified date and wanting to know what pain relievers she can take. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Vaccination site pain
Clinical narrative: Pain/pain in the right arm/most severe pain patient had ever had; patient would say 30 times worse than any fly shot for example; Pain into shoulder area, deltoid muscle nearly totally paralyzed; pain down arm to elbow; This is a spontaneous report from a contactable Physician (patient). A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9263; expiration date: unknown), via an unspecified route of administration on right arm on 21Jan2021 at 14:30 (02:30 PM) at the age of 77 years old at a single dose for COVID-19 immunisation. Medical history included S/P CABG in 2015, S/P ruptured appdx in 2007. He was asymptomatic, major operations (laparotomy and open-heart surgery) and a retired surgeon. He was still solo skydiving from 14,000 feet with no problems. Allergies were none. Concomitant medications included losartan, metoprolol, vit D (ergocalciferol), aspirin (acetylsalicylic acid) and lipitor (atorvaostatin). It was reported that no problems at all until approximately 10 hours post injection. The most severe pain patient had ever had; patient would say 30 times worse than any fly shot for example. Pain into shoulder area, deltoid muscle nearly totally paralyzed, pain down arm to elbow. Got one hour of sleep that night. Amazingly, at about 11 a.m. the next morning while still in severe pain (R arm) all symptoms immediately disappeared. Like a switch was thrown. Two major operations in patient life (laparotomy and open heart surgery) and patient also a retired surgeon. Patient was not exaggerating the degree of this pain in the right arm. Have felt great ever since and would get Shot # 2 tomorrow. The events onset date reported as 21Jan2021 11:30 PM. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. No treatment received for the events. The patient recovered from all the events on an unspecified date in 2021.; Sender's Comments: Based on temporal association and known vaccine safety profile, the reported events are assessed as related to BNT162B2 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Pain in extremity, Peripheral swelling
Clinical narrative: sore left arm, little bit swollen; sore left arm, little bit swollen; covid vaccine in the bicep area/vaccine very low in the arm (into the bicep) and not the deltoid; This is a spontaneous report from a contactable other hcp (Nurse). A 76-years-old male patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm on an unspecified date (Batch/Lot Number: EM9809) as 0.3 mL, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously received first dose of bnt162b2 (Lot: EL3249) via intramuscular in left deltoid on 18Jan2021, unknown time as single dose for covid-19 immunisation. On 08Feb2021, covid vaccine was administered in the bicep area/vaccine very low in the arm (into the bicep) and not the deltoid and on 09Feb2021, sore left arm, little bit swollen. Clinical course of the events includes, someone at a vaccine clinic, the second dose of the covid vaccine was administered very low in the arm. States the injection probably did not go into the deltoid, probably went in the bicep. She is asking if the injection would need to be repeated. She wants to know if the vaccines will need to be repeated. She also had a sore left arm and it was little bit swollen which started on the morning of 09Feb2021. The outcome for the event covid vaccine in the bicep area/vaccine very low in the arm (into the bicep) and not the deltoid was unknown and for the events sore left arm, little bit swollen was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: after receiving their vaccine, they have contracted the Covid-19 infection; after receiving their vaccine, they have contracted the Covid-19 infection; This is a spontaneous report from a contactable pharmacist via medical information team. A patient of unspecified age and gender received first dose BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. After receiving their vaccine, the patient experienced contracted with the covid-19 infection an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: they have contracted the covid-19 infection. Outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the events drug ineffective and COVID 19 are possibly related to BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Mouth swelling, Oral pain, Pain in extremity, Tenderness
Clinical narrative: Left arm got tender/Tenderness and redness in arm; Left arm got tender/Tenderness and redness in arm; Tenderness and redness in arm; mouth felt a bit funny and started to swell; mouth felt a bit funny and started to swell; This is a spontaneous report from a contactable consumer (patient). This 78-year-old female consumer A 78-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown, Expiration Date: Unknown) via an unspecified route of administration in left arm on an unspecified date as a single dose for covid-19 immunization. Medical history included allergic reaction to eating shellfish and Allergic to Sulfa. The patient's concomitant medications were not reported. The patient experienced left arm got tender/tenderness and redness in arm, nose got red, tenderness and redness in arm, mouth felt a bit funny and started to swell, mouth felt a bit funny and started to swell. The reporter has said that She just had the first shot on Tuesday at around 11. She was fine and just had tenderness in arm. She had nothing else except today around noon, she noticed her nose was red and around the area of the nose and it just felt like there could be swelling, but it is not. The arm is not swollen, it is just red. The outcome of the event was unknown
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive diagnosis for COVID-19; positive diagnosis for COVID-19; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 34-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 18Dec2020 as single dose and second dose (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 08Jan2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 11Feb2021, the patient had positive diagnosis for covid-19. The patient underwent lab tests which included sars-cov-2 test: positive on 11Feb2021. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure / COVID-19 cannot be ruled out.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid vaccine after receiving the first dose of vaccine; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 55-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 01Feb2021 (Batch/Lot Number: EL9265) as SINGLE DOSE for covid-19 immunisation. There was no patient medical history. There were no concomitant medications. The patient stated that on 01Feb2021 that she had her first vaccine and on 08Feb2021 tested positive for Covid. Stated that she is supposed to go back on 22Feb2021 for her second dose. Stated that she was told that she could go back to work. She wanted to know if she could get a second dose or if it was a waste of time. It was reported that the 2nd dose is scheduled on 22Feb2021. Caller said she tested positive for Covid after 1st dose. She can go back to work on 18Feb2021. Caller is asking if she can take the 2nd dose on the 22nd. It was reported that the reason why the patient took Pfizer Covid vaccine was school teacher so symptoms are lighter for Covid. Stated that she went through the health department. Outcome of the event was unknown.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test positive
Clinical narrative: This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The physician stated that the Covid Vaccine is not listed above, the physician has had patients who received 2 doses of the COVID vaccine, waited 2 weeks and went to a lab to get the Sar's Covid antibody serum test. One was positive for antibodies, one negative. Based on what I read the MRNA technology should not give an antibody positive test unless someone was exposed to the virus. The physician wanted to know whether the COVID vaccine would induce a positive Sar's antibody test. Outcome of the event was unknown. Information about Batch/Lot number has been requested.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Afib; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 22Mar2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer, the patient. An 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in Arm on 30Jan2021 at 11:30 (Batch/Lot number: EL9265 and Expiration date: Jan2021) (at the age of 87-years-old) and dose 2 intramuscular, administered in Arm on 27Feb2021 at 13:30 (Batch/Lot number: EN6205 and Expiration date: 27Feb2021); both as single dose for covid-19 immunization. Medical history included none. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On an unspecified date in 2021, the patient experienced Afib (Atrial fibrillation). Lab tests was none. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing
Clinical narrative: whole body flushing; light headed; This is a Spontaneous report from a Contactable Pharmacist. This 67-year-old female pharmacist reported that she received bnt162b2 (BNT162B2, solution for injection), dose 2 intramuscular, administered in Arm Left on 10Feb2021 10:00 (Batch/Lot Number: EM9810) as SINGLE DOSE for covid-19 immunisation. Medical history included hypertension, blood cholesterol increased, asthma, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included losartan (LOSARTAN); fluoxetine hydrochloride (PROZAC); cyanocobalamin (B12 [CYANOCOBALAMIN]); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE; magnesium (MAGNESIUM); atorvastatin (LIPITOR [ATORVASTATIN]) and colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. On 10Feb2021 the patient experienced whole body flushing and light headed. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the event was reported as unknown.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain
Clinical narrative: Headache; muscle aches in neck and shoulders; aches all over; This is a spontaneous report received from a contactable consumer. A 72-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Formulation: Solution for injection, Batch/Lot number was EL9265), via an unspecified route of administration, administered in Arm Right on 02Feb2021 13:00 at single dose for covid-19 immunization. Medical history included hypertension. Concomitant medication included losartan; atenolol taken for an unspecified indication, start and stop date were not reported.  The patient experienced headache on 02Feb2021 19:00, muscle aches in neck and shoulders on, aches all over. The outcome of events is not recovered.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19 after receiving the first dose; This is a spontaneous report from a sponsored program. A contactable consumer reported that, A female patient of an unspecified age received first dose of BNT162B2 (solution for injection) via an unspecified route of administration on 08Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced covid -19 positive after receiving the first dose on 11Feb2021 with outcome of unknown. The patient underwent lab tests which included sars-cov-2 test: tested positive for covid-19 on 11Feb2021 after her second dose. The patient was supposed to get the second dose on 01Mar2021. she enquired if she should get the second dose or wait? Will it hurt her The outcome of the event was unknown.  Follow-up information was received on 15-Feb-2021: follow-up information was received from a contactable consumer. No new medically significant information was received.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: 2nd dose of the vaccine on 11Feb2021 but tested positive today for COVID/tested positive for covid virus; 2nd dose of the vaccine on 11Feb2021 but tested positive today for COVID/tested positive for covid virus; This is a spontaneous report from Pfizer sponsored program COVAX US Support. A contactable consumer reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Feb2021 as a single dose for COVID-19 immunization.The patient medical history and concomitant medications were not reported. The patient historical vaccine includes BNT162B2 (1st dose) for COVID immunization. It was reported that patient had 2nd dose of covid vaccine 11Feb2021. Had tested positive for covid virus today. Also received infusion after testing positive. Wants to know shouldn't they have waited to give dad infusion. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on 16Feb2021 tested positive today for COVID. The action taken in response to the event(s) for bnt162b2 was not applicable. Therapeutic measures were taken as a result of event. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: violent shaking of all limbs / shaking so hard; This is a spontaneous report from a contactable consumer. A 74-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on the left arm on 26Jan2021 at 12:30 PM at the age of 74 years old at a single dose for COVID-19 immunisation at nursing home. Medical history included hypertension, osteoporosis and spinal stenosis. Concomitant medications included hydrocodone bitartrate, paracetamol (HYDROCODONE/ACETAMINOPHEN) 5/325 mg, clonidine hcl. The patient previously took fluconazole, sulfamethoxazole, clindamycin and experienced allergies. Patient reported that patient fell asleep in chair after dinner 2-3 nights after vaccination was awakened by violent shaking of all limbs / shaking so hard on 28Jan2021 at 21:00 (09:00 PM) that her head and arm banged hard against the table almost fell out of the chair. She was awake but could not stop the shaking as though dreaming yet saw herself violently shaking as if in an earthquake lasted a full minute before completely waking no problems only being weirded out was told to report this incident by staff administering her second dose of vaccine. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. No treatment received for the event. The patient recovered from the event on an unspecified date in 2021.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Drug ineffective, Dysgeusia
Clinical narrative: the vaccine does not seem to be working like the first one; arthritic pains; A medicine taste in her mouth which appeared about 1 minute or so after receiving the 2nd shot of the vaccine.; This is a spontaneous report from a contactable consumer (patient). A 90-year-old female patient received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9269), via an unspecified route of administration in left upper arm on 12Feb2021 as single dose for COVID-19 immunisation. Medical history included arthritis. The patient previously took the first dose of bnt162b2 () for COVID-19 immunization. Concomitant medications were not reported. On 12Feb2021, the patient experienced a medicine taste in her mouth which appeared about 1 minute or so after receiving the 2nd shot of the vaccine and soreness at the injection site. She stated that she felt the arthritic pains more after the 2nd shot than the 1st shot. The 1st shot felt good and cleared up her sinuses. On 12Feb2021, the patient experienced does not seem to be working like the first one. The patient reported that with the first one she did not feel as bad and it is taking her longer to get over the second shot. The patient stated that with the first dose, her sinuses and her joint pain cleared up faster. The patient reported that her symptoms seem to be a little bit better on the day of reporting. She clarified that she got over her symptoms faster last time. Her left ear feels clogged up and it cleared up faster with the initial shot. She has arthritis on her right side with her hips and shoulder and stated that the joint pain is still there. It is still quite sore. On 12Feb2021, the outcome of the event a medicine taste in her mouth which appeared about 1 minute or so after receiving the 2nd shot of the vaccine was recovered and was unknown for the rest of the events.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: A staff member contacted them about one of the staff that got COVID after receiving the vaccine; A staff member contacted them about one of the staff that got COVID after receiving the vaccine; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 21Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified a staff member contacted them about one of the staff that got COVID after receiving the vaccine. Now there was an out break at the facility. Residents and staff have tested positive for COVID. Some people have COVID symptoms, and some are asymptomatic. They were due for the second dose 11Feb 2021. She was wondering how to approach the facility getting the second vaccine. I was questioned that if they were asymptomatic should they get the second dose, or wait until they are negative. She just wanted to know what to do now for the second dose. Even the people with symptoms when should they get the second dose. Outcome of the events were unknown.  Information on the lot/batch number has been requested; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and Suspected COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Toothache, X-ray
Clinical narrative: Toothache was reported as worsened; Toothache; This is a spontaneous report from a contactable consumer (patient). A 75-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration, administered in Arm Left on 31Jan2021 09:30 (Batch/Lot Number: EL9265; Expiration Date: 31May2021) as single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced toothache on 01Feb2021 07:00 and toothache was reported as worsened on an unspecified date. The reporter stated that the dentist did an X-ray on Feb2021 and oral evaluation. Was told to go get a bite because he may be grinding his teeth. Stated that he got the bite thing and it does not seem to be helping. The outcome of the event Toothache was reported as not recovered and other event was reported as unknown.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Pruritus, Rash, Swelling
Clinical narrative: around her neck looks swollen; rash on neck is brown; itchy; worried; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: Unknown, Expiry Date: Unknown) via an unspecified route of administration on 23Jan2021 (at the age of 84-years-old) at single dose for COVID-19 immunisation. Patient's medical history included heart troubles. Patient's concomitant medication was heart medication. The patient experienced around her neck looks swollen, rash on neck is brown on 03Feb2021 and it was still ongoing and itchy, worried on an unspecified date. Patient stated she read information about a rash all over the body after the COVID vaccine. She has had none of the side effects. She read about severe allergic reactions. She does have a history or heart troubles. She was washing her hair on Wednesday, and she noticed around her neck it looked swollen. Like a little band around her neck. It could have been there before the vaccine. She called her doctor that same day and she said to call Pfizer, and that she thinks she should cancel the second one. She got her first COVID vaccine on 23Jan2021, and she is scheduled for the second 13Feb2021. She does take a heart medication. The place on her neck is not itchy. She knows the vaccine could cause a severe allergic reaction. She sees her dermatologist for Basal cells and other things that are itchy. This place on her neck, if it is a rash, is brown not red. She gets a lot of those places on her skin. Her doctor told her to call Pfizer and then cancel her second appointment. She just wants to speak to medical information first. She doesn't even know if it is a rash. She hasn't had any side effects. Her arm didn't even hurt. This little rash is only on her neck. She had worked as a dental assistant. She is just worried now about getting the second shot. The outcome of event for itchy and worried was unknown and for other events it was not recovered.  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: 'had her second dose of the covid-19 vaccine on 05Feb2021 and tested positive for covid-19 on 10Feb2021'; 'had her second dose of the covid-19 vaccine on 05Feb2021 and tested positive for covid-19 on 10Feb2021'; This is a spontaneous report from a contactable consumer received from Pfizer sponsored program Pfizer First Connect. A female patient of an unspecified age received the second dose of BNT162B2 (Covid-19 Vaccine, solution for injection) via an unspecified route of administration on 05Feb2021 as a single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Swap from IBCC - Caller had her second dose of covid-19 vaccine on and tested positive for covid-19 on 10Feb2021, relayed PMI number for future reference, transferred, relayed long hold time, will fax AE/PCOM, Pfizer First Connectd cep id 2191. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Nausea, Pain in extremity, SARS-CoV-2 test negative
Clinical narrative: second dose produced sore arm, nausea and a headache; second dose produced sore arm, nausea and a headache; second dose produced sore arm, nausea and a headache; This is a spontaneous report from a contactable Nurse. A 33-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number EJ1485), via an intramuscular route of administration, anatomical location Arm left Deltoid left On 12Jan2021 12:55 at single dose for Covid-19 immunization. The patient medical history included HSV I Onset date 01Apr2008 Ongoing outbreaks 6xyear, exacerbated with viral infection, Onset date: 05Apr2020 no change in breastfeeding frequency or output, on 19Dec2020 Viral illness, sore throat, congestion. 23Dec2020 05:00 soreness, headache, myalgias fatigue. The patient historic vaccine include first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number EJ1685, Expiration Date: unknown), via an intramuscular route of administration, On 22Dec2020 at single dose for COVID-19 immunization. Concomitant medication included Prenatal vitamin DHA Start date: 03Aug2019 Indication: dietary supplement, ibuprofen 200-400mg 12Jan2021 Indication: Body aches, Tylenol 500mg Indication: headaches. The patient experienced second dose produced sore arm, nausea and a headache. Vaccination facility type, at Hospital. On 21Dec2021, the patient underwent lab test SARS-CoV-2 test Nasal Swab result-negative. The outcome of event was recovering.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Exposure via breast milk, Headache, Nausea, Pain in extremity, SARS-CoV-2 test negative
Clinical narrative: second dose produced sore arm, nausea and a headache; second dose produced sore arm, nausea and a headache; second dose produced sore arm, nausea and a headache; This is a spontaneous report from a contactable Nurse. A 33-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number EJ1485), via an intramuscular route of administration, anatomical location Arm left Deltoid left On 12Jan2021 12:55 at single dose for Covid-19 immunization. The patient medical history included HSV I Onset date 01Apr2008 Ongoing outbreaks 6xyear, exacerbated with viral infection, Onset date: 05Apr2020 no change in breastfeeding frequency or output, on 19Dec2020 Viral illness, sore throat, congestion. 23Dec2020 05:00 soreness, headache, myalgias fatigue. The patient historic vaccine include first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number EJ1685, Expiration Date: unknown), via an intramuscular route of administration, On 22Dec2020 at single dose for COVID-19 immunization. Concomitant medication included Prenatal vitamin DHA Start date: 03Aug2019 Indication: dietary supplement, ibuprofen 200-400mg 12Jan2021 Indication: Body aches, Tylenol 500mg Indication: headaches. The patient experienced second dose produced sore arm, nausea and a headache. Vaccination facility type, at Hospital. On 21Dec2021, the patient underwent lab test SARS-CoV-2 test Nasal Swab result-negative. The outcome of event was recovering.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got Covid Virus after receiving her 1st dose of Covid Vaccine; got Covid Virus after receiving her 1st dose of Covid Vaccine; This is a spontaneous report from a contactable consumer or other non hcp (Patient) from a Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient got covid virus after receiving her 1st dose of covid vaccine on an unspecified date. Her 2nd dose of the Vaccine schedule is due this week (as reported). She wanted to know if she can take that, or she should wait 90 days. The patient underwent lab tests and procedures which included sars-cov-2 test: got covid virus on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymph node pain
Clinical narrative: This is a spontaneous report from a contactable consumer. A 65-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number, Expiration date: unknown) via an unspecified route of administration on 16Feb2021 02:00 on left arm at single dose for COVID-19 Immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 14:30 PM, anatomical location was left arm. The patient's medical history included Migraines. Concomitant medication included Prempro. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Feb2021 10:00 PM patient experienced Lymph nodes in left armpit swollen and painful, on day 2 of second vaccination patient had small headache and very tired. The outcome for the events saw recovering at the time of report. No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Enlarged/ painful axillary lymph node of same side as injection site; Enlarged/ painful axillary lymph node of same side as injection site; This is a spontaneous report from a contactable Nurse. A 46-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 12Feb2021 08:30 (Batch/Lot Number: EL9265) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took fist dose of BNT162B2 (Lot no: EH9899), on 21Jan2021, 09:30 AM Left arm at single dose for Covid-19 Immunization. It was reported that on 12Feb2021 11:00 AM patient experienced Enlarged/ painful axillary lymph node of same side as injection site. There was no covid prior vaccination, there was no covid test post vaccination. Outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: pain from the elbow to shoulder; pain from the elbow to shoulder; This is a spontaneous report from a contactable consumer or other non hcp. A 90-decade-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 30Jan2021 14:00 (Batch/Lot number was not reported) as single dose for COVID-19 Immunisation. The patient's medical history and concomitant medications were not reported. In jan2021, the patient experienced pain from the elbow to shoulder. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: superficial arm pain; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received second dose BNT162B2 (Comirnaty, Formulation: solution for injection), dose 2 via an unspecified route of administration on 30Jan2021 as single dose for covid-19 immunisation. The patient medical history included historical vaccine BNT162B2 at the time of her first dose she was just starting increasing her amantadine dosage for neurological tremor control, per physician instructions, at that time of increase from two to three tablets a day, she accidentally took a fourth dose, at that time at which the COVID vaccination and increase in amantadine dosage occurred together, she quickly developed dramatic instability and fell four or five times, subsequently (about 2 weeks later), she commenced weaning off of amantadine. she is just now down to one tablet a day, and her condition is steadily improving. physician attributes this to weaning off of amantadine, and all of us believe that the pfizer vaccination had nothing to do with the dizziness and falling, and that amantadine was the cause and also had an asymptomatic UTI for which she took a round of Cipro. UTI's can, we are told, cause instability and apparently more so in older people. So this is another conceivable cause. Notably, the second Pfizer vaccination occurred while these other conditions were being addressed and the vaccination did nothing to exacerbate or reinvigorate the dizziness symptoms. The concomitant medication were not reported. The patient experienced superficial arm pain on an unspecified date with outcome of recovered on an unspecified date.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid after receiving first Covid-19 vaccine; Tested positive for Covid after receiving first Covid-19 vaccine/low grade fever; This is a spontaneous report from a contactable consumer. A 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL8982, Expiration date: 20May2021), via an unspecified route of administration, administered in Arm Right on 23Jan2021 14:00 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient had got the vaccine, then 16 days later got symptoms of Covid, then on the 17th day, tested positive for Covid and this was after the first dose of the vaccine. He had a low grade fever on 10Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 10Feb2021. The outcome of the events was unknown.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Eye swelling, Fluid retention, Hyperhidrosis, Rash macular
Clinical narrative: This is a spontaneous report from a contactable consumer. A 64-year-old male patient received the second dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number unknown, Expiration Date: unknown),via an unspecified route of administration on Arm Right On 02Feb2021 01:00 at single dose for COVID-19 immunization. The patient historic vaccine include second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number unknown, Expiration Date: unknown), via an unspecified route of administration, On Jan2021at single dose for COVID-19 immunization. concomitant medication was not reported. On 04Feb2021 patient experienced swelling under armpit a little larger than an egg, fluid went into his chest and back, red blotches on chest and back, event recovered on 06Feb2021. On 07Feb2021 patient experienced swelling in face primarily around the eyes(ongoing), face was as red as a beet as if he had a sunburn (ongoing). Patient took treatment Benadryl. The first dose was 21 days exactly prior to the second Vaccination. Vaccination Facility Type at Hospital. The outcome of swelling under armpit a little larger than an egg, fluid went into his chest and back, red blotches on chest and back, event was recovered on 06Feb2021 and red as a beet as if he had a sunburn, event eye swelling, erythema Recovering. Information on the lot/batch number has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node in left armpit; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EM9810, Expiration date unknown), via an unspecified route of administration, anatomical location- Left Arm on 05Feb2021, at single dose for Covid-19 immunization. Patient received first  dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EL8982, Expiration date unknown), via an unspecified route of administration, anatomical location- Left Arm on 15Jan2021 03:30 PM , at single dose for Covid-19 immunization. The patient medical history included allergies: lime, Benign prostatic hyperplasia (BPH), arthritis, microhematuria Concomitant medication include terazosin, Finasteride, supplements. On Feb2021 patient experience swollen lymph node in left armpit patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient did not receive any treatment for the event Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not tested for COVID-19. The outcome of event was not recovered.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pyrexia, SARS-CoV-2 test
Clinical narrative: slight fever; Felt little poorly for 24 hours; This is a spontaneous report from a contactable consumer. A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 20Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced slight fever and felt little poorly for 24 hours on an unspecified date. It was reported that patient had the COVID second dose vaccine on Tuesday and you know the first dose patient did not have significant side effect, patient had slight fever and just felt little poorly for 24 hours but the second dose has been quite doozy, patient had experienced the high fever for 2 days, vomiting and nausea and the vomiting stopped 24 hours ago but still have significant nausea and a headache that is from 1 to 10 it's a 9 and patient had it for you know, It started about 24 hours after patient took the vaccine, her question was you know, when she reached out to her doctor and she had me take a COVID test because she have not heard the vomiting and you know nausea to be one of the common side effects of the COVID Vaccine so I took a COVID test yesterday, and she got it back this morning and it is negative so thank god she didn't have that but she was wondering how, A was the nausea, vomiting and the severe headaches normal if so how long can she expect these symptoms to occur and is there anything she can do, can she take something for this, she had been very reluctant to take anything because they, you know she hear that you did not want to take things because you want to immune, you want to immune system it to work. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 12Feb2021. Outcome of the event slight fever was recovering and outcome of the other event was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Insomnia, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer. A 52-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in arm left on 17Feb2021 at 10:30AM as a single dose for COVID-19 immunization. Medical history included Known allergies: Penicillin. Concomitant medications included plecanatide (TRULANCE) for an unspecified indication. Historical drug included BNT162B2 on 20Jan2021 at10:30 AM. The patient experienced Arm/shoulder pain - diminished mostly after 4 days, "Foggy" thinking. Shoulder pain is worse at night, difficult to sleep, Six days after vaccine, still "foggy." Not just sleepy from lack of sleep on 17Feb2021 at 2:00. Taking oral steroids and it is improving. The patient has said that It worsened for a couple days, then started to get better after about 4 days. Then it started worsening probably on 22Feb2021. Patient went to the doctor 26Feb2021. Seems the inflammation went into my rotator cuff. Taking oral steroids and it is improving. The outcome of event was recovering. Information on the lot/batch number has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID 19 today; tested positive for COVID 19 today; This is a spontaneous report from a contactable consumer (patient's son). A 71-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: Unknown, Expiry Date: Unknown) via an unspecified route of administration on 11Feb2021 at single dose for COVID-19 immunisation. Patient previously took BNT162B2 in Jan2021 for COVID-19 immunization. There was no additional vaccines administered on same date of the suspect. There was no prior vaccinations (within 4 weeks). The patient medical history and concomitant medications were not reported. On 16Feb2021, the patient experienced tested positive for covid 19 today.The reporter father tested positive for COVID 19 today. The doctor recommended a Bamlanivimab infusion which is a new agency authorized drug. The caller thought that  it was recommended to wait 2 weeks before an infusion treatment. Is that true? He just wanted more information on how to proceed. There are no studies on the drug because it is something very new. The doctor probably wants his dad to start the infusion because of age and comorbidities, but if it was recommended to wait two weeks the caller would like to know. The reporter doesn't know the lot numbers or anything for his father vaccines. There was no visit of emergency room and physician office. The patient underwent lab tests and procedures which included COVID 19 test positive on 16Feb2021. The outcome of event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: In the recovery time frame my wife contracted covid and also tested positive; In the recovery time frame my wife contracted covid and also tested positive; This is a spontaneous report from a contactable physician. A female patient (Wife) of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on unspecified date in Jan2021as single dose for COVID-19 immunization. The patient 's medical history and concomitant medications were not reported. She was recently tested positive for COVID-19 infection on an unspecified date and have since recovered. In the recovery time frame she contracted COVID-19 infection and also tested positive on unspecified date. Reporter does not know if needs to be concerned about as patient case is extremely rare. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on unspecified date. The outcome of events was unknown.  Information about lot/batch number is requested.; Sender's Comments: The efficacy of a drugs and vaccines varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported events drug ineffective and COVID 19 infection cannot be ruled out.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Pain, Pain in extremity
Clinical narrative: Had pain in her arm at first; Now has severe bloating and pain; Now has severe bloating and pain; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) and another consumer (patient's husband) reported that a 73-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) at the age of 73-year-old as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received first covid vaccine shot. Had pain in her arm at first. Now had severe bloating and pain. The outcome of the events was unknown.  Information on the lot/batch number has been requested.