chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Arthralgia, Back pain, Headache
Clinical narrative: bad stomach pain; throwing up for more than three days; fever; pain in back right shoulder and arm; pain in back right shoulder and arm; pain in back right shoulder and arm; headache; feeling bloated; white count elevated; This is a spontaneous report from a contactable consumer nurse (patient, self-reported). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 09Sep2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported several side effects including bad stomach pain, throwing up for more than three days, fever, pain in back right should and arm, headache, feeling bloated, white count elevated on an unspecified date in Sep2021. The patient visited to emergency department (ED). The patient asked if there were reports of violent vomiting or stomach pain after getting the vaccine and response included provided information from PI (LAB-1457-13.0, Revised: 01 September 2021), table 2 from section 6.2 sharing that none of the clinical trial participants reported severe vomiting after the first dose of the vaccine and that stomach pain was not specifically mentioned. The patient asked if a fever lasting for five days have been reported and response included shared with caller information from the attached CONS document, that systemic side effects generally started within one to two days and resolved within a few days but that a specific time range was not provided. The patient asked if she would be required to get the second dose of the vaccine, which was mandated, because her side effects from the first one. The patient asked "immunocompromised people shouldn't get the vaccine" and asked if hypothyroidism was considered to be an immunocompromised condition and response included provided treatment disclaimer to caller and referred to HCP. The patient underwent lab tests and procedures which included White blood cell count: elevated on an unspecified date in Sep2021. Outcome of the events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vomiting, White blood cell count
Clinical narrative: bad stomach pain; throwing up for more than three days; fever; pain in back right shoulder and arm; pain in back right shoulder and arm; pain in back right shoulder and arm; headache; feeling bloated; white count elevated; This is a spontaneous report from a contactable consumer nurse (patient, self-reported). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 09Sep2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported several side effects including bad stomach pain, throwing up for more than three days, fever, pain in back right should and arm, headache, feeling bloated, white count elevated on an unspecified date in Sep2021. The patient visited to emergency department (ED). The patient asked if there were reports of violent vomiting or stomach pain after getting the vaccine and response included provided information from PI (LAB-1457-13.0, Revised: 01 September 2021), table 2 from section 6.2 sharing that none of the clinical trial participants reported severe vomiting after the first dose of the vaccine and that stomach pain was not specifically mentioned. The patient asked if a fever lasting for five days have been reported and response included shared with caller information from the attached CONS document, that systemic side effects generally started within one to two days and resolved within a few days but that a specific time range was not provided. The patient asked if she would be required to get the second dose of the vaccine, which was mandated, because her side effects from the first one. The patient asked "immunocompromised people shouldn't get the vaccine" and asked if hypothyroidism was considered to be an immunocompromised condition and response included provided treatment disclaimer to caller and referred to HCP. The patient underwent lab tests and procedures which included White blood cell count: elevated on an unspecified date in Sep2021. Outcome of the events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Cough, Nasal congestion, Oropharyngeal pain, Productive cough
Clinical narrative: Cough; Cough and phlegm; Congestion; Sore throat (similar to Laryngitis); Pain on the right underarm/axillary; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the right arm on 07Sep2021 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 08Sep2021, the patient experienced cough and phlegm, congestion, sore throat (similar to laryngitis) and pain on the right underarm/axillary. The patient took multiple COVID tests and all came out negative. The events resulted in a visit to the doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment prescribed by the doctor with an unspecified inhaler (MANUFACTURER UNKNOWN), guaifenesin (MUCINEX) and an unspecified nasal spray (MANUFACTURER UNKNOWN). Since the vaccination, the patient had been tested for COVID-19. On 10Sep2021, the patient underwent Nucleic Acid Amplification Test (NAATS) via nasal swab and the result was negative. On 10Sep2021, the patient underwent 3 Antigen Tests via nasal swab and the result was negative. On 11Sep2021, the patient underwent Polymerase Chain Reaction (PCR) test via nasal swab and the result was negative. The clinical outcome of the events cough and phlegm, congestion, sore throat (similar to laryngitis) and pain on the right underarm/axillary was resolving at the time of the report.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Cough; Cough and phlegm; Congestion; Sore throat (similar to Laryngitis); Pain on the right underarm/axillary; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the right arm on 07Sep2021 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 08Sep2021, the patient experienced cough and phlegm, congestion, sore throat (similar to laryngitis) and pain on the right underarm/axillary. The patient took multiple COVID tests and all came out negative. The events resulted in a visit to the doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment prescribed by the doctor with an unspecified inhaler (MANUFACTURER UNKNOWN), guaifenesin (MUCINEX) and an unspecified nasal spray (MANUFACTURER UNKNOWN). Since the vaccination, the patient had been tested for COVID-19. On 10Sep2021, the patient underwent Nucleic Acid Amplification Test (NAATS) via nasal swab and the result was negative. On 10Sep2021, the patient underwent 3 Antigen Tests via nasal swab and the result was negative. On 11Sep2021, the patient underwent Polymerase Chain Reaction (PCR) test via nasal swab and the result was negative. The clinical outcome of the events cough and phlegm, congestion, sore throat (similar to laryngitis) and pain on the right underarm/axillary was resolving at the time of the report.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: had an allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and Expiration date were not reported) via an unspecified route of administration on 26Aug2021 (age at vaccination: 56-years-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. After first vaccination on 26Aug2021, immediately the patient had experienced an allergic reaction due to which she was admitted to emergency room. The outcome of the event was unknown.   The Lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Peripheral swelling, Vaccination site pain, Vaccination site swelling
Clinical narrative: there is swelling and pain in the arm with the injection site; there is swelling and pain in the arm with the injection site; she can't "hardly lift" her arm; her "pinky and thumb" is also swelling as well as her arm on the same side; her "pinky and thumb" is also swelling as well as her arm on the same side; This is a spontaneous report from a contactable female consumer (Patient reported for herself) via medical information team. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot Number: Unknown), via unspecified route of administration, on 27Aug2021 as a dose 1, single for COVID-19 immunization. The patient medical history and concomitant medication was not reported. On an unspecified date of 2021 the patient stated that she had some issues with the first dose. Patient reported that there was swelling and pain in the arm with the injection site and added that she can't "hardly lift" her arm. Patient specifically mentioned that her "pinky and thumb" was also swelling as well as her arm on the same side. Patient also reported that she can't understand the information since there was an echo and could not hear properly. Outcome of all the reported events was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: had light red rash all over her body that started after getting the vaccine; Caller reports she's had "severe itching" in addition to the rash; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received bnt162b2 (Batch/Lot number was not reported), first dose via an unspecified route of administration on 13Sep2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had light red rash all over her body that started after getting the vaccine, she had "severe itching" in addition to the rash in Sep2021. Caller was calling for herself, she received the first dose of the Pfizer-Biontech Covid19 vaccine on 13Sep2021.  caller had light red rash all over her body that started after getting the vaccine. Caller reported she's had "severe itching" in addition to the rash, and "no relief from taking diphenhydramine hydrochloride (BENADRYL)". Her HCP (health professional) told her to switch to cetirizine hydrochloride (ZYRTEC), and she still hasn't had any relief. Therapeutic measures were taken as a result of events. The outcome of events was not resolved.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Dyspnoea, SARS-CoV-2 test
Clinical narrative: Hole in heart; Difficult breathing; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration in left arm, on 15Mar2021 at 14:00 (at the age of 71 years), as dose 1, single, for COVID-19 immunization. The patient had no medical history and concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The most recent COVID-19 vaccine was administered in a pharmacy or drug store. On 30Apr2021 at 14:00, the patient experienced hole in heart and difficult breathing. The events were considered serious as life-threatening and requiring hospitalization for 2 days in 2021. It was unknown if treatment was given for the events. Since the vaccination, the patient has been tested with COVID-19 nasal swab that was negative on 30Apr2021. The patient had not recovered from the events.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Liver disorder, Pneumonia, Vaccination site pain
Clinical narrative: she is not feeling good and wanted to go and lay down; I am diabetic and the sugar is up to 308; messing with my liver; I got a pneumonia in May and I still have it; I am internally bleeding; It's a bleeding ulcer it bleeds here and there nothing serious but I am loosing blood; My arm still really really hurts from it when I push on it; I have to suck on the breathing treatment every 4 hours; Have a heart problems too; This is a spontaneous report from a contactable consumer (patient) or other non HCP.  A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date was not reported), via unspecified route, on 05May2021 as dose 2, single for COVID-19 immunization. Patient historical vaccine includes flu shot (she got a flu shot way before she got Pfizer covid 19 vaccine) on an unspecified date for immunization. The patient medical history includes Type 2 diabetes mellitus. concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, on 14Apr2021 as dose 1, single for COVID-19 immunization. On an unspecified date in 2021, the patient experienced arm pain from it when she pushes on it, she thought it was fine next thing that it still hurts, she had internally bleeding, She has a bleeding ulcer it bleeds and there was nothing serious, but she was losing blood, her arm still really  hurts from it when she push on it, she must suck on the breathing treatment every 4 hours, patient had a heart problems too, her diabetic and the sugar was up to 308, messing with her liver. on 14 sep2021, she was not feeling good and wanted to go and lay down. Patient got a pneumonia in May and still have it and can't get rid of it. she got double pneumonia it is in both lungs and it is a nasty kind that just grows and grows, and she was on oxygen now, she must suck on the breathing treatment every 4 hours. She has a heart problem too. She had internally bleeding too which they cannot fix because of her lungs because they cannot put her under, or it will kill her. she had to have a blood transfusion while in the hospital because of the pneumonia. She was taking so much medicine that is messing up with her liver. She was diabetic and the sugar was up to 308. Caller stated that she did not want to be on the phone for a very long time because she was not feeling good and wanted to go and lay down. The patient underwent lab tests and procedures which included Blood glucose level monitoring on an unspecified date with a reading of 308 on an unspecified date. The outcome of the events Patient got a pneumonia in May and still have it was not recovered, while outcome of other events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Palpitations
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 13Sep2021 at 17:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included patient currently recovering from miscarriage. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included unspecified prenatal vitamins for an unknown indication from an unknown date and unknown if ongoing. On 14Sep2021 at 08:30, the patient experienced feelings of having a fast-beating or pounding heart. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events feelings of having a fast-beating or pounding heart was unknown at the time of this report.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: After the first shot she experienced a changed in her menstrual cycle, So it was longer and heavy than normal; After the first shot she experienced a changed in her menstrual cycle, So it was longer and heavy than normal; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 35-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FC3180, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 23Aug2021 at 15:00 pm (age at vaccination was 35 years) as dose 1, single for COVID-19 immunization. The patient did not have any medical history. The patient's concomitant medications were not reported. The facility where the first COVID-19 vaccine was administered was Pharmacy. The vaccine was not administered at Facility. There was no history of any previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines were administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Aug2021, after the first shot the patient experienced a change in her menstrual cycle. Her normal period was 4-5 days and starts low with a small amount in the first day, then on the 2nd-3rd days was heavy, then the last days was just a small portion of blood. She was also very regular, it comes every 27-28 days. This time, after the first vaccine it came early. Then it was 1.5 days with no blood. After that, it came really strong and heavy, lasting for another 6 days. So it was longer and heavy than normal, from the first signs of blood it was 9 days total instead of the 4-5 days it normally lasts. She marked her calendar as it starting on 30Aug2021 but it was the 28Aug2021 when she had the first sign and nothing until the 30Aug2021. The caller noted she didn't have accidents anymore, she was too regular. This time there was no sign and she was surprised. The caller asked if that happens after the second dose should she call back. The adverse events did not require a visit to Emergency room or Physician office. No relevant tests were done. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0177, Expiration date: unknown) via an unspecified route of administration, administered in left arm on an unspecified date in Sep2021 at around 10:30 to 11:00 am (age at vaccination was 35 years) as dose 2, single for COVID-19 immunization. After the second dose of vaccine, the patient noted that she felt sick and she couldn't even talk right, she woke up feeling that way. The outcome of the events was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Dizziness postural, Fatigue, Headache
Clinical narrative: Extremely fatigued; Headache; Leg and knee, sciatica pain/not justjoint pain but any injury site; Scar under eye hurts; Leg and knee, sciatica pain; Not just joint pain but any injury site/literally anywhere that have injured has sharp stabbing pain; Sciatica pain; Leg and knee, sciatica pain, back; Nausea; Blurred vision; Memory fog.; Tongue tingles; Heart races for no reason; Dizzy when stand up; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the right arm on 07Sep2021 at 14:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety and unspecified injury. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included unspecified anti anxiety medications from an unknown date and unknown if ongoing. On 07Sep2021 at 14:00, the patient felt extremely fatigued, headache, not just joint pain but any injury site, scar under eye was hurting, leg and knee, sciatica pain, back, literally anywhere the patient was injured had sharp stabbing pain, nausea when she ate, blurred vision, memory fog, tongue tingled, heart raced for no reason and got dizzy when she stood up. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extremely fatigued, headache, not just joint pain but any injury site, scar under eye was hurting, leg and knee, sciatica pain, back, literally anywhere that she had injured, had sharp stabbing pain, nausea, blurred vision, memory fog, tongue tingles, heart races for no reason, dizzy when stand up was not resolved at the time of this report.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Nausea, Pain, Pain in extremity, Palpitations
Clinical narrative: Extremely fatigued; Headache; Leg and knee, sciatica pain/not justjoint pain but any injury site; Scar under eye hurts; Leg and knee, sciatica pain; Not just joint pain but any injury site/literally anywhere that have injured has sharp stabbing pain; Sciatica pain; Leg and knee, sciatica pain, back; Nausea; Blurred vision; Memory fog.; Tongue tingles; Heart races for no reason; Dizzy when stand up; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the right arm on 07Sep2021 at 14:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety and unspecified injury. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included unspecified anti anxiety medications from an unknown date and unknown if ongoing. On 07Sep2021 at 14:00, the patient felt extremely fatigued, headache, not just joint pain but any injury site, scar under eye was hurting, leg and knee, sciatica pain, back, literally anywhere the patient was injured had sharp stabbing pain, nausea when she ate, blurred vision, memory fog, tongue tingled, heart raced for no reason and got dizzy when she stood up. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extremely fatigued, headache, not just joint pain but any injury site, scar under eye was hurting, leg and knee, sciatica pain, back, literally anywhere that she had injured, had sharp stabbing pain, nausea, blurred vision, memory fog, tongue tingles, heart races for no reason, dizzy when stand up was not resolved at the time of this report.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Scar pain, Sciatica, Vision blurred
Clinical narrative: Extremely fatigued; Headache; Leg and knee, sciatica pain/not justjoint pain but any injury site; Scar under eye hurts; Leg and knee, sciatica pain; Not just joint pain but any injury site/literally anywhere that have injured has sharp stabbing pain; Sciatica pain; Leg and knee, sciatica pain, back; Nausea; Blurred vision; Memory fog.; Tongue tingles; Heart races for no reason; Dizzy when stand up; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the right arm on 07Sep2021 at 14:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety and unspecified injury. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included unspecified anti anxiety medications from an unknown date and unknown if ongoing. On 07Sep2021 at 14:00, the patient felt extremely fatigued, headache, not just joint pain but any injury site, scar under eye was hurting, leg and knee, sciatica pain, back, literally anywhere the patient was injured had sharp stabbing pain, nausea when she ate, blurred vision, memory fog, tongue tingled, heart raced for no reason and got dizzy when she stood up. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extremely fatigued, headache, not just joint pain but any injury site, scar under eye was hurting, leg and knee, sciatica pain, back, literally anywhere that she had injured, had sharp stabbing pain, nausea, blurred vision, memory fog, tongue tingles, heart races for no reason, dizzy when stand up was not resolved at the time of this report.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Impaired driving ability, Pain in jaw, Performance status decreased, Stomatitis
Clinical narrative: Severe headache; Clouded my abilities to drive and be productive; Clouded my abilities to drive and be productive; Jaws and teeth hurt a lot; Jaws and teeth hurt a lot; Small sores in the roof of mouth; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Sep2021 at 09:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had some unspecified medical history. The patient had unknown allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 11Sep2021 at 03:00 (It had started about 18 hours after the vaccine), the patient experienced jaws and teeth hurt a lot. On 11Sep2021, the patient also reported small sores in the roof of mouth. On 12Sep2021 at 09:00 (about 48 hours after the first injection), the patient experienced severe headache that clouded her abilities to drive and be productive on Sunday. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events which included treatment with an over-the-counter (OTC) mouthwash and prescription for headache.  The clinical outcome of the events jaws and teeth hurt a lot, small sores in the roof of mouth, severe headache, clouded abilities to drive and be productive were not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: Severe headache; Clouded my abilities to drive and be productive; Clouded my abilities to drive and be productive; Jaws and teeth hurt a lot; Jaws and teeth hurt a lot; Small sores in the roof of mouth; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Sep2021 at 09:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had some unspecified medical history. The patient had unknown allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 11Sep2021 at 03:00 (It had started about 18 hours after the vaccine), the patient experienced jaws and teeth hurt a lot. On 11Sep2021, the patient also reported small sores in the roof of mouth. On 12Sep2021 at 09:00 (about 48 hours after the first injection), the patient experienced severe headache that clouded her abilities to drive and be productive on Sunday. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events which included treatment with an over-the-counter (OTC) mouthwash and prescription for headache.  The clinical outcome of the events jaws and teeth hurt a lot, small sores in the roof of mouth, severe headache, clouded abilities to drive and be productive were not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: 'I' have been having episodes of severe vertigo shortly after the second dose.; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the left arm on 08Aug2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 09Jul2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Aug2021, the patient had episodes of severe vertigo shortly after the second dose. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event had episodes of severe vertigo shortly after the second dose was not resolved at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Tinnitus
Clinical narrative: Headaches almost daily since vaccine; Tinnitus got much worse hours after vaccine and continues; 3 bouts of lethargy since the vaccine; This is a spontaneous report from a contactable nurse, the patient. A 52-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the right arm on 13Aug2021 at 14:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included small intestinal bacterial overgrowth (SIBO), irritable bowel syndrome (IBS), tinnitus and allergy to peanuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included alprazolam (XANAX) as needed (prn) at night taken for an unknown indication from an unknown date and unknown if ongoing. On 13Aug2021 at 17:00, the patient experienced headaches almost daily since vaccine. Tinnitus got much worse hours after vaccine and continued. The patient also experienced 3 bouts of lethargy since she had the vaccine. It was reported that the patient did not plan on getting second 'bc' if side effects. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were taken as a result of event headaches which included treatment with sumatriptan succinate (IMITREX). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headaches almost daily since vaccine, tinnitus got much worse hours after vaccine and continued, and 3 bouts of lethargy since the vaccine were not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Back pain lower muscles then upper back pain pretty bad back pain; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Sep2021 at 15:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications included lorazepam (MANUFACTURER UNKNOWN) 1mg and bupropion (MANUFACTURER UNKNOWN) 75mg; both for an unknown indication from an unknown date and unknown if ongoing. On 13Sep2021 at 16:00, the patient experienced back pain, lower muscles then upper back pain, reported as pretty bad back pain. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event back pain lower muscles then upper back pain pretty bad back pain was resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Fatigue, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Pounding headache in left temporal lobe and left eye; Pounding headache in left temporal lobe and left eye; Fever; Fatigue; Injection site pain; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an intramuscular route of administration in the left arm on 03Sep2021 at 10:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included intracranial ventricular peritoneal drainage and COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-vaccine. Concomitant medications were not reported. On 03Sep2021 at 10:00, the patient experienced pounding headache in left temporal lobe and left eye that was still present 12 days after receiving the vaccine. Patient also experienced fever, fatigue and injection site pain lasting 1-2 days after the injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, fatigue and injection site pain after the injection were recovered with sequelae on an unknown date in Sep2021 (reported as lasting 1-2 days), while the clinical outcome of the event pounding headache in left temporal lobe and left eye was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Missed menstrual period; This is a spontaneous report from a non-contactable nurse, the patient. A 29-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 30Aug2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (also reported as none). Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 03Sep2021, it was reported that the patient missed menstrual period. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the event missed menstrual period. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event missed menstrual period was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Heart rate abnormal, Hypoaesthesia, Palpitations, Pruritus
Clinical narrative: Bruises on the legs; Itching all over body; Numbness on hands, arms, legs, and toes; Heartbeat Palpitations; Heartbeat Palpitations; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on 25Aug2021 at 12:30 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. On 05Sep2021, the patient had bruises on the legs, numbness on hands, arms, legs and toes, itching all over body and heartbeat palpitations. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with methylprednisolone (MANUFACTURER UNKNOWN). Since the vaccination, the patient had been tested for COVID-19. On 10Sep2021, the patient underwent COVID-19 test via nasal swab and the result was negative. The clinical outcome of the events bruises on the legs, numbness on hands, arms, legs and toes, itching all over body and heartbeat palpitations were resolving at the time of this report.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Bruises on the legs; Itching all over body; Numbness on hands, arms, legs, and toes; Heartbeat Palpitations; Heartbeat Palpitations; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on 25Aug2021 at 12:30 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. On 05Sep2021, the patient had bruises on the legs, numbness on hands, arms, legs and toes, itching all over body and heartbeat palpitations. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with methylprednisolone (MANUFACTURER UNKNOWN). Since the vaccination, the patient had been tested for COVID-19. On 10Sep2021, the patient underwent COVID-19 test via nasal swab and the result was negative. The clinical outcome of the events bruises on the legs, numbness on hands, arms, legs and toes, itching all over body and heartbeat palpitations were resolving at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Her fiance received the first dose on 24Aug2021 and had a headache after this that she still has from the first dose; This is a spontaneous report from a contactable consumer. A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 24Aug2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date it was reported as patient received her first dose on 24Aug2021 and had a headache after this that she still has from the first dose. The seriousness of the event was non-serious. The outcome of event was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: most recent period "seems different" and is "redder, heavier, and more clotting" than normal; most recent period "seems different" and is "redder, heavier, and more clotting" than normal; This is a spontaneous report from a contactable 50-year-old female consumer reported for herself via medical information team. A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 23Aug2021 as single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. She reported that her most recent period "seems different" and was "redder, heavier, and more clotting" than normal, her period started on 12Sep2021. She's also seen social media reports of changes in menstruation. She's decided not to take the second dose. She did indicate she was approaching menopause, and that she has an appointment scheduled with her doctor. She experienced changes in her menstrual cycle after receiving the first dose of the Pfizer-Biontech Covid19 vaccine. She asked, the vaccine does require an immune response, right? Could that cause changes in her menstrual cycle? She was asking have other people reported similar changes to menses after vaccination? Will there be additional studies looking into menstrual changes? No studies for changes in menstruation. Provided that there was an arm of the study that focuses on pregnant women. The Comirnaty Prescribing Information and the authorized Prescribing Information for the Pfizer-BioNTech COVID-19 Vaccine do not list menstrual changes as adverse reaction from clinical studies and post authorization experience. The organization that provides leadership in education, research and gynecologic care to improve the reproductive health of young people states that: There have been anecdotal and media reports of irregular menstrual cycles, including skipped periods, prolonged periods, spotting after COVID-19 vaccines in adults and similar changes in menstrual cycles have been reported after COVID-19 infection. This was not surprising because infections, immune reactions, and fevers can cause short-term, self-limited changes in cycles. However, further studies are needed to verify these changes in people who have received COVID-19 vaccines. Reporter considered events as non-serious. The outcome of events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: a couple that die from COVID and left 5 kids behind; This is a spontaneous report from a Pfizer-sponsored program Pfizer.com - General Company Information via a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at an unknown dose via an unknown route on an unknown date for COVID-19 immunization. The patient medical history and concomitant medications were not reported. A couple died from COVID and left 5 kids behind. The patient died on an unspecified date. It was not reported if an autopsy was performed.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101212055 same reporter, same event, drug/ different patient; Reported Cause(s) of Death: a couple that die from COVID and left 5 kids behind
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: A couple die from COVID and left 5 kids behind; This is a spontaneous report from a contactable consumer. A patient of an unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at an unknown dose via an unknown route on an unknown date for Covid-19 immunization. Medical history and concomitant drug were not provided. A couple died from COVID and left 5 kids behind. Patient knew the family. Outcome of the event was fatal.  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-202101211957 same reporter, same event, drug/ different patient; Reported Cause(s) of Death: a couple that die from COVID.