chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Streptococcus test, Throat lesion, Tongue blistering
Clinical narrative: Night sweats; little shortness of breath; white dots on back of throat; Throat pain; bunch of bumps on the back of her tongue/throat; little cough; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number EL3248) via an unspecified route of administration in left arm on 12Jan2021 as unknown, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was also reported that on 12Jan2021 patient took the Pfizer COVID vaccine and 3 days later i.e., on 15Jan2021, she had night sweats and a little shortness of breath, like upstairs, or if she runs too fast, or talks too much, that was pretty much for two weeks now, then the last 2 days she had white dots, white dots in the back of her throat, and she went to urgent care and it was negative for strep, she was prone to strep. They said it was not strep, she was having throat pain, and now that morning, she had a bunch of bumps on the back of her tongue, and she was given Clindamycin, she wondered if the throat pain was related to the vaccine, she got tested for strep, and they said it was negative so now maybe it was related to the vaccine. Night sweats outcome: if she puts on a fleece blanket, which she loves to as she was always cold, but now she cannot unless she was waking up with a drenching sweat, and she did not sweat. She did not call about the sweats, since she thought she was 41, and it maybe that, but then with more thought it could be the vaccine. She did light jogs up and down stairs, she walked all over the hospital, and never got out of breath, and now she had to stop and breathe in deep. She had a little cough every now and then, and when she went to urgent care, because of the cough and her throat hurting, they did a COVID test, and it was negative. She told them she got vaccinated, they said they would still do the test, it was a rapid COVID, in the office strep and they put strep in the lab for 3 days. For white dots: her throat was hurting a while, and she looked with a flashlight and saw white dots, now states this was more than 3 days ago, the test took 3 days, so this was 4 or 5 days since she saw white dots. Last night, she did not see before the bumps in the back of her throat, she thought she had food in the back of her throat, she felt something there, and she looked at it with a flashlight and now she has bumps in the back of her throat, she tried to remove what was in the back of her throat. She did not see the white dots anymore, before the test came in, when they saw white dots. Treatment included clindamycin which was at home and she has not started. On an unspecified date in Jan2021, the patient underwent lab tests and procedures which included rapid COVID test and strep test with results of negative. The outcome of the events was unknown.  Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Skin lesion
Clinical narrative: previous Covid vaccine administration gave skin lesion; This is a spontaneous report from a contactable Other HCP (Nurse).   Nurse reported for A 50-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: El1284; Expiry date: unknown) intramuscularly administered in the left arm on 08Jan2021 at 10:30 as a single dose for COVID-19 immunization. The patient medical history concomitant medications were not reported. The patient did not have any other vaccines in four weeks. It was unknown if the patient had any other vaccines in two weeks. The patient did not have COVID prior to vaccination. COVID was not tested post vaccination. On an unspecified date in Jan2021, patient experienced skin lesion. Patient had not tested positive post vaccination. The patient did not receive any treatment. The clinical outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity, Pyrexia
Clinical narrative: sore back; sore arm; maybe a slight fever; This is a spontaneous report from a contactable other hcp. A 71-years-old female patient received bnt162b2 (BNT162B2; formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date (at the age of 71-years-old) as UNKNOWN, SINGLE for covid-19 immunization. On an unspecified date patient experienced a sore arm and back and maybe a slight fever from the vaccine. The outcome of the events was unknown.   Information on the lot/ batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Somnolence
Clinical narrative: sleepiness; weak; upset stomach; This is a spontaneous report from a contactable consumer or other non hcp.   A 65-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration in Arm Left on 18Jan2021 (Lot number and Expiry date was not reported) as 1st dose, single dose for COVID-19 immunisation (age at vaccination 65-years-old). Medical history included Penicillin allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. It was unknown if patient had COVID prior vaccination and unknown if COVID tested post vaccination. On 18Jan2021, the patient experienced sleepiness, weak and upset stomach for 4 days starting day of vaccination. Therapeutic measures not taken due to events. The outcome of the events was resolved (4 days starting day of vaccination) on 22Jan2021.  No follow-up attempts are possible, Information about batch/lot number cannot be obtained. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Lymphadenopathy
Clinical narrative: knots on both sides of her neck underneath her chin; two knots on neck under chin on either side was reported as worsened; This is a spontaneous report from a contactable consumer or other non hcp.   A 87-years-old female patient received BNT162B2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 22Jan2021 (Batch/Lot Number: EL8982) as 1st dose, single for covid-19 immunisation.  Medical history included a lung problem, and a pacemaker, diagnosed a good while ago, no details provided. Has had pacemaker for about 8 or 9 years. There were no concomitant medications. On 29Jan2021, the patient experienced knots on both sides of her neck underneath her chin, two knots on neck under chin on either side was reported as worsened. The patient stated that "she can press on the knots and they can push down". Caller stated she had the Covid shot on 22Jan2021, stated that on Friday she started to get these knots on both sides underneath her chin on her neck, they are like good sized knots, wondered if that could have anything to do with the vaccine. States she tried to get to her regular doctor today but it snowed and they were closed today. Caller was encouraged to reach out to them when they are open. States she can press on the knots and they can push down. She stated that she read the vaccine could cause swollen lymph nodes.The events were considered as non serious. The outcome of the events were not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: swelling causes pain and it hurts a lot; achy; she experienced having a swollen lymph node under the arm/lymph node swollen around, a little into her back and down to her fore arm; This is a spontaneous report freceived rom a contactable consumer or other non hcp. A 75-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot number and expiry date was not reported), dose 2 via an unspecified route of administration, administered in arm right on 28Jan2021 11:00, single dose for covid-19 immunisation.  The patient's medical history and concomitant medications was not reported. Historical vaccine included bnt162b2 (BNT162B2, solution for injection, Lot number and expiry date was not reported), dose 1 via an unspecified route of administration, administered in arm right on unspecified date, single dose for covid-19 immunisation and Flu vaccine VII (Flu shot) and Shingrix (shingles shot) and had swollen lymph under her arm (This is swollen and it is going down the whole arm, it is altogether different). The patient reported she got the first dose 07Jan2021 or the 02Jan2021 she was not sure. she says just take 07Jan2021, and put it was exactly 3 weeks before the 28Jan 2021she does not think it was the 07Jan2021. It was reported she was really been feeling fine she had no fever. The patient experienced having a swollen lymph node under the arm/lymph node swollen around, a little into her back and down to her forearm on 28Jan2021, achiness on 29Jan2021, swelling causes pain and it hurts a lot  on an unspecified date. The events swollen lymph node under the arm/lymph node swollen around, a little into her back and down to her forearm was not recovered, while achiness got recovered on 30Jan2021 and outcome was unknown for swelling causes pain and it hurts a lot.    Information about lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Contusion, Fatigue, Feeling abnormal, Lymphadenopathy
Clinical narrative: He did not feel good the next day; Woke up with sweats; fatigue; Swelling of lymph nodes in neck in opposite side of injection; scratchy throat; Pain; Bruising on left arm; He can still see a little discoloration in his arm; had no energy; he felt worse; This is a spontaneous report from a contactable consumer. A 66-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EL3248), via intramuscularly, administered in left arm muscle on 15Jan2021 at 14:00 (at the age of 66-years-old) as a single dose for COVID-19 immunization at School/Student Health Clinic. Patient's medical history included asthma (diagnosed many years ago as a child) and blood cholesterol. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR) 60 units 100/50 two puffs daily, acid reducer and cholesterol medication, uses inhaler (unspecified) for Asthma. The patient previously took fluticasone propionate (FLOVENT). Patient had no vaccines administrated prior to covid 19 vaccine no additional Vaccines were administered on same day of the vaccine. On 16Jan2021, at 06:00 (reported as after the first few days) patient had had bruising on arm, not out of the ordinary. On 21Jan2021, at 06:00 patient started getting pain and swelling in lymph nodes in neck and a scratchy throat. That has been on for a while now. It was reported that last Friday, he felt worse and had fatigue at 10:00, did not feel well and in the middle of night, woke up with sweats on 30Jan2021 at 01:00. He did not feel good the next day. Now, he was back to swelling in lymph nodes and sore throat. There was a couple of days where he did not notice it at all and was supposed to get next vaccine on Wednesday and was not sure if he should or not. He provided his weight as 140ish. There was no prescriber. Patient still had a little discoloration in his arm, but it was not tender. Last Wednesday and Thursday, he felt good and could feel a little swelling in his lymph nodes, and on Friday, he felt more fatigued. Patient was always felt fatigued, but on Friday, he had no energy. The scratchy throat this morning was not as bad, but by this afternoon, it is least as sore or more of the same. He is still fatigued, but he can work. When he gets done with work, he was much more tired and fatigued and even during the day, he felt he was not quite right. The outcome events were not recovered for swollen lymph nodes, scratchy throat, fatigue, bruising on left arm and night sweats, and unknown for the rest of the events.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Night sweats, Pain, Skin discolouration, Throat irritation
Clinical narrative: He did not feel good the next day; Woke up with sweats; fatigue; Swelling of lymph nodes in neck in opposite side of injection; scratchy throat; Pain; Bruising on left arm; He can still see a little discoloration in his arm; had no energy; he felt worse; This is a spontaneous report from a contactable consumer. A 66-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EL3248), via intramuscularly, administered in left arm muscle on 15Jan2021 at 14:00 (at the age of 66-years-old) as a single dose for COVID-19 immunization at School/Student Health Clinic. Patient's medical history included asthma (diagnosed many years ago as a child) and blood cholesterol. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR) 60 units 100/50 two puffs daily, acid reducer and cholesterol medication, uses inhaler (unspecified) for Asthma. The patient previously took fluticasone propionate (FLOVENT). Patient had no vaccines administrated prior to covid 19 vaccine no additional Vaccines were administered on same day of the vaccine. On 16Jan2021, at 06:00 (reported as after the first few days) patient had had bruising on arm, not out of the ordinary. On 21Jan2021, at 06:00 patient started getting pain and swelling in lymph nodes in neck and a scratchy throat. That has been on for a while now. It was reported that last Friday, he felt worse and had fatigue at 10:00, did not feel well and in the middle of night, woke up with sweats on 30Jan2021 at 01:00. He did not feel good the next day. Now, he was back to swelling in lymph nodes and sore throat. There was a couple of days where he did not notice it at all and was supposed to get next vaccine on Wednesday and was not sure if he should or not. He provided his weight as 140ish. There was no prescriber. Patient still had a little discoloration in his arm, but it was not tender. Last Wednesday and Thursday, he felt good and could feel a little swelling in his lymph nodes, and on Friday, he felt more fatigued. Patient was always felt fatigued, but on Friday, he had no energy. The scratchy throat this morning was not as bad, but by this afternoon, it is least as sore or more of the same. He is still fatigued, but he can work. When he gets done with work, he was much more tired and fatigued and even during the day, he felt he was not quite right. The outcome events were not recovered for swollen lymph nodes, scratchy throat, fatigue, bruising on left arm and night sweats, and unknown for the rest of the events.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: the thumb was hurt for scratching so much; a mild itchiness all over the body; This is a spontaneous report was received from a contactable consumer or Other Non-Hcp. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in right arm on 29Jan2021 as 1st dose, single dose for covid-19 immunization. The patient's medical history and concomitant medication was not reported. The reporter mentioned that he received the first dose of covid vaccine on Friday 29Jan2021. He was asked to wait 30 minutes along with his wife for some adverse effects, but nothing happened. However, during night he started with a mild itchiness all over the body, not severe. On 30Jan2021, Saturday night it was severe but Sunday night it was selective: began in the right hand (arm where he received the vaccine) and 30-40 minutes after it disappears and appears in the right ankle. This repeated from knee to thigh and then through the other half of the body ending in the right hand, in 4 of 5 fingers, the thumb was hurt for scratching so much. He stated that this only happens through the nights and he is fine during the day and he is taking Zyrtec. He just wants to know if can continue taking this medicine or other. The patient was recovering from the events.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Fatigue, Headache
Clinical narrative: Experienced chill; Felt fast heartbeat; Headache; Muscle pain; Dizziness; Breathing difficulty; Felt exhausted; This is a spontaneous report from a non-contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number: Not reported, Expiration date: Not reported) as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021 the patient experienced chill, Felt fast heartbeat, Muscle pain, headache Dizziness, Breathing difficulty and Felt exhausted. The patient stated she received her pfizer covid vaccine on Friday afternoon and experienced chill, felt fast heartbeat, in the evening chills again and heart palpitation but the heart rate measure was normal, next morning a little better but had headache, muscle pain. dizziness a few times, breathing difficulty, felt exhausted. Then the next day felt little more batter, but out of breath when climbing stairs. Patient wanted to know how long the side effects lasted for the people into the clinical trials. The outcome of the events was unknown.  No follow-up attempts are possible; Information about batch/lot number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Myalgia
Clinical narrative: Experienced chill; Felt fast heartbeat; Headache; Muscle pain; Dizziness; Breathing difficulty; Felt exhausted; This is a spontaneous report from a non-contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number: Not reported, Expiration date: Not reported) as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021 the patient experienced chill, Felt fast heartbeat, Muscle pain, headache Dizziness, Breathing difficulty and Felt exhausted. The patient stated she received her pfizer covid vaccine on Friday afternoon and experienced chill, felt fast heartbeat, in the evening chills again and heart palpitation but the heart rate measure was normal, next morning a little better but had headache, muscle pain. dizziness a few times, breathing difficulty, felt exhausted. Then the next day felt little more batter, but out of breath when climbing stairs. Patient wanted to know how long the side effects lasted for the people into the clinical trials. The outcome of the events was unknown.  No follow-up attempts are possible; Information about batch/lot number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: For First Dose: arm was sore; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 07Jan2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arm was sore after first dose on an unspecified date in Jan2021. When she went on 28Jan2021 for her second dose, her husband had a sore arm but she had no symptoms. She doubt the person gave her the vaccine because she didn't feel anything and had zero symptoms. Se feel frightened, scared, worried and regret going there. They need to train these people. The person that vaccinated her did put the needle but didn't push the plunger. The outcome of the event was unknown.  Follow-up attempts have been completed and no further information is expected. lot/batch number is not available despite the follow-up attempts made.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure measurement, Dizziness, Heart rate, Palpitations
Clinical narrative: dizziness, heart palpitation, and anxiety after 1-2 minutes; dizziness, heart palpitation, and anxiety after 1-2 minutes; dizziness, heart palpitation, and anxiety after 1-2 minutes; my heart racing/palpitating like having an anxiety attack; my heart racing/palpitating like having an anxiety attack; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non-pregnant female patient received BNT162B2 (COMIRNATY, solution for injection, Lot Number: Unknown), via intramuscular route of administration in left arm on 31Jan2021 11:45 1st dose, single for covid-19 immunisation. The patient medical history included fibromyalgia, arthritis, postnasal drip and allergy to penicillin, sulfa drugs, dust mites, some trees. Concomitant medication included Bupropion, Trazodone and Lamotrigine; all were taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine in four weeks. Patient did not have COVID prior vaccination. Patient was not COVID tested post vaccination. On 31Jan2021 at 11:45 AM the patient experienced dizziness, heart palpitation, and anxiety after 1-2 minutes. About a minute or two after the shot, I experienced dizziness, my heart racing/palpitating like having an anxiety attack, which I rarely have. It lasted around 15 to 30 minutes. A doctor was on hand. An assistant checked my heart rate and blood pressure and was told it was fine. Patient did not receive any treatment for events. Patient had blood pressure/pulse taken. Outcome of the events was recovered on 31Jan2021.  Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A sore arm/arm soreness; This is a spontaneous report from a contactable consumer (husband). This consumer reported similar events for two patients. This is 2nd of 2 reports. A female patient of unspecified age received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unspecified) on an unspecified date in Jan2021 as single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced no problems, except a sore arm/ arm soreness. She was taking Eliquis. The outcome of event was unknown.  Information about lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : 2021099187 Same reporter/drug/AE and different patient.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Rash
Clinical narrative: chills; slight fever; rashes on the stomach; This is a spontaneous report from a contactable consumer or other non health care professional.  A female patient of an unspecified age 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 was not reported. The patient's concomitant medications were not reported.  The patient experienced chills  on 22Jan2021 with outcome of unknown , slight fever  on 22Jan2021 with outcome of unknown , rashes on the stomach  on 22Jan2021 with outcome of unknown.  The action taken in response to the event(s) for bnt162b2 was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: feeling sick; This is a spontaneous report from a contactable consumer (Patient) via a Pfizer Sponsored Program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration on 27Jan2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 08Jan2021 for COVID-19 immunisation. Patient received Pfizer Covid-19 vaccine first and 2nd dose and experienced strong side effects yesterday and feeling sick (on 29Jan2021) today but not like yesterday. The outcome of event was unknown.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Feeding disorder
Clinical narrative: She has not eaten anything; Diarrhea; This is a spontaneous report from a contactable consumer (patient) received through Pfizer sponsored program. A 82-year-old female patient received first dose of BNT162B2 (Pfizer Covid-19 Vaccine, Formulation: Solution for injection, Batch/Lot number was not reported) via, an intramuscular route of administration, administrated in left arm on 22Jan2021 at 10:00AM as 1ST dose, single for COVID-19 immunization. The patient medical history included as diabetes. The patient concomitant medications included as Metformin two tablets in the morning, and one tablet at night by mouth taken for diabetes. On 27Jan2021 patient experienced with diarrhea and patient was calling about the Pfizer Covid vaccine. Everything was fine. Patient had the corona virus first shot on 22Jan2021. On 27Jan2021, the patient experienced diarrhea. On an unspecified date, the patient patient had not eaten anything today. Patient had diarrhea for a day or two. Patient called her doctor for an appointment and Patient was told that diarrhea was a sign of the coronavirus and that patient should go to urgent care. Patient was asking if this was true. patient was confused and in shock, now patient was scared patient may have coronavirus. patient was told that even though patient had the shot could still have the coronavirus. Patient had diarrhea once or twice. patient not had any diarrhea today but patient had not eaten anything today. Patient had to go back 13Feb2021 for the second shot. Patient was not given a card and patient cannot provide lot, ndc, or expiration date. Patient called the doctor and they said no they wouldn't see her because that is a sign of the coronavirus and wants to know if that is true since she already had the first shot. No further details provided. Unable to provide an email address. Declines report and wants to speak to someone about this. The outcome of the event resolved on 29Jan2021 and outcome of remaining event was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Nasal congestion
Clinical narrative: Congestion; Chills; Cough; This is a Spontaneous report from Pfizer Sponsored Program. A contactable consumer reported for male patient (Husband) that: A male patient of an unknown age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On an unknown date, the patient experienced congestion, cough and chills, after the first dose of the covid vaccine. The outcome of the events was unknown.  Information about lot/batch number has been requested.  Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Itching and burning sensation on my arm near the injection site; Itching and burning sensation on my arm near the injection site; My upper left arm was notably red and hot to the touch,; My upper left arm was notably red and hot to the touch,; There was also a hard bump where the injection was administered; This is a spontaneous report from a contactable consumer (patient). A 25 years old non-pregnant female patient received first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: EL3249), an unspecified route of administration, administered in left arm on 22Jan2021 at 11:30 AM as 1st dose, single dose covid-19 immunisation. The patient's medical history included asthma, allergy to unspecified antibiotics. The patient's concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. On 30Jan2021, the patient experienced an itching and burning sensation on her arm near the injection site. Her upper left arm was notably red and hot to the touch, there was also a hard bump where the injection was administered. Her arm was itchy and hot for approximately 1 1/2 hours and then it dissipated. The same thing happened again on 31Jan2021. Since the vaccination the patient had not been tested for COVID-19. Treatment was not received for the adverse event. On an unspecified date in 2021, the patient had recovered from the events.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Renal pain, SARS-CoV-2 test
Clinical narrative: Severe pain left kidney (left side), Moderate to Severe Kidney (Right side); This is a spontaneous report from a contactable Other Hcp. A 48-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: eh9899), via an unspecified route of administration, administered in left arm on 29Dec2020 (at the age of 48-year-old) as a Single Dose for covid-19 immunization. The patient did not receive any other vaccine within 4 weeks prior to COVID Vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. After the vaccination the patient tested for COVID-19. The patient past Medical history included Type 1 diabetes mellitus. Concomitant medication included insulin lispro (Humalog), Ramipril, Carvedilol and Atorvastatin. There were no allergies were reported. on 01Jan2021,3Day after the administration of vaccine the patient experienced severe pain left kidney (left side), moderate to severe kidney (right side). No seriousness criteria were reported. Therapeutic measures were taken. The Lab test includes: CT scan (computerized tomogram): Result was Pending. On 29Jan2021 Nasal Swab (SARS-CoV-2 test) result: Negative (Lumiradx-SARS-COV 2 AG Test). The patient received second dose of BNT162b2 (Lot number: EL3246), via unspecified route administered on left arm on 19Jan2021. The even outcome was Not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pain, Pyrexia
Clinical narrative: Chills; fever; aches; weakness; This is a spontaneous report from a contactable consumer (patient herself).  A 65-year-old non-pregnant female patient received second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EL8982, Expiration Date was not reported), via an unspecified route of administration, administered in right arm on 31Jan2021 (at the age of 65-year-old) as a single dose for covid-19 immunisation. Medical history included hypertension (High blood pressure), blood cholesterol increased (high cholesterol). Concomitant medications included amlodipine ; omega-3-acid ethyl ester (LOVAZA).  The patient historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EL1283, Expiration Date was not reported), via an unspecified route of administration, administered in right arm on 10Jan2021 10:00am for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested positive since the vaccination. The patient does not have any Allergies to medications, food, or other products. On 31Jan2021 10:00 PM patient experienced Chills fever aches weakness. Tylenol treatment received for the adverse event.Therapeutic measures were taken as a result of chills, fever, aches, weakness. The outcome of the events was reported as recovered.  Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Rhinorrhoea, Sneezing
Clinical narrative: sneezing bout; runny nose; congestion; This is a spontaneous report from a contactable consumer (patient). A 94-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL9262) via an unspecified route of administration in left arm on 31Jan2021 02:15 AM as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Medical history included parkinson's disease and allergies to medications, food, or other products was reported as trees. Concomitant medications (within 2 weeks of vaccination) included carbidopa, levodopa; amiodarone; calcium carbonate (CALTRATE) and docusate sodium (COLACE). It was reported that, during the night after receiving the vaccine, patient experienced sneezing bout. The day after the vaccine very runny nose and congestion all on 01Feb2021 04:00 AM. 2 days after the vaccine nose was still runny but not as much. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Treatment was not received for the adverse events. The outcome of the events was reported as recovering.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Tinnitus
Clinical narrative: headache; tiredness; ringing in my ear; Muscle ache; This is a spontaneous report from a non-contactable consumer reported for herself. A 45-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration at left arm on 29-Jan-2021 14:30 as a 1st dose single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient had no allergies to medications, food, or other products. The patient had not diagnosed with COVID-19 prior to vaccination and since vaccination. On 30Jan2021 the patient experienced Muscle ache, headache, tiredness, ringing in my ear. Outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: I have problems with my first vaccine, I did it on the 19th and I'm still in a lot of pain; This is a spontaneous report from non-contactable consumer (patient) via Pfizer Sponsored program. A patient of unspecified age and gender received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch no.: not reported, expiration: not reported), via an unspecified route of administration on 19Jan2021 date at 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had problems with first vaccine, patient did it on the 19Jan2021 and was still in a lot of pain. Patient asked should I get my second vaccine done on the 8th. The outcome of the events was not recovered.  No follow-up attempts are possible. Information on the batch/lot number cannot be requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Ear pain, Headache, Pain
Clinical narrative: dizziness; headache; ear ache; fever; chills; overall ache; Left arm developed large lump, was swollen and appx 4" diameter redness; Left arm developed large lump, was swollen and appx 4" diameter redness; Left arm developed large lump, was swollen and appx 4" diameter redness; This is a Spontaneous report received from a contactable consumer (patient). A 69-year-old female non-pregnant patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: PFREL 1283), via unspecified route of administration on the left arm on 08Jan2021 at 10:30 AM, as 1st dose single for COVID-19 immunisation. The Patient's medical history included RA (rheumatoid arthritis), neuropathy, fibromyalgia and COVID-19 (diagnosed prior to vaccination). Concomitant medications included certolizumab pegol (CIMZIA), prednisone, baclofen, gabapentin and hydrocodone (all are received within 2 weeks of vaccination). The patient previously took infliximab (REMICADE) and adalimumab (HUMIRA) and experienced allergies with both. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that, on 08Jan2021, at 25-30 min after vaccine, the patient began with dizziness then headache. Within hour, earache, then fever and chills. Within 3 hours, started overall ache. Left arm developed large lump, was swollen and appx 4" diameter redness. Symptoms kept her in bed 4 days, then limited activity for another 2 days. Since the vaccination, the patient had not been tested for COVID-19. The patient received second dose of BNT162B2 (Lot Number: EL9262), via an unspecified route of administration on the left arm on 29Jan2021 at 10:30 AM, as single dose for COVID-19 immunisation. The events were assessed as non-serious by the reporter. The outcome of the events was reported as recovering.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site mass, Vaccination site swelling
Clinical narrative: dizziness; headache; ear ache; fever; chills; overall ache; Left arm developed large lump, was swollen and appx 4" diameter redness; Left arm developed large lump, was swollen and appx 4" diameter redness; Left arm developed large lump, was swollen and appx 4" diameter redness; This is a Spontaneous report received from a contactable consumer (patient). A 69-year-old female non-pregnant patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: PFREL 1283), via unspecified route of administration on the left arm on 08Jan2021 at 10:30 AM, as 1st dose single for COVID-19 immunisation. The Patient's medical history included RA (rheumatoid arthritis), neuropathy, fibromyalgia and COVID-19 (diagnosed prior to vaccination). Concomitant medications included certolizumab pegol (CIMZIA), prednisone, baclofen, gabapentin and hydrocodone (all are received within 2 weeks of vaccination). The patient previously took infliximab (REMICADE) and adalimumab (HUMIRA) and experienced allergies with both. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that, on 08Jan2021, at 25-30 min after vaccine, the patient began with dizziness then headache. Within hour, earache, then fever and chills. Within 3 hours, started overall ache. Left arm developed large lump, was swollen and appx 4" diameter redness. Symptoms kept her in bed 4 days, then limited activity for another 2 days. Since the vaccination, the patient had not been tested for COVID-19. The patient received second dose of BNT162B2 (Lot Number: EL9262), via an unspecified route of administration on the left arm on 29Jan2021 at 10:30 AM, as single dose for COVID-19 immunisation. The events were assessed as non-serious by the reporter. The outcome of the events was reported as recovering.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache
Clinical narrative: Tiredness; headache; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received (BNT162B2, Solution for injection, Batch/Lot number was not reported, Reason for batch/lot was unknown was due to unable to locate or read the details), via an unspecified route of administration, administered in right arm on 28Jan2021 12:00 as 1st dose, single for covid-19 immunisation. Patient's age at vaccination was 43 years. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as other. Medical history included asthma from an unknown date and unknown if ongoing. No allergies to medications, food, or other products/known allergies. Concomitant medications included omeprazole taken for an unspecified indication, start and stop date were not reported. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was omeprazole. On 29Jan2021, the patient experienced tiredness, headache and diarrhoea. No treatment received for the adverse event. The report was non-serious. Prior to vaccination, the patient was diagnosed with COVID-19 and Since the vaccination, the patient was not tested for COVID-19. Outcome of the events was not recovered.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Vomiting
Clinical narrative: Her Mom, experienced chills for two hrs; She vomited; Fatigue; Fever; This is a spontaneous report from a contactable consumer (reported for mother) via Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient had experienced chills for two hours then she vomited, got fatigue and fever. The outcome of the events was unknown.   Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Aches "in every muscle in her body as if she had just worked out"/ soreness; This is a spontaneous report from a contactable consumer. An adult female patient received BNT162B2 (BNT162B2), via an unspecified route of administration on 27Jan2021 (Batch/Lot number was not reported) as UNKNOWN, SINGLE DOSE for covid-19 immunisation administered in Hospital. The patient did not receive any vaccines within 4 weeks prior to the COVID vaccine. The patient medical history and concomitant medications were not reported. She described no adverse effects immediately after vaccination, but 2 days later she felt aches in every muscle in her body as if she had just worked out/ soreness on 29Jan2021. The soreness lasted only 1 day. Prior to vaccination, the patient diagnosed with COVID-19 was unknown; Since the vaccination, the patient not been tested for COVID-19. Outcome of the event was recovered.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Lump near my collar bone/ swollen lymph node; Lump is painful to touch; This is a spontaneous report from a non-contactable consumer (patient herself). A 45-years-old not-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: el3247) via an unspecified route of administration, administered in arm left on 27Jan2021 at 08:15 as 1ST DOSE, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Medical history included prediabetic and lymphedema in right foot. No allergies to medications, food, or other products were reported. Concomitant medications included daily multivitamin. On 02Feb2021 at 08:30 AM, six days after receiving the Covid-19 vaccine, she developed a lump near her collar bone. Lump was painful to touch. She reached out to her doctor, but they were unavailable due to a snow storm in our area. She believed it was a swollen lymph node. Patient has not been tested for COVID-19 since the vaccination. It was unknown if the patient received treatment for the adverse event. The case was considered as non-serious as per reporter. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, SARS-CoV-2 test
Clinical narrative: Whole body aches; Chills; Extremely tired; This is a spontaneous report from a contactable Other HCP (Patient). A-27-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: EL9265) via unspecified route of administration, administrated in left arm on 02Feb2021 at 10:15 AM as 1ST DOSE, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Feb2021 at 12:00 PM patient whole body experienced with whole body aches, chills, and extremely tired. The patient underwent lab test and procedures which include covid test type post vaccination by Nasal Swab result was negative. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.