chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pollakiuria, Vomiting
Clinical narrative: frequent urination; diarrhea; chills; nausea; vomiting; loss of appetite; intermittent chest pain; This is a spontaneous report from a Pfizer sponsored Program. A contactable Consumer reported A 81-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included sarcoidosis from an unknown date and unknown if ongoing. Took their 1st Pfizer vaccine dose on 23Jan2021 for covid immunisation. The patient's concomitant medications were not reported. on 20Feb2021 Caller states, starting on the 20Feb2021, her husband started having frequent urination, chills, diarrhea, nausea, vomiting, loss of appetite and intermittent chest pain. Outcome of the events was unknown No follow up attempts are possible. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching all over; This is a spontaneous report from a contactable Nurse (patient). An 82-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 18Feb2021 (Batch/Lot Number: EL9267; Expiration Date: May2021) (at the age of 82 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included an unspecified medicine. The patient experienced itching all over (reported as non-serious) on 18Feb2021 with outcome of not recovered. Patient took the COVID shot, the first dose, and she has been itching ever since. Patient thought it was something else at first, but then went off that medicine for three days and the itching was still just as bad as it was when she was on that medicine. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: mild rash on the front of her torso; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on 23Feb2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced mild rash on the front of her torso on an unspecified date. The patient was asking if the side effect has been reported and if developing a rash after the second dose of the Pfizer COVID-19 vaccine would be a contraindication to any future booster shots created for variants strains that are created. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Swollen arm; Nauseated; Headache; all over her joints; even her toes everything she said the pain is excruciating; intense body pain; unbelievable pain in arm/even her toes everything; This is a spontaneous report from a contactable consumer reporting for her mom. An 81-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 at the age of 81-years-old via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included macular degeneration from an unknown date. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS) taken for an unspecified indication, start and stop date were not reported and unspecified pills for macular. The reporter reported that they were calling regarding their mom (patient), she has had her second Pfizer shot yesterday, she felt fine afterwards as they held them there to monitor her, she actually felt fine up until she went to bed last night which was around 10 o'clock, but she woke up in the middle of the night on 20Feb2021 with unbelievable pain not only in her arm but all over her joints. The reporter checked her a little while ago and her arm is very swollen and she says she feels like she is very nauseated she has bad headache, and she said even her toes everything she said the pain is excruciating. They have got a little worse, she is feeling nausea, headache, intense body pain, she said every part of her body hurts and her arm is still very swollen. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swollen arm; Nauseated; Headache; all over her joints; even her toes everything she said the pain is excruciating; intense body pain; unbelievable pain in arm/even her toes everything; This is a spontaneous report from a contactable consumer reporting for her mom. An 81-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 at the age of 81-years-old via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included macular degeneration from an unknown date. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS) taken for an unspecified indication, start and stop date were not reported and unspecified pills for macular. The reporter reported that they were calling regarding their mom (patient), she has had her second Pfizer shot yesterday, she felt fine afterwards as they held them there to monitor her, she actually felt fine up until she went to bed last night which was around 10 o'clock, but she woke up in the middle of the night on 20Feb2021 with unbelievable pain not only in her arm but all over her joints. The reporter checked her a little while ago and her arm is very swollen and she says she feels like she is very nauseated she has bad headache, and she said even her toes everything she said the pain is excruciating. They have got a little worse, she is feeling nausea, headache, intense body pain, she said every part of her body hurts and her arm is still very swollen. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Weight
Clinical narrative: some swollen lymph node; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient experienced some swollen lymph node on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included weight: 170 or 165 (probably 170 or165, something like that). The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure measurement, Chest X-ray, Chest pain, Chills
Clinical narrative: frightened about taking the second dose; worsened gastritis; doubled up on medication; severe chest pain on left side; Chills; left rib cage is killing her and around her kidney; has not been eating; This is a spontaneous report from a contactable consumer. A 73-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6200), via an unspecified route of administration, administrated in left arm on 24Feb2021 01:00 (age at the time of vaccination 73-years-old), as a single dose for COVID-19 immunization. The patient's medical history included breast cancer, she had breast cancer in 2014 or 2015, the nodes were removed, she was on an antibiotic when she had cancer, and surgeries. The patient's concomitant medication included Nexium 20mg daily for a hiatal hernia and acid reflux and it works. On 24Feb2021, the patient experienced worsened gastritis, doubled up on medication, severe chest pain on left side, Chills, left rib cage is killing her and around her kidney, has not been eating; and on an Unspecified date frightened about taking the second dose. On an unspecified date, the patient underwent lab tests and procedures which included Blood pressure measurement: normal; and Chest X-ray: unknown results, she had a Chest X-ray two years. The outcome for all the events was not recovered and frightened about taking the second dose was unknown.  No follow attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Decreased appetite, Pain
Clinical narrative: frightened about taking the second dose; worsened gastritis; doubled up on medication; severe chest pain on left side; Chills; left rib cage is killing her and around her kidney; has not been eating; This is a spontaneous report from a contactable consumer. A 73-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6200), via an unspecified route of administration, administrated in left arm on 24Feb2021 01:00 (age at the time of vaccination 73-years-old), as a single dose for COVID-19 immunization. The patient's medical history included breast cancer, she had breast cancer in 2014 or 2015, the nodes were removed, she was on an antibiotic when she had cancer, and surgeries. The patient's concomitant medication included Nexium 20mg daily for a hiatal hernia and acid reflux and it works. On 24Feb2021, the patient experienced worsened gastritis, doubled up on medication, severe chest pain on left side, Chills, left rib cage is killing her and around her kidney, has not been eating; and on an Unspecified date frightened about taking the second dose. On an unspecified date, the patient underwent lab tests and procedures which included Blood pressure measurement: normal; and Chest X-ray: unknown results, she had a Chest X-ray two years. The outcome for all the events was not recovered and frightened about taking the second dose was unknown.  No follow attempts are possible. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Epistaxis, Hypertension
Clinical narrative: nose bleeds mostly early morning (Am); dizziness; high BP; This is a spontaneous report from a contactable consumer received via COVID-19 Vaccine Adverse Event Reporting System . An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number unknown), via an unspecified route of administration, administered in the right arm on 11Feb2021, at 14:30 (at the age of 81 years old) as dose 1, single for COVID-19 immunisation. Medical history included heart problem, hypertension, hypothyroidism, back pain, and known allergies: fish. She was not pregnant at the time of report. Concomitant medications included tramadol, lorazepam, atorvastatin calcium (LIPITOR), paracetamol (TYLENOL), and levothyroxine sodium (LEVOTHYROXIN). The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 21Feb2021, at 09:00, the patient experienced nose bleeds mostly early morning (Am), dizziness, and high BP. The patient was not diagnosed with COVID-19 prior to vaccination and she has not been tested for COVID-19 since the vaccination. No therapeutic measures were taken as a result of the events. The patient has not recovered from the events at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Ankle brachial index, Contusion, Peripheral swelling
Clinical narrative: swelling and bruising of bilateral feet from toes to proximal ankle area; swelling and bruising of bilateral feet from toes to proximal ankle area; This is a spontaneous report from a contactable physician received via Pfizer study. A non-pregnant 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EN5318 and Expiration date: not reported) via an unspecified route of administration on 02Feb2021 (at the age of 87 years old) as dose 2, single for COVID-19 immunisation. The patient's medical history included HTN, GERD w/ duodenal ulcer, anemia, osteoporosis, and penicillin allergy. Concomitant medications included calcium carbonate;colecalciferol (CALCIUM +D), iron (IRON 325), furosemide (LASIX 20), and MVI for unspecified indications. The patient previously received the 1st dose of BNT162B2 (Lot number: EK9231) on 12Jan2021 (at the age of 86 years old) for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination. On 08Feb2021, the patient experienced swelling and bruising of bilateral feet from toes to proximal ankle area. There was no pain, not hot nor cool to touch, normal pedal pulses and papillary refill, non blanchable, no fever or chills. On an unspecified date in 2021, an ankle brachial index testing was performed to rule out any circulatory impairment; the result was within normal limits. The patient came back to the physician's office on 26Feb2021 and, overall, swelling improved by 75% (left lateral foot/ankle swelling noted and minimal on right foot). Discoloration of blue cyanosis/bruising color was noted minimally on the 3rd digit of the left foot. The right foot still had blue cyanotic/bruised type discoloration at the base of 2nd-3rd-4th digits, extending proximally by 1 inch and approximately 1.5 inches laterally. The outcome of the reported events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Decreased appetite, Dizziness, Fatigue
Clinical narrative: experienced dizziness; ultra high blood pressure reading for one day; headache; no appetite; flushing; weakness in legs; fatigue; malaise; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that: A 81-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number were not reported), via an unspecified route of administration, administered in left arm on 17Feb2021 14:00 (at the age of 81-years-old) as Dose 2, SINGLE for COVID-19 immunization. The patient medical history had not reported. The patient had not any allergies. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient had not received any other vaccine within four weeks prior to vaccination. The patient had not received any other medication within two weeks prior vaccination. The patient had not covid prior vaccination. The patient had not covid tested post vaccination. The patient had received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number were not reported), via an unspecified route of administration, administered in left arm on 27Jan2021 19:00 (at the age of 81-years-old) as Dose 1, SINGLE for COVID-19 immunization. On 21Feb2021 07:00 after the second dose of vaccination, the patient experienced dizziness, ultra-high blood pressure reading for one day, headache, no appetite, flushing, weakness in legs, fatigue and malaise. It was reported no side effects at all initially from either vaccination but after second shot on the 4th day after patient experienced dizziness, ultra-high blood pressure reading for one day, headache, no appetite, flushing but no fever, weakness in legs, fatigue, malaise...lasted 4 days and then reverted back to totally normal. On an unspecified date, the patient underwent lab tests and procedures which included blood pressure measurement: ultra-high blood pressure reading for one day. The patient had not received any treatment for the adverse events. The outcome of events was recovered on an unspecified date.  Information about Lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Malaise, Muscular weakness
Clinical narrative: experienced dizziness; ultra high blood pressure reading for one day; headache; no appetite; flushing; weakness in legs; fatigue; malaise; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that: A 81-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number were not reported), via an unspecified route of administration, administered in left arm on 17Feb2021 14:00 (at the age of 81-years-old) as Dose 2, SINGLE for COVID-19 immunization. The patient medical history had not reported. The patient had not any allergies. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient had not received any other vaccine within four weeks prior to vaccination. The patient had not received any other medication within two weeks prior vaccination. The patient had not covid prior vaccination. The patient had not covid tested post vaccination. The patient had received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number were not reported), via an unspecified route of administration, administered in left arm on 27Jan2021 19:00 (at the age of 81-years-old) as Dose 1, SINGLE for COVID-19 immunization. On 21Feb2021 07:00 after the second dose of vaccination, the patient experienced dizziness, ultra-high blood pressure reading for one day, headache, no appetite, flushing, weakness in legs, fatigue and malaise. It was reported no side effects at all initially from either vaccination but after second shot on the 4th day after patient experienced dizziness, ultra-high blood pressure reading for one day, headache, no appetite, flushing but no fever, weakness in legs, fatigue, malaise...lasted 4 days and then reverted back to totally normal. On an unspecified date, the patient underwent lab tests and procedures which included blood pressure measurement: ultra-high blood pressure reading for one day. The patient had not received any treatment for the adverse events. The outcome of events was recovered on an unspecified date.  Information about Lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: eyes are swollen; This is a spontaneous report from a contactable health care professional (patient's son). A male patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 25Feb2021 (lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient has no trouble breathing but his eyes are swollen on an unknown date in Feb2021. The reporter wanted to know if this could be an allergic reaction and what medication the patient can take for it. The outcome of the event was unknown.   The lot number for BNT161B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: bad flair up of her Hidradenitis Suppurativa; This is a spontaneous report from a contactable physician. A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. Medical history included Hidrandenitis Suppurativa, rheumatoid arthritis, Inflammatory bowel, autoimmune issues, Flares. The patient's concomitant medications were not reported. The patient previously took dose 1 BNT162B2 for COVID-19 immunization. The patient experienced 2 days later bad flair up of her hidradenitis suppurativa (condition aggravated) on an unspecified date. Reporter stated, Strong family history of this Hidrandenititis Suppurativa. She flares once a Month, it was temporary, but pretty bad, on the buttocks. Would it be a Flare up caused by the vaccine? The inflammatory reaction looks like a boil, not necessarily with any bacteria. In the long run chronic condition, you end up with sinus tracks. It hasn't formed a pus pocket. Reporter didn't have much of a reaction from the vaccine, either, and was assuming I am safe. reporter have taken the HEP B vaccine and have never had any antibodies after these shots. Patient received treatment of steroids. The outcome of event was unknown.  No follow up attempts are needed. Information on Lot/batch cannot be requested. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Underdose
Clinical narrative: I blew my nose and a ton of blood came out; when the administrator removed the needle from his arm, he saw a small amount/stream of liquid squirt in the trash can; This is a spontaneous report received from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on 24Feb2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 24Feb2021, when the administrator removed the needle from the patient's arm, he saw a small amount/stream of liquid squirt in the trash can. The reporter queried if this means that he did not receive the full dose amount and if he should repeat the dose. On the night of 24Feb2021, the patient experienced he blew his nose and a ton of blood came out and it didn't stop for a few hours. The outcome of the event blew his nose and a ton of blood came out and it didn't stop for a few hours was not recovered; the event has been ongoing, off and on. The reporter stated he did not know if that was related to the vaccine or not and asked if he should tell his doctor. The reporter was querying regarding the third dose of the Pfizer Covid-19 vaccine. Patient was also querying if he gets the 2nd dose (of the Pfizer Covid-19 vaccine), will the side effects be worse and if so, why are they worse.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Defaecation urgency, Dizziness, Feeling cold, Paraesthesia, Peripheral coldness
Clinical narrative: light headedness; migrating sensation of tingling over the body and the face; coldness of feet, and hands with decreased perfusions; coldness of feet, and hands with decreased perfusions; upper gums, eyelids, and nose became extremely cold; bowel urgency; This is a spontaneous report from a non-contactable other hcp. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number, and Expiration date were not reported), via an unspecified route of administration on 22Feb2021, as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced light headedness, migrating sensation of tingling over the body and the face, coldness of feet, and hands with decreased perfusions, upper gums, eyelids, and nose became extremely cold, and bowel urgency on 22Feb2021. It was reported that patient had an immediate post vaccination onset of intermittent light headedness, and migrating sensation of tingling over the body and the face. After 45 minutes, patient also experienced a sequence of coldness of feet, and hands with decreased perfusions. As those resolved, the core/trunk warmed. Then 75 minutes post injection, patient's upper gums, eyelids, and nose became extremely cold. Patient also had bowel urgency. After 2 hours, HCP said that the patient had a warm flush sensation, clearer mind, better color vision, and was feeling stronger. She said the lightheadedness resolved within 3 hours with Pharmacist's supervision. No urticaria, angioedema, or respiratory distress was observed. No treatment was done as patient could still stand and walk with assistance. HCP said patient just rested at home. However, HCP said there was a representation of light headedness and tingling sensation on 22Feb, and mildly on 24Feb while patient was resting. HCP wanted to know if the 2nd dose would be contraindicated to the patient based on her reaction to the 1st dose. She also wanted to know what are the other side effects that they should watch out for, and if Pfizer would classify these side effects as an allergic reaction. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Poor peripheral circulation
Clinical narrative: light headedness; migrating sensation of tingling over the body and the face; coldness of feet, and hands with decreased perfusions; coldness of feet, and hands with decreased perfusions; upper gums, eyelids, and nose became extremely cold; bowel urgency; This is a spontaneous report from a non-contactable other hcp. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number, and Expiration date were not reported), via an unspecified route of administration on 22Feb2021, as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced light headedness, migrating sensation of tingling over the body and the face, coldness of feet, and hands with decreased perfusions, upper gums, eyelids, and nose became extremely cold, and bowel urgency on 22Feb2021. It was reported that patient had an immediate post vaccination onset of intermittent light headedness, and migrating sensation of tingling over the body and the face. After 45 minutes, patient also experienced a sequence of coldness of feet, and hands with decreased perfusions. As those resolved, the core/trunk warmed. Then 75 minutes post injection, patient's upper gums, eyelids, and nose became extremely cold. Patient also had bowel urgency. After 2 hours, HCP said that the patient had a warm flush sensation, clearer mind, better color vision, and was feeling stronger. She said the lightheadedness resolved within 3 hours with Pharmacist's supervision. No urticaria, angioedema, or respiratory distress was observed. No treatment was done as patient could still stand and walk with assistance. HCP said patient just rested at home. However, HCP said there was a representation of light headedness and tingling sensation on 22Feb, and mildly on 24Feb while patient was resting. HCP wanted to know if the 2nd dose would be contraindicated to the patient based on her reaction to the 1st dose. She also wanted to know what are the other side effects that they should watch out for, and if Pfizer would classify these side effects as an allergic reaction. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Feeling hot, Hypoaesthesia
Clinical narrative: dizziness; hand is getting numb; feeling hot all over; Grabbed at chest "it feels a little tight"; This is a spontaneous report from a contactable pharmacist. A 30-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3302, Expiration date was not reported), dose 2 intramuscular, administered in Arm Left on 14Jan2021 11:30 (age at vaccination 30 years) as dose 2, single for covid-19 immunisation. Medical history included none. There were no concomitant medications. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL1284, Expiration date was not reported), dose 1 intramuscular, administered in Arm Left on 23Dec2020 01:15 as dose 1, single for covid-19 immunisation and experienced 1155 c/o headache. The patient previously took azithromycin, ibuprofen experienced drug hypersensitivity (unknown reaction). Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. on 14Jan2021 11:45 the patient experienced dizziness, hand is getting numb, feeling hot all over, grabbed at chest it feels a little tight. The patient visited emergency room for reported events. The patient experienced Took pt to adult urgent care in wheelchair. Patient was seen in urgent care and referred to ED at 12:50pm. The patient did not receive any treatment for reported for events. On an unspecified date in 2021, the patient had recovered from the events.  No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cough, Oropharyngeal pain
Clinical narrative: sore throat; cough; weakness; This is a spontaneous report from a non-contactable consumer received via the Medical Information Team. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on 12Feb2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sore throat, cough, and weakness on an unspecified date in Feb2021. The consumer wanted to know if the second dose of vaccine administration could be delayed for medical reasons, since the patient was experiencing side effects from the first dose. The patient did not recover from the events on the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Alanine aminotransferase abnormal, Aspartate aminotransferase, Aspartate aminotransferase abnormal, Biopsy liver
Clinical narrative: abnormal liver values / liver enzymes, ALT and AST specifically, are in the 600's range. Her Hepatologist believes that these levels are drug induced; abnormal liver values / liver enzymes, ALT and AST specifically, are in the 600's range. Her Hepatologist believes that these levels are drug induced; This is a spontaneous report from a contactable physician. A 74-year-old female patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE, and second dose via an unspecified route of administration on an unspecified date (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 abnormal liver values / liver enzymes, ALT and AST specifically, are in the 600's range. her hepatologist believes that these levels are drug induced on unspecified date. The physician states that a 74 year old female has received both doses of the Pfizer COVID-19 vaccine and her liver enzymes, ALT and AST specifically, are in the 600's range. Her Hepatologist believes that these levels are drug induced. The patient has had extensive testing and a liver biopsy as well. The patient has not reported this AE yet to Drug Safety at Pfizer. The patient underwent lab tests and procedures which included ALT (alanine aminotransferase) and AST (aspartate aminotransferase): are in the 600's range on an unspecified date and Liver Biopsy (biopsy liver): unknown results on an unspecified date and extensive testing (investigation): unknown results on an unspecified date. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained; Sender's Comments: based on the available information the causal relation ship between the suspect vaccine BNT162B2 and thnte adverse event ALT (alanine aminotransferase) and AST (aspartate aminotransferase) increased cannot be totally ruled out  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Investigation
Clinical narrative: abnormal liver values / liver enzymes, ALT and AST specifically, are in the 600's range. Her Hepatologist believes that these levels are drug induced; abnormal liver values / liver enzymes, ALT and AST specifically, are in the 600's range. Her Hepatologist believes that these levels are drug induced; This is a spontaneous report from a contactable physician. A 74-year-old female patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE, and second dose via an unspecified route of administration on an unspecified date (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 abnormal liver values / liver enzymes, ALT and AST specifically, are in the 600's range. her hepatologist believes that these levels are drug induced on unspecified date. The physician states that a 74 year old female has received both doses of the Pfizer COVID-19 vaccine and her liver enzymes, ALT and AST specifically, are in the 600's range. Her Hepatologist believes that these levels are drug induced. The patient has had extensive testing and a liver biopsy as well. The patient has not reported this AE yet to Drug Safety at Pfizer. The patient underwent lab tests and procedures which included ALT (alanine aminotransferase) and AST (aspartate aminotransferase): are in the 600's range on an unspecified date and Liver Biopsy (biopsy liver): unknown results on an unspecified date and extensive testing (investigation): unknown results on an unspecified date. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained; Sender's Comments: based on the available information the causal relation ship between the suspect vaccine BNT162B2 and thnte adverse event ALT (alanine aminotransferase) and AST (aspartate aminotransferase) increased cannot be totally ruled out  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoglycaemia, Hypotension, Pruritus, Rash
Clinical narrative: itching of skin; bilateral hand numbness; Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash); Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash); Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash); This is a spontaneous report from a non-contactable other hcp. A 34-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6205), via an unspecified route of administration on an unspecified date (at the age of 34-years-old) as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. It was reported during her 15-minute waiting period after the injection, the patient experienced itching of skin, bilateral hand numbness, differential diagnosis: systemic reaction (hypoglycemia, hypotension, generalized rash) on an unspecified date. The patient was stable to go home and follow up with PCP. Therapeutic measures were taken as a result of events that included antihistamines and water initially with zyrtec, she was not seeing improvement. Two doses of 25 mg of benadryl of 15 minutes within each other, pt was able to see improvement. Pt aware of when she is able to take more benadryl if needed. If symptoms worsen or do not respond to benadryl, pt aware to go to ED. The follow up response to treatment was reported as good. The outcome of the events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: feeling itchy on her back and legs, experiencing a lot of itching, her skin is itching; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 24Feb2021 (Batch/Lot Number: EN6200) (at the age of 62 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced feeling itchy on her back and legs, experiencing a lot of itching, her skin is itching on 26Feb2021 with outcome of not recovered.    No follow-up attempts are possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Neuralgia, Pain
Clinical narrative: extreme pain/mild soreness; muscle spasm; nerve pain in my right arm into my neck; This is a spontaneous report from a contactable pharmacist.   A adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration on 04Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient took historical vaccine (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 product COVID 19, lot unknown False, for covid 19 immunisation.  On 05Feb2021 the day after receiving the second dose of my Pfizer COVID vaccine, patient began having extreme pain and muscle spasm/nerve pain in my right arm (where patient got my injection) into her neck. The pain was only resolved after IM Toradol and PO cyclobenzaprine. Patient still have some mild soreness in these areas. Pain was 10 out of 10 - worst pain ever experienced. There is no seriousness criteria such as Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. Prior to vaccination, was the patient diagnosed with COVID-19 was Unknown Since the vaccination, has the patient been tested for COVID-19 also unknown. Therapeutic measures were taken as a result of extreme pain/mild soreness (pain), muscle spasm (muscle spasms), nerve pain in my right arm into my neck (neuralgia). Outcome of the events was unknown. Information on the lot/batch number has been requested Follow-up attempts completed. No further information expected
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: She experienced consistent rash all over body that involved itching. Rash blotches were on her neck, legs, and arm.; This is a spontaneous report from a contactable pharmacist received via regulatory authority portal. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 26Jan2021 (Batch/Lot Number: EL8982; Expiration Date: 31May2021) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number not reported) on 05Jan2021 for COVID-19 immunisation. The patient experienced consistent rash all over body that involved itching, rash blotches were on her neck, legs, and arm on an unspecified date in 2021. The rash at times would disappear from one area and appear in another. It would also appear in multiple sites at once. As of Wednesday, 10Feb2021, rash was still present. The patient did not experience the event with the first dose. The outcome of event was not recovered. The adverse event resulted in none.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Quarter size raised red circle; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the right arm on 22Feb2021 at 11:45 (at the age of 68-years-old) (Lot Number: 6201) as dose 1, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of the events. The patient has known allergies. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior to vaccination and had not been tested for COVID post-vaccination. On 22Feb2021 at 12:00, the patient experienced quarter size raised red circle where the shot was given. It was reported that it does not hurt and has not gone away after 4 days. No treatment was received for the event. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash developed on both forearms from wrists to elbows; This is a spontaneous report from a contactable healthcare professional (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6200, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 24Feb2021 at 16:00 (at the age of 52-years-old) as dose 1, single for COVID-19 immunisation. Medical history included high blood pressure and gastroesophageal reflux disease (GERD). The patient has no known allergies. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. Concomitant medications included lisinopril, acetylsalicylic acid (ASPIRIN), ibuprofen, multivitamins and P. The patient experienced rash developed on both forearms from wrists to elbows on 26Feb2021 at 12:00. The event occurred approximately two days after receiving the vaccine. Nothing abnormal at injection site and no other rashes seen. No treatment was received for the event. Since the vaccination the patient has not been tested for COVID-19. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Gait disturbance, Insomnia, Loss of personal independence in daily activities, SARS-CoV-2 test
Clinical narrative: cannot walk or exercise; cannot sit/cannot walk or exercise; I had arthritis before the shots, but this pain is worse than I have ever felt; can't sleep; This is a spontaneous report from a contactable consumer.   A non-pregnant 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 14Jan2021 10:00 (Batch/Lot Number: EL3249) as dose 1, single (at the age o 42 years old) for COVID-19 immunisation.  Medical history included ongoing arthritis before the shots. No known allergies. The patient's concomitant medications were not reported.  The patient stated, "I had arthritis before the shots, but this pain is worse than I have ever felt. I cannot sleep. I cannot sit. I cannot walk or exercise". AE treatment: Cortisone shot for hip. Covid test type post vaccination: Nasal Swab on 21Feb2021 and the result is negative. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm after the vaccine on the injection site; This is a spontaneous report from Pfizer-via Regulatory Authority Support from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 20Feb2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm after the vaccine on the injection site on an unspecified date. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood urine present
Clinical narrative: sore arm after the vaccine on the injection site; This is a spontaneous report from Pfizer-via Regulatory Authority Support from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 20Feb2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm after the vaccine on the injection site on an unspecified date. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain in extremity, Pyrexia
Clinical narrative: slight arm soreness; head ache; fever (100 degrees); This is a spontaneous report from a contactable other healthcare professional (patient). A 19-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number: EI3302; Expiration date was not reported), via an unspecified route of administration in the left arm on 12Feb2021 04:45 PM (at the age of 19-years-old) as dose 1, single for COVID-19 immunisation at a workplace clinic. The patient's medical history was not reported. The patient has no concomitant medications. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The patient experienced slight arm soreness, head ache and fever (100 degrees; unit: unspecified) on 13Feb2021 01:00 PM. No treatment was received for the events. The outcome of the events was recovered on 14Feb2021.