chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: The injection site was the size of a quarter. Now it's the size of two half dollar bills with itching & warm to touch; The injection site was the size of a quarter. Now it's the size of two half dollar bills with itching & warm to touch; The injection site was the size of a quarter. Now it's the size of two half dollar bills with itching & warm to touch; This is a spontaneous report received from a contactable pharmacist. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection,Batch/Lot number was not reported), via administered in the tricep on an unspecified date as single for covid-19 immunisation.The patient's medical history and concomitant medications were not reported.The vaccine was administered in the tricep. On an unspecified date, it was reported that the injection site was the size of a quarter. now it's the size of two half dollar bills with itching & warm to touch. The outcome of the events was unknown.  Follow-up attempts are needed; information about lot/batch number can be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Rash; Itching all over; Skin was red; This is a spontaneous report from a contactable pharmacist. A 52-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on May2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. In May2021, the patient experienced rash, itching all over and skin was red. He says she got the first dose on a Friday and on Sunday was when she got the side effect. He wants to know was she should be able to get the second dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Discomfort, Dry mouth, Fatigue
Clinical narrative: Fever; Shivers; Tiredness; Dry mouth; Weird mouth taste and changes in flavor; Leg pain and cramps; Leg pain and cramps; Headache; General discomfort and skin hypersensitivity; General discomfort and skin hypersensitivity; Chest Pressure; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 29-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0187), via an unspecified route of administration, in left arm on 25May2021 at 16:15 (at the age of 29-years-old) as 2nd dose, single for covid-19 immunization. The patient previously took the first dose of bnt162b2 (Lot number: EW0173) on 04May2021 at 04:30 PM (at the age of 29-years-old). Patient was allergic to Dewormers. The patient's concomitant medications were not reported. The patient did not receive any other medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25May2021, the patient experienced fever, shivers, tiredness, dry mouth, weird mouth taste and changes in flavor, leg pain and cramps, chest pressure, headache, general discomfort and skin hypersensitivity. No treatment was received by the patient. Outcome of the events was not recovered.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersensitivity, Muscle spasms, Pain in extremity, Pyrexia
Clinical narrative: Fever; Shivers; Tiredness; Dry mouth; Weird mouth taste and changes in flavor; Leg pain and cramps; Leg pain and cramps; Headache; General discomfort and skin hypersensitivity; General discomfort and skin hypersensitivity; Chest Pressure; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 29-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0187), via an unspecified route of administration, in left arm on 25May2021 at 16:15 (at the age of 29-years-old) as 2nd dose, single for covid-19 immunization. The patient previously took the first dose of bnt162b2 (Lot number: EW0173) on 04May2021 at 04:30 PM (at the age of 29-years-old). Patient was allergic to Dewormers. The patient's concomitant medications were not reported. The patient did not receive any other medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25May2021, the patient experienced fever, shivers, tiredness, dry mouth, weird mouth taste and changes in flavor, leg pain and cramps, chest pressure, headache, general discomfort and skin hypersensitivity. No treatment was received by the patient. Outcome of the events was not recovered.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: Fever; Shivers; Tiredness; Dry mouth; Weird mouth taste and changes in flavor; Leg pain and cramps; Leg pain and cramps; Headache; General discomfort and skin hypersensitivity; General discomfort and skin hypersensitivity; Chest Pressure; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 29-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0187), via an unspecified route of administration, in left arm on 25May2021 at 16:15 (at the age of 29-years-old) as 2nd dose, single for covid-19 immunization. The patient previously took the first dose of bnt162b2 (Lot number: EW0173) on 04May2021 at 04:30 PM (at the age of 29-years-old). Patient was allergic to Dewormers. The patient's concomitant medications were not reported. The patient did not receive any other medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25May2021, the patient experienced fever, shivers, tiredness, dry mouth, weird mouth taste and changes in flavor, leg pain and cramps, chest pressure, headache, general discomfort and skin hypersensitivity. No treatment was received by the patient. Outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer (patient daughter). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot/batch no. was not reported) via unspecified route, as 1st dose, single dose on 10May2021 for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated that patient had the vaccine shot on 10May2021, she developed Shingles on an unspecified date in May2021 (last week). Reporter also stated that patient had second vaccine on Monday, the 31May2021 so she wanted to know if it was safe to do it with Shingles. Patient did not take any medication yet for Shingles because she wanted to make sure before that if she could get the vaccine first and maybe she would start the viral medication after. Reporter googled it and there were many people to get this related to the vaccine. The clinical outcome for the event was unknown.  Information about batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Little small bump; it started to appear more and it's comeback behind on my right side; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A patient of unspecified age and gender received BNT162B2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Batch/Lot Number: EW0172), via an unspecified route of administration on 24May2021 as second dose, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient has previously received first dose of BNT162B2 (Batch/Lot Number: ER8736) for Covid-19 immunization. On 25May2021, Tuesday patient had a little small bump come up, that was mosquito bite or something and then the next day had another bump and it started to appear more and it has comeback behind on patient's right side. Hasn't spread but they start to break open and are very sore and very tinted to touch. Patient wanted to report but patient wanted to know Is that normal. Patient stated that it was getting worse. Outcome of the event was reported as unknown.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Respiratory disorder
Clinical narrative: Affecting breathing; Shoulder and neck hurting; Shoulder and neck hurting; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient came fine while they gave the Pfizer shot, it did not hurt but it was affecting breathing and shoulder and neck hurting. Consumer stated that patient did not know if its normal, was it affect shoulder and neck, breathing and got it this morning. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Skin burning sensation
Clinical narrative: Burning sensation all over her skin; Very tired; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch no: EN6205, NDC number; expiration date: unknown), via unspecified route in the deltoid left on 26Feb2021 at 15:00 as single dose for COVID-19 immunization. The patient medical history included blood pressure. Concomitant medication included atenolol taken for blood pressure as 25 mg, amlodipine as 2.5 mg and doxazosin as 1 mg, both taken for blood pressure measurement. Patient previously had first dose of BNT162b2 (Lot: EL9264, NDC; expiration date: unknown) on 05Feb2021 for COVID-19 immunization. On 27Feb2021, in the morning when she woke up, she had burning sensation all over her skin. She rested all day on the 27Feb2021 and then Sunday 28Feb2021 she was just a little tired but there was no more of the burning sensation. She confirmed the tiredness started on Saturday 27Feb2021. She usually works on Saturday, but she could not work because she was too tired. By Sunday 28Feb2021 she was better. She thought she rested and continued to rest because she was still a little tired. She recovered by Monday and she went back to work. The patient did not receive any treatment for the events. The clinical outcome for the event burning sensation was recovered on 28Feb2021 and very tired was recovered on 01Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: She wasn't feeling well; This is a spontaneous report from a contactable consumer or other non hcp.  A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0158 and Expiry date: Unknown) dose 1 via an unspecified route of administration, administered in Arm Left on 10Apr2021 as 1st dose, single dose (at the age of 60-year-old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no prior vaccinations within last 4 weeks. The patient experienced she wasn't feeling well on Apr2021. The caller stated she received her first shot 10Apr2021 and she was supposed to get the second shot 3 weeks later but she was not feeling well. She was afraid to get it. She went to the place and they told her she probably should not get it. She wasn't feeling well and so she postponed it. She got the shot on 27May2021and that is 6 weeks later. The outcome of event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: First dose- soreness to unknown arm at injection site; This is a spontaneous report from a contactable consumer or other non-HCP (Patient).    A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in arm on 05May2021 (Lot Number: EN6205, expiry date was not reported) as single dose for COVID-19 immunisation. The patient's medical history included ongoing hypothyroidism stated that she has had it since she was a child. The patient's concomitant medication included levothyroxine taken for hypothyroidism from an unspecified start date (Started when she was 8 years old) and ongoing; liothyronine taken for hypothyroidism from an unspecified start date and ongoing. On 05May2021, after first dose, the patient had soreness to unknown arm at injection site. It was reported that, dates for stated that the second dose was given closer to four weeks than three weeks after. She took the Pfizer vaccine first and second dose and had no symptoms prior to it. Stated that after approximately two weeks that she had a metallic, salty taste a lot of times not all of times. Stated that when she was not eating that the taste was on the tip of her tongue. She was not sure if it was from the vaccine, but she was reporting it due to the timing. Was getting feedback. Clarified that it was for Pfizer COVID vaccine. Stated that she had soreness to her unknown arm at injection site. Later clarified it as Pfizer BioNTech. Wanted to see if they can help her in any way. Stated that she hoped that this helped someone in some way. Stated that she went to the withheld and there were doctors there. Stated that the soreness to the injection site lasted the first day and was gone. Stated that the second dose was given closer to four weeks instead of three weeks because she could not go on that date. Stated that the metallic taste started on 17Apr2021 or 18Apr2021. Treatment reported as none. Did not have the NDC or expiration date for the second dose. Provided a lot number of EN6207. Stated that it was an unknown dose injection into the arm. Stated that it was for the prevention of COVID. Advised caller that she might speak with Medical Information and they might be able to provide her with medical information based on literature from research or studies. They could not provide recommendations. They could only provide information based on what she provided or were experiencing. They might refer her to the healthcare provider that was medically overseeing them. The outcome of the event was recovered on 06May2021.   Information on Lot/Batch number was available. Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Illness
Clinical narrative: Diarrhea; Sick; This is a spontaneous report from a non-contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications were not reported. The patient experienced diarrhea, sick on an unspecified date. The clinical outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 81.0
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Gait disturbance, Headache, Tremor
Clinical narrative: I had slight headache for about 3 to 4 hours; it bothers with my walking and it still bothers with my walking; my left arm and hand shakes; my left arm and hand shakes when I am on the walker; This is a spontaneous report from a contactable consumer (Patient). An 81-years-old patient of an unspecified gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 14May2021 (Batch/Lot Number: GW0176) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. Patient historical vaccine included bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 23Apr2021 (Batch/Lot Number: EW0153) as 1ST DOSE, SINGLE for covid-19 immunisation and reported first one cause I had have DBS and my hand and I have shaking in left hand. Concomitant medication(s) included apixaban (ELIQUIS) 5 mg, levothyroxine 50 mg, prednisone 50 mg taken for an unspecified indication, start and stop date were not reported. The patient reported I had slight headache for about 3 to 4 hours, it bothers with my walking and it still bothers with my walking; my left arm and hand shakes, my left arm and hand shakes when i am on the walker on an unspecified date in 2021. Patient stated, For the first one cause I had have DBS (Deep brain stimulation) and my hand and I have shaking in left hand and my right hand feels good but it bothers with the first shot it bothers if walked in and my left hand will also shake more, the second shot it bothers with my walking and it still bothers with my walking and my left arm and hand shakes when I am on the walker, usual walker a walk with and I had slight headache for about 3 to 4 hours it wasnt heavy that was all I have and thats all I got so just wanted to report that to you to let you know. The outcome of events was unknown. The patient underwent lab tests and procedures which included blood test: unknown on (Blood work before I had the shot, I didn't know my medications). No treatment was given to the patient.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 77-years-old female patient received bnt162b2 first dose of BNT162B2 (Pfizer-BioNTech COVID-19, Solution for injection, Batch/Lot number, NDC number, UPC number and Expiration date: unknown) via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After the first dose, patient had couple of days of fatigue. Patient asked about not having many side effects after getting the vaccine. Event recovered on an unspecified date.  Information about lot/batch number has been requested.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Pain in extremity
Clinical narrative: First dose: His arm was sore; First dose: He was weak; This is a spontaneous report from a Pfizer sponsored program COVAX US Support via a contactable consumer (patient, self-reported). A 18-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 20Apr2021, as a single dose for COVID-19 immunization. The reason for no lot number was he lost his vaccine record card. The patient taking Pfizer COVID vaccine because he could be able to go to events and participate in different things, so whenever he was around family, they were not worried and feeling unsafe. He was tired of wearing a mask. The patient's medical history and concomitant medications were not reported. The patient reported that on 20Apr2021, his arm was sore, and he felt weak, after first dose. He clarified that the first dose of the COVID vaccine actually hurt his arm more. After the first dose of the COVID vaccine, he was weak for 2 or 3 days. He did not have many side effects. He lost his vaccine record card. He and his step dad both received the COVID vaccine on the same day. He had his step dad's vaccine record card, so he was able to provide exact dates. Outcome of the events was recovered on 22Apr2021.  Information about lot/batch number has been requested.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence
Clinical narrative: His arm was only sore the same day he received the second dose of the covid vaccine, and the next morning; He slept a lot that night; This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored Program COVAX US Support. A 18-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCIN, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11May2021 (at the age of 18-years-old) as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCIN, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 22Apr2021 as single dose for covid-19 immunisation and had arm was sore and weak for 2 or 3 days. On 11May2021, on the same day of second dose of vaccine, patient arm was sore of the first day and the next morning, then it was fine. He slept a lot that night. He did not have nearly as much symptoms as most people say. He did not have many side effects. Outcome of the event pain in arm was recovered on 12May2021 and for other event was unknown.  Information about lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Pain in extremity, Rash pruritic, SARS-CoV-2 test
Clinical narrative: small itchy rash on lower back approx 2 days after vax; 2nd vax heavy fatigue; arm pain for a week-1/2 and about the 4th week; having difficulty breathing/getting a full breath which has continued to this point; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 57-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0164), dose 2 via an unspecified route of administration, in the right arm on 16Apr2021 08:45 (at the age of 57 years old) as 2nd dose, single dose for COVID-19 immunization. The patient medical history included fibromyalgia and the patient was allergic to codeine, levaquin, cipro [ciprofloxacin], sulfa antibiotics, and Shrimp allergy. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), lorazepam (ATIVAN) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8730), dose 1 via an unspecified route of administration, in the left arm on 25Mar2021 08:45 as 1st dose, single dose for COVID-19 immunization. On 11May2021, the patient experienced heavy fatigue, arm pain for a half week and about the 4th week, she had been having difficulty breathing/getting a full breath which was continued to this point. The patient reported that she can get full breath when leaning forward. This comes and goes throughout the day. It was also improved if she walks or workout but returns. The patient went to emergency room on 21May2021, workup came back negative for cardiac, looked good, lungs looked good. The patient reported that she saw pulmonologist -PFT on June 1st. The patient had small itchy rash on lower back approximately 2 days after vaccine and cleared up after a few days. Fatigue had lessened and breathing issues still at same level. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 14May2021. The outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: now has a fever and is wanted to know if she can take Tylenol; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer reported for a female patient 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 an unspecified date (Batch/Lot number was not reported) as unknown, single dose for covid-19 immunization. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced fever. It was reported that patient received the vaccine yesterday and next day has a fever and wanted to know if she can take Tylenol. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, SARS-CoV-2 test
Clinical narrative: It made me sick; This is a spontaneous report from a contactable consumer. A 44-years-old female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: unknown),via an unspecified route of administration on 28Apr2021 as a single dose for COVID-19 immunization. Patient reported he was rested from Covid only to take Pfizer vaccine. Medical history included Long COVID and he was already tested positive for Covid in January. Patient also had cardiac arrest twice in 90days wait time for vaccine, and bilateral pulmonary embolism(PE), and four upper extremity DVT from COVID. No family history of adverse effect. Concomitant medication included ELIQUIS 2.5mg tablet taken in the morning and night to prevent blood clot. The patient reported vaccine made him sick and it's normal because he had Covid. Patient underwent lab tests and procedures which included sars-cov-2 test: positive on Jan2021. Investigation assessment reported as yes. The clinical outcome of event was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Heart rate increased
Clinical narrative: Rapid Heart rate; Shortness of breath; Weakness; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), dose 1 via an unspecified route of administration on an unspecified date (Reason for no lot number: of Covid Vaccine: Complainant hung up abruptly/transfer incomplete Expiry Date of Covid Vaccine: Not Supplied) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient experienced rapid heart rate, shortness of breath, weakness on an unspecified date. The outcome of the event was reported as unknown for all event.  Information on batch/number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Vaccination site pain
Clinical narrative: first 3 days sore arm around injection site; mild headache; woke up 4am with nerve-like pain in left arm in middle of night starting at injection site in shoulder and going down arm to first and second fingers, with slightly less intense pain radiating out to entire arm (and to pinky finger).; This is a spontaneous report from a contactable consumer reported herself. A 37-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 11May2021 01:00 (Batch/Lot Number: EW0177) as a Single Dose for covid-19 immunization. The patient past Medical history included long mumps. The patient's concomitant medications were not reported. The patient previously took Penicillin B. On 28May2021 at 04:00, The patient experienced first 3 days sore arm around injection site, mild headache. No other side effects until 16 and woke up 4am with nerve-like pain in left arm in middle of night starting at injection site in shoulder and going down arm to first and second fingers, with slightly less intense pain radiating out to entire arm (and to pinky finger). 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 and the patient was not tested for COVID-19. The outcome for all the events recovered on Unspecified date 2021.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Fever; Mild headache; Nausea; This is a spontaneous report from a contactable consumer (patient himself) via Pfizer COVAX US Support study programme (CEP ID: 159558). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0173/Batch number was not reported), dose 2 via an unspecified route of administration on an unspecified date as 2nd dose, single dose for covid-19 immunisation. Medical history included covid-19 on an unspecified date in Jan2021 (when probed if consumer had COVID before taking the COVID-19 Vaccine, consumer stated, "Yes, before getting the shot in January"). The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8735/Batch number was not reported), dose 1 on an unspecified date, for covid-19 immunisation. On an unspecified date, the patient experienced fever, mild headache and nausea. The consumer stated that: he is experiencing symptoms starting yesterday, it's fever, mild headache and nausea. He is just asking if these are the possible reaction from the second dose or if he has COVID-19 Vaccine again. He was wondering it's because he had the second dose about 15 days ago and he was wondering if it's possible that the symptoms are due the reactions of that vaccine or is more because he had COVID before when he got two shots so, reporter wondering if it's possible to that he gets COVID again (Consumer was unsure) or it's just a reaction from vaccine". Consumer wanted to know if it is possible that it's a reaction from the vaccine since he got the second dose 14 days ago but he hasn't seen anything online that states that you can still get reactions far away from when you get the shot. The consumer did not provide product details (Expiration date, NDC#, UPC#) and other details were unknown. The outcome of the events was unknown. Limited information was available over the call.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Peripheral swelling, Pyrexia, SARS-CoV-2 test
Clinical narrative: My arm swelled up, has aches and kind of lumps; My arm swelled up, has aches and kind of lumps; High temperature; Nauseous; I had like a sun burn and very upsetting; I had the bad reaction; This is a spontaneous report from a contactable other health care professional (retired nurse).  A patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0176), via an unspecified route of administration on 12May2021 as 1st dose, single dose for covid-19 immunization. The patient's medical history included diagnosed with the Covid virus in end of Dec2020 and then patient tested negative in Jan2021, but patient continued to have antibodies (not clarified) and patient's doctor insisted that he/she should still get the vaccination. The patient's concomitant medications were not reported. Patient thought that Pfizer would have less side effects but when patient got first dose vaccination. On an unspecified date in 2021, Patient's arm was really swollen up and had aches, kind of lumps, so patient was afraid to get the second vaccination. Patient felt good at the first day then next night when patient went to bed, patient woke up with high temperature his/her arm was all swollen. Patient felt nauseous and then patient had like a sun burn kind of and it lasted for a couple of days but was very upsetting. Patient just wanted to make sure, Patient was scared and afraid to get the second dose and scheduled on 02Jun2021. Patient was trying to figure out, was it normal and what they do from now. Patient's doctor wanted him/her to get the second one, but patient was nervous. Patient hoped they had some advice. The outcome of the events was unknown.  Follow-up attempts are needed. Further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Sunburn
Clinical narrative: My arm swelled up, has aches and kind of lumps; My arm swelled up, has aches and kind of lumps; High temperature; Nauseous; I had like a sun burn and very upsetting; I had the bad reaction; This is a spontaneous report from a contactable other health care professional (retired nurse).  A patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0176), via an unspecified route of administration on 12May2021 as 1st dose, single dose for covid-19 immunization. The patient's medical history included diagnosed with the Covid virus in end of Dec2020 and then patient tested negative in Jan2021, but patient continued to have antibodies (not clarified) and patient's doctor insisted that he/she should still get the vaccination. The patient's concomitant medications were not reported. Patient thought that Pfizer would have less side effects but when patient got first dose vaccination. On an unspecified date in 2021, Patient's arm was really swollen up and had aches, kind of lumps, so patient was afraid to get the second vaccination. Patient felt good at the first day then next night when patient went to bed, patient woke up with high temperature his/her arm was all swollen. Patient felt nauseous and then patient had like a sun burn kind of and it lasted for a couple of days but was very upsetting. Patient just wanted to make sure, Patient was scared and afraid to get the second dose and scheduled on 02Jun2021. Patient was trying to figure out, was it normal and what they do from now. Patient's doctor wanted him/her to get the second one, but patient was nervous. Patient hoped they had some advice. The outcome of the events was unknown.  Follow-up attempts are needed. Further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Pain
Clinical narrative: Feel cold; I experienced severe chills, fatigue, aches; I experienced severe chills, fatigue, aches; I experienced severe chills, fatigue, aches; This is a spontaneous report from a contactable consumer (patient reported himself) . A 69-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 04Mar2021 (at the age of 69-years-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date, as single dose for covid-19 immunisation. On 04Mar2021, after the second dose of vaccination, the patient experienced minor chills. On 05Mar2021, the patient chills became sever and she also experienced fatigue, aches and feel cold most of the time. The patient reported that these events occur every day and sporadically throughout the day. It was reported that the side effects continue. He stated that the side effects were not uncommon after the second dose. He had experienced these side effects after other vaccines and did not think it was out of the ordinary. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy
Clinical narrative: Chills; swollen lymph nodes in right armpit and lower neck; This is a spontaneous report from a contactable other hcp (Patient). A 52-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (Age at vaccination 52-year) in arm right on 28May2021 16:45 as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took Latex penicillin erythromycin. Since the vaccination the patient has not been tested for COVID-19 and prior to vaccination, the patient was not diagnosed with COVID-19. On 30May2021 08:30 the patient experienced chills and swollen lymph nodes in right armpit and lower neck. The seriousness of the events was reported as non-serious. The clinical outcome of the events was not recovered.  Information on the lot/batch number has been requested. Follow up needed, further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain upper, Chest pain, Dyspepsia
Clinical narrative: Reflux; GI Symptoms; Doing exact same stuff; GI Symptoms; Doing exact same stuff/abdominal bloating; GI Symptoms; Doing exact same stuff/intermittent nausea; GI Symptoms; Doing exact same stuff/epigastric pain; GI Symptoms; Doing exact same stuff/indigestion; GI Symptoms; Doing exact same stuff/chest pain; This is a spontaneous report from a contactable other hcp (Patient's Friend). This is report 5 of 5. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unknown date, at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated that on an unknown date, the patient experienced the same events as her and presented with reflux, waves of intermittent nausea, abdominal bloating, epigastric pain, indigestion and chest pain. The reporter stated that she was trying to find all of the literature she can and wanted to know about the symptoms seen post vaccination in the area of reflux and gastritis. The reporter stated that the people had their second doses in Jan2021 and Feb2021 and it was not an immediate side effect. The outcome of the events was reported as unknown. The report is cross referenced to report ID: FUKQGV65.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021619792 same reporter/drug/similar events, different patient;US-PFIZER INC-2021623328 same reporter/drug/similar events, different patient;US-PFIZER INC-2021623215 same reporter/drug/similar events, different patient
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Reflux gastritis
Clinical narrative: Reflux; GI Symptoms; Doing exact same stuff; GI Symptoms; Doing exact same stuff/abdominal bloating; GI Symptoms; Doing exact same stuff/intermittent nausea; GI Symptoms; Doing exact same stuff/epigastric pain; GI Symptoms; Doing exact same stuff/indigestion; GI Symptoms; Doing exact same stuff/chest pain; This is a spontaneous report from a contactable other hcp (Patient's Friend). This is report 5 of 5. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unknown date, at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated that on an unknown date, the patient experienced the same events as her and presented with reflux, waves of intermittent nausea, abdominal bloating, epigastric pain, indigestion and chest pain. The reporter stated that she was trying to find all of the literature she can and wanted to know about the symptoms seen post vaccination in the area of reflux and gastritis. The reporter stated that the people had their second doses in Jan2021 and Feb2021 and it was not an immediate side effect. The outcome of the events was reported as unknown. The report is cross referenced to report ID: FUKQGV65.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021619792 same reporter/drug/similar events, different patient;US-PFIZER INC-2021623328 same reporter/drug/similar events, different patient;US-PFIZER INC-2021623215 same reporter/drug/similar events, different patient
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Food allergy, Nasal congestion, Rhinalgia, Rhinorrhoea, Sleep disorder
Clinical narrative: Extreme sneezing; runny nose both indoors and outdoors; Sensitive nose; Nose congestion in the mornings; Sleep disorders; Developed allergies towards avocados; This is a spontaneous report from a contactable consumer. This consumer (patient reported for herself). A 26-year-old (at the time of vaccination) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: ER8736), via an unspecified route of administration, administered in left arm on 10May2021 at 16:00 as 1st dose, single dose for COVID-19 immunization. Patient's medical history included allergy of Ibuprofen. Patient received other medications the patient received within 2 weeks of vaccination Tylenol, Allegra. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not been tested for COVID-19 nor before neither since the vaccination. On an unspecified date, the patient experienced extreme sneezing, runny nose both indoors and outdoors, sensitive nose, nose congestion in the mornings, sleep disorders and developed allergies towards avocados. The events were reported as non-serious. The Patient was not hospitalized. The outcome of events was not recovered.  Follow-up attempts are possible. Other information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: Extreme sneezing; runny nose both indoors and outdoors; Sensitive nose; Nose congestion in the mornings; Sleep disorders; Developed allergies towards avocados; This is a spontaneous report from a contactable consumer. This consumer (patient reported for herself). A 26-year-old (at the time of vaccination) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: ER8736), via an unspecified route of administration, administered in left arm on 10May2021 at 16:00 as 1st dose, single dose for COVID-19 immunization. Patient's medical history included allergy of Ibuprofen. Patient received other medications the patient received within 2 weeks of vaccination Tylenol, Allegra. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not been tested for COVID-19 nor before neither since the vaccination. On an unspecified date, the patient experienced extreme sneezing, runny nose both indoors and outdoors, sensitive nose, nose congestion in the mornings, sleep disorders and developed allergies towards avocados. The events were reported as non-serious. The Patient was not hospitalized. The outcome of events was not recovered.  Follow-up attempts are possible. Other information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Migraine, Sleep disorder, Vaccination site pain
Clinical narrative: Mild metal taste in mouth approx. 1 minute after shot was administered; Soreness in left arm, around site injection started approximately 6 hours after administration; spread to about 3 inches outward around from site of injection; Migraine started around 24 hours after shot was administered, with pain concentrated behind right eye; Fatigue; ended up sleeping nearly 12 hours; This is a spontaneous report received from a non-contactable consumer or other non hcp. A 40-years-old non pregnancy female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0186), via an unspecified route of administration in Arm Left on 28May2021 15:00 (age at vaccination 40years old, No pregnancy at time of Vaccination) as single dose for covid-19 immunization. Medical history included lactose intolerance from an unknown date and unknown if ongoing. Prior to vaccination, the patient was diagnosed with covid-19. Concomitant medication(s) included Vitamin C, Vitamin D, Calcium Citrate, Iron taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination the patient was not diagnosed with covid-19.  The patient received other medications in two weeks. On 28May2021 21:00 the patient experienced mild metal taste in mouth approx. 1 minute after shot was administered; dissipated a few minutes afterward. Soreness in left arm, around site injection started approximately 6 hours after administration; spread to about 3 inches outward around from site of injection; no swelling. Migraine started around 24 hours after shot was administered, with pain concentrated behind right eye. Fatigue; ended up sleeping nearly 12 hours. After 42 hours, migraine has gone away; remaining symptom is soreness - now reduced to half the area and still concentrated around site injection area. Patient was not received treatment for the events. Since the vaccination, the patient has not been tested for covid-19. The clinical outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: PVC; This is a spontaneous report from a contactable consumer or other non hcp. A 39-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number EW0150 and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in left arm on 23Apr2021 07:15 (at the age of 39-years-old) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included multiple sclerosis, fibromyalgia, seasonal allergy, food allergy (artificial sugar) from an unknown date and unknown if ongoing. Concomitant medications included ibuprofen (IBUPROFEN); chlorzoxazone, paracetamol (SKELAXINE) and Vitamin (unspecified) taken for an unspecified indication, start and stop date were not reported. The patient previously took Cymbalta, Lyrica and Tecfidera for unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced premature ventricular contractions (PVC) in Apr2021. Device date was 30May2021 (details were not specified). It was reported that there was no prolonged hospitalization. The patient was referred to Cardiologist and given treatment for the event. The outcome of the event was not recovered.  Follow up attempts are needed. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Having allergic sensitivity issue/ allergic reaction; This is a spontaneous report from a contactable consumer. A 14-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection), via an unspecified route of administration on 04May2021, as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date, as single dose for covid-19 immunization. The reporter stated that her daughters had the covid vaccine (second) on 04May2021, and they developed an allergic reaction. The reporter had a picture of their cards but did not have demographic information of the patient as the patient did not want to share the information. Limited information available over the call. On an unspecified date in May2021 (after receiving second dose of Pfizer Covid vaccine), the patient experienced having allergic sensitivity issue. The outcome of the event was unknown.   Information on lot/Batch number has been requested.