chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: stomach muscle spasms - quite strong at times-beginning 16 hours after onset of symptoms; Feeling not well; Chills; Muscle aches; Headache; Tired; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 15Apr2021 at 19:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received concomitant medications within 2 weeks of vaccination which are unspecified. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 23Mar2021 at 17:00 (at the age of 54-year-old) as a single dose for COVID-19 immunisation with no symptoms (reported by the patient). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 15:30, twenty hours after the vaccination, the patient experienced feeling not well, chills, muscle aches, headache, tired. On 16Apr2021, 16 hours after onset of symptoms also had stomach muscle spasms - quite strong at times. 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 feeling not well, chills, muscle aches, headache, tired were recovered on 17Apr2021.The clinical outcome of the event stomach muscle cramps was recovered on 18Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort
Clinical narrative: Strange pressure in ear, kind of like water in ear or airplane pressure; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 13Apr2021 at 02:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications taken within two weeks of vaccination were not reported. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021, the patient experienced a strange pressure in ear, kind of like water in ear or airplane pressure. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event a strange pressure in ear, kind of like water in ear or airplane pressure 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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Pounding headache every morning since the vaccine; This is a spontaneous report from a contactable healthcare professional. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8733) via intramuscular route of administration in the left arm on 07Apr2021 at 11:30 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant 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 vaccination. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6205) via intramuscular route of administration in the left arm on 17Mar2021 at 11:30 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. On 08Apr2021, the patient experienced  pounding headache. The patient described that  "from the top" goes away after taking Tylenol, but there was a pounding headache, every morning since the vaccination. It had been going on for at least a week. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pounding headache every morning since the vaccine was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus both ears; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 26Feb2021 at 09:30 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products. 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 zolpidem tartrate (AMBIEN) and amfetamine aspartate; amfetamine sulfate; dexamfetamine saccharate; dexamfetamine sulfate (ADDERALL), both for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN95212) via an unspecified route of administration in the left arm on 05Feb2021 at 09:30 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. On 24Mar2021 at 00:00, the patient experienced tinnitus both ears. The event 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 taken as a result of the event and included treatment with steroids antibiotics. The clinical outcome of the event tinnitus both ears was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site nodule
Clinical narrative: Nodule at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 10Apr2021 at 11:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. The patient previously took bupropion hydrochloride (WELLBUTRIN) for unknown indication on an unknown date and experienced drug allergy. On an unknown date in Apr2021, the patient developed nodule at injection site. The adverse event did not result in doctor or other healthcare professional office/clinic visit/emergency visit. Since the vaccination, the patient had been tested for COVID-19. On 14Apr2021, the patient underwent COVID-19 virus test via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the reported event. The clinical outcome of event nodule at injection site was 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: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Tiredness; Full body ache; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 17Apr2021 at 10:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included acid reflux and allergy to surgical glue. 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 paracetamol (TYLENOL), ibuprofen (MANUFACTURER UNKNOWN), loratadine (CLARITIN), vitamin D nos (MANUFACTURER UNKNOWN) and probiotics all from unknown dates, for unknown indications and unknown if ongoing. The patient previously received amoxicillin/ clavulanic acid (AUGMENTIN) on an unknown date for an unknown indication and experienced allergy to antibiotic. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 27Mar2021 at 09:45 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. On 17Apr2021 at 15:00, the patient experienced tiredness and full-body ache. 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 not taken as a result of the events. The clinical outcome of the events tiredness and full-body ache were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Hyperaesthesia, Illness, Pain
Clinical narrative: Heightened senses, smell, hearing, skin; Smells made the patient sick; Change in body thermostat...I'm usually cold, and I have been hot ever since 4 days later; Vomited (dry heaved) for a full 12 hours, about every 35-40 minutes.; Vomited (dry heaved) for a full 12 hours, about every 35-40 minutes.; Still tired; Aching (mostly due to wretching so badly); This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 14Apr2021 at 13:30 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included bipolar disorder and allergy to lithium (allergy to metal). Concomitant medications included bipolar medication (Unspecified) from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 26Mar2021 at 13:30 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. 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. On 15Apr2021 at 23:00, the patient experienced heightened senses, smell, hearing, skin. All smells made the patient sick. Change in body thermostat. The patient was usually cold, and had been hot for 4 days. The patient vomited (dry heaved) for a full 12 hours, about every 35-40 minutes. Still tired and aching (mostly due to retching so badly). 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 heightened senses, smell, hearing, skin, all smells made the patient sick, change in body thermostat and had been hot, vomited (dry heaved) for a full 12 hours, tired and aching was resolved with sequelae on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Retching, Vomiting
Clinical narrative: Heightened senses, smell, hearing, skin; Smells made the patient sick; Change in body thermostat...I'm usually cold, and I have been hot ever since 4 days later; Vomited (dry heaved) for a full 12 hours, about every 35-40 minutes.; Vomited (dry heaved) for a full 12 hours, about every 35-40 minutes.; Still tired; Aching (mostly due to wretching so badly); This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 14Apr2021 at 13:30 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included bipolar disorder and allergy to lithium (allergy to metal). Concomitant medications included bipolar medication (Unspecified) from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 26Mar2021 at 13:30 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. 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. On 15Apr2021 at 23:00, the patient experienced heightened senses, smell, hearing, skin. All smells made the patient sick. Change in body thermostat. The patient was usually cold, and had been hot for 4 days. The patient vomited (dry heaved) for a full 12 hours, about every 35-40 minutes. Still tired and aching (mostly due to retching so badly). 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 heightened senses, smell, hearing, skin, all smells made the patient sick, change in body thermostat and had been hot, vomited (dry heaved) for a full 12 hours, tired and aching was resolved with sequelae on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Pain in extremity
Clinical narrative: Soreness (left arm); Slight headache; Lethargy; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734) via an unspecified route of administration in the left arm on 14Apr2021 at 09:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to soy. 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 loratadine (MANUFACTURER UNKNOWN), metronidazole (MANUFACTURER UNKNOWN), fluticasone propionate (FLONASE) and unspecified vitamins; all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via an unspecified route of administration in the left arm on 23Mar2021 at 10:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 14Apr2021 at 19:00, the patient experienced soreness (left arm), slight headache and lethargy. 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 soreness (left arm), slight headache and lethargy were recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pain in extremity, Retching
Clinical narrative: Sore muscles; Moderate headache; 14 instances of retching (dry-heaving).; Sore left arm/  arm continued to be sore; Generally fatigued/ felt moderately fatigued; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER0730) via an unspecified route of administration in the left arm on 27Mar2021 (at the age of 41-years old) as a single dose for COVID-19 immunisation. The patient's medical history included acid reflux, irritable bowel syndrome (IBS-C) and hyperprolactinemia. Concomitant medications included citalopram (MANUFACTURER UNKNOWN) and naproxen sodium (ALEVE) for unknown indications from an unknown start date and unknown if ongoing.  The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 06Mar2021 (at the age of 41-years old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Mar2021, the patient had experienced sore left arm and was generally fatigued. On 28Mar2021, in the morning, the patient's arm continued to be sore, felt moderately fatigued, experienced sore muscles and moderate headache all day. The patient also experienced 14 instances of retching (dry-heaving) over a 15minute timeframe early in the morning on the same day. The events did not result in doctors 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 outcomes of the events sore left arm, generally fatigued, sore muscles, moderate headache and retching (dry-heaving) were recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Migraine
Clinical narrative: Migraine headache; Migraine headache; 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: ER8733) via an unspecified route of administration in the right arm on 29Mar2021 at 15:45 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and history of migraines. 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. Concomitant medications were not reported. The patient previously received DEMEROL and CIPRO and experienced allergy. On 11Apr2021, the patient experienced migraine headache. The event resulted in 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 migraine headache which included treatment with meds and testing. The clinical outcome of the event migraine headache was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysgeusia, Headache, Nausea, Pain in extremity
Clinical narrative: Headache; Nausea; Chills; Sore arm; Very distinct metallic taste in mouth.; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration on an unknown date in Apr2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and sleep apnea. The patient had a known allergy to sulfa based drugs. 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. Concomitant medications included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) and procaterol hydrochloride (PRO-AIR); both for unknown indications from unknown dates and unknown if ongoing. On 16Apr2021 at 19:00, the patient experienced headache, nausea and chills which only lasted for a few hours and a sore arm that lasted for about 48 hours. On an unknown date in Apr2021, about 24 hours post vaccination, the patient developed a very distinct metallic taste in mouth. It had been almost 72 hours after vaccination and the taste persisted. 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 not taken as a result of the events. The clinical outcome of the events headache, nausea and chills were resolved on an unknown date in Apr2021; whereas sore arm was resolved on 18Apr2021. The clinical outcome of the event very distinct metallic taste in mouth was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, SARS-CoV-2 test
Clinical narrative: Tinglingly and numbness in fingers of left arm; Tinglingly and numbness in fingers of left arm; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) in the left arm on 04Apr2021 at 10:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have allergies to medications, food, or other products. 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. Concomitant medications included norethisterone acetate, ethinylestradiol, ferrous fumarate (MINASTRIN 24 FE) for unknown indication from an unknown date and unknown if ongoing. On 22Mar2021, the patient underwent for COVID-19 virus test (nasal swab) and the result was negative. On 07Apr2021, the patient experienced tinglingly and numbness in fingers of left arm. 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 taken as a result of the events and included treatment with ALIEVE. The clinical outcome of the events tinglingly and numbness in fingers of left arm was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node in neck area, same side as injection.; This is a spontaneous report from a non-contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 02Apr2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021, a week after first dose, the patient experienced swollen lymph node in neck area same side as injection and as of 18Apr2021, it was still swollen/present. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph node in neck area was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: The skin on my fingers and palms turned an orange colour. This happened 11 days after my first injection; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, deep vein thrombosis of left leg and COVID-19 exposure in Feb2020. Prior to the vaccination, the patient was diagnosed with COVID-19, on an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included rivaroxaban (XARELTO) started from an unknown date for deep vein thrombosis of legs and was ongoing and blood thinners (unspecified) started from an unknown date for clot and was ongoing.   On an unknown date, the skin on the patient fingers and palms turned an orange color. This happened 11 days after her first injection, and at day 13 after her  second dose, on 14Apr2021. The patient was currently being treated with Xarelto for a DVT that was in her left leg, likely due to a COVID exposure back in February of 2020. She went to the ER for the clot which was quite extensive and was still on the blood thinners. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event- skin on the fingers and palms turned to an orange colour was recovered on an unknown date Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea
Clinical narrative: Impacted my period/ It came the following week, 12 days early/ It never come this early or twice in a month.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 13Apr2021 at 08:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included labetalol (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021, following the week of vaccination, the patient's period was early by 12 days. The patient stated that the vaccine impacted her periods which was always every 28 days and never came this early or twice in a month. The event did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event impacted her periods, period was early by 12 days and never came this early or twice in a month was unknown at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Hypoaesthesia, Muscle twitching
Clinical narrative: Muscle twitching throughout body; Stomach pain; Numbness in finger tips; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: ER8727) via an unspecified route of administration in the left arm on 12Apr2021 at 14:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not take concomitant medications within two weeks of vaccination. On 13Apr2021, the patient experienced muscle twitching throughout body, stomach pain and numbness in finger tips. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events muscle twitching throughout body, stomach pain and numbness in finger tips was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea
Clinical narrative: Nausea; Headache; Feeling unwell; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 16Apr2021 at 09:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported. The patient had no known allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 17:00, the patient experienced nausea, headache and felt unwell. 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 nausea, headache and felt unwell was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Dull and frequent headaches; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EP7534) via an unspecified route of administration in the left arm on 30Mar2021 at 12:00 (at the age of 20-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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 medication within two weeks of vaccination. Patient previously took amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. On 30Mar2021, the patient experienced dull and frequent headaches for the past couple of weeks. The patient did not receive any treatment for the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The. The clinical outcome of the event of dull and frequent headaches was not recovered at the time of this report.    No follow-up attempts are needed; No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: Weakness; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 11Apr2021 at 00:45 (at the age of 19-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and anemia. The patient had no allergies to any medications, food, or other products. Concomitant medications included guaifenesin (MUCINEX) and antibiotics (unspecified) both for unknown indications from an unknown date and unknown if ongoing. 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. On 11Apr2021 at 00:45, the patient experienced weakness and dizziness. The events resulted in 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 weakness and dizziness were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Parosmia, Pyrexia, Taste disorder
Clinical narrative: Headache; Fever; Chills; Sense of smell affected greatly as was sense of taste; Sense of smell affected greatly as was sense of taste; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on 19Apr2021 at 11:30 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included reflux and COVID-19 since Dec2020 and stopped on an unknown date. 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-19 vaccine. Concomitant medications included paracetamol (TYLENOL), melatonin (MANUFACTURER UNKNOWN), venlafaxine (MANUFACTURER UNKNOWN) and omeprazole (MANUFACTURER UNKNOWN); all taken from unknown dates for unknown indications and unknown if ongoing. The patient previously received povidone-iodine (BETADINE) on an unknown date for unknown indication and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 29Mar2021 at 11:45, as a single dose for COVID-19 immunisation. On 20Apr2021 at 10:00, the patient experienced headache, fever, chills, sense of smell affected greatly as was sense of taste just like when the patient had COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events headache, fever, chills, sense of smell affected greatly and as was sense of taste were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Baseball sized (or larger) swelling under left armpit; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 20Apr2021 at 14:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included thyroid (ARMOUR THYROID) for an unknown indication, from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021 at 05:00 the patient experienced baseball sized (or larger) swelling under left armpit. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19.The events did not result in any of these doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event baseball sized (or larger) swelling under left armpit was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Feeling abnormal, White blood cell count, White blood cell count decreased
Clinical narrative: low WBC significant drop; Tired; feeling off; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EP7534, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 02Apr2021 14:00 (at the age of 62-year-old) as dose 1, single for COVID-19 immunization, at hospital. The patient medical history included known allergies (unspecified). There were no concomitant medications. The patient did not receive other vaccine in four weeks. No other medications in two weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On 03Apr2021, the patient experienced low WBC significant drop, tired, feeling off, and diarrhea. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included white blood cell count: low WBC significant drop on 03Apr2021. The outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Tired; Entire arm sore after; Body aches; Headache; Fatigue; Intense dizzy spells; Developed a bad rash spreading from both triceps down both lats; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 11Apr2021 at 16:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure , asthma, sjogren's syndrome, fibromyalgia, known allergies  to tea tree, turkey and gold. Concomitant medications included cetirizine (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN), chlortalidone (CHLORTHALIDONE) and omeprazole (MANUFACTURER UNKNOWN); all taken for an unknown indication on an unknown date and unknown if ongoing. The patient previously took propylene glycol (MANUFACTURER UNKNOWN), formaldehyde solution (FORMALDEHYDE), glutaral (MANUFACTURER UNKNOWN), propolis (MANUFACTURER UNKNOWN), carbamazepine(CARMINE), 2-hydroxyethyl methacrylate (MANUFACTURER UNKNOWN), p-phenylenediamine(MANUFACTURER UNKNOWN), aminopropylon (MANUFACTURER UNKNOWN), dimethylaminopropylamine and ethyl 2-cyanoacrylate (MANUFACTURER UNKNOWN) and experienced drug 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. On 11Apr2021, at 17:00, the patient was tired and entire arm sore after. She had body aches, headache, and fatigue and intense dizzy spells for the next week. She developed a bad rash spreading from both triceps down both lats, which progressively got worse over the next week and a half until prescribed prednisone. The event rash started to calm down after second dose of prednisone, but not gone. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events and included treatment with protopic, antihistamine, antibiotic and prednisone. Since the vaccination, the patient had been tested for COVID_19. On 22Apr2021, the patient underwent lab test and procedures which included SARS CoV-2 Antigen carestart 87811 (Nasal Swab) and the result was negative. The clinical outcome of the events tired, entire arm sore after, body aches, headache, fatigue and intense dizzy spells for the next week was not resolved. The clinical outcome of the event developed a bad rash spreading from both triceps down both lats was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test
Clinical narrative: Tired; Entire arm sore after; Body aches; Headache; Fatigue; Intense dizzy spells; Developed a bad rash spreading from both triceps down both lats; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 11Apr2021 at 16:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure , asthma, sjogren's syndrome, fibromyalgia, known allergies  to tea tree, turkey and gold. Concomitant medications included cetirizine (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN), chlortalidone (CHLORTHALIDONE) and omeprazole (MANUFACTURER UNKNOWN); all taken for an unknown indication on an unknown date and unknown if ongoing. The patient previously took propylene glycol (MANUFACTURER UNKNOWN), formaldehyde solution (FORMALDEHYDE), glutaral (MANUFACTURER UNKNOWN), propolis (MANUFACTURER UNKNOWN), carbamazepine(CARMINE), 2-hydroxyethyl methacrylate (MANUFACTURER UNKNOWN), p-phenylenediamine(MANUFACTURER UNKNOWN), aminopropylon (MANUFACTURER UNKNOWN), dimethylaminopropylamine and ethyl 2-cyanoacrylate (MANUFACTURER UNKNOWN) and experienced drug 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. On 11Apr2021, at 17:00, the patient was tired and entire arm sore after. She had body aches, headache, and fatigue and intense dizzy spells for the next week. She developed a bad rash spreading from both triceps down both lats, which progressively got worse over the next week and a half until prescribed prednisone. The event rash started to calm down after second dose of prednisone, but not gone. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events and included treatment with protopic, antihistamine, antibiotic and prednisone. Since the vaccination, the patient had been tested for COVID_19. On 22Apr2021, the patient underwent lab test and procedures which included SARS CoV-2 Antigen carestart 87811 (Nasal Swab) and the result was negative. The clinical outcome of the events tired, entire arm sore after, body aches, headache, fatigue and intense dizzy spells for the next week was not resolved. The clinical outcome of the event developed a bad rash spreading from both triceps down both lats was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in left calf and foot and left forearm and hand; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Apr2021 at 16:45 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. 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. On 18Apr2021 at 15:30, the patient experienced numbness in left calf and foot and left forearm and hand. 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 numbness in left calf and foot and left forearm and hand was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Chills, Dissociation, Dizziness
Clinical narrative: Forgetful; Detached; Stomach still feels strange; Dizzy; Stomach hurt; Felt miserable; Fever; Chills; Headache; Body aches; This is a spontaneous report from a contactable healthcare professional, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 16Apr2021 at 12:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid. The patient had no known allergies to medications, food, or other products. 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 venlafaxine hydrochloride (EFFEXOR), levothyroxine sodium (SYNTHROID) and esomeprazole (NEXIUM); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 26Mar2021 at 11:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021 at 17:00 (reported as the following day), the patient experienced fever, chills, headache, body aches and she knew "rhoa" was typical. On 19Apr2021 (Monday), the patient tried to go to work and could not, she was dizzy, her stomach hurt and she felt miserable. The patient did go back to work on Wednesday (on 21Apr2021) after spending 48 hours in bed. On 21Apr2021, the patient was still feeling dizzy, forgetful and detached. Her stomach still felt strange. 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 fever, chills, headache, body aches, dizzy, stomach hurt, felt miserable, forgetful, detached and stomach still feels strange were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.