chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: It's like a vibrating or quivering of my heart; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported) dose number unknown via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medication was not reported. No pqc was reported. On an unspecified date the patient experienced it's like a vibrating or quivering of my heart. The patient reported that for every 2 minutes it does it for about 20 seconds. It's very strange and she never had it before. Feels like there was an electric something going on in the heart. No heart racing or fluttering. Feels like holding something that was vibrating up to my chest. The clinical outcome of the event was unknown.  AE- Caller spoke with me and she did not want to file a report, I tried again and she still did not want to file a report and did not want to provide all of her demographic information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: injection site pain; arm was sore; This is a spontaneous report from a contactable consumer. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Apr2021 at 10:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included musculoskeletal shoulder issues. It was unknown whether the patient received other medications in two weeks of vaccination. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID vaccine. On 14Apr2021, the patient experienced some injection site pain and her arm was sore. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the events. The clinical outcomes of the events injection site pain and arm was sore were unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: body aches; fever; headache; chills; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 14Apr2021 at 10:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included curcuma longa rhizome (TURMERIC), multivitamin(MANUFACTURER UNKNOWN) and beclometasone dipropionate (QVAR REDIHALER) all for unknown indication from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 24Mar2021 at 12:15 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 23:00 the patient experienced fatigue, fever, headache, body aches and chills. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, fever, headache, body aches and chills was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Nausea, Pyrexia
Clinical narrative: brain fog; Ongoing low grade fever; Fatigue; nausea; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EQ0150) via an unspecified route of administration in the left arm on 05Apr2021 at 11:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included borderline personality disorder, kidney stones, latex allergy, adhesives allergy. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), lamotrigine (LAMICTAL), trazodone hydrochloride (OLEPTRO), famotidine (PEPCID), paracetamol (TYLENOL) all from an unknown date for an unspecified indication. The patient previously took fentanyl (MANAFACTURER UNKNOWN) from an unknown date for an unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 06:30, the patient experienced ongoing low-grade fever, brain fog, fatigue, nausea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events ongoing low-grade fever, brain fog, fatigue, nausea was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles; rash eruption; This is a spontaneous report from a contactable physician, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248) via an unspecified route of administration in the right arm on 29Jan2021 at 08:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis, vitamin d deficiency, migraine headache and irritable bowel syndrome (IBS). The patient had no known drug allergy. Concomitant medications included famotidine (MANUFACTURER UNKNOWN), macrogol 3350 (MIRALAX), meloxicam (MANUFACTURER UNKNOWN), nebivolol hydrochloride (BYSTOLIC) and MVI; all taken for unknown indications from an unknown date and unknown if onging. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EH9899) via an unspecified route of administration in the right arm on 07Jan2021 at 07:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 13:00, the patient developed shingles with rash eruption. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the reported events and included treatment with acyclovir (MANUFACTURER UNKNOWN) and NSAIDs. The clinical outcome of the events shingles and rash eruption were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: lips felt numb; This is a spontaneous report from a contactable consumer, the patient. A 57-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 15Apr2021 at 09:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had known allergy (unspecified). The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021, 30 minutes after vaccination at 10:00 the patient experienced lips felt numb like she had Novocain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event lips felt numb was recovered on 15Apr2021, after the duration of one hour.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: facial numbness; This is a spontaneous report received from a contactable Pharmacist via other health care professional. A patient of unknown demographics received pfizer-biontech covid-19 vaccine (BNT162B2) dose 1, via an unspecified route of administration on unspecified date (Batch/Lot Number: not reported) as SINGLE DOSE for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, patient had developed facial numbness 30 mins after the Pfizer covid vaccine first dose. He wanted to know if there is any information about the second dose for this patient. The patient still has the unilateral facial numbness. The outcome of the event facial numbness was not recovered. Additionally it was reported that Caller stated they had 8 patients (gender and age is unknown) who received the Pfizer covid vaccine that they think, not sure, if the vial was over diluted or if the doses were drawn not full 0.3ml. caller wanted to know if the vaccine losses its effectiveness if they are over diluted..  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Very painful area where injection was given, painful without even touching area.; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the right arm on 13Apr2021 at 10:45 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 infection, post-traumatic stress disorder (PTSD) and cardiac disorder (the patient was stabbed 14x on 24Aug2019 nicked heart, jugular, etc. The patient was survived and was ok at the time of this report). The patient had known allergies to amphetamine (MANUFACTURER UNKNOWN), dextroamphetamine (MANUFACTURER UNKNOWN), cephalosporins, sucralose (MANUFACTURER UNKNOWN). The patient received unspecified concomitant medication on an unknown date, for unknown indication and unknown if ongoing. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 13Apr2021, the patient experienced very painful area where injection was given, painful without even touching area. It was still continued at the time of this report. No therapeutic measures were taken as a result of the event. The clinical outcome of the event very painful area where injection was given, painful without even touching area was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Pain, Pyrexia
Clinical narrative: Fever; Aches; Chills; Feeling of a heavy weight on their chest; This is a spontaneous report from a non-contactable consumer. An adult non-pregnant female patient of an unknown age received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on 14Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported.  It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination and was tested for COVID-19 since the vaccination. It was unknown whether the patient had received any other vaccines within four weeks prior to the vaccination. On 14Apr2021, the patient experienced fever, aches, chills and a feeling of a heavy weight on the chest. It was unknown whether any therapeutic measures were taken as a result of the reported events. The clinical outcome of the events fever, aches, chills and feeling of a heavy weight on the chest were unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: Day after became nauseous for 4-5 days with occasional vomiting; then in addition developed fever along with prior symptoms for the next 5 days followed by continued nausea with occasional vomiting.; in addition developed fever; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 29Mar2021 at 13:30 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included none. Concomitant medications included paracetamol (TYLENOL) used for unknown indication from unspecified dates, unknown if ongoing. The patient was not allergic to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 04:00, the patient became nauseous for 4-5 days with occasional vomiting, then in addition developed fever along with prior symptoms for the next 5 days followed by continued nausea with occasional vomiting. The adverse events resulted in a visit to the doctors or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of these events. On 07Apr2021, the patient underwent nasal swab test and the result was negative. The clinical outcome of the events nauseous, vomiting and fever was resolving at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Disturbance in attention, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional (patient). A 53-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 53, via an unspecified route of administration, right arm, on Apr 10, 2021, at 21:30, single dose, for COVID-19 immunisation. Medical history included hypertension. Concomitant medications included lisinopril from an unknown date. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 52, via an unspecified route of administration, left arm, on Mar 21, 2021, at 13:30, single dose, for COVID-19 immunisation. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 11, 2021, at 13:15, patient experienced chills, fever of 101.9ºF, soreness in right arm, weakness and difficulty of concentrating. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event chills, fever of 101.9ºF, soreness in right arm, weakness and difficulty of concentrating were recovering (at the time of this report). No follow-up attempts required. Information about lot/batch number cannot be obtained. No further information expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional (patient). A 53-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 53, via an unspecified route of administration, right arm, on Apr 10, 2021, at 21:30, single dose, for COVID-19 immunisation. Medical history included hypertension. Concomitant medications included lisinopril from an unknown date. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 52, via an unspecified route of administration, left arm, on Mar 21, 2021, at 13:30, single dose, for COVID-19 immunisation. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 11, 2021, at 13:15, patient experienced chills, fever of 101.9ºF, soreness in right arm, weakness and difficulty of concentrating. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event chills, fever of 101.9ºF, soreness in right arm, weakness and difficulty of concentrating were recovering (at the time of this report). No follow-up attempts required. Information about lot/batch number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever; Chills; Body aches; This is a spontaneous report from a non-contactable consumer. A non-pregnant female patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 12Apr2021 as a single dose for COVID-19 immunization. Medical history was not reported. The patient did not receive any concomitant medication. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 13Apr2021, the patient had fever, chills and body ache. It was unknown whether any therapeutic measures were taken as a result of the reported events. The clinical outcome of the events fever, chills and body ache was unknown at the time of report.   No follow-up attempts are possible; Information about lot\batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Oral disorder, Oropharyngeal pain, Pharyngeal swelling, Urticaria
Clinical narrative: Sore throat; Bumps in mouth; Bumps in throat; Large hives on entire body; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733) via an unspecified route of administration in the left arm on 13Apr2021 at 14:00 (at the age of 29-years-old) as single dose for COVID-19 immunisation. The medical history of the patient included hashimotos disease and COVID-19. The patient did not have any allergies to medications, food, or other products. Concomitant medication included levothyroxine (MANUFACTURER UNKNOWN), clavulanate potassium and amoxicillin trihydrate (AMOXICLAV), cefalexin (MANUFACTURER UNKNOWN) and colecalciferol (VITAMIN D3); all for an unspecified indication and unknown start date. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccination within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 14Apr2021 at 17:00, the patient developed large hives on entire body, sore throat, bumps in mouth and throat. Therapeutic measures were taken as a result of the events and included treatment with steroid cream(unspecified). The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events of large hives on entire body, sore throat, bumps in mouth and bumps in throat were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Fever; Body aches; vomiting; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 10:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Apr2021 at 04:30, the patient experienced fever, body aches and vomiting. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, body aches and vomiting was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache which was constant all day; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 09:00 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. It was unknown if the patient had allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19.  On 11Apr2021, the patient experienced headache since 4 days which was constant all day. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if the patient had tested for COVID post vaccination. The clinical outcome of the event headache was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Rash, Rash morbilliform, Skin lesion
Clinical narrative: rash developed predominately on torso, but also affected arms legs and neck.; The measles like rash created a burning sensation that lasted 2 days and resulted in some lesions t; rash created a burning sensation; some lesions; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 07Apr2021 at 10:30 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies and the patient had no chronic health conditions. Concomitant medications included red beet powder and only beet powder as reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 17Mar2021 at 10:45 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 11:00, 4 days after 2nd dose a rash developed predominately on torso, but also affected the arms legs and neck. The measles like rash created a burning sensation that lasted 2 days and resulted in some lesions that persisted and required additional days of healing. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcomes of the events rash, measles like rash, rash created a burning sensation and some lesions were recovering at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rash
Clinical narrative: Tired; Small rash on leg, arms, back, legs, thighs, wrists and butt; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on 14Apr2021 at 09:00 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history included depression and post-traumatic stress disorder. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to food, medications, or other products. Concomitant medications included paracetamol (ACETAMINOPHEN) from an unknown date, for unspecified indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 25Mar2021 at 10:00 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 14:45 the patient experienced, as she got home she went to bed, cause the vaccine made her tired. She woke up at approximately 14:47  and had a small rash on her leg. The next day her rash was worse. It was on her arms, back, legs, thighs, wrists and her butt. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events tired and small rash on leg, arms, back, legs, thighs, wrists and butt was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Feeling abnormal, Hypoaesthesia oral, Tinnitus
Clinical narrative: Dizzy/brain fog; Brain fog; tongue tip numbness; lower lip numbness; joint pain; vision blurry; ringing in ears; This is a spontaneous report from a non-contactable consumer, the patient. A 75-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0IS0) via an unspecified route of administration in the left arm on an unknown date in Apr2021 (at the age of 75-year-old) as a single dose for COVID-19 immunisation. Medical history included candida and sinus infection. The patient had allergy to molds and patient previously took codeine on an unknown date for unknown indication and experienced drug allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN) and tamsulosin (MANUFACTURER UNKNOWN) all for unknown indication from unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 10:45 the patient experienced dizzy/brain fog, tongue tip and lower lip numbness, joint pain, vision blurry and ringing in ears. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizzy/brain fog, tongue tip and lower lip numbness, joint pain, vision blurry and ringing in ears were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Dizzy/brain fog; Brain fog; tongue tip numbness; lower lip numbness; joint pain; vision blurry; ringing in ears; This is a spontaneous report from a non-contactable consumer, the patient. A 75-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0IS0) via an unspecified route of administration in the left arm on an unknown date in Apr2021 (at the age of 75-year-old) as a single dose for COVID-19 immunisation. Medical history included candida and sinus infection. The patient had allergy to molds and patient previously took codeine on an unknown date for unknown indication and experienced drug allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN) and tamsulosin (MANUFACTURER UNKNOWN) all for unknown indication from unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 10:45 the patient experienced dizzy/brain fog, tongue tip and lower lip numbness, joint pain, vision blurry and ringing in ears. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizzy/brain fog, tongue tip and lower lip numbness, joint pain, vision blurry and ringing in ears were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Vomiting
Clinical narrative: fever; chills; vomiting; headache; This is a spontaneous report from a contactable consumer. A male patient of unknown age received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 14Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19.It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 14Apr2021,the patient experienced fever, chills, vomiting and headache. It was unknown whether therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, chills, vomiting and headache was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Lymph node pain, Lymphadenopathy, Pain in extremity
Clinical narrative: Running down the arm past elbow almost feels a little numb; Discomfort in arm where shot given-sort of on back side of arm; Pain in arm where shot given-sort of on back side of arm; Discomfort/pain under arm; Lymph node swelling; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the  left arm on 10Apr2021 at 12:00(at the age of 56-year-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as none.The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration on 06Mar2021 at 12:00(at the age of 56-year-old) as a single dose for COVID-19immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.The patient did not receive any medication within two weeks of vaccination.  On 11Apr2021, the patient experienced discomfort/pain in the arm where the shot was given (sort of on backside of arm) lymph node swelling discomfort/pain underarm and running down the arm past elbow almost felt a little numb on day 5. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and the emergency room/department or urgent care. The clinical outcome of the event discomfort/pain in arm where shot was given (sort of on the backside of arm) lymph node swelling discomfort/pain underarm and running down the arm past the elbow almost felt a little numb on day 5 was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Peripheral coldness
Clinical narrative: my left arm (the arm I got theshot in) got very cold; Tingle from elbow all the way down to  ringfinger and pinky finger; tingle from elbow all the way down to ringfinger and pinky finger. A short time after that area became numb and remained numb; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Apr2021 at 13:15 (at the age of 56-year-old) as a single dose for COVID-19 immunization. Medical history included asthma, blood pressure high, suspected covid-19 on unknown date. The patient was allergic to penicillin, sulfur and clindamycin. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Apr2021 at 13:45 roughly 30 minutes after receiving the vaccine the patient experienced felt left arm  very cold and the under side of it started to tingle from elbow all the way down to ring finger and pinky finger. A short time after that area became numb and remained numb for roughly 5/6 hours. The patient described it as a similar sensation to when hit the funny bone in elbow however, this lasted for 5/6 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not received any treatment for the events. The clinical outcome of the events left arm got very cold ,tingling and numbness  resolved with the duration of 5/6 hours on an unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Pain
Clinical narrative: Chills; Body Ache; Headache; Lymph node swelling under injectionsite Arm and neck ( Size of Lemon); This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8729) via an unspecified route of administration in the left arm on 10Apr2021 at 09:15 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER2613) via an unspecified route of administration in the left arm on 20Mar2021 at 09:15 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 01:00, the patient experienced chills, body ache, headache, lymph node swelling under the injection site arm and neck (size of a lemon). The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events chills, body ache, headache and lymph node swelling under injection site arm and neck (size of a lemon) were recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Peripheral swelling, Vaccination site mass
Clinical narrative: I had a strange reaction to the first COVID Vaccine; 2 weeks after shot arm swelled and injection site a large lump in arm; 2 weeks after shot arm swelled and injection site a large lump in arm; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on [10Aug2021], this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (Lot Number: EN6251), via an unspecified route of administration, administered in left arm, on 15Feb2021 11:00, as dose 1, single for COVID-19 immunisation.  The patient medical history was not reported. Prior vaccinations and concomitant medications were reported as none. On an unspecified date, the patient had a strange reaction to the first covid vaccine, also 2 weeks after shot, on 01Mar2021, arm swelled and injection site with a large lump in arm. It lasted for 2 weeks. No relevant lab tests were done in response to the event. The outcome of the event had a strange reaction to the first COVID vaccine was unknown and of other events was recovered in Mar2021.  Follow-up attempts are completed. No further information is expected.  Follow-up (10Aug2021): New information from a contactable consumer (patient) includes: the case was updated as valid, new events added.  Follow-Up (18Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Renal pain
Clinical narrative: Moderate right kidney pain and light left kidney pain; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0158) via an unspecified route of administration in the left  arm on 12Apr2021 at 14:00 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic idiopathic pancreatitis, previous kidney infections right kidney, migraine, sulfonamide (sulfa) allergy and fruit (banana) allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included pantoprazole (MANUFACTURER UNKNOWN), meloxicam (MANUFACTURER UNKNOWN), levonorgestrel (NORTREL 1/35), promethazine (MANUFACTURER UNKNOWN) for an unknown indication from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: GR8727) via an unspecified route of administration in the left arm on 22Mar2021 at 12:00 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. On 13Apr2021 at 10:00, the patient experienced moderate right kidney pain and light left kidney pain. Therapeutic measures were not taken as a result of the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events, moderate right kidney pain and light left kidney pain was recovered on an unspecified date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Nausea, Pain
Clinical narrative: Headache; Chills; Lightheaded; Nausea; Vomiting; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 15Apr2021 at 12:45(at the age of 26-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Concomitant medication included birth control (MANUFACTURER UNKNOWN) for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 16Mar2021 at 13:30(at the age of 26-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 02:00, the patient experienced headache, chills, lightheaded, nausea, vomiting and body aches. Therapeutic measures were not taken as a result of adverse events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, chills, lightheaded, nausea, vomiting and body aches was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Headache; Chills; Lightheaded; Nausea; Vomiting; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 15Apr2021 at 12:45(at the age of 26-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Concomitant medication included birth control (MANUFACTURER UNKNOWN) for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 16Mar2021 at 13:30(at the age of 26-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 02:00, the patient experienced headache, chills, lightheaded, nausea, vomiting and body aches. Therapeutic measures were not taken as a result of adverse events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, chills, lightheaded, nausea, vomiting and body aches was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue
Clinical narrative: Mild chill; achy joints; mild fatigue; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 14Apr2021 at 11:30 (at the age of 38-years-old), as a single dose for COVID-19 immunisation. Medical history included known allergy to raw walnuts (mildly). Concomitant medications included vitamin d nos (VITAMIN D), lysine (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), withania somnifera (ASHWAGANDHA) and hericium erinaceus mycelium (LION'S MANE); all for unspecified indication from unknown date and unknown if ongoing. The patient previously received first dose BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN) in the right arm on 24Mar2021 at 12:45 (at the age of 38-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 15Apr2021 at 08:30, the patient experienced mild chill, achy joints and mild fatigue. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event mild chill, achy joints and mild fatigue was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.