chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: There was an excrusion from freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excrusion from freezer) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excrusion from freezer). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excrusion from freezer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.  There was an excursion from freezer on 01 Oct 2021.  Used the excursion tool but there was no option for the excursion. The tool only gave options for excursions above one hour and not less than, so  does not know how to do the analysis. The minimum temperature reached was minus 4.2-degree Fahrenheit and maximum was 5.2-degree Fahrenheit. Excursion duration was 6 minutes. Vials were returned to freezer. All the vials were thawed before administration and there was no color change or anything abnormal. 10 vials were impacted. There  another excursion happened on September.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow-up received included reporter, patient and product details updated.
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage
Clinical narrative: bleeding event/lost a couple of units of blood; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (bleeding event/lost a couple of units of blood) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (bleeding event/lost a couple of units of blood) (seriousness criterion medically significant). At the time of the report, HAEMORRHAGE (bleeding event/lost a couple of units of blood) outcome was unknown.            No concomitant medications reported by reporter.  No treatment medications provided by the reporter.  Patient took booster dose.  Company comment: This is a spontaneous case concerning a male patient of unknown age with no reported medical history, who experienced the serious  unexpected event haemorrhage. The event occurred on an unknown day  after dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 13-Nov-2021: Follow up received and contains no new information.; Sender's Comments: This is a spontaneous case concerning a male patient of unknown age with no reported medical history, who experienced the serious  unexpected event haemorrhage. The event occurred on an unknown day  after dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: States he did have a sinus infection she thinks in between the Pfizer COVID Vaccine doses; This is a spontaneous report from a Contactable consumer or other non HCP (parent). This consumer reported for 12 years old male patient.  A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0176, Expiration Date: 31Aug2021), dose 1 via an unspecified route of administration, administered in Arm Left on 14May2021 (age at vaccination: 12 year) as dose 1, single for covid-19 immunisation. Time the Vaccination Was Given between 1:30pm and 4:00pm in the afternoon. Medical history included asthma from an unknown date and unknown if ongoing. There were no concomitant medications. Patient had a sinus infection she thinks in between the Pfizer COVID Vaccine doses (May2021) stated the sinus infection began right before holiday on that Thursday and he was put on a Zpack and took about a week to completely resolve from the sinus infection. Patient was fine from the sinus infection and had no illness at the time of the Pfizer COVID 19 vaccination. Patient did not have testing for covid. And no lot, expiry date or NDC to provided for the Zpack as it had been discarded and he started taking it the Thursday before Memorial Day and finished it 5 days later on probably Monday holiday. Therapeutic measures taken as a result of sinusitis with Zpack. Physician Office, hosp and emergency room reported as no. The clinical outcome of the event was recovered in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on his upper arms (both); This is a spontaneous report from a contactable consumer (Reported for himself). A 70-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL3246), dose 1 via an unspecified route of administration, administered in arm left on 11Jan2021 (age at vaccine 70-years-old) as dose 1, single for covid-19 immunisation at Senior Living Facility. Medical history included cardiac disorder (heart disease), diabetes mellitus and hypertension (High blood pressure); all from an unknown date and unknown if ongoing. Concomitant medications, the patient received within two weeks of vaccination: Yes. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Relevant past drug history was not reported. The patient has no reported allergies. On an unspecified date in 2021, the patient experienced rash on his upper arms (both). The case assessed as non-serious. No treatment was given for the events. The second dose was scheduled on 02Feb2021. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Eye disorder, Facial paralysis, Gait disturbance, Hypoaesthesia
Clinical narrative: Mouth is drooping; Feeling numb; Walking is off; Eye is dropping/ Eye was not close all; Achy/Flu; Achy/Flu; Feeling of stroke on left side; I am not feeling good; The initial safety information received was reporting only non-serious adverse drug reaction. Upon receipt of follow-up information on 08Nov2021, this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report from a contactable consumer, reporting for herself. A 28-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number FC3182) intramuscularly in arm left on 29Sep2021 15:45 (at the age of 28-year-old) at single dose for COVID-19 immunisation. Relevant medical history included attention deficit hyperactivity disorder (AHDH). Family medical history included throat cancer, lung cancer, dementia and alcoholism. Concomitant medications included oral amfetamine (ADZENYS XR ODT) ongoing since Aug2021 for ADHD, oral norethindrone acetate ongoing since an unspecified date for birth control and unspecified steroids. On 29Sep2021 18:30, few hours later lock jaw the patient felt stroke on left side. On 29Sep2021 she was not feeling good. All next day she was achy and had flu line symptoms. On 01Oct2021 the patient had left side still feeling numb, walking was off, eye was dropping and mouth was drooping. Eye was not close all the way, eye drops were needed. The patient used eye patch for relief. Three weeks later the patient still had the same symptoms with no relief. Second should would be due on 20Oct2021. Not feeling good required physician office visit and was treated with 5-day steroid pack. Not feeling good was not resolved, outcome for the other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Malaise, Pain
Clinical narrative: Mouth is drooping; Feeling numb; Walking is off; Eye is dropping/ Eye was not close all; Achy/Flu; Achy/Flu; Feeling of stroke on left side; I am not feeling good; The initial safety information received was reporting only non-serious adverse drug reaction. Upon receipt of follow-up information on 08Nov2021, this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report from a contactable consumer, reporting for herself. A 28-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number FC3182) intramuscularly in arm left on 29Sep2021 15:45 (at the age of 28-year-old) at single dose for COVID-19 immunisation. Relevant medical history included attention deficit hyperactivity disorder (AHDH). Family medical history included throat cancer, lung cancer, dementia and alcoholism. Concomitant medications included oral amfetamine (ADZENYS XR ODT) ongoing since Aug2021 for ADHD, oral norethindrone acetate ongoing since an unspecified date for birth control and unspecified steroids. On 29Sep2021 18:30, few hours later lock jaw the patient felt stroke on left side. On 29Sep2021 she was not feeling good. All next day she was achy and had flu line symptoms. On 01Oct2021 the patient had left side still feeling numb, walking was off, eye was dropping and mouth was drooping. Eye was not close all the way, eye drops were needed. The patient used eye patch for relief. Three weeks later the patient still had the same symptoms with no relief. Second should would be due on 20Oct2021. Not feeling good required physician office visit and was treated with 5-day steroid pack. Not feeling good was not resolved, outcome for the other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: Sever tooth pain with teeth on my left side; This is a spontaneous report from a contactable consumer, (patient himself).  A 68-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: FR2613), via an unspecified route of administration on 27Sep2021 (at the age of 68 years old) as dose 3 (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE8729) via an unspecified route of administration on 08Apr2021 (at the age of 67-years-old) as a single dose for COVID-19 immunisation and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30145ba) via an unspecified route of administration on 18Apr2021 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. On 28Sep2021, the patient experienced severe tooth pain with teeth on his left side. This happened the day after he got the vaccine and went away after a week. Therapeutic measures were not taken because of the event. The outcome was recovered for the event severe tooth pain with teeth on his left side in OCT-2021.  Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Mass, Muscle spasms, Muscle twitching, Musculoskeletal disorder
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 67-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8727), dose 2 via an unspecified route of administration, administered in Arm Left on 23Mar2021 (At the age of 67 years) as DOSE 2, SINGLE for covid-19 immunization. Medical history included anxiety (Verbatim: Anxiety), dyspepsia, stress from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Historical vaccine included Flu shot for immunization leading to pain on unspecified date. Patient also had bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ENU205), dose 1 via an unspecified route of administration, administered on (At the age of 67 years) 02Mar2021 as DOSE 1, SINGLE for covid-19 immunization. On 23Mar2021 the patient experienced arm had been start hurting, shoulder has been start hurting it was very painful, patient cannot turn his arm and could not try to move the arm if need to move; it moves a little bit sometimes and had like a little lump and on unspecified date of 2021 patient had kind of give like spasm and twitches. Patient did not get any treatment for adverse events. The patient underwent lab tests and procedures which included x-ray and had everything came out okay on unspecified date of 2021. The outcome of the event like a little lump, kind of give like spasm and twitches was unknown, while the outcome of the rest of the events was not recovered.No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, X-ray
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 67-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8727), dose 2 via an unspecified route of administration, administered in Arm Left on 23Mar2021 (At the age of 67 years) as DOSE 2, SINGLE for covid-19 immunization. Medical history included anxiety (Verbatim: Anxiety), dyspepsia, stress from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Historical vaccine included Flu shot for immunization leading to pain on unspecified date. Patient also had bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ENU205), dose 1 via an unspecified route of administration, administered on (At the age of 67 years) 02Mar2021 as DOSE 1, SINGLE for covid-19 immunization. On 23Mar2021 the patient experienced arm had been start hurting, shoulder has been start hurting it was very painful, patient cannot turn his arm and could not try to move the arm if need to move; it moves a little bit sometimes and had like a little lump and on unspecified date of 2021 patient had kind of give like spasm and twitches. Patient did not get any treatment for adverse events. The patient underwent lab tests and procedures which included x-ray and had everything came out okay on unspecified date of 2021. The outcome of the event like a little lump, kind of give like spasm and twitches was unknown, while the outcome of the rest 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: Biopsy, Condition aggravated, Paranasal sinus hypersecretion, Swelling, Thyroid function test
Clinical narrative: This is a spontaneous report from a non-contactable other HCP. This 45-year-old female other HCP (patient) reported for herself that:A 45-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EL1284), via an unspecified route of administration, administered in left arm as dose 2, single on 20Jan2021 (at the age of 45-year-old) for covid-19 immunisation at hospital. The patient medical history was not reported. Patient had no known allergies. There were no concomitant medications. Historical vaccine included patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EL3302), via an unspecified route of administration, administered in left arm as dose 1, single on 30Dec2020 (at the age of 45-year-old) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received no other medications within 2 weeks of vaccination. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On unspecified date in Mar2021, two months after her second dose she noticed a swelling in her neck at first it was thought to be just sinus drainage but after a few weeks it just seem to get worse. When she went to PCP there was a mass on her thyroid on unspecified date in Mar2021. Since she had no prior history of any issues and since it seems to have grown in a matter of months it seems as those the two were related. The mass was biopsied and non-cancerous. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included biopsy: unknown results and thyroid function test: The mass was biopsied and non-cancerous. Therapeutic measures were taken as a result of adverse events as thyroid ultrasound and biopsy. At the time of this report, the outcome of events was recovered with lasting effects on unspecified date in 2021. No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroid mass
Clinical narrative: This is a spontaneous report from a non-contactable other HCP. This 45-year-old female other HCP (patient) reported for herself that:A 45-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EL1284), via an unspecified route of administration, administered in left arm as dose 2, single on 20Jan2021 (at the age of 45-year-old) for covid-19 immunisation at hospital. The patient medical history was not reported. Patient had no known allergies. There were no concomitant medications. Historical vaccine included patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EL3302), via an unspecified route of administration, administered in left arm as dose 1, single on 30Dec2020 (at the age of 45-year-old) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received no other medications within 2 weeks of vaccination. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On unspecified date in Mar2021, two months after her second dose she noticed a swelling in her neck at first it was thought to be just sinus drainage but after a few weeks it just seem to get worse. When she went to PCP there was a mass on her thyroid on unspecified date in Mar2021. Since she had no prior history of any issues and since it seems to have grown in a matter of months it seems as those the two were related. The mass was biopsied and non-cancerous. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included biopsy: unknown results and thyroid function test: The mass was biopsied and non-cancerous. Therapeutic measures were taken as a result of adverse events as thyroid ultrasound and biopsy. At the time of this report, the outcome of events was recovered with lasting effects on unspecified date in 2021. No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Polymenorrhoea
Clinical narrative: Menstruation started 01Oct21 (vaccination #1 date) and 13Oct21, 2 weeks apart; Severe headache; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on 08Nov2021, this case now contains serious adverse reaction(s). Information processed together.  This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 01Oct2021 (Batch/Lot Number: EW0217) (at the age of 44-years-old) as dose 1, single for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. On 07Oct2021, 6 days after vaccination, patient experienced severe headache. Patient also reported that menstruation started on 01Oct2021 then on 13Oct2021, 2 weeks apart. After patient's first shot on 01Oct2021, patient started feeling debilitating headaches on the left side of her head starting on 07Oct2021. Patient never had headaches, so this adverse effect was a significant disruption to her life. Patient started her period on 01Oct2021 which was a little early, but the next period occurred on 13Oct2021 and lasted 2 days longer than usual. The patient took ibuprofen (ADVIL) for the headache. On 20Oct2021, patient started acupuncture treatments to balance her body and avoid adverse effects after second shot of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EW0217) on 22Oct2021 administered intramuscularly in the left arm. Patient had no adverse effects experienced after second shot. The reporter assessed the events as serious, medically significant. Outcome of headache was recovered on 10Oct2021 while remaining event was unknown. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Alopecia, Arthralgia, Depressed mood, Energy increased, Fatigue
Clinical narrative: Increase in energy; pain in hands and knees; pain in hands and knees; harder to bend knees; fatigue; hair falling out; feels discouraged or depressed; right middle finger was 'locking up'; stress; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 58-years-old female patient received bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: was not reported, Expiration Date: was not reported), via an unspecified route of administration, administered anatomical location was not reported, on an unspecified date in Oct2021 (at the age of 58 year), as dose number unknown, single for COVID-19 immunization; tofacitinib citrate (XELJANZ XR), oral from Aug2021 (Batch/Lot number was not reported) and ongoing, at 11 mg, once daily for rheumatic arthritis. Medical history included pre-existing anxiety from an unknown date and unknown if ongoing, rheumatoid arthritis from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient stated, medical doctor instructed her to stop XELJANZ XR a couple of days after receiving COVID-19 vaccine. The patient stated, during that time she initially noticed an increase in energy on first day off XELJANZ XR, then increase in pain in hands and knees, right middle finger was locking up and harder to bend knees. The patient stated, she was unsure if increased pain and mobility is related to pause in XELJANZ XR, change in weather, or vaccine. The patient stated, symptoms subsiding since re-start of XELJANZ XR. The patient stated, unknown if medical doctor was aware. The patient stated, she feels fatigue after taking dose of XELJANZ XR, like she needs a nap. The patient experienced, her hair falling out, but unsure if it is related to stress, pre-existing anxiety, or other medications. No date or time frame given in relation to start of XELJANZ XR. The patient stated, she agrees it is hard to cope with rheumatoid arthritis and sometimes she feels discouraged or depressed. The outcome of the events was unknown. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Joint stiffness, Pain in extremity, Stress, Trigger finger
Clinical narrative: Increase in energy; pain in hands and knees; pain in hands and knees; harder to bend knees; fatigue; hair falling out; feels discouraged or depressed; right middle finger was 'locking up'; stress; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 58-years-old female patient received bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: was not reported, Expiration Date: was not reported), via an unspecified route of administration, administered anatomical location was not reported, on an unspecified date in Oct2021 (at the age of 58 year), as dose number unknown, single for COVID-19 immunization; tofacitinib citrate (XELJANZ XR), oral from Aug2021 (Batch/Lot number was not reported) and ongoing, at 11 mg, once daily for rheumatic arthritis. Medical history included pre-existing anxiety from an unknown date and unknown if ongoing, rheumatoid arthritis from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient stated, medical doctor instructed her to stop XELJANZ XR a couple of days after receiving COVID-19 vaccine. The patient stated, during that time she initially noticed an increase in energy on first day off XELJANZ XR, then increase in pain in hands and knees, right middle finger was locking up and harder to bend knees. The patient stated, she was unsure if increased pain and mobility is related to pause in XELJANZ XR, change in weather, or vaccine. The patient stated, symptoms subsiding since re-start of XELJANZ XR. The patient stated, unknown if medical doctor was aware. The patient stated, she feels fatigue after taking dose of XELJANZ XR, like she needs a nap. The patient experienced, her hair falling out, but unsure if it is related to stress, pre-existing anxiety, or other medications. No date or time frame given in relation to start of XELJANZ XR. The patient stated, she agrees it is hard to cope with rheumatoid arthritis and sometimes she feels discouraged or depressed. The outcome of the events was unknown. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast mass, Lymphadenopathy
Clinical narrative: This is a spontaneous report from a contactable consumer (patient herself). A 49-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: EW0126, Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 30Apr2021 11:00 (Age at vaccination 48-years-old) as dose 1, single for covid-19 immunization at pharmacy/drug store. The patient was not pregnant at time of vaccination. The patient medical history was not reported. There were no concomitant medications. The patient previously took penicillin b and experienced hypersensitivity on an unspecified date. The patient experienced a stable nodule in the right breast was on 04May2021. One week after first dose. Left underarm lymph node swelled to Size of baseball, Joint pain on 30Apr2021. The patient receive any other vaccines within four weeks prior to the COVID vaccine was unknown. The patient did not received any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not received treatment for the events. The clinical outcome of the events was recovering.Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Pain in extremity
Clinical narrative: had a sore arm; This is a spontaneous report from a contactable nurse.   A male patient of an unspecified age received the second dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient previously received the first dose of BNT162B2 on an unspecified date and experienced had a sore arm and felt more uncomfortable after the first. The patient had a sore arm on an unspecified date.  The patient underwent lab tests and procedures which included antibody test: 64 in 2021. The outcome of  had a sore arm was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Immunisation, SARS-CoV-2 test, Transient ischaemic attack
Clinical narrative: woke up on 03Nov2021 with symptoms of a stroke went to the ER. It was a TIA stroke; woke up on 03Nov2021 with symptoms of a stroke went to the ER. It was a TIA stroke; Dose: 03; administration date: 18Oct2021; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 66-year-old non pregnant female patient received third dose(BOOSTER), of BNT162B2 (BNT162B2, Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE Lot Number: Fe3590), via an unspecified route of administration in arm left on 18Oct2021 as SINGLE for (at the age of 66) covid-19 immunization (Pharmacy or Drug Store). The patient medical history was not reported. Concomitant medications included influenza vaccine (INFLUENZA) taken for immunization on 08Oct2021; pneumococcal vaccine polysacch (PNEUMOCOCCAL POLYSACCHARIDE VACCINE) taken for immunization on 08Oct2021, estradiol, pantoprazole, multi vitamin, calcium all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, patient was not diagnosed with COVID-19, Since the vaccination, the patient has not been tested for COVID-19 (received within 2 weeks of vaccination). Patient was not pregnant at the time of vaccination. Historical vaccine included BNT162B2 (BNT162B2, Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE Lot Number: EN6200) via an unspecified route of administration, administered in arm left on 18Feb20121 as dose 1, single and dose 2 of BNT162B2, PFIZER-BIONTECH Solution for injection, COVID-19 VACCINE Lot Number: EN6208) via an unspecified route of administration, administered in arm left on 11Mar2021 as dose 2, single (both at the age of 66) for COVID-19 immunization. The patient had dose: 03, administration date on 18oct2021, patient woke up on 03Nov21 with symptoms of a stroke went to the ER. It was a Transient ischaemic attack (TIA) stroke. The events resulted in Emergency room/department or urgent care, Hospitalization. Patient was hospitalized for one day from 03Nov2021 to 04Nov2021. Events was assessed as serious and seriousness criteria was reported as caused/prolonged hospitalization. The patient underwent lab tests and procedures which included nasal swab (covid 19,) test with negative result on 03Nov2021. Therapeutic measures were taken as a result of events (lots of medications). The outcome of evets was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chest pain, Dizziness, Dyspnoea, Gait inability
Clinical narrative: very low pulse 46; unable to walk; unable to stand; Headache; sore throat; pain on the legs; difficult breathing; chest pain; dizziness; This is a spontaneous report from a contactable consumer (patient herself). A 67-year-old female non-pregnant received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: FE3592, Expiration date was not reported), via an unspecified route of administration in arm right on 01Oct2021 at 09:30 (at the age of 66-year-old) as a dose 2, single for COVID-19 immunization. Medical history included sleeping apnea, Sulfa allergy, known allergies: Codeine and Sulfa. Past drug event included codeine and experienced allergy. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8736, Expiration date was not reported), via an unspecified route of administration in arm right on 13Sep2021 (at the age of 66-year-old) as a dose 1, single for COVID-19 immunization. It was reported that, the patient was not pregnant at time of vaccination. No other vaccines received within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as yes. On 07Oct2021, the patient experienced headache, sore throat, unable to stand, unable to walk, pain on the legs, difficult breathing, dizziness, very low pulse 46, chest pain. Most of these symptoms have lasted longer than 30 days. The events resulted in the emergency room visit and physician office visit. The reporter considered this report as serious (medically significant). No prolonged hospitalization was reported. Treatment was not received for the events. The patient underwent lab tests and procedures which included heart rate: 46, low on an unspecified date in Oct2021 and Nasal Swab (SARS-CoV-2 test), resulted as negative on 20Oct2021. The device date was on 06Nov2021. The outcome of the events was recovering.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate decreased, Oropharyngeal pain, Pain in extremity
Clinical narrative: very low pulse 46; unable to walk; unable to stand; Headache; sore throat; pain on the legs; difficult breathing; chest pain; dizziness; This is a spontaneous report from a contactable consumer (patient herself). A 67-year-old female non-pregnant received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: FE3592, Expiration date was not reported), via an unspecified route of administration in arm right on 01Oct2021 at 09:30 (at the age of 66-year-old) as a dose 2, single for COVID-19 immunization. Medical history included sleeping apnea, Sulfa allergy, known allergies: Codeine and Sulfa. Past drug event included codeine and experienced allergy. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8736, Expiration date was not reported), via an unspecified route of administration in arm right on 13Sep2021 (at the age of 66-year-old) as a dose 1, single for COVID-19 immunization. It was reported that, the patient was not pregnant at time of vaccination. No other vaccines received within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as yes. On 07Oct2021, the patient experienced headache, sore throat, unable to stand, unable to walk, pain on the legs, difficult breathing, dizziness, very low pulse 46, chest pain. Most of these symptoms have lasted longer than 30 days. The events resulted in the emergency room visit and physician office visit. The reporter considered this report as serious (medically significant). No prolonged hospitalization was reported. Treatment was not received for the events. The patient underwent lab tests and procedures which included heart rate: 46, low on an unspecified date in Oct2021 and Nasal Swab (SARS-CoV-2 test), resulted as negative on 20Oct2021. The device date was on 06Nov2021. The outcome of the events was recovering.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: very low pulse 46; unable to walk; unable to stand; Headache; sore throat; pain on the legs; difficult breathing; chest pain; dizziness; This is a spontaneous report from a contactable consumer (patient herself). A 67-year-old female non-pregnant received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: FE3592, Expiration date was not reported), via an unspecified route of administration in arm right on 01Oct2021 at 09:30 (at the age of 66-year-old) as a dose 2, single for COVID-19 immunization. Medical history included sleeping apnea, Sulfa allergy, known allergies: Codeine and Sulfa. Past drug event included codeine and experienced allergy. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8736, Expiration date was not reported), via an unspecified route of administration in arm right on 13Sep2021 (at the age of 66-year-old) as a dose 1, single for COVID-19 immunization. It was reported that, the patient was not pregnant at time of vaccination. No other vaccines received within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as yes. On 07Oct2021, the patient experienced headache, sore throat, unable to stand, unable to walk, pain on the legs, difficult breathing, dizziness, very low pulse 46, chest pain. Most of these symptoms have lasted longer than 30 days. The events resulted in the emergency room visit and physician office visit. The reporter considered this report as serious (medically significant). No prolonged hospitalization was reported. Treatment was not received for the events. The patient underwent lab tests and procedures which included heart rate: 46, low on an unspecified date in Oct2021 and Nasal Swab (SARS-CoV-2 test), resulted as negative on 20Oct2021. The device date was on 06Nov2021. The outcome of the events was recovering.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Muscle spasms, Myalgia
Clinical narrative: Every joint and bone in his body hurt; every joint and bone in his body hurt; muscle aches; cramps; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, administered in the right arm, on 02Aug2021 10:30 (Batch/Lot number unknown), at age 60 years old, as dose 2, single, for COVID-19 immunisation, at a pharmacy/drug store. Relevant medical history and concomitant medications were not reported. The patient has no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection) administered in the left arm, on an unspecified date (Batch/Lot number unknown), as dose 1, single, for COVID-19 immunisation. The patient did not receive other vaccines in four weeks. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. On 02Aug2021 11:30, the patient experienced every joint and bone in his body hurt, had constant muscle aches and cramps. The events resulted to disability or permanent damage. It was unknown if the patient received treatment for the events. The outcome of the events was not resolved.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Head injury, Immunisation, Loss of consciousness
Clinical narrative: abruptly loss consciousness; extremely dizzy; fell hitting back of head on floor; fell hitting back of head on floor; cuts to both legs; hearing buzzing noise in ears; Dose number=3/third dose; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 3 via an unspecified route of administration, administered in arm right on 06Nov2021 12:30 (at the age of 58-years-old) (Batch/Lot Number: ER8732) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. The vaccine was given in the workplace clinic. Medical history included osteoarthritis, NMH (Hypotension), TMD (Temporomandibular joint syndrome), known allergies to citrus, shrimp, scallops, walnuts, pecans, portabella/cremini and cilantro. The patient's concomitant medications were not reported. The patient previously took and had allergies to thimerosal and neomycin. Historical vaccine included BNT162B2 dose 1 administered in the right arm on 27Mar2021 12:15 PM (at 57-years-old) (lot number: FN8030) and BNT162B2 dose 2 administered in the left arm on 17Apr2021 12:00 PM (at 57-years-old) (lot number: ER8731) for COVID-19 immunisation. The patient was not pregnant. The patient had no other vaccines in four weeks. The patient had no covid prior vaccination. She had not been tested for covid since vaccination. Approximately 22 hours, on 07Nov2021 10:30 AM, after receiving the third dose, felt extremely dizzy.  While trying to pour water in the kitchen, abruptly loss consciousness and fell hitting back of head on floor. After getting up to walk to another room, abruptly lost consciousness and fell again, resulting in cuts to both legs, lay down on sofa after hearing buzzing noise in ears. Waited a few minutes, then returned to the kitchen to finish retrieving water and abruptly lost consciousness for a third time again falling to the floor. Drinking water seemed to help alleviate dizziness. Had experienced a similar reaction after receiving an MMR vaccine several decades ago. The patient was recovering from the events without any treatment.   Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Skin laceration, Tinnitus
Clinical narrative: abruptly loss consciousness; extremely dizzy; fell hitting back of head on floor; fell hitting back of head on floor; cuts to both legs; hearing buzzing noise in ears; Dose number=3/third dose; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 3 via an unspecified route of administration, administered in arm right on 06Nov2021 12:30 (at the age of 58-years-old) (Batch/Lot Number: ER8732) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. The vaccine was given in the workplace clinic. Medical history included osteoarthritis, NMH (Hypotension), TMD (Temporomandibular joint syndrome), known allergies to citrus, shrimp, scallops, walnuts, pecans, portabella/cremini and cilantro. The patient's concomitant medications were not reported. The patient previously took and had allergies to thimerosal and neomycin. Historical vaccine included BNT162B2 dose 1 administered in the right arm on 27Mar2021 12:15 PM (at 57-years-old) (lot number: FN8030) and BNT162B2 dose 2 administered in the left arm on 17Apr2021 12:00 PM (at 57-years-old) (lot number: ER8731) for COVID-19 immunisation. The patient was not pregnant. The patient had no other vaccines in four weeks. The patient had no covid prior vaccination. She had not been tested for covid since vaccination. Approximately 22 hours, on 07Nov2021 10:30 AM, after receiving the third dose, felt extremely dizzy.  While trying to pour water in the kitchen, abruptly loss consciousness and fell hitting back of head on floor. After getting up to walk to another room, abruptly lost consciousness and fell again, resulting in cuts to both legs, lay down on sofa after hearing buzzing noise in ears. Waited a few minutes, then returned to the kitchen to finish retrieving water and abruptly lost consciousness for a third time again falling to the floor. Drinking water seemed to help alleviate dizziness. Had experienced a similar reaction after receiving an MMR vaccine several decades ago. The patient was recovering from the events without any treatment.   Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Blood clot in my lung about two months after second dose; This is a spontaneous report from a contactable consumer (the patient).     A male patient of an unspecified age received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), dose 2 via an unspecified route of administration, administered in Arm Left on 06Aug2021 15:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation  .  Medical history included tobacco user (Smoker). Concomitant medications included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported.  The patient experienced blood clot in my lung about two months after second dose (pulmonary embolism) (medically significant) on 30Sep2021 with outcome of recovered.  Therapeutic measures were taken as a result of the reported event including blood thinner.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Immunisation, Pyrexia
Clinical narrative: received bnt162b2; dose 3 (booster); Severe fever (103 degrees); joint pain for two days; This is a spontaneous report from a non-contactable consumer. An adult patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the arm on an unspecified date (batch/lot number was not reported) as dose 3 (booster), single for COVID-19 immunization in a pharmacy/drug store. The patient's medical history and concomitant medications were not reported. The patient had no covid prior vaccination. The patient previously took dose 1 and dose 2 of BNT162B2; both on unspecified date (batch/lot number unknown for COVID-19 immunization. The patient had no other vaccine in four weeks. On an unspecified date, the patient experienced severe fever (103 degrees), joint pain for two days. The patient had no covid tested post vaccination. Therapeutic measures were taken as a result of severe fever (103 degrees), joint pain for two days which included OTC medication. The outcome of the event severe fever (103 degrees) was unknown, while joint pain for two days was recovered.  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, Dizziness, Dyspnoea, Fatigue, Headache
Clinical narrative: headache; dizzy; getting tired; was trying to catch her breath; She feels like she is getting her taste buds back; Covid after being vaccinated/  Covid: positive/ contracted Covid; Covid after being vaccinated/  Covid: positive/ contracted Covid; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), vaccinated at age of 56 year old, dose 2 via an unspecified route of administration, administered in Arm Left on 24Mar2021 (Batch/Lot Number: BP7534) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 (Batch/Lot Number: SN6205) as DOSE 1, SINGLE for covid-19 immunisation. There were no concomitant medications and medical history. Patient just contracted Covid. She felt like she was getting her taste buds back and reported that she had a headache at the beginning of the week that got worse at night. She said that with standing up and moving she got dizzy. She was getting tired and was trying to catch her breath. She had no fever and she was keeping up with her pulse. She had no infection in the chest or anything. Patient got Covid after being vaccinated on 04Nov2021. The patient underwent lab tests and procedures which included Covid: positive on 04Nov2021. The outcomes of events were unknown.