chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Mild itching throughout different parts of the body; This is a spontaneous report received from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El3246), via an unspecified route of administration in left arm, on 07Jan2021 11:15 at single dose, for COVID-19 immunization, in a public health facility. Medical history included mitral valve prolapse, glaucoma, and allergy to strawberry. The patient is not pregnant. Concomitant medication included latanoprost; estradiol, norethisterone acetate (MIMVEY); multivitamins; and ergocalciferol (VIT D). The patient did not receive any vaccine within 4 weeks prior to COVID vaccine. The patient experienced mild itching throughout different parts of the body beginning on day 2, 09Jan2021 10:00, and continuing on day 5. Prior to vaccination, the patient was not diagnosed with COVID-19. Since 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 is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Insomnia, Vaccination site pain
Clinical narrative: Chills; Insomnia; soreness at injection site; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 09Jan2021 12:15 in left arm at single dose for COVID-19 immunization. Medical history included chronic sinusitis from an unknown date and unknown if ongoing. There were no concomitant medications. On 09Jan2021 12:45, the patient experienced chills, insomnia and soreness at injection site. No treatment was given to the patient for the events. The outcome of the events was recovering. The facility where the most recent COVID-19 vaccine was administered was in the Public Health Clinic/Veterans Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events was considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pain
Clinical narrative: Nausea; dizziness; body ache; This is a spontaneous report from a contactable healthcare professional. A 24-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: PF13K9231), via an unspecified route of administration on the right arm on 09Jan2021 14:45 at single dose for COVID-19 immunisation.  Medical history included bipolar 2, ADHD and obesity.  Concomitant medication included sertraline, methylphenidate hydrochloride (RITALIN) and methylphenidate.  The patient experienced nausea, dizziness and body ache on 09Jan2021 19:00. The patient received no treatment. The outcome of the events was recovering.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pyrexia
Clinical narrative: High fever; chills; sweats; This is a spontaneous report from a contactable Other HCP (patient). A 41-year-old male patient received the second dose of BNT162B2 (Lot/batch number and expiry date unknown), via an unspecified route of administration on 08Jan2021 at single dose in the left arm for an unspecified indication. Medical history included high blood pressure and allergy to coconut. There were no concomitant medications. The patient previously took acetylsalicylic acid (ASPIRIN) and experienced allergies. Historical vaccine includes BNT162B2 received via intramuscular on 11Dec2020 14:00 ("also reported as 12Dec2020 14:00) at single dose (first dose) in the left arm for COVID-19 immunization. On 09Jan2021 07:00, the patient experienced high fever, chills and sweats. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The vaccine was given in the Hospital. The outcome of the events was not recovered.  Information regarding lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Itchy rash/ hives  neck area, trunk; Itchy rash/ hives  neck area, trunk; This is a spontaneous report from a contactable consumer (patient) reported that a 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiration date: not reported), via an unspecified route of administration on the left arm on 08Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included psoriasis and allergies to Penicillin; both from unknown dates. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine and rosuvastatin calcium (CRESTOR) taken from unspecified dates for unspecified indications. On 08Jan2021, the patient experienced itchy rash/hives neck area, trunk with outcome of recovering. As treatment, patient received Benedryl (as reported). Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot number was already obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Pain in extremity
Clinical narrative: but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever; but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever; Got the vaccine early Friday afternoon and had a sore arm; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the vaccine early Friday (08Jan2021) afternoon and had a sore arm but then yesterday (10Jan2021) her stomach was hurting and she had a headache but no fever. The patient asked if that normal for side effects to occur 2 days later. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: the anitbody test was negative; This is a spontaneous report from a contactable other healthcare professional reporting for herself. A female patient of unspecified age received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, on 23Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was vaccinated with the Pfizer-BioNTech COVID-19 vaccine on 23Dec2020. She was given 1 of 2 shots. She then donated blood on 06Jan2021 but the anitbody test was negative. She was scheduled for 2nd vaccine on 13Jan2021. The patient asked when she would be expected to start building antibodies from the vaccine and how many weeks after the 2nd vaccine. She asked the estimated time span. Outcome of the event was unknown.   Information on batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Parosmia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Had change in smell; severe malaise; muscle aches with pain in injection site arm; muscle aches with pain in injection site arm; This is a spontaneous report from a Pfizer-sponsored program. A contactable other health professional (patient) reported that a female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications was not reported. On 18Dec2020 patient received first dose of Covid-19 vaccine. 24 hrs post vaccine on 19Dec2020, had severe malaise, muscle aches with pain in injection site arm. day 18 (05Jan2021), Had change in smell that she would describe as a foul burnt smell. No loss of smell or taste. Concerned that COVID-19 on day 21 (08Jan2021), had Covid-19 PCR that was non detectable. The outcome of events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain under her arm; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of unspecified age received the second dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. The patient received the second dose of the vaccine and noticed that the pain under her arm is still there. It started on Saturday 09Jan2021, and she was wondering how long that will persist. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: slight swelling on the first dose; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of unspecified age received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had taken both doses of the Pfizer covid vaccine and did not experience any side effects like everybody else. She stated that she is concerned since everyone she had talked to who received the vaccine experienced some kind of side effects (fever, chills, body ache) and was wondering if the vaccine might not be working. She only experienced slight swelling on the first dose. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Erythema, Fatigue, Headache, Peripheral swelling
Clinical narrative: headache; fatigue; diarrhea; swollen arm; red spot on her arm; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the 2nd dose of the vaccine on 08Jan2021 and has had symptoms of headache, fatigue, diarrhea, swollen arm and a red spot on her arm. She is asking how long do these side effects usually last. Events outcome was unknown.  Information on the lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: received first dose of bnt162b2/ symptoms started on the 26th (26Dec2020) but did not test positive until the 29th (29Dec2020); received first dose of bnt162b2/ symptoms started on the 26th (26Dec2020) but did not test positive until the 29th (29Dec2020); This is a spontaneous report from a Pfizer-sponsored program via a contactable nurse (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number: VAC0002881; expiration date not provided), via an unspecified route of administration on 17Dec2020 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history included hypothyroidism and osteoporosis from unknown dates, both ongoing. Concomitant medications included levothyroxine for hypothyroidism and alendronate sodium (FOSAMAX) for osteoporosis. Patient reported that her symptoms started on the 26th (26Dec2020) but did not test positive until the 29th (29Dec2020). Patient further stated "She received the first dose of Pfizer vaccine last 17Dec (17Dec2020) and 26Dec she was positive with COVID (later clarified of tested positive on 29Dec2020) because of someone else, it seems that it has been transferred, the virus has been transferred to her and then after a few days she got fully recovered, no symptoms, just fully recovered. She is just asking if she really need the second dose of vaccine if she is fully recovered right now." It was reported that patient did not receive treatment for the event. Laboratory test included COVID-19 virus test on 29Dec2020 with positive result. Outcome of the event was recovered.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Moderate allergic reaction; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) at a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had moderate allergic reaction after the first dose of vaccination. The outcome of the event, moderate allergic reaction, was unknown. The patient was concerned if she should take the second dose.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching face, scalp and back; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) at a single dose, with route of administration and therapy dates unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had itching face, scalp and back. The outcome of the events, 'itching face, scalp and back', was unknown.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling cold, Hypoaesthesia, Nasal congestion, Oropharyngeal pain
Clinical narrative: coldness; numbness with  extremities; sore throat; congested; shortness of breath; This is a spontaneous report from a non-contactable physician (patient). A 31-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on unknown date in Jan2021 at single dose for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient received the second dose of the covid vaccine on Friday. The patient had coldness, numbness with extremities within 2 hours. She was not sure if it was just in her head. Saturday she had sore throat, was congested and had some shortness of breath. "Today" the patient was still congested and still with some shortness of breath, the patient wanted know if she should get tested for covid. The events were assessed non-serious. The was outcome was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Platelet count, Platelet count increased
Clinical narrative: High platelets (over 1000; unit was not provided); This is a spontaneous report from a contactable healthcare professional. This healthcare professional reported similar events for two patients. This is the first of the two reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) at a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had high platelets (over 1000; unit was not reported). The outcome of the event, high platelets, was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021022206 same reporter/drug/events, different patient
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Influenza like illness, Pain, Pyrexia
Clinical narrative: flu-like symptoms; body aches; low grade fever; didn't have the energy; This is a spontaneous report from a contactable Nurse. This female Nurse reported for herself received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jan2021 10:00 at single dose for COVID-19 immunisation. The medical history and concomitant medications were not reported. The patient woke up at midnight with flu-like symptoms and she was still having them in Jan2021. The body aches and low grade fever are the worst in Jan2021, enough that she called out of work. The patient just didn't have the energy in Jan2021. The outcome of didn't have the energy was unknown. The outcome of other events was not recovered.  Information on the Lot/Batch Number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Heart rate, Heart rate increased
Clinical narrative: felt flushed; Elevated heart rate; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient asked for some recommendations in taking the second dose of the vaccine since she had experienced the side effects- felt flushed and had elevated heart rate on an unspecified date. The outcome of the events was unknown.   Information about the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis, Rhinorrhoea, SARS-CoV-2 test, Sneezing
Clinical narrative: head cold; nose running; stuffy; sneeze; This is a spontaneous report from a contactable Nurse. This nurse (patient) reported that the (Age:59; Unit: Unknown) female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient reported that "I got my first Covid vaccine on 21Dec. Today is three weeks and I am scheduled for my second shot.  I have a head cold: nose running, stuffy, and I sneeze. I don't have Covid- I was tested and I'm negative. Its not my allergies. Its just a head cold.  Can I get my second dose?  No one can give me an answer." The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Headache, Myalgia, Sneezing
Clinical narrative: headache; muscle pain in the neck and back; cough; sneezing; dizziness; This is a spontaneous report from a contactable Nurse (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient got first dose of the vaccine this Saturday and is experiencing headache and muscle pain in the neck and back (main concerns), as well as cough, sneezing (starting to go away), and dizziness; all on Jan2021. She wants to know how long these will last. She was wondering if she can take Tylenol for these symptoms. Event outcome of sneezing was recovering, while for others was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Maternal exposure during pregnancy
Clinical narrative: a 13 week pregnant patient who received the first shot of the vaccine; lymphadenopathy; This is a spontaneous report from a contactable Physician via medical information team. A 13-week pregnant female patient of an unspecified age received first shot of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date at single dose, for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. Reporter was asking for any recommendations regarding the 2nd dose for a 13-week pregnant patient who received the first shot of the vaccine and developed lymphadenopathy a week after the 1st dose. She told that her gynecologist allowed her and gave her a note to take the 1st dose. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. It was reported that patient's husband would like to know if Pfizer recommends use of acetaminophen to treat systemic side effects of the Covid vaccine due to possibility of blunted antibody response as it has been documented in the journal that this can occur, so he wanted to determine Pfizer's experience in relation to the Covid-19 vaccine. Patient's husband and patient received the vaccine yesterday (unspecified date) and were told that they could take APAP to treat systemic possible side effects. It was reported that the patient did develop a headache. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Pruritus
Clinical narrative: itching; bottom lip was swollen; This is a spontaneous report from a contactable consumer via the Medical Information Team. An 85-year-old male patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from an unspecified date at a single dose for an unspecified indication. Medical history included hard of hearing. The patient's concomitant medications were not reported. It was reported that the patient started itching and bottom lip was swollen. Bottom lip swelling has gone down today but she has still itching all over the body. She tried Benadryl but not helping. The outcome of the event itching was not recovered while recovering for the other event. Information about Lot/Batch has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Cough, Diarrhoea, Fatigue, Pain
Clinical narrative: experiencing pain in her back where kidneys; fatigued/extreme fatigue; dry cough; diarrhea; aches/pains/aches and pains around her body; severe pain in injection arm; injection site very painful; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 06Jan2021 at single dose for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. She reported that the evening of her first dose, she experienced severe pain in injection arm on 06Jan2021. She stated that night injection site very painful. She had to take Tylenol Extra Strength overnight. She stated that she woke up and she was fine. On 09Jan2021, she reported feeling fatigued, dry cough, extreme fatigue, diarrhea, aches/pains, and aches and pains around her body, but no fever. She woke up this morning on 11Jan2021, experiencing pain in her back where kidneys, still fatigued but no fever. She has taken the Covid test and does not have the results. She wanted to know if these are side effects of the vaccine or is this potentially the Covid virus. The events were assessed non-serious. The outcome of severe pain in injection arm, injection site very painful was recovered, of fatigued was not recovered, of other events were unknown.  Information on the lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: experiencing pain in her back where kidneys; fatigued/extreme fatigue; dry cough; diarrhea; aches/pains/aches and pains around her body; severe pain in injection arm; injection site very painful; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 06Jan2021 at single dose for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. She reported that the evening of her first dose, she experienced severe pain in injection arm on 06Jan2021. She stated that night injection site very painful. She had to take Tylenol Extra Strength overnight. She stated that she woke up and she was fine. On 09Jan2021, she reported feeling fatigued, dry cough, extreme fatigue, diarrhea, aches/pains, and aches and pains around her body, but no fever. She woke up this morning on 11Jan2021, experiencing pain in her back where kidneys, still fatigued but no fever. She has taken the Covid test and does not have the results. She wanted to know if these are side effects of the vaccine or is this potentially the Covid virus. The events were assessed non-serious. The outcome of severe pain in injection arm, injection site very painful was recovered, of fatigued was not recovered, of other events were unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Electrocardiogram, Magnetic resonance imaging, Off label use, Product use issue
Clinical narrative: she takes an autoimmune suppressant, Tremfya, but did not disclose it when she got the vaccine; she takes an autoimmune suppressant, Tremfya, but did not disclose it when she got the vaccine; This is a spontaneous report from a contactable consumer via the Medical Information Team. A female patient of an unspecified age started to receive bnt162b2 (BNT162B2) , via an unspecified route of administration from 09Jan2021 to 09Jan2021 at a single dose for an unspecified indication; and guselkumab (TREMFYA), via an unspecified route of administration from 29Dec2020 to 29Dec2020 at an unspecified dose for an unspecified indication. Medical history included COVID from Mar2020. The patient's concomitant medications were not reported. It was reported that the patient got the first dose of Pfizer COVID-19 vaccine on Saturday 09Jan2021. She takes an autoimmune suppressant, Tremfya, but did not disclose it when she got the vaccine. The patient also reported to have a chest X-ray, an EKG, a stress echo test, and an MRI. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Stress echocardiogram
Clinical narrative: she takes an autoimmune suppressant, Tremfya, but did not disclose it when she got the vaccine; she takes an autoimmune suppressant, Tremfya, but did not disclose it when she got the vaccine; This is a spontaneous report from a contactable consumer via the Medical Information Team. A female patient of an unspecified age started to receive bnt162b2 (BNT162B2) , via an unspecified route of administration from 09Jan2021 to 09Jan2021 at a single dose for an unspecified indication; and guselkumab (TREMFYA), via an unspecified route of administration from 29Dec2020 to 29Dec2020 at an unspecified dose for an unspecified indication. Medical history included COVID from Mar2020. The patient's concomitant medications were not reported. It was reported that the patient got the first dose of Pfizer COVID-19 vaccine on Saturday 09Jan2021. She takes an autoimmune suppressant, Tremfya, but did not disclose it when she got the vaccine. The patient also reported to have a chest X-ray, an EKG, a stress echo test, and an MRI. Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: patient was last in the presence of a family member on Saturday (unspecified date) who two days later developed chills and fever and was diagnosed with the virus; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. It was reported that patient was given the COVID vaccine at work on an unspecified date and was due to take part two of the vaccine on Monday (unspecified date). However, it was reported that patient was last in the presence of a family member on Saturday (unspecified date) who two days later developed chills and fever and was diagnosed with the virus. Patient stated, "So, like I said two days after I left visiting this family member they developed it. I have no symptoms do I still take the vaccine on Monday as I am due to take it, part two of the vaccine?" Outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive for Covid, 10 days after receiving the vaccine; Tested positive for Covid, 10 days after receiving the vaccine; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID on an unspecified date 10 days after receiving the vaccine. The patient underwent lab tests and procedures which included Covid test: positive on an unspecified date. The outcome of the events was unknown.  The information on the batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm hurt; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced arm hurt after getting it. Outcome of the event was unknown.   Information about Lot/batch has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Movement disorder, Pain in extremity
Clinical narrative: arm was sore; hard to move without pain; This is a spontaneous report from a contactable nurse. A patient of an unspecified age and gender received first dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine) in dominant arm on an unspecified date in Dec2020 (approximate 24 days ago) at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Within hours that arm was sore and hard to move without pain. Patient could not get keys out of pocket without pain. Pain continued for 12 days. The outcome of the events was unknown. The patient received her second dose on 03Jan2021 in non dominant arm to avoid the lack of mobility.   Information about Lot/Batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy
Clinical narrative: swollen lymph nodes and headache after the first dose; swollen lymph nodes and headache after the first dose; This is a spontaneous report from a contactable other health professional (patient) from a Pfizer Sponsored Program Pfizer First Connect.  A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced swollen lymph nodes and headache on Dec2020. The patient outcome of the events was unknown.  Information about Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: broke out in a rash; This is a spontaneous report from a contactable consumer reporting for herself. A 68-year-old female patient received first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 08Jan2021, at a single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD) . She had many comorbidities including COPD. Concomitant medications were not reported. The patient broke out in a rash on 10Jan2021. She had a virtual HCP (healthcare professional) appointment and noticed it was on her face. Outcome of the event was unknown.  Information on batch number has been requested.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Dysstasia, Feeling abnormal
Clinical narrative: dizziness; he couldn't stand up; he laid down the bed would float; This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiry: Apr2021), via an unspecified route of administration on 09Jan2021 11:45 at a single dose for COVID-19 immunization. Medical history included retired, he became allergic to penicillin when he was 17 year old and hasn't taken it since, lost his taste and smell, potassium is high sometimes - the doctor recommend he cut down on banana and potatoes, extra heart beat, stomach acid, and thyroid disorder. Ongoing concomitant medications included levothyroxine sodium - has been taking it for a year and a half to two years for thyroid, metoprolol succinate - has been on it about a year and half because an EKG showed he had an extra heart beat, and omeprazole capsule - been on it two or three years for stomach acid. The patient previously took trimethoprim/sulfamethoxazole (BACTRIM) and experienced allergy. After having a Pfizer shot on Saturday, he had a reaction - dizziness. His wife also received the COVID vaccine but did not have any reaction. He sat in the office for 15 minutes like he was supposed to. He drove home and was fine. Two hours later he was so dizzy he couldn't stand up. He was holding onto things to walk through the house. That was two hours after he took the vaccine. After that he thought it would go away in a day. All day yesterday, which was the second day, he was still dizzy. If he laid down the bed would float. It was an awful experience. He received the vaccine at 11:45am on 09Jan2021. Two hours later is when it started. He had to hold onto the rail to get up there. If he gets up quick it is still there. He just had blood work and was due back in Apr for check up. He hasn't had taste and smell for four years or better. He lost his taste and smell and never got it back. He doesn't know what caused that. He hasn't been sick. Outcome of the event dizziness was recovering, for the other events was unknown.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Body temperature, Chills, Dizziness, Feeling abnormal
Clinical narrative: fever went up 99.9; woke up covered in sweat; shaking so bad; shivering; had trouble keeping balance; swaying when walking; felt like crap; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Dec2020 at a single dose SINGLE DOSE for COVID-19 immunization. Medical history included COVID-19 in Apr2020. The patient's concomitant medications included celecoxib (CELEBREX). After receiving the vaccine fever went up 99.9, woke up covered in sweat, shaking so bad, shivering, had trouble keeping balance, was swaying when he was walking on an unspecified date. The patient also stated he felt ill for 3-4 days. The outcome of the events was unknown.    Information about lot/batch number has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pyrexia, Tremor
Clinical narrative: fever went up 99.9; woke up covered in sweat; shaking so bad; shivering; had trouble keeping balance; swaying when walking; felt like crap; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Dec2020 at a single dose SINGLE DOSE for COVID-19 immunization. Medical history included COVID-19 in Apr2020. The patient's concomitant medications included celecoxib (CELEBREX). After receiving the vaccine fever went up 99.9, woke up covered in sweat, shaking so bad, shivering, had trouble keeping balance, was swaying when he was walking on an unspecified date. The patient also stated he felt ill for 3-4 days. The outcome of the events was unknown.    Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Vaccination site pain
Clinical narrative: has a little bit or arm pain and back pain on the side that she received the vaccine; has a little bit or arm pain and back pain on the side that she received the vaccine; This is a spontaneous report from a non-contactable consumer (caregiver). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in arm, on an unspecified date, at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient recently received the vaccine and had a little bit of arm pain and back pain on the side that she received the vaccine on an unspecified date. The reported asked if this was normal and asked if the patient can use acetaminophen to treat pain and some warm compress. The outcome of the events was unknown.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Lymphoedema
Clinical narrative: lymphedema; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A male patient of an unspecified age (reported as 47, unit not provided, pending clarification) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on 08Jan2021, at single dose, for COVID-19 immunization, in the hospital. The patient's medical history and concomitant medications were not reported. The patient received his second dose of the COVID19 vaccine on Friday (08Jan2021) and experienced lymphedema as a side effect in Jan2021. The patient would like to know if there is anything he can do for it. The outcome of the event was unknown.  Information on lot/batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: feeling fatigue; "just not herself, out of whack in her body"; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as Pfizer-Biontech Covid-19 Vaccine; unknown lot number and expiration date), via an unspecified route of administration on 07Jan2021 at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient reported that she received the Covid 19 vaccine on 07Jan2021 then the day after (08Jan2021), she began feeling fatigue, "just not herself, out of whack in her body", and diarrhea. The patient reported that she was fine now. She inquired if those were normal. The outcome of the events was recovered on Jan2021.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dysphonia, Headache, Malaise, SARS-CoV-2 test positive
Clinical narrative: coughs once in a while, may be a nervous cough every 40 min; voice hoarse; tested positive for Covid-19; tested positive for Covid-19; didn't feel well at all; bad headache; dry cough; This is a spontaneous report from a contactable consumer who reported for himself, a 70-year-old male patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on 06Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he received the first dose of the Pfizer-BioNtech Covid-19 vaccine on Wednesday, 06Jan2021, and on that day he had no problem. On Thursday, 07Jan2021, he started experiencing dry cough. On Friday, 08Jan2021, he didn't feel well at all and had a bad headache. On Saturday, 09Jan2021, he felt better but he tested positive for Covid-19. Today, 11Jan2021, he stated he feels good, he coughs once in a while, may be a nervous cough every 40 min. He had not experienced fever or chills, he breathes well, he can hold his breath for 5-10 seconds, no chest pain or congestion, but his voice was hoarse. Patient wanted to know if this has been reported before, and wanted to know how long should he test himself again for Covid-19. The events were reported as non-serious. The outcome of the events was unknown.  Information about lot/batch number is requested.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Headache, Myalgia
Clinical narrative: headache; chills; muscle & joint pain; muscle & joint pain; some GI Symptoms (nausea and diarrhea); some GI Symptoms (nausea and diarrhea); injections site soreness; This is a spontaneous report from a contactable pharmacist reported for self. This 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 at single dose for covid-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation. She experienced injections site soreness on the day 07Jan2021 then resolved. The next day (08Jan2021) experienced headache, chills, muscle & joint pain, and some GI Symptoms (nausea and diarrhea). Outcome of the event injections site soreness was recovered. Outcome of other events was unknown.  Information on batch/lot number was requested.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: headache; chills; muscle & joint pain; muscle & joint pain; some GI Symptoms (nausea and diarrhea); some GI Symptoms (nausea and diarrhea); injections site soreness; This is a spontaneous report from a contactable pharmacist reported for self. This 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 at single dose for covid-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation. She experienced injections site soreness on the day 07Jan2021 then resolved. The next day (08Jan2021) experienced headache, chills, muscle & joint pain, and some GI Symptoms (nausea and diarrhea). Outcome of the event injections site soreness was recovered. Outcome of other events was unknown.  Information on batch/lot number was requested.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Body temperature increased, Chills, Fatigue
Clinical narrative: headache; chills; muscle & joint pain; muscle & joint pain; some GI Symptoms (nausea and diarrhea); some GI Symptoms (nausea and diarrhea); injections site soreness; This is a spontaneous report from a contactable pharmacist reported for self. This 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 at single dose for covid-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation. She experienced injections site soreness on the day 07Jan2021 then resolved. The next day (08Jan2021) experienced headache, chills, muscle & joint pain, and some GI Symptoms (nausea and diarrhea). Outcome of the event injections site soreness was recovered. Outcome of other events was unknown.  Information on batch/lot number was requested.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gastrointestinal disorder, Headache, Myalgia
Clinical narrative: headache; chills; muscle & joint pain; muscle & joint pain; some GI Symptoms (nausea and diarrhea); some GI Symptoms (nausea and diarrhea); injections site soreness; This is a spontaneous report from a contactable pharmacist reported for self. This 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 at single dose for covid-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation. She experienced injections site soreness on the day 07Jan2021 then resolved. The next day (08Jan2021) experienced headache, chills, muscle & joint pain, and some GI Symptoms (nausea and diarrhea). Outcome of the event injections site soreness was recovered. Outcome of other events was unknown.  Information on batch/lot number was requested.