chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR, MMRV
Symptoms: Product storage error
Clinical narrative: No other AE reported; PROQUAD administered during a temperature excursion/temperature excursion involving PROQUAD and MMR II; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.     On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 ml (strength, route of administration were not provided, lot # T009931, expiration date: 16-SEP-2021) one time as prophylaxis. Measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, strength, route of administration, lot number and expiration date were not provided) as prophylaxis was also reported but was not administered during the temperature excursion (incorrect product storage).    On 10-FEB-2020, the vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was exposed to a temperature range between temperature 14°F to 46°F for 14 hours and 10 minutes and 6°F to 14°F for 2 hours and 55 minutes (incorrect product storage).  There was an previous temperature excursion. Data logger was involved.
Age: 84.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Abdominal pain upper, Body temperature, Chills, Headache, Pain
Clinical narrative: hospital for Covid, she has been hospitalized for about 5 days; hospital for Covid, she has been hospitalized for about 5 days; This is a spontaneous report from a contactable  consumer reporting for herself and from her husband.    A 84-years-old female patient  received the first dose of bnt162b2 (BNT162B2; Lot #EL9261 ) vaccine  , via an unspecified route of administration on  22Jan2021 12:45 at single dose for covid-19 immunisation .  Medical history included dyspnoea, hypertension, the patient is a cardiac assistance device user.  Concomitant medication included apixaban (ELIQUIS).  The patient stated she experienced fever, stomachache, and body aches on an unknown date after the first dose of vaccine. Her husband also stated she has been hospitalized for about 5 days for Covid-19  since an unknown date, with outcome of unknown   Patient's body temperature: went up to  100 °F.  Follow up information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021162138 Same reporter/drug, different patient/event
Age: 84.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Pyrexia
Clinical narrative: hospital for Covid, she has been hospitalized for about 5 days; hospital for Covid, she has been hospitalized for about 5 days; This is a spontaneous report from a contactable  consumer reporting for herself and from her husband.    A 84-years-old female patient  received the first dose of bnt162b2 (BNT162B2; Lot #EL9261 ) vaccine  , via an unspecified route of administration on  22Jan2021 12:45 at single dose for covid-19 immunisation .  Medical history included dyspnoea, hypertension, the patient is a cardiac assistance device user.  Concomitant medication included apixaban (ELIQUIS).  The patient stated she experienced fever, stomachache, and body aches on an unknown date after the first dose of vaccine. Her husband also stated she has been hospitalized for about 5 days for Covid-19  since an unknown date, with outcome of unknown   Patient's body temperature: went up to  100 °F.  Follow up information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021162138 Same reporter/drug, different patient/event
Age: 84.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Blood pressure measurement, Body temperature, COVID-19, Drug ineffective
Clinical narrative: hospital for Covid, she has been hospitalized for about 5 days; hospital for Covid, she has been hospitalized for about 5 days; This is a spontaneous report from a contactable  consumer reporting for herself and from her husband.    A 84-years-old female patient  received the first dose of bnt162b2 (BNT162B2; Lot #EL9261 ) vaccine  , via an unspecified route of administration on  22Jan2021 12:45 at single dose for covid-19 immunisation .  Medical history included dyspnoea, hypertension, the patient is a cardiac assistance device user.  Concomitant medication included apixaban (ELIQUIS).  The patient stated she experienced fever, stomachache, and body aches on an unknown date after the first dose of vaccine. Her husband also stated she has been hospitalized for about 5 days for Covid-19  since an unknown date, with outcome of unknown   Patient's body temperature: went up to  100 °F.  Follow up information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021162138 Same reporter/drug, different patient/event
Age: 20.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Greater than 1-month between HEPLISAV-B dosing; Initial Report Received on 05-Jan-2021  A pharmacist reported that a 20 year-old female (race and ethnicity not provided) received her second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization greater than 1 month after the first dose.  No medical history was reported.   No concomitant medications were reported.  On 18-Sep-2020, the patient received the first dose of HEPLISAV-B (Lot # 933625, expiration date 12-Sep-2021 and NDC # 805181463558) to the left deltoid at an unknown facility.  The flu vaccine was administered concomitantly.  The patient reported no adverse reactions.    On 05-Jan-2021, 110 days (greater than 1 month) after receiving the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B (Lot # 933625, expiration date 12-Sep-2021 and NDC # 805181463558) to the left deltoid at a pharmacy.  At the time of the report, the patient reported no adverse reactions to either injection.  No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patients under 18 have been vaccinated; A spontaneous report was received from a pharmacist concerning a patient of unknown age and unknown gender who received Moderna's COVID-19 vaccine and patients under 18 have been vaccinated.  The patient's medical history was not provided.  Concomitant product use was unknown by the reporter.     Prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number was unknown) intramuscularly for prophylaxis of COVID-19 infection. Question about any efficacy in patients under 18. Some patients under 18 have been vaccinated, should you wait until 18 to give second dose? Agent called back reporter who stated that patients under the age of 18 have been administered the vaccine. Reporter requested response to be sent to email provided. The reporter who stated that patients under the age of 18 have been administered the vaccine but he did not have patient identifiers or details at the time agent called. He stated that he can obtain the information if needed. He reported that he has already submitted the AE  to VAERS.  He provided consent to contact him.   Action taken with mRNA-1273 in response to the event(s) was not provided.   The outcome of the event was considered to be resolved.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age without any associated adverse events.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Pain in extremity, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: vaccination site area started itching; Given (unknown dose) sub-cutaneous injection; left arm was sore; vaccination site "pinched" rasied bump that gradually grew darker red and then became hard; vaccination site "pinched" rasied bump that gradually grew darker red and then became hard; A spontaneous report was received from a consumer concerning a 42-year-old female, who received Moderna's COVID-19 vaccine and experienced given (unknown dose) sub-cutaneous injection, left arm was sore, pinched" raised bump, bump gradually grew darker red and area started itching.  The patient's medical history includes allergies to sulfa drugs and shellfish. No relevant concomitant medications were reported.  On 06-JAN-2021, patient received first of the two planned doses of Moderna covid-19 vaccine (Lot#011J20A) on her left arm by subcutaneous route. It was given on the back of flabby part of the arm. Her left arm became sore after the injection and in couple of hours she noticed a "pinched" raised bump on the vaccination site. It gradually grew darker red  and became hard. It lasted for 10 days. After 10 days, the area started itching which lasted for 1 week. No treatment medications were used.   On 03-FEB-2021, she received the second dose  (Lot#042L20A) intramuscularly on her left deltoid.  Action taken with Moderna Covid-19 vaccine was not applicable as patient already received two doses of vaccine.  The outcome of the events pain in extremity, vaccination site induration, vaccination site erythema, vaccination site pruritus was considered resolved on an unknown date and Incorrect route of product administration was considered resolved on 06-JAN-2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: In the course of administering the vaccine, there was a leakage.; Not sure if the patient recieved full dose?; A spontaneous report was received from a physician concerning a 58-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the events, inappropriate dose of vaccine administered and syringe leakage.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unreported date, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.  On an unreported date, The health Care professional stated that in the course of administering the vaccine, there was a leakage. Not sure if the patient received full dose or not. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not applicable.   The outcome of the events, inappropriate dose of vaccine administered and syringe leakage were considered resolved on an unreported date.; Reporter's Comments: This report refers to a case of Incorrect dose administered and syringe issue for mRNA-1273, with no associated AEs.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: muscle aches; Fatigue; This is a spontaneous report from a contactable consumer (patient himself). A 54-year-old male patient received his first dose of bnt162b2 (BNT162B2 also reported as COVID 19 brand Pfizer, lot EL3302), via an unspecified route of administration in left arm on 21Jan2021 07:30 at SINGLE DOSE for Covid-19 immunisation. Medical history included hypertension, obesity and had PCN Allergy.  The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included carvedilol (COREG), testosterone, valsartan, fexofenadine hydrochloride (ALLEGRA). The patient experienced muscle aches and fatigue on 22Jan2021. No treatment for the events. The outcome of event was recovering.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: This is a spontaneous report from a contactable consumer (patient).  A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3246, via an unspecified route of administration in the left arm, on 14Jan2021 08:30 at SINGLE DOSE for covid-19 immunization.  Medical history included penicillin allergy. 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 hasn't been tested for COVID-19. Concomitant medications included loratadine (CLARITINE), ascorbic acid (VIT C), vitamin b complex and ergocalciferol (VIT D).  On 21Jan2021 13:00, exactly 7 days after receiving 1st dose, the patient developed shingles. The outcome of event was recovering. The patient received Valacyclovir HCL 1 G as treatment for the event. The event was considered as non-serious by the reporter.  No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Diarrhoea, Nausea, Vomiting
Clinical narrative: This is a spontaneous report from a contactable healthcare professional. A 77-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on her left arm, via an unspecified route of administration on 28Jan2021 13:30 at a single dose for covid-19 immunization.  Medical history included diabetes type 2 and neuropathy (reported as neuropothy). The patient experienced Upper and middle back severe pain, nausea, vomiting, diarrhea; all on 01Feb2021 04:00 AM. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: This is a spontaneous report from a nurse who reported for himself  A 28-years-old male patient received  first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from Lot# EK5730 in left arm on 28Dec2020 09:00 09:00 at SINGLE DOSE for covid-19 immunisation . Age at vaccination: 28 Years. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine:Medical history included none.  The patient's concomitant medications were not reported.  The patient experienced palpitations on 14Jan2021 11:00 with outcome of not recovered.  Event reported as non serious.The adverse event result in Emergency room/department or urgent care.No treatment received.Prior to vaccination,  the patient was not  diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Insomnia, Nausea, Pain
Clinical narrative: aches and pains; nausea; some confusion; the patient woke up in the middle of the night on 20Jan; This is a spontaneous report from a contactable consumer  A 79-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on  19Jan2021 in the left arm at 18:00 at SINGLE DOSE for covid-19 immunisation .  Age at vaccination: 79 Years. Facility where the most recent COVID-19 vaccine was administered:Public Health Clinic.The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included history high blood pressure, covid-19 (covid prior vaccination: Yes)  and the patient has a pace maker.  Concomitant medication included hydrochlorothiazide, losartan potassium (HYZAAR), carvedilol (COREG), acetylsalicylic acid (ASPIRIN ,  colecalciferol (D3 VITAMIN).  The patient experienced Sleeplessness on 20Jan2021, Ache , nausea and confusion on 21Jan2021 02:00.Clincal course reported as follows: the patient woke up in the middle of the night on 20Jan with aches and pains, nausea and some confusion, confusion resolved in 15 min, tylenol administered for aches and pains, no issues when patient woke up in the morning.All events reported as non serious . The patient was recovered from confusion on 21Jan2021, while the outcome of the other events was recovered on unknown date .Since the vaccination, the patient had not been tested for COVID-19 information on the lot/batch number has been requested
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy skin rash; This is a spontaneous report from a contactable consumer (patient). An 87-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration in left arm on 19Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included thyroid, high blood pressure and cholesterol from an unknown date and unknown if ongoing. The patient has no known allergies to medications, food, or other products. Concomitant medication included levothyroxine, lisinopril and atorvastatin. The facility where the most recent COVID-19 vaccine was administered was not specified. 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 itchy skin rash on 29Jan2021. The outcome of the event was not recovered. No treatment was given to the patient for the events. The event was considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and was not a congenital anomaly/birth defect.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site swelling
Clinical narrative: I now have a large discolored area on my arm post vaccine; I had a large area the was swollen on my right arm; This is a spontaneous report from a contactable nurse reporting for herself. A 42-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot number EL1283, Expiration date Apr2021, in Hospital, via intramuscular route in right arm on 10Jan2021 at 08:45 (at 42 years of age) at single dose for COVID-19 immunization. Medical history included asthma from an unknown date. The patient was not pregnant at the time of the report. She has not been tested for COVID-19 since the vaccination. The patient had received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot number EJ1685, via intramuscular route in left arm on 20Dec2020 at 10:00 AM. There were no concomitant medications. On 15Jan2021 the patient experienced a large discolored area on her arm and a large swollen area on her right arm. She wrapped it and applied an ice pack for 10 minutes on day 5 post vaccination. The darker area appeared after she iced it and has not gone away. The reported event had not resolved yet at the time of the report.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature, Eye pain, Headache, Inappropriate schedule of product administration
Clinical narrative: woke next morning w/ temp. 100.8 fever; full body aches; left armpit swollen / sore (inj. arm); left armpit swollen / sore (inj. arm); extreme shaking last 2-3 hours; severe headache; eye ache; administration date of dose 1: 11Jan2021/ administration date of dose 2: 28Jan2021; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249 and expiration date not provided), via an unspecified route of administration left arm second dose on 28Jan2021 at single dose for Covid-19 immunization. The vaccine was administered in the hospital. The Patient's medical history included Esophageal Cancer. The patient's concomitant medications were not reported. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1686 and expiration date not provided) via an unspecified route of administration left arm first dose on 11Jan2021 for Covid-19 immunization. On 28Jan2021 17:30, the patient experienced extreme shaking last 2-3 hours, severe headache, eye ache, full body aches, left armpit swollen/sore (injection arm). Woke next morning 29Jan2021 with temperature 100.8 fever, later evening, temperature of 99.6. Symptoms lasted almost 72 hours. The patient stayed in bed the entire time. The patient did not received treatment for the events.  The outcome of the events was recovered.  The reporter assesses the events as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Swelling, Tremor
Clinical narrative: woke next morning w/ temp. 100.8 fever; full body aches; left armpit swollen / sore (inj. arm); left armpit swollen / sore (inj. arm); extreme shaking last 2-3 hours; severe headache; eye ache; administration date of dose 1: 11Jan2021/ administration date of dose 2: 28Jan2021; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249 and expiration date not provided), via an unspecified route of administration left arm second dose on 28Jan2021 at single dose for Covid-19 immunization. The vaccine was administered in the hospital. The Patient's medical history included Esophageal Cancer. The patient's concomitant medications were not reported. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1686 and expiration date not provided) via an unspecified route of administration left arm first dose on 11Jan2021 for Covid-19 immunization. On 28Jan2021 17:30, the patient experienced extreme shaking last 2-3 hours, severe headache, eye ache, full body aches, left armpit swollen/sore (injection arm). Woke next morning 29Jan2021 with temperature 100.8 fever, later evening, temperature of 99.6. Symptoms lasted almost 72 hours. The patient stayed in bed the entire time. The patient did not received treatment for the events.  The outcome of the events was recovered.  The reporter assesses the events as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Red rash all over body; Hives on legs, butt, stomach, lower stomach, arms, hands, feet, face, neck and back; This is a spontaneous report from a contactable consumer, the patient.  A 31-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL4262), via an unspecified route of administration in the left arm on 27Jan2021 at 14:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products.  The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19.  On 29Jan2021 at 15:00, the patient experienced red rash all over body and hives on legs, butt, stomach, lower stomach, arms, hands, feet, face, neck and back. The events required a visit to the emergency room and physician's office. The patient was treated with methyprednisolone (MANUFACTURER UNKNOWN), epinephrine (MANUFACTURER UNKNOWN), and diphenhydramine (MANUFACTURER UNKNOWN). The clinical outcomes red rash all over body and hives were not recovered.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Chills; Fatigue; Headache; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient (not pregnant at the time of vaccination) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration at Left arm on 30Jan2021 17:45 at single dose for covid-19 immunization. Medical history included allergies. The patient had allergies to medications, food, or other products. 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. Concomitant medications were yes but unspecified. The patient received other medications within 2 weeks of vaccination. The patient experienced chills, fatigue and headache, all on 30Jan2021 19:30. Since the vaccination, the patient had not been tested for COVID-19. The outcome was unknown. The seriousness from reporter was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Presyncope
Clinical narrative: Vasovagal response; This is a spontaneous report from a contactable consumer.  A 45-year-old female patient reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3247) into the left arm on 01Feb2021 08:15 AM at single dose for COVID-19 immunization. Age at vaccination 45 years. Concomitant drugs included multi-vitamin, D3, AERids eye vitamins. The patient had not history of allergies to medications, food, or other products. On 01Feb2021 at 08:30 AM the patient experienced a vasovagal response.Occupational Health/Wellness nurse checked blood pressure and had her lay down with legs up. After 10 minutes she went away and felt back to normal. No treatment was received. The outcome was recovered.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: 103 fever 12-16 hrs later after vaccine lasting 36 hrs; Sore throat; Aches; Chills; This is a spontaneous report from a contactable other hcp. A 36-year-old female patient reported that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number El9231) into the left arm on 29Jan2021 at 07:00 AM at single dose for COVID-19 immunization. Age at vaccination 36 years old. The patient received first dose of BNT162B2 on an unknown date. The patient did not received other drugs within 2 weeks of vaccination. Medical history was none. On 30Jan2021 the patient reported 103 fever 12-16 hrs after vaccine lasting 36 hrs. Sore throat, aches and chills. No treatment was received. the outcome of the events was recovered.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Disorientation, Fatigue, Headache, Lymphadenopathy
Clinical narrative: joint/muscle ache on left arm (site of injection); joint/muscle ache on left arm (site of injection); joint/muscle ache on left arm (site of injection); Swelling of left arm and left armpit (possibly lymph node swelling); Swelling of left arm and left armpit (possibly lymph node swelling); Unable to lift left arm past shoulder; mild fever; full body ache/pain; slight disorientation when standing; headache; fatigue; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 27Jan2021 17:45 at a single dose for COVID-19 immunization. Medical history included latex allergy. Concomitant medication included influenza vaccine (TRIVALENT INFLUENZA VACCINE) on 11Jan2021. The patient previously received first dose of BNT162B2 on 06Jan2021 for COVID-19 immunisation (first dose at 05:45 PM, left arm). First symptom: headache/fatigue at 3:30 pm on 28Jan2021, sleep at 11 pm. Woke up at 8 am 29Jan2021, symptoms include mild fever (temperature not taken), severe headache, full body ache/pain, slight disorientation when standing. Symptoms alleviated by taking 1 acetaminophen (TYLENOL) pill (extra strength). Symptoms returned at 4 pm, another Tylenol pill taken to relieve symptoms. On 30Jan2021, mild symptoms in the morning including headache, joint/muscle ache on left arm (site of injection). Treated with Tylenol. Swelling of left arm and left armpit (possibly lymph node swelling). Unable to lift left arm past shoulder. On 31Jan2021, persisting mild headache and left arm aches, now able to lift left arm past shoulder, but with some discomfort. Treat with Tylenol. On 01Feb2021, mild headache still persisting, significantly reduced swelling of left arm/armpit. Full motion with left arm without discomfort. Treat with Tylenol. Events were reported as non-serious; 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. The facility where the vaccine was administered was in a Public Health Clinic/Veterans Administration facility. There were no other medications the patient received within 2 weeks of vaccination. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the event swelling arm was unknown while recovering for the other events.   Information on the lot/batch number has been requested.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Myalgia, Pain, Peripheral swelling, Pyrexia
Clinical narrative: joint/muscle ache on left arm (site of injection); joint/muscle ache on left arm (site of injection); joint/muscle ache on left arm (site of injection); Swelling of left arm and left armpit (possibly lymph node swelling); Swelling of left arm and left armpit (possibly lymph node swelling); Unable to lift left arm past shoulder; mild fever; full body ache/pain; slight disorientation when standing; headache; fatigue; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 27Jan2021 17:45 at a single dose for COVID-19 immunization. Medical history included latex allergy. Concomitant medication included influenza vaccine (TRIVALENT INFLUENZA VACCINE) on 11Jan2021. The patient previously received first dose of BNT162B2 on 06Jan2021 for COVID-19 immunisation (first dose at 05:45 PM, left arm). First symptom: headache/fatigue at 3:30 pm on 28Jan2021, sleep at 11 pm. Woke up at 8 am 29Jan2021, symptoms include mild fever (temperature not taken), severe headache, full body ache/pain, slight disorientation when standing. Symptoms alleviated by taking 1 acetaminophen (TYLENOL) pill (extra strength). Symptoms returned at 4 pm, another Tylenol pill taken to relieve symptoms. On 30Jan2021, mild symptoms in the morning including headache, joint/muscle ache on left arm (site of injection). Treated with Tylenol. Swelling of left arm and left armpit (possibly lymph node swelling). Unable to lift left arm past shoulder. On 31Jan2021, persisting mild headache and left arm aches, now able to lift left arm past shoulder, but with some discomfort. Treat with Tylenol. On 01Feb2021, mild headache still persisting, significantly reduced swelling of left arm/armpit. Full motion with left arm without discomfort. Treat with Tylenol. Events were reported as non-serious; 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. The facility where the vaccine was administered was in a Public Health Clinic/Veterans Administration facility. There were no other medications the patient received within 2 weeks of vaccination. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the event swelling arm was unknown while recovering for the other events.   Information on the lot/batch number has been requested.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: joint/muscle ache on left arm (site of injection); joint/muscle ache on left arm (site of injection); joint/muscle ache on left arm (site of injection); Swelling of left arm and left armpit (possibly lymph node swelling); Swelling of left arm and left armpit (possibly lymph node swelling); Unable to lift left arm past shoulder; mild fever; full body ache/pain; slight disorientation when standing; headache; fatigue; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 27Jan2021 17:45 at a single dose for COVID-19 immunization. Medical history included latex allergy. Concomitant medication included influenza vaccine (TRIVALENT INFLUENZA VACCINE) on 11Jan2021. The patient previously received first dose of BNT162B2 on 06Jan2021 for COVID-19 immunisation (first dose at 05:45 PM, left arm). First symptom: headache/fatigue at 3:30 pm on 28Jan2021, sleep at 11 pm. Woke up at 8 am 29Jan2021, symptoms include mild fever (temperature not taken), severe headache, full body ache/pain, slight disorientation when standing. Symptoms alleviated by taking 1 acetaminophen (TYLENOL) pill (extra strength). Symptoms returned at 4 pm, another Tylenol pill taken to relieve symptoms. On 30Jan2021, mild symptoms in the morning including headache, joint/muscle ache on left arm (site of injection). Treated with Tylenol. Swelling of left arm and left armpit (possibly lymph node swelling). Unable to lift left arm past shoulder. On 31Jan2021, persisting mild headache and left arm aches, now able to lift left arm past shoulder, but with some discomfort. Treat with Tylenol. On 01Feb2021, mild headache still persisting, significantly reduced swelling of left arm/armpit. Full motion with left arm without discomfort. Treat with Tylenol. Events were reported as non-serious; 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. The facility where the vaccine was administered was in a Public Health Clinic/Veterans Administration facility. There were no other medications the patient received within 2 weeks of vaccination. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the event swelling arm was unknown while recovering for the other events.   Information on the lot/batch number has been requested.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), at age 32 years, via an unspecified route of administration on the left arm, first dose on 29Jan2021 09:30, at 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, was the patient was not diagnosed with COVID-19. On 30Jan2021 , the patient experienced migraine. Facility where the most recent COVID-19 vaccine was administered was at a hospital. The patient did not receive any other medications within 2 weeks of vaccination. Treatment was not received for the adverse event. Since the vaccination, has the patient has not been tested for COVID-19. The outcome of the event was recovering.   Information on the lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration in left arm on 31Jan2021 13:45 at single dose for COVID-19 immunization. The patient was not pregnant at time of vaccination. The patient's medical history and concomitant medications were not reported. The patient had historical vaccine first dose of BNT162B2 (lot number: EL3246), on 09Jan2021 09:00 AM in the left arm at single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was in the 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 left armpit soreness on 01Feb2021. The outcome of the event was recovered on unspecified date. No treatment was given to the patient for the event. The event was considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and was not a congenital anomaly/birth defect.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Spinal pain
Clinical narrative: Brief episodes of chest tightening, followed by spinal pain between shoulders.; Brief episodes of chest tightening, followed by spinal pain between shoulders.; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9262 and expiration date not provided), via an unspecified route of administration (left arm) on Jan2021 at single dose for Covid-19 immunization. There was no medical history. The patient's concomitant medications were not reported. On 30Jan2021, the patient experienced brief episodes of chest tightening, followed by spinal pain between shoulders. The patient did not received treatment for the event. The outcome of the events was not recovered.  The reporter assesses the events as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Eye movement disorder, Nausea, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL0142; expiration date: unknown), via an unspecified route of administration left arm on 13Jan2021 12:15 PM at a single dose for covid-19 immunization. The patient's medical history concomitant medications were not reported. The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been diagnosed with COVID-19 prior to vaccination. The patient reported that he felt fine after the shot for the rest of the day and the first night other than the soreness where he received the shot. The patient went to bed around 11 pm and woke up the next day (14Jan2021) at around 6:30 am with very bad dizziness. He felt like his eyes were rolling around in his head which made him very nauseous and sick to his stomach. His wife called a friend who is a nurse and she said to keep an eye on him for a little while and see how he was in an hour or so. She said that if it gets worse call 911 otherwise get him to the clinic at 10 am. He reported that he was feeling much better by then but went to clinic at 10 and doctor saw him asked questions gave me something for nausea and dizziness. He felt good the rest of the day with slight lightheaded. He mentioned that he needs get his second shot on 03Feb2021 and was concerned about getting it. He inquired on what is the recommendation on getting dose #2. It was not reported if the patient been tested for COVID-19 since vaccination. The adverse event result in doctor or other healthcare professional office/clinic visit. The patient received treatment for the adverse events. They gave me ondansetron (ZAFRAN ODT [orally disintegrating tablets]) 4 mg for nausea. The patient considered the events was non-serious. The outcome of the events was recovered on an unspecified date with sequelae (recovered with lasting effects).
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Neck pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). An 84-year-old male patient received first dose of bnt162b2 (COVID 19, Pfizer, Solution for injection, Lot number: EL9262), via an unspecified route of administration on Left arm on 29Jan2021 14:00 at single dose for covid-19 immunisation. Medical history included high blood pressure and the patient also had PE. No allergies to medications, food, or other products was reported. The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included valsartan, metoprolol succinate (TOPROL), doxazosin mesilate (CARDURA), rivaroxaban (XARELTO); all received within 2 weeks of vaccination. The patient had neck pain and can't move head to either side without pain on 31Jan2021 14:00. No treatment was received for the adverse event. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex reactivation
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration in the right arm on 29Jan2021 09:45 at a single dose for COVID-19 immunization. Medical history included herpes simplex virus from an unknown date. For the concomitant products, the patient mention she only takes vitamins and minerals and no other medications. The patient had her first dose on the 29Jan2021 at 09:45AM and 2 days later on 31Jan2021 had a herpes simplex virus (HSV) outbreak on leg where she have had in the past. She had it there before and doesn't get it very often but that is the usual location of the HSV outbreak. She is scheduled to receive the second dose of the vaccine on 20Feb2021. Outcome of the event was not recovered. The event did not require a visit to physician or ER. There were no prior vaccinations (within 4 weeks).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive for COVID-19; positive for COVID-19; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was positive for COVID-19 on an unspecified date after the first dose of vaccine. Outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cold sweat, Fatigue, Feeling cold
Clinical narrative: 6 hrs post vax and 48 hours post vax: injection site pain; 6 hrs post vax:  headache/ 48 hours post vax: remaining symptoms headache; 24 hours post vax: as above plus extreme fatigue/ 48 hours post vax: extreme fatigue; 24 hours post vax: chills/inability to feel warm; 24 hours post vax: inability to feel warm; 28 hours post vax: hot and cold flashes/ 48 hours post vax: remaining symptoms hot and cold flashes; 28 hours post vax: as the above plus nausea; 32 hours post vax: as above plus vomiting/ 38 hours post vax: vomiting ended; 38 hours post vax: otherwise as above with simultaneous hot sweats at upper body and cold sweats at lower body; 38 hours post vax: otherwise as above with simultaneous hot sweats at upper body and cold sweats at lower body; 48 hours post vax: general physical weakness and malaise; 48 hours post vax: general physical weakness and malaise; This is a spontaneous report from a contactable other Health professional (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL9261), via an unspecified route of administration on 28Jan2021 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at Workplace clinic. Age at vaccination was 50-years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL0142) administered on 07Jan2021 (at the age of 50 years), at single dose in left arm. Medical history included anxiety, depression, obesity. The patient has allergies to certain unspecified antibiotics. Concomitant medications included citalopram, linum usitatissimum seed oil (FLAX SEED OIL), daily multivitamin 50+. It was reported that 6 hrs post vax on 29Jan2021 the patient experienced injection site pain, headache, 24 hours post vax: as above plus extreme fatigue, chills/inability to feel warm, 28 hours post vax: as the above plus nausea, hot and cold flashes, 32 hours post vax: as above plus vomiting, 38 hours post vax: vomiting ended, otherwise as above with simultaneous hot sweats at upper body and cold sweats at lower body, 48 hours post vax: remaining symptoms headache, injection site pain, hot and cold flashes, ex-treme fatigue, general physical weakness and malaise. The events were reported as non serious. No treatment was received for the events. The events resolved on an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Headache, Hyperhidrosis, Malaise, Nausea
Clinical narrative: 6 hrs post vax and 48 hours post vax: injection site pain; 6 hrs post vax:  headache/ 48 hours post vax: remaining symptoms headache; 24 hours post vax: as above plus extreme fatigue/ 48 hours post vax: extreme fatigue; 24 hours post vax: chills/inability to feel warm; 24 hours post vax: inability to feel warm; 28 hours post vax: hot and cold flashes/ 48 hours post vax: remaining symptoms hot and cold flashes; 28 hours post vax: as the above plus nausea; 32 hours post vax: as above plus vomiting/ 38 hours post vax: vomiting ended; 38 hours post vax: otherwise as above with simultaneous hot sweats at upper body and cold sweats at lower body; 38 hours post vax: otherwise as above with simultaneous hot sweats at upper body and cold sweats at lower body; 48 hours post vax: general physical weakness and malaise; 48 hours post vax: general physical weakness and malaise; This is a spontaneous report from a contactable other Health professional (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL9261), via an unspecified route of administration on 28Jan2021 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at Workplace clinic. Age at vaccination was 50-years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL0142) administered on 07Jan2021 (at the age of 50 years), at single dose in left arm. Medical history included anxiety, depression, obesity. The patient has allergies to certain unspecified antibiotics. Concomitant medications included citalopram, linum usitatissimum seed oil (FLAX SEED OIL), daily multivitamin 50+. It was reported that 6 hrs post vax on 29Jan2021 the patient experienced injection site pain, headache, 24 hours post vax: as above plus extreme fatigue, chills/inability to feel warm, 28 hours post vax: as the above plus nausea, hot and cold flashes, 32 hours post vax: as above plus vomiting, 38 hours post vax: vomiting ended, otherwise as above with simultaneous hot sweats at upper body and cold sweats at lower body, 48 hours post vax: remaining symptoms headache, injection site pain, hot and cold flashes, ex-treme fatigue, general physical weakness and malaise. The events were reported as non serious. No treatment was received for the events. The events resolved on an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.