chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Pyrexia, Throat irritation, Throat tightness
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A 23-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 01Mar2021 09:30 (Batch/Lot Number: EN 6202) as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included known allergies Pollen from an unknown date and unknown if ongoing. Concomitant medications included escitalopram oxalate (LEXAPRO); ethinylestradiol/ferrous fumarate/norethisterone acetate (JUNEL FE) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, Batch/Lot Number: EL 9264), administered in right arm on 08Feb2021 09:30AM, as a SINGLE DOSE for COVID-19 immunization. Patient did not take other vaccine in four weeks. Patient did not diagnose with covid prior to vaccination. No covid tested post vaccination. Several hours after the vaccine, on 01Mar2021 22:00 patient took tylenol to relieve symptoms associated with a slight fever (99.6 F). Fifteen minutes after taking tylenol, the interior and exterior of my throat became very itchy. patient began to cough and feel restrictions in her throat. Symptoms did not subside until after taking benadryl. The outcome of all the events was recovering. No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Headache, Nausea, Pain in extremity, Sinus pain
Clinical narrative: constant nausea; facial and sinus pain; facial and sinus pain; headache; Sore left arm; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Left arm on 20Feb2021 11:00 at the age of 40-years-old as unknown, single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included metoprolol (METOPROLOL) taken for an unspecified indication, on an unspecified date received in two weeks of vaccination. The patient did not receive other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. On 21Feb2021 at 16:00, the patient experienced constant nausea for 3 days, facial and sinus pain, headache, and sore left arm and did not receive treatment for adverse events. The outcome of events was not recovered.  No follow up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysphagia, Dyspnoea, Nausea, Paraesthesia
Clinical narrative: respiratory reaction; throat started to tighten; I started coughing a lot; I couldn't catch my breath; I had tingling in my fingers; difficulty swallowing; itching; waves of nausea; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was unknown and expiration date not reported) via an unspecified route of administration, administered in Arm Left on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient received her first dose of the COVID vaccine to her left arm and on Monday around 2:30 in the parking lot by the hospital. She pulled up to the waiting section where they instruct you to wait for a bit to make sure you did not have a reaction. On an unspecified date, her throat started to tighten, she started coughing a lot, could not catch her breath, they gave Benadryl to patient. They checked her pulse and her oxygen, and they said she was getting enough Oxygen, so the patient did not need an epi pen. On an unspecified date, the patient had tingling in her fingers and difficulty swallowing and itching with waves of nausea. The patient was concerned about taking the second shot and asked that should she get the second shot after having a respiratory reaction to the first dose. The patient received treatment for throat started to tighten, she started coughing a lot and I could not catch my breath. The outcome of events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Respiratory disorder, Throat tightness
Clinical narrative: respiratory reaction; throat started to tighten; I started coughing a lot; I couldn't catch my breath; I had tingling in my fingers; difficulty swallowing; itching; waves of nausea; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was unknown and expiration date not reported) via an unspecified route of administration, administered in Arm Left on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient received her first dose of the COVID vaccine to her left arm and on Monday around 2:30 in the parking lot by the hospital. She pulled up to the waiting section where they instruct you to wait for a bit to make sure you did not have a reaction. On an unspecified date, her throat started to tighten, she started coughing a lot, could not catch her breath, they gave Benadryl to patient. They checked her pulse and her oxygen, and they said she was getting enough Oxygen, so the patient did not need an epi pen. On an unspecified date, the patient had tingling in her fingers and difficulty swallowing and itching with waves of nausea. The patient was concerned about taking the second shot and asked that should she get the second shot after having a respiratory reaction to the first dose. The patient received treatment for throat started to tighten, she started coughing a lot and I could not catch my breath. The outcome of events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Rash
Clinical narrative: : Approximately 3-4 days my rt arm broke out, was bright pink, sore, hotand swollen and itchy; Approximately 3-4 days my rt arm broke out, was bright pink, sore, hotand swollen and itchy; Approximately 3-4 days my rt arm broke out, was bright pink, sore, hotand swollen and itchy; Approximately 3-4 days my rt arm broke out, was bright pink, sore, hotand swollen and itchy; This is a spontaneous report from a contactable consumer or other non Healthcare Professional (The patient, reported for self).   A 74-years-old female patient received second dose of BNT162B2, ((COMIRNATY), Formulation: Solution for injection, Batch/lot number: EN6203, Expiration date: UNKNOWN), via an unspecified route of administration, administered in Arm Right on 02Feb2021 13:30 as single dose for COVID-19 immunisation.    Medical history included stent placement from an unknown date and unknown if ongoing Other medical history: Heart 3 stents, mastectomy, breast cancer double mastectomy, arthritis from unspecified date and unknown if ongoing. Known allergies (Drug hypersensitivity) includes: flu shots, Statin drugs, codeine, ibuprofens. Patient had earlier received first dose of BNT162B2 on 01Feb2021 (Lot  number: EL3246; Vaccine location: Rt arm) for COVID-19 immunisation. Concomitant medication included ergocalciferol, retinol palmitate (VITAMINS A & D); coenzyme q10 [ubidecarenone] (COENZYME Q10 [UBIDECARENONE]); isosorbide; levothyroxine sodium (SYNTHROID), Losartan all taken for an unspecified indication, start and stop date were not reported.    On 26Feb2021, The patient reported that approximately 3-4 days "my rt arm was bright pink, sore, hot, swollen, itchy". Events were non-serious. Outcome of the events was reported as  recovered on an unspecified date.    No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Genital herpes
Clinical narrative: I had a small breakout of vaginal herpes which I haven't had for two years.; This is a spontaneous report from a contactable consumer (patient). A 74-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EL9269, Expiration Date was not reported), via an unspecified route of administration, administered in right arm on 05Feb2021 10:30 (at the age of 74-year-old) as 1st dose, single dose for covid-19 immunisation. The patient medical history included food allergy (Known allergies: mussels, clams, oysters). Concomitant medication included thyroid (ARMOUR THYROID) 60mg. The patient have Known allergies to mussels, clams and oysters. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested positive since the vaccination. It was reported that, on 22Feb2021 the patient had a small breakout of vaginal herpes which I haven't had for two years.  Treatment received for vaginal herpes. Therapeutic measures were taken as a result of i had a small breakout of vaginal herpes which i haven't had for two years. The outcome of the event was reported as recovering.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Huge cold sore on my upper right lip; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EN6203, Expiration Date: not reported) via an unspecified route of administration in right arm on 27Feb2021 18:45 as 1st dose, single dose for COVID-19 immunization. Medical history included known allergies to Penicillin and other medical history was reported as none. Patient did not receive any other vaccine in four weeks and received other unspecified medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Feb2021, the patient experienced huge cold sore on my upper right lip. Patient was treated with Famciclovir. The outcome of the event was reported as recovering.  No follow up attempts are Possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: I woke up the next morning after getting my shot was huge cold sore on my right upper lip; This is a spontaneous report received from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6203 and Expiry Date was unknown) via an unspecified route of administration on an unspecified date as unknown single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The consumer reported that she woke up the next morning after getting vaccine shot, she had huge cold sore on her right upper lip. The patient usually when got a cold sore, she could feel it was coming on and stated "It was not boom and it was just there". The consumer was assuming, it was some type of side effects. The consumer asked if she take medicines for cold sores. Consumer was advised to consult her healthcare provider. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Body height decreased, Genital herpes, Paraesthesia, Skin ulcer
Clinical narrative: she is 5'11" and shrinking; ulcers; Bad recurrence of genital herpes; Tingling sensation; This is a spontaneous report from a contactable consumer (patient reported herself).   A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6202), via an unspecified route of administration, administered in upper right arm on 27Feb2021 (Saturday) at 11:30 (at the age of 65-years-old) as single dose for covid-19 immunisation. Medical history included ongoing arthritis, fibromyalgia, insomnia, and irritable bowel syndrome. The patient concomitant medications included Ibuprofen 200mg, taking 400-600 mg daily for decades for arthritis from an unspecified start date (taking ibuprofen for decades), she stated it was as needed, but she takes daily; Gabapentin 300 mg capsules, 1 to 2 capsules by mouth daily at bed  time (can take up to 3 daily) for fibromyalgia from an unspecified date (since a few years ago),  started a few years ago for fibromyalgia; Dicyclomine 10 mg tablets by mouth taking about a year from an unspecified start date for irritable bowel syndrome and zolpidem tartrate (AMBIEN) 10 mg by mouth every night for over 10 years from an unspecified date for insomnia. All the concomitant medications are ongoing. The patient previously received an unspecified vaccine for shingles. On 27Feb2021, the patient experienced bad recurrence of genital herpes and tingling sensation at night after the vaccination. On 28Feb2021 (Sunday), the patient had ulcers started forming. She stated that it got progressively worse over the week and that it was still healing but it was slow to heal. It was reported that the tingling stopped once the ulcers began to form. She stated that it was now open ulcers that were beginning to resolve but not fully healed. She stated that she was 5.11 and was shrinking. She reported that one of the worst cases she has ever had after not having an outbreak for years. She had a prescription for valacyclovir and considered filling once the symptoms began coming on but was afraid to fill the prescription as she thought that it might negate the Covid vaccine. She was calling to inquire if there was any information regarding her ability to take valacyclovir after receiving the Covid-19 vaccine. The events did not require a visit to emergency room and physician office. No relevant tests were performed. All events were reported as non-serious. The outcome of the event tingling sensation was resolved on 28Feb2021, bad recurrence of genital herpes and ulcers was reported as resolving and the outcome of height shrinking was unknown.    No follow up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Throat tightness
Clinical narrative: This is a spontaneous report from a contactable consumer (The patient). A 51-year-old female The patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6206), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 14:00 (at the age of 51-year) as 1st dose, single dose for COVID-19 immunization. Medical history included ongoing asthma, ADD and vitamin d deficiency from an unknown date and unknown if ongoing. The patient had Bee stings allergy from an unknown date and unknown if ongoing. Concomitant medication(s) included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported (Other medications in two weeks). The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. Facility where vaccine was administered was Hospital. On 05Mar2021 at 14:15, the patient experienced constriction feeling in throat and cough. The patient stated within 30 min of injection constriction feeling in throat, cough within 1 hour, asthma events x 3 within 2 days (throat spasms cause coughing fits). Symptoms decreased with use of inhaler. Still experiencing some mild asthma symptoms 3 days after injection. The patient visited doctor or other healthcare professional office/clinic for adverse events. The patient received Ventolin inhaler (at home) as treatment for adverse event. Therapeutic measures were taken as a result of constriction feeling in throat and cough. The outcome of events was recovering.    No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Oropharyngeal pain, Pharyngeal erythema, Pruritus, Rash
Clinical narrative: itch; cold sore; Rash on my lower back; red and minorly sore throat; red and minorly sore throat; This is a spontaneous report from a contactable consumer or other non hcp.  A 70-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9267 and expiration date was not reported), via an unspecified route of administration on 24Feb2021 (at the age of 70 years) as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. On 08Mar2021(two weeks after first injection) the patient experienced cold sore that was dormant over 20 years, rash on lower back, red and minorly sore throat, red and minorly sore throat, itch. Adverse events resulted in clinic visit. Reporter assessed the event as non-serious. Patient was treated with Steroid for itch and antiviral for cold sore. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Palpitations, Pharyngeal swelling, Swelling
Clinical narrative: dizziness; heart was racing/rapid heart beat; throat was closing; felt like her throat/neck was swelling; felt like her throat/neck was swelling; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of bnt162b2 (BNT162B2- PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, with a needle, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 14Mar2021 at 11:30 (at the age of 56 year-old) as First dose, SINGLE DOSE for covid-19 immunisation. Patient took Covid-19 vaccine to protect against covid-19. Medical history included ongoing Blood pressure diagnosed probably 7 years ago and Abdominal aortic aneurysm burst from an unknown date and unknown if ongoing. AE(s) following prior vaccinations reported as none. Family Medical History Relevant to AE reported as none. No relevant test was performed. Concomitant medications included losartan and metoprolol been on it for years, taken for blood pressure from an unspecified start date and ongoing. Patient was not received any additional vaccine on same date of COVID-19 vaccination. Patient was not received any other vaccine prior four weeks of vaccination. On 14Mar2021 the patient experienced dizziness, heart was racing/rapid heartbeat, throat was closing and felt like her throat/neck was swelling. She reported that immediately after received her first dose of the Pfizer-Biontech Covid19 vaccine, yesterday, she had dizziness, her heart was racing, and she felt like her throat was closing. She was treated on site with benadryl and was able to leave 30 minutes later. She may not be able to get the second dose due to severe reaction after the first dose. She received her first dose yesterday, 14Mar2021, and she had an immediate reaction like within a minute or minute and a half of receiving the vaccine. She felt dizziness, rapid heartbeat, and felt like her throat/neck was swelling. She clarifies she doesn't know if it was swelling, it may have been psychological. She could have just gotten herself worked up once she was in that situation all happened immediately after the vaccine at 11:30 AM. She clarifies further she doesn't think they saw swelling in her throat because they didn't give her an epi-pen, she was given Benadryl. She reported that the symptoms stopped within a half hour after the Benadryl. The patient underwent lab tests and procedures which included heart rate: rapid on unspecified date. Patient was not visited to emergency room and Physician Office for the events. Therapeutic measures were taken as a result of the events with benadryl. The outcome of the events was reported as recovered on 14Mar2021.   No follow-up attempts are possible; Information about lot/batch number cannot been obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: dizziness; heart was racing/rapid heart beat; throat was closing; felt like her throat/neck was swelling; felt like her throat/neck was swelling; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of bnt162b2 (BNT162B2- PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, with a needle, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 14Mar2021 at 11:30 (at the age of 56 year-old) as First dose, SINGLE DOSE for covid-19 immunisation. Patient took Covid-19 vaccine to protect against covid-19. Medical history included ongoing Blood pressure diagnosed probably 7 years ago and Abdominal aortic aneurysm burst from an unknown date and unknown if ongoing. AE(s) following prior vaccinations reported as none. Family Medical History Relevant to AE reported as none. No relevant test was performed. Concomitant medications included losartan and metoprolol been on it for years, taken for blood pressure from an unspecified start date and ongoing. Patient was not received any additional vaccine on same date of COVID-19 vaccination. Patient was not received any other vaccine prior four weeks of vaccination. On 14Mar2021 the patient experienced dizziness, heart was racing/rapid heartbeat, throat was closing and felt like her throat/neck was swelling. She reported that immediately after received her first dose of the Pfizer-Biontech Covid19 vaccine, yesterday, she had dizziness, her heart was racing, and she felt like her throat was closing. She was treated on site with benadryl and was able to leave 30 minutes later. She may not be able to get the second dose due to severe reaction after the first dose. She received her first dose yesterday, 14Mar2021, and she had an immediate reaction like within a minute or minute and a half of receiving the vaccine. She felt dizziness, rapid heartbeat, and felt like her throat/neck was swelling. She clarifies she doesn't know if it was swelling, it may have been psychological. She could have just gotten herself worked up once she was in that situation all happened immediately after the vaccine at 11:30 AM. She clarifies further she doesn't think they saw swelling in her throat because they didn't give her an epi-pen, she was given Benadryl. She reported that the symptoms stopped within a half hour after the Benadryl. The patient underwent lab tests and procedures which included heart rate: rapid on unspecified date. Patient was not visited to emergency room and Physician Office for the events. Therapeutic measures were taken as a result of the events with benadryl. The outcome of the events was reported as recovered on 14Mar2021.   No follow-up attempts are possible; Information about lot/batch number cannot been obtained.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Throat tightness; This is a spontaneous report from a contactable healthcare professional. A 31-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH; lot number: EN6205) via an unspecified route administration and anatomical site on 15Mar2021 (at the age of 31-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 15Mar2021 (15 minutes post vaccination), the patient experienced throat tightness during waiting period. The patient denied any symptoms of rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, hoarseness, stridor, itching, light headedness, dizziness, facial swelling, lip swelling and tongue swelling. The patient was noted with clear oropharynx and was speaking full sentences with no throat clearing. The patient was treated with water that showed excellent results hence was discharged and stable to go home. The patient was advised to follow-up with primary care physician (PCP). At the time of reporting, the outcome of the event throat tightness was recovering.   Amendment: This follow-up report is being submitted to amend previously reported information: Added patient first name, patient age, vaccination facility country, treatment received captured as yes, concomitant therapy updated as blank and removed duplicate suspect product indication.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Musculoskeletal stiffness, Off label use, Product use issue, Vaccination site pain
Clinical narrative: soreness at sight of injection; fatigue; shoulder stiffness; breastfed 7-month-old daughter has not been herself since/had poor sleeping, fussiness, and feeds less/has been 3 nights in a row of abnormal behavior; breastfed 7-month-old daughter has not been herself since/had poor sleeping, fussiness, and feeds less/has been 3 nights in a row of abnormal behavior; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in left arm on 14Mar2021 at 12:30 (at 31 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. The patient medical history was not reported. The patient had no known allergies. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and fluticasone propionate (FLONASE ALLERGY RELIEF); all from unspecified date for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 14Mar2021 at 18:00, the patient experienced soreness at sight of injection, fatigue, and shoulder stiffness. It was also reported that the personal side effects were mild. However, her breastfed 7-month-old daughter, experienced poor sleeping, fussiness, and feeds less which continued for 3 nights in a row of abnormal behavior for her. The patient did not receive treatment for the events. Outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021305422 infant case
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Raised rash around collarbone neck and back [...] red and itchy; Raised rash around collarbone neck and back [...] red and itchy; This is a spontaneous report from a contactable consumer.  A 75-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm, on 24Feb2021 (Batch/Lot Number: EL3247SCH), at the age of 75 years old, as 1st single dose, for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included hydrochlorothiazide, omeprazole, pregabalin (LYRICA), meloxicam, propranolol, loratadine, fluticasone propionate (FLONASE ALLERGY RELIEF), vitamin D, docusate, paracetamol (TYLENOL), and leflunomide. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced raised rash around collarbone neck and back occurring approximately 1 week post vaccination. It was not fluid filled, but red and itchy.  She saw her primary care provider (PCP) about 1 week post symptoms (about 2 weeks post vaccination) and was given triamcinolone 0.25% cream as treatment and was told to follow-up with a dermatologist and immunologist. Itching relieved temporarily with cream but the rash was still there at the time of the reporting. Dermatology appointment was scheduled for 19Mar2021. She was scheduled to receive second vaccination dose on the day of this initial reporting. The patient was considered not recovered from the event. Since the vaccination, has the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Chest pain, Flatulence, Pain
Clinical narrative: extreme Upper GI distress/ extreme GI distress; Painful gas/ gas pains; Bloating; Sharp stabbing pain on left side rib cage, with each inspiration.; Sharp stabbing pain on left side rib cage, with each inspiration/ Could only take shallow breaths to temper the pain; the pain on the right side is much worse when sleeping/ Difficult to find any position to sleep/ could not find a position to sleep in; This is a spontaneous report received from a contactable health care professional (patient) and consumer (patient's mother). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6260), via unspecified route of administration in left arm on 09Mar2021 09:30 AM as 2nd dose, single dose for COVID-19 immunization. The patient was not pregnant at the time of event and at the time of vaccination. The patient's medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications included levothyroxine sodium (SYNTHROID), from unspecified date. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9264), via unspecified route of administration in left arm on unspecified date in Feb2021 02:00 PM (at the age of 71-year-old) for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On the day after second dose (10May2021 07:00 PM) the patient experienced extreme upper gastrointestinal (GI) distress beginning around 7 PM in the evening. Very painful gas and bloating. Sharp stabbing pain on left side rib cage, with each inspiration. She could only take shallow breaths to temper the pain. Difficult to find any position to sleep. Seven days later, still have residual pain. Daughter (patient) provided her adverse event (AE) symptoms and then handed the phone over to her mother. Mother (caller) stated that she had her second dose of the Pfizer Covid-19 vaccine on 09Mar2021. Caller reported that on 10Mar2021 at 7 o clock that she had extreme GI distress, bloating and gas pains. Caller reported she could not take deep breaths which caused pains on the left side. Caller stated she could not find a position to sleep in. Caller reported the pain on the right side was much worse when sleeping. Caller stated that seven days later she had improved some. Caller wanted to know if these are reported side effects. It was unknown if treatment was received due to the event. The events resulted in doctor or other healthcare professional office/clinic visit. The case was reported as non-serious. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was resolving.  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Painful respiration
Clinical narrative: extreme Upper GI distress/ extreme GI distress; Painful gas/ gas pains; Bloating; Sharp stabbing pain on left side rib cage, with each inspiration.; Sharp stabbing pain on left side rib cage, with each inspiration/ Could only take shallow breaths to temper the pain; the pain on the right side is much worse when sleeping/ Difficult to find any position to sleep/ could not find a position to sleep in; This is a spontaneous report received from a contactable health care professional (patient) and consumer (patient's mother). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6260), via unspecified route of administration in left arm on 09Mar2021 09:30 AM as 2nd dose, single dose for COVID-19 immunization. The patient was not pregnant at the time of event and at the time of vaccination. The patient's medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications included levothyroxine sodium (SYNTHROID), from unspecified date. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9264), via unspecified route of administration in left arm on unspecified date in Feb2021 02:00 PM (at the age of 71-year-old) for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On the day after second dose (10May2021 07:00 PM) the patient experienced extreme upper gastrointestinal (GI) distress beginning around 7 PM in the evening. Very painful gas and bloating. Sharp stabbing pain on left side rib cage, with each inspiration. She could only take shallow breaths to temper the pain. Difficult to find any position to sleep. Seven days later, still have residual pain. Daughter (patient) provided her adverse event (AE) symptoms and then handed the phone over to her mother. Mother (caller) stated that she had her second dose of the Pfizer Covid-19 vaccine on 09Mar2021. Caller reported that on 10Mar2021 at 7 o clock that she had extreme GI distress, bloating and gas pains. Caller reported she could not take deep breaths which caused pains on the left side. Caller stated she could not find a position to sleep in. Caller reported the pain on the right side was much worse when sleeping. Caller stated that seven days later she had improved some. Caller wanted to know if these are reported side effects. It was unknown if treatment was received due to the event. The events resulted in doctor or other healthcare professional office/clinic visit. The case was reported as non-serious. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was resolving.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Ear infection
Clinical narrative: ear infection; This is a spontaneous report received from a contactable consumer (Patient) or other non HCP.  A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as first dose single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date patient had ear infection last week and he was taking antibiotic for the past five days for adverse event. patient wanted to know if it was safe to take the second dose vaccine. Patient scheduled to get the second dose of the Covid19 vaccine on 13Mar2021. The outcome of event was unknown.     No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tiredness; This is a spontaneous report from a non-contactable Pharmacist reporting for a patient.  A female patient (unknown if pregnant) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation . The patient medical history and concomitant medications were not reported. It was unknown if patient had covid prior vaccination and if was covid tested post vaccination.On an unknown date the patient experienced tiredness post vaccination. Unknown if treatment were given. The  outcome of the event was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Parosmia
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via unspecified route of administration in left arm on 30Mar2021 03:00 PM (at the age of 52-year-old) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history included hepatitis, hemochromatosis, high blood pressure, known allergy to nickel. No COVID prior vaccination was reported. The patient's concomitant medications included losartan, from unspecified date at 50 mg, daily. No other vaccine was received four weeks. The patient previously took ciprofloxacin (CIPRO) and she experienced allergy. Patient reported that he received the Pfizer vaccine and he was involved in a vaccine clinic where they made some mistakes. He might or might not have received the first vaccine. They were not sure. They did not think he did. They scheduled me for 3 weeks in case he did get the vaccine. They think he might have gotten just saline solution instead of the vaccine. He knew Pfizer was doing testing on receiving a third dose instead of just two doses. Patient asked information on receiving a third dose. It was also reported that on 31Mar2021 12:00 PM the patient was suffering from weird smells that were not actually there, kind of bitter and sulfur like. It was very strong. Please note, he never actually had COVID. No treatment was received due to the event "smell alteration". The patient was not tested for COVID post vaccination. The outcome of the events was not resolved for "smell alteration" and unknown for the other event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: left arm to be a bit sore; tiny little headache; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6206), on 16Mar2021 at 13:00, after lunch (at the age of 76-years-old) at 2nd dose, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was in good health for age 76, as reported. The patient played semi pro sports. The patient received the first dose of BNT162b2 (lot number: EN6200) on 23Feb2021, at the age of 76-years-old, for COVID-19 immunisation. The patient experienced his left arm to be a bit sore and just one tiny little headache in Mar2021. He had no fever or other possible side effects. Patient asked if drinking alcohol had any effect a few hours later the vaccine. He clarified he was not drunk; only for a couple of glasses of wine/beers. The patient clarified that he had a couple of glasses of wine with dinner and had no reaction. He was speaking about having a couple of glasses of wine with dinner and the pharmacist told him that he was pretty sure that would be fine to do. Patient stated he had a lady friend coming over the night of the report and she was getting her 2nd Pfizer vaccine on that day and he was convinced that a glass of wine would not hurt. The patient asked when after the shot you would have the highest level of protection and how long after the 2nd booster of BNT162b2 he would be best protected and if it would be in another week or 2 weeks before full protection occurred. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia, Rash, Vaccination site erythema
Clinical narrative: I had a red whelp at the vaccination site; Painful arm; rash; Fever 100.7F; This is a spontaneous report from a contactable consumer (patient).  A 67-year-old female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Mar2021 at 11:03 at single dose for COVID-19 immunisation at the age of 67-year-old. Lot number was EN6206. Medical history and concomitant medications were unknown. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Feb2021 at single dose for COVID-19 immunisation (lot number EL9267) at the age of 67-year-old. On an unknown date, body temperature resulted 100.7 F (97-98.6F). On unknown date, the patient experienced whelp at the vaccination site; in Mar2021, the patient experienced rash, fever 100.7F; on 14Mar2021, the patient experienced Painful arm. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Illness, Nausea
Clinical narrative: sick; queasiness and an upset stomach; queasiness and an upset stomach; This is a spontaneous report from a contactable consumer (patient).   A 62-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left (at the age of 62) on 13Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included blood cholesterol from an unknown date and unknown if ongoing. Concomitant medication included rosuvastatin calcium (CRESTOR) taken for blood cholesterol abnormal (start date probably 3 years ago). The patient experienced sick on an unspecified date, queasiness and an upset stomach on an unspecified date. Patient was treated with Pepto-Bismol. Patient took some Tylenol for soreness but her arm never got sored. She just took Tylenol for prophylaxis. The outcome of illness was unknown. The outcome of the other events was not recovered.    Additional information: Per the caller: 'I have never been sick with covid and now I feel like this after getting the vaccine. This has been going on for 4 days now for me. It may be a stomach bug going around, but I am not sure. I saw my doctor on Monday and did not think to ask about this. I will be having an ultrasound (reason not provided) and if things get worse I may ask about it then. How long are symptoms supposed to last after getting the vaccine?'  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Rash vesicular, Vaccination site urticaria
Clinical narrative: had a few welts on my left arm where the vaccine was administered; Entire body was broken out in a rash/on my entire body head-to-toe/The rash is very itchy and sometimes oozes clear liquid; Entire body was broken out in a rash/on my entire body head-to-toe/The rash is very itchy and sometimes oozes clear liquid; Entire body was broken out in a rash/on my entire body head-to-toe/The rash is very itchy and sometimes oozes clear liquid; This is a spontaneous report from a contactable consumer (patient). A 27-year-old-female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN6203) via an unspecified route of administration, administered on the left arm on 25Feb2021 14:15 as 1st dose, single for COVID-19 immunization. Medical history included eczema an Allergy to Propylene Glycol. Concomitant medication included birth control pills. After receiving the first dose of the vaccine, patient had a few welts on her left arm where the vaccine was administered about an hour after the vaccine on 25Feb2021. About 3-4 days later (Feb2021), she noticed my entire body was broken out in a rash. The rash was very itchy and sometimes oozes clear liquid. She used steroid cream, creams, allergy medication, but the rash has not went down. It was on her entire body head-to-toe and has been here for 2 and 1/2 weeks with no sign of improvement. No treatment was received. Patient was not pregnant at the time of vaccination. The facility where the vaccine was administered was in a hospital. 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. Post vaccination, the patient has not been tested for COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Glossitis, Lymphadenopathy, Palpitations
Clinical narrative: swollen glands in her throat; dizzy/lightheaded; heart palpitations; inflammation on both sides of the back of her tongue; This is a spontaneous report from a contactable consumer (patient herself). A 40-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ENG203) intramuscularly on 25Feb2021 (at the age of 40-year-old) at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient reported that the first day and a couple of days after (not clarified further) she had swollen glands in her throat, inflammation on both sides of the back of her tongue and lightheaded. These symptoms lasted a couple of days. The following week she was dizzy and had heart palpitations. She informed that "heart stops sometimes" (as reported) and she was experiencing that on and off. The caller was apprehensive about the second dose and wanted to know if her symptoms were an allergic reaction. The patient did her normal routine blood work with her doctor, unsure whether it was before or after the shot: it was normal. Tongue and throat were improving, reported to be resolved (not clarified further). Outcome of the other events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient).   A 29-year-old female patient received first dose and second dose od BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), both on an unspecified date at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On an unspecified date the patient experienced chills, pyrexia (99.8 degree temp) and pain. The patient recovered from the events on an unspecified date.  No follow-up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.