chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Cheilitis, Conjunctivitis, Headache, Hypoaesthesia, Lymphadenopathy
Clinical narrative: My lymph node in my neck swelled to the point it stuck out like a robin egg; sores in mouth (roof, gums, and inside lips); sores in nostril; sores on nose and lips; sores on nose and lips; Face swelled significantly on my left side; pink eye; severe headache; sinus pain; jaw main and numbness in my molars; severe shooting nerve pain in my front teeth; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL9262; expiration date: unknown), via an unspecified route of administration right arm on 23Jan2021 18:45 at a single dose for covid-19 immunization. Medical history included breast cancer survivor as of 11Sep2019. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), clonazepam, anastrozole (ARIMIDEX), vitamin D3, calcium, vitamins NOS (MULTIVITAMIN), "It Works" and "Fat Fighter". The patient previously took fentanyl but had allergies. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that her lymph node in her neck swelled to the point it stuck out like a robin egg. It was mentioned that it was more swelled there as well and super sensitive to touch. These reactions occurred only on left side of her face, sores in mouth (roof, gums, and inside lips) and sores in nostril. She had sores on nose and lips. The patient mentioned that her face swelled significantly on her left side. She had pink eye, severe headache, sinus pain, jaw main and numbness in her molars, severe shooting nerve pain in her front teeth. The events were considered as non-serious and adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient has not been tested for COVID-19 since vaccination. The events required treatment for the adverse events that included Keflex, Bactroban, prednisone, Valtrex, and lidocaine viscous-aluminum &magnesium hydrAM. The outcome of the events was recovering.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal disorder, Neuralgia, Sinus pain, Skin lesion, Stomatitis
Clinical narrative: My lymph node in my neck swelled to the point it stuck out like a robin egg; sores in mouth (roof, gums, and inside lips); sores in nostril; sores on nose and lips; sores on nose and lips; Face swelled significantly on my left side; pink eye; severe headache; sinus pain; jaw main and numbness in my molars; severe shooting nerve pain in my front teeth; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL9262; expiration date: unknown), via an unspecified route of administration right arm on 23Jan2021 18:45 at a single dose for covid-19 immunization. Medical history included breast cancer survivor as of 11Sep2019. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), clonazepam, anastrozole (ARIMIDEX), vitamin D3, calcium, vitamins NOS (MULTIVITAMIN), "It Works" and "Fat Fighter". The patient previously took fentanyl but had allergies. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that her lymph node in her neck swelled to the point it stuck out like a robin egg. It was mentioned that it was more swelled there as well and super sensitive to touch. These reactions occurred only on left side of her face, sores in mouth (roof, gums, and inside lips) and sores in nostril. She had sores on nose and lips. The patient mentioned that her face swelled significantly on her left side. She had pink eye, severe headache, sinus pain, jaw main and numbness in her molars, severe shooting nerve pain in her front teeth. The events were considered as non-serious and adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient has not been tested for COVID-19 since vaccination. The events required treatment for the adverse events that included Keflex, Bactroban, prednisone, Valtrex, and lidocaine viscous-aluminum &magnesium hydrAM. The outcome of the events was recovering.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: My lymph node in my neck swelled to the point it stuck out like a robin egg; sores in mouth (roof, gums, and inside lips); sores in nostril; sores on nose and lips; sores on nose and lips; Face swelled significantly on my left side; pink eye; severe headache; sinus pain; jaw main and numbness in my molars; severe shooting nerve pain in my front teeth; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL9262; expiration date: unknown), via an unspecified route of administration right arm on 23Jan2021 18:45 at a single dose for covid-19 immunization. Medical history included breast cancer survivor as of 11Sep2019. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), clonazepam, anastrozole (ARIMIDEX), vitamin D3, calcium, vitamins NOS (MULTIVITAMIN), "It Works" and "Fat Fighter". The patient previously took fentanyl but had allergies. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that her lymph node in her neck swelled to the point it stuck out like a robin egg. It was mentioned that it was more swelled there as well and super sensitive to touch. These reactions occurred only on left side of her face, sores in mouth (roof, gums, and inside lips) and sores in nostril. She had sores on nose and lips. The patient mentioned that her face swelled significantly on her left side. She had pink eye, severe headache, sinus pain, jaw main and numbness in her molars, severe shooting nerve pain in her front teeth. The events were considered as non-serious and adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient has not been tested for COVID-19 since vaccination. The events required treatment for the adverse events that included Keflex, Bactroban, prednisone, Valtrex, and lidocaine viscous-aluminum &magnesium hydrAM. The outcome of the events was recovering.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Headache, Nausea, Rash, Vision blurred
Clinical narrative: Rash; blurred vision; loss of balance; headache; nausea; This is a spontaneous report from a contactable other health care professional (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302 and expiration date not provided), via an unspecified route of administration (left arm) first dose on 27Jan2021 08:30 at single dose for Covid-19 immunization. The patient was not pregnant at time of vaccination. The Patient's medical history included Hbp (Blood pressure high). The Patient's concomitant medication included lisinopril, famotidine, and ferrous sulfate. The patient previously took Procardia and Amoxicillin; both experienced allergies. On 28Jan2021, the patient experienced rash, blurred vision, loss of balance, headache, and nausea. The patient did not received treatment for the events. The outcome of the events was recovering.  The reporter assesses the events as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered in the Hospital. The patient did not tested for covid since vaccination.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling of body temperature change, Vaccination site pain
Clinical narrative: Injection site was moderately sore; I felt extremely tired and fatigued; chilled to the bone alternating with hot spells; This is a spontaneous report from a contactable consumer.  A 53-year-old female consumer reported that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL8982), into the left arm on 29Jan2021 at 10:30 at single dose for COVID-19 immunization. Age at vaccination 53 Years. The patient had received first dose of BNT162B2 on 09Jan2021. The patient had no allergies to medications, food, or other products. Medical history was none. Concomitant drugs included Prozac  daily and Lyrica one daily. The patient reported that the injection site was moderately sore. The main side effect started 24 hours post shot. She felt extremely tired and fatigued as well as chilled to the bone alternating with hot spells.  No body aches. No other effects. No treatment was received. Resolved in 24 hours.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia
Clinical narrative: Moderate to severe muscle aches; joint pain; fatigue; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number: EK9231, expiry date: not reported), via an unspecified route of administration on 07Jan2021 05:30 PM at a single dose on the right arm for COVID-19 immunization. The most recent COVID-19 vaccine was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history included arthritis, hypersomnia, depression, anxiety, IBS (irritable bowel syndrome) and allergy to sulfa. Concomitant medications included desvenlafaxine succinate (PRISTIQ), modafinil (MODAFINIL), fluticasone propionate (FLONASE), ibuprofen (IBUPROFEN). The patient  previously received the first dose of bnt162b2 (BNT162B2, lot number: EK5730) on 16Dec2020 05:30 PM at a single dose on the right arm for COVID-19 immunization (age at vaccination: 37-year-old). On 08Jan2021 07:00 AM, the patient experienced moderate to severe muscle aches, joint pain, and fatigue. No treatment was received for the events. Outcome of the events was recovered/resolved with sequel. The reporter assessed the events as non-serious. Since the vaccination, the patient not been tested for COVID-19.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm was killing her for 2 days after the first dose; This is a spontaneous report from a contactable health care professional (patient).  A 33-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 07Jan2021 on the arm at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  Prior to the vaccination, the patient has not been diagnosed with COVID-19. The patient stated that her arm was killing her for 2 days after the first dose on an unspecified date in Jan2021. The outcome of the event was unknown. The event was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19.   Information on the lot/batch number has been requested
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Flank pain, Headache, Lymphadenopathy, Myalgia
Clinical narrative: This is a spontaneous report from a contactable conusmer (patient). A 38-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number: 9L3248, expiry date: not reported), via an unspecified route of administration on 29Jan2021 12:15 PM at a single dose on the left arm for COVID-19 immunization. The most recent COVID-19 vaccine was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history included migraines, reaction to soy, allergy to penicillin. The patient had no concomitant medications (as reported). Past drug history included estrogen medications which causes migraines and fatigue. The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: EL0140) on 08Jan2021 03:15 PM at a single dose on the left arm for COVID-19 immunization (age at vaccination: 38-year-old). On 30Jan2021 12:45 AM (as reported), the patient experienced soreness in left arm, lasted 72 hrs; woke up after 12 hours with bad headache, muscle aches, chills, fever; headache lasted 36s hours, fever lasted about 36 hours, muscle aches ongoing after 72 hrs, chills still persistent, subside with Tylenol (As reported).  After about 60 hours swelling in left arm pit lymph node to about the size of a golf ball, sore all down left flank; after 72 hours swelling in lymph nodes near pubic bone and on neck as well, swelling in arm pit lymph node is decreasing. The patient received Tylenol for chills. She did not receive any treatment for the remaining events. Outcome of the events was recovering. The reporter assessed the events as non-serious. Since the vaccination, the patient not been tested for COVID-19.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable conusmer (patient). A 38-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number: 9L3248, expiry date: not reported), via an unspecified route of administration on 29Jan2021 12:15 PM at a single dose on the left arm for COVID-19 immunization. The most recent COVID-19 vaccine was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history included migraines, reaction to soy, allergy to penicillin. The patient had no concomitant medications (as reported). Past drug history included estrogen medications which causes migraines and fatigue. The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: EL0140) on 08Jan2021 03:15 PM at a single dose on the left arm for COVID-19 immunization (age at vaccination: 38-year-old). On 30Jan2021 12:45 AM (as reported), the patient experienced soreness in left arm, lasted 72 hrs; woke up after 12 hours with bad headache, muscle aches, chills, fever; headache lasted 36s hours, fever lasted about 36 hours, muscle aches ongoing after 72 hrs, chills still persistent, subside with Tylenol (As reported).  After about 60 hours swelling in left arm pit lymph node to about the size of a golf ball, sore all down left flank; after 72 hours swelling in lymph nodes near pubic bone and on neck as well, swelling in arm pit lymph node is decreasing. The patient received Tylenol for chills. She did not receive any treatment for the remaining events. Outcome of the events was recovering. The reporter assessed the events as non-serious. Since the vaccination, the patient not been tested for COVID-19.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: very bad chills; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 29Jan2021 14:45 at a single dose for COVID-19 immunisation. Medical history included diabetes, cancer and sleep apnea. Concomitant medications were not reported (received within 2 weeks of vaccination). It was reported that 24 hours after getting the shot (30Jan2021 03:00 PM), she had a very bad chills, they lasted at least an hour. 12 hours after that, she got the chills again and 12 hours after that, the same thing. She took acetaminophen (TYLENOL) and that seems to help. Event was reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Outcome of the event was recovered on an unspecified date.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Hereditary haemorrhagic telangiectasia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient).  A 69-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EN5318, via an unspecified route of administration in the left arm, on an unspecified date at SINGLE DOSE for covid-19 immunization. Medical history included hereditary haemorrhagic telangiectasia. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine (as reported). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medications included benazepril, folic acid, torsemide, tamsulosin and iron. This patient has a history of Hereditary Hemorrhagic Talengiectasia, a bleeding disorder causing very brittle veins in my nose. He gets injections every 6 months to partially control the extreme nosebleeds. Starting the next day after getting the vaccination (30Jan2021, 04:00), there was an increase in the number and intensity of them. It has been the third day and they are getting more frequent. Outcome of events was not recovered. Events are considered non-serious.  No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Oral pain
Clinical narrative: Sore Mouth; This is a spontaneous report from a contactable Nurse. An 86-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Jan2021 (last week) at SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced sore mouth on Jan2021 (reported as yesterday).  The outcome was recovered on Jan2021.  Information on the lot/batch number has been requested.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Lip swelling, Paraesthesia, Swollen tongue
Clinical narrative: Flush feeling; tingling in the face, hands and feet; swelling of the tongue and lips; swelling of the tongue and lips; dizziness; This is a spontaneous report from a contactable other healthcare professional (patient). A 65-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN5318) intramuscular on the left arm on 01Feb2021 10:45 at a single dose for COVID-19 immunization. Medical history included high BP and allergy sulfa drugs. Concomitant medication included losartan, acetylsalicylic acid (BABY ASPIRIN), colecalciferol (D3), zinc and ascorbic acid (VIT C). On 01Feb2021 11:00 AM the patient experienced flush feeling, tingling in the face, hands, and feet, swelling of the tongue and lips and dizziness. Diphenhydramine (BENADRYL) was used to control. Events were reported as non-serious, did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The events resulted to a doctor or other healthcare professional office/clinic visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was recovered on an unspecified date.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19 virus; tested positive for Covid-19 virus; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect via a contactable female consumer(patient).  A female patient of an unspecified age received first dose BNT162B2, via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient receive 1st dose 11Jan2021, then experienced tested positive for covid-19 virus on Jan2021 with outcome of unknown.     Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was sore; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a male patient (reporter's husband) of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 29Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient's arm was sore on an unspecified date in Jan2021. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231 and expiry date: 30Apr2021), intramuscular on left arm, on 15Jan2021 13:15 at a single dose for COVID-19 immunization. Medical history included allergic to shampoo products and chemicals and vaccine has Peg). Patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported.  The patient experienced severe itching and rash in right arm on the 11th day after vaccine administration on 26Jan2021 16:30. It grew from 3.5 inches to as big as 12 inches going around my arm. Patient had to go to emergency room. Adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Keflex 500mg 4 times a day and bacrim twice a day was given as treatment. Outcome of the events was recovering. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache
Clinical narrative: headache; chills; feeling generally bad; This is a spontaneous report from a contactable consumer via the Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on an unspecified date, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that the patient (reporter's wife) experienced headache, chills and was feeling generally bad. The reporter wanted to know if Tylenol can be taken. The outcome of the events was unknown.  Information about the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Week later she tested positive for Covid virus.; Week later she tested positive for covid virus.; This is a spontaneous report from a Pfizer-sponsored program Pfizer first connect from a contactable consumer.  A female patient of an unspecified age received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration, on 11Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported.  The patient received COVID vaccine on 11Jan2021. A week later she tested positive for COVID virus. Ended up in hospital. Wanting to know when and if she can get next dose of vaccine. The clinical outcome of the event was not reported.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Inquiring if side effects are from the vaccine. Or if she received covid after the vaccine.; Inquiring if side effects are from the vaccine. Or if she received covid after the vaccine.; This is a spontaneous report from a Pfizer Sponsored program Pfizer First Connect. A contactable registered nurse reported for herself that a female patient of an unspecified age received first and second dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The nurse received both doses of covid vaccine shots. She was inquiring if side effects are from the vaccine or if she received covid after the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: received covid. The outcome of the event was unknown.   Information on lot/batch number has been requested.; Sender's Comments: Based on the limitedly available information, the lack of efficacy cannot be excluded for vaccine BNT162B2. The case should be reassessed when the administration date of BNT162B2 injection, the test date of SARS-COV-2, medical history and concomitant medication become available.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID virus; This is a spontaneous report from a Pfizer Sponsored Program. A contactable pharmacist reported for a patient that a patient of unspecified age and gender received first dose of BNT162B2, via an unspecified route of administration in Jan2021 at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The pharmacist reported that last week the patient was given COVID vaccine to Health Care Worker, this week (in Jan2021) the patient had tested positive for COVID virus. Wondering if and when person can get 2nd dose of vaccine. The event outcome was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 02-Feb-2021 this case now contains all required information to be considered valid.   This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient).  A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose, on an unspecified date, in 2012, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, in 2012, the patient was hospitalized with high temperature and swollen arm. She stayed in the hospital for 3 days. Clinical outcome of the events was unknown at time of this report.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Diarrhoea, Nausea, Pyrexia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient received 1st dose of Covid vaccine. Right after her husband had tested positive for Covid virus. Patient did not take test. Said had all symptoms. Such as fever, loss of smell, taste, diarrhea and being nauseous on unspecified dates. Was sick for whole month. Patient wondering if she could not get 2nd dose of Covid vaccine or what to do as she wanted to return work. The outcome of the events was unknown. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: They are supposed to take the 2nd dose of the vaccine tomorrow. However, they tested positive last Saturday; They are supposed to take the 2nd dose of the vaccine tomorrow. However, they tested positive last Saturday; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (patient) reported similar events for 2 patients. This is the first of two reports.   The female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at SINGLE  DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported "They are supposed to take the 2nd dose of the vaccine tomorrow. However, they tested positive last Saturday on 23Jan2021. Asking if they should still take the 2nd dose of the vaccine." The patient underwent lab tests and procedures which included test (sars-cov-2 test): positive on 23Jan2021. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021106620 Same reporter, same product. same event, different patient
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Herpes zoster
Clinical narrative: flare up of shingles; disease recurrence; This initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow up information on 30Jan2021, this case now contains all required information to be considered valid.   This is a spontaneous report from a contactable consumer and nurse based on information received by Pfizer from   A 58 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 18Jan2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included ongoing psoriatic arthritis and shingles. Previous therapy included VIOXX and methotrexate, both for psoriatic arthritis. Concomitant medications included etanercept (ENBREL) for psoriatic arthritis. On 20Jan2021 two days later after received the vaccine the patient had a flare up of shingles. At the time of the reporting event outcome was unknown.    No follow-up attempts are possible, information about batch number cannot be obtained
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a male patient of an unspecified age (reporter's father) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced shingles an unspecified date. The reporter's father took the first dose of the vaccine. After the vaccine his father got shingles and on topical medication. Reporter is asking if it's okay to take the second dose of the vaccine. Therapeutic measures were taken as a result of shingles which included unspecified topical medication. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Hypokalaemia, Laboratory test, Palpitations, Troponin
Clinical narrative: hypokalemia; heart started pounding hard/diagnosed with heart palpitations and hypokalemia; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL9262), via an unspecified route of administration on 01Feb2021 at a single dose for COVID-19 immunization. Medical history included preexisting cardiac issues, she has heart arrhythmia, PAC's and PVC's (all ongoing). The patient's concomitant medications were not reported. On 01Feb2021, later that night (about 12 hours after vaccination), patient's heart started pounding hard. She stated that she has preexisting cardiac issues, she has heart arrhythmia and also has PAC's and PVC's. This is what she used to experience years ago before she was treated with medication. During event on 01Feb2021, EMT that came did EKG at the house, they were concerned about what was seen and patient was taken to Emergency Department and was given some medication to slow her heart rate down. Her EKG was "very erratic" and she was given Cardizem which resolved the issue quickly and was also given some Potassium chloride. Troponins and labs drawn on 01Feb2021. The patient was diagnosed with heart palpitations and hypokalemia. She received new cardiac home medications to take and referral to see Cardiologist next week. The patient was wondering if these were side effects from vaccine. Outcome of the events was unknown. The patient was hospitalized for the events.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Rectal haemorrhage
Clinical narrative: Rectal Bleeding; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE , solution for injection, lot number: EN5318, expiration date not reported), via an unspecified route of administration on the right arm on 02Feb2021 10:45 at single dose for COVID-19 immunization. Medical history included osteoporosis and allergic reaction to penicillin. The patient is not pregnant. The patient has no prior COVID vaccination. There was no other vaccine given within four weeks. Concomitant medication included atorvastatin, calcium, magnesium. The patient experienced rectal bleeding on 03Feb2021 09:00. Patient reported that she had her first shot yesterday morning and today when she went to the bathroom she has rectal bleeding, bright red blood, which is not normal for her. The patient was not tested for COVID post vaccination. Outcome of the event was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Blood urine present, Discomfort, Headache, Tooth abscess
Clinical narrative: I had an abscess tooth that became infected; UTI; headache; stomach bloating; pressure and discomfort; blood in my urine; This is a spontaneous report from a contactable consumer (patient herself). A 52-year-old female received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EL3247), via an unspecified route of administration in the left arm on 18Jan2021 at 10:30 AM as a single dose for COVID-19 immunization. The patient had no relevant medical history. The patient ha d no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination, has not been tested for COVID-19 since the vaccination, and was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine and also did not receive any other medication within two weeks of vaccination. The patient had a headache on 22Jan2021 for 5 days. She also had stomach bloating and pressure and discomfort on 22Jan2021. It was reported that when she saw blood in her urine, she went to a walk-in and was diagnosed with a UTI on 22Jan2021. She did 7 days of an antibiotic. Then on 30Jan2021, she had an abscess tooth that became infected. It was reported that the patient received antibiotics for both infections. It was reported that the events result in a doctor or other healthcare professional office/clinic visit and an Emergency room/department or urgent care. Outcome of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: I had an abscess tooth that became infected; UTI; headache; stomach bloating; pressure and discomfort; blood in my urine; This is a spontaneous report from a contactable consumer (patient herself). A 52-year-old female received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EL3247), via an unspecified route of administration in the left arm on 18Jan2021 at 10:30 AM as a single dose for COVID-19 immunization. The patient had no relevant medical history. The patient ha d no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination, has not been tested for COVID-19 since the vaccination, and was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine and also did not receive any other medication within two weeks of vaccination. The patient had a headache on 22Jan2021 for 5 days. She also had stomach bloating and pressure and discomfort on 22Jan2021. It was reported that when she saw blood in her urine, she went to a walk-in and was diagnosed with a UTI on 22Jan2021. She did 7 days of an antibiotic. Then on 30Jan2021, she had an abscess tooth that became infected. It was reported that the patient received antibiotics for both infections. It was reported that the events result in a doctor or other healthcare professional office/clinic visit and an Emergency room/department or urgent care. Outcome of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Just tested positive for covid.; Just tested positive for covid.; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer (patient's wife) reported for a male patient (husband). A male patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received their first dose. Just tested positive for covid on an unspecified date. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Deafness, Magnetic resonance imaging
Clinical narrative: She almost instantly completely lost hearing in her right ear / loss of hearing; 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/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 28Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported she had the first shot of the vaccine on 28Jan2021, then on 30Jan2021 she reported that she almost instantly completely lost hearing in her right ear. She said it hasn't changed since. She already had a CT scan and MRI scan with her doctor, and she wanted to eliminate the vaccine shot as the cause of her loss of hearing. Outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Fall, Hip fracture, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: broken hip; fell out of bed; positive test for COVID19; This is a spontaneous report from a contactable consumer (patient's child). An 80-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history included parkinson's disease. Concomitant medications were not reported. The patient was scheduled to receive the second dose on 12Feb2021. Yesterday (01Feb2021), the patient fell out of bed with a broken hip. The patient was hospitalized and was scheduled for surgery today (02Feb2021) with a positive test for COVID-19. Outcome of the events was unknown. The reporter was asking if the vaccine would register a false positive on a rapid test and if her father is positive for COVID in between both doses of the vaccine, is it recommended that he not get the shot.  Information on the lot/batch number has been requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Computerised tomogram, Echocardiogram, Magnetic resonance imaging, Mental impairment
Clinical narrative: Unable to comprehend description of movie displayed on monitor/did not make convey idea, but each word was understood; word finding difficulty; Medical history included Crohn's and prostate cancer (CA)/vedolizumab (ENTYVIO); Medical history included Crohn's and prostate cancer (CA)/vedolizumab (ENTYVIO); This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El1283), via an unspecified route of administration, left arm, first dose on 09Jan2021 16:00 at a single dose and for COVID-19 immunization. Medical history included Crohn's and prostate cancer (CA). The patient has no known allergies. Concomitant medication included celecoxib, vedolizumab (ENTYVIO), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) and vitamin b complex. The patient also takes "garlic multi". The patient had no other vaccine in four weeks. The patient has no COVID prior to vaccination. Covid test via nasal swab on 11Jan2021 with result of negative. On 11Jan2021 at 19:30, the patient was unable to comprehend description of movie displayed on monitor. Words did not make convey idea, but each word was understood. The patient went to hospital for transient ischaemic attack (TIA), no findings overnight then at home word finding difficult about 12 hours later (Jan2021). The patient was brought back to the hospital, no evidence of TIA or cerebrovascular accident (CVA). The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization for four days. The patient recovered with lasting effects. The patient had MRI, CT and ECHO with unknown results in Jan2021. The patient received statins, topiramate magnesium infusion as treatment. The patient received the second dose (lot number: El9265) via an unspecified route of administration, right arm on 30Jan2021 for COVID-19 immunization.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product use issue, SARS-CoV-2 test
Clinical narrative: Unable to comprehend description of movie displayed on monitor/did not make convey idea, but each word was understood; word finding difficulty; Medical history included Crohn's and prostate cancer (CA)/vedolizumab (ENTYVIO); Medical history included Crohn's and prostate cancer (CA)/vedolizumab (ENTYVIO); This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El1283), via an unspecified route of administration, left arm, first dose on 09Jan2021 16:00 at a single dose and for COVID-19 immunization. Medical history included Crohn's and prostate cancer (CA). The patient has no known allergies. Concomitant medication included celecoxib, vedolizumab (ENTYVIO), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) and vitamin b complex. The patient also takes "garlic multi". The patient had no other vaccine in four weeks. The patient has no COVID prior to vaccination. Covid test via nasal swab on 11Jan2021 with result of negative. On 11Jan2021 at 19:30, the patient was unable to comprehend description of movie displayed on monitor. Words did not make convey idea, but each word was understood. The patient went to hospital for transient ischaemic attack (TIA), no findings overnight then at home word finding difficult about 12 hours later (Jan2021). The patient was brought back to the hospital, no evidence of TIA or cerebrovascular accident (CVA). The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization for four days. The patient recovered with lasting effects. The patient had MRI, CT and ECHO with unknown results in Jan2021. The patient received statins, topiramate magnesium infusion as treatment. The patient received the second dose (lot number: El9265) via an unspecified route of administration, right arm on 30Jan2021 for COVID-19 immunization.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller had Covid vaccine on 28Jan and tested positive for Covid today; Caller had Covid vaccine on 28Jan and tested positive for Covid today; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 28Jan2021 at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had Covid vaccine on 28Jan2021 and tested positive for Covid today 30Jan2021. She is wondering what to do about 2nd dose and wonders if this is normal. The patient underwent lab tests and procedures which included COVID: positive on 30Jan2021. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test; positive COVID-19 test; This is a spontaneous report received from a contactable nurse. An 88-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) Intramuscularly on 13Jan2021 at single dose for COVID-19 immunization in a nursing home/senior living facility. Medical history included s/p cerebrovascular accident (CVA), Insulin dependent diabetes mellitus (IDDM) and hypertension (HTN). The patient had no allergies with medications, food or other products. Concomitant medication included insulin glargine (LANTUS). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The resident (patient) tested positive in the SARS-Cov2-RT PCR (nasal swab) on 01Feb2021. Patient did not receive treatment for the adverse event. Event was considered by the reporter as non-serious. Outcome of events was recovering.  Information on the lot number and batch number has been requested.; 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.