chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I came up positive to Covid-19; positive COVID-19 test with symptoms; arm sore; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer reported for herself.  A female patient of unspecified age received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), at single dose on 23Feb2021 for COVID-19 immunization from lot EN6203, the patient was not sure if it is G or 6. Relevant medical history and concomitant medications were not reported. After the vaccination the patient experienced arm sore only. On 28Feb2021 she was with her girlfriend and had dinner together, were social distancing but no masks and her girlfriend on 04Mar2021 was tested positive for the virus. The patient had runny nose, fever, nasal congestion and coughing. She was scheduled to get her second dose on 16Mar2021 but she tested positive on 11Mar2021, with a rapid COVID-19 antigen test.  She was advised that she can't get the 2nd dose until after 20Mar2021. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Pain in extremity, SARS-CoV-2 test
Clinical narrative: she also tested positive for COVID (rapid test); she also tested positive for COVID (rapid test); This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age (reported as 61 without units) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on 23Feb2021 as a single dose for COVID-19 immunization.  Medical history and concomitant medications were not reported.  On an unknown date the patient tested positive for COVID (rapid test). The patient was scheduled to have the 2nd dose on 16Mar2021 the patient's husband got COVID  and the patient was experiencing cough and congestion and thought it was just an allergy, however now she also tested positive for COVID (rapid test) and will have confirmatory test later. The patient is inquiring if she can still have the 2nd shot of the vaccine. The clinical outcome of the event was unknown.    The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she also tested positive for COVID (rapid test); she also tested positive for COVID (rapid test); This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age (reported as 61 without units) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on 23Feb2021 as a single dose for COVID-19 immunization.  Medical history and concomitant medications were not reported.  On an unknown date the patient tested positive for COVID (rapid test). The patient was scheduled to have the 2nd dose on 16Mar2021 the patient's husband got COVID  and the patient was experiencing cough and congestion and thought it was just an allergy, however now she also tested positive for COVID (rapid test) and will have confirmatory test later. The patient is inquiring if she can still have the 2nd shot of the vaccine. The clinical outcome of the event was unknown.    The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Blood pressure measurement, Rash
Clinical narrative: Anaphylactic reaction: full body rash; Anaphylactic reaction: full body rash; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at 69-year-old on 22Feb2021 (lot number: EL9267, expiration date unknown), at single dose for COVID-19 immunization. Medical history included cardiac disease, triple bypass operation, diabetes, thyroid, high blood pressure, known allergies: penicillin. The patient was not diagnosed with COVID prior vaccination. The patient's concomitant medications were not reported. The patient did not receive other vaccine in four weeks. On 01Mar2021 the patient experienced anaphylactic reaction: full body rash. The event resulted in doctor or other healthcare professional office/clinic visit. The COVID was not tested post vaccination. The patient received treatment for the events, included unspecified medications. The outcome of the events was not recovered.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Lip swelling, Pharyngeal swelling, Throat tightness
Clinical narrative: anaphylaxis; throat tightness; shortness of breath; lip swelling; throat swelling; This is a spontaneous report from a contactable nurse. A 27-year-old female patient received the first dose of bnt162b2 (lot number EN6199) via intramuscular on 04Mar2021 at 13:45 PM at single dose in left arm for COVID-19 immunisation. The patient had no COVID prior vaccination. The patient's medical history included ADHD, obesity, anxiety, history anaphylaxis to peanuts and allergies: peanuts. The patient's concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERRAL), diphenhydramine hydrochloride (BENADRYL). "5 min after injection", the patient developed throat tightness, shortness of breath, lip and throat swelling consistent with anaphylaxis. Events onset date reported as 04Mar2021 at 13:45 PM. Events resulted in emergency room/department or urgent care. The patient received epinephrine as treatment. The outcome of events was unknown. It is unknown if COVID tested post vaccination.; Sender's Comments: Based on temporal association  and known drug profile the reported  anaphylaxis with throat tightness, shortness of breath, lip and throat swelling are assessed as  due to  bnt162b2.  Case will be reassessed if additional information is  received.
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: nose bleeds; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (Age 68; unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Mar2021 at a single dose for covid-19 immunisation. Medical history included patient has a heart problem and he is on a blood thinner because he has atrial fibrillation, nose bleeds, dizziness and tiredness because of his medical problems. The patient's concomitant medications were not reported. On 03Mar2021, patient received the covid 19 vaccination.  Patient have gotten nose bleeds periodically since the vaccine but he did get nose bleeds anyway because he was on blood thinners. He was just curious if this is a side effect of the vaccine or if it's just his normal nose bleed. The patient feel fine, and had some of the symptoms anyway without the vaccine that are listed in this packet like dizziness and tiredness because of his medical problems. The nurse asked the patient if he was on blood thinner which he was, he had been on blood thinner through 3, 4-5 years, he has atrial-fib (History details) and that night (03Mar2021), he had a nose bleed and then the next day, he had another nose bleed and then on 05Mar2021, he had a couple but they were very small. He was going through the pamphlets they gave him to read about it and everything and none of the side effects mentions, nose bleed or anything like that. So, patient was only calling to see if this one of the side effects because he was on a blood thinner. Outcome of the event was unknown.  Information on the batch/lot number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: I have been feeling a little dizzy and very tired.; I have been feeling a little dizzy and very tired.; This is a spontaneous report from a contactable consumer.   A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation. Medical history included ongoing ovarian cancer. There were no concomitant medications.  "For the last two days I have been feeling a little dizzy and very tired. I am dealing with active ovarian cancer at this time and am concerned about my ability to tolerate this vaccine. I am scheduled for chemo therapy treatment a week before my second shot. I am wondering if I should get the second shot. Could the second shot be delayed for a week?" The outcome of the events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hypersensitivity, Rhinorrhoea
Clinical narrative: HAVING A LITTLE BIT OF CHILLS; RUNNY NOSE; ALLERGIES; This is a spontaneous report from a non-contactable consumer (patient himself) via a Pfizer-sponsored program. A 70-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization and started to receive tofacitinib citrate (XELJANZ XR, 11 mg prolonged-release tablet), via an unspecified route of administration from an unspecified date in Nov2020 and ongoing, at unspecified dosage and frequency for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient reported that he got the COVID-19 vaccine and on an unspecified date he was having a little bit of chills. The patient also reported having a runny nose and had allergies on an unspecified date. The action taken in response to the events for tofacitinib citrate was unknown. The outcome of the events was unknown.  No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Illness, Vomiting
Clinical narrative: became very ill; had diarrhea; throwing up; This is a spontaneous report received from a contactable consumer (patient) via a  sponsored program. This female patient of unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 26Feb2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 01Mar2021 the patient became very ill, had diarrhea and was throwing up. She inquired if that could be from the vaccine. The clinical outcomes of became very ill, had diarrhea, and throwing up were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain; This is a spontaneous report received from a contactable consumer (patient). This 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on an unspecified date via an unspecified route of administration (at the age of 50 years old; Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced injection site pain on an unspecified date. The clinical outcome of injection site pain was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Knees hurt; This is a spontaneous report from a contactable consumer (patient) via a  Sponsored Program. This female patient of unspecified age received the first dose of BNT162B2 (UNSPECIFIED TRADE NAME; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported that she took numerous medications; she received the first dose of COVID vaccine last week (as of 02Mar2021) and stopped taking "1/2" of her medications and was wondering if she could start them again. She was also wondering if she needed to stop taking medications during the second dose as well. She further reported that she needed to take acetaminophen (TYLENOL) for her knees after taking the first dose of the vaccine as her knees hurt. The clinical outcome of knees hurt was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID infection; COVID infection; COVID infection; This is a spontaneous report from a contactable consumer. A 95-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 28Jan2021 (Lot Number: EL0140) as single dose for COVID-19 immunization. Medical history included Alzheimer's dementia from an unknown date. Concomitant medication(s) included memantine hydrochloride (NAMENDA); donepezil hydrochloride (ARICEPT); buspirone; sertraline hydrochloride (ZOLOFT); and metoprolol taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (lot number: EL1284), first dose on 07Jan2021 at left arm, for COVID-19 immunization. The patient experienced COVID infection on 07Mar2021 16:00, along with several other residents in the facility. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization. The patient underwent lab tests and procedures which included COVID infection test: positive on 01Mar2021 (pending clarification). The outcome of the event was not recovered.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Weight
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer (patient).  A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration, on 02Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 02Mar2021,  the patient experienced sore arm. The patient's weight was 130 on an unspecified date. The event took place after the use of the product. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: drug Ineffective as after Covid 19 vaccine, the patient was diagnosed with Covid; drug Ineffective as after Covid 19 vaccine, the patient was diagnosed with Covid; This is a spontaneous report from a contactable consumer.   A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1, via an unspecified route of administration on 16Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The reporter stated that she and her husband had the first vaccine on 16Feb2021 and set for Tuesday, 09Mar2021 for the second one. The reporter's husband has been diagnosed with Covid yesterday (07Mar2021) The reporter stated her husband has flu like symptoms which includes cough, sneezing, stuffy and no smell. The reporter reports for drug Ineffective as after Covid 19 vaccine, the patient was diagnosed with Covid. The reporter is asking if the patient should take the second dose next week. The outcome of the events was unknown.  Information about lot/batch no. has been requested
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Exposure to SARS-CoV-2
Clinical narrative: drug Ineffective as after Covid 19 vaccine, the patient was diagnosed with Covid; drug Ineffective as after Covid 19 vaccine, the patient was diagnosed with Covid; This is a spontaneous report from a contactable consumer.   A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1, via an unspecified route of administration on 16Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The reporter stated that she and her husband had the first vaccine on 16Feb2021 and set for Tuesday, 09Mar2021 for the second one. The reporter's husband has been diagnosed with Covid yesterday (07Mar2021) The reporter stated her husband has flu like symptoms which includes cough, sneezing, stuffy and no smell. The reporter reports for drug Ineffective as after Covid 19 vaccine, the patient was diagnosed with Covid. The reporter is asking if the patient should take the second dose next week. The outcome of the events was unknown.  Information about lot/batch no. has been requested
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: soreness around the site of the injection; shoulder pain; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported), via an unspecified route of administration on 01Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received annual flu vaccine and experienced soreness. It was reported that starting 01Mar2021 (reported as yesterday night), patient began to experience shoulder pain/soreness around the site of the injection; the pain has continued up to now though has been localized to the upper shoulder. Patient was aware that pain and swelling of the arm are common side effects of the vaccine, but as this is more soreness than patient had experienced with other vaccines (eg, annual flu vaccine), patient wanted to report out of an abundance of caution. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Rash maculo-papular
Clinical narrative: angioedema/swollen lips, fingers and toes and slight swelling of tongue; diffuse blanching maculopapular eruption/itchy raised rash /Rash was wide spread and there was a concentration on injection site; This is a spontaneous report from a contactable consumer (patient herself). A non-pregnant 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6202), via an unspecified route of administration, administered in arm left at the age of 68 years old on 25Feb2021 18:00 at single dose for covid-19 immunization.  Medical history included high blood pressure, hashimotos thyroditis, eczema, osteopenia, hepatitis b, and allergies to penicillins, erythromycin nitrofuran analogues, oxycodone. Concomitant medications included metoprolol and hydrochlorothiazide. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient began to develop itchy raised rash on 05Mar2021, 8 days after 1st injection. Rash was wide spread and there was a concentration on injection site. Took Advil and Claritin and used cold packs. On morning of 08Mar2021 patient awoke to swollen lips, fingers and toes and slight swelling of tongue. Went to urgent care. Diagnosed with angioedema and diffuse blanching maculopapular eruption. Placed on steroid pack and cetirizine. Because of time lapse between injection and rash, the patient sought counseling on whether or not to proceed with second shot. Treatment Steroids and antihistamine were received for events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering. Event result in emergency room/department or urgent care. Events were reported as non-serious, no seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness; 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; lot number and expiration date not reported), via an unspecified route of administration on an unspecified date (at an unspecified age) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced arm soreness. It was reported that the event took place after use of the product. Outcome of the event was unknown.           No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: Has anxiety; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, on Feb2021 (reported as about 3 weeks ago) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On unspecified date in 2021, it was reported that the patient had anxiety about getting the second dose after getting the first dose about 3 weeks ago. The patient wanted to know if she can take lorazepam (ATIVAN). The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, SARS-CoV-2 test
Clinical narrative: 104 fever for two days; This is a spontaneous report from a contactable consumer (patient). A 74-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration, at the age of 74 years old and administered in left arm on 05Mar2021 14:00 at single dose for covid-19 immunization. Medical history included osteoporosis, penicillin allergy and COVID-19. In addition, the patient had COVID test via Nasal Swab with result Negative on Jan2021. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has been tested for COVID-19. The patient experienced 104 fever on 06Mar2021 06:00 for two days.  Treatment Tylenol was received. The outcome of the event was recovered with sequelae (reported as Recovered with lasting effects) on 08Mar2021 06:00. This case reported as non-serious.  Information on the lot/batch number has been requested.; Sender's Comments: The reported event hyperpyrexia was confirmed with temperature value below 106.7°F, a value which, from a medical point of view is not consistent with hyperpyrexia. The Company therefore coded this event as pyrexia.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pyrexia
Clinical narrative: fever; body aches in shoulder, elbows, and ankles; This is a spontaneous report from a contactable other health care professional and consumer. A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received COVID vaccine and reported that for 24 hours on an unspecified date, she had a fever, body aches in shoulder, elbows, and ankles and then felt fine. The outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Therapeutic product effect incomplete, Vaccination site pain
Clinical narrative: she thinks she did not get the full effect of the vaccine.; she experienced extreme pain and tenderness after the vaccine; she experienced extreme pain and tenderness after the vaccine; vaccine was administered to the fatty layer of her arm not in the muscle.; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) of an unspecified age received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE)via an unspecified route of administration on 03Feb2021, second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 24Feb2021, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported that the vaccine was administered to the fatty layer of her arm not in the muscle. She said that she experienced extreme pain and tenderness after the vaccine. Her daughter who is a nurse practitioner said that the vaccine site is too high. She also explained how they administer the vaccine. She also wants to ask if there is some test for the efficacy of the vaccine because she thinks she did not get the full effect of the vaccine. She wanted to be revaccinated. She got her first dose on 03Feb2021 and her second dose was done on 24Feb2021.The outcome of the events was unknown.  Information about the Lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: contracted covid; contracted covid; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient contracted COVID on 05Mar2021. The patient got the Pfizer vaccine in Dec/Jan (not specified) because he worked in health care. He just contracted COVID last Friday. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 05Mar2021. The outcome of the events was unknown. The events were considered as serious (medically significant).  Information on the lot/batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity, Rash pruritic, Urticaria
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient). A 75-year-old female 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 05Mar2021 13:00 at a single dose for COVID-19 immunisation. Medical history included blood pressure (abnormal), depression, both hips replaced and allergic to sulfur. Concomitant medications included ibuprofen, blood pressure and depression pill. The patient previously received first dose of BNT162B2 on an unknown date for COVID-19 immunization and experienced mild arm soreness. The patient received her second Pfizer COVID vaccine on 05Mar2021 at 1 PM. The following morning on 06Mar2021 she woke up at 6:30 AM with an itchy rash on her buttocks and hips. She took diphenhydramine (BENADRYL) and it subsided but came back later and started spreading to her thighs, chest, arms, stomach, and back. She was taking Benadryl to treat it and wanted to know what else to do. She was covered with a rash and itching and going crazy, they were welts like little welts kind of hives; It is itching all over; It didn't go away, it was itching all through the day. It just kept getting more and more in covers like her knees up to her butt, her butt was all covered, her lower back was covered and her arms were getting it now that just keep travelling. It is all around the area, it's travelling everywhere my legs, my arms and my chest. The patient had the 2nd dose yesterday (05Mar2021). She experienced little soreness on her arm and rashes starting to spread all over to her body after the vaccine. Outcome of the events going crazy and little soreness on her arm was unknown while not recovered for the other events.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Felt pain; This is a spontaneous report received from non-contactable consumer, the patient, through a Pfizer colleague. A patient of unspecified age/gender received a single dose (unspecified dose number) of BNT162b2 (solution for injection; batch/lot and expiry information not provided) via unspecified route on an unspecified date for COVID-19 immunisation. There was no history, concomitant medications or past drug history reported. The patient reported they felt pain after the vaccination. Treatment details, if any, were not reported. The outcome of the event felt pain was unknown.   No follow-up attempts possible as reporter declined consent to further contact; No further information expected and information about batch /lot number(s) cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Delusion, Patient elopement
Clinical narrative: Delusions; wandering (attempting to leave the home with no purpose); This is a spontaneous report from a contactable consumer.  A 70-year-old female patient (not pregnant) received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3249), via an unspecified route of administration in left arm on 16Jan2021 at 11:30 AM (at the age of 70-years-old) at single dose for covid-19 immunisation.  The patient had a history of Early-onset Alzheimer's, high blood pressure and allergy to fire ants (Allergy to insect sting resulted in anaphylaxis). Relevant concomitant medications included memantine hydrochloride (NAMENDA), amlodipine, clopidogrel and atorvastatin. On 22Jan2021 the patient experienced delusions. Believing that people are trying to get into home. Belief that people on TV are in her home and speaking with her. Frequency and severity have increased since second dose. Also wandering (attempting to leave the home with no purpose), patient has dementia.  Clinical outcome of the events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: bled (where he received the injection)/Blood was dripping from injection site; This is a spontaneous report from a contactable consumer (patient's wife) via a Pfizer-sponsored program. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 04Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of Pfizer-BioNTech COVID-19 Vaccine on 12Feb2021 for COVID-19 immunisation. Reporter stated she was calling on behalf of her husband who called her after the vaccination today and told her "he bled (where he received the injection), vaccinators seemed surprised". Then asked: "if you bleed then it is not intramuscular, right?". He wanted to know if his injection was IM or not IM; and what would happen to the efficacy if it was not administered intramuscularly. She was not sure vaccine went into muscle. Blood was dripping from injection site. The patient believes it wasn't inter muscular and wants to know if it's still effective and will he get the desired response. The outcome of the event was unknown.  Information about the Lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a non-contactable consumer, the patient. This consumer reported similar events for two patients. This is the first of two reports. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23Feb2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 08Mar2021, the patient tested positive for COVID-19. The patient's second dose was scheduled for 16Mar2021, and she had requested to reschedule the appointment. The clinical outcome of "tested positive for COVID-19" was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021269588 same reporter/product/events, different patient.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Somnolence, Vaccination site pain
Clinical narrative: Tired; Sleepiness and Groggy; The injection arm is sore like a 4-5 out on of 10 as far as pain; Sleepiness and Groggy; This is a spontaneous report received from a contactable consumer, the patient.  A patient of unspecified age and gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 03Mar2021 as single dose for COVID-19 immunisation.  The patient medical history was not reported.  The patient reported no concomitant drugs ("Extremely healthy, I take no medicine"). The patient reported that on 03Mar2021, the injection arm was sore like a 4-5 out on of 10 as far as pain and she felt a bit tired. She slept 10 hours yesterday (03Mar2021)  and feel a little groggy today (on 04Mar2021). The outcome of the events was unknown.   Follow up attempt possible. Information on the lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: body aches; fatigue; headache; This is a spontaneous report from a contactable nurse, the patient. This 36-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3240) via intramuscular route in the left deltoid on 11Jan2021 at 14:00 (at the age of 36-years-old) as a single dose for COVID-19 immunization. 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: EK5730, Expiry Date: 31Mar2021) via unspecified route in the left arm on 21Dec2020 at 14:00 (at the age of 36-years-old) and experienced extreme/severe fatigue, headache, sore throat, lightheaded, felt run down, felt out of sorts/ feeling unwell, bizarre feeling/felt really bad, soreness around injection site/sore arm, and wondered if being on Stelera made the symptoms from the COVID vaccine worse. On 12Jan2021 at 02:00, the patient experienced body aches, fatigue and headaches, all worse with second vaccine. The symptoms started approximately 12 hours post vaccine. The patient reported that the second dose reaction was much worse but shorter in duration. The body aches, fatigue and headaches did not require a visit to the emergency room and the patient was not admitted to the hospital. The body aches, fatigue and headaches did require a phone visit to the physician's office. There was no treatment required for body aches, fatigue and headaches. The clinical outcome of body aches, fatigue and headaches was recovered on an unspecified date
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Muscle spasms, Urticaria, Vaccination site pain
Clinical narrative: Within a day or two, the inside of my mouth, my tongue, and my lips have become partially numb.; centered on the injection site - some pain,; hives; muscle spasms; This is a spontaneous report received from a Pfizer A contactable consumer (female Patient) reported for herself that a female patient of an unspecified age received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation .  The patient medical history and concomitant medications were not reported.  The patient received her 2nd Covid 19 vaccine in mid-February (Feb2021). Within a day or two, the inside of her mouth, her tongue, and her lips had become partially numb. The condition continued. It was reported "Has this be reported as a side effect. Does it resolve." The other effects were all centered on the injection site - some pain, but also hives and muscle spasms. The outcome of the events was unknown.  Information regarding lot/batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Flatulence
Clinical narrative: severe gas; diarrhea; This is a spontaneous report from a contactable consumer (patient).    A 76-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EL9264), via an unspecified route of administration, in Arm Left on 09Feb2021 as single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced severe gas and diarrhea on 13Feb2021 with outcome of not recovered. The patient reported that severe gas started on 13Feb2021. It would last about an hour and then she would go to the bathroom and have diarrhea. Severe gas and diarrhea have been intermittent, and they continued throughout. The patient received the second dose on 02Mar2021 (Lot EN6205) in left arm and about 4 days later she had the same gas effect. The patient mentioned her stomach swelled and had loud gas which was shocking to her. She continues to state that she was basically a vegetarian that ate well and did not normally have diarrhea issues.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021269680 same patient, different dose/AE
Sex: F
Vaccine: COVID19
Symptoms: Rash morbilliform
Clinical narrative: rash on her legs which is measles like; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced rash on her legs which is measles like on an unspecified date with outcome of unknown.  Information on the lot/batch number has been requested.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tiredness; This is a spontaneous report from a contactable consumer (patient himself). A 36-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6199), via an unspecified route of administration in right arm, on 09Mar2021 11:30, at a single dose, for covid-19 immunization. Medical history included diagnosed with recurring MDD (major depressive disorder), general anxiety disorder, and high cholesterol. Concomitant medications included atorvastatin taken for an unspecified indication, start and stop date were not reported; duloxetine taken for an unspecified indication, start and stop date were not reported; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for MDD (major depressive disorder) from an unspecified start date and ongoing; and clonazepam (KLONOPIN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient informed that he returned home, ate lunch and slept for approx. 3-hours. He mentioned that he was diagnosed w/ recurring MDD and without his Adderall he will sleep most of the day. He stated he didn't take Adderall till after waking up. He stated that it was hard to tell if tiredness on 09Mar2021 13:30 was due to vaccine or MDD. No treatment was received for tiredness. The outcome of the event tiredness was unknown. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Received both COVID vaccine doses over a month ago and had to go to urgent care due to issues with breathing which resulted in positive results carrying COVID; resulted in positive results carrying Covid while at clinic/issues with breathing; This is a spontaneous report from a contactable consumer, the patient. A patient of unspecified age and gender received the second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3246),   via an unspecified route of administration on 2021 ' over a month ago'  as a single dose, first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3246),   via an unspecified route of administration on 2021 ' over a month ago' as a single dose. The patient medical history and concomitant medications were not reported. Event took place after use of product. On an unspecified date 2021,  The patient received both covid vaccine doses over a month ago and had to go to urgent care due to issues with breathing which 'resulted in positive results carrying Covid while at clinic'. The patient underwent lab tests and procedures which included sars-cov-2 test  results Positive in2021 . The clinical outcome of the events Covid-19 and Drug Ineffective  was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue, Feeling abnormal, Hypersomnia
Clinical narrative: couldn't concentrate at all or read the newspaper; extreme fatigue and exhaustion; slept 19 hours out of a 24 hour period; brain fog; This is a spontaneous report received from a contactable physician reporting for herself. A 73 years old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283) at single dose via an unknown route in right arm on 08Feb2021 14:00 for Covid-19 immunization. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284) on 18Jan2021 12:30 PM in right arm for Covid-19 immunization. Medical history included chronic mild-medium renal failure s/p left nephrectomy and adrenalectomy in 2017 due to left renal cancer, followed by severe renal failure one month p/o. Breast cancer p/o left mastectomy and reconstruction in 2005, hysterectomy in 2007, and mild hypertension which was treated. Patient had no known allergies to medications, food, or other products. Other medications the patient received within 2 weeks of vaccination included citalopram, bupropion, lisinopril, zolpidem, etc. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Feb2021 11:00, patient experienced extreme fatigue and exhaustion. Patient slept 19 hours out of a 24 hour period and had significant brain fog, where she couldn't concentrate at all or read the newspaper. No treatment was received for the events. Outcome of the events was resolved.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Pain in left arm; Rash in neck and upper body; heat and itching in area; heat and itching in area; This is a spontaneous report received from a contactable consumer reporting for self. A 43-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 07Mar2021 11:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Patient received the first dose on 14Feb2021. Medical history included asthma, lactose intolerance. Patient had allergies to Bactrim, Sudafed. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), diphenhydramine hydrochloride (BENADRYL), ibuprofen, colecalciferol (VITAMIN D [COLECALCIFEROL]), vitamins. The patient experienced Pain in left arm, Rash in neck and upper body, heat and itching in area on 08Mar2021 16:00. Outcome of events was not recovered.   Information on the lot/batch number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint lock, Pain
Clinical narrative: shooting joint pain in both hands both wrists when moving, lifting small items, finger and wrist joints "lock"; finger and wrist joints "lock" during routine tasks; during routine tasks followed by radiating pain; This is a spontaneous report from a contactable consumer reported for himself. A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, lot number: en6198), dose 2 via an unspecified route of administration, administered in arm left on 26Feb2021 as a single dose for COVID-19 immunisation. The patient previously took first dose of bnt162b2 via an unspecified route of administration, administered in arm right on 05Feb2021 12:15 (lot number: el3246) as a single dose for COVID-19 immunisation. Medical history included known allergy to lithium, meloxicam, nightshade vegetables. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications in two weeks included losartan 100, spironolactone 50, loratadine 5, all taken for an unspecified indication, start and stop date were not reported. On 27Feb2021 08:00, the patient experienced shooting joint pain in both hands both wrists when moving, lifting small items, finger and wrist joints "lock" during routine tasks followed by radiating pain. No treatment received for the adverse event. This is a non-serious report. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The outcome of events was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: had fever/ individual had fever; This is a spontaneous report received from a contactable non-healthcare professional. A 43-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number and expiration date unknown) via an unspecified route of administration on 07Mar2021 at single dose (at 43-year-old) for COVID-19 immunization. The patient wasn't pregnant at the time of vaccination. The patient's medical history was not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine or any other medications within 2 weeks of vaccination (none concomitant therapy). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number and expiration date unknown) at single dose on an unspecified date for COVID-19 immunization. The patient had fever/ individual had fever a day after the administration of the vaccine at 03:45 of 08Mar2021 (Monday) at 101-102 "degree c", reported as non-serious. The treatment [self administered paracetamol (TYLENOL)] was received for the event fever. Prior to/ since the vaccination, the patient wasn't diagnosed with COVID-19. The outcome of the event was resolved in Mar2021.  Information on the lot/batch number has been requested.