chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Trigger finger
Clinical narrative: Trigger thumb; This is a spontaneous report from a contactable Other HCP (Patient). A 51-year-old female patient (Not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), second vaccination dose via an unspecified route of administration at the age of 51-years, administered in the right arm on 12Feb2021 15:00 (Batch/Lot Number: EL9269) as single dose for covid-19 immunization. Medical history included narcolepsy. First dose of bnt162b2 was administered on 18Jan2021 for COVID 19 immunization, lot EL3246, in the right arm. Concomitant medications included escitalopram escitalopram oxalate (LEXAPRO 10mg), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL 30mg) and valaciclovir hydrochloride (VALTREX 500mg). It was reported that patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Also, patient was not diagnosed with COVID-19 prior to vaccination nor been tested for COVID-19 after the vaccination. Since the vaccination, patient had not tested for COVID-19. Patient had no allergies to medications, food, or other products. On 13Feb2021 at 11:00, the patient experienced trigger thumb. Patient was not received any treatment for the event. The patient was not recovered from the event. The reporter considered there was a reasonable possibility that the event was caused by bnt162b2.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nasal congestion, Oropharyngeal pain
Clinical narrative: Headache; Sore throat; Muscle aches; Congestion; This is a spontaneous report from a contactable other Health care professional. A 24-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown and Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in arm Left on 25Mar2021 at 14:30 (at the age of 24-year-old) as SINGLE DOSE for covid-19 immunization. Medical history included Endometriosis, anxiety and IBS. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included fluoxetine (FLUOXETINE); ethinylestradiol, norethisterone acetate (MICROGESTIN) and acetaminophen (ACETAMINOPHEN). The patient was not diagnosed with COVID-19 prior to vaccination. On 26Mar2021, the patient experienced headache, sore throat, muscle aches and congestion. The patient did not receive treatment for the adverse event. Since the vaccination, patient has not been tested for COVID-19. At the time of this report outcome of the events were recovering.  No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Woke up during night after the vaccine with chills and body aches.Following day after the vaccine I had a fever, body aches, chills, and a headache throughout the whole day.Two days after the vaccine; Woke up during night after the vaccine with chills and body aches.Following day after the vaccine I had a fever, body aches, chills, and a headache throughout the whole day.Two days after the vaccine; Woke up during night after the vaccine with chills and body aches.Following day after the vaccine I had a fever, body aches, chills, and a headache throughout the whole day.Two days after the vaccine; Woke up during night after the vaccine with chills and body aches.Following day after the vaccine I had a fever, body aches, chills, and a headache throughout the whole day.Two days after the vaccine; This is an initial spontaneous report received from the non-contactable consumer (patient himself). A 24-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EP7533) via an unspecified route of administration in left arm on 05Apr2021 18:00 as 2nd dose, single dose and had previously received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6208) via an unspecified route of administration in left arm on 18Mar2021 13:00 as 1st dose, single dose for COVID-19 immunization. Patient was 24-years-old at the time of vaccination. Patient medical history was not reported. Patient had no known allergies to food, medications or other products. The concomitant medications included ibuprofen (ADVIL MAX) and amoxicillin at a dose of 500 mg. Facility where the most recent COVID-19 vaccine was administered was reported as Public Health Clinic. Patient was not diagnosed with COVID-19, prior to vaccination. Patient has not been tested for COVID-19, since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient woke up during night after the vaccine with chills and body aches. Following day after the vaccine patient had a fever, body aches, chills, and a headache throughout the whole day. Two days after the vaccine, all symptoms cleared except the headache worsened. The patient did not receive any treatment for the adverse events. The outcome of the event headache was not recovered while for other events was recovered.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Hypoaesthesia
Clinical narrative: left leg temporarily went numb and she dropped to the floor; left leg temporarily went numb and she dropped to the floor; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Lot Number: ER8727 Expiry Date unknown ), via an unspecified route of administration, administered in the right arm on 22Mar2021 at 08:00 as a single dose for COVID-19 immunization.  Medical history included polycystic ovarian syndrome (PCOS) from an unknown date and unknown if ongoing. The patient did not have COVID prior to vaccination. There were no concomitant medications.  The patient previously received clindamycin and experienced allergies on an unknown date. The patient was not tested for COVID post vaccination. On 24Mar2021 at 15:00, the patient's left leg temporarily went numb and she dropped to the floor. The event resulted in a visit to the emergency room/department or urgent care. The patient did not receive treatment for the event. The outcome of the events was recovered.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Headache, Heavy menstrual bleeding, SARS-CoV-2 test
Clinical narrative: subsequent mentstrual periods have been uncharacteristically heavy bleeding and more intense cramps/headaches; subsequent mentstrual periods have been uncharacteristically heavy bleeding and more intense cramps/headaches; intense cramps/headaches; This is a spontaneous report from a contactable consumer. A 37-year-old non-pregnant female patient of  received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 04Feb2021 10:30 (Batch/Lot Number: EL9264) as 2nd dose, single (at the age of 36 years) for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient has no known allergies. The patient has not had Covid-19 prior to vaccination.  The patient received OTC multivitamin in two weeks. The patient received the first dose of BNT162B2 (Lot:EL3246), via unspecified route of administration in the right arm on 13Jan2021 at 10:30am (at the age of 36 years) for Covid-19 immunisation. The patient experienced since receiving her second dose, all of her subsequent menstrual periods have been uncharacteristically heavy bleeding and more intense cramps/headaches on 29Mar2021 at 18:00 than she experienced in many years. The patient was not treated for the events. The patient was tested negative for Covid-19 on 31Mar2021 via nasal swab. The outcome of the events was unknown.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest scan, Decreased appetite, Electrocardiogram, Fatigue
Clinical narrative: after the second dose he went to see his doctor and he was palpitating and this was thought to be caused by a stress response; had trouble sleeping; very fatigued/ really fatigued; vomiting; a drastic increase in eye floaters/a huge increase in eye floaters; but I have been like falling asleep really early and then like popping awake really early.; dry heaving; I was 180, but I lost 10 pounds during all this I am 170 right now; appetite is still poor; This is a spontaneous report from a contactable consumer (patient). This 31-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 06Apr2021 (Lot number: ER8737), as single dose, at the age of 30 years, in left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. On an unknown date after second dose of vaccine patient experienced palpitating and this was thought to be caused by a stress response, had trouble sleeping, very fatigued/ really fatigued, vomiting every couple days, a drastic increase in eye floaters/a huge increase in eye floaters, patient falling asleep really early and then like popping awake really early, dry heaving, patient was 180, but now lost 10 pounds during all this and 170 right now and appetite is still poor. The events were considered as non-serious. Patient was taking Propranolol for the heart palpitation. On an unknown date patient undergone tests which includes Electrocardiogram (EKG), chest scan and had a full panel blood work results of all were unknown. The outcome of all the events was unknown.   No follow-up attempts needed. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Palpitations, Retching, Sleep disorder, Vitreous floaters
Clinical narrative: after the second dose he went to see his doctor and he was palpitating and this was thought to be caused by a stress response; had trouble sleeping; very fatigued/ really fatigued; vomiting; a drastic increase in eye floaters/a huge increase in eye floaters; but I have been like falling asleep really early and then like popping awake really early.; dry heaving; I was 180, but I lost 10 pounds during all this I am 170 right now; appetite is still poor; This is a spontaneous report from a contactable consumer (patient). This 31-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 06Apr2021 (Lot number: ER8737), as single dose, at the age of 30 years, in left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. On an unknown date after second dose of vaccine patient experienced palpitating and this was thought to be caused by a stress response, had trouble sleeping, very fatigued/ really fatigued, vomiting every couple days, a drastic increase in eye floaters/a huge increase in eye floaters, patient falling asleep really early and then like popping awake really early, dry heaving, patient was 180, but now lost 10 pounds during all this and 170 right now and appetite is still poor. The events were considered as non-serious. Patient was taking Propranolol for the heart palpitation. On an unknown date patient undergone tests which includes Electrocardiogram (EKG), chest scan and had a full panel blood work results of all were unknown. The outcome of all the events was unknown.   No follow-up attempts needed. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting, Weight decreased
Clinical narrative: after the second dose he went to see his doctor and he was palpitating and this was thought to be caused by a stress response; had trouble sleeping; very fatigued/ really fatigued; vomiting; a drastic increase in eye floaters/a huge increase in eye floaters; but I have been like falling asleep really early and then like popping awake really early.; dry heaving; I was 180, but I lost 10 pounds during all this I am 170 right now; appetite is still poor; This is a spontaneous report from a contactable consumer (patient). This 31-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 06Apr2021 (Lot number: ER8737), as single dose, at the age of 30 years, in left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. On an unknown date after second dose of vaccine patient experienced palpitating and this was thought to be caused by a stress response, had trouble sleeping, very fatigued/ really fatigued, vomiting every couple days, a drastic increase in eye floaters/a huge increase in eye floaters, patient falling asleep really early and then like popping awake really early, dry heaving, patient was 180, but now lost 10 pounds during all this and 170 right now and appetite is still poor. The events were considered as non-serious. Patient was taking Propranolol for the heart palpitation. On an unknown date patient undergone tests which includes Electrocardiogram (EKG), chest scan and had a full panel blood work results of all were unknown. The outcome of all the events was unknown.   No follow-up attempts needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: Pre-syncope during physical exertion; This is a spontaneous report from a contactable consumer (patient). This 35-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0170) via an unspecified route of administration on 02May2021 at 11:30 (at the age of 35-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included persistent depressive disorder. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included escitalopram oxalate (LEXAPRO) and dexamfetamine sulfate (DEXEDRINE) from unknown dates for unknown indications. The patient previously received dose 1 of BNT162B2 (lot number ER8737) on 05Apr2021 at 15:30 in the right arm for COVID-19 immunization. On 04May2021 at 16:30 the patient experienced pre-syncope during physical exertion. The event was reported as non-serious. The patient was not hospitalized for the event. The patient did not receive any treatment for the event. The outcome of pre-syncope was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: cold symptoms going on; half congested; This is a spontaneous report from a contactable consumer (patient's caregiver). An 87-year-old patient of unspecified gender received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient had cold symptoms going on. The patient was "half congested." The outcomes of cold symptoms and congestion were unknown. It was also reported that since the vaccination the patient was tested for COVID-19 and did not have it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired; This is a spontaneous report from a contactable consumer (the patient) from a Pfizer-sponsored program. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient received both Pfizer shots at work. She stated she did not have any reactions, then she stated that following the second shot, she was tired and stuff but the effect wore off. The outcome of tired was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: A week after the 1st shot my period came on extremely heavy.Gushing, passing clots and bleeding through both pad and tampon quickly!; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, dose 1 via an unspecified route of administration, administered in Arm Left on 07May2021 15:00 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included iron deficiency anemia, and pernicious anemia. Concomitant medications included iron; cyanocobalamin (VIT B12); ascorbic acid, biotin, calcium pantothenate, calcium phosphate dibasic, cyanocobalamin, ferrous fumarate, folic acid, magnesium oxide, manganese sulfate, nicotinamide, potassium sulfate, pyridoxine hydrochloride, riboflavin, thiamine mononitrate, tocopheryl acid succinate, zinc sulfate (MULTI VITAMINS & MINERALS); and ibuprofen. The patient experienced a week after the 1st shot her period came on extremely heavy, gushing, passing clots and bleeding through both pad and tampon quickly on 14May2021 16:30 with outcome of recovering. Patient had iron deficiency anemia that had been under control until now. Had not bled like this in years. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. No treatment was received. Information about batch/Lot number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, SARS-CoV-2 test
Clinical narrative: I have been bleeding heavily for 11 days now.; This is a spontaneous report from a contactable consumer. A 31-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 26Apr2021 02:15 (Batch/Lot Number: EW0164) as 2nd dose, single for covid-19 immunisation. Medical history included anaemia requires iron infusions, allergies: latex, sulfa meds, penicillins, shellfish, birth control. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included prednisone (PREDNISONE) 2.5 mg daily; lamotrigine (LAMICTAL) 200 mg daily. Historical vaccine included BNT162B2 on 02Apr2021: 12:00 PM, for covid-19 immunisation, batch/lot number: EW0150, anatomical location: arm left, dose number: 1. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient stated 14 days after vaccine, I got my period for the first time in over a year. I am on birth control to help me not have them due to anemia that requires iron infusions. I have been bleeding heavily for 11 days now. Event start date was on 10May2021,12:00 PM. The patient underwent lab tests and procedures which included sars-cov-2 test: negative. Outcome was not recovered. No treatment received. Doctor or other healthcare professional office/clinic visit required.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Neuralgia
Clinical narrative: pain significantly increased and has remained elevated following the second dose of the vaccine (Neuropathic pain); pain significantly increased and has remained elevated following the second dose of the vaccine (Neuropathic pain); This is a spontaneous report from a contactable physician (patient). A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration and administered in left arm at age of 63-years, on 11Mar2021 15:30 (Lot Number: EN6205) as single dose for covid-19 immunisation. Medical history included ongoing burning mouth syndrome and a neuropathic pain condition (patient had the condition for over 8 years). The patient was not pregnant. Concomitant medication included metoprolol; escitalopram oxalate (LEXAPRO); cetirizine hydrochloride (ZYRTEC) and ibuprofen (patient received them within 2 weeks of vaccination). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration and administered in left arm at age of 63-years, on 18Feb2021 12:30 PM (Lot Number: EL9266) as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that, following the second dose of the vaccine, her pain significantly increased and had remained elevated. She had been working with her pain specialist to change medication to find help for this intense pain. She had the condition for over 8 years so was very familiar with it and had never experienced an increase in pain at this magnitude. Above events started on 12Mar2021 and resulted in "Doctor or other healthcare professional office/clinic visit". Treatment was received included that "Changing medications". The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since the vaccination. Events outcome was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: she developed a red rash from her knees to her ankle, and from the elbow to the wrist; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Right Arm on 03May2021 10:55 AM (Lot Number: ER8735) as 2nd dose, single for covid-19 immunisation. Medical history included ongoing diabetic (diagnosed at least 12 years ago), she has breathing problems (she is not allowed out in public even after her vaccination). The patient's concomitant medications included she has been taking the medicines now for a while, she did not feel like it was a reaction to any of that. Historical Vaccine included Patient gets a flu shot every year for immunization; she also received the first dose of BNT162B2 (at age of 78 years old, lot number: EP7533) on 31Mar2021 injected before noon at right arm for COVID-19 immunization. Patient has received both doses of the Pfizer Covid 19 Vaccine. The second vaccine was received on 03May2021. Patient reports that on 18May2021 she developed a red rash from her knees to her ankle, and from the elbow to the wrist. Caller denied stinging, pain, or burning. She also denied any changes to detergent. Caller asking if symptom has been reported. Patient calling to see if she is having a reaction to the Covid vaccine. Patient states she is calling because she at her wits end, she had her second shot on 03May2021 and maybe three days ago now, she started breaking out with a red rash, it does not sting, burn, or hurt but it was from her knees to her ankles and from her elbows to her wrist. Patient states thought everything they can think of and she has had no new laundry detergents or eaten no new foods. breaking out with a red rash: Caller states she would say this past Tuesday and it seems to be more predominant when she takes a shower, with the warm water it seems to bring it back out. Caller states she has been taking some Benadryl. Patient states like she says, its just there, it did not sting, it did not itch, it did not burn, she just looks down at her arm or leg and it was kind of weird looking. Pfizer Covid Vaccine: No Investigation Assessment. The event was not required a visit to Emergency Room nor Physician Office. Outcome of the event was not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: worsening of dizziness; headache worsened after vaccination; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, first dose on 22Apr2021 and second dose on 11May2021 (Lot Number: EP7533) as a single dose for COVID-19 immunisation. Medical history included accident on an unspecified date, dizziness, and ongoing atrial fibrillation. Concomitant medications included and apixaban (ELIQUIS) taken for atrial fibrillation. The patient experienced worsening of dizziness and headache worsened after vaccination on an unspecified date. The clinical course was reported as follows: The patient stated he is kind of at a loss because he has been dizzy since getting the vaccinations altogether and stated he was involved in an accident before receiving the vaccine and he has always been dizzy but it has gotten worse. He felt like it was a merry-go-round dizziness. His pharmacist changed him from apixaban to a different medication and he is tired of being dizzy. He was already experiencing headache even before taking the vaccine but it got worsened after getting the vaccination. The clinical outcome of worsening of dizziness and headache worsened after vaccination was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dizziness, Dyspnoea, Ear pain
Clinical narrative: Earache and Ear Drainage; Dizziness; Chills; Fever; Problems Breathing; Shaking worse than usual; Headache; Nausea; Chest Pains; Soreness; Spitting up Blood; The initial case was missing the following minimum criteria: unspecified AE. Upon receipt of follow-up information on 21May2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 doses. This is the first of two reports for dose 1. This 58-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 14Apr2021 (Lot Number: EW0164) at single dose for COVID-19 immunization. The patient's medical history included seasonal allergies and ear trouble. The patient's family medical history was none. The patient's concomitant medication was none. The patient no adverse effect following prior vaccinations. The patient had no other vaccine within 4 weeks. The patient experienced events including earache and ear drainage from 17Apr2021 to 20Apr2021; dizziness from 15Apr2021 to Apr2021; chills and fever from 15Apr2021 to Apr2021; soreness from 15Apr2021 to Apr2021; spitting up blood from 15Apr2021 to Apr2021; problems breathing from 15Apr2021 to Apr2021; shaking worse than usual from 15Apr2021 to Apr2021; headache from 15Apr2021 to Apr2021; nausea from 15Apr2021 to Apr2021; chest pains from 15Apr2021 to Apr2021. The patient stated the symptoms from the first dose started on 15Apr2021 and recovered by 18Apr2021 or 19Apr2021. The patient stated he almost called the ER after the first shot because it was new to him and he did not know what he was dealing with. The events did not require a visit to emergency room neither physician office. All the events except earache did not require treatment. The patient stated he got both vaccines at the beginning of allergy season, but he had no reason to believe it was all from his allergies, it was seemingly related to the vaccine. The outcome of events was resolved.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021580978 same drug/ patient, different dose number/ event
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoptysis, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Earache and Ear Drainage; Dizziness; Chills; Fever; Problems Breathing; Shaking worse than usual; Headache; Nausea; Chest Pains; Soreness; Spitting up Blood; The initial case was missing the following minimum criteria: unspecified AE. Upon receipt of follow-up information on 21May2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 doses. This is the first of two reports for dose 1. This 58-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 14Apr2021 (Lot Number: EW0164) at single dose for COVID-19 immunization. The patient's medical history included seasonal allergies and ear trouble. The patient's family medical history was none. The patient's concomitant medication was none. The patient no adverse effect following prior vaccinations. The patient had no other vaccine within 4 weeks. The patient experienced events including earache and ear drainage from 17Apr2021 to 20Apr2021; dizziness from 15Apr2021 to Apr2021; chills and fever from 15Apr2021 to Apr2021; soreness from 15Apr2021 to Apr2021; spitting up blood from 15Apr2021 to Apr2021; problems breathing from 15Apr2021 to Apr2021; shaking worse than usual from 15Apr2021 to Apr2021; headache from 15Apr2021 to Apr2021; nausea from 15Apr2021 to Apr2021; chest pains from 15Apr2021 to Apr2021. The patient stated the symptoms from the first dose started on 15Apr2021 and recovered by 18Apr2021 or 19Apr2021. The patient stated he almost called the ER after the first shot because it was new to him and he did not know what he was dealing with. The events did not require a visit to emergency room neither physician office. All the events except earache did not require treatment. The patient stated he got both vaccines at the beginning of allergy season, but he had no reason to believe it was all from his allergies, it was seemingly related to the vaccine. The outcome of events was resolved.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021580978 same drug/ patient, different dose number/ event
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Earache and Ear Drainage; Dizziness; Chills; Fever; Problems Breathing; Shaking worse than usual; Headache; Nausea; Chest Pains; Soreness; Spitting up Blood; The initial case was missing the following minimum criteria: unspecified AE. Upon receipt of follow-up information on 21May2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 doses. This is the first of two reports for dose 1. This 58-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 14Apr2021 (Lot Number: EW0164) at single dose for COVID-19 immunization. The patient's medical history included seasonal allergies and ear trouble. The patient's family medical history was none. The patient's concomitant medication was none. The patient no adverse effect following prior vaccinations. The patient had no other vaccine within 4 weeks. The patient experienced events including earache and ear drainage from 17Apr2021 to 20Apr2021; dizziness from 15Apr2021 to Apr2021; chills and fever from 15Apr2021 to Apr2021; soreness from 15Apr2021 to Apr2021; spitting up blood from 15Apr2021 to Apr2021; problems breathing from 15Apr2021 to Apr2021; shaking worse than usual from 15Apr2021 to Apr2021; headache from 15Apr2021 to Apr2021; nausea from 15Apr2021 to Apr2021; chest pains from 15Apr2021 to Apr2021. The patient stated the symptoms from the first dose started on 15Apr2021 and recovered by 18Apr2021 or 19Apr2021. The patient stated he almost called the ER after the first shot because it was new to him and he did not know what he was dealing with. The events did not require a visit to emergency room neither physician office. All the events except earache did not require treatment. The patient stated he got both vaccines at the beginning of allergy season, but he had no reason to believe it was all from his allergies, it was seemingly related to the vaccine. The outcome of events was resolved.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021580978 same drug/ patient, different dose number/ event
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: "covid arm" rash - itchy , hot to the touch; "covid arm" rash - itchy , hot to the touch; "covid arm" rash - itchy , hot to the touch; Extreme fatigue; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 41-year, on 19May2021 19:45 at single dose in right arm for COVID-19 immunisation. Medical history included Seasonal allergies and COVID-19. The patient was not Pregnant at time of Vaccination. The patient had not been tested for COVID-19 Since the vaccination. Concomitant medication was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20May2021, the patient experienced "covid arm" rash - itchy , hot to the touch. Extreme fatigue. Treatment received for the events included benadryl and cortisone creme. The outcome of all events was not resolved.   Information on the lot/batch number has been requested.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, SARS-CoV-2 test
Clinical narrative: shortness of breath; This is a spontaneous report from a contactable consumer (patient).  as single dose for covid-19 immunization.  Medical history included none. Concomitant medications included vitamins nos (MULTIVITAMIN); colecalciferol (VITAMIN D3); whey protein (WHEY PROTEIN ISOLATE) received within 2 weeks of vaccination. 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. In 2021, the patient suffered from shortness of breath 20 days after first dose and 3 days prior to second dose. Tested for COVID-19 was negative. The patient underwent lab tests and procedures which included COVID-19 PCR Nasal Swab was negative on 17Apr2021 and on 21Apr2021. Treatment received for the event included indomethacin and colchicine. The outcome of the event was not recovered.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Inappropriate schedule of product administration, Overdose, Panic attack
Clinical narrative: Severe anxiety and panic attacks; Severe anxiety and panic attacks; covid vaccine details administration date 13Apr2021 / other vaccine same date vaccine date 13Apr2021; covid vaccine details administration date 13Apr2021 / other vaccine same date vaccine date 13Apr2021; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EW0162, at the age of 38-year, on 13Apr2021 11:00, and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ER8732, at the age of 38-year, on 13Apr2021, both at single dose in left arm for COVID-19 immunisation. Medical history was not reported. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. Concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received Penicillin. On 06May2021 13:00, the patient experienced Severe anxiety and panic attacks that has lasted over 2 weeks. Both events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the events included Therapy and prescription. The outcome of Severe anxiety and panic attacks was not resolved.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Hypoaesthesia, Insomnia, Nausea
Clinical narrative: lost feeling in legs; nausea; Dehydration; insomnia; This is a spontaneous report received from COVAES from a contactable consumer (patient).  A 41-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 14Apr2021 14:30 at the age of 41-years-old (Batch/Lot Number: ER2613) as 2ND DOSE, SINGLE for covid-19 immunisation.  The patient's medical history was not reported. The patient was not pregnant. 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. There were no any other medications the patient received within 2 weeks of vaccination. The patient experienced lost feeling in legs 10 days after 2nd vaccine (as reported), extreme nausea, dehydration and extreme insomnia on 15May2021 04:00 with outcome of recovering. Since the vaccination, the patient had not been tested for COVID-19.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Dyskinesia, Fatigue, Hyperpyrexia, Lymphadenopathy
Clinical narrative: tired; pain in my left arm pit; I felt around its very swollen; It feels like swollen lymp node but its large; having issues lifting my arm due to the pain; spiked a temp of 103.5; didnt feel well in the evening; This is a spontaneous report from a contactable Nurse (patient). 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 20May2021 12:30 (Batch/Lot Number: Ew0186) as 2ND DOSE, SINGLE for covid-19 immunisation. Patient received the first dose on 29Apr2021. Medical history included asthma and migraine. Concomitant medication included butalbital, caffeine, paracetamol (FIORICET) taken for an unspecified indication, start and stop date were not reported.  After the first dose, I had a terrible migraine. I Took medication it didn't work. After the second dose, from 20May2021 21:00, I didn't feel well in the evening, was tired the following day. During the evening I spiked a temp of 103.5, took Tylenol. I feel a little better but still not well. I took a shower and had pain in my left arm pit. I felt around it's very swollen. It feels like swollen lymp node but it's large. I'm having issues lifting my arm due to the pain. Patient also felt tired on 20May2021. Outcome of events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Peripheral swelling, Pyrexia
Clinical narrative: tired; pain in my left arm pit; I felt around its very swollen; It feels like swollen lymp node but its large; having issues lifting my arm due to the pain; spiked a temp of 103.5; didnt feel well in the evening; This is a spontaneous report from a contactable Nurse (patient). 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 20May2021 12:30 (Batch/Lot Number: Ew0186) as 2ND DOSE, SINGLE for covid-19 immunisation. Patient received the first dose on 29Apr2021. Medical history included asthma and migraine. Concomitant medication included butalbital, caffeine, paracetamol (FIORICET) taken for an unspecified indication, start and stop date were not reported.  After the first dose, I had a terrible migraine. I Took medication it didn't work. After the second dose, from 20May2021 21:00, I didn't feel well in the evening, was tired the following day. During the evening I spiked a temp of 103.5, took Tylenol. I feel a little better but still not well. I took a shower and had pain in my left arm pit. I felt around it's very swollen. It feels like swollen lymp node but it's large. I'm having issues lifting my arm due to the pain. Patient also felt tired on 20May2021. Outcome of events was not recovered.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Dyspnoea, Fatigue, Influenza
Clinical narrative: some with severe SOB ongoing; loss of taste and smell; loss of taste and smell; had some symptoms on covid of flu dose #1; fatigue; This is a spontaneous report from a contactable consumer. This consumer reported for two of five patients. A patient of an unspecified age and gender received the first dose of BNT162B2 (BNT162B2, Formulation: Solution for injection), via intramuscular route of administration from 05Feb2021 10:20 (Batch/Lot Number: EL9261) as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated that "All 5 of us there ongoing fatigue, some with severe SoB, ongoing loss of taste & smell. All had some symptoms of covid of flu dose #1. One sibling is resistant to vaccine based upon our reactions to vaccine". The clinical outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Depressed mood, Drug interaction, SARS-CoV-2 antibody test
Clinical narrative: she continued to take her methotrexate and xeljanz medications; I am very upset; This is a spontaneous report from a contactable retired nurse/other hcp (patient herself). A 71-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6203; Expiration Date: 30Jun2021) via an unspecified route of administration, administered in left arm/left upper arm on 24Feb2021 (at the age of 71-years-old) as single dose for COVID-19 immunization. She previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318, (Expiration date: It says First 31May2021, second it says 30Jun2021) on 03Feb2021 as single dose for COVID-19 immunization. The patient received TOFACITINIB CITRATE (Xeljanz, Batch/Lot Number: Unknown, Expiration Date: Unknown) and METHOTREXATE SODIUM (Methotrexate Sodium, Batch/Lot Number: Unknown, Expiration Date: Unknown) via an unspecified route of administration on an unspecified date for Rheumatoid arthritis. Medical history included rheumatoid arthritis and little higher on hearing from an unknown date and unknown if ongoing. Concomitant medication(s) included blood pressure medicine, Arthritis medicine, cholesterol medicine; however, unspecified and a medicine-Tegretol 200mg.  Retired Nurse stated that she was little higher on hearing. She was a Rheumatoid arthritis patient. She had been on Xeljanz and Methotrexate. She took the Pfizer shot in early 03Feb and then repeated again in 24Feb. She was never told to stop her medication and so she got antibody test on Friday and it said that she was negative for antibodies.  And she was just wondering could she get a third shot, and asking suggestion. She stated that "I am very upset about all this. My rheumatologist never told me to stop my medication, never get a hold on me anyway". She reported that she continued to take her methotrexate and xeljanz medications the entire time while receiving her vaccinations. She underwent a surgery recently. She was very upset about all this. She wants to know if her medications caused her not to have an immune response and how her antibody test can be negative. The patient underwent lab tests and procedures which included blood test: unknown and sars-cov-2 antibody test: negative with levels less than 100. The outcome of the event was unknown. The reporter stated about causality that retired nurse stated, she thought it was due to the medications (Xeljanz and Methotrexate).  Information on Lot/Batch number was available. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Diarrhoea, Pain in extremity, Product preparation error
Clinical narrative: Accidently administered an undiluted dose of the Pfizer BioNTech Covid 19 vaccine; He has experienced is a sore arm; He also had some diarrhea; Accidently administered an undiluted dose of the Pfizer BioNTech Covid 19 vaccine; This is a spontaneous report from a contactable pharmacist. A 17-year-old male patient (age at vaccination 17-year) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 20May2021 as unknown, single dose for COVID-19 immunization. Medical history included autism and bowel issues from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date the patient experienced he has experienced is a sore arm and he also had some diarrhea. Pharmacist accidently administered an undiluted dose of the Pfizer BioNTech Covid 19 vaccine on 20May2021. Mother reports that all that he has experienced is a sore arm. He also had some diarrhea a few days later but he has a history of bowel issues. The clinical outcome of the events was unknown.   Information on the lot/batch number has been requested.  Amendment: This follow-up report is being submitted to amend the previously reported information which includes: Deleted the event "Vaccination site pain" since there was no indication the pain in injection site and removed the classification "At Risk".
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Cheilitis, Fatigue, Feeding disorder
Clinical narrative: Small rash developed near his lip; excessive tiredness; he wasnt able to eat.; This is a spontaneous report from a non-contactable consumer (parent, caregiver).  A 13-year-old male patient (reporter's son) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number unknown) via an unspecified route of administration in May2021 about one week ago at 13 years old at 1st dose, single for COVID-19 immunization. The patient was a special needs child who was non verbal autistic. Concomitant medications were not reported. The patient experienced small rash developed near his lip last Thursday (20May2021) and by the weekend (May2021) he was not able to eat. His mom took him to see hcp and antibiotic cefalexin (CEPHALEXIN) was prescribed which was helping. The patient was having excessive tiredness on May2021 but was unsure if related to covid vaccine. Was it common to have excessive tiredness one week after the covid vaccine? Therapeutic measures were taken as a result of small rash developed near his lip, and he was not able to eat. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.