chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye pruritus, Ocular hyperaemia, Pruritus, Rash
Clinical narrative: Rash shoulder / chest; hives neck/face; Generalized pruritus with skin rash- chest, neck, face, scalp, eyelids; Generalized erythema- right shoulder, chest; Red eye and itchy eyes; Red eye; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Deltoid Right on 26Mar2021 09:30 (Batch/Lot Number: ER8733) as single dose for COVID-19 immunization. Medical history included, rheumatoid arthritis from 2004 and ongoing, ongoing osteoarthritis (replaces left knee, left hip, left shoulder), ongoing left adrenal tumor, neuropathy, sleep disorder. Family history included osteoarthritis, adrenal tumor and brother deceased kidney cancer. Concomitant medications included ongoing gabapentin (NEUROTIN) taken for neuropathy; ongoing tramadol taken for arthritis; ongoing tofacitinib citrate (XELJANZ) taken for rheumatoid arthritis; colecalciferol (VITAMIN D) taken for an unspecified indication; vitamins NOS (MVI) taken for an unspecified indication; ongoing zolpidem tartrate (AMBIN) taken for sleep; all from an unspecified start date. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Intramuscular in the Right shoulder, on 05Mar2021 09:30, Lot/Batch number-EN6206, for COVID-19 immunization. The patient also took IVP dye and Avelox and experienced hives. If IV contrast to be used must do steroid/Benadryl combo. The patient experienced rash - shoulder, chest and hives neck/face, urticaria on face, eyelid, head, eyes. Rash started 9 hrs after, hives 1 1/2 days after (36 hrs). Had generalized urticaria (neck x 6 days), generalized erythema on right shoulder and chest, Generalized pruritus with skin rash- chest, neck, face, scalp, eyelids; and Red and itchy eyes-eyelids. Antihistamine: Benadryl every 6 hours initial 50mg, took 25 then X 6 days was given as treatment. The patient was not hospitalized/admitted in the ICU or seen in the emergency department. The patient did not receive any recent vaccines for any other conditions prior to the event or around the time of Pfizer-BioNTech COVID-19 vaccination. The outcome of the events was recovered.   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Rash shoulder / chest; hives neck/face; Generalized pruritus with skin rash- chest, neck, face, scalp, eyelids; Generalized erythema- right shoulder, chest; Red eye and itchy eyes; Red eye; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Deltoid Right on 26Mar2021 09:30 (Batch/Lot Number: ER8733) as single dose for COVID-19 immunization. Medical history included, rheumatoid arthritis from 2004 and ongoing, ongoing osteoarthritis (replaces left knee, left hip, left shoulder), ongoing left adrenal tumor, neuropathy, sleep disorder. Family history included osteoarthritis, adrenal tumor and brother deceased kidney cancer. Concomitant medications included ongoing gabapentin (NEUROTIN) taken for neuropathy; ongoing tramadol taken for arthritis; ongoing tofacitinib citrate (XELJANZ) taken for rheumatoid arthritis; colecalciferol (VITAMIN D) taken for an unspecified indication; vitamins NOS (MVI) taken for an unspecified indication; ongoing zolpidem tartrate (AMBIN) taken for sleep; all from an unspecified start date. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Intramuscular in the Right shoulder, on 05Mar2021 09:30, Lot/Batch number-EN6206, for COVID-19 immunization. The patient also took IVP dye and Avelox and experienced hives. If IV contrast to be used must do steroid/Benadryl combo. The patient experienced rash - shoulder, chest and hives neck/face, urticaria on face, eyelid, head, eyes. Rash started 9 hrs after, hives 1 1/2 days after (36 hrs). Had generalized urticaria (neck x 6 days), generalized erythema on right shoulder and chest, Generalized pruritus with skin rash- chest, neck, face, scalp, eyelids; and Red and itchy eyes-eyelids. Antihistamine: Benadryl every 6 hours initial 50mg, took 25 then X 6 days was given as treatment. The patient was not hospitalized/admitted in the ICU or seen in the emergency department. The patient did not receive any recent vaccines for any other conditions prior to the event or around the time of Pfizer-BioNTech COVID-19 vaccination. The outcome of the events was recovered.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Feeling of body temperature change, Lymphadenopathy, Nausea
Clinical narrative: experiencing changing temperatures between hot and cold; I had chills; nauseated; my body just felt so cold; swollen lymph nodes in his clavicle area; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 10Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 COVID-19 immunization.  In this case it was reported that, after he received his second dose on 10Mar2021, he developed swollen lymph nodes in his clavicle area on 14Mar2021 and they were still there. They have improved some. After the first dose, he did not have any reports of side effects at all. After his second dose, he also started experiencing changing temperatures between hot and cold. he had chills, he was nauseated, and his body just felt so cold. On the 14Mar2021, that was when he noticed the swelling of the lymph nodes in the clavicle on his left side. Since then, it has shrunk in size, but he could still feel it. Some of his colleagues had swollen lymph nodes under the armpit, for him just happened to be in the clavicle. He pressed on it and barely felt it. He did not think it was any cause of concern. The patient experienced swollen lymph nodes in his clavicle area on 14Mar2021 and changing temperatures between hot and cold, i had chills, nauseated and my body just felt so cold on an unspecified date. The patient underwent lab tests and procedures which included physical examination on Dec2020: Everything checked out fine. Outcome of the event swollen lymph nodes in his clavicle area was recovering and unknown for other events.
Sex: M
Vaccine: COVID19
Symptoms: Physical examination
Clinical narrative: experiencing changing temperatures between hot and cold; I had chills; nauseated; my body just felt so cold; swollen lymph nodes in his clavicle area; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 10Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 COVID-19 immunization.  In this case it was reported that, after he received his second dose on 10Mar2021, he developed swollen lymph nodes in his clavicle area on 14Mar2021 and they were still there. They have improved some. After the first dose, he did not have any reports of side effects at all. After his second dose, he also started experiencing changing temperatures between hot and cold. he had chills, he was nauseated, and his body just felt so cold. On the 14Mar2021, that was when he noticed the swelling of the lymph nodes in the clavicle on his left side. Since then, it has shrunk in size, but he could still feel it. Some of his colleagues had swollen lymph nodes under the armpit, for him just happened to be in the clavicle. He pressed on it and barely felt it. He did not think it was any cause of concern. The patient experienced swollen lymph nodes in his clavicle area on 14Mar2021 and changing temperatures between hot and cold, i had chills, nauseated and my body just felt so cold on an unspecified date. The patient underwent lab tests and procedures which included physical examination on Dec2020: Everything checked out fine. Outcome of the event swollen lymph nodes in his clavicle area was recovering and unknown for other events.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (who is also the patient). A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0150), via an unspecified route of administration in the arm, on 02Apr2021 16:15, as single dose, for COVID-19 immunisation, at a pharmacy/drug store. There were no medical history and concomitant medications. The patient did not receive other vaccines on the same day as BNT162B2 and did not receive prior vaccinations (within 4 weeks). On 13Apr2021, the patient tested positive for COVID-19 (reported as "8 days after, maybe 10 days after received the first dose of the vaccine"). The patient clarified that she had symptoms before but tested positive on 13Apr2021. The event required physician office visit (medical office visit). The patient finished quarantine on 18Apr2021 and would like to know if she can get the second dose. The outcome of the event was unknown.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (who is also the patient). A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0150), via an unspecified route of administration in the arm, on 02Apr2021 16:15, as single dose, for COVID-19 immunisation, at a pharmacy/drug store. There were no medical history and concomitant medications. The patient did not receive other vaccines on the same day as BNT162B2 and did not receive prior vaccinations (within 4 weeks). On 13Apr2021, the patient tested positive for COVID-19 (reported as "8 days after, maybe 10 days after received the first dose of the vaccine"). The patient clarified that she had symptoms before but tested positive on 13Apr2021. The event required physician office visit (medical office visit). The patient finished quarantine on 18Apr2021 and would like to know if she can get the second dose. The outcome of the event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity, Pyrexia
Clinical narrative: He states that the next day on Monday he experienced back pain that went down to his legs; He states that the next day on Monday he experienced back pain that went down to his legs; Received his second dose of the Pfizer BioNTech COVID-19 vaccine last Saturday 17APR2021 at 9:45 and reports that the next day  (Sunday) in the afternoon about 5:00, he had a fever; This is a spontaneous report received from a contactable consumer. This 56-year-old consumer (patient) reported for himself that the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) on 17Apr2021 at 9:45 for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine) on an unspecified date for COVID-19 immunization. As per the description, it was reported that he received second dose of the Pfizer BioNTech COVID-19 vaccine last Saturday 17Apr2021 at 9:45. Then he reported that the next day (Sunday i.e 18apr2021) in the afternoon about 5:00, he had a fever. He states that the next day on Monday i.e 19Apr2021 he experienced back pain that went down to his legs. He reports he got over the counter Tylenol for this and reports he normally does not take medications like this. He states that with the pain, he cannot stand for long periods of time and reports that the pain was still bothering him when he stands on his feet. Caller would like to know if this has been reported by others with the vaccine. He was concerned with how long this will last and does not know if he should go see a doctor about it, as he stated he does not actually have a primary care doctor. The outcome for the event fever is recovered/resolved in Apr2021 and for the event back pain and pain in extremity was unknown.  No follow up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: headaches; dizziness; This is a spontaneous report received from a contactable consumer. A 58-year-old female consumer (patient) reported for a herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 25Jan2021, second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 22Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. As per the caller, she has experienced headaches and dizziness. Moreover, she asked are these symptoms that have been reported by other people and how long will it last.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: shingles; she presented a rash on her left hand; This is a spontaneous report received from a contactable consumer (patient).  A female consumer of unknown age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Apr2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Mar2021 for COVID-19 immunisation. The patient presented a rash on her left hand since 18Apr2021 and she went to urgent care, where they prescribed viral medication for shingles. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Fatigue, Headache, Muscle tightness
Clinical narrative: tight feeling in his chest; nausea; dizziness; paresthesia in his hands, feet, and right arm; stinging and itching in his legs and right arm; stinging and itching in his legs and right arm; feeling sore and weak in his legs; feeling sore and weak in his legs; bad tension headaches; pain and tightness in his jaw; pain and tightness in his jaw; sore throat; feeling "flu-y" and feverish; groggy felling; body muscle aching; was tired; soreness at the injection site; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient reported that received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unknown date as sin-gle dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced on the following Wednesday he experienced soreness at the injection site, feeling "flu-y" and feverish, had a "groggy feeling" and was tired, and had general "body muscle aching." He states that these symptoms lasted from Wednesday through Friday night, and then reports that on Saturday and Sunday he was fine. He then reports that on the 11th and the 12th (forgot to ask caller to specify month) he started experiencing a tight feeling in his chest, nausea, dizziness, paresthesia in his hands, feet, and right arm, stinging and itching in his legs and right arm, feeling sore and weak in his legs, bad tension headaches, pain and tightness in his jaw, and a sore throat. Caller wonders if these side effects are even related because he states he had the standard "expected" reaction, got better, then experienced these other things. Caller would like to know if he should get the second dose of the vaccine, which he is due for on Wednesday. Outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Myalgia, Nausea, Oropharyngeal pain, Pain
Clinical narrative: tight feeling in his chest; nausea; dizziness; paresthesia in his hands, feet, and right arm; stinging and itching in his legs and right arm; stinging and itching in his legs and right arm; feeling sore and weak in his legs; feeling sore and weak in his legs; bad tension headaches; pain and tightness in his jaw; pain and tightness in his jaw; sore throat; feeling "flu-y" and feverish; groggy felling; body muscle aching; was tired; soreness at the injection site; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient reported that received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unknown date as sin-gle dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced on the following Wednesday he experienced soreness at the injection site, feeling "flu-y" and feverish, had a "groggy feeling" and was tired, and had general "body muscle aching." He states that these symptoms lasted from Wednesday through Friday night, and then reports that on Saturday and Sunday he was fine. He then reports that on the 11th and the 12th (forgot to ask caller to specify month) he started experiencing a tight feeling in his chest, nausea, dizziness, paresthesia in his hands, feet, and right arm, stinging and itching in his legs and right arm, feeling sore and weak in his legs, bad tension headaches, pain and tightness in his jaw, and a sore throat. Caller wonders if these side effects are even related because he states he had the standard "expected" reaction, got better, then experienced these other things. Caller would like to know if he should get the second dose of the vaccine, which he is due for on Wednesday. Outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pain in jaw, Paraesthesia, Pruritus, Pyrexia
Clinical narrative: tight feeling in his chest; nausea; dizziness; paresthesia in his hands, feet, and right arm; stinging and itching in his legs and right arm; stinging and itching in his legs and right arm; feeling sore and weak in his legs; feeling sore and weak in his legs; bad tension headaches; pain and tightness in his jaw; pain and tightness in his jaw; sore throat; feeling "flu-y" and feverish; groggy felling; body muscle aching; was tired; soreness at the injection site; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient reported that received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unknown date as sin-gle dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced on the following Wednesday he experienced soreness at the injection site, feeling "flu-y" and feverish, had a "groggy feeling" and was tired, and had general "body muscle aching." He states that these symptoms lasted from Wednesday through Friday night, and then reports that on Saturday and Sunday he was fine. He then reports that on the 11th and the 12th (forgot to ask caller to specify month) he started experiencing a tight feeling in his chest, nausea, dizziness, paresthesia in his hands, feet, and right arm, stinging and itching in his legs and right arm, feeling sore and weak in his legs, bad tension headaches, pain and tightness in his jaw, and a sore throat. Caller wonders if these side effects are even related because he states he had the standard "expected" reaction, got better, then experienced these other things. Caller would like to know if he should get the second dose of the vaccine, which he is due for on Wednesday. Outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site pain
Clinical narrative: tight feeling in his chest; nausea; dizziness; paresthesia in his hands, feet, and right arm; stinging and itching in his legs and right arm; stinging and itching in his legs and right arm; feeling sore and weak in his legs; feeling sore and weak in his legs; bad tension headaches; pain and tightness in his jaw; pain and tightness in his jaw; sore throat; feeling "flu-y" and feverish; groggy felling; body muscle aching; was tired; soreness at the injection site; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient reported that received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unknown date as sin-gle dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced on the following Wednesday he experienced soreness at the injection site, feeling "flu-y" and feverish, had a "groggy feeling" and was tired, and had general "body muscle aching." He states that these symptoms lasted from Wednesday through Friday night, and then reports that on Saturday and Sunday he was fine. He then reports that on the 11th and the 12th (forgot to ask caller to specify month) he started experiencing a tight feeling in his chest, nausea, dizziness, paresthesia in his hands, feet, and right arm, stinging and itching in his legs and right arm, feeling sore and weak in his legs, bad tension headaches, pain and tightness in his jaw, and a sore throat. Caller wonders if these side effects are even related because he states he had the standard "expected" reaction, got better, then experienced these other things. Caller would like to know if he should get the second dose of the vaccine, which he is due for on Wednesday. Outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Immune system disorder, Pain
Clinical narrative: extremely exhausted; having extreme pain; she already had an immune problem but now it's worse; she already had an immune problem but now it's worse; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation; solution for injection), via an unspecified route of administration on an unspecified date (a week ago; as reported) at single dose for covid-19 immunisation. The patient medical history and concomitant medication were not reported. Caller stated that on an unspecified date she received her first dose of the Pfizer Covid-19 vaccine a week ago and she would like to know if there any statistics on people with immune problems after vaccination. Stated that she already had an immune problem but now it's worse. She has been feeling extremely exhausted and having extreme pain. The report was non-serious. Outcome was not reported.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face, Urticaria
Clinical narrative: Experienced an allergic reaction of hives, facial swelling, lip swelling "lips were bouncy" and inflamed hives.; Experienced an allergic reaction of hives, facial swelling, lip swelling "lips were bouncy" and inflamed hives.; Experienced an allergic reaction of hives, facial swelling, lip swelling "lips were bouncy" and inflamed hives.; This is a spontaneous report received from a contactable consumer or other non hcp. A 57-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 14Apr2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient experienced an allergic reaction of hives, facial swelling, lip swelling "lips were bouncy" and inflamed hives. The events assessed as non-serious. She reports that her doctor wants to her to have an allergy test where they inject vaccine to see if she is allergic to components to investigate what she is allergic to. She reports concern and asks, what are the risks of doing that and is anaphylaxis a potential risk. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Feeling abnormal, Migraine, Nausea
Clinical narrative: Migraines; Brain fog; Sensation of light pressure in his head when doing any physical activity; Mild nausea; This is a spontaneous report from a contactable consumer or other non HCP. A 23-year-old male received first dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, Solution for injection) via an unspecified route of administration as a single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient experienced migraines, mild nausea for 2 days, brain fog, and the sensation of light pressure in his head when doing any physical activity on an unspecified date. The clinical outcome of the events was reported as unknown.   No follow up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Pain, Pain in jaw
Clinical narrative: she reports not feeling like herself all day; jaw pain; her whole left side is painful and heavy; she has numbness in her jaw on the left side and her ear feels heavy and numb as well.; This is a spontaneous report from a contactable consumer. A 69-years-old female patient received 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) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that patient received the first dose of the Pfizer Covid-19 vaccine yesterday, in which patient reported not feeling like herself all day and developed jaw pain on the same side as the injection was administered. Stated her whole left side is painful and heavy. Stated that she has numbness in her jaw on the left side and her ear feels heavy and numb as well. Stated that she feels better today but is worried about getting through the weekend and doctor's offices being closed. Reporter asked if this was normal to experience. The reporter considered the events non serious. The outcome of the events she reports not feeling like herself all day, jaw pain and her whole left side is painful and heavy was reported as recovering and she has numbness in her jaw on the left side and her ear feels heavy and numb as well was reported as recovered on an unspecified date.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Vaccination site reaction
Clinical narrative: She developed a raised area described as "looking like a moon" at the injection site; rash down her arm; This is a spontaneous report from a contactable consumer (reporting his daughter). A female patient of an unspecified age received first BNT162B2 (Pfizer Covid 19 Vaccine, solution for injection, Lot number: unknown) via an unspecified route of administration on 28Mar2021, as single dose for COVID-19 immunization. Patient developed a raised area described as looking like a moon at the injection site. Four days later she developed a rash down her arm. She was seen in the emergency department (ED) and was prescribed an unspecified steroid & creams. Her PCP has advised that she should receive a different brand for her second covid vaccine. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Limb discomfort
Clinical narrative: slight discomfort of the arm; pain in her chest/pain in her rib cage; pain in her chest/pain in her rib cage and shoulders; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 03Apr2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported, she had her first dose of the Pfizer covid 19 vaccine on 3Apr2021. She had slight discomfort of the arm, but she woke up on 12Apr2021 to intense pain in her chest, pain in her rib cage and shoulders. She took aspirin and the symptoms lasted for nine hours. She had her second dose tomorrow and wanted to know how she should proceed. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Diarrhoea, Fatigue, Pain in extremity, Rash erythematous
Clinical narrative: diarrhea; vomiting; extreme tiredness; My arm is sometimes paining me a little and jolts; rash/rash is still raised and quite red and ugly; bruise is beginning to fade; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 12Apr2021 for covid-19 immunisation. Medical history and concomitant medication were not reported. The patient reported, she had a weird prickly rash on her arm where they gave the Pfizer COVID vaccine injection on 12Apr2021. She stated the bruise is beginning to fade, but she still has the rash. Her arm is sometimes paining me a little and jolts me a little. The rash is still raised and quite red and ugly. It's all bumpy and raised. She stated she had diarrhea, vomiting, and extreme tiredness. She is asking if this is normal and if she should receive the second dose? She didn't get vomiting or rash. Outcome of event for bruise is beginning to fade was recovering and for rest of the events it was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: diarrhea; vomiting; extreme tiredness; My arm is sometimes paining me a little and jolts; rash/rash is still raised and quite red and ugly; bruise is beginning to fade; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 12Apr2021 for covid-19 immunisation. Medical history and concomitant medication were not reported. The patient reported, she had a weird prickly rash on her arm where they gave the Pfizer COVID vaccine injection on 12Apr2021. She stated the bruise is beginning to fade, but she still has the rash. Her arm is sometimes paining me a little and jolts me a little. The rash is still raised and quite red and ugly. It's all bumpy and raised. She stated she had diarrhea, vomiting, and extreme tiredness. She is asking if this is normal and if she should receive the second dose? She didn't get vomiting or rash. Outcome of event for bruise is beginning to fade was recovering and for rest of the events it was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Poor quality sleep, Vaccination site discomfort, Vaccination site pain
Clinical narrative: Ache and today he was feeling "more achy"; Burning sensation, discomfort, and aching in his arm "right where he got the shot"; Burning sensation, discomfort, and aching in his arm "right where he got the shot"; Did not sleep well/ did not sleep good; This is a spontaneous report from a contactable consumer (patient himself) via a medical information team. A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in arm on 14Apr2021 (at the age of 41-year-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. He reports that on Monday 19Apr2021 he experienced a burning sensation, discomfort, and aching in his arm "right where he got the shot" and reports that it feels like he just received the vaccine. He tells me that right after he got the vaccine he worked out and that night (Wednesday night on 14Apr2021) he did not sleep well. He states on Thursday night he slept okay, Friday and Saturday night did not sleep good, Sunday "so so", and then states yesterday (22Apr2021) he started to ache and today he was feeling "more achy." Caller would like to know if it was normal to have a reaction this late to the vaccine. He was concerned about whether he should take the second dose of the vaccine because of this, and states his next dose was due 5May2021. Response: Spoke from the prescribing information PFIZER-BIONTECH COVID-19 VACCINE to let caller know that side effects were reported over a 7-day period following each dose of the vaccine and also let caller know that "the mean duration of pain at the injection site after dose 2 was 2.5 days (range 1 to 36 days)." Spoke from the attached documents regarding contraindications to receiving a dose of the vaccine and what signs of a severe allergic reaction could include. Referred caller to healthcare professional (HCP) for further guidance. Caller would like to know if it was okay to take a medication such as Advil to treat his symptoms that he was experiencing after receiving the Pfizer BioNTech COVID-19 vaccine. Response: Spoke from the attached document regarding the use of medications such as Tylenol and Ibuprofen after vaccination to treat symptoms. Referred caller to HCP for any further guidance on medication recommendations. The outcome of the events was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness
Clinical narrative: My Mom and I have been light headed and had some  diarrhea; My Mom and I have been light headed and had some  diarrhea; This is a spontaneous report from a Non-contactable consumer (patient). A male patient of an unknown age reported that he had received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) via unknown route on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. The patient had experienced diarrhoea and dizziness on an unspecified date. The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021474462 different patient, same reporter, drug, event
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This is a spontaneous report from a contactable consumer (patient, self-reported). A 45-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on an unknown date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on an unknown date as single dose for COVID-19 immunization. On an unknown date patient received the second dose of the Pfizer Covid-19 vaccine 6 hours ago. Patient reports that he had hives and asked if he can take Benadryl or Claritin and if this reaction is normal. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program COVAX US support. A contactable 23-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown, expiration date unknown), via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient  received her first dose of the Pfizer covid vaccine and experiencing really bad fever, chills, headache, her arm hurts a lot. its been 3 days now and she still have bad headache and arm soreness, She said she is constantly taking Tylenol for fever. The outcome of the events were unknown.   No Follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Sinusitis
Clinical narrative: Sinus infection; he started feeling bad; This is a spontaneous report from a contactable consumer(patient). A 70-year-old male received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On an unspecified date patient stated that he received his Pfizer COVID19 vaccine dose a couple of weeks ago, and is due for second dose next Wednesday. On Saturday patient started feeling bad, went to the rapid care. Patient does not have a fever but was diagnosed with a sinus infection. Patient was given a couple of medications which he doesn't currently have on him but from memory patient can remember: flonase, cough syrup, antibiotic, decongestant. Patient is wondering if that is okay to be given with the vaccine or if he could be refused his vaccine at the vaccination clinic. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity, Pyrexia, Rash
Clinical narrative: developed patches of rash; developed aches; chills; fevers; her arm is still sore; This is a spontaneous report received from a contactable consumer or other non hcp. A 58-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8734; Expiration Date: Jul2021), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. Medical history included influenza from an unknown date and unknown if ongoing it occurred 20 years ago. Mentioned allergy to Flu shot on initial report. Has no NDC/LOT/EXP for Flu shot and it occurred 20years ago. She doesn't think she is allergic to the things in the COVID shot. She was allergic to the flu shot. Was told to never take the Flu shot again. The patient's concomitant medications were not reported. Patient received her first dose of the Pfizer BioNTech COVID-19 vaccine 36 hours ago. Approximately 7 hours later she developed patches of rash here and there and developed aches, chills, fevers and her arm is still sore. The outcome of the events was unknown. Requested medical information if there is something she can take before the second COVID shot so the side effects are not as bad like a Benadryl.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: Since then she's been feeling drained, tired and queasy; Since then she's been feeling drained, tired and queasy; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date (on Tuesday) for COVID-19 immunization. The patients medical history and concomitant medications were not reported. It was reported that patient was feeling drained, tired and queasy on unspecified date and patient reported her friend has also received the vaccine and has been feeling tired over a week. The outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Pruritus, Rash
Clinical narrative: She's been itchy every since; Roughness coming up; Rash coming up; This is a spontaneous report from a non-contactable nurse (Other HCP) (patient's mother). A 17-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown, Expiry date: unknown) via an unspecified route of administration on 08Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 10Apr2021, the patient experienced she's been itchy every-since, roughness coming up and rash coming up. Caller states, her daughter got the first Pfizer vaccine on 08Apr2021, she has been itchy every-since, this started 2 days later. Caller spoke to her doctor and he said it's probably a reaction to vaccine. Her daughter has no rash, just itchy skin, the only difference today was it looks like or has roughness or rash coming up. Dermatologist says it's probably from her scratching, and says it makes sense that it's probably the vaccine. The way it looks, he didn't feel it would be a problem to get the second dose, since it occurred 2 days later. Caller asked, was it recommend to get the second dose. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: I appear to be developing Shingles.; This is a spontaneous report from Pfizer-sponsored program . A contactable consumer (patient) reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported) via an unspecified route of administration on 16Apr202 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. As of 20Apr2021, the patient appeared to be developing shingles (event start date: 20Apr2021). The outcome of the event was unknown. The outcome of the event was non-serious.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Myalgia
Clinical narrative: Moderate headache; Muscle pain; Chills; General feeling unwell; This is a spontaneous report from a contactable consumer (Patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number and Expiration date was not reported), via an unspecified route of administration on 20Apr2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced moderate headache, muscle pain, chills and general feeling unwell. The patient had four side effects that started on the third day after the vaccine. The patient had taken tylenol 500mg for her headache and it gives her some relief. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Back pain, Irritable bowel syndrome
Clinical narrative: Back pain; Irritable bowel syndrome; Stomach problems; This is a spontaneous report from a non contactable consumer (Patient). This female consumer reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via an unspecified route of administration on 07Apr2021 as a single dose for COVID-19 immunization. The patient reported that 2 days after receiving the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 7Apr2021, on 09Apr2021, she had back pain and irritable bowel syndrome accompanied by stomach problems. She said the symptoms had not gone away, and was only relieved when she ate bland mild food. She wants to know if this was a normal reaction to the vaccine, and if she could still get the 2nd dose. She was scheduled to receive the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine a month after her 1st dose. The outcome for the events was not recovered.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gastrointestinal disorder, Illness
Clinical narrative: Back pain; Irritable bowel syndrome; Stomach problems; This is a spontaneous report from a non contactable consumer (Patient). This female consumer reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via an unspecified route of administration on 07Apr2021 as a single dose for COVID-19 immunization. The patient reported that 2 days after receiving the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 7Apr2021, on 09Apr2021, she had back pain and irritable bowel syndrome accompanied by stomach problems. She said the symptoms had not gone away, and was only relieved when she ate bland mild food. She wants to know if this was a normal reaction to the vaccine, and if she could still get the 2nd dose. She was scheduled to receive the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine a month after her 1st dose. The outcome for the events was not recovered.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained