chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: nosebleed; This is a spontaneous report from a non-contactable consumer reporting for their husband via the medical information team. An 87-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date (Tuesday afternoon) at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. A consumer reported that their husband received the first dose of vaccine on Tuesday afternoon of unspecified date.  He developed a nosebleed on 21Jan2021 at 0230. Outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: blood sugar crowding to the 130 mg/dL upper limit/numbers have been higher than normal; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (patient) reported that an 81-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number requested), via an unspecified route of administration on 19Jan2021 at a single dose for COVID-19 immunization. Medical history included being diagnosed as pre-diabetic from an unknown date. The patient's concomitant medications were not reported. The patient reported that he noticed in the last 2 days his blood sugar crowding to the 130 mg/dL upper limit on 19Jan2021. He stated that after getting vaccine, numbers have been higher than normal. The patient wants to know if that's from vaccine or something else. The outcome of the event was unknown.  Information on the batch number/lot number  has been requested
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Insomnia, Pruritus, Urticaria
Clinical narrative: bad allergic reaction; itching and welts, like hives; itching and welts, like hives; didn't get any sleep last night; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302 and expiration date not provided), via an unspecified route of administration in the left arm on 18Jan2021 18:00 at  a single dose for COVID-19 immunization. The patient has no medical history. Concomitant medication included other medications that she has never had a reaction to. The patient stated that she got her first dose of COVID vaccine on 18Jan2021 evening. On 19Jan2021, she had a bad allergic reaction, itching and welts, like hives or whatever that started on her arms that progressed to the rest of her body especially the buttocks, everywhere. She did not get any sleep on 19Jan2021 and was itching. She called the doctor's office to see if they could help her and they said they couldn't and told her she needed to contact the health department "or something." They aren't familiar with the vaccine and does not want to do anything that would put them in a legal situation. She stated she has an appointment on 08Feb for her next dose and she doesn't know if she can go through this again. She asked what can she do about this reaction. She started to get itching and "stuff" that was not bad until last night (unspecified date). She stated that it was like she had hives all over and itching out of control. She did not get any sleep and is still itching out of control. She wanted to know if she goes back to hospital if they will be able to do anything for her. It was her first shot and is scheduled for her second one on 08Feb2021. She was wondering will she have to go through all of this again. She had noticed hives on her arms on 19Jan2021 morning but mostly now are on her buttocks and thighs.  She stated that she had thought it was an allergic reaction to a fabric softener that she changed to. No treatment was given in response to the events. She has stated that she takes other medications that she has never had a reaction to. She does not think that they were related to this. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: little soreness; This is a spontaneous report from a contactable consumer (patient).  A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. Patient is taking medications as blood like thinner and for osteoporosis. She has allergies previously to grass and dust mites. She always has a wet nose when having allergies and does a nose drop and cleaner. Her nose was always on the runny side, she cannot live without a tissue. She uses a nasal spray and the cleaner. Concomitant medication included levothyroxine sodium (SYNTHROID), lisinopril, amlodipine, simvastatin, acetylsalicylic acid (BABY ASPIRIN) as blood thinner and paracetamol (TYLENOL ARTHRITIS) for osteoporosis. On an unspecified date in Jan2021 she had little soreness and had no other symptoms. The patient was asking if she should stop taking the BABY ASPIRIN and TYLENOL ARTHRITIS now that she got the vaccine. She read some place one should not take any aspirin. The case was reported as non-serious. The outcome of the event was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Lip swelling, Paraesthesia
Clinical narrative: I had the sensations of facial tingling; eye swelling; lip swelling; This is a spontaneous report from a contactable Nurse. A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unspecified route of administration on the right arm on 20Jan2021 08:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing known allergies: Sulfa  and allergy to animal (cats) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 20Jan2021 08:45 AM, the patient stated, "I had no symptoms during the 15 minute observation after the vaccine. After leaving the site, about 30 minutes after the shot I had the sensations of facial tingling, eye swelling and lip swelling (nothing visible on a photograph). My pulse remained stable and I had no throat symptoms or trouble breathing. This all resolved spontaneously within an hour after the shot. I am allergic to cats and sulfa but have never had anaphylaxis. I plan to stay in observation for a little longer after the 2nd shot. Any other recommendations?" No treatment was received for the events. The outcome of the events was recovered on 20Jan2021.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer. A 54-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL9262), via an unspecified route of administration on 20Jan2021 19:00 at SINGLE DOSE at right arm for covid-19 immunisation. Medical history included Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included tamsulosin hydrochloride (FLOMAX), atorvastatin (LIPITOR), duloxetine hydrochloride (CYMBALTA), varicella zoster vaccine rge (cho) (SHINGRIX). On 21Jan2021 02:00, the patient experienced sore arm, normal effect with most shots. The patient did not receive treatment for the adverse event. The outcome of the event was recovering.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling cold, Pain, Pyrexia
Clinical narrative: Fever recorded was 101.6/fever recorded was 101.9; body aches; feel chill/fet chill; This is a spontaneous report from a contactable other hcp (patient). A 47-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247; expiration date not provided), via an unspecified route of administration (anatomical location: left arm) on 20Jan2021 at 09:20 am at SINGLE DOSE for covid-19 immunisation. Patient's medical history was reported as none. The patient's concomitant medications were not reported. Patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient has no allergies to medications, food, or other products. Patient reported that she got the vaccine at 9:20 am on Tuesday (20Jan2021). Patient started to feel chill at 08:30 pm. Fever recorded was 101.6 at 11 pm. Patient took paracetamol (TYLENOL extra strength). Felt chill again and fever recorded was 101.9. Took again 1 extra strength paracetamol. Felt chill and fever at 11 am. It was reported that patient also experienced body aches on 20Jan2021 at 08:30 pm. The patient underwent lab tests and procedures which included body temperature with result of 101.9 and body temperature with result of 101.6 on 20Jan2021. The events were assessed as non-serious. Outcome of the events was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site lymphadenopathy
Clinical narrative: clavical lymph node swelling on injection side; This is a spontaneous report from a contactable other healthcare professional (patient). A 60-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EJ1686 and expiry date unknown) via unspecified route of administration at the right arm on 18Jan2021 08:45 at single dose for Covid-19 immunization in a hospital. Medical history was none. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. Historical vaccine included first dose of  BNT162B2 on unspecified date for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Jan2021 12:00, the patient experienced clavical lymph node swelling on injection side. The event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included Covid test nasal swab: unknown results on 21Jan2021, PCR test: unknown results post vaccination (Jan2021). The patient did not receive treatment due to the event. The event was clavical lymph node swelling on injection side recovering. The event was reported non-serious; results in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating, congenital anomaly/birth defect; all no.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: Low grade fever; fatigue for 4-5 days post injection; This is a spontaneous report from a contactable nurse (patient). A 70-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 16Jan2021 08:00 at single dose for covid-19 immunisation. Medical history included Hashimoto's thyroiditis, celiac and allergy to wheat. Patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine, estradiol (ESTRACE) and colecalciferol (VIT D3). The patient experienced low grade fever and fatigue for 4-5 days post injection on 16Jan2021 at 16:30. Patient recovered from the events on Jan2021 and had not received any treatment. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The events were reported as non-serious.  Information on the lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Myalgia, Nasopharyngitis
Clinical narrative: felt overall crummy; muscle aches; headache; fatigue; cold; This is a spontaneous report from a non-contactable consumer.  A 32-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EJ1686, expiry date not reported), via an unspecified route of administration on 19Jan2021 at a single dose in the right arm for covid-19 immunization.  The patient's medical history was not reported. The patient was not pregnant at the time of the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included citalopram at 20 mg, daily; melatonin at 5 mg, as needed; and ibuprofen at 400 mg, as needed. The patient received the first dose of BNT162B2 (brand Pfizer, lot number EL1284, expiry date not reported, age at vaccination as 32 years old) on 28Dec2020 at the right arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The recent COVID-19 vaccine was administered in the hospital. Morning after vax, 20Jan2021, patient felt overall crummy, muscle aches, headache, fatigue, cold (cold is unusual for patient). The events improved throughout the day. Next morning, woke up with similar headache, but improved with daily activity and otherwise felt normal. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). No treatments received in response to the events reported. Since the vaccination, the patient has not been tested for COVID-19. The events felt overall crummy, muscle aches, headache, fatigue, and cold were recovered in Jan2021.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Gland swelling in neck and clavicle, same side as injection site, 8 days post vaccination.; This is a spontaneous report from a contactable 38-year-old female consumer reporting for herself. A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL1284), via an unspecified route of administration (left arm) on 11Jan2021 20:15 at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Patient is not pregnant at vaccination time. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included fluoxetine hydrochloride (PROZAC), albuterol [salbutamol], fluticasone propionate, salmeterol (WIXELA INHUB) from unspecified dates for unspecified indications. Patient is also using unspecified birth control product. The patient was administered on workplace clinic. The patient experienced gland swelling in neck and clavicle, same side as injection site, 8 days post vaccination on 20Jan2021 06:00. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. Test Name: Saliva on 20Jan2021 with unknown result. No treatment was given. Outcome of the event was not recovered. Event was reported as non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: she was not good with needles, so it was certainly good that it went quicker and less painful than she expected; This is a spontaneous report from a contactable consumer reporting for herself. An 18-year-old female patient received bnt162b2 (BNT162B2, lot number: EL1283, expiration date: not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The vaccine was administered at a school or student health clinic. The patient was not pregnant at the time of vaccination. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. Medical history and concomitant medication were not reported. The patient was just nervous for a good amount of the time. When she got the vaccine she was overthinking and her left hand began to throb. She was not in pain but just a sinking feeling. She stated that she was not good with needles, so it was certainly good that it went quicker and less painful than she expected. She added that her nurse treated her so well and was so patient with her and she appreciated it so much. Since the vaccination, the patient has been tested for COVID-19: Nasal Swab with result of negative on an unspecified date. No treatment was received for the event. Outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dysstasia, Gait inability, Lethargy, Pyrexia
Clinical narrative: very weak; couldn't stand or walk; couldn't stand or walk; fever; could barely speak; lethargic; fell into a deep sleep; This is a spontaneous report from a contactable consumer (patient). A 95-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9261) via an unspecified route of administration on the left arm on 19Jan2021 17:30 at a single dose for COVID-19 immunization. Medical history included AFIB, chronic anemia, hip surgery in Aug2020 (recovering) and diagnosed with COVID-19 (prior to vaccination). Concomitant medication included levothyroxine sodium (L-THYROXINE), omeprazole (PRILOSEC), calcium carbonate, magnesium carbonate, magnesium trisilicate (TUMS); sodium chloride; ferrous sulfate; folic acid; vitamin D3; guaifenesin (MUCINEX) and clarithromycin (CLARITINE) reported as 'Claratinde'. Approximately 22 hours after injection, on 20Jan2021 03:30 PM patient became very weak, couldn't stand or walk, had a fever, could barely speak, lethargic and fell into a deep sleep. No treatment was received for the events. Events were reported as non-serious. Patient was not pregnant. The facility where the vaccine was administered was in a clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was unknown.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Speech disorder
Clinical narrative: very weak; couldn't stand or walk; couldn't stand or walk; fever; could barely speak; lethargic; fell into a deep sleep; This is a spontaneous report from a contactable consumer (patient). A 95-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9261) via an unspecified route of administration on the left arm on 19Jan2021 17:30 at a single dose for COVID-19 immunization. Medical history included AFIB, chronic anemia, hip surgery in Aug2020 (recovering) and diagnosed with COVID-19 (prior to vaccination). Concomitant medication included levothyroxine sodium (L-THYROXINE), omeprazole (PRILOSEC), calcium carbonate, magnesium carbonate, magnesium trisilicate (TUMS); sodium chloride; ferrous sulfate; folic acid; vitamin D3; guaifenesin (MUCINEX) and clarithromycin (CLARITINE) reported as 'Claratinde'. Approximately 22 hours after injection, on 20Jan2021 03:30 PM patient became very weak, couldn't stand or walk, had a fever, could barely speak, lethargic and fell into a deep sleep. No treatment was received for the events. Events were reported as non-serious. Patient was not pregnant. The facility where the vaccine was administered was in a clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was unknown.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Dysstasia, Fatigue, Myalgia, Pain
Clinical narrative: trouble breathing; fatigue; muscle and body aches; muscle and body aches; trouble standing up; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number:  EK 4176), via an unspecified route of administration on 18Jan2021 11:30 AM at single dose on left arm for COVID-19 immunization. Vaccine facility type is hospital, Medical history included dialysis patient, "dibeties" and High blood pressure. No known allergies and no COVID prior vaccination. No other vaccines in four weeks. Concomitant medications included unspecified medications (reported as "other medications in two weeks: yes"). The patient experienced trouble breathing, muscle and body aches, trouble standing up and fatigue which occurred within 1 hour after taking shot on 18Jan2021 12:15 PM. No treatment was given for the events. Outcome of the events was recovered in Jan2021. Patient was not tested for COVID post vaccination.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, SARS-CoV-2 test, Vaccination site mass, Vaccination site pain
Clinical narrative: hard large lump that  hurts at the injection site /Left arm has a knot in it from injection site; hard large lump that  hurts at the injection site; chest pain; shortness of breath; This is a spontaneous report from contactable consumer (patient).  A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration into the upper left arm on 05Jan2021 at single dose as a precaution because she works in nursing home (COVID-19 immunisation). Medical history included Covid positive back in Oct2020. Concomitant medication included biotin and one a day women's vitamin. Family members have medical issues. Dad has heart tumors, seizure, sleep apnea and osteoporosis. Mom has asthma, diabetes, has had cancer, neuropathy and macular degeneration. The patient received first dose of the covid vaccine on 05Jan2021 and had some symptoms after the vaccine. On unspecified date in Jan2021, the patient hard large lump that hurts at the injection site, chest pain and shortness of breath; similar to when she had Covid positive back in October. She still has a lump at the injection side which has gotten smaller in size but still hurts to touch. Left arm has a knot in it from injection site; does not reuired ER or visit to physician's office. It feels like a bump with something in her arm. She doubts that is the case. She wanted to see if that was normal and when it might go away, especially since she should be getting second dose on 26Jan2021. She is a speech therapist. There is no prescriber. They came and gave to everyone all at once. It was really big at first. It felt like someone punched her. It was a big giant lump, but it is getting better. The injection was given in the upper left arm and it felt like it went into the muscle. The outcome of the event vaccination site mass was recovering, and the outcome of the remaining events was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Nausea
Clinical narrative: feeling nauseous from the first dose of vaccine; shoulder hurting; This is a spontaneous report from a contactable consumer (patient).  A 58-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK9231), via an unspecified route of administration on 20Jan2021 at 12:30 on the left arm at a single dose for COVID-19 immunization.  The patient had no medical history.  There were no concomitant medications.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that she was feeling nauseous from the first dose of the vaccine. She called to find out how long she will be nauseous because this is the second day. The patient stated that she started feeling nauseous about 15 minutes after. The only other symptom is her shoulder hurting since an unspecified date in Jan2021. The patient added that she still feels nauseous. The outcome of the event feeling nauseous from the first dose of vaccine was not recovered while the outcome of the event shoulder hurting was unknown. The case was reported as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: headache; nausea; This is a spontaneous report from a contactable consumer via Medical information team. A 48-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient took her 1st dose of the COVID vaccine and experienced side effects such as 9 days of strong headache and 4 days of nausea. The consumer wants to know if her mother should get her 2nd dose or not. The outcome of the events was recovered on unspecified dates.  Information on lot number/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Accidental exposure to product, Exposure via skin contact, Underdose, Vaccination site extravasation
Clinical narrative: a lot of the volume of the vaccine came out of the arm after the needle was drawn out; a lot of the volume of the vaccine came out of the arm after the needle was drawn out; a lot of the volume of the vaccine came out of the arm after the needle was drawn out; a lot of the volume of the vaccine came out of the arm after the needle was drawn out; This is a spontaneous report received from a contactable pharmacist. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in the arm, on an unspecified date, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The pharmacist reported that the patient received the first dose of the vaccine on an unspecified date and mentioned that a lot of the volume of the vaccine came out of the arm after the needle was drawn out. The patient wanted to get revaccinated and the pharmacist wanted to confirm if this is recommended as she has not seen anything on the website. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dry mouth, Myalgia, Odynophagia
Clinical narrative: Injection site pain; Moderate to severe myalgia; Arthralgia; Uncontrollable rigors began 12 h post vaccination lasting for 2.5 h; Mild odynophagia; xerostomia; This is a spontaneous report from a non-contactable physician (patient).  A 72-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL0142), via an unspecified route of administration on 19Jan2021 at 09:30 on the right arm at a single dose for COVID-19 immunization.  Medical history included allergies to mussles from an unknown date and unknown if ongoing. The patient did not have COVID-19 prior to vaccination. Concomitant medication included atenolol (manufacturer unknown), amlodipine (manufacturer unknown), asa (acetylsalicylic acid, manufacturer unknown), tamsulosin hydrochloride (TAMSULO) and hctz (hydrochlorothiazide, manufacturer unknown). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EH9899) on 29Dec2020 at 10:30 AM on the left arm for COVID-19 immunization. The patient reported that the events began 8 hours post vaccination and peaked 12 hours post vaccination. The patient experienced moderate to severe myalgia, arthralgia, injection site pain, uncontrollable rigors began 12 hours post vaccination lasting for 2.5 hours which was finally relieved by 500mg Tylenol/25mg Benadryl (Tylenol PM ES). The patient also experienced mild odynophagia and xerostomia. All the events were reported to have occurred on 19Jan2021 at 15:00. All symptoms has basically resolved by 60 hours post vaccinations. The events were reported to have recovered on an unspecified date in Jan2021. The patient has not been tested for COVID-19 post vaccination.  No follow up attempts are possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain; Moderate to severe myalgia; Arthralgia; Uncontrollable rigors began 12 h post vaccination lasting for 2.5 h; Mild odynophagia; xerostomia; This is a spontaneous report from a non-contactable physician (patient).  A 72-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL0142), via an unspecified route of administration on 19Jan2021 at 09:30 on the right arm at a single dose for COVID-19 immunization.  Medical history included allergies to mussles from an unknown date and unknown if ongoing. The patient did not have COVID-19 prior to vaccination. Concomitant medication included atenolol (manufacturer unknown), amlodipine (manufacturer unknown), asa (acetylsalicylic acid, manufacturer unknown), tamsulosin hydrochloride (TAMSULO) and hctz (hydrochlorothiazide, manufacturer unknown). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EH9899) on 29Dec2020 at 10:30 AM on the left arm for COVID-19 immunization. The patient reported that the events began 8 hours post vaccination and peaked 12 hours post vaccination. The patient experienced moderate to severe myalgia, arthralgia, injection site pain, uncontrollable rigors began 12 hours post vaccination lasting for 2.5 hours which was finally relieved by 500mg Tylenol/25mg Benadryl (Tylenol PM ES). The patient also experienced mild odynophagia and xerostomia. All the events were reported to have occurred on 19Jan2021 at 15:00. All symptoms has basically resolved by 60 hours post vaccinations. The events were reported to have recovered on an unspecified date in Jan2021. The patient has not been tested for COVID-19 post vaccination.  No follow up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: experienced a bad headache; had arm pain in the vaccinated arm (left), only when lifting my arm; This is a spontaneous report received from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiry date: unknown), via an unspecified route of administration in the left arm, on 19Jan2021 13:00, at single dose, for COVID-19 immunization, at workplace clinic. There were no medical history and no allergies to medication, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included vitamin c, colecalciferol (VITAMIN D), vitamin b and ibuprofen (ADVIL). The patient did not receive other vaccines within 4 weeks prior to BNT162B2 vaccine. On 20Jan2021 at 08:00, the patient had a bad headache and had arm pain in the vaccinated arm (left), only when lifting her arm. The headache went away during the evening without treatment. The patient did not take any pain relief medication. No treatment was given for the events. The patient recovered from headache on the evening of 20Jan2021 and recovered from "had arm pain in the vaccinated arm (left), only when lifting my arm" on an unspecified date. The events were assessed as non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Headache; Chills; Fever; Sore Throat; Body aches; This is a spontaneous report from a contactable Nurse.  A 49-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number and expiration date unknown) intramuscularly on 20Jan2021 (at the age of 49-years-old) as a single dose for COVID-19 vaccination.  The patient's medical history was not reported. Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE on 30Dec2020. Prior to vaccination, the patient had not been diagnosed with COVID-19. The patient was administered the vaccine in a Nursing Home/Senior Living Facility. The patient's concomitant medications were not reported. On 20Jan2021 at 11:00 the patient experienced headache, chills, fever, sore throat, and body aches. Treatment was not received for the events. The clinical outcome of headache, chills, fever, sore throat, and body aches was reported as not recovered. It was also reported that since the vaccination the patient has not been tested for COVID-19.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperaesthesia, Rash vesicular
Clinical narrative: Rash on right side of chest, sensitive to touch and liquid filled; Rash on right side of chest, sensitive to touch and liquid filled; This is a spontaneous report from a contactable consumer. A 75-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunization. Medical history included arthritis, apnea, and post-traumatic stress disorder (PTSD), all from unknown dates. Concomitant medications were not reported. The patient experienced rash on right side of chest, sensitive to touch and liquid filled on 17Jan2021 13:00 (reported started 2 days after vaccination). It was subsiding as of 3 days after initial appearance. The events were recovering at the time of report.   Information on the batch/lot number has been requested.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Body temperature decreased, Discomfort, Dizziness
Clinical narrative: Lightheaded/dizziness; Feeling warm; Uncomfortable tingling sensations that started in my fingers and moved up my arms; Uncomfortable tingling sensations that started in my fingers and moved up my arms; Feeling quite unwell; Strong flu symptoms; Felt very hot/cold; Intense aching; Muscle soreness all over; Inflamed lymph nodes (esp in neck); Some nausea; Internal temp (taken under tongue) was also very low, about 95 degrees; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302; Expiration date was not reported) on 20Jan2021 (14:30) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included naproxen sodium (ALEVE) and cannabidiol (CBD OIL). On 20Jan2021 (14:45), after the vaccination, the patient became lightheaded/dizziness; had started feeling warm; and had uncomfortable tingling sensations that started in the fingers and moved up to the arms. On 20Jan2021, about an hour or two after the vaccination, the patient had begun feeling quite unwell; had strong flu symptoms; was feeling very hot/cold; had intense aching; muscle soreness all over; inflamed lymph nodes (especially in the neck); some nausea; and internal temperature (taken under the tongue) was very low at about 95 degrees. The patient had received treatment for the reported events; blood pressure was taken; and he was given water. The adverse events had required doctor or other healthcare professional office/clinic visit. The outcome of the events, 'lightheaded/dizziness', 'feeling warm', 'uncomfortable tingling sensations that started in the fingers and moved up to the arms', 'feeling quite unwell', 'strong flu symptoms', 'feeling very hot/cold', 'intense aching', 'muscle soreness all over', 'inflamed lymph nodes (especially in the neck)', 'nausea' and 'internal temperature (taken under the tongue) was very low at about 95 degrees', was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Feeling of body temperature change, Influenza, Lymphadenopathy, Malaise
Clinical narrative: Lightheaded/dizziness; Feeling warm; Uncomfortable tingling sensations that started in my fingers and moved up my arms; Uncomfortable tingling sensations that started in my fingers and moved up my arms; Feeling quite unwell; Strong flu symptoms; Felt very hot/cold; Intense aching; Muscle soreness all over; Inflamed lymph nodes (esp in neck); Some nausea; Internal temp (taken under tongue) was also very low, about 95 degrees; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302; Expiration date was not reported) on 20Jan2021 (14:30) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included naproxen sodium (ALEVE) and cannabidiol (CBD OIL). On 20Jan2021 (14:45), after the vaccination, the patient became lightheaded/dizziness; had started feeling warm; and had uncomfortable tingling sensations that started in the fingers and moved up to the arms. On 20Jan2021, about an hour or two after the vaccination, the patient had begun feeling quite unwell; had strong flu symptoms; was feeling very hot/cold; had intense aching; muscle soreness all over; inflamed lymph nodes (especially in the neck); some nausea; and internal temperature (taken under the tongue) was very low at about 95 degrees. The patient had received treatment for the reported events; blood pressure was taken; and he was given water. The adverse events had required doctor or other healthcare professional office/clinic visit. The outcome of the events, 'lightheaded/dizziness', 'feeling warm', 'uncomfortable tingling sensations that started in the fingers and moved up to the arms', 'feeling quite unwell', 'strong flu symptoms', 'feeling very hot/cold', 'intense aching', 'muscle soreness all over', 'inflamed lymph nodes (especially in the neck)', 'nausea' and 'internal temperature (taken under the tongue) was very low at about 95 degrees', was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Paraesthesia
Clinical narrative: Lightheaded/dizziness; Feeling warm; Uncomfortable tingling sensations that started in my fingers and moved up my arms; Uncomfortable tingling sensations that started in my fingers and moved up my arms; Feeling quite unwell; Strong flu symptoms; Felt very hot/cold; Intense aching; Muscle soreness all over; Inflamed lymph nodes (esp in neck); Some nausea; Internal temp (taken under tongue) was also very low, about 95 degrees; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302; Expiration date was not reported) on 20Jan2021 (14:30) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included naproxen sodium (ALEVE) and cannabidiol (CBD OIL). On 20Jan2021 (14:45), after the vaccination, the patient became lightheaded/dizziness; had started feeling warm; and had uncomfortable tingling sensations that started in the fingers and moved up to the arms. On 20Jan2021, about an hour or two after the vaccination, the patient had begun feeling quite unwell; had strong flu symptoms; was feeling very hot/cold; had intense aching; muscle soreness all over; inflamed lymph nodes (especially in the neck); some nausea; and internal temperature (taken under the tongue) was very low at about 95 degrees. The patient had received treatment for the reported events; blood pressure was taken; and he was given water. The adverse events had required doctor or other healthcare professional office/clinic visit. The outcome of the events, 'lightheaded/dizziness', 'feeling warm', 'uncomfortable tingling sensations that started in the fingers and moved up to the arms', 'feeling quite unwell', 'strong flu symptoms', 'feeling very hot/cold', 'intense aching', 'muscle soreness all over', 'inflamed lymph nodes (especially in the neck)', 'nausea' and 'internal temperature (taken under the tongue) was very low at about 95 degrees', was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Pain in extremity, SARS-CoV-2 test positive
Clinical narrative: patient received first dose on 14Jan2021 and tested positive for COVID-19 on 20Jan2021; patient received first dose on 14Jan2021 and tested positive for COVID-19 on 20Jan2021; Sore Arm; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246), intramuscular on 14Jan2021 at a single dose on left arm for COVID-19 immunization. Medical history included heart disease (unspecified). The patient is taking a lot of medication (unspecified). The patient had no prior vaccinations within 4 weeks. He tested positive yesterday, 20Jan2021, for COVID-19. His question was if he should get the second shot. The patient stated he had a sore arm on 14Jan2021, but really had no adverse reactions. The patient underwent COVID-19 rapid test: positive on 20Jan2021. The patient recovered from sore arm on 15Jan2021. Outcome of event "tested positive for COVID-19" was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Illness, Lethargy, Rash macular, Swelling face
Clinical narrative: splotches/ hives on my cheeks; splotches/ hives on my cheeks; face was swollen around my nose; sick; lightheaded; lethargic; This is a spontaneous report from a contactable consumer (patient) via a Medical information team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient experienced side effects following her first dose of PFIZER-BIONTECH COVID-19 VACCINE. She wants to know how well she will be protected if she refuses the second dose?  She stated it protected "up to 25%" in what she read. She also asked "if she could still spread COVID? Why would the CDC recommend social distancing and mask wearing if the vaccine works so well?" The patient experienced not severe splotches/hives on my cheeks and was just starting to subside. The patient stated, "I could see that my face was swollen, and my face was swollen around my nose (Wednesday). Then saturday I was so sick all day lightheaded and lethargic so I'm inclined not to receive the second dose since experiencing these effects". The outcome of the events was unknown.  Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: splotches/ hives on my cheeks; splotches/ hives on my cheeks; face was swollen around my nose; sick; lightheaded; lethargic; This is a spontaneous report from a contactable consumer (patient) via a Medical information team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient experienced side effects following her first dose of PFIZER-BIONTECH COVID-19 VACCINE. She wants to know how well she will be protected if she refuses the second dose?  She stated it protected "up to 25%" in what she read. She also asked "if she could still spread COVID? Why would the CDC recommend social distancing and mask wearing if the vaccine works so well?" The patient experienced not severe splotches/hives on my cheeks and was just starting to subside. The patient stated, "I could see that my face was swollen, and my face was swollen around my nose (Wednesday). Then saturday I was so sick all day lightheaded and lethargic so I'm inclined not to receive the second dose since experiencing these effects". The outcome of the events was unknown.  Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Body height, Epistaxis, Headache, Malaise, Off label use
Clinical narrative: not feeling that great; his arm hurts where he was given the shot/left arm sore; two nosebleeds; headache; sneezed; medical history included: real bad arthritis and adrenal insufficiency; medical history included: real bad arthritis and adrenal insufficiency; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via intramuscular route of administration on 19Jan2021 at 14:30 in the arm left at a single dose to prevent covid. The patient's medical history included high blood pressure from Feb2019, cancer (three times, for clarification), real bad arthritis and adrenal insufficiency. Also, the patient had lost a kidney, two adrenal glands, and part of his prostate. Concomitant medications included hydrocortisone (strength: 10 mg) for adrenal insufficiency, amlodipine (strength: 5 mg) for high blood pressure, colchicine (strength: 0.6 mg), irbesartan (strength: 150 mg), and fludrocortisone (strength: 0.1 mg) for adrenal insufficiency. The patient previously took a flu shot in Oct (as reported) and experienced sore arm. Patient goes to the doctor to get the flu shot each year. On 20Jan2021, the patient had two nosebleeds and headache. He has never had a nose bleed and could not remember the last time he had a nose bleed. The first nose bleed was worse and was concerning. He sneezed and that is what started the second nose bleed. The first nose bleed was worse than the second one. He asked if nosebleed was one of the side effects of the vaccine. It was not listed as side effect on the website when he looked it up. He also stated that his arm hurts where he was given the shot/left arm sore and was not feeling that great on an unspecified date. His height was 5'10'' or 5'11'' on an unspecified date. The outcome of the events two nosebleeds and  headache was recovered on 21Jan2021; events not feeling that great and his arm hurts where he was given the shot/left arm sore was recovering; while unknown for the other events.