chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Illness
Clinical narrative: Sick; Felt weak/ no energy; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program. A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 05Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported he took his first dose on 05Mar2021 and was schedule for his second dose on 26Mar2021. He mentioned he got sick last Monday, 22Mar2021, and felt weak and had no energy. He went to his pharmacy to get tested and would be back in two to three days for his results. He inquired about rescheduling his second dose. The clinical outcomes of sick and felt weak/no energy were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: After receiving covid vaccine it actually woke her up, even after 1st dose; This is a spontaneous report from a contactable consumer (patient's daughter) received via the Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history included ongoing Alzheimer's. Concomitant medications were not reported. The patient has Alzheimer's and after receiving the vaccination, it woke her up, on an unspecified date. The clinical outcome of "after receiving covid vaccine it actually woke her up, even after 1st dose" was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Bone disorder
Clinical narrative: she had a procedure Bone graft; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 05Mar2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. She had her 1st dose of Covid 19 Vaccine on 05Mar2021 but on the 18Mar2021 she had a procedure Bone graft and took Amoxicillin 500mg on 19Mar2021. She has 2nd dose scheduled on 31Mar2021 that is more than the usual 21days interval between doses. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Teeth chattering/ Chills; Headache; Tiredness; Muscle pain; Joint pain; 101 fever; Sweating; Soreness in the arm; This is a spontaneous report received from a contactable consumer (patient). A 55-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: EN6205), via an unspecified route of administration in the left arm on 07Mar2021 at 13:00 (at the age of 55-year-old) at a single dose for COVID-19 immunisation. Patient medical history included thyroid and blood pressure from years and it was still ongoing. Concomitant medications included ongoing levothyroxine sodium (LEVOXYL) for thyroid and ongoing lisinopril for blood pressure. The patient did not receive any other vaccines within four weeks prior to the first date of vaccination. Patient historical vaccine included first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9267) via an unspecified route of administration, administered in left arm on 14Feb2021 at 13:00 at a single dose for COVID-19 immunisation. On an unspecified date in 2021, the patient experienced headache, tiredness, chills/teeth chattering, muscle pain, joint pain, 101 fever, sweating and soreness in the arm. The outcome of the events was unknown.  Information on the lot/batch number already available. Other information has been requested.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Teeth chattering/ Chills; Headache; Tiredness; Muscle pain; Joint pain; 101 fever; Sweating; Soreness in the arm; This is a spontaneous report received from a contactable consumer (patient). A 55-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: EN6205), via an unspecified route of administration in the left arm on 07Mar2021 at 13:00 (at the age of 55-year-old) at a single dose for COVID-19 immunisation. Patient medical history included thyroid and blood pressure from years and it was still ongoing. Concomitant medications included ongoing levothyroxine sodium (LEVOXYL) for thyroid and ongoing lisinopril for blood pressure. The patient did not receive any other vaccines within four weeks prior to the first date of vaccination. Patient historical vaccine included first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9267) via an unspecified route of administration, administered in left arm on 14Feb2021 at 13:00 at a single dose for COVID-19 immunisation. On an unspecified date in 2021, the patient experienced headache, tiredness, chills/teeth chattering, muscle pain, joint pain, 101 fever, sweating and soreness in the arm. The outcome of the events was unknown.  Information on the lot/batch number already available. Other information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Oropharyngeal pain, Pain in extremity, Rhinorrhoea
Clinical narrative: runny nose; sniffles; arm soreness; sore throat; Feeling bad; This is a spontaneous report received from Pfizer-sponsored program, received from a contactable consumer (patient's mother). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1, via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. In Mar2021, the patient experienced feeling bad after that with runny nose, sniffles, arm soreness, and sore throat. 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: Headache
Clinical narrative: little bit of headache; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. This female patient of an unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 24Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. On 24Mar2021, the patient was experiencing a little bit of headache and wants to know if she can take Tylenol. The clinical outcome of "a little bit of headache" was unknown.  No follow-up attempts are needed; information about batch/lot number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: UNK
Symptoms: Abdominal pain upper, Abnormal faeces, Asthenia, Back pain, Blood cholesterol abnormal
Clinical narrative: He thinks the vaccine may have affected the Mefalamine or something.; Caller stated he was not eating much but did eat a banana, yogurt, and apple sauce.; States that something in the vaccine aggravated his Crohn's or Ulcerative Colitis.; lost weight; This is a spontaneous report from a contactable consumer (patient herself). A 71-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on 15Mar2021 18:30 at single dose for covid-19 immunisation. Medical history included ongoing crohn's disease, colitis ulcerative. Concomitant medication included mesalamine taken for crohn's disease, colitis ulcerative from 15Feb2021.The patient underwent lab test blood cholesterol was abnormal. The patient experienced he thinks the vaccine may have affected the mefalamine or something (drug interaction), caller stated he was not eating much but did eat a banana, yogurt, and apple sauce, states that something in the vaccine aggravated his crohn's or ulcerative colitis, lost weight on an unspecified date. On Sunday 21Mar2021, he had a bout with vomiting, stomach pain, chest pain, back pain, skeleton pain on the right side. Caller stated he felt constipated and needed to go to the bathroom. When he finally went to the bathroom it was not solid or compacted, it was more stringy and long. Caller stated it was hard to swallow water and the pill he takes for Crohn's or Ulcerative Colitis, which is Mefalamine. Caller stated he was not eating much but did eat a banana, yogurt, and apple sauce. He thinks the vaccine may have affected the Mefalamine or something. He stated he felt lousy. He said he still feels weak. Caller stated he does not know his current weight but he has probably lost weight because of not being able to eat much and the vomiting. Caller stated he started vomiting at 7:00PM on Sunday 21Mar2021 until 7:00-10:00AM Monday morning. Caller stated the first time he vomited was at 7:00PM and it was solid. It looked like the banana, apple sauce and yogurt he had ate, brown in color. The second time he vomited it was a green liquid, like bile from the stomach. States that something in the vaccine aggravated his Crohn's or Ulcerative Colitis. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 71.0
Sex: M
Vaccine: UNK
Symptoms: Bone pain, Chest pain, Colitis ulcerative, Condition aggravated, Constipation
Clinical narrative: He thinks the vaccine may have affected the Mefalamine or something.; Caller stated he was not eating much but did eat a banana, yogurt, and apple sauce.; States that something in the vaccine aggravated his Crohn's or Ulcerative Colitis.; lost weight; This is a spontaneous report from a contactable consumer (patient herself). A 71-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on 15Mar2021 18:30 at single dose for covid-19 immunisation. Medical history included ongoing crohn's disease, colitis ulcerative. Concomitant medication included mesalamine taken for crohn's disease, colitis ulcerative from 15Feb2021.The patient underwent lab test blood cholesterol was abnormal. The patient experienced he thinks the vaccine may have affected the mefalamine or something (drug interaction), caller stated he was not eating much but did eat a banana, yogurt, and apple sauce, states that something in the vaccine aggravated his crohn's or ulcerative colitis, lost weight on an unspecified date. On Sunday 21Mar2021, he had a bout with vomiting, stomach pain, chest pain, back pain, skeleton pain on the right side. Caller stated he felt constipated and needed to go to the bathroom. When he finally went to the bathroom it was not solid or compacted, it was more stringy and long. Caller stated it was hard to swallow water and the pill he takes for Crohn's or Ulcerative Colitis, which is Mefalamine. Caller stated he was not eating much but did eat a banana, yogurt, and apple sauce. He thinks the vaccine may have affected the Mefalamine or something. He stated he felt lousy. He said he still feels weak. Caller stated he does not know his current weight but he has probably lost weight because of not being able to eat much and the vomiting. Caller stated he started vomiting at 7:00PM on Sunday 21Mar2021 until 7:00-10:00AM Monday morning. Caller stated the first time he vomited was at 7:00PM and it was solid. It looked like the banana, apple sauce and yogurt he had ate, brown in color. The second time he vomited it was a green liquid, like bile from the stomach. States that something in the vaccine aggravated his Crohn's or Ulcerative Colitis. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 71.0
Sex: M
Vaccine: UNK
Symptoms: Crohn's disease, Decreased appetite, Discoloured vomit, Dysphagia, Feeling abnormal
Clinical narrative: He thinks the vaccine may have affected the Mefalamine or something.; Caller stated he was not eating much but did eat a banana, yogurt, and apple sauce.; States that something in the vaccine aggravated his Crohn's or Ulcerative Colitis.; lost weight; This is a spontaneous report from a contactable consumer (patient herself). A 71-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on 15Mar2021 18:30 at single dose for covid-19 immunisation. Medical history included ongoing crohn's disease, colitis ulcerative. Concomitant medication included mesalamine taken for crohn's disease, colitis ulcerative from 15Feb2021.The patient underwent lab test blood cholesterol was abnormal. The patient experienced he thinks the vaccine may have affected the mefalamine or something (drug interaction), caller stated he was not eating much but did eat a banana, yogurt, and apple sauce, states that something in the vaccine aggravated his crohn's or ulcerative colitis, lost weight on an unspecified date. On Sunday 21Mar2021, he had a bout with vomiting, stomach pain, chest pain, back pain, skeleton pain on the right side. Caller stated he felt constipated and needed to go to the bathroom. When he finally went to the bathroom it was not solid or compacted, it was more stringy and long. Caller stated it was hard to swallow water and the pill he takes for Crohn's or Ulcerative Colitis, which is Mefalamine. Caller stated he was not eating much but did eat a banana, yogurt, and apple sauce. He thinks the vaccine may have affected the Mefalamine or something. He stated he felt lousy. He said he still feels weak. Caller stated he does not know his current weight but he has probably lost weight because of not being able to eat much and the vomiting. Caller stated he started vomiting at 7:00PM on Sunday 21Mar2021 until 7:00-10:00AM Monday morning. Caller stated the first time he vomited was at 7:00PM and it was solid. It looked like the banana, apple sauce and yogurt he had ate, brown in color. The second time he vomited it was a green liquid, like bile from the stomach. States that something in the vaccine aggravated his Crohn's or Ulcerative Colitis. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 71.0
Sex: M
Vaccine: UNK
Symptoms: Laboratory test, Vomiting, Weight decreased
Clinical narrative: He thinks the vaccine may have affected the Mefalamine or something.; Caller stated he was not eating much but did eat a banana, yogurt, and apple sauce.; States that something in the vaccine aggravated his Crohn's or Ulcerative Colitis.; lost weight; This is a spontaneous report from a contactable consumer (patient herself). A 71-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on 15Mar2021 18:30 at single dose for covid-19 immunisation. Medical history included ongoing crohn's disease, colitis ulcerative. Concomitant medication included mesalamine taken for crohn's disease, colitis ulcerative from 15Feb2021.The patient underwent lab test blood cholesterol was abnormal. The patient experienced he thinks the vaccine may have affected the mefalamine or something (drug interaction), caller stated he was not eating much but did eat a banana, yogurt, and apple sauce, states that something in the vaccine aggravated his crohn's or ulcerative colitis, lost weight on an unspecified date. On Sunday 21Mar2021, he had a bout with vomiting, stomach pain, chest pain, back pain, skeleton pain on the right side. Caller stated he felt constipated and needed to go to the bathroom. When he finally went to the bathroom it was not solid or compacted, it was more stringy and long. Caller stated it was hard to swallow water and the pill he takes for Crohn's or Ulcerative Colitis, which is Mefalamine. Caller stated he was not eating much but did eat a banana, yogurt, and apple sauce. He thinks the vaccine may have affected the Mefalamine or something. He stated he felt lousy. He said he still feels weak. Caller stated he does not know his current weight but he has probably lost weight because of not being able to eat much and the vomiting. Caller stated he started vomiting at 7:00PM on Sunday 21Mar2021 until 7:00-10:00AM Monday morning. Caller stated the first time he vomited was at 7:00PM and it was solid. It looked like the banana, apple sauce and yogurt he had ate, brown in color. The second time he vomited it was a green liquid, like bile from the stomach. States that something in the vaccine aggravated his Crohn's or Ulcerative Colitis. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral venous disease, Phlebitis superficial
Clinical narrative: superficial phlebitis; venous insufficiency; This is a spontaneous report from a contactable consumer (patient). A 85-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 17Mar2021 as single dose for COVID-19 immunization. Medical history included blood clot. The patient stated that about 20-25 years ago she had a blood clot. She saw online that after 3-4 weeks some people had DVT, but it did not mention which vaccine (Pfizer or other). The patient's concomitant medications were not reported. The patient experienced superficial phlebitis and venous insufficiency on an unspecified date. The patient was asking if it is safe to receive the second dose. She said her doctor did not seem concerned with her getting the vaccine. She was due next Wednesday to have the 2nd dose. The patient was also asking if it is typical to have more side effects after the 2nd dose vs 1st dose; how long before getting symptoms, after getting the 2 dose; if people got blood clots after getting the vaccine; and how much immunity do they have after 1st dose. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: She felt a little bit nauseated; This is a spontaneous report from a Pfizer-Sponsored Program, from a contactable consumer (patient). This female patient of unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on 24Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported that she had the first shot today (24Mar2021) and she felt a little bit nauseated. The clinical outcome of nauseated was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Panic attack
Clinical narrative: she experienced a panic attack; This is a spontaneous report from a Pfizer sponsored program, from a contactable consumer (patient). This female patient of unspecified age reported that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on 23Mar2021 as a single dose for COVID-19 immunization. Medical history included panic attack. Concomitant medications were not reported. On 24Mar2021, the patient experienced panic attack. The event took place after use of product (vaccine). The clinical outcome of panic attack was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: after 3hrs, she felt a sore in her arm; This is a spontaneous report from a contactable consumer, patient.   A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 02Mar2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced after 3hrs, she felt a sore in her arm on 02Mar2021.  The outcome of the event, after 3hrs, she felt a sore in her arm was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: I could breathe like I have not able to breathe in years; This is a spontaneous report received from Pfizer. A contactable consumer, the patient, reported a patient of unspecified age/gender received the first dose BNT162b2 (solution for injection; batch/lot and expiry information not reported) as a single dose via unspecified route on 15Mar2021, for COVID-19 immunisation. Relevant medical history included ongoing Chronic Obstructive Pulmonary Disease (COPD). There were no concomitant medications reported. The patient reported that he/she received the first dose of the vaccine last Monday (15Mar2021) and Tuesday and Wednesday he/she could breath like they have not been able to in years. The patient reported that he/she has COPD and unfortunately it was only a two-day good breathing event. The patient explained that he/she has asked around and several people that have COPD have said the same thing and for them it was also was short-lived. The outcome of the event breathe like I have not able to breathe in years was recovered on 18Mar2021.  No follow-up attempts possible; No further information expected and information about batch /lot number(s) cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: sore arm; arm got red; This is a spontaneous report (letter response) received from a contactable consumer (patient). A patient of unspecified age and gender received first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284) via intramuscular in left arm on 15Jan2021 at 13:00 as a single dose for COVID-19 immunisation. The medical history was not reported. The patient concomitant medication was none. On 15Jan2021, the patient experienced sore arm, arm got red. The patient did not receive any treatment for the events. The outcome of the events was recovered on an unknown date in 2021.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: He only had a sore arm the next day with the 1st dose; This is a spontaneous report from a Pfizer sponsored program  from a non contactable male consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included spinal cord injury from an unknown date and unknown if ongoing (3-4 years he's been doing acupuncture for a spinal injury).  The patient's concomitant medications were not reported. The patient reported he only had a sore arm the next day with the 1st dose, on an unspecified date. He believes he had no side effects because for 3-4 years he's been doing acupuncture for a spinal injury. He had no side effects with the 2nd dose that he got last Thursday (unknown date). The outcome of the event, sore arm the next day was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Therapeutic response unexpected, Vaccination site pain
Clinical narrative: Bit of soreness at the injection site; General malaise; It seems to have cleared my sinuses 100 percent. I feel like my brain is getting so much oxygen and I can breathe normally.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 2, via an unspecified route of administration, on 20Mar2021 (Batch/Lot number was unknown) as single dose for COVID-19 immunization. Medical history included "sinuses" from an unknown date. Concomitant medication(s) included cetirizine hydrochloride (ALLERGY CARE) taken for sinuses, start and stop date were not reported.  Patient previously received BNT162B2 dose 1, via unspecified route of administration, on unspecified date as single dose for COVID-19 immunization. Patient received the second dose on 20Mar2021. She had a bit of soreness at the injection site, general malaise for 24 hours but the craziest thing was that it seemed to have cleared her sinuses 100 percent (in Mar2021). She felt like her brain was getting so much oxygen and she can breathe normally (she took daily allergy meds for reference). The clinical outcome of soreness at the injection site, general malaise, and cleared her sinuses 100 percent was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Neoplasm, Skin mass, Swelling of eyelid
Clinical narrative: Several lumps on right side of head and neck.; Several lumps on right side of head and neck.; Welt on Eye/swollen eyelid right side; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 23Mar2021 12:30 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation. Medical history included hypercholesterolaemia from an unknown date and unknown if ongoing. Concomitant medication included rosuvastatin, calcium, vitamin, fluticasone propionate (FLONASE) and multivitamins. The patient experienced several lumps on right side of head and neck, welt on eye and swollen eyelid right side on 26Mar2021 07:00 with outcome of not recovered. No treatment was given for the events.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Herpes zoster, Nausea, Vaccination site pain
Clinical narrative: minor shingles outbreak (left side face nerve pain, headache, itching chin/head and blister on lips); light headed/dizzy on day 2; exhaustion for four days; intense arm pain at injection site (pain began when shot was being given); slight nausea; This is spontaneous report from consumer (Patient) via (Pfizer/Bio-Tech). A 55-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on 03Mar2021 at 15:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation at hospital. Medical history included restless legs syndrome. The patient was not pregnant at the time of vaccination. Patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included carbidopa, levodopa (SINEMET), levothyroxine sodium (LEVOTHYROXIN). On an unspecified date in Mar2021, patient experienced minor shingles outbreak (left side face nerve pain, headache, itching chin/head and blister on lips), exhaustion for four days, intense arm pain at injection site (pain began when shot was being given), slight nausea, lightheaded/dizzy on day 2. It was unknown whether patient treatment for the adverse events. Outcome for the events were unknown.  Information for lot/batch number has been requested
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Herpes zoster, Lip blister, Pain, Pruritus
Clinical narrative: minor shingles outbreak (left side face nerve pain, headache, itching chin/head and blister on lips); light headed/dizzy on day 2; exhaustion for four days; intense arm pain at injection site (pain began when shot was being given); slight nausea; This is spontaneous report from consumer (Patient) via (Pfizer/Bio-Tech). A 55-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on 03Mar2021 at 15:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation at hospital. Medical history included restless legs syndrome. The patient was not pregnant at the time of vaccination. Patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included carbidopa, levodopa (SINEMET), levothyroxine sodium (LEVOTHYROXIN). On an unspecified date in Mar2021, patient experienced minor shingles outbreak (left side face nerve pain, headache, itching chin/head and blister on lips), exhaustion for four days, intense arm pain at injection site (pain began when shot was being given), slight nausea, lightheaded/dizzy on day 2. It was unknown whether patient treatment for the adverse events. Outcome for the events were unknown.  Information for lot/batch number has been requested
Sex: F
Vaccine: UNK
Symptoms: Magnetic resonance imaging, Unevaluable event
Clinical narrative: she had taken the tablets so it can be helpful for her right shoulder; This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored Program. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 24Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient called to advise that she had taken two (2) tablets of Ibuprofen the night after she got her first dose of the covid-19 vaccine yesterday (24Mar2021) around 2 o'clock in the afternoon. According to patient, she had taken the tablets so it can be helpful for her right shoulder since that morning she had an MRI, only then she realized why she had taken the tablets when she knew that she was not supposed to be taking Ibuprofen during the vaccine. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain in his arm where the vaccine injected; This is a spontaneous report from Pfizer. A contactable consumer (patient) reported that a male patient of an unspecified age received second dose of BNT162B2 (Pfizer Covid-19 Vaccine, solution for injection, Batch/Lot number and expiry: not reported), via an unspecified route of administration on 24Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included 1st dose BNT162B2 on 03Mar2021 for COVID-19 immunization. It was asked about the expiration date of the vaccine, upon stating he mentioned that his wife (name) had a reaction with Pfizer vaccine like diarrhea, and he added that he experienced a pain in his arm where the vaccine injected on an unspecified date in 2021. Their 1st dose was last 03Mar2021 and the 2nd dose was 24Mar2021. Both of them received the 1st dose and 2nd dose on the same date. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021349482
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Diagnostic procedure, Fatigue, Gait disturbance
Clinical narrative: My entire body experienced extremely severe body pain; I couldn't walk; rash; Very weak and tired; Very weak and tired; This is a spontaneous report from a contactable consumer (reporting for herself). This 70-year-old female patient received first doe of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318) via an unspecified route of administration on left arm at a single dose on 04Feb2021 09:45 AM, for Covid-19 immunization. She Received second dose BNT162B2 (Pfizer Covid 19 vaccination, lot number EN6200) via an unspecified route of administration, on left arm at an single dose on 25Mar2021 for Covid-19 immunization. She was not pregnant at the time of vaccination. She had not received any other vaccine in four weeks. Medical history included type II diabetes, high blood pressure and pneumoconiosis. She was allergic to Chlorol Hydrate and Thimerasol. Concomitant medications included Metformin, Losartan HCTZ, Amlodipine, Zyrtec. On 09Mar2021 07:00 AM, the patient experienced a rash above her right knee, up my thigh, and knee pit, felt very weak and tired, her entire body experienced extremely severe body pain from upper neck down to feet. It got so bad that she could not walk, only took baby steps. It was stated that she would cry with hand on the wall with each baby step. On 12Mar2021, the patient went to the hospital emergency room and the patient was tested for Covid-19, blood test came out to be negative, results of SARS CoV-2, diagnostic radiologic EC EKG were unknown. She was treated with intravenous and pain medication. The outcome of the events of rash, felt very weak and tired, extremely severe body pain and could not walk was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Haematology test, Laboratory test, Pain, Rash, SARS-CoV-2 test
Clinical narrative: My entire body experienced extremely severe body pain; I couldn't walk; rash; Very weak and tired; Very weak and tired; This is a spontaneous report from a contactable consumer (reporting for herself). This 70-year-old female patient received first doe of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318) via an unspecified route of administration on left arm at a single dose on 04Feb2021 09:45 AM, for Covid-19 immunization. She Received second dose BNT162B2 (Pfizer Covid 19 vaccination, lot number EN6200) via an unspecified route of administration, on left arm at an single dose on 25Mar2021 for Covid-19 immunization. She was not pregnant at the time of vaccination. She had not received any other vaccine in four weeks. Medical history included type II diabetes, high blood pressure and pneumoconiosis. She was allergic to Chlorol Hydrate and Thimerasol. Concomitant medications included Metformin, Losartan HCTZ, Amlodipine, Zyrtec. On 09Mar2021 07:00 AM, the patient experienced a rash above her right knee, up my thigh, and knee pit, felt very weak and tired, her entire body experienced extremely severe body pain from upper neck down to feet. It got so bad that she could not walk, only took baby steps. It was stated that she would cry with hand on the wall with each baby step. On 12Mar2021, the patient went to the hospital emergency room and the patient was tested for Covid-19, blood test came out to be negative, results of SARS CoV-2, diagnostic radiologic EC EKG were unknown. She was treated with intravenous and pain medication. The outcome of the events of rash, felt very weak and tired, extremely severe body pain and could not walk was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Viral test positive
Clinical narrative: I have the herpes simplex genital virus/But I had a breakout a couple days ago; This case was considered as invalid initially upon follow-up (14-APR-2021) case was considered as valid. This is a spontaneous report from a contactable consumer or other non hcp (patient). A 73-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 23Mar2021 as single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included aciclovir sodium (ACYCLOVIR ABBOTT VIAL). The patient stated, he had the herpes simplex genital virus and occasionally get outbreaks. He was not taking the suppression dosage daily while he was getting the vaccine. But on an unspecified date he had a breakout (viral test positive). He took 3 Acyclovir 800mg doses per day for 2 days. He had done that and would like to take the suppression dose which was 400mg to 600mg per day. Caller also questioned if he gets the second dose 4 weeks from the first dose, would the vaccine efficacy be compromised as time goes on. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Oropharyngeal pain, Pain in extremity, Throat irritation
Clinical narrative: Sore Arm; Sore Throat/Scratchy Throat; Sore Throat/Scratchy Throat; Headache; Chills; This is a spontaneous report received from a contactable consumer (Patient) reported for himself. A 48-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK5730 and expiration date was not provided) and (lot number: EK5730 and expiration date was not provided), via an unspecified route of administration, in Arm left, on 25Mar2021 at 01:30 PM (at the age of 48-years-old) at a single dose for COVID-19 immunisation, at workplace clinic. Medical history and concomitant medications were not reported. Allergies to medications, food, or other products included: gluten, penicillin, ciprofloxacin, differin, tessalon pearls. The patient previously took first dose of BNT162B2 (lot number: EJ1685) on 04Mar2021 at 03:30 PM (at the age of 48-years-old) in Left arm for COVID-19 immunisation and experienced headache /sore arm started after first dose, headache started within 1 hour of receiving vaccine. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive other medications in two weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. It was reported that on 26Mar2021 at 01:00, the symptoms started after receiving second dose at around 1 am after 2nd dose, dose time was 1:30 pm day before sore arm sore throat/scratchy throat, headache, chills. The events were reported as non-serious. No treatment was received for the events. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metal taste still in mouth April. Getting worse, had to seek drs advice; This is a spontaneous report from a contactable 45years old female consumer (patient). A 45-year-old female patient received BNT162B2 (BNT162B2, Formulation: Solution for injection, Batch/Lot: EL8982) second dose via intramuscular, administered in left arm on 11Feb2021 11:30 AM and first dose via intramuscular, administered in left arm on 21Jan2021 10:15AM (Batch/Lot no: EL3246) as a single dose for COVID-19 immunization. Vaccination administered at living facility. The patient medical history included fibromyalgia, IBS, unknown heart issue causing hypertension. The patient concomitant medications the patient received within 2 weeks of vaccination are Omeprazole, losartan, atorvastatin, metoprolol. The patient underwent lab test and procedures which included COVID-19 tests, Prior to vaccination, was the patient diagnosed with COVID-19 was yes, Since the vaccination, has the patient been tested for COVID-19 was No. Allergies to medications, food, or other products:Sulfa based drugs . Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Feb2021 patient experienced with metal taste still in mouth April. Getting worse, had to seek doctors advice. The outcome of the event was not recovered.  No follow-up attempt are needed. further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling drunk
Clinical narrative: Felt drunk; This is a spontaneous report from a contactable consumer based on information received by Pfizer from  (manufacturer control number: ). A 44-year-old male patient received COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration, on unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. The patient's historical drugs included steroid which caused weight gain. Concomitant medication(s) included etanercept (ENBREL) with Reusable Autoinjector on an unknown date in Oct2020 and ongoing taken for rheumatoid arthritis. The patient previously took steroids and experienced weight increased. On an unknown date in Feb2021, the patient felt drunk for about three hours after receiving "COVID vaccine". The clinical outcome of felt drunk 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: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Her daughter's mother in law tested positive after getting the first dose of the vaccine; Her daughter's mother in law tested positive after getting the first dose of the vaccine; This is a spontaneous report from a contactable consumer (patient relative/her daughter's mother-in-law). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unknown date (Lot number: UNKNOWN) as a single dose for COVID-19 immunization. The patient's medical history and concomitant were not reported. Patient tested positive after getting the first dose of the vaccine on unspecified date. The outcome of the events was unknown.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Head deformity, Intracranial mass
Clinical narrative: Had like a ball developing in my head and brain, a round ball; Developed a little knot or a little ball on the top of my head; Had like a ball developing in my head and brain, a round ball; Developed a little knot or a little ball on the top of my head; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6205; Expiration Date: Jun2021), first dose via an unspecified route of administration on 08Mar2021 as 0.3 mL (SINGLE DOSE ) for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had like a ball developing in his head and brain. A ball developed, a round ball. A week later (Mar2021) it developed a little knot or a little ball on the top of my head. No treatment for the events. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: had his first dose 4th of March then a week after his first dose, he tested positive; This is a spontaneous report from a contactable consumer.  A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 04mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 12Mar2021, he felt some symptoms a week after his first dose, he tested covid-19 positive on 15Mar2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test
Clinical narrative: had his first dose 4th of March then a week after his first dose, he tested positive; This is a spontaneous report from a contactable consumer.  A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 04mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 12Mar2021, he felt some symptoms a week after his first dose, he tested covid-19 positive on 15Mar2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: slight headache; fatigue; This is a spontaneous report received from a contactable pharmacist (patient, self-reported). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated that i received the COVID vaccine yesterday through Pfizer and experienced a slight headache and fatigue today. I am not certain that these symptoms were related to the vaccine or not. Outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.