chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cognitive disorder, Culture urine, Fatigue, Rash
Clinical narrative: Rashes on neck; High blood pressure; This is a spontaneous report from a contactable consumer (patient) via the Medical Information Team. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration on 16Feb2021 (lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she got her first BNT162B2 dose in in (institution name) in (state name) last 16Feb2021 and was scheduled on 09Mar2021 for her second dose. On an unspecified date, the patient experienced rashes on her neck and high blood pressure. The patient was given Benadryl and Aveeno lotion for the rashes. The patient added that already spoke to her doctor regarding this and was continuing to update him. Her doctor told her to call her vaccination provider. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous, Rash pruritic, Vaccination site pain
Clinical narrative: Rashes on neck; High blood pressure; This is a spontaneous report from a contactable consumer (patient) via the Medical Information Team. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration on 16Feb2021 (lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she got her first BNT162B2 dose in in (institution name) in (state name) last 16Feb2021 and was scheduled on 09Mar2021 for her second dose. On an unspecified date, the patient experienced rashes on her neck and high blood pressure. The patient was given Benadryl and Aveeno lotion for the rashes. The patient added that already spoke to her doctor regarding this and was continuing to update him. Her doctor told her to call her vaccination provider. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: The two big toes where swollen, red and painful underneath; four toes on each feet developed dark red spots on top/ fourth toes each were darkish red and also had the dark red spots on top; This is a spontaneous report from a contactable 75-year-old female consumer reported for herself that.  A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 05Feb2021 14:00 as (At the age of 75-years) dose 1, single for covid-19 immunisation. Medical history included sleep apnoea syndrome, and obesity from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously took clindamycin and experienced drug hypersensitivity. Patient was not Pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Patient did not diagnose with COVID-19 Prior to vaccination. Patient was not been tested for COVID-19 Since the vaccination. It was reported that on 09Feb2021 13:00, 3 days after the vaccines, four toes on each of his feet developed dark red spots on top. The two big toes where swollen, red, and painful underneath. The fourth toes each were darkish red and also had the dark red spots on top. Patient was visited Doctor or other healthcare professional office/clinic for the events. Patient did not receive any other treatment for the events. The events were assessed as Non serious by reporter. The outcome of events was recovering.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Extreme injection site soreness; Low grade fever; Body aches; Fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 46-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the left arm on 25Feb2021 at 10:00 (Lot Number: EL3247) as dose 2, single for COVID-19 immunization.  Medical history included high BP on an unknown date. The patient had no known allergies. The patient did not have COVID prior to vaccination. Concomitant medication included amlodipine besilate (NORVASC) taken for an unspecified indication, start and stop date were not reported.  The patient previously received the first dose of BNT162B2 on 04Feb2021 at 10:00 (lot number: EL3247) on the left arm for COVID-19 immunization (at 46-years-old). The patient was not tested for COVID post vaccination. On 25Feb2021 at 22:00, the patient experienced extreme injection site soreness, low grade fever, body aches and fatigue. The patient did not receive treatment for the events. The events recovered on Feb2021.   No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: extremely fatigued; body aches; This is a spontaneous report from a contactable consumer or other non hcp. A 37-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 26Feb2021 (at the age of 37-years-old) as dose 1, single for covid-19 immunisation.  Medical history included multiple sclerosis, allergic to Kiwi and Tomatoes. Concomitant medication included vitamin d nos. On 26Feb2021 at 14:30, the patient experienced extremely fatigued and body aches. Treatment was not received for the events. Facility where the most recent COVID-19 vaccine was administered was workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. This case was reported as non-serious as it did not meet any of the seriousness criteria. Prior to vaccination, the patient was not diagnosed with COVID. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events were recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema
Clinical narrative: I have redness about an inch below the injection site with fever in it.; fever; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration on 23Feb2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had redness about an inch below the injection site with fever in it. One spot was one inch below and the size of a quarter but not round. It was sideways. It then breaks down into a lower spot that was a little bigger. Outcome of redness below the injection site and fever was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Glossitis, Throat tightness, Tongue discomfort
Clinical narrative: tightness in my throat; my tongue has been burning; My tongue, it is irritating; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3302; Expiration Date: May2021), via an unspecified route of administration on 24Feb2021 10:30 (Wednesday) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date (since Wednesday, 40 minutes later), the patient experienced tightness in my throat, her tongue has been burning (it's not swollen, it's not red, it's not peeling), it is irritating. The doctor instructed her to take antihistamines, and they help a little bit. It was still happening on Friday (26Feb2021). The patient has no other problems. Injection site was fine, there was no swelling, have no fever and no flu like symptoms. The outcome of the events was unknown. There was no product quality complaint (PQC) present.  No follow-up attempts are possible. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling, Vaccination site pain
Clinical narrative: pain; swelling; aching at injection site; This is a spontaneous report from a non-contactable consumer. An 86-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration at the age of 86 years old on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pain, swelling and aching at injection site. The outcome of the events was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Eczema, Skin exfoliation
Clinical narrative: Ear Eczema: dry peeling skin inside ears; skin peeling; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 44-years-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9629), via an unspecified route of administration, administered in Arm Left on 05Feb2021 15:15 (Age at vaccination: 44-years-old) as single dose for covid-19 immunization. (Vaccination facility: Hospital). Medical history was reported as none. The patient concomitant medications were not reported. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination patient was not diagnosed with COVID-19. Had no Allergies to medications, food, or other products. On 08Feb2021 08:00 The patient experienced ear eczema: dry peeling skin inside ears. Patient was not received any treatment for the events. The outcome for the events was reported as not resolved at the time of this report.   Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Oral discomfort
Clinical narrative: Facial flushing; Lips felt funny; This is a spontaneous report from a contactable physician via the Medical Information Team. A female patient of an unspecified age (reported as age: 81, unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration on an unspecified date (lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The physician reported that the patient got her first dose of BNT162B2 and experienced facial flushing and lips felt funny a few days later. The physician wanted to know if the patient can get the second dose and if Benadryl can be taken before the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: I suffered intense general itching of from my knees to my shoulders approximately 36 hours after the vaccination.; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9236), via an unspecified route of administration, administered in arm left on 30Jan2021 at 08:45 (at the age of 72-years-old as dose 1, single for COVID-19 immunisation. Medical history included high cholesterol from an unknown date. Concomitant medication included meloxicam taken for an unspecified indication, start and stop dates were not reported. On 31Jan2021, the patient experienced suffered intense general itching of from his knees to his shoulders approximately 36 hours after the vaccination. It lasted about an hour and has not recurred. There was no treatment received for the event. The outcome of the event was recovered on an unspecified date.     No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: joint pain; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 10Feb2021 (Lot number was not reported) as dose number unknown, single for COVID-19 immunization.  The patient's medical history was not reported. There were no concomitant medications. The patient experienced joint pain on Feb2021. The outcome of the event was unknown. The event was reported as non-serious.   No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Swelling in lower lip after first dose; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EL3302), via an unspecified route of administration, administered in the left arm on 18Jan2021 08:30 (at the age of 38-years-old) as dose 1, single for COVID-19 immunization. Medical history included Sulfa allergy, dust allergy, allergy to some roots, gastroesophageal reflux disease (GERD), obesity, temporomandibular joint (TMJ) syndrome, Cameron ulcers, and hiatal hernia. Prior to vaccination, the patient did not have COVID-19. Concomitant medication included omeprazole. The patient did not receive any other vaccine within 4 weeks of the COVID vaccination. On 20Jan2021, the patient experienced swelling in lower lip after first dose. The event resulted in physician office visit. The patient took Benadryl (did not help) and Prednisone (helped) for the event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Hot flush, Injection site injury, Oropharyngeal pain
Clinical narrative: hot flashes; pain in rotator cuff and back; spot on arm sore about the size of a nickel where they gave the shot; sore throat; This is a spontaneous report from a contactable consumer or other non-healthcare professional. An 81-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), dose 2 via an unspecified route of administration on 12Feb2021 (Batch/Lot Number: EN9809) (at the age of 81-years-old) as DOSE 2, SINGLE for covid-19 immunization.  Medical history included none. There were no concomitant medications reported. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), dose 1 via an unspecified route of administration on 22Jan2021 (Batch/Lot Number: EN5318) for covid-19 immunization ns experienced sore throat. On 21Feb2021, the patient experienced sore throat. On an unspecified date, the patient experienced hot flashes, pain in rotator cuff and back, spot on arm sore about the size of a nickel where they gave the shot. It was reported that she received her first covid vaccine dose on 22Jan2021 and 10 days later on 02Feb2021 got a sore throat that lasted about 8 days before going away, had to take a Z-pack, which was not normal for her. She reported that she received her second vaccine dose on 12Feb2021 and again 10 days later on 21Feb2021 she experienced another sore throat. Stated that she got up Sunday morning, 21Feb2021, with a sore throat again, states it is worse today that it was when she woke up yesterday. She also endorses some hot flashes. It was also reported that she has a tear in her rotator cuff, started hurting her last week, got a corticosteroid injection in that area about 6 weeks ago prior to vaccine, states now arm is hurting and back is hurting and is unsure if it is related to the vaccine. States she did have little spot about the size of a nickel after the vaccine where they gave the shot that was a little sore, whole arm was fine. Wanted to know if this could be a delayed reaction to the vaccine. The clinical 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: Pain in extremity
Clinical narrative: hurt her hand; This is a spontaneous report from a non-contactable consumer. A 62-year-old 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 on an unspecified date as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Enquired, the caller was offered to be connected with safety department but caller refused, (e-transmitted the AE) Anonymous 62-years-old female patient refused to provide name or any demographics. Stated that, few days ago she received her first dose of the Pfizer COVID vaccine. On an unspecified date, she hurt her hand and wanted to know whether she can take Advil for it. Stated that, how long they have to wait before they can take anti-inflammatory medication. Stated that, her next dose was due in 2.5 weeks. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Body Rash; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received bnt162b2 (BNT162B2, Lot Number: EL9261), dose 1 via an unspecified route of administration, administered in Left arm on 27Jan2021 16:15 (at the age of 79-year-old) as dose 1, single for Covid-19 immunization. The patient medical history was not reported. Concomitant therapy included unspecified vaccine administered in Left arm on 21Feb2021(Lot Number: EN6201). The patient experienced body rash on 30Jan2021 17:30. The patient received no treatment for the event. The outcome of the event was not recovered.    No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Redness and itchiness on inside of right hand, near wrist, opposite side of thumb; Redness and itchiness on inside of right hand, near wrist, opposite side of thumb; This is a spontaneous report from a non-contactable consumer (patient). A 68-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EL9266), via an unspecified route of administration, administered in the left arm on 22Feb2021 10:00 (at the age of 68-years-old) as dose 1, single for COVID-19 immunization. Medical history included sulfa allergy. Prior to vaccination, the patient did not have COVID-19. Concomitant medications included bupropion, levothyroxine (LEVOTHYROXINE), and pitavastatin magnesium (ZYPITAMAG). The patient did not receive any other vaccine within 4 weeks of the COVID vaccination. On 22Feb2021 15:15, the patient experienced redness and itchiness on inside of right hand, near wrist, opposite side of thumb which lasted for one hour. Therapeutic measures were not taken as result of the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered on 22Feb2021 16:15.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This is a spontaneous report from a contactable other hcp (patient). A 74-year-old female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: ER8727), via intramuscular route of administration in arm left on 01Apr2021 at 13:00 (at the age of 74-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included ongoing migraine. The concomitant medications of the patient were not reported. The patient previously took flu vaccine and had a Guillain Barre reaction to Flu vaccine in 1965 when she was 18 years of age and she also took first dose of BNT162B2(solution for injection, Batch/Lot number: EN6206), via intramuscular route of administration in arm right on 011Mar2021 at 12:45 (at the age of 74-years-old) as single dose for COVID-19 immunisation and experienced sore arm and Fatigue. She had never taken a flu vaccine since. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The family medical history relevant to AE(s) was reported as severe reactions to vaccines and nephew's child- Respiratory arrest with 1st childhood vaccine. On 02Apr2021, the patient experienced fatigue. The patient stated, she had concerns about taking the Covid 19 vaccine because of the reaction she had to the flu vaccine. She had read that the Influenza virus and the Covid 19 virus are both in the family of Corona Viruses. She was concerned that there was something in the Covid 19 vaccine or during the production that would cause a worse reaction than what she had to the flu vaccine. She sated no confirmed testing for anyone in her family but because of their history of alcoholism and reactions to vaccines, was this enzyme studied during the clinical trial. The reporter reported the events as not serious. The patient recovered from the event on 10Apr2021.  Follow-up(30Jul2021): This is a follow up  spontaneous report from a contactable other HCP. This 74-year-old female consumer (patient) reported for herself that included: Patient age at vaccination, patient medical history, Family medical history relevant to AE(s), date and time of vaccination, Lot numbers, route of administration, Anatomical site of injection of both first and second doses, adverse events, onset date and outcome of the events.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Lip swelling, Pruritus, Rash
Clinical narrative: her head started itching; lip was swollen; rash all over the place; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 02Feb2021 (at the age of 67-years-old) (Lot Number: EL3302) as dose 1, single for COVID-19 immunisation; oxycodone hydrochloride, paracetamol (OXYCODONE/APAP [OXYCODONE HYDROCHLORIDE;PARACETAMOL], tablet strength: 5mg/325mg), via an unspecified route of administration from 15Feb2021 (Batch/Lot number was not reported) to an unspecified date, at 3 DF (5-325mg, caller only took three total tablets) for an unspecified indication.  Medical history included reactions to adhesives used in surgery and gallbladder operation on 15Feb2021. It was reported by the patient that her gallbladder surgery was not an emergency and knew she needed the surgery prior to getting the COVID vaccine. There were no concomitant medications.  On 16Feb2021, the patient experienced lip was swollen, rash all over the place, and her head started itching. The patient does not know if the reaction was due to the vaccine or the medication she got from her surgery. The patient informed that she was due for the second dose of the product and was wondering if she should still get it. The outcome of the events lip swelling, and rash all over was recovering/resolving whereas outcome of the event itching was recovered/resolved on an unspecified date.    No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia, Dysgeusia, Pollakiuria, Urinary tract infection
Clinical narrative: UTI; Frequent urination; amber to brown urine; Everything I put into my mouth tasted bitter for a day; This is a spontaneous report from a non-contactable consumer (patient). A 65-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration in left arm on 16Feb2021 12:15 as dose 2, single for COVID-19 immunization (at the age of 65-year-old, non-pregnant). Patient historical vaccine included first dose of BNT162B2 via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had no known allergies. The patient did not receive any other vaccine in four weeks. Patient had no covid prior vaccination and covid was not tested post vaccination. The patient experienced UTI (urinary tract infection), frequent urination, amber to brown urine and everything she put into her mouth tasted bitter for a day on an unspecified date. Patient did not receive treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021225127 same reporter/drug with different patient, similar AE
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Myalgia, Pain in extremity
Clinical narrative: facial flushing; muscle soreness in upper left arm and left shoulder; pain in right hand; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (BNT162B2, Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in left arm on 22Feb2021 09:00 (at the age of 48-year-old) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history was none. The patient's concomitant medications were not reported. On 22Feb2021 12:00, the patient experienced facial flushing, muscle soreness in upper left arm and left shoulder and pain in right hand. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received no treatment for the reported events. The patient recovered from the events on unspecified date in 2021.    No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: got like a rash developing on front torso; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Lot Number: EN6201, Expiration Date not reported) via an unspecified route of administration, administered in the left arm, on 23Feb2021 (at the age of 59-years-old), as dose 2, single for COVID-19 immunisation. The patient has no relevant medical history and no concomitant medications. The patient got like a rash developing on front torso on an unspecified date in Feb2021. Patient was wondering if it was a typical reaction or if it was from the Pfizer vaccine possibly. Patient did not receive any treatment. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Dizziness, Fatigue, Headache
Clinical narrative: Very dizzy; Felt suffocating/ Oxygen level got to 92 and is fluctuating; Temperature was 73; Weird pain; Headache; Tiredness and fatigue; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVI-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Feb2021 as single dose for covid-19 immunization. Medical history included Chronic obstructive pulmonary disease, Asthma both from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 on 05Feb2021 for covid-19 immunization. It was reported that had second COVID-19 Vaccine on 26Feb2021. Was ok on Friday, fine on Saturday. Sunday, when she woke up was feeling very dizzy, suffocating, and had a headache. When she checked her temperature, it was 73. Caller did not provide a unit of measurement for her temperature. Her oxygen level went down to 92. Yesterday, her body temperature began to be normal. Her oxygen level is fluctuating. She is having too much dizziness and shortness of breath. It was also reported that First dose was on 05Feb2021 and second dose was 26Feb2021. She was fine on Friday and Saturday. Began suddenly on Sunday. She is worried about it. It is weird pain, tiredness, and fatigue. Cannot express what is going on. Worried about fluctuation of oxygen level. She is a COPD and asthma patient. Asked what she should do. Should she contact her PCP or the vaccine facility. Stated it is a weird thing. Feeling too tired to complete report. The patient underwent lab tests and procedures which included oxygen consumption: 92, body temperature: 73. The outcome for the events was reported as unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Oxygen consumption, Pain, Suffocation feeling
Clinical narrative: Very dizzy; Felt suffocating/ Oxygen level got to 92 and is fluctuating; Temperature was 73; Weird pain; Headache; Tiredness and fatigue; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVI-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Feb2021 as single dose for covid-19 immunization. Medical history included Chronic obstructive pulmonary disease, Asthma both from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 on 05Feb2021 for covid-19 immunization. It was reported that had second COVID-19 Vaccine on 26Feb2021. Was ok on Friday, fine on Saturday. Sunday, when she woke up was feeling very dizzy, suffocating, and had a headache. When she checked her temperature, it was 73. Caller did not provide a unit of measurement for her temperature. Her oxygen level went down to 92. Yesterday, her body temperature began to be normal. Her oxygen level is fluctuating. She is having too much dizziness and shortness of breath. It was also reported that First dose was on 05Feb2021 and second dose was 26Feb2021. She was fine on Friday and Saturday. Began suddenly on Sunday. She is worried about it. It is weird pain, tiredness, and fatigue. Cannot express what is going on. Worried about fluctuation of oxygen level. She is a COPD and asthma patient. Asked what she should do. Should she contact her PCP or the vaccine facility. Stated it is a weird thing. Feeling too tired to complete report. The patient underwent lab tests and procedures which included oxygen consumption: 92, body temperature: 73. The outcome for the events was reported as unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Insomnia, Pruritus
Clinical narrative: itching all over and that the first one wasn't so bad; couldn't sleep; asthma was worse also; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EL892, Expiration date: 31May2021), via an unspecified route of administration on 30Jan2021 (at the age of 81-years-old) as dose 1, single for COVID-19 immunisation. Medical history included diabetes mellitus, cancer twice, asthma, osteoporosis, heart problems, poison ivy (hospitalized), cholesterol, and allergies (about 18 allergies of things that she is allergic to). Concomitant medications included unspecified cholesterol medication. On an unspecified date after the first vaccine, the patient experienced itching all over and that the first one wasn't so bad, couldn't sleep, and asthma was worse also. It was reported that the patient has about 18 allergies of things that she was allergic to; she has dealt with allergies since she had poison ivy and she was hospitalized with it and has dealt with allergies a long time and knew that each time of getting around something or having same medicine or whatever it gets worse. The patient stated that she can get a list of all her allergies from her doctor. She stayed in the house as all around her has been the virus and people in the hospital and she was scared to even go out. She was scared to walk down the street and people have the virus and don't feel it and she doesn't want to get it and people with the virus shouldn't be out. The patient stated that when she took her 1st shot, she had reaction and thought it was because her heart doctor had put on different cholesterol medication and she thought that she was reacting to that a little bit but then it eased off in a couple days. When the virus first came out the patient's doctor wouldn't see her and sent her to the ER, and they checked her thoroughly for the virus and a month later she went to the health department for a check for the virus. It was reported that the patient had some sort of virus for about 3 weeks. The patient's friend told her that if she had a reaction to the shots, she would have to take them again, but her doctor said she would not have to. The patient was concerned about having to repeat the vaccine and wanting that question addressed. The patient was querying if the shots will be as effective if she has taken Benadryl. Treatment with diphenhydramine hydrochloride (BENADRYL) was taken for the events. The events resulted in a physician office visit (consultation with her doctor). The outcome of the events was unknown. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EL9266, Expiration date: 31May2021), via an unspecified route of administration on 21Feb2021 (at the age of 81-years-old) for COVID-19 immunisation  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Dizziness, Eating disorder, Hyperhidrosis
Clinical narrative: diaphoretic; light-headed; nausea; hadn't eaten all day; BP initially low at 85/53; hypotensive; hypoglycemic; This is a spontaneous report from a contactable physician (reported for patient). A 29-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9810, Expiration date was not reported), dose 1 intramuscular, administered in Arm Left on 27Feb2021 14:07 (age at vaccination 29 years) as dose 1, single for covid-19 immunisation. The patient Medical history was none. There were no concomitant medications. No Prescription over the counter medication, dietary supplements, or herbal remedies being taken at the time of vaccination. Patient had no allergies to medication, food or other products, no Other illness at the time of vaccination and up to one month prior, also not Chronic or long-standing health conditions. Patient visited Doctor or other healthcare professional office/clinic visit. On 27Feb2021 14:17 the patient experienced diaphoretic, light-headed, nausea, hadn't eaten all day, bp initially low at 85/53 which improved upon lying down, hypotensive, hypoglycemic event most likely unrelated to vaccine. Patient discharged to home in stable condition after observation over 30 minutes. The patient underwent lab tests and procedures which included blood pressure measurement was 85/53 on low, blood pressure measurement was 110/70 (normalized), vital signs measurement was stable. Therapeutic measures were taken as a result of bp initially low at 85/53 given water as treatment. On an unspecified date in 2021, the patient had recovered from the events.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoglycaemia, Hypotension, Nausea, Vital signs measurement
Clinical narrative: diaphoretic; light-headed; nausea; hadn't eaten all day; BP initially low at 85/53; hypotensive; hypoglycemic; This is a spontaneous report from a contactable physician (reported for patient). A 29-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9810, Expiration date was not reported), dose 1 intramuscular, administered in Arm Left on 27Feb2021 14:07 (age at vaccination 29 years) as dose 1, single for covid-19 immunisation. The patient Medical history was none. There were no concomitant medications. No Prescription over the counter medication, dietary supplements, or herbal remedies being taken at the time of vaccination. Patient had no allergies to medication, food or other products, no Other illness at the time of vaccination and up to one month prior, also not Chronic or long-standing health conditions. Patient visited Doctor or other healthcare professional office/clinic visit. On 27Feb2021 14:17 the patient experienced diaphoretic, light-headed, nausea, hadn't eaten all day, bp initially low at 85/53 which improved upon lying down, hypotensive, hypoglycemic event most likely unrelated to vaccine. Patient discharged to home in stable condition after observation over 30 minutes. The patient underwent lab tests and procedures which included blood pressure measurement was 85/53 on low, blood pressure measurement was 110/70 (normalized), vital signs measurement was stable. Therapeutic measures were taken as a result of bp initially low at 85/53 given water as treatment. On an unspecified date in 2021, the patient had recovered from the events.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Vaccination site erythema
Clinical narrative: site where the patient got second shot was red a little red; arm was red a little red; This is a spontaneous report from a non-contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on an unspecified date (Batch/lot number unknown), as dose 2, single, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the site where the patient got second shot was red a little red. On an unspecified date, the patient's arm was red a little red. The patient asked if there was something the patient can put on it. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Symmetrical rash on back of both hands.; This is a spontaneous report from a non-contactable consumer (patient). A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via an unspecified route of administration on 11Feb2021 12:00 single dose for covid-19 immunisation. Medical history included covid prior to vaccination from an unspecified date to an unspecified date. The patient had no known allergies. The patient did not receive other vaccine in four weeks. Concomitant medication included levothyroxine (MANUFACTURER UNKNOEN). The patient experienced symmetrical rash on back of both hands on 12Feb2021. As a result, the patient had a doctor/clinic visit and was given an unspecified topical cream as treatment for the event. The patient had not tested positive for covid post vaccination. Outcome of symmetrical rash on back of both hands was not recovered at the time of the report.   No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: Arm pain at site of injection; Too sore to move normally; This is a spontaneous report from a non-contactable consumer (patient). A 25-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EN6202), via an unspecified route of administration, administered in the right arm on 26Feb2021 11:00 (at the age of 25-years-old) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient did have history of COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26Feb2021 14:00, the patient experienced arm pain at site of injection. It was too sore to move normally. Therapeutic measures were not taken as result of the events. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site mass
Clinical narrative: Had first shot and noticed that I am getting like bump on my arm, it's getting hard around inside of it; Had first shot and noticed that I am getting like bump on my arm, it's getting hard around inside of it; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Expiration date: Unknown) via an unspecified route of administration on an unspecified date (70-year-old at vaccination) as a Dose 1, Single for COVID-19 immunization. The patient medical history was not reported.  The patient reported that he took different kinds of medications (unspecified). He had the first shot on he believe it was on Wednesday of this week and have he noticed now he was getting like a bump on his arm it's like getting hard around inside of it. He queried if that was normal. The reported provide limited information. No investigation assessment was provided. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site mass
Clinical narrative: lump in my arm that is no where near the injection site; itches; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A female patient of (Age: 71; Unit: unknown) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 for COVID-19 immunization. The patient experienced lump in my arm that is nowhere near the injection site, itches on an unspecified date. Patient had a concern. Patient had a lump in her arm that is nowhere near the injection site. An inch or two from where the shot was given. It is hot and the size of a small egg and itches like crazy. Second shot. It's hard and hurts when you press on it. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: swelling on his face; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on 24Feb2021 (Batch/lot number unknown), as dose 1 single, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, after the first dose, the patient experienced slight swelling on his face. The patient was asking if it was normal or if it was a side effect. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: arthritis; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable consumer (patient) reported that a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via an unspecified route of administration on 26Feb2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced arthritis on an unspecified date. The patient asked if and when can she take Tylenol for arthritis. Outcome of arthritis was unknown.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Somnolence
Clinical narrative: Bad Cough; has been really sleepy; This is a spontaneous report from a Pfizer-sponsored program Support. A contactable consumer reported that a female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on 06Feb2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient has been suffering a really bad cough and has been really sleepy. Spoke to her doctor about it already and he suggested she gets tested for Covid before getting second dose of vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain
Clinical narrative: her neck and shoulders still hurt; her neck and shoulders still hurt; This is a spontaneous report from Regulatory Authority from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 06Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced her neck and shoulders still hurt on an unspecified date with outcome of not recovered. Clinical course was as follows: Patient got the first dose of the Covid19 vaccine last 06Feb2021 and scheduled to get the second dose on 27Feb2021. However, her neck and shoulders still hurt until now and the patient wanted to reschedule the appointment for later. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.