chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pneumonia, Pyrexia, Unresponsive to stimuli
Clinical narrative: Pneumonia; Unresponsive at times; Weak; Diarrhea; Feeling Punky; Body aches/muscle aches; Fever; Chills; Nausea; Vomiting; Sore arm at site of injection; A spontaneous report, was received from a nurse (caregiver), regarding a 96 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced pneumonia, unresponsive at times (unresponsive to stimuli), weak (asthenia), diarrhea, feeling punky (malaise), body aches/muscle aches (myalgia), fever (pyrexia), chills, nausea, vomiting, sore arm at site of injection (vaccination site pain), and vomiting.   The patient's medical history was not reported. Historical vaccine reported was flu shot. Concomitant medications included insulin, unspecified medication for pulmonary hypertension and heart failure.  On 05 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013M20A), intramuscular for the prophylaxis of COVID-19 infection.   On 05 Feb 2021, the patient experienced the sore arm. On 07 Feb 2021, the patient experienced body aches, sore arms, felt punky, weak, fevers with a body temperature of 103.7 (unknown units), chills, nausea, vomiting, diarrhea and muscle aches. Treatment medication included acetaminophen. On 08 Feb 2021, the patient continued with high fever, unresponsive at times, and all other symptoms. On 09 Feb 2021, the patient's fever was control, very weak and passed away on the same day at 04 45 pm. The death occurred and death certificate stated that pneumonia was the cause of death.  Action taken with second dose of mRNA-1273 in response to the events was not applicable.   The outcome of the event, pneumonia was considered as fatal, and that of other events unresponsive at times, weak, diarrhea, feeling punky, body aches/muscle aches, fever, chills, nausea, vomiting, sore arm at site of injection, and vomiting were considered as unknown. The patient died on 09 Feb 2021. Plans for an autopsy was unknown. The cause of death was reported as pneumonia.; Reporter's Comments: This case concerns a 96 year old, female patient, who experienced a serious unexpected event of Pneumonia (fatal) among others, 5 days after receiving 1st dose of mRNA- 1273 (Lot# 013M20A). Very limited information regarding these events has been provided at this time. The subject's con meds included insulin, unknown medications for pulmonary HTN and heart failure. The cause of death was determined to be pneumonia. Advanced age and co-morbidities may remain as risk factors.; Reported Cause(s) of Death: Pneumonia
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: Pneumonia; Unresponsive at times; Weak; Diarrhea; Feeling Punky; Body aches/muscle aches; Fever; Chills; Nausea; Vomiting; Sore arm at site of injection; A spontaneous report, was received from a nurse (caregiver), regarding a 96 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced pneumonia, unresponsive at times (unresponsive to stimuli), weak (asthenia), diarrhea, feeling punky (malaise), body aches/muscle aches (myalgia), fever (pyrexia), chills, nausea, vomiting, sore arm at site of injection (vaccination site pain), and vomiting.   The patient's medical history was not reported. Historical vaccine reported was flu shot. Concomitant medications included insulin, unspecified medication for pulmonary hypertension and heart failure.  On 05 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013M20A), intramuscular for the prophylaxis of COVID-19 infection.   On 05 Feb 2021, the patient experienced the sore arm. On 07 Feb 2021, the patient experienced body aches, sore arms, felt punky, weak, fevers with a body temperature of 103.7 (unknown units), chills, nausea, vomiting, diarrhea and muscle aches. Treatment medication included acetaminophen. On 08 Feb 2021, the patient continued with high fever, unresponsive at times, and all other symptoms. On 09 Feb 2021, the patient's fever was control, very weak and passed away on the same day at 04 45 pm. The death occurred and death certificate stated that pneumonia was the cause of death.  Action taken with second dose of mRNA-1273 in response to the events was not applicable.   The outcome of the event, pneumonia was considered as fatal, and that of other events unresponsive at times, weak, diarrhea, feeling punky, body aches/muscle aches, fever, chills, nausea, vomiting, sore arm at site of injection, and vomiting were considered as unknown. The patient died on 09 Feb 2021. Plans for an autopsy was unknown. The cause of death was reported as pneumonia.; Reporter's Comments: This case concerns a 96 year old, female patient, who experienced a serious unexpected event of Pneumonia (fatal) among others, 5 days after receiving 1st dose of mRNA- 1273 (Lot# 013M20A). Very limited information regarding these events has been provided at this time. The subject's con meds included insulin, unknown medications for pulmonary HTN and heart failure. The cause of death was determined to be pneumonia. Advanced age and co-morbidities may remain as risk factors.; Reported Cause(s) of Death: Pneumonia
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Myalgia, Nausea
Clinical narrative: headache; tiredness; muscle pain; fever; nausea; feeling unwell; Injection site pain; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/lot number: EL9262;) via an unspecified route of administration on 26Jan2021 at single dose for covid-19 immunisation. Medical history included parkinson's disease ongoing. Concomitant medication included carbidopa monohydrate, levodopa (CARBIDOPA + LEVODOPA) for Parkinsons disease, clonazepam. The patient previously received first single dose of bnt162b2 for Covid-19 immunization (she had no side effects after the first dose of the vaccine). Patient had Parkinsons disease received the second dose of the Pfizer COVID-19 vaccine yesterday, 26Jan2021, and today she was experiencing most of the symptoms listed including: injection site pain in Jan2021, on 26Jan2021, had tiredness, headache (Had a headache, headache for the most part gone but still lingering), muscles pain, fever, nausea and feeling unwell. The caller states that she had no side effects after the first dose of the vaccine. The caller wants to know how long her symptoms are going to last. The outcome of the event Injection site pain was unknown, rest of the events was not recovered.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: headache; tiredness; muscle pain; fever; nausea; feeling unwell; Injection site pain; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/lot number: EL9262;) via an unspecified route of administration on 26Jan2021 at single dose for covid-19 immunisation. Medical history included parkinson's disease ongoing. Concomitant medication included carbidopa monohydrate, levodopa (CARBIDOPA + LEVODOPA) for Parkinsons disease, clonazepam. The patient previously received first single dose of bnt162b2 for Covid-19 immunization (she had no side effects after the first dose of the vaccine). Patient had Parkinsons disease received the second dose of the Pfizer COVID-19 vaccine yesterday, 26Jan2021, and today she was experiencing most of the symptoms listed including: injection site pain in Jan2021, on 26Jan2021, had tiredness, headache (Had a headache, headache for the most part gone but still lingering), muscles pain, fever, nausea and feeling unwell. The caller states that she had no side effects after the first dose of the vaccine. The caller wants to know how long her symptoms are going to last. The outcome of the event Injection site pain was unknown, rest of the events was not recovered.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymph node pain, Lymphadenopathy, Vaccination site pain
Clinical narrative: lymph node under my left arm, close to my left breast is swollen; it is sore; felt chills; injections site pain; tiredness; This is a spontaneous report from a contactable consumer reporting for herself. A 44-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 11:15 (Lot number: EN5318) via an unspecified route of administration in the left arm at SINGLE DOSE for COVID-19 Immunization. The patient's medical history included high blood pressure from an unknown and unknown if ongoing. Concomitant medications included lisinopril, amlodipine, metoprolol and levocabastine hydrochloride (Zyrtec). The patient had no allergies to medications, food or other products. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated that the lymph node under his left arm, close to his left breast was swollen. The patient also felt chills, injections site pain, and tiredness on 27Jan2021 04:00. The events assessed as non-serious by the reporter. It was unknown if the patient received treatment. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Insomnia, Nausea
Clinical narrative: arm hurt; felt headache; uncontrollable chills; absolute exhaustion; nausea; fever; not able to sleep; This is a spontaneous report from a contactable consumer (patient). A 57-(unit: unknown)-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 18Jan2021 at single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller (patient) wanted to know if side effects to the Pfizer covid vaccine have been reported outside of 12-36 hours post-vaccine. The patient received the Pfizer covid vaccine on 18Jan2021, her arm hurt on the next day (19Jan2021), but on the Friday in Jan2021 she felt headache, uncontrollable chills, absolute exhaustion although not able to sleep, nausea and fever. She went to get tested for the virus twice since then, on 25Jan2021 and 27Jan2021 but was negative both times. She has never called off work before and has had to 'take a few days' because of the side effects. Caller would like to know if her side effects will be worse after the second dose of the covid vaccine. The events outcome was unknown.  Information regarding lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: arm hurt; felt headache; uncontrollable chills; absolute exhaustion; nausea; fever; not able to sleep; This is a spontaneous report from a contactable consumer (patient). A 57-(unit: unknown)-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 18Jan2021 at single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller (patient) wanted to know if side effects to the Pfizer covid vaccine have been reported outside of 12-36 hours post-vaccine. The patient received the Pfizer covid vaccine on 18Jan2021, her arm hurt on the next day (19Jan2021), but on the Friday in Jan2021 she felt headache, uncontrollable chills, absolute exhaustion although not able to sleep, nausea and fever. She went to get tested for the virus twice since then, on 25Jan2021 and 27Jan2021 but was negative both times. She has never called off work before and has had to 'take a few days' because of the side effects. Caller would like to know if her side effects will be worse after the second dose of the covid vaccine. The events outcome was unknown.  Information regarding lot/batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Extreme arm soreness which is getting progressively worse; making it difficult to lift or move the arm entirely; This is a spontaneous report from a contactable consumer (patient). A 26-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 29Jan2021 10:30 (at the age of 26-years-old) as a single dose for covid-19 immunisation. The patient medical history was not reported. It was unknown if patient had any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included gabapentin (MANUFACTUTERE UNKNOWN), fish oil (MANUFACTUTERE UNKNOWN), ascorbic acid, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, magnesium, malpighia glabra fruit, manganese, molybdenum, nicotinamide, pantothenic acid, phytomenadione, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (MULTIVITAMIN ACTIVE WOMAN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Jan2021 13:00, the patient experienced extreme arm soreness which is getting progressively worse and making it difficult to lift or move the arm entirely. Seriousness criteria was considered as non-serious. The patient did not receive any treatment for the events. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymphadenopathy, Pain, Pain in extremity
Clinical narrative: sore arm; restlessness; Body aches; chills; fatigue; Swollen lymph node under left clavicle; This is a spontaneous report from a contactable consumer (reported for himself). A 44-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: 9262), on Left Arm via an unspecified route of administration on 26Jan2021 13:30 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took first dose of PFIZER-BIONTECH COVID-19 VACCINE (Lot no: 3248) on left arm on 07Jan2021 12:00 PM for Covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jan2021 10:00 PM No symptoms besides a sore arm and restlessness for first 12 hours. Body aches, chills, fatigue for following 24 hours. Fatigue for an additional 24 hours. Swollen lymph node under left clavicle starting at 36 hours and still present. Outcome of the events was not recovered.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Restlessness
Clinical narrative: sore arm; restlessness; Body aches; chills; fatigue; Swollen lymph node under left clavicle; This is a spontaneous report from a contactable consumer (reported for himself). A 44-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: 9262), on Left Arm via an unspecified route of administration on 26Jan2021 13:30 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took first dose of PFIZER-BIONTECH COVID-19 VACCINE (Lot no: 3248) on left arm on 07Jan2021 12:00 PM for Covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jan2021 10:00 PM No symptoms besides a sore arm and restlessness for first 12 hours. Body aches, chills, fatigue for following 24 hours. Fatigue for an additional 24 hours. Swollen lymph node under left clavicle starting at 36 hours and still present. Outcome of the events was not recovered.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash macular
Clinical narrative: A rash 5" x 7" on my back, rash on neck; spots on various parts of the body; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 68-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ENS318, Expiry date: unknown), via an unspecified route of administration on 28Jan2021 at 08:30 am (age at the time of vaccination was 68-years-old) on left arm at single dose for covid-19 immunisation. Medical history included hypothryoidism, high blood pressure, C-Diff. The patient did not have allergies to medications, food, or other products. Concomitant medication patient received within 2 weeks of vaccination included levothyroxine sodium (SYNTHROID), lisinopril, desvenlafaxine, solifenacin. The patient A rash 5" x 7" on my back, rash on neck, and spots on various parts of the body on 29Jan2021 at 07:00 am. The adverse event result in Emergency room/department or urgent care. The event was considered as non-serious. 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 received Decadron IM 10 mg shot & Medrol 4 mg tab as treatment for the events. The outcome of the events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: he received series of vaccine and antibody testing negative; This is a spontaneous report from a contactable pharmacist (patient). A male patient of unknown age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration, on an unknown date at a single dose for COVID-19 immunisation. The relevant medical history was not reported. The concomitant medication included azathioprine sodium (IMURAN) and eculizumab (SOLIRIS). The patient underwent antibody testing which was negative on an unknown date. It was also reported that patient was asking for information on testing and those immunosuppressed (as reported) since patient was taking IMURAN and SOLIRIS. The outcome of the event was unknown.  Information on the lot/batch number has been requested
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia, Somnolence
Clinical narrative: right arm was feverish, painful and difficult to move; right arm was feverish, painful and difficult to move; right arm was feverish, painful and difficult to move; fatigued; developed a fever/reached 101.3 and was steady at 100 F for the duration of day/fever broke; piercing headache; sleepiness; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A 49-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262, Expiry date: unknown), via an unspecified route of administration on 30Jan2021 at 09:15 am (Age at the time of vaccination was 49-years-old) at single dose on right arm for covid-19 immunisation. Medical history included hypertension an obesity. The patient did not have allergies to medications, food, or other products. Concomitant medication patient received within 2 weeks of vaccination included propranolol, triamterene, bupropion, valaciclovir hydrochloride. The patient reported that, within 4 hours of injection, on 31Jan2021 at 08:00 my right arm was feverish, painful and difficult to move. Within 8 hours, I became fatigued and developed a fever the next day at 8 am that reached 101.3 and was steady at 100 F for the duration of day. I also developed a piercing headache and sleepiness. At 1:45 am on 02Feb2021, my fever broke. My headache remained until 02Feb2021. The events were considered as non-serious. 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. No treatment was received for the adverse events. The patient recovered from the event headache on 02Feb2021 and recovered from other events on an unspecified date in 2021.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site pain, Vaccination site warmth
Clinical narrative: right arm was feverish, painful and difficult to move; right arm was feverish, painful and difficult to move; right arm was feverish, painful and difficult to move; fatigued; developed a fever/reached 101.3 and was steady at 100 F for the duration of day/fever broke; piercing headache; sleepiness; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A 49-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262, Expiry date: unknown), via an unspecified route of administration on 30Jan2021 at 09:15 am (Age at the time of vaccination was 49-years-old) at single dose on right arm for covid-19 immunisation. Medical history included hypertension an obesity. The patient did not have allergies to medications, food, or other products. Concomitant medication patient received within 2 weeks of vaccination included propranolol, triamterene, bupropion, valaciclovir hydrochloride. The patient reported that, within 4 hours of injection, on 31Jan2021 at 08:00 my right arm was feverish, painful and difficult to move. Within 8 hours, I became fatigued and developed a fever the next day at 8 am that reached 101.3 and was steady at 100 F for the duration of day. I also developed a piercing headache and sleepiness. At 1:45 am on 02Feb2021, my fever broke. My headache remained until 02Feb2021. The events were considered as non-serious. 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. No treatment was received for the adverse events. The patient recovered from the event headache on 02Feb2021 and recovered from other events on an unspecified date in 2021.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Injection site is red, itchy and slightly raised.; Injection site is red, itchy and slightly raised.; This is a spontaneous report from a contactable consumer (patient, self-reported). A 73-year-old female patient received (who was not pregnant, at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL3302 and expiry date was unknown) via an unspecified route of administration, in Arm Left, on 26Jan2021 15:00, as single dose for COVID-19 immunization, at hospital. Patient's medical history was not reported. Concomitant medications were included women's Multi-Vitamin, Calcium and Fish Oil (within two weeks of vaccination). Patient previously took sertraline and citalopram; had allergies with these two medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, Prior to vaccination. Since the vaccination, Patient has not been tested for COVID-19. On 02Feb2021, 23:00, patient experienced Injection site is red, itchy and slightly raised. Patient was not received treatment for the events. Seriousness of the events was reported as non-serious. Outcome of the events was reported as not recovered.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Nausea, Night sweats
Clinical narrative: nausea; weakness; fever; photophobia; body aches; night sweats; chills; headache; arm pain; This is a spontaneous report from a contactable Pharmacist (Patient). A 35-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Lot Number: EL3246) via intramuscular in the left arm on 13Jan2021, at 12:30 (at the age of 35-year-old) as a single dose for COVID-19 immunization. The patient medical history included ulcerative colitis, adhd (Attention deficit hyperactivity disorder), prediabetes, high cholesterol. 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. Since the vaccination, the patient had not been tested for COVID-19. The concomitant medication included mesalazine (LIALDA), methylphenidate hydrochloride (CONCERTA), cetirizine hydrochloride (ZYRTEC), vitamin d, citalopram and atorvastatin. The patient previously took historical vaccine first dose of bnt162b2 (Lot number: EK5730), via intramuscular, on left arm on 22Dec2020, at 16:30 (at the age of 35-year-old) for COVID-19 immunization and experienced arm pain. On 13Jan2021, the patient experienced arm pain at 13:30 and, headache at 14:30. On 14Jan2021, at 00:30 body aches, night sweats, chills and at 12:30 patient had fever and photophobia. On 15Jan2021, at 12:30 the patient had weakness. On 16Jan2021 at 12:30 the patient had nausea. The patient did not receive any treatment for the events. The outcome of the events was reported as non-serious. The outcome for all the events was recovered on an unknown date in 2021.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Photophobia, Pyrexia
Clinical narrative: nausea; weakness; fever; photophobia; body aches; night sweats; chills; headache; arm pain; This is a spontaneous report from a contactable Pharmacist (Patient). A 35-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Lot Number: EL3246) via intramuscular in the left arm on 13Jan2021, at 12:30 (at the age of 35-year-old) as a single dose for COVID-19 immunization. The patient medical history included ulcerative colitis, adhd (Attention deficit hyperactivity disorder), prediabetes, high cholesterol. 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. Since the vaccination, the patient had not been tested for COVID-19. The concomitant medication included mesalazine (LIALDA), methylphenidate hydrochloride (CONCERTA), cetirizine hydrochloride (ZYRTEC), vitamin d, citalopram and atorvastatin. The patient previously took historical vaccine first dose of bnt162b2 (Lot number: EK5730), via intramuscular, on left arm on 22Dec2020, at 16:30 (at the age of 35-year-old) for COVID-19 immunization and experienced arm pain. On 13Jan2021, the patient experienced arm pain at 13:30 and, headache at 14:30. On 14Jan2021, at 00:30 body aches, night sweats, chills and at 12:30 patient had fever and photophobia. On 15Jan2021, at 12:30 the patient had weakness. On 16Jan2021 at 12:30 the patient had nausea. The patient did not receive any treatment for the events. The outcome of the events was reported as non-serious. The outcome for all the events was recovered on an unknown date in 2021.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from a contactable consumer (herself). A 25-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL3302) via an unspecified route of administration on 2Feb2021 16:00 to Left arm at single dose for COVID-19 immunization. Medical history included Depression, High Cholesterol, Asthma and High b/p. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN) at 88ug and metformin at 500 mg twice a day. It was reported as on 02Feb2021 patient experienced with Sore arm day after injection. Seriousness was reported as non-serious and patient did not receive any treatment for the event.  No follow-up attempts are possible. No further information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Dental discomfort
Clinical narrative: One of my fillings came out yesterday so, I have a dental appointment; This is a spontaneous report received from a contactable consumer (patient herself). An unspecified aged female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) via an unspecified route if administration on 30Jan2021 at single dose for COVID-19 immunization. Medical history included blood pressure and knee replacement in 2014. Concomitant medications were not reported. Patient received her first shot of the Pfizer COVID vaccine 30Jan2021. Yesterday on 03Feb2021 her crown fell out. Today, 04Feb2021 she is going in for a dental appointment to get it taken care of. She is required to take antibiotics and Novocaine for the procedure later today. She mentioned history of taking blood pressure medication and a knee replacement in 2014. Second dose of the Pfizer vaccine is scheduled 20Feb2021. Patient stated that one of her fillings came out yesterday, so she has a dental appointment. Outcome of event was unknown.  Information on the batch/lot number has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Frequent bowel movements
Clinical narrative: diarrhea which persisted for more than four days with liquid or very loose stools; Five or more bowel movements/day with considerable gas; This is a spontaneous report from a contactable consumer reported that a 78-year-old female patient (consumer) received first dose BNT162B2 (COVID 19, brand: Pfizer, Solution for injection, lot number: EN5318) via an unspecified route of administration on 28Jan2021 at 15:30 on Left arm for covid-19 immunization. Patient medical history included Type II diabetes, heart problems, bypass surgery in Sep2019. Concomitant medications were not reported. It was reported that, three days after receiving the injection, on 31Jan2021 she developed diarrhea which persisted for more than four days with liquid or very loose stools. Five or more bowel movements/day with considerable gas. No fever, aches. No urge for bowel movement when there was nothing to evacuate. Age at vaccination was 78 Years. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received for the adverse event. No seriousness criteria was reported. Outcome of events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: some loose bowel movements; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: Not Provided, NDC number of Pfizer COVID vaccine: Not Provided, Expiry Date of Pfizer COVID vaccine: Not Provided), via an unspecified route of administration on 04Feb2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The caller (patient) mentioned that "she got her first dose of the covid 19 vaccine today. She says that she had some loose bowel movements on Feb2021 and she would like to know if that is normal. She asked also what would happen if someone got a vaccine that was not kept in refrigeration since she lives in a little town and she does not know if they have the conditions to keep the vaccines in the right refrigeration." Caller wanted to know how long the side effect will last. On 04Feb2021 following details were provide: Unspecified if Pfizer COVID vaccine a Pfizer product; Unspecified if Pfizer COVID vaccine manufacturer. Reason for no lot number of Pfizer COVID vaccine reported as caller unwilling to complete the report. Investigation Assessment was not provided. The patient experienced some loose bowel movements on Feb2021. The outcome was unknown.  Information on the lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Headache, Pyrexia
Clinical narrative: Fever of 102.5 degrees lasting about 30 hrs; joint pain; Headache; This is a spontaneous report from a contactable other health professional. A 58-year-old female patient received BNT162B2, (Solution for injection, Batch/Lot: EL3249), in right arm via intramuscular on 02Feb2021 10:30 at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included allergies. The patient's concomitant medications was not reported. Historical vaccine of BNT162B2 on 12Jan2021 for COVID-19 immunization, lot number: EK9231, administration time: 10:45 AM, route: Intramuscular, vaccine location: Right arm, dose number: one. The most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Allergies to medications, food, or other products was yes. The patient had event fever of 102.5 degrees lasting about 30 hrs, joint pain, headache on 02Feb2021 at 08:45 PM. The treatment was not received for the adverse events. The patient underwent lab tests and procedures which included body temperature: 102.5 degrees. The outcome of the events was recovering.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Headache, Pyrexia
Clinical narrative: Fever of 102.5 degrees lasting about 30 hrs; joint pain; Headache; This is a spontaneous report from a contactable other health professional. A 58-year-old female patient received BNT162B2, (Solution for injection, Batch/Lot: EL3249), in right arm via intramuscular on 02Feb2021 10:30 at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included allergies. The patient's concomitant medications was not reported. Historical vaccine of BNT162B2 on 12Jan2021 for COVID-19 immunization, lot number: EK9231, administration time: 10:45 AM, route: Intramuscular, vaccine location: Right arm, dose number: one. The most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Allergies to medications, food, or other products was yes. The patient had event fever of 102.5 degrees lasting about 30 hrs, joint pain, headache on 02Feb2021 at 08:45 PM. The treatment was not received for the adverse events. The patient underwent lab tests and procedures which included body temperature: 102.5 degrees. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle spasms, Muscle twitching, Myalgia, Pruritus
Clinical narrative: Hives; Rash/rash...spotty kind of thing/rash was mostly across her abdomen and back; Itching/It was itchy nut not horrible on her wrist, elbow/her elbows, wrists, and ankles would itch sometimes; Headache; Muscle aches in her arms and legs; Twitching in her thigh; Muscle cramping; This is a spontaneous report from contactable other HCP (patient). A female patient of an unspecified age received bnt162b2 (Solution for injection) , via an unspecified route of administration from 21Jan2021 at single dose for covid-19 immunisation. The patient medical history was and concomitant medications were not reported. She had her 1st dose of the vaccine on 21Jan2021, and had on 21Jan2021 hives hours later and a rash on and off for a few days. States that the rash was mostly across her abdomen and back, but her elbows, wrists, and ankles would itch sometimes. In Jan2021, She also has had headaches, muscle aches in her arms and legs, and twitching in her thigh, which she still has. Caller states that she has read the literature, and it's not clear if she is or is not a candidate for the 2nd shot. States that she could ask her doctor, but her doctor will just refer her to the literature. Caller received the covid vaccine on Thursday 21Jan2021, a few hours later though, she developed a rash, spotty kind of thing, on and off. She took some Benadryl. In Jan2021, It was itchy nut not horrible on her wrist, elbow. Also, she experienced muscle cramping, headache and 'all that stuff. The outcome of event Twitching in her thigh was not recovered and other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hives; Rash/rash...spotty kind of thing/rash was mostly across her abdomen and back; Itching/It was itchy nut not horrible on her wrist, elbow/her elbows, wrists, and ankles would itch sometimes; Headache; Muscle aches in her arms and legs; Twitching in her thigh; Muscle cramping; This is a spontaneous report from contactable other HCP (patient). A female patient of an unspecified age received bnt162b2 (Solution for injection) , via an unspecified route of administration from 21Jan2021 at single dose for covid-19 immunisation. The patient medical history was and concomitant medications were not reported. She had her 1st dose of the vaccine on 21Jan2021, and had on 21Jan2021 hives hours later and a rash on and off for a few days. States that the rash was mostly across her abdomen and back, but her elbows, wrists, and ankles would itch sometimes. In Jan2021, She also has had headaches, muscle aches in her arms and legs, and twitching in her thigh, which she still has. Caller states that she has read the literature, and it's not clear if she is or is not a candidate for the 2nd shot. States that she could ask her doctor, but her doctor will just refer her to the literature. Caller received the covid vaccine on Thursday 21Jan2021, a few hours later though, she developed a rash, spotty kind of thing, on and off. She took some Benadryl. In Jan2021, It was itchy nut not horrible on her wrist, elbow. Also, she experienced muscle cramping, headache and 'all that stuff. The outcome of event Twitching in her thigh was not recovered and other events was unknown.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Vaccination site pain
Clinical narrative: Injection site soreness; enlarged, painful lymph nodes in left arm pit; enlarged, painful lymph nodes in left arm pit; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received second dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EM9810), via an unspecified route of administration at Arm Left on 04Feb2021 17:00 at the 33 years old at single dose for COVID-19 immunization.  The medical history was none. The Known allergies was None. The concomitant medication was hydrochlorothiazide, lisinopril (LISINOPRIL/HCTZ). The Historical Vaccine was first dose BNT162B2(lot number EL3249) on 15Jan2021 07:00 at 33-year-old at Left arm for COVID-19 immunization. The patient experienced Injection site soreness and enlarged, painful lymph nodes in left arm pit on 06Feb2021 05:00. The event Injection site soreness was resolving after 36 hours. There was no other vaccine in four weeks. There was not treatment received for all the events. The patient had no Covid prior vaccination. There was no Covid tested post vaccination. The outcome of the event Injection site soreness was recovering, the other events was unknown.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; Chills; dizziness; aches; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received second dose bnt162b2 (reported as PFIZER COVID 19 VACCINE, lot number: unknown, Lot number wasn't given when receiving shot), via an unspecified route of administration in right arm on 05Feb2021 07:45 AM at single dose for COVID-19 immunisation.  The patient did not have other medical history or known allergies.  There were no concomitant medications (no other medications in two weeks). The patient was not pregnant. The patient previously received first dose bnt162b2 (reported as PFIZER COVID 19 VACCINE), via an unspecified route of administration in right arm on 15Jan2021 07:45 AM at single dose for COVID-19 immunisation.  The patient experienced Fever, chills, dizziness, aches on 05Feb2021 07:15 PM. AE resulted in 'None of the above'. The patient did not receive treatment for the events. The patient did not have COVID prior vaccination. The patient had COVID tested post vaccination, type was Nasal Swab and result was negative. The outcome of the event was recovering.  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: fever, a 100.2 Fahrenheit; Headache; achiness; Sore arm; This is a spontaneous report from a contactable consumer(patient). A 76 years old female patient received second dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EM9810), via an unspecified route of administration on 05Feb2021 at single dose for COVID-19 immunization.  The medical history and concomitant medications were not reported. The Historical Vaccine was first dose BNT162B2(LOT number ET1686) for COVID-19 immunization. The patient received the 2nd dose of the vaccine yesterday. She was very happy to get it and she had of course achiness and a headache and a sore arm in Feb2021. She also had fever, a 100.2 Fahrenheit in Feb2021. Her husband will help her take it again, sometimes she cannot hear at the thermometer when it beeps. All she wanted to know they were going up to see her daughter and son-in-law, her grandchildren and her son-in-law's parents today. Of course they would all be wearing mask and when they would be outside, they would be in garage. She wanted to know if it was catching.  She did not want to give COVID to anybody. The patient underwent lab tests and procedures, which included Body temperature 100.2 Fahrenheit fever in Feb2021. The outcome of the events was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Rash
Clinical narrative: Chills; Fever; Tired; Rash; This is a spontaneous report from a contactable consumer reported for herself. A 50-year-old patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL9629 and Expiration Date unknown) via an unspecified route of administration on 04Feb2021 03:00 PM at age of 50-year-old (vaccine location: Left arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3249 and Expiration Date unknown) via an unspecified route of administration on 13Jan20210 3:15 PM at age of 50-year-old (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's medical history was reported as stroke from Oct2019, no previous covid and no known allergy. There is no other vaccine in four weeks. The concomitant medications reported as acetylsalicylic acid (ASPIRIN) and metoprolol succinate (Toprol 25MG). Patient experienced Chills, then fever, tired, rash from 05Feb2021 06:00 PM. The outcome of events was recovering without treatment given.  Information on the batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: a small rash on her back and chest; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on an unspecified date (lot/batch number and expiration date not provided), the second dose on 05Feb2021 (lot number: lot number: EL9269), both via an unspecified route of administration at single dose as COVID-19 Vaccine. Medical history included Hypertension, Prediabetes. The patient's concomitant medications were not reported. Caller stated she had gotten the second covid vaccine shot yesterday and had gotten a small rash on her back and chest. Caller wanted to know if it is from the covid vaccine. Consumer further stated she was just wondering if and she had just gotten her second shot yesterday, but after her first shot she had gotten a little bit of a rash on her back and on her chest and she wonder if that were a common occurrence or side effect of this shot. Consumer stated no treatment. No Investigation Assessment. The outcome of the event was unknown.  Information about the lot/batch number has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Insomnia, Myalgia, Vaccination site pain
Clinical narrative: Fatigue; injection site pain got worse couldn't sleep on my right side; injection site pain got worse couldn't sleep on my right side; Headache; Muscle aches; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received second dose of bnt162b2 (lot number: EN5318), via an unspecified route of administration, at Arm Right, on 05Feb2021 11:30 at Single dose for COVID-19 immunisation. Medical history included allergies to medications, food, cardio vascular disease, glaucoma, high BP, all from an unknown date. The patient's concomitant medications were not reported. The patient previously took tramadol, Lisinopril, statins, lactose and experienced allergies. The patient historical vaccine included first dose of bnt162b2 on 15Jan2021 at Right arm, for COVID-19 immunisation. No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. The patient experienced injection site pain got worse couldn't sleep on his right side, headache unusual for him transient but sharp, woke up at 1:00AM serious muscle aches and fatigue like his legs and arms were made of lead. Adverse event started from 06Feb2021 12:00 AM. 90% of all above side effects abated by 8:00AM this morning 06Feb2021. No treatment ae. The outcome of the events were recovered on unspecified date.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness, SARS-CoV-2 test
Clinical narrative: started getting sick; positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported.  The patient's concomitant medications were not reported. Caller said she got her first covid vaccine shot last on 19Jan2021 and started getting sick. HCP asked her to get tested with covid and on 29Jan2021 results came out positive. Wanted to know if it is possible for her to get the second covid shot that is scheduled 09Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 29Jan2021. The outcome of the events was unknown. Information on Lot/ Batch number has been requested.