chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Right Lymph node breast swelling; This is a spontaneous report from a contactable healthcare professional (patient). A 34-year-old female patient received first single dose of BNT162B2 (Pfizer, Solution for injection, lot number: EL1283, exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 11Jan2021 for COVID-19 immunization. Facility Type Vaccine: Hospital. The patient had no relevant history and had no known allergies. The patient was not pregnant at the time of vaccination and at the time of reporting. The patient did not have Covid prior vaccination. There was no other vaccine given within four weeks; and no other medications given within two weeks. On 19Jan2021 09:00 AM, the patient experienced right lymph node breast swelling. No treatment was given for the adverse event. The patient was not Covid tested post vaccination. The patient recovered from the event on an unspecified date in 2021.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Pain, SARS-CoV-2 antibody test
Clinical narrative: chills; aches; malaise; headache; tingling in right arm for about 3-4 minutes/ vaccine location=Right arm; This is a spontaneous report from a contactable nurse. An adult male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular on 08Jan2021 at a single dose in right arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no known allergies. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899) on 18Dec2020 at a single dose for COVID-19 immunization. About 12.5 hours after patient received the second dose (Lot EL1284) on 08Jan2021, he had tingling in right arm for about 3-4 minutes. When he went to work that next morning (09Jan2021) he started to develop chills, aches, malaise, and a headache around 0930/1000, about 24 hours after receiving the second dose. He did not become febrile at all after receiving the second the dose. The chills, aches, and malaise resolved within six hours after taking some Ibuprofen. The headache lasted for the next two days, with the worst of it being that Sunday (10Jan2021). It resolved the next day. Therapeutic measures were taken as a result of the events chills, aches, malaise, and headache which included ibuprofen. No treatment for vaccination site paresthesia. The outcome of the events was recovered on Jan2021. Facility type Vaccine was Hospital. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. COVID tested post vaccination with Nasal Swab, covid test result is Negative.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site paraesthesia
Clinical narrative: chills; aches; malaise; headache; tingling in right arm for about 3-4 minutes/ vaccine location=Right arm; This is a spontaneous report from a contactable nurse. An adult male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular on 08Jan2021 at a single dose in right arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no known allergies. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899) on 18Dec2020 at a single dose for COVID-19 immunization. About 12.5 hours after patient received the second dose (Lot EL1284) on 08Jan2021, he had tingling in right arm for about 3-4 minutes. When he went to work that next morning (09Jan2021) he started to develop chills, aches, malaise, and a headache around 0930/1000, about 24 hours after receiving the second dose. He did not become febrile at all after receiving the second the dose. The chills, aches, and malaise resolved within six hours after taking some Ibuprofen. The headache lasted for the next two days, with the worst of it being that Sunday (10Jan2021). It resolved the next day. Therapeutic measures were taken as a result of the events chills, aches, malaise, and headache which included ibuprofen. No treatment for vaccination site paresthesia. The outcome of the events was recovered on Jan2021. Facility type Vaccine was Hospital. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. COVID tested post vaccination with Nasal Swab, covid test result is Negative.
Sex: F
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Osteoarthritis
Clinical narrative: COPD; osteoarthritis; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 30Jan2021 at SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced chronic obstructive pulmonary disease (COPD) and osteoarthritis which she takes 800 mg ibuprofen and inhaler as treatment. Furthermore, an antibiotic doxycycline. Asking if she should reduce medications. Therapeutic measures were taken as a result of COPD and osteoarthritis. The outcome of all the events was unknown.  Information on lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Filler swelling (face); This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El9265, expiry date: unknown), via an unspecified route of administration on the left arm, on 29Jan2021 17:00, at single dose, for covid-19 immunization, at a public health department. Medical history included hypothyroidism. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiry date: unknown) received at 41 years of age, via an unspecified route of administration on the right arm, on 08Jan2021 17:00, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. On 31Jan2021, the patient experienced filler swelling (face) (pending clarification). It was unknown if treatment was received for the event. The outcome of the event was not recovered. The reporter assessed the event as non-serious.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen glands left side only; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received first 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 left arm on 11Jan2021 12:00 PM at single dose for Covid-19 immunization in a hospital. Medical history was none. The patient's concomitant medications were not reported. The patient has no other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jan2021 12:00 PM, the patient experienced swollen glands left side only. The patient has not been tested for COVID-19 since vaccination. The patient did not received treatment due to the events. The outcome of the event was recovering. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Myalgia, Pain
Clinical narrative: I experienced sharp pain laterally through my deltoid muscle; ached/painful/ douloureux; Higher than normal blood sugar; This is a spontaneous report from a contactable consumer (patient herself). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not provided), via an unspecified route of administration in left arm on 27Jan2021 14:00 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. She had no allergies to medications, food, or other products. She was not pregnant. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine or any other medications within 2 weeks of vaccination. The patient stated "I experienced sharp pain laterally through my deltoid muscle, ached/painful, and higher than normal blood sugar" on 27Jan2021 14:30. The events were reported as non-serious and no treatment was received. The outcome of the events was recovering. The patient had not been tested for COVID-19 since the vaccination.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: skin on head started to feel itchy; urticaria on her body; some rash on the area on front of both thighs; This is a spontaneous report from a non-contactable consumer (patient).  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 on the left arm, on 11Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After 3 days since he vaccination, on Jan2021, patient's skin on head started to feel itchy, and it lasted for so many days, and recently her body feels itchy too. After that she checked her body and found urticaria on her body, under arm pit of both armpit, vaccination side was on her left side, on her belly in some areas, and there was also some rash on the area on front of both thighs. There was also in her head, beneath her hair. Patient had never had before the Covid vaccine and was still experiencing those effects. Outcome of the events was unknown. Patient was due to go back 08Feb2020 of the second dose  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue/tiredness on second day after shot; This is a spontaneous report from a contactable consumer (patient). A 90-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration at right arm on 30Jan2021 10:45 at single dose for COVID-19 immunization. Medical history included Congestive heart failure (CHF). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. On 31Jan2021 13:00, the patient experienced fatigue/tiredness on second day after shot. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Oropharyngeal pain, Pyrexia
Clinical narrative: Light fever; sore throat; chills; feeling unwell; tiredness; Sleepy; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration at the left arm on 28Jan2021 16:45 at single dose for COVID-19 immunization. Medical history included open heart surgery and being diabetic. Concomitant medication included metformin, sitagliptin (JANUVIA), acetylsalicylic acid (ASPRIN), atorvastatin, and fenofibrate (TRICOR). The patient previously took moxifloxacin (AVELOX), levofloxaxin (LEVAQUIN), ciprofloxacin (CIPRO), and cloxacillin sodium (LOXACIN) and experienced allergies. The patient experienced light fever, sore throat, chills, feeling unwell, tiredness, and sleepy on 28Jan2021 16:45. The patient did not receive treatment for the events. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Light fever; sore throat; chills; feeling unwell; tiredness; Sleepy; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration at the left arm on 28Jan2021 16:45 at single dose for COVID-19 immunization. Medical history included open heart surgery and being diabetic. Concomitant medication included metformin, sitagliptin (JANUVIA), acetylsalicylic acid (ASPRIN), atorvastatin, and fenofibrate (TRICOR). The patient previously took moxifloxacin (AVELOX), levofloxaxin (LEVAQUIN), ciprofloxacin (CIPRO), and cloxacillin sodium (LOXACIN) and experienced allergies. The patient experienced light fever, sore throat, chills, feeling unwell, tiredness, and sleepy on 28Jan2021 16:45. The patient did not receive treatment for the events. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Pain, Paraesthesia
Clinical narrative: tingling; throbbing; pressure on the top and back of her head; This is a spontaneous report from a contactable nurse (patient). A female patient of unspecified age (39, age unit unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; lot and expiry were not reported), via an unspecified route of administration on 25Dec2020 at single dose for COVID-19 immunization. The patient's medical history were not reported. Concomitant medication included paracetamol (TYLENOL) as prophylaxis on 25Dec2020. The patient called to report her side effects after receiving the Covid vaccine. She received the first dose of the Covid vaccine on 25Dec2020, in which she prophylactically took 1000 mg of paracetamol. The patient reported tingling, throbbing, and pressure on the top and back of her head on unspecified dates. The patient stated that this feeling would subside and then come back. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold
Clinical narrative: feel a cold sensation in my groin and in my upper thighs; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration at right arm on 31Jan2021 09:45 at a single dose for COVID-19 immunisation. Medical history included liver damage from hepatitis C. Concomitant medications were not reported. On 31Jan2021, the patient reported that she felt fine and walked back to her vehicle.  As she began to drive home (after an additional 5 minutes), the patient began to feel a cold sensation in her groin and in her upper thighs. It continued for about 1/2 hour and then subsided. No treatment was received. The outcome of the event was recovered on an unspecified date.   Information on the lot/batch number has been requested.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: Higher than normal blood sugar; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), via an unspecified route of administration on 31Jan2021 08:30 (at 64-year-old) at single dose for COVID-19 immunization. Medical history included Type 2 diabetes. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication was not reported. Patient received Diabetes medication within 2 weeks of vaccination. The patient previously took Percocet and Bactrim, and experienced drug allergy for both. The patient experienced higher than normal blood sugar on 31Jan2021 10:30. Therapeutic measures were taken as a result of higher than normal blood sugar, patient took extra insulin. The outcome of the event was recovering. Event was reported as non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Dizziness, Headache, Vomiting
Clinical narrative: extreme stomach cramps; vomiting; dizzy; headache; chills; This is a spontaneous report from a non-contactable other health professional (patient). A 30-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL3302 and expiry date unknown, via unspecified route of administration on 28Jan2021 14:30 at single dose for Covid-19 immunization in a workplace clinic. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior vaccination. Historical vaccine included first dose of BNT162B2 lot number EL1284 on 01Jan2021 for Covid-19 immunization. The patient received other vaccines within 4 weeks prior to the COVID vaccine. On 29Jan2021, the patient experienced extreme stomach cramps, vomiting, dizzy, headache, chills. The patient did not received treatment for the adverse events. The patient has not been tested for COVID-19 since vaccination. The outcome of the events was recovering. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Paraesthesia, Paraesthesia oral
Clinical narrative: shortness of breath, tingling feeling in lip and face; shortness of breath, tingling feeling in lip and face; shortness of breath, tingling feeling in lip and face; This is a spontaneous report from a contactable other healthcare professional (HCP) who reported for herself. A 61-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscularly on 20Jan2021 at 14:45 (at the age of 61-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included restless leg syndrome from an unspecified date and unspecified if ongoing. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications (received within 2 weeks of vaccination) included tretinoin (RETIN A; skin cream), biotin, vitamin D NOS, calcium and multivitamin, all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced shortness of breath, tingling feeling in lip and face, all on 20Jan2021, all reported as non-serious. The events did not cause hospitalization. No treatment was received for the events. The clinical outcomes of the events shortness of breath, tingling feeling in lip and face were all unknown. It was also reported that since the vaccination the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain
Clinical narrative: Nasal congestion; sore throat; This is a spontaneous report from a contactable consumer (reported for himself). A 42-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 29Jan2021 08:30 at a single dose in the left arm for covid-19 immunization. Medical history included diabetic and traumatic brain injury, both from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jan2021, the patient experienced nasal congestion and sore throat. No treatment received for the adverse events reported. 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). Since the vaccination, the patient had not been tested for COVID-19. The events were reported as not recovered.    Information on the lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Musculoskeletal chest pain, Neoplasm, Pain in extremity
Clinical narrative: sore arm; diarrhea; sore rib; lump on neck; This is a spontaneous report from a contactable consumer. A 29-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; Lot number: Ek4176), via an unspecified route of administration in the left arm on 12Jan2021 at 16:45 as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, PCOS (polycystic ovaries), and allergy to penicillin. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine, was not diagnosed with COVID-19 prior to vaccination, and was not pregnant at the time of vaccination. Concomitant medications included levothyroxine, metformin, and daily multivitamins (also reported as medication that the patient received within two weeks of vaccination). After the first dose, on 15Jan2021, the patient experienced sore arm, diarrhea starting day 3 through today, sore rib, and lump on neck. It was unknown if the events were treated. It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Insomnia, Pain, Pyrexia
Clinical narrative: rash on legs, arms, chest and stomach; headache; fever; chills; body ache; 3 days with out sleeping; This is a spontaneous report from a non-contactable consumer (patient herself) via Medical Information team. A 70-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL8982, expiration date was unknown), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization. Relevant medical history included anaphylaxis with insect bites from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took codeine and diazepam (VALIUM) and experienced hyperkinetic reaction. The patient stated that she received the vaccine on 14Jan2021, and that day 6 hours later, she had headache, fever, chills and body ache; and the next day on 15Jan2021, when she woke up, she had rash on legs, arms, chest and stomach, and she still had the rash. On an unspecified date, the patient had 3 days with out sleeping. The patient assessed the events as non-serious. The patient further reported that she was hyperkinetic and she has had that reaction many years prior reporting, before when taking codeine or VALIUM, one of the ingredients in VALIUM. She went to the doctor the first day, who saw her rash and told her to report that. It was not itching. The patient had the appointment for the second dose of the Pfizer vaccine, this coming Thursday and wanted to know if there would be a problem to get the second dose. She was afraid to get the vaccine the first time, because she had a history of anaphylaxis with insect bites. She carried an epi pen, and the vaccine provider had one too and the paramedics was there, and everything was okay; they were nice with her. The patient didn't have any problem until later. The patient spoke to her health care professional and he thought it was okay for her to get the second dose and the health care professional just told her to put a cream on her rash. Therapeutic measures were taken as a result of rash on legs, arms, chest and stomach, which included putting a cream on her rash. The patient was not recovered from the rash on legs, arms, chest and stomach, while the outcome of the events "headache, fever, chills, body ache, and 3 days with out sleeping" was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on legs, arms, chest and stomach; headache; fever; chills; body ache; 3 days with out sleeping; This is a spontaneous report from a non-contactable consumer (patient herself) via Medical Information team. A 70-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL8982, expiration date was unknown), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization. Relevant medical history included anaphylaxis with insect bites from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took codeine and diazepam (VALIUM) and experienced hyperkinetic reaction. The patient stated that she received the vaccine on 14Jan2021, and that day 6 hours later, she had headache, fever, chills and body ache; and the next day on 15Jan2021, when she woke up, she had rash on legs, arms, chest and stomach, and she still had the rash. On an unspecified date, the patient had 3 days with out sleeping. The patient assessed the events as non-serious. The patient further reported that she was hyperkinetic and she has had that reaction many years prior reporting, before when taking codeine or VALIUM, one of the ingredients in VALIUM. She went to the doctor the first day, who saw her rash and told her to report that. It was not itching. The patient had the appointment for the second dose of the Pfizer vaccine, this coming Thursday and wanted to know if there would be a problem to get the second dose. She was afraid to get the vaccine the first time, because she had a history of anaphylaxis with insect bites. She carried an epi pen, and the vaccine provider had one too and the paramedics was there, and everything was okay; they were nice with her. The patient didn't have any problem until later. The patient spoke to her health care professional and he thought it was okay for her to get the second dose and the health care professional just told her to put a cream on her rash. Therapeutic measures were taken as a result of rash on legs, arms, chest and stomach, which included putting a cream on her rash. The patient was not recovered from the rash on legs, arms, chest and stomach, while the outcome of the events "headache, fever, chills, body ache, and 3 days with out sleeping" was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Myalgia
Clinical narrative: shaking chills (rigor) 12H post shot; muscle aches; headache; fatigue (slept all next day); brain fog; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: el3247 and expiry date: unknown), via an unspecified route of administration on 28Jan2021 10:45 at a single dose for COVID-19 immunization. Medical history included mild asthma and mild hypertension. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine within 4 weeks prior to covid vaccine and had unspecified medications within 2 weeks. The patient experienced shaking chills (rigor) 12H post shot, lasted 3 hrs; also has muscle aches, headache (3days), fatigue (slept all next day), brain fog on 28Jan2021 23:00. Outcome of the events was recovering. Patient took ibuprofen 36 hours after shot as treatment for the adverse events. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Dyspnoea, Epistaxis, Lethargy
Clinical narrative: Severe injection site swelling (grapefruit size); Nose bleed; Fever of 102; Lethargy; Tachycardia; Shortness of Breath; Severe joint pain; Migraine; Muscle pain; This is a spontaneous report from a contactable other healthcare professional (HCP reporting for self). A 26-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 27Jan2021 11:30 at a single dose in the right arm for COVID-19 immunization. Other medical history and known allergies were reported as none. The patient had no COVID prior vaccination. The patient was not pregnant at the time of the report and vaccination. Concomitant medications included zinc, ascorbic acid (VIT C), ergocalciferol (VIT D) and an unspecified birth control medication. The first dose of BNT162B2 (brand: Pfizer as reported) was received on 06Jan2021 12:00 PM in the left arm for COVID-19 immunization.  The patient had no other vaccine in the four weeks prior to second dose vaccination. On 27Jan2021 23:00, the patient experienced nose bleed, fever of 102, severe injection site swelling (grapefruit size), lethargy, tachycardia, shortness of breath, severe joint pain, migraine and muscle pain. The patient did not receive treatments for the reported adverse events. Patient had COVID test post vaccination specified as nasal swab on 27Jan2021 with test result as negative. The events were reported as recovered with lasting effects.   Information on the Lot/Batch number has been requested.; Sender's Comments: Considering the close drug-event temporal association and the location,  the reasonable possibility that the reported severe injection site swelling is related to BNT162B2 seems likely.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Myalgia, Pyrexia, SARS-CoV-2 test, Tachycardia
Clinical narrative: Severe injection site swelling (grapefruit size); Nose bleed; Fever of 102; Lethargy; Tachycardia; Shortness of Breath; Severe joint pain; Migraine; Muscle pain; This is a spontaneous report from a contactable other healthcare professional (HCP reporting for self). A 26-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 27Jan2021 11:30 at a single dose in the right arm for COVID-19 immunization. Other medical history and known allergies were reported as none. The patient had no COVID prior vaccination. The patient was not pregnant at the time of the report and vaccination. Concomitant medications included zinc, ascorbic acid (VIT C), ergocalciferol (VIT D) and an unspecified birth control medication. The first dose of BNT162B2 (brand: Pfizer as reported) was received on 06Jan2021 12:00 PM in the left arm for COVID-19 immunization.  The patient had no other vaccine in the four weeks prior to second dose vaccination. On 27Jan2021 23:00, the patient experienced nose bleed, fever of 102, severe injection site swelling (grapefruit size), lethargy, tachycardia, shortness of breath, severe joint pain, migraine and muscle pain. The patient did not receive treatments for the reported adverse events. Patient had COVID test post vaccination specified as nasal swab on 27Jan2021 with test result as negative. The events were reported as recovered with lasting effects.   Information on the Lot/Batch number has been requested.; Sender's Comments: Considering the close drug-event temporal association and the location,  the reasonable possibility that the reported severe injection site swelling is related to BNT162B2 seems likely.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Severe injection site swelling (grapefruit size); Nose bleed; Fever of 102; Lethargy; Tachycardia; Shortness of Breath; Severe joint pain; Migraine; Muscle pain; This is a spontaneous report from a contactable other healthcare professional (HCP reporting for self). A 26-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 27Jan2021 11:30 at a single dose in the right arm for COVID-19 immunization. Other medical history and known allergies were reported as none. The patient had no COVID prior vaccination. The patient was not pregnant at the time of the report and vaccination. Concomitant medications included zinc, ascorbic acid (VIT C), ergocalciferol (VIT D) and an unspecified birth control medication. The first dose of BNT162B2 (brand: Pfizer as reported) was received on 06Jan2021 12:00 PM in the left arm for COVID-19 immunization.  The patient had no other vaccine in the four weeks prior to second dose vaccination. On 27Jan2021 23:00, the patient experienced nose bleed, fever of 102, severe injection site swelling (grapefruit size), lethargy, tachycardia, shortness of breath, severe joint pain, migraine and muscle pain. The patient did not receive treatments for the reported adverse events. Patient had COVID test post vaccination specified as nasal swab on 27Jan2021 with test result as negative. The events were reported as recovered with lasting effects.   Information on the Lot/Batch number has been requested.; Sender's Comments: Considering the close drug-event temporal association and the location,  the reasonable possibility that the reported severe injection site swelling is related to BNT162B2 seems likely.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pain
Clinical narrative: I had some pretty bad flu like symptoms/Began to have flu like symptoms, pretty severe flu like symptoms; pain; This is a spontaneous report from a contactable nurse (patient). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) solution for injection, via an unspecified route of administration on 08Jan2021 (first dose, lot/batch number: EL1284, expiry date: Apr2021) at a single dose, then via an unspecified route of administration on 29Jan2021 (second dose, lot/batch number: EL1284 , expiry date: Apr2021) at a single dose for Covid-19 immunization. Medical history included was reported as none. There were no concomitant medications. Patient received his first vaccine on the 8th of this month and the second dose the 29th of this month. On both occasions for 3 days after the vaccine, he had some pretty bad flu like symptoms. He began to have flu like symptoms, pretty severe flu like symptoms and pain on 09Jan2021. He stated taking some Ibuprofen 400mg, every 8 hours as needed for pain. Outcome of the event flu like symptoms was not recovered while pain was unknown at the time of the report.  No follow-up activities are needed. No further information is expected. Information regarding the lot/batch number has been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Exposure to SARS-CoV-2, Feeling cold, Headache, Pyrexia
Clinical narrative: think they might have been exposed to COVID-19 after receiving the vaccine; slight headache; a little bit of fever; little of bit of cold; chills; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient and her husband were near to a person who was diagnosed with COVID-19; but they haven't been tested for COVID-19, they think they might have been exposed to COVID-19 after receiving the vaccine. She asked if they would test positive for COVID-19 after the exposure and if that was the case, would their doctor defer or re-schedule their second dose which was currently scheduled for 15Feb2021. On an unspecified date after getting first dose of the COVID-19 vaccine, the patient experienced a slight headache and a little bit of fever, little of bit of cold and chills. The outcome of the event "think they might have been exposed to COVID-19 after receiving the vaccine" was unknown while the outcome of all other events was recovered on an unspecified date.  Information on the batch/lot number has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chills, Fatigue, Headache, Malaise
Clinical narrative: Anxiety; tiredness; headache; chills; nausea; feeling unwell; This is a spontaneous report from a contactable healthcare professional (patient). A 71-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) solution for injection, intramuscular on right arm on 26Jan2021 at 10:30 AM at single dose for COVID-19 immunization. Medical history included chronic back pain. The patient has no allergies to medications, food, or other products. Concomitant medications included unspecified blood pressure and pain medications which he received within 2 weeks of vaccination. The patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular at left arm on 05Jan2021 at 2:00 PM at single dose for COVID-19 immunization and experienced headaches for a week. The patient received his most recent COVID-19 vaccine at a hospital. He did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. On 28Jan2021 at 06:00 AM, the patient experienced anxiety, tiredness, headache, chills, nausea, and feeling unwell. All these feelings come and go but made him very uncomfortable. He was told that it would dissipate in 48 hours. There was no treatment received in response to the events. The outcome of the events was not recovered. The events were assessed as non-serious.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Anxiety; tiredness; headache; chills; nausea; feeling unwell; This is a spontaneous report from a contactable healthcare professional (patient). A 71-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) solution for injection, intramuscular on right arm on 26Jan2021 at 10:30 AM at single dose for COVID-19 immunization. Medical history included chronic back pain. The patient has no allergies to medications, food, or other products. Concomitant medications included unspecified blood pressure and pain medications which he received within 2 weeks of vaccination. The patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular at left arm on 05Jan2021 at 2:00 PM at single dose for COVID-19 immunization and experienced headaches for a week. The patient received his most recent COVID-19 vaccine at a hospital. He did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. On 28Jan2021 at 06:00 AM, the patient experienced anxiety, tiredness, headache, chills, nausea, and feeling unwell. All these feelings come and go but made him very uncomfortable. He was told that it would dissipate in 48 hours. There was no treatment received in response to the events. The outcome of the events was not recovered. The events were assessed as non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, SARS-CoV-2 test
Clinical narrative: left arm completely numb; tingling; This is a spontaneous report from a contactable other health professional (patient). A 34-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL1284 and expiry date unknown, via unspecified route of administration at the left arm on 30Dec2020 12:30 at single dose for Covid-19 immunization in a workplace clinic. Medical history included sinusitis, placenta precreta, infertility, C-section, sulfa allergy, seasonal allergy. The patient's concomitant medications were not reported. The patient previously took hydrocodone, coriander oil; both experienced allergies. The patient had no other vaccine in four weeks. On 31Dec2020 06:00, the patient experienced left arm completely numb and tingling for 4 weeks. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment due to the events. The patient underwent lab tests and procedures which included nasal swab (Covid-19): negative on 26Jan2021. The outcome of the events was recovering.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Body aches; headache; fatigue; This is a spontaneous report from a non-contactable other health professional reporting for himself. A 32-year-old male patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, Lot# el9263), via an unspecified route of administration in the left arm, on 24Jan2021, at single dose, for COVID-19 immunisation. Medical history included penicillin allergy. The patient was not diagnosed with COVID-19 prior to vaccination. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced body aches, headache and fatigue all on 31Jan2021 at 15:30 with outcome of not recovered. No therapeutic measures were taken as a result of the events. Since vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Sciatica, Sleep disorder due to a general medical condition
Clinical narrative: Very achy for next 2 days; triggered what I believe could be a very bad sciatica situation; Both legs ache, sitting feels like cuts off circulation, standing hurts less but hurts. Leaning forward front of legs hurt, standing flat, back of legs hurt; Have not been able to sleep for last 3 days due to the pain; This is a spontaneous report from a contactable consumer who reported for himself, a 65-year-old male patient who received the first fose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm, on 28Jan2021 at 15:30, at the age of 65 years, at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient had no known allergies. Patient was very achy for next 2 days, that seems consistent with all he have read. Reaction to vaccine has transitioned to or triggered what he believe could be a very bad sciatica situation. Both legs ache, sitting feels like cuts off circulation, standing hurts less but hurts. Leaning forward front of legs hurt, standing flat, back of legs hurt. Have not been able to sleep for last 3 days due to the pain. Tried lying on back, side, with pillows under legs, on floor with legs up on a chair. Have never had sciatica issue before. Patient experienced all reported events on 28Jan2021 at 19:30. The patient asked what can be done to eliminate the pain. Patient had no COVID prior vaccination, and was not COVID tested post vaccination. No treatment was received for the events. The outcome of the events was not recovered.  Information on the batch/lot number has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Rash erythematous, Rash macular
Clinical narrative: Bright red rash; large welts covering across butt; purple in spots; Chills; fatigue; Loss appetite; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received first single dose of BNT162B2 (Pfizer, Solution for injection, batch/lot number and expiration date not reported), via an unspecified route of administration (vaccine location: left arm) on 27Jan2021 10:00 for COVID-19 immunization. Facility type Vaccine: Pharmacy/Drug Store. Medical history included high blood pressure and heart surgery in past. The patient was not pregnant at the time of vaccination and at the time of reporting. The patient had no known allergies. The patient had no Covid prior vaccination. Concomitant medications/ other medications included metoprolol, rosuvastatin, and OTC anti acid. There was no other vaccine given withiin four weeks. On 27Jan2021 23:00, the patient experienced chills, fatigue and loss appetite; bright red rash and large welts covering across butt - needed to seek treatment at urgent care. It was now 4 days later and still present and purple in spots. Prescription cream (unspecified) was given. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Bright red rash; large welts covering across butt; purple in spots; Chills; fatigue; Loss appetite; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received first single dose of BNT162B2 (Pfizer, Solution for injection, batch/lot number and expiration date not reported), via an unspecified route of administration (vaccine location: left arm) on 27Jan2021 10:00 for COVID-19 immunization. Facility type Vaccine: Pharmacy/Drug Store. Medical history included high blood pressure and heart surgery in past. The patient was not pregnant at the time of vaccination and at the time of reporting. The patient had no known allergies. The patient had no Covid prior vaccination. Concomitant medications/ other medications included metoprolol, rosuvastatin, and OTC anti acid. There was no other vaccine given withiin four weeks. On 27Jan2021 23:00, the patient experienced chills, fatigue and loss appetite; bright red rash and large welts covering across butt - needed to seek treatment at urgent care. It was now 4 days later and still present and purple in spots. Prescription cream (unspecified) was given. The outcome of events was not recovered.  Information on the lot/batch number has been requested.