chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia, Salivary gland pain
Clinical narrative: Arm soreness; Huge headache; Low grade fever (99.5); Felt cold, couldn't get warm; chills; Stabbing, shooting pain in right parotid glands; General feeling of unwellness; This is a spontaneous report from a contactable nurse. A 54-years-old female patient started to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EL0142, on 06Jan2021 (at the age of 54-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included chronic granulomatous disease. Concomitant medication were unspecified. The patient previously received the  first dose of BNT162B2, Lot number: EK5730, on 17Dec2020, administration time: 08:00 AM, in the left arm for covid-19 immunization. The patient previously took Oxacillin and Levaquin and experienced allergies. The most recent COVID-19 vaccine was administered in the workplace clinic. The patient was not pregnant at the time of vaccination.   Prior to vaccination, the patient was not diagnosed with COVID-19. On 07Jan2021 09:30, the patient experienced arm soreness, huge headache, Low grade fever (99.5), Felt cold, couldn't get warm, chills, Stabbing, shooting pain in right parotid glands and General feeling of unwellnessThe events arm soreness, Huge headache, Low grade fever (99.5), Felt cold, couldn't get warm, chills, Stabbing, shooting pain in right parotid glands and General feeling of unwellness did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events. Outcome of the events arm soreness, Huge headache, Low grade fever (99.5), Felt cold, couldn't get warm, chills, Stabbing, shooting pain in right parotid glands and General feeling of unwellness was recovered. Since the vaccination, the patient has not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Patient reported fatigue the day of the 1st injection; This is a spontaneous report from a contactable healthcare professional. An adult male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown) at the hospital, intramuscular in the left arm on 06Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. Patient reported fatigue the day of the 1st injection on 06Jan2021. No other symptoms were reported. No treatment was received for the event. The event was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the event on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: throat tightness; This is a spontaneous report from a non-contactable other hcp. A 60-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number not provided), dose #2, intramuscularly in the right deltoid on an unspecified date (at an unspecified age) as a single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number: EK9231), dose #1, via an unspecified route of administration on an unspecified date as a single dose for COVID-19 vaccination. On an unspecified date, the patient was given vaccination dose #2 in the right deltoid muscle. During her 15 minute waiting period following the injection, the patient began to experience throat tightness. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. Therapeutic measures taken as a result of the event was antihistamines and bendadryl. Folllow-up response to treatment: no side effects. The patient was assessed as stable to go home and was discharged. The clinical outcome of the throat tightness was unknown.   No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: chills; body aches; headache; nausea; fatigue; This is a spontaneous report from a contactable Physician, the patient. This 29-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EK5730) (dose #1), via an unspecified route of administration in the right arm on 18Dec2020 at 14:30 (at the age of 29-years-old) as a single dose for COVID-19 vaccination. The patient's medical history was not reported. Concomitant medication included cetirizine hydrochloride (ZYRTEC SUMITOMO), levonorgestrel (KYLEENA), melatonin (MELATONIN), spironolactone (SPIRONOLACTONE). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took Celebrex for an unknown indication and experienced drug hypersensitivity. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. On 20Dec2020 at 10:00, 44 hours after receiving the vaccine, the patient developed chills, body aches, headache, nausea and fatigue. These symptoms persisted for 5 days total. She was not febrile at any time. The adverse events resulted in a doctor or other healthcare professional/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of chills, body aches, headache nausea and fatigue was resolved on 25Dec2020. It was also reported that since the vaccination, the patient had been tested for COVID-19: negative on 21Dec2020 (saliva test) and negative on 22Dec2020 (nasal swab test).
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: chills; body aches; headache; nausea; fatigue; This is a spontaneous report from a contactable Physician, the patient. This 29-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EK5730) (dose #1), via an unspecified route of administration in the right arm on 18Dec2020 at 14:30 (at the age of 29-years-old) as a single dose for COVID-19 vaccination. The patient's medical history was not reported. Concomitant medication included cetirizine hydrochloride (ZYRTEC SUMITOMO), levonorgestrel (KYLEENA), melatonin (MELATONIN), spironolactone (SPIRONOLACTONE). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took Celebrex for an unknown indication and experienced drug hypersensitivity. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. On 20Dec2020 at 10:00, 44 hours after receiving the vaccine, the patient developed chills, body aches, headache, nausea and fatigue. These symptoms persisted for 5 days total. She was not febrile at any time. The adverse events resulted in a doctor or other healthcare professional/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of chills, body aches, headache nausea and fatigue was resolved on 25Dec2020. It was also reported that since the vaccination, the patient had been tested for COVID-19: negative on 21Dec2020 (saliva test) and negative on 22Dec2020 (nasal swab test).
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain in extremity
Clinical narrative: Pain in arm like a tents shot for about a day and a half; headache; dizziness; This is a spontaneous report from a contactable other hcp, the patient. This 19-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EK4176) (dose #1), via an unspecified route of administration in the left arm on 04Jan2021 at 19:00 (at the age of 19-years-old) as a single dose for COVID-19 vaccination. Medical history included depression from an unknown date and unknown if ongoing, panic disorder from an unknown date and unknown if ongoing and a weak immune system from an unknown date and unknown if ongoing. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included escitalopram oxalate (LEXAPRO) and an unspecified antiacid. On an unspecified date in Jan2021, the patient experienced pain in arm like a tents shot about a day and half, some headache and dizziness the first few hour. No pain or symptoms reported after 3 days following the vaccination first dose. No therapeutic measures were taken as a result of the events. The clinical outcome of pain in arm like a tents shot about a day and half, some headache and dizziness was resolved on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in jaw, Toothache
Clinical narrative: Headache; some mild jaw pain, like a dull tooth ache/jaw/tooth pain; some mild jaw pain, like a dull tooth ache/jaw/tooth pain; This is a spontaneous report from a contactable consumer reporting for himself. A 66-year-old male patient started to receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: unknown) via an unspecified route of administration (left arm) on 07Jan2021 at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient wanted to know if there was a known jaw or tooth pain side effects after receiving the COVID vaccine. 15 minutes after injection, he started having mild jaw pain, described as a dull tooth ache, that has not subsided yet (24 hours later). Patient reported that the jaw/tooth pain is making him eat on the other side this morning. Patient stated he was seeking some reassurance. He mentioned he thought he was a tough guy and would not have side effects but within 2 minutes (also reported within 60 seconds or less than 5 minutes of receiving the vaccine) he had a headache. When he developed the headache, he did pull over and waited it out, but he stated that before he left the clinic after getting his vaccine, he did have some mild jaw pain, like a dull tooth ache, and he still feels it. He stated that he does not believe it could be a tooth problem, and that it had to have been triggered by the vaccine because it occurred 15 minutes after he got the vaccine. Patient was wondering if there are any know jaw problem side effects with the vaccine. He stated that it feels like a dull pain on just one side. Outcome of the event some mild jaw pain, like a dull tooth ache/jaw/tooth pain was not recovered while unknown for headache.  Information about Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: The sore deltoid side effect is moderate; This is a spontaneous report from a contactable other healthcare professional (patient herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: unknown), via an unspecified route of administration on an unspecified date single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced the sore deltoid side effect is moderate on an unspecified date.  Patient stated that having this happen yearly may deter some people from getting the vaccine especially those who must utilize both arms during their occupation such as herself and other health professionals. Nonetheless, having two doses to take weeks apart. Event outcome was unknown.  Information about lot/batch number has been requested.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Sinus pain
Clinical narrative: Lightheaded; sinus discomfort; This is a spontaneous report from a contactable consumer reporting for himself. A 75-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number Ek9231/expiration date: not provided), via an unspecified route of administration, on 06Jan2021 at 10:00 AM (at the age of 75 years old) as a single dose in the arm for COVID-19 vaccination. Relevant medical history included prostate cancer and rheumatoid arthritis. The patient has a known allergy to sulphar. Prior to the vaccination, the patient was diagnosed with COVID-19, on an unspecified date. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Jan2021, at 04:00 PM, the patient was lightheaded the first day with some sinus discomfort. The patient did not receive any treatment for these events. The outcome of the events lightheaded and sinus discomfort was recovering. Since the vaccination, the patient had not been tested for COVID-19.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Painful axillary lymph node swelling; Painful axillary lymph node swelling; This is a spontaneous report from a contactable physician reporting for himself. A 31-year-old male received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: ek9231/expiration date: not provided), via intramuscular route of administration, on 06Jan2021 at 08:00 AM (at the age of 31 years old) as a single dose in the left arm for COVID-19 vaccination. Relevant medical history was none. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was not provided. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 07Dec2020 at 08:15 AM (at the age of 31 years old) as a single dose for COVID-19 vaccination. The patient did not receive any other vaccines within 4 weeks prior to the second dose of COVID vaccine (except for the first dose of BNT162B2). On 08Jan2021, at 04:00 AM, the patient experienced painful axillary lymph node swelling, ipsilateral to injection. The patient received ibuprofen as treatment for the event painful axillary lymph node swelling. The outcome of the event painful axillary lymph node swelling was recovering. Since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Incredibly strong salty taste in mouth which started approximately 1 hour after vaccination...still persists...; This is a spontaneous report from a contactable nurse. A 68-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EK9231, intramuscularly on 01JAN2021 16:15 (at the age of 68-years-old) as a single dose in the left arm  for COVID-19 immunization.  Medical history includes Type II diabetes mellitus, Chronic bronchitis, coronary artery disease (CAD). The patient previously took Gemfibrozil and experienced allergies. Concomitant medication included unspecified medications. The most recent COVID-19 vaccine was administered in the hospital. The patient was not pregnant at the time of vaccination.  Prior to vaccination, the patient was not diagnosed with COVID-19. On 01JAN2021 17:00, the patient experienced incredibly strong salty taste in mouth which started approximately 1 hour after vaccination...still persists. The incredibly strong salty taste in mouth which started approximately 1 hour after vaccination...still persists did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the event. Outcome of the event incredibly strong salty taste in mouth which started approximately 1 hour after vaccination...still persists was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: my arm started to ache that night, slowly travelling down my arm and into my hand; my arm started to ache that night, slowly travelling down my arm and into my hand; This is a spontaneous report from a non-contactable consumer, the patient. An elderly female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 06Jan2021 as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. Concomitant medication taken within two weeks of vaccination was unknown. It was unknown whether  patient received any other vaccines within four weeks prior to the vaccination. The patient reported that the only side effect was her arm started to ache that night, slowly travelling down her arm and into her hand", in Jan2021. It was gone when she awoke in the morning. The events were reported as non-serious. The patient did not receive any treatment for her arm started to ache that night, slowly travelling down her arm and into her hand. The clinical outcome of "her arm started to ache that night, slowly travelling down her arm and into her hand" was recovered on an unspecified date in Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Soreness to injection site; Headache, mild; This is a spontaneous report from a contactable nurse, the patient. A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via unspecified route of administration, on 07Jan2021 at 17:00 PM (at the age of 37-year-old) as a single dose for COVID-19 immunization. Medical history included asthma, and polycystic ovaries. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included cetirizine hydrochloride (ZYRTEC), ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS), ubidecarenone (COQ10). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have any allergies to medications, food, or other products. On 07Jan2021 at 21:00 PM, the patient experienced headache, mild. It started 4-5 hours after, continued to next day. The next day, 08Jan2021 the patient experienced soreness to injection site. The events were reported as non-serious. The patient did not receive any treatment for the headache, mild and soreness to injection site. The clinical outcome of the events headache, mild and soreness to injection site was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   Information on the Lot/Batch number has been requested
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Mildly feverish evening after vaccine; Soreness and tenderness at left arm injection site; This is a spontaneous report from a contactable physician (patient). A 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; second dose (lot number: EL1284, expiry date: unknown) via an unspecified route of administration on 07Jan2021 07:00 at single dose (Left arm) for COVID-19 immunization. Patient took bnt162b2 first dose (lot number: EK5730, expiry date: unknown) on 17Dec2020  07:00 am (Left arm) for COVID-19 immunization. Medical history included known allergies: Sulfa, Hypothyroid, Asthma, Hi Cholesterol.  Concomitant medication included cetirizine hydrochloride (ZYRTEC), atorvastatin, levothyroxine. The patient previously took tamiflu and experienced allergies.  Facility type vaccine was hospital. The patient 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. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced Mildly feverish evening after vaccine, Soreness and tenderness at left arm injection site on 07Jan2021. The patient took Motrin as treatment. Therapeutic measures were taken as a result of mildly feverish evening after vaccine, soreness and tenderness at left arm injection site. The outcome of the events was recovered on an unspecified date. The events were reported as non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Muscle swelling, Myalgia, Off label use
Clinical narrative: Left axillary lymphadenopathy pain and swelling extending into the left pectoral muscle.; Left axillary lymphadenopathy pain and swelling extending into the left pectoral muscle.; Left axillary lymphadenopathy pain and swelling extending into the left pectoral muscle.; Left axillary lymphadenopathy pain and swelling extending into the left pectoral muscle.; Date of start of drug: 06Jan2021; Date of start of drug: 06Jan2021; This is a spontaneous report from a contactable Other healthcare professional (patient). A 41-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 06Jan2021 09:00 in left arm at single dose for covid-19 immunization.  There were no medical history,  known allergies or concomitant medications in two weeks. There was no other vaccine in four weeks. The patient previously took the first dose of bnt162b2 on 19Dec2020 12:00 PM in left arm (Batch/lot number: EJ1685) for COVID-19 immunization. The patient experienced left axillary lymphadenopathy pain and swelling extending into the left pectoral muscle on 07Jan2021 07:00. The patient underwent lab tests and procedures which included Covid antibody blood test: negative on 23Dec2020. The events did not resulted in emergency room or physician visit. The events was reported as non-serious. There was no treatment for left axillary lymphadenopathy pain and swelling extending into the left pectoral muscle. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of left axillary lymphadenopathy pain and swelling extending into the left pectoral muscle were not resolved.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Product use issue, SARS-CoV-2 antibody test
Clinical narrative: Left axillary lymphadenopathy pain and swelling extending into the left pectoral muscle.; Left axillary lymphadenopathy pain and swelling extending into the left pectoral muscle.; Left axillary lymphadenopathy pain and swelling extending into the left pectoral muscle.; Left axillary lymphadenopathy pain and swelling extending into the left pectoral muscle.; Date of start of drug: 06Jan2021; Date of start of drug: 06Jan2021; This is a spontaneous report from a contactable Other healthcare professional (patient). A 41-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 06Jan2021 09:00 in left arm at single dose for covid-19 immunization.  There were no medical history,  known allergies or concomitant medications in two weeks. There was no other vaccine in four weeks. The patient previously took the first dose of bnt162b2 on 19Dec2020 12:00 PM in left arm (Batch/lot number: EJ1685) for COVID-19 immunization. The patient experienced left axillary lymphadenopathy pain and swelling extending into the left pectoral muscle on 07Jan2021 07:00. The patient underwent lab tests and procedures which included Covid antibody blood test: negative on 23Dec2020. The events did not resulted in emergency room or physician visit. The events was reported as non-serious. There was no treatment for left axillary lymphadenopathy pain and swelling extending into the left pectoral muscle. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of left axillary lymphadenopathy pain and swelling extending into the left pectoral muscle were not resolved.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Injection site cyst
Clinical narrative: when she was given the injection her cyst "bubbled up"; she believes that it was inadvertently given subcutaneously; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch and expiration date unspecified), subcutaneous on 07Jan2021 at single dose at left arm for COVID-19 immunization. Medical history included history of cyst on her upper left arm. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 on an unspecified date for COVID-19 immunization. The patient reported that when she was given the injection, her cyst "bubbled up" on an unspecified date. She believed that it was inadvertently given subcutaneously. She wanted more information on the effectiveness of the vaccine if given subcutaneously. Outcome of event when she was given the injection her cyst "bubbled up" was unknown.  Information on the Lot/Batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable healthcare professional (patient). A 54-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL0140, expiration date unspecified), via an unspecified route of administration on 22Dec2020 at 13:30 at single dose at left arm for COVID-19 immunization. Medical history included hypertension and hypothyroidism. The patient had no known allergies and no allergies to medications, food or other products and patient was not pregnant. The patient's concomitant medications were not reported. On 22Dec2020 at 13:30, the patient experienced sore arm. There was no therapy received for the event. The most recent COVID-19 vaccine was administered at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient had other medications that was received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Outcome of event was recovered on an unspecified date.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient 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. The patient was not pregnant at the time of vaccination. On an unspecified date, the patient experienced fatigue with outcome of recovering. The patient did not receive any treatment for the event. The event was assessed as non-serious.  No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: mild nausea; dizziness/dizzy; This is a spontaneous report from the Pfizer-Sponsored program,  received by a contactable consumer (patient).  A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number E10142), via an unknown route, on 04Jan2021 at single dose in the left arm for COVID-19 immunisation. The patient received tetanus vaccine (at single dose in the right arm for tetanus immunization, due to overdue) in Dec2020 (3-4 weeks before vaccination for COVID-19). No additional medical history was provided. No relevant concomitant medications were provided. On 06Jan2021, she developed dizziness, she started feeling dizzy. On 07Jan2021, the patient developed mild nausea to the point that if she was laying on her right to turn on her left that her head was dizzy. The patient stated that she could not go in the bathroom at all last night because she could not make it due to dizziness. She stated that she had to pee in a cup. The patient reported that her niece, aged 27, with a history of vertigo also experienced severe dizziness after her first shot (reported under AER#2021015495). The patient had recovered from mild nausea on 07Jan2021 while she was recovering from dizziness/dizzy.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Musculoskeletal stiffness, Productive cough
Clinical narrative: neck stiffness; coughing with production of white mucous; felt like she couldn't breath with tightness for about a half hour; felt like she couldn't breath with tightness for about a half hour; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot /batch and expiration date unspecified), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she got the vaccine yesterday (07Jan2021) and that a couple of hours later she began to experience neck stiffness, coughing with production of white mucous and felt like she couldn't breath with tightness for about a half hour. The patient was asking if this was normal. Outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; chills; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), intramuscular on 24Dec2020 14:30 (reported as "02:30 PM") at single dose on left arm as COVID vaccine. Patient was not pregnant.  Medical history included asthma and hypothyoridism. The patient was diagnosed with COVID-19 prior to vaccination.  Concomitant medications included levothyroxine sodium (SYNTHROID), fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), reported as "Other medications in twoweeks: synthroid, Breo".  The patient previously took cefalexin (KEFLEX) and experienced allergies. The patient experienced fever and chills on 25Dec2020 at "08:00PM". The events were assessed as non-serious. No treatment was given. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered on an unspecified date.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Migraine, Pain
Clinical narrative: body aches; chills; headaches; migraines; This is a spontaneous report from a contactable consumer. An adult patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced body aches, chills, headaches and migraines on Jan2021 with outcome of recovering. The events was considered non-serious.  Information on the lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Burning after injection; This is a spontaneous report from a contactable pharmacist.  A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK9231, intramuscular in the left arm, from 08Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. The patient experienced burning after injection on 08Jan2021. The outcome of event was recovering.  No follow-up attempts possible. No further information expected. Information on the batch number has been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Rhinorrhoea, SARS-CoV-2 test positive, Somnolence
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; The patient had MS and was immune compromised; The patient had MS and was immune compromised; This is a spontaneous report from a contactable consumer (patient). This female consumer of unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021, for COVID-19 immunization. She had MS and was immune compromised. Concomitant medications were not reported. On 07Jan2021 the patient woke up with headache, runny nose, groggy and muscle aches. She went to pharmacy and got a rapid COVID test that resulted positive. She was asking if the 1st dose could have caused her to be positive on the test. Events outcome was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching; This is a spontaneous report from a contactable pharmacist. A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EK9231, intramuscularly in the right arm on 08Jan2021 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Medical history included allergies to peanuts and shellfish, COVID-19 on an unspecified date (reported as a COVID-19 diagnosis prior to vaccination). The patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 08Jan2021 (reported as 3 minutes after receiving the vaccine), the patient experienced itching. The patient was treated with diphenhydramine (BENADRYL) 50 mg for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of "itching" was not resolved.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, SARS-CoV-2 test positive
Clinical narrative: tested COVID Positive; tested COVID Positive; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced tested COVID positive on 01Jan2021. She still has a few symptoms and is scheduled for the 2nd dose on 12Jan2020 or 13Jan2020. She was asking if there were any recommendations on the scheduling of the vaccine for her. The outcome of event was unknown.  information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Hyperhidrosis, Myalgia
Clinical narrative: chills; headache; nausea; sweating; muscle and joint pain; muscle and joint pain; This is a spontaneous report from a contactable consumer communicated to a Pfizer colleague. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced chills, headache, nausea, sweating, muscle and joint pain shortly after vaccine in Jan2021 with outcome of unknown. Was treatment received for the adverse event: unknown. Prior to vaccination, was the patient diagnosed with COVID-19: Unknown. Since the vaccination, has the patient been tested for COVID-19: Unknown. Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: chills; headache; nausea; sweating; muscle and joint pain; muscle and joint pain; This is a spontaneous report from a contactable consumer communicated to a Pfizer colleague. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced chills, headache, nausea, sweating, muscle and joint pain shortly after vaccine in Jan2021 with outcome of unknown. Was treatment received for the adverse event: unknown. Prior to vaccination, was the patient diagnosed with COVID-19: Unknown. Since the vaccination, has the patient been tested for COVID-19: Unknown. Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle soreness; This is a spontaneous report from a contactable healthcare professional. An adult female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 07Jan2021 in left arm at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient had historical vaccine of first dose of BNT162B2 on unspecified date. The patient had no allergies to medications, food, or other products. On 07Jan2021, the patient experienced muscle soreness the day of the injection. No other symptoms were reported. No treatment was given to the patient for the event. The outcome of the event was unknown. The facility where the most recent COVID-19 vaccine was administered was in the hospital. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, it was unknown if the patient was tested for COVID-19. The event was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Tired; headache; achy; This is a spontaneous report from a contactable other healthcare professional (hcp).  A 59-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot EL1283, expiry date not reported), intramuscular in the left arm on 07Jan2021 11:45 at a single dose for Covid-19 immunization. The patient had no medical history. The patient had no known allergies; no allergies to medications, food, or other products. The patient was not pregnant at the time of the vaccination. The patient had no COVID prior to vaccination (not diagnosed with COVID-19). Concomitant medication included pantoprazole. The patient had the first dose of BNT162B2 (lot EK5730, expiry date reported) for Covid-19 immunization on 17Dec2020 16:00 at a single dose in the right arm intramuscularly. The patient had no other vaccine in four weeks. Both Covid-19 vaccinations were administered in the hospital. On 08Jan2021 12:00, the patient was tired, had headache, and was achy. 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 treatment was received in response to the events reported. Since the vaccination (post vaccination), the patient has not been tested for COVID-19. The outcome of the events tired, headache, and achy was recovering.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Pain
Clinical narrative: Pain at injection site; body aches; headache; This is a spontaneous report from a contactable other health professional. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, on 06Jan2021 at SINGLE DOSE for covid-19 immunization. The patient's medical history was not reported. Historical vaccine included BNT162B2, intramuscular from 16Dec2020 to 16Dec2020 (1st dose; lot: PAA156051). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. There were no concomitant medications. The patient experienced pain at injection site, body aches and headache. The outcome of event was recovering. No treatment received.   No follow-up attempts possible. No further information expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL0140, expiration date unspecified), intramuscular on 28Dec2020 at single dose at left arm for COVID-19 immunization.  Medical history included depression and anxiety. The patient was not pregnant and had no known allergies. The patient had no allergies to medications, food or other products. Concomitant medications were not reported. On 29Dec2020, the patient experienced sore arm. The patient did not received therapy for the event. The most recent COVID-19 vaccine was administered at the hospital. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Outcome of event was recovered on an unspecified date.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Pain, Peripheral swelling, Pyrexia
Clinical narrative: My armpit is swollen; Swelling in the arm; Fever; Ache; Headache; Flu like symptoms; This is a spontaneous report from a contactable Physician (patient).  A 43-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EL1284), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization. Medical history included gastrooesophageal reflux disease (GERD), birth control. Concomitant medication included omeprazole for GERD, estradiol pills for birth control. The patient got the second dose of the Pfizer vaccine and she had some pretty severe flu like symptoms afterwards in Jan2021. But she noticed something odd and that was her armpit was swollen. She thought that is listed as one of the side effects but she wanted to know more about it. She had a pneumococcal vaccine (Unspecified vaccine) reaction and she wanted to make sure that there was nothing that would cross reactivity associated with this vaccine (Covid19 Vaccine). The weight is like 160. About 10 hours, she got 2 or 3 symptoms. Fever, aches, headache, bad headache. That lasted about overnight on the 05Jan2021. Swelling in the arm only started on 06Jan2021. That was when the armpit got swollen. The outcome of the events were unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Weight
Clinical narrative: My armpit is swollen; Swelling in the arm; Fever; Ache; Headache; Flu like symptoms; This is a spontaneous report from a contactable Physician (patient).  A 43-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EL1284), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization. Medical history included gastrooesophageal reflux disease (GERD), birth control. Concomitant medication included omeprazole for GERD, estradiol pills for birth control. The patient got the second dose of the Pfizer vaccine and she had some pretty severe flu like symptoms afterwards in Jan2021. But she noticed something odd and that was her armpit was swollen. She thought that is listed as one of the side effects but she wanted to know more about it. She had a pneumococcal vaccine (Unspecified vaccine) reaction and she wanted to make sure that there was nothing that would cross reactivity associated with this vaccine (Covid19 Vaccine). The weight is like 160. About 10 hours, she got 2 or 3 symptoms. Fever, aches, headache, bad headache. That lasted about overnight on the 05Jan2021. Swelling in the arm only started on 06Jan2021. That was when the armpit got swollen. The outcome of the events were unknown.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: striking headache since receiving the COVID-19 Vaccine; This is a spontaneous report from a contactable consumer (patient).  A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EK9231), via an unspecified route of administration on the right upper arm on 07Jan2021 12:45 at SINGLE DOSE for COVID-19 immunization.  Medical history reported as none. Concomitant medication included unspecified allergy medication. It was reported that the patient got the COVID-19 Vaccine this morning (07Jan2021 at 12:45 PM). He said he waited 15 minutes after receiving the COVID-19 Vaccine, until 1:00 pm, and everything seemed to be okay and he had no major problems. On the same day of 07Jan2021, he said he was now having an annoying, striking headache. He described the pain like someone was stabbing him in the head, and then the headache pain goes away.  He said the headache was not constant and only lasts 3-4 seconds. He said the headache has been hitting him every 10-15 minutes. He also mentioned that he takes allergy medication, so it was not unusual for him to have a headache. As treatment, the patient took a loratadine (CLARITIN 24 Hour), and naproxen sodium (ALEVE Liqui-Gel). He said the headache was not getting any worse. He said the headache started slow and was really painful, and then the headache pain lessens up. Outcome of the event was recovering.