chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: felt little tired after first dose; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 05Jan2021 as single dose for COVID-19 immunisation. Medical history included crohn's disease. she is partial immunosuppressed has crohn's disease takes prednisone "budesonide targeted prednisone. The patient's concomitant medications were not reported. Patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 26Jan2021 as single dose for COVID-19 immunisation. The patient stated that she felt little tired after first dose on unknown date in 2021. Outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Bladder disorder, Muscle spasms, Urinary incontinence
Clinical narrative: Loss of bladder control; Loss of bladder control; Cramping in abdomen and lower back; Cramping in abdomen and lower back; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 05Aug2021 at 08:15 AM (age at vaccination was 50 years) as DOSE 1, SINGLE for covid-19 immunisation at public health clinic/veterans administration facility. The patient was not pregnant at the time of vaccination. Medical history included allergy to bananas, watermelon, tomatoes from an unknown date and unknown if ongoing. No other vaccines were received within four weeks to the administration of bnt162b2. Concomitant medications included multivitamin, pantoprazole sodium sesquihydrate (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]), boron, calcium, cimicifuga racemosa extract, folic acid, glycine max extract, magnolia officinalis, nicotinic acid, pyridoxine hydrochloride, riboflavin, selenium, thiamine, tocopherol, vitamin b12 nos (ESTROVEN); both taken within two weeks for an unspecified indication, start and stop date were not reported. The patient previously received amoxicillin, kefzol, aspirin and experienced allergies. On 05Aug2021 at 05:00 PM, the patient experienced loss of bladder control for 4 days, cramping in abdomen and lower back. No treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The outcome of the event loss of bladder control was recovered with sequelae on 10Aug2021 and outcome of other events was recovered with sequelae on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report from a contactable nurse.   A 56 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular, administered in Deltoid Right on 31Mar2021 (Batch/Lot Number: ER8733) as DOSE 1, SINGLE (age at vaccination 56 years old) for covid-19 immunisation.  Medical history included type 2 diabetes mellitus from 05Feb2006 and ongoing, hypertension from 15Feb2006 and ongoing, diabetes mellitus from 15Feb2006 and ongoing , cerebrovascular accident (CVA) from 01Apr2012 and ongoing, depression from 21Aug2012 (also reported as "21Aug2021"). The patient's concomitant medications were not reported.   On 20Apr2021, the patient experienced COVID-19.  The patient received the BNT162B2 at the doctor's office/ urgent care. "There were no side effects for this event".  Relevant tests were none. The event did not require the initiation of new medication/other treatment/procedure. Outcome of the event COVID-19 was recovered in 2021. On 05Jul2021, the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), 2nd dose, intramuscular in the left deltoid, Batch number: EW0180.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness cannot be ruled out.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Back pain, Chills, Limb discomfort, Malaise
Clinical narrative: feeling chills like it is going to a fever; feeling chills like it is going to a fever; her legs don't feel good; she wasn't feeling good at all; pain in her entire back; feels pain in her womb, like in her belly to lower abdomen area; she feels sometimes like she has to throw up; This is a spontaneous report from a contactable consumer. This 62-year-old female consumer (patient) reported for herself. A 62-year-old female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Batch/lot number: Unknown, Expiry date: unknown), via an unspecified route on 21Aug2021, Saturday (age at vaccination: 62-year-old), as a single dose for covid-19 immunization. Medical history included diabetic, ongoing. It has been a long time since she was diagnosed. The patient concomitant medications were not reported. On 22Aug2021 (Sunday), patient was feeling chills like it is going to a fever and her legs don't feel good. She went to work like that, but she wasn't feeling good at all, and they said for her to go back home because she couldn't work like that. She was having pain in her entire back, feels pain in her womb, like in her belly to lower abdomen area and ever since she got it she has felt like she wanted to throw up but she hasn't done it, she only has the feeling of the symptom. herapeutic measures taken as a result of the events included Tylenol which she already took. The clinical outcome of the events was ongoing.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: feeling chills like it is going to a fever; feeling chills like it is going to a fever; her legs don't feel good; she wasn't feeling good at all; pain in her entire back; feels pain in her womb, like in her belly to lower abdomen area; she feels sometimes like she has to throw up; This is a spontaneous report from a contactable consumer. This 62-year-old female consumer (patient) reported for herself. A 62-year-old female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Batch/lot number: Unknown, Expiry date: unknown), via an unspecified route on 21Aug2021, Saturday (age at vaccination: 62-year-old), as a single dose for covid-19 immunization. Medical history included diabetic, ongoing. It has been a long time since she was diagnosed. The patient concomitant medications were not reported. On 22Aug2021 (Sunday), patient was feeling chills like it is going to a fever and her legs don't feel good. She went to work like that, but she wasn't feeling good at all, and they said for her to go back home because she couldn't work like that. She was having pain in her entire back, feels pain in her womb, like in her belly to lower abdomen area and ever since she got it she has felt like she wanted to throw up but she hasn't done it, she only has the feeling of the symptom. herapeutic measures taken as a result of the events included Tylenol which she already took. The clinical outcome of the events was ongoing.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal
Clinical narrative: Sore Shoulder; Felt Blah; This is a spontaneous report from a contactable consumer reporting same events under the same suspect product for 6 patients. This is Report 2 of 6. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced sore shoulder and felt blah. Caller stated after he got the shot, he had talked to several people. Caller stated he had a sister who was a CNA, a niece who was a RN and another niece that was a Nurse Practitioner. Caller stated his brother in law and mom also thought he should get his shot. Caller stated they said their shoulder got sore the next day and they felt blah but that was it. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal
Clinical narrative: Felt blah; Shoulder got sore; This is a spontaneous report from a contactable consumer (brother-in-Law) reporting same events under the same suspect product for 6 patients and this is one of 6 reports. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reportedly, the reporter was calling to report side effects for himself and reported about family members, report for family member number 5. The reporter was calling about the Covid Shot; verified Pfizer Covid Vaccine. The reporter got the shot, he had talked to several people, he had a sister who was a CNA, a niece who was a RN and another niece that was a nurse practitioner. Reporter stated his brother-in-law and mom also thought he should get this shot. Reporter stated they said their shoulder got sore the next day (on an unspecified date) and they felt blah on an unspecified date but that was it. Outcome of events was unknown. Follow-up attempts have been completed and no further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Diarrhoea, Headache
Clinical narrative: Chills; headache; diarrhea; fever of 100.5; full body aches; right hip pain; This is a spontaneous report from a contactable consumer, the patient.  A 33-years-old non pregnant female patient received bnt162b2 (BNT162B2, formulation: solution for injection, lot number was not reported) via an unspecified route of administration, administered in arm left on 30Jul2021 at 17:30 as dose 1, single (age at vaccination 33 years) for covid-19 immunisation. Medical history included asthma, heart murmurs, prediabetes, high blood pressure, pcos and the patient was allergic to avocados. Concomitant medication(s) included hydrochlorothiazide, metformin and ascorbic acid, chromium, copper, folic acid, inositol, magnesium, manganese, nicotinamide, pantothenic acid, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (MULTI VIT). On 31Jul2021 at 14:00 the patient experienced chills, headache, diarrhea, fever of 100.5, full body aches, right hip pain. The patient underwent lab tests which included body temperature 100.5 on 31Jul2021. The patient did not have covid prior to the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not covid tested post vaccination. No therapeutic measures were taken as a result of the events. Prior to vaccination, the patient was not diagnosed with COVID-19. The outcome of all the events was recovered on an unknown date in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Chills; headache; diarrhea; fever of 100.5; full body aches; right hip pain; This is a spontaneous report from a contactable consumer, the patient.  A 33-years-old non pregnant female patient received bnt162b2 (BNT162B2, formulation: solution for injection, lot number was not reported) via an unspecified route of administration, administered in arm left on 30Jul2021 at 17:30 as dose 1, single (age at vaccination 33 years) for covid-19 immunisation. Medical history included asthma, heart murmurs, prediabetes, high blood pressure, pcos and the patient was allergic to avocados. Concomitant medication(s) included hydrochlorothiazide, metformin and ascorbic acid, chromium, copper, folic acid, inositol, magnesium, manganese, nicotinamide, pantothenic acid, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (MULTI VIT). On 31Jul2021 at 14:00 the patient experienced chills, headache, diarrhea, fever of 100.5, full body aches, right hip pain. The patient underwent lab tests which included body temperature 100.5 on 31Jul2021. The patient did not have covid prior to the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not covid tested post vaccination. No therapeutic measures were taken as a result of the events. Prior to vaccination, the patient was not diagnosed with COVID-19. The outcome of all the events was recovered on an unknown date in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: My wife still has morning nausea from the second shot.; This is a spontaneous report from a contactable consumer or other non-HCP who reported for his wife.  A female patient of an unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced nausea. Clinical course was reported as my wife still has morning nausea from the second shot. The clinical outcome of the event was not recovered.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal
Clinical narrative: Shoulder Got Sore; Felt Blah; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 3 patients. This report is for 3rd of 3 patient.   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient's shoulder got sore and felt blah. The outcome of the events was unknown.  The lot number for the vaccine (BNT162B2) was not provided and will be requested during follow-up. ; Sender's Comments: Linked Report(s) : -PFIZER INC-202101090541 same reporter/drug, different patient.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported, expiry date: unknown), at the age of 42, via an unspecified route of administration, left arm, on Jul 25, 2021, at 13:30, single dose, for COVID-19 immunisation. No  medical history reported (including any illness at time of vaccination). No family medical history to adverse event. There were no concomitant medications. No history of any previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. Adverse event did not require an emergency room visit/physician office. No vaccinations within 4 weeks prior to the first administration date of the suspect vaccine. No adverse events following prior vaccinations. No tests done. The patient experienced pain down her left leg three days after the vaccine from Jul 28, 2021 (still not subsided). She wanted to know if it was a side effect of the vaccine. The outcome of the events: not recovered. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Headache; Fever; Body aches; Swollen lymph node; This is a spontaneous report from a contactable consumer. This is report 1 of 2. This 54-Year-old female consumer (patient) reported. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: FC3182 or FC318Z but thinks it is a 2 not a Z), dose 2 via an unspecified route of administration, administered in right arm on 23Aug2021 14:00 (at the age of 54-years-old) as a single dose for covid-19 immunization. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EW0176) via an unspecified route of administration, administered in right arm on 02Aug2021 at around 10 something in the morning (at the age of 54-years-old) as a single dose for covid-19 immunization. Medical history included none. When she had shingles shot, it did the same thing and gave her fever and chills. She does not have further details to provide for shingles shot last dose she received in Jan 2021. She clarifies she does not have chills right now after the covid vaccine. The patient's medical history and concomitant medications were not reported. She just takes her medication every day. She does not think they are relevant to add. The patient experienced headache, fever, body aches and underneath her jaw she guess the lymph nodes there are swollen. The patient decline any treatment. No emergency room and physician office. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101100496 same reporter/product/event, different patient
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Fatigue, Pyrexia
Clinical narrative: fever; chills; tiredness; feels weak; This is a spontaneous report from a contactable consumer via medical information team. A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date: was not reported), (at the age of 64-Years-old) dose 2 via an unspecified route of administration on 23Aug2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 for covid-19 immunisation. On 23Aug2021, patient experienced chills right away, as soon as the patient received the second dose of Pfizer Covid 19 Vaccine and also felt tired. Later the chills went away. On 24Aug2021, the fever began at midnight or 01:00, very early morning. Clarified he was referring to the early morning of 24Aug2021. The Patient stated it was 40% better. The caller stated the tiredness was little better. On an unknown date in Aug2021, the patient stated he felt weak and slightly kind of warm. Weak like when you go through that it tares up, weak inside. The caller stated he just wanted to know if the symptoms linger and does not want to go through all of this. The patient underwent lab tests and procedures which included body temperature and results was unknown on 24Aug2021. At the time of this report, the outcome of fever, tiredness was recovering, chills recovered on an unknown date in Aug2021 and feels weak was unknown.  No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Pain in extremity, Thirst
Clinical narrative: diarrhea; a little sore in her right arm; abdominal pain; thirsty; This is a spontaneous report received from a contactable consumer (patient) reported herself via a Pfizer sponsored program. A 59-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration at right arm on 23Aug2021 (at the age of 59-year-old) as dose 2, single for COVID-19 immunisation. The patient's medical history included diabetes. Concomitant medications included metformin and she was a diabetic and she takes Metformin medication and other medications she takes every day such as she takes medication for cholesterol and triglycerides, but her medication has been the same since before her first shot. No further details provided about her medications. Patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EW0175) via an unspecified route of administration at right arm on 04Aug2021 (at the age of 59-year-old) as dose 1, single for COVID-19 immunisation. It was reported that caller stated that she got her 2nd dose of the Pfizer BioNTech covid-19 Vaccine yesterday and experienced abdominal pain in the evening. Caller wanted to know if abdominal pain and diarrhea are among the commonly reported adverse events after getting the Pfizer BioNtech covid-19 vaccine. Caller wanted to know if there was a need for her to self-isolate after receiving her 2nd dose of the Pfizer BioNTech covid-19 vaccine and if she was still experiencing diarrhea and abdominal pain after being vaccinated. Caller says she was concerned because she lives with her mom who was 85 years old and sometimes her brother who lives in the front of the house wants her to take care of their children, on whether this was just a side effect or should she be isolating herself from people. She says she got both doses given to her in her right arm. She says after getting shot she was a little sore in her right arm, and then last night she had abdominal pain and woke up with diarrhea. Caller says that has stayed the same, and she hasn't eaten since she still has abdominal pain in there. She says she has done no treatment other than not eating, which was another thing, it was not on side effect list but she has been thirsty a lot, she does not know if that was normal. The patient experienced abdominal pain, a little sore in her right arm on 23Aug2021, diarrhea on 24Aug2021 and thirsty on Aug2021. Patient did not receive any treatment for the events. Outcome of all events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Psoriasis
Clinical narrative: A person who has psoriasis and is in remission on medication for it, will they relapse? Well it happened to me; A person who has psoriasis and is in remission on medication for it, will they relapse? Well it happened to me; This is a spontaneous report from a non-contactable consumer(patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown dose number, single for COVID-19 immunization. The patient medical history and concomitant was not reported. The patient experienced a person who has psoriasis and is in remission on medication for it, will they relapse? well it happened to me on an unspecified date. It was reported that A person who has psoriasis and is in remission on medication for it, will they relapse. Well, it happened to me. It was directly after the injection (caller: age unknown, female -did not remember if it was after the first or 2nd dose of the Pfizer covid vaccine). Now that I was going to need a 3rd injection and I started to clear up I was scared to get it. All of sudden broke out. It was very hard to get back and I'm still dealing with it. I don't want to set it up again or worse again. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal
Clinical narrative: Shoulder Got Sore; Felt Blah; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient. Reporter reported side effects for himself and reported about family members. This was report 5 of 6 for family member #4. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported) via an unspecified route of administration, on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, reporter stated that the patient shoulder got sore the next day and felt blah but that was it. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Malaise, Pain in extremity, Rash, SARS-CoV-2 test
Clinical narrative: Arm was really sore the next day; Didn't feel good the day after getting the shot; Rash; Eyes were swollen; This is a spontaneous report received from a contactable consumer or other non hcp. A 60-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of ad-ministration on 07Aug2021 (age at vaccination 60years old) as single dose for covid-19 immunisation. Medical history included rheumatoid arthritis, autoimmune thyroiditis, Raynaud's phenomenon, Sjogren's syndrome, thyroiditis all from an unknown date and unknown if ongoing, covid-19 from Dec2020 to an unknown date Verbatim: She had COVID back on unspecified date in Dec2020. Concomitant medication(s) included hydroxychloroquine (HYDROXYCHLOROQUINE) taken for rheumatoid arthritis, start and stop date were not reported; levothyroxine sodium (GENERIC SYNTHROID) taken for thyroid disorder, start and stop date were not reported; mirabegron (MYRBETRIQ); metformin (METFORMIN) all taken for an unspecified indication, start and stop date were not reported. The patient experienced rash, eyes were swollen on unspecified date in Aug2021, and arm was really sore the next day, didn't feel good the day after getting the shot on 08Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test positive on Dec2020 She had COVID back in Dec2020. The clinical outcome of the event rash was recovered, and other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Aphonia, Cough, Productive cough, SARS-CoV-2 test
Clinical narrative: coughing the day after first vaccine/Cough was dry; Coughed so much I lost my voice for 2 days; Cough was dry then became phlegmy - green phlegm; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in left arm, on 24Jul2021 at 11:00 hours, as dose 1 single (at the age of 67-years-old) for COVID-19 immunization. The patient medical history included Covid-19 (diagnosed prior to vaccination). Patient had no known allergies. Patient had no other vaccine in four weeks. Concomitant medications included fish oil, acetylsalicylic acid (low dose Aspir), calcium and Multivitamins. On 25Jul2021 at 09:00 hours (the day after first vaccine), patient started coughing, patient coughed so much that he lost his voice for 2 days. Patient stated that cough was dry then became phlegmy - green phlegm on Jul2021. Patient called the doctor to take COVID test and then patient tested on 01Aug2021 via nasal swab, but result was negative. Patient still had cough a week after 2nd covid vaccine. Patient had a doctor or other healthcare professional office/clinic visit for the events. Patient received no treatment for the events. The outcome of lost his voice was recovered on 27Jul2021 and not recovered for rest of the events.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain lower, Blood test, Computerised tomogram, Decreased appetite, Diarrhoea
Clinical narrative: Abdominal pain lower right side; diarrhea; loss of appetite; spasms all unexplained; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration, administered in the right arm on 24Mar2021 12:00 as dose 2, single for COVID-19 immunization at pharmacy or drug Store. The patient medical history and concomitant medication was not reported. Patient previously took dose 1 of bnt162b2 via an unspecified route of administration, administered in arm right on 03mar2021 12:00 (lot number was not reported) as dose 1, single for COVID-19 immunization. No other vaccines were given within 4 weeks. No other medications were given within 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On an unspecified date of 2021 the patient experienced abdominal pain lower right side, diarrhoea, loss of appetite, spasms all unexplained. The patient underwent lab tests and procedures which included blood test resulted normal on an unknown date, computerised tomogram resulted normal on an unknown date, stool analysis resulted normal on an unknown date. Reporter stated that 3 other friends that had the vaccine at same time frame are experience similar complications. The clinical outcome of the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101098968 Same reporter/drug/event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms, Stool analysis
Clinical narrative: Abdominal pain lower right side; diarrhea; loss of appetite; spasms all unexplained; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration, administered in the right arm on 24Mar2021 12:00 as dose 2, single for COVID-19 immunization at pharmacy or drug Store. The patient medical history and concomitant medication was not reported. Patient previously took dose 1 of bnt162b2 via an unspecified route of administration, administered in arm right on 03mar2021 12:00 (lot number was not reported) as dose 1, single for COVID-19 immunization. No other vaccines were given within 4 weeks. No other medications were given within 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On an unspecified date of 2021 the patient experienced abdominal pain lower right side, diarrhoea, loss of appetite, spasms all unexplained. The patient underwent lab tests and procedures which included blood test resulted normal on an unknown date, computerised tomogram resulted normal on an unknown date, stool analysis resulted normal on an unknown date. Reporter stated that 3 other friends that had the vaccine at same time frame are experience similar complications. The clinical outcome of the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101098968 Same reporter/drug/event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain lower, Blood test, Computerised tomogram, Decreased appetite, Diarrhoea
Clinical narrative: Abdominal pain lower right side; diarrhea; loss of appetite; spasms all unexplained; This is a spontaneous report from a contactable consumer reported for a patient. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection.), dose 2 via an unspecified route of administration, administered in right arm on 24Mar2021 at 12:00 (Batch/Lot Number: ER8727) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration, administered in right arm on 03Mar2021 at 12:00 (Batch/Lot Number: EN6205) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included sinusitis from an unknown date and unknown if ongoing. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medication received within 2 weeks of vaccination. No COVID prior vaccination. Patient had no known allergies. On 29Jul2021 at 13:00, the patient experienced abdominal pain lower right side, diarrhea, loss of appetite and spasms all unexplained. Seriousness criteria-results in death, life threatening, prolonged hospitalization, disabling/incapacitating and congenital anomaly/birth defect all were reported as no. Adverse event resulted in Doctor or other health care professional office/clinic visit, Emergency room/department or urgent care. No treatment received for adverse events. No COVID tested post vaccination. The patient underwent lab tests and procedures which included computerised tomogram, stool analysis normal (stool) and blood test (blood sample) all were normal. The outcome of the events were not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101098968 Same reporter/drug/event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms, Stool analysis normal
Clinical narrative: Abdominal pain lower right side; diarrhea; loss of appetite; spasms all unexplained; This is a spontaneous report from a contactable consumer reported for a patient. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection.), dose 2 via an unspecified route of administration, administered in right arm on 24Mar2021 at 12:00 (Batch/Lot Number: ER8727) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration, administered in right arm on 03Mar2021 at 12:00 (Batch/Lot Number: EN6205) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included sinusitis from an unknown date and unknown if ongoing. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medication received within 2 weeks of vaccination. No COVID prior vaccination. Patient had no known allergies. On 29Jul2021 at 13:00, the patient experienced abdominal pain lower right side, diarrhea, loss of appetite and spasms all unexplained. Seriousness criteria-results in death, life threatening, prolonged hospitalization, disabling/incapacitating and congenital anomaly/birth defect all were reported as no. Adverse event resulted in Doctor or other health care professional office/clinic visit, Emergency room/department or urgent care. No treatment received for adverse events. No COVID tested post vaccination. The patient underwent lab tests and procedures which included computerised tomogram, stool analysis normal (stool) and blood test (blood sample) all were normal. The outcome of the events were not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101098968 Same reporter/drug/event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain lower, Decreased appetite, Diarrhoea, Muscle spasms
Clinical narrative: Abdominal pain lower right side; diarrhea; loss of appetite; spasms all unexplained; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported, expiry date: not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history and concomitant medication were not reported. On 29Jul2021 01:00 PM, patient experienced abdominal pain lower right side, diarrhea, loss of appetite, spasms all unexplained. The outcome of events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101098968 Same reporter/drug/event, different patient.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, SARS-CoV-2 test
Clinical narrative: Still have cough a week after 2nd covid vaccine; This is a spontaneous report from a contactable consumer or other non-health care professional.  A 67-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 14Aug2021 03:00 PM (at the age of 67-year-old) in left arm as a dose 2, single for covid-19 immunization. The patients medical history included covid-19 prior vaccination from an unknown date. Concomitant medications included Multi-vitamin, fish oil, low dose acetylsalicylic acid (ASPIR), calcium. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 24Jul2021 11:00 AM (at the age of 67-year-old) in left arm as a dose 1, single for covid-19 immunization and experienced coughed so much patient lost his voice for 2 days. Cough was dry then became phlegmy, green phlegm. Patient had not received any other vaccine in four weeks. patient had no known allergies. Patient was tested to COVID post vaccination. On unspecified date in Aug2021 patient had cough a week after 2nd covid vaccine. The patient underwent lab tests and procedures which included Nasal Swab which was negative on 01Aug2021. The outcome of cough was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.   The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Eyelid disorder, Ocular hyperaemia, Oropharyngeal pain, Pain in extremity, Rhinorrhoea
Clinical narrative: Runny nose; Sore throat; My arm was killing me; right eye had a red redness in it like a red very red; I have three dot on my eyelid; This is a spontaneous report from a contactable consumer (patient). A 52-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported, Expiration date: Unknown) via an unspecified route, administered in Left Arm of top on an unspecified date (52-year-old at vaccination) as Dose number unknown, Single for COVID-19 immunization. The patient's medical history and concomitant medications was reported as none. The patient did not received any other vaccine before four weeks prior to vaccination. On an unspecified date, the reporter mentioned that the patient had the shot on Saturday and the patient was experiencing runny nose, sore throat and arm was killing the patient. The next following days (Sunday), the patient's right eye had a red redness in it like a red very red, the patient did not know what to call it, but it was in the right part, the next day on the patient's eyelids which was today the patient have three dot on eyelid. The patient queried if that was normal. No investigation assessment was reported. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Therapeutic response unexpected
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP. A patient, of unspecified age and gender, received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose; and received the third (booster) of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. Medical history included ongoing rheumatoid arthritis. Concomitant medications included prednisone for rheumatoid arthritis from an unspecified start date and ongoing. After receiving the 2nd vaccine, patient experienced 3 days of energy and no pain. Patient received the booster shot and the exact same thing happened. I get a boost of energy and pain relief for a few days on an unspecified date. The outcome of unexpected therapeutic response/immunization/off-label use: unknown. Information about lot/batch number cannot be obtained. No further information expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: vertigo upon standing; Dizziness; This is a spontaneous report from a contactable consumer (Patient). A 64-years-old Non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 16Aug2021 (at the age of 64-years-old) as dose number unknown, single for COVID-19 immunization. The Patient medical history included asthma from an unknown date. The patient concomitant medications was not reported. The Patient was not pregnant at the time of vaccination. The Patient had no known allergies. The Patient did not received any other vaccine in four weeks. Patient was not diagnosed with COVID-19 prior vaccination and Patient was not tested COVID-19 post vaccination. On 21Aug2021, the patient experienced dizziness, vertigo upon standing. The Patient did not received treatment for the events. The outcome for the events dizziness, vertigo upon standing was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Sore arm,; fatigue,; nausea,; diarrhea; abdominal cramps,; body aches,; headache; tiredness; This is a spontaneous report from a contactable other healthcare professional. A 21-year-old non-pregnant female patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 24Aug2021 14:45 (at the age of 21-year-old), in the left arm, as dose 2, single for COVID-19 immunization. The patient's medical history included Penicillin allergy from an unknown date and unknown if ongoing. The patient previously took amoxicillin and experienced drug hypersensitivity from an unknown date and unknown if ongoing. Patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 02Aug2021 16:30 (at the age of 21-year-old), in the left arm, as dose 1, single for COVID-19 immunization. Patient did not take any other vaccine within four weeks and received other medication within two weeks. Patient had not been tested for COVIID before vaccination and patient had tested for post vaccination as negative. On 25Aug2021 at 07:00, the patient experienced sore arm, fatigue, nausea, diarrhea, abdominal cramps, body aches, headache, tiredness. Treatment was not taken. On 24Aug2021 the patient underwent lab tests and procedures which included sars-cov-2 test negative. The clinical outcome of events was unknown.  Information about lot/batch number has been requested.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Sore arm,; fatigue,; nausea,; diarrhea; abdominal cramps,; body aches,; headache; tiredness; This is a spontaneous report from a contactable other healthcare professional. A 21-year-old non-pregnant female patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 24Aug2021 14:45 (at the age of 21-year-old), in the left arm, as dose 2, single for COVID-19 immunization. The patient's medical history included Penicillin allergy from an unknown date and unknown if ongoing. The patient previously took amoxicillin and experienced drug hypersensitivity from an unknown date and unknown if ongoing. Patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 02Aug2021 16:30 (at the age of 21-year-old), in the left arm, as dose 1, single for COVID-19 immunization. Patient did not take any other vaccine within four weeks and received other medication within two weeks. Patient had not been tested for COVIID before vaccination and patient had tested for post vaccination as negative. On 25Aug2021 at 07:00, the patient experienced sore arm, fatigue, nausea, diarrhea, abdominal cramps, body aches, headache, tiredness. Treatment was not taken. On 24Aug2021 the patient underwent lab tests and procedures which included sars-cov-2 test negative. The clinical outcome of events was unknown.  Information about lot/batch number has been requested.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle spasms
Clinical narrative: Mild muscle spasms and intermittent numbness in arm, leg and hip muscles on same side as injection site; Mild muscle spasms and intermittent numbness in arm, leg and hip muscles on same side as injection site; This is a spontaneous report from a contactable consumer (patient). A 16-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 19Aug2021 16:15 (at the age of 16-years-old) as dose 1, single for covid-19 immunisation. Medical history included Benign Pineal gland brain tumor and known allergies Adhesive. Concomitant medication included birth control, received medication in two weeks. The patient was not pregnant at Time of Vaccination. No other vaccine in four weeks. The patient had no covid prior vaccination and no covid tested post vaccination. On 19Aug2021 18:00, the patient had Mild muscle spasms and intermittent numbness in arm, leg and hip muscles on same side as injection site, still continues and not present prior to injection. No treatment was received for the events. The outcome of the events was not recovered.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.