chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: Pain at injection site; Tiredness; Headache; Chills; Joint pain; Fever; Felt paralyzed at one point; This is a spontaneous report from a contactable consumer.  A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: K5730, via an unspecified route of administration from 29Dec2020 16:15 at a SINGLE DOSE for covid-19 immunization. Medical history included migraine with aura. Concomitant medication included gabapentin, pravastatin, estradiol, diphenhydramine hydrochloride (ALLERGY), and ascorbic acid, calcium pantothenate, colecalciferol, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol (VITAM).  The patient previously took amoxicillin and had allergies.  On 30Dec2020 15:00, the patient experienced pain at injection site, tiredness, chills, joint pain, fever and felt paralyzed at one point. The outcome of events was recovering.  No follow-up attempts possible. No further information expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Pain at injection site; Tiredness; Headache; Chills; Joint pain; Fever; Felt paralyzed at one point; This is a spontaneous report from a contactable consumer.  A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: K5730, via an unspecified route of administration from 29Dec2020 16:15 at a SINGLE DOSE for covid-19 immunization. Medical history included migraine with aura. Concomitant medication included gabapentin, pravastatin, estradiol, diphenhydramine hydrochloride (ALLERGY), and ascorbic acid, calcium pantothenate, colecalciferol, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol (VITAM).  The patient previously took amoxicillin and had allergies.  On 30Dec2020 15:00, the patient experienced pain at injection site, tiredness, chills, joint pain, fever and felt paralyzed at one point. The outcome of events was recovering.  No follow-up attempts possible. No further information expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Malaise, Pain in extremity
Clinical narrative: Soreness in my arm,  dizziness, tiredness and over all not feeling well; Soreness in my arm,  dizziness, tiredness and over all not feeling well; Soreness in my arm,  dizziness, tiredness and over all not feeling well; Soreness in my arm,  dizziness, tiredness and over all not feeling well; This is a spontaneous report from a contactable healthcare professional, the patient.  A 46-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 31Dec2020 at 15:30 as a single dose for COVID-19 immunization.   Medical history included allergy to tomatoes. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Dec2020 at 21:00, the patient experienced soreness in my arm, dizziness, tiredness and overall not feeling well.  The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the soreness in my arm, dizziness, tiredness and overall not feeling well were recovering.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: body aches (just legs ache); very mild sore arm; fatigue; This is a spontaneous report from contactable nurse (patient) from a Pfizer-sponsored program. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 28Dec2020 (at the age of 51-years-old) as a single dose for COVID-19 immunization. Medical history included possible exposure to COVID-19 patient on 22Dec2020 to 23Dec2020 (patient's patient tested positive on 24Dec2020 and saw the patient on 22Dec2020 and 23Dec2020). The patient's concomitant medications were not reported. The patient experienced fatigue on 28Dec2020, very mild sore arm on 29Dec2020, and body aches (just legs ache) on 02Jan2020. The clinical course was reported as: The patient felt fatigue on the day of vaccination and very mild sore arm the next day. The patient experienced body ache (just legs) on 02Jan2021, but it was less on 03Jan2021. The clinical outcome of fatigue and very mild sore arm was unknown and of body aches (just legs ache) was recovering.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itchy everyday since then all over body; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. Medical history included allergies to cilantro and iron. The patient's concomitant medications were not reported. The patient received vaccine on 28Dec2020 and reported she had been itchy every day since then all over body. Treatment for the event included diphenhydramine hydrochloride (BENADRYL). The outcome of the event, itchy, was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Ear pain, Fear, Pain in extremity, Pain in jaw
Clinical narrative: some memory loss; locked jaw/unable to open mouth; her arm hurt; pain went in her jaws; she was really scared; Excruciating pain on left ear; swelling in arm; This is a spontaneous report from a contactable other healthcare professional. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: ES1685, Expiry date: 01Mar2021) via intramuscular (left deltoid) on 28Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  She stated she is very healthy and don't have any medical conditions. She further stated that it was a scary moment, she don't want to take any chances, she was really frightened (28Dec2020). She made a complaint to let know her experience with the vaccine. Her cousin took the vaccine and told her she needed to report these events. The patient stated she experienced side effects after the first dose of the vaccine: Excruciating pain on left ear, locked jaw, her left upper arm was hurting on 28Dec2020. The pain went in her jaws and she was unable to open her mouth on 28Dec2020. She took 2 Benadryl and it relieved her. She saw on television if you experienced any side effects to take Benadryl. She also took Tylenol for the pain. She also had swelling in arm on an unspecified date in Dec2020.  She also experienced some memory loss described as short-term memory loss on 30Dec2020. She stayed in bed after the vaccine, she was really scared, and stated she had memory loss and she don't have any memory problems. She was unable to remember if her car was black. She was looking for a white car. She drives a black car. She stayed in bed all day on Tuesday. Patient was asking what will happen if she does not take the second vaccine. The same morning while she was waiting to get the vaccine, a co-worker sent her a video of a woman who had received a COVID vaccine. She does not know which one. The woman experienced Bell's Palsy. The woman was crying and her face was turning side ways. She stated some people were talking negatively about the vaccine. She stated doesn't want her face to be deformed. She stated what are the cons of not taking the second vaccine. Reporter assessed the events as non-serious. Outcome of the events some memory loss and locked jaw/unable to open mouth was recovered on 30Dec2020, outcome of the events excruciating pain on her left ear, pain went in her jaws, her arm was hurt was recovering. Outcome of swelling in arm and she was really scared was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Trismus
Clinical narrative: some memory loss; locked jaw/unable to open mouth; her arm hurt; pain went in her jaws; she was really scared; Excruciating pain on left ear; swelling in arm; This is a spontaneous report from a contactable other healthcare professional. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: ES1685, Expiry date: 01Mar2021) via intramuscular (left deltoid) on 28Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  She stated she is very healthy and don't have any medical conditions. She further stated that it was a scary moment, she don't want to take any chances, she was really frightened (28Dec2020). She made a complaint to let know her experience with the vaccine. Her cousin took the vaccine and told her she needed to report these events. The patient stated she experienced side effects after the first dose of the vaccine: Excruciating pain on left ear, locked jaw, her left upper arm was hurting on 28Dec2020. The pain went in her jaws and she was unable to open her mouth on 28Dec2020. She took 2 Benadryl and it relieved her. She saw on television if you experienced any side effects to take Benadryl. She also took Tylenol for the pain. She also had swelling in arm on an unspecified date in Dec2020.  She also experienced some memory loss described as short-term memory loss on 30Dec2020. She stayed in bed after the vaccine, she was really scared, and stated she had memory loss and she don't have any memory problems. She was unable to remember if her car was black. She was looking for a white car. She drives a black car. She stayed in bed all day on Tuesday. Patient was asking what will happen if she does not take the second vaccine. The same morning while she was waiting to get the vaccine, a co-worker sent her a video of a woman who had received a COVID vaccine. She does not know which one. The woman experienced Bell's Palsy. The woman was crying and her face was turning side ways. She stated some people were talking negatively about the vaccine. She stated doesn't want her face to be deformed. She stated what are the cons of not taking the second vaccine. Reporter assessed the events as non-serious. Outcome of the events some memory loss and locked jaw/unable to open mouth was recovered on 30Dec2020, outcome of the events excruciating pain on her left ear, pain went in her jaws, her arm was hurt was recovering. Outcome of swelling in arm and she was really scared was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Herpes zoster, Pain, Paraesthesia, Sensitisation
Clinical narrative: Shingle type pain burning; Shingle type pain burning; Shingle type pain burning; tingling; very sensitive from left flank down toward mid buttocks slightly toward anterior area; This is a spontaneous report from the Medical Information Team. A contactable nurse reported that a 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK9231, via intramuscular route of administration in the left arm, from 24Dec2020 08:15 at a single dose for COVID-19 immunization. Patient had no other medical history (reported as "none"). Concomitant medication included melatonin, calcium and bupropion hydrochloride (WELLBUTRIN). The patient is not pregnant. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 27Dec2020 09:00, the patient experienced shingle type pain burning, tingling and very sensitive from left flank down toward mid buttocks slightly toward anterior area. The outcome of events was reported as "not recovered". Therapeutic measures were taken as a result of events included motrin, tylenol and lidocaine. Patient was unable to go to work for a few days.  No follow-up attempts are possible. No further information is expected. Information on the batch number has been obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Double stranded DNA antibody, Menstruation irregular
Clinical narrative: She got her period two weeks early; This is spontaneous report from a contactable Nurse. This Nurse reported similar events for 3 patients. This is the first of 3 reports, reporting for one of the colleagues. A 41-year-old female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK5730, exp: 31Mar2021, via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. She was ANA and double strand is positive for autoimmune but it is watch and see thing. Patient's other medical history and concomitant medications were not reported.  Patient is not pregnant at the time of reporting. Reporter was wondering if other people were also reporting if they got their periods early. She got her period two weeks early (on 02Jan2021) and mentioned she also has two colleagues who had that as well on an unspecified date. The outcome of the event was reported as not recovered.  Information on the lot/batch number has been obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021004161 same reporter/drug/AE, different patient;US-PFIZER INC-2021004222 same reporter/drug/AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: swollen lymph nodes in the armpit; arm pit pain; This is a spontaneous report from the Medical Information Team.  A contactable other health professional reported that a 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 27Dec2020 at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was having arm pit pain, it felt like a swollen lymph node. She saw that this was a side effect. Outcome of events was unknown.  Information about lot/batch number requested
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Exposure to SARS-CoV-2, Feeling abnormal, Pain in extremity
Clinical narrative: COVID-19/Caller received the first dose of the vaccine and she tested positive with Covid; COVID-19/Caller received the first dose of the vaccine and she tested positive with Covid; arm pain; she felt like crap the night; chills; This is a spontaneous report from a contactable pharmacist (patient). A 51-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899, expiration date Mar2021), intramuscular on left arm, on 18Dec2020 at 0.3 mL, a single dose for vaccination. The patient medical history and concomitant medications were not reported. The patient received the first dose of the vaccine and she tested positive with Covid. She received the Pfizer Covid vaccine on 18Dec2020. She was exposed to the virus through close personal contact right around this same time-frame and did develop the virus herself.  She wanted to know if there were any recommendations regarding her needing to get the second dose in series.  She stated that her husband, who was not vaccinated, had the virus and developed more serious symptoms than she did.  She is concerned about worsening side effects with the second dose and stated that she felt like crap the night after her first dose with chills and arm pain. The patient tested positive for COVID-19 on 26Dec2020. Specific test name was unknown, but she knows it was not a rapid test. She is scheduled to get the second dose of the Pfizer COVID-19 Vaccine on 08Jan2021. She called to ask if she should or should not get the second dose relative to the COVID-19 diagnosis. She has not been able to find the information she is asking about. The outcome of the event of Covid-19 was recovering while other events was unknown. The Covid-19 was assessed as unrelated to the suspect drug.; Sender's Comments: No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the positive COVID represents the pre-existing infection prior to vaccine use.  Further information like confirmative COVID 19 Nucleic acid/ PCR test together with any associated symptoms are needed for full medical assessment. COVID-19 antigen test positive.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: COVID-19/Caller received the first dose of the vaccine and she tested positive with Covid; COVID-19/Caller received the first dose of the vaccine and she tested positive with Covid; arm pain; she felt like crap the night; chills; This is a spontaneous report from a contactable pharmacist (patient). A 51-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899, expiration date Mar2021), intramuscular on left arm, on 18Dec2020 at 0.3 mL, a single dose for vaccination. The patient medical history and concomitant medications were not reported. The patient received the first dose of the vaccine and she tested positive with Covid. She received the Pfizer Covid vaccine on 18Dec2020. She was exposed to the virus through close personal contact right around this same time-frame and did develop the virus herself.  She wanted to know if there were any recommendations regarding her needing to get the second dose in series.  She stated that her husband, who was not vaccinated, had the virus and developed more serious symptoms than she did.  She is concerned about worsening side effects with the second dose and stated that she felt like crap the night after her first dose with chills and arm pain. The patient tested positive for COVID-19 on 26Dec2020. Specific test name was unknown, but she knows it was not a rapid test. She is scheduled to get the second dose of the Pfizer COVID-19 Vaccine on 08Jan2021. She called to ask if she should or should not get the second dose relative to the COVID-19 diagnosis. She has not been able to find the information she is asking about. The outcome of the event of Covid-19 was recovering while other events was unknown. The Covid-19 was assessed as unrelated to the suspect drug.; Sender's Comments: No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the positive COVID represents the pre-existing infection prior to vaccine use.  Further information like confirmative COVID 19 Nucleic acid/ PCR test together with any associated symptoms are needed for full medical assessment. COVID-19 antigen test positive.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test, Vaccination site erythema, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: welt on the injection site that was very hot and red; welt on the injection site that was very hot and red; welt on the injection site that was very hot and red; rash all over the body; This is a spontaneous report from a contactable consumer (patient).  A non-pregnant 43-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration in the left arm on 24Dec2020 (as reported) at 07:45 at 43-years-old at a single dose for COVID-19 immunization.  Medical history included fibromyalgia, hypertension, and shellfish allergy; all from an unknown date and unknown if ongoing. Concomitant medications included escitalopram (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), ergocalciferol (VIT D); all taken for an unspecified indication from an unspecified date to an unspecified date (received within two weeks of vaccination).  The patient previously took iodine (MANUFACTURER UNKNOWN) and experienced iodine allergy, and codeine (MANUFACTURER UNKNOWN) and experienced codeine allergy; both from an unspecified date to an unspecified date. On 17Dec2020 at 13:15 (as reported), the patient experienced: welt on the injection site that was very hot and red, and rash all over the body. The patient also reported, "I have all the symptoms of COVID-19."  It was unknown if the patient received treatment for the adverse events. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included Rapid test (SARS-CoV-2 test): negative on 04Jan2021. The clinical outcome of the events was not recovered.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid-19 after receiving 1st dose; COVID-19 PCR test: positive on 31Dec2020, Covid-19 rapid test: positive on 31Dec2020; smell was gone/no sense of smell; no sense of taste; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899, expiry date unknown) via unspecified route of administration in the left arm on 26Dec2020 at single dose for Covid-19 immunization. Medical history included cholesterol, blood pressure (controlled blood pressure), hypothyroidism. Concomitant medications included TELMISARTAN (MICARDIS) for blood pressure and ATORVASTATIN (LIPITOR) for cholesterol; both on unspecified date. The patient was asking if she was able to get the 2nd dose of vaccine, since she was tested positive for Covid-19 (31Dec2020) after receiving 1st dose. The patient was asking information about missing 2nd dose and when can she get it and wanted to know if it was still okay to get the second dose. The patient asked if she needed to have a test negative for covid-19 prior to receiving 2nd dose. The patient experienced no sense of taste and actually realized it on 29Dec2020 that her food was not tasting good. The patient didn't notice her smell was gone until she was cooking the chicken curry, she even tested it out by spraying some perfume, she has no sense of smell on 30Dec2020. The patient informed that both her taste and smell returned 02Jan2021 but was not recovered completely. The patient underwent lab tests and procedures which included A1C: 6.4 on 12Dec2020, COVID-19 PCR test: positive on 31Dec2020, Covid-19 rapid test: positive on 31Dec2020. The patient informed that she had no positive test before the Covid-19 vaccine, she took Covid-19 antibody test in Apr2020 and it was negative. The outcome of the events tested positive for Covid-19 after receiving 1st dose was unknown, no sense of taste and smell was gone/no sense of smell was recovered with sequel on 02Jan2021.; Sender's Comments: No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the positive COVID represents the pre-existing infection prior to vaccine use.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: congestion; positive for Covid-19; positive for Covid-19; This is a spontaneous report from a contactable healthcare professional (patient).  A 61-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899, expiration date not reported), via an unspecified route of administration on left arm on 31Dec2020 at 08:15  at a single dose for Covid-19 immunization/precaution because she works with hospice patients. Medical history included blood pressure (abnormal), diabetes, cholesterol (abnormal), and acid reflux, all are ongoing.  The patient has no family medical history. Concomitant medications included amlodipine besilate, benazepril hydrochloride for blood pressure taking about 4-5 years, metformin for diabetes taking about 5 years, rosuvastatin for cholesterol Taking about 5 years, pantoprazole for acid reflux taking 5 years, and vitamin D as supplement taking for 3 years. No previous immunization nor vaccines administered on same date of the suspect drug. The patient was calling about the COVID vaccination, which she received on Thursday, 31Dec2020. Her husband tested positive on Thursday, so she took the test on Thursday after she took the vaccination and they just told her today, 04Jan2021, that she is positive for Covid-19. She wanted to know if that was going to mess up her vaccination in any way and if there are recommendations for second dose. She is a CNA. There was no prescriber. She received it because she works with hospice patients. Test was administered on 31Dec2020. COVID Test resulted on 10:00 04Jan2020 as positive. ER or physician's office required: She just went to get a COVID test when her husband tested and they gave her a azithromycin (Z-PACK) 250 mg because she had congestion. Take two tabs first day and then one daily for 4 more days. She is taking last one today (04Jan2021). Outcome of the events was unknown.; Sender's Comments: A causal association between reported events and BNT162B2 cannot be excluded.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Diarrhoea, Fatigue, Feeling cold
Clinical narrative: suspected COVID-19; suspected COVID-19; Fatigue; Body aches; Headache; chills; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 04Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable healthcare professional, the patient, from a Pfizer sponsored program IBCC (Inbound Call Center for HCPs).  A 32-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730), intramuscular in the left deltoid on 15Dec2020 at 21:00 (at the age of 32-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing hypertension from 2009 and COVID-19 from 10Jun2020 to an unknown date in 2020.  Ongoing concomitant medications included fosinopril (MANUFACTURER UNKNOWN) taken for hypertension from 2017. The patient did not receive any other vaccines on the same day as the BNT162B2 vaccine.  On 19Dec2020, shy of about 96 hours of getting the vaccine, the patient experienced fatigue, body aches, headache and chills. He did not have any fever. The patient stated that he recovered from the fatigue, body aches, headache and chills by 19Dec2020. The patient was fine from 19Dec2020 until 01Jan2021. On 28Dec2020, the patient had a COVID-19 PCR test that came back negative. On 01Jan2021, the patient suspected that he had COVID-19. He had a fever of 103.1 degrees Fahrenheit, body aches, chills like he was freezing to death, fatigue, diarrhea; however, he did not have nausea or loss of taste or smell. He had swollen lymph nodes, but no sore throat and his oxygen saturation was okay in Jan2021.  He was also having chest pain but it was more like intercoastal pain. He stated that these current symptoms were significantly worse than the ones he had just after getting the vaccine and felt more like the symptoms he had when he had COVID-19 before on 10Jun2020 (positive IgG for COVID-19-tested in 2020). The patient had a COVID nasal swab (PCR) done at an urgent care (physician's office) on 02Jan2020 or 03Jan2020 and was awaiting the results. The clinical outcome of the suspected COVID-19 was not recovered.; Sender's Comments: A causal association between reported suspected COVID-19 cannot be excluded.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Musculoskeletal chest pain, Pain, Pyrexia
Clinical narrative: suspected COVID-19; suspected COVID-19; Fatigue; Body aches; Headache; chills; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 04Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable healthcare professional, the patient, from a Pfizer sponsored program IBCC (Inbound Call Center for HCPs).  A 32-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730), intramuscular in the left deltoid on 15Dec2020 at 21:00 (at the age of 32-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing hypertension from 2009 and COVID-19 from 10Jun2020 to an unknown date in 2020.  Ongoing concomitant medications included fosinopril (MANUFACTURER UNKNOWN) taken for hypertension from 2017. The patient did not receive any other vaccines on the same day as the BNT162B2 vaccine.  On 19Dec2020, shy of about 96 hours of getting the vaccine, the patient experienced fatigue, body aches, headache and chills. He did not have any fever. The patient stated that he recovered from the fatigue, body aches, headache and chills by 19Dec2020. The patient was fine from 19Dec2020 until 01Jan2021. On 28Dec2020, the patient had a COVID-19 PCR test that came back negative. On 01Jan2021, the patient suspected that he had COVID-19. He had a fever of 103.1 degrees Fahrenheit, body aches, chills like he was freezing to death, fatigue, diarrhea; however, he did not have nausea or loss of taste or smell. He had swollen lymph nodes, but no sore throat and his oxygen saturation was okay in Jan2021.  He was also having chest pain but it was more like intercoastal pain. He stated that these current symptoms were significantly worse than the ones he had just after getting the vaccine and felt more like the symptoms he had when he had COVID-19 before on 10Jun2020 (positive IgG for COVID-19-tested in 2020). The patient had a COVID nasal swab (PCR) done at an urgent care (physician's office) on 02Jan2020 or 03Jan2020 and was awaiting the results. The clinical outcome of the suspected COVID-19 was not recovered.; Sender's Comments: A causal association between reported suspected COVID-19 cannot be excluded.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test negative, Suspected COVID-19
Clinical narrative: suspected COVID-19; suspected COVID-19; Fatigue; Body aches; Headache; chills; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 04Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable healthcare professional, the patient, from a Pfizer sponsored program IBCC (Inbound Call Center for HCPs).  A 32-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730), intramuscular in the left deltoid on 15Dec2020 at 21:00 (at the age of 32-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing hypertension from 2009 and COVID-19 from 10Jun2020 to an unknown date in 2020.  Ongoing concomitant medications included fosinopril (MANUFACTURER UNKNOWN) taken for hypertension from 2017. The patient did not receive any other vaccines on the same day as the BNT162B2 vaccine.  On 19Dec2020, shy of about 96 hours of getting the vaccine, the patient experienced fatigue, body aches, headache and chills. He did not have any fever. The patient stated that he recovered from the fatigue, body aches, headache and chills by 19Dec2020. The patient was fine from 19Dec2020 until 01Jan2021. On 28Dec2020, the patient had a COVID-19 PCR test that came back negative. On 01Jan2021, the patient suspected that he had COVID-19. He had a fever of 103.1 degrees Fahrenheit, body aches, chills like he was freezing to death, fatigue, diarrhea; however, he did not have nausea or loss of taste or smell. He had swollen lymph nodes, but no sore throat and his oxygen saturation was okay in Jan2021.  He was also having chest pain but it was more like intercoastal pain. He stated that these current symptoms were significantly worse than the ones he had just after getting the vaccine and felt more like the symptoms he had when he had COVID-19 before on 10Jun2020 (positive IgG for COVID-19-tested in 2020). The patient had a COVID nasal swab (PCR) done at an urgent care (physician's office) on 02Jan2020 or 03Jan2020 and was awaiting the results. The clinical outcome of the suspected COVID-19 was not recovered.; Sender's Comments: A causal association between reported suspected COVID-19 cannot be excluded.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Contusion, Decreased appetite, Dizziness, Fatigue
Clinical narrative: Swelling that looked like an egg under my arm, very visible very very sore; Swelling that looked like an egg under my arm, very visible very very sore/couldn't move my arm without it hurting; rash; hot to the touch; bruising; dizziness; nauseous; headache; body ache; muscle ache; very tired; joint pain; loss of appetite; This is a spontaneous report from a contactable healthcare professional. A 38-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ET1685, expiration date not reported), via an unspecified route of administration on the left arm, on 30Dec2020 at 11:45 at a single dose for Covid-19 immunization.  Medical history included latex and shellfish allergy. Patient was diagnosed with Covid-19 prior to vaccination.  The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included ergocalciferol (VITAMIN D), calcium, topiramate, and cyanocobalamin (vitamin B12).  The patient previously took erythromycin, terbutaline, iodine and experienced drug allergies.  On 30Dec2020 at 11:45, the patient experienced swelling that looked like an egg under her arm, very visible very very sore, rash, hot to the touch, bruising, dizziness, nauseous, headache, body ache, muscle ache, very tired, couldn't move arm without it hurting, joint pain, and loss of appetite. On 04Jan2021, the patient had a nasal swab and was tested for COVID-19, both with unknown result. The patient did not receive treatment for the events. The outcome of the events was recovering. The reporter assessed the events as non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Investigation, Myalgia, Nausea
Clinical narrative: Swelling that looked like an egg under my arm, very visible very very sore; Swelling that looked like an egg under my arm, very visible very very sore/couldn't move my arm without it hurting; rash; hot to the touch; bruising; dizziness; nauseous; headache; body ache; muscle ache; very tired; joint pain; loss of appetite; This is a spontaneous report from a contactable healthcare professional. A 38-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ET1685, expiration date not reported), via an unspecified route of administration on the left arm, on 30Dec2020 at 11:45 at a single dose for Covid-19 immunization.  Medical history included latex and shellfish allergy. Patient was diagnosed with Covid-19 prior to vaccination.  The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included ergocalciferol (VITAMIN D), calcium, topiramate, and cyanocobalamin (vitamin B12).  The patient previously took erythromycin, terbutaline, iodine and experienced drug allergies.  On 30Dec2020 at 11:45, the patient experienced swelling that looked like an egg under her arm, very visible very very sore, rash, hot to the touch, bruising, dizziness, nauseous, headache, body ache, muscle ache, very tired, couldn't move arm without it hurting, joint pain, and loss of appetite. On 04Jan2021, the patient had a nasal swab and was tested for COVID-19, both with unknown result. The patient did not receive treatment for the events. The outcome of the events was recovering. The reporter assessed the events as non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Peripheral swelling, Rash, SARS-CoV-2 test
Clinical narrative: Swelling that looked like an egg under my arm, very visible very very sore; Swelling that looked like an egg under my arm, very visible very very sore/couldn't move my arm without it hurting; rash; hot to the touch; bruising; dizziness; nauseous; headache; body ache; muscle ache; very tired; joint pain; loss of appetite; This is a spontaneous report from a contactable healthcare professional. A 38-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ET1685, expiration date not reported), via an unspecified route of administration on the left arm, on 30Dec2020 at 11:45 at a single dose for Covid-19 immunization.  Medical history included latex and shellfish allergy. Patient was diagnosed with Covid-19 prior to vaccination.  The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included ergocalciferol (VITAMIN D), calcium, topiramate, and cyanocobalamin (vitamin B12).  The patient previously took erythromycin, terbutaline, iodine and experienced drug allergies.  On 30Dec2020 at 11:45, the patient experienced swelling that looked like an egg under her arm, very visible very very sore, rash, hot to the touch, bruising, dizziness, nauseous, headache, body ache, muscle ache, very tired, couldn't move arm without it hurting, joint pain, and loss of appetite. On 04Jan2021, the patient had a nasal swab and was tested for COVID-19, both with unknown result. The patient did not receive treatment for the events. The outcome of the events was recovering. The reporter assessed the events as non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Lymphadenopathy, Nausea, Pain
Clinical narrative: Nausea; Swollen lymph nodes; tired all day; did not feel like herself-like she had the flu; soreness; This is a spontaneous report from a contactable nurse, the patient.  A 28-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246), intramuscular in the right arm on 02Jan2021 at 11:45 as a single dose for COVID-19 immunization.  Medical history included polycystic ovarian syndrome, prehypertension, prediabetic, and vitamin D deficiency. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient's concomitant medications were not reported.  The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took amoxicillin (MANUFACTURER UNKNOWN), erythromycin (MANUFACTURER UNKNOWN), and ciprofloxacin (CIPRO); all for unspecified indications from unknown dates to unknown dates and experienced drug allergy. On 02Jan2021 at 18:00, the patient started having soreness. On 03Jan2021 at 16:45, the patient had nausea. On 03Jan2021, she also had swollen lymph nodes,  was tired all day, and "she just did not feel like herself-like she had the flu". The patient was not given any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcomes of the soreness, nausea, swollen lymph nodes, tiredness, and "she did not feel like herself-like she had the flu" were recovering.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Dizziness, Fatigue, Headache, Insomnia
Clinical narrative: headache; dizziness; fatigue; couldn't sleep; severe abdominal pain; This is a spontaneous report from a contactable healthcare professional (patient herself). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiry date not reported), via an unspecified route of administration on the left arm on 29Dec2020 11:30 at single dose for COVID-19 immunisation. Medical history included Addison's disease, papaya allergy, and gluten intolerance. Concomitant medications included hydrocortisone and fludrocortisone acetate (FLORINEF ACETATE). The patient verbalized, "At first, on 29Dec2020, I experienced only mild side effects such as headache, dizziness and fatigue. Later, I woke up in the middle of the night with severe abdominal pain and couldn't sleep the pain was so bad. I had to take the following day off due to abdominal pain and fatigue." No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovered on an unspecified date.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Dizziness, Fatigue, Headache, Impaired work ability
Clinical narrative: headache; dizziness; fatigue; couldn't sleep; severe abdominal pain; This is a spontaneous report from a contactable healthcare professional (patient herself). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiry date not reported), via an unspecified route of administration on the left arm on 29Dec2020 11:30 at single dose for COVID-19 immunisation. Medical history included Addison's disease, papaya allergy, and gluten intolerance. Concomitant medications included hydrocortisone and fludrocortisone acetate (FLORINEF ACETATE). The patient verbalized, "At first, on 29Dec2020, I experienced only mild side effects such as headache, dizziness and fatigue. Later, I woke up in the middle of the night with severe abdominal pain and couldn't sleep the pain was so bad. I had to take the following day off due to abdominal pain and fatigue." No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovered on an unspecified date.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Sleep disorder
Clinical narrative: headache; dizziness; fatigue; couldn't sleep; severe abdominal pain; This is a spontaneous report from a contactable healthcare professional (patient herself). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiry date not reported), via an unspecified route of administration on the left arm on 29Dec2020 11:30 at single dose for COVID-19 immunisation. Medical history included Addison's disease, papaya allergy, and gluten intolerance. Concomitant medications included hydrocortisone and fludrocortisone acetate (FLORINEF ACETATE). The patient verbalized, "At first, on 29Dec2020, I experienced only mild side effects such as headache, dizziness and fatigue. Later, I woke up in the middle of the night with severe abdominal pain and couldn't sleep the pain was so bad. I had to take the following day off due to abdominal pain and fatigue." No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovered on an unspecified date.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), on an unspecified date as single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced anaphylaxis on an unspecified date. The outcome of anaphylaxis was unknown.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Pain
Clinical narrative: the injection site is very painful; chills; body aches; swollen lymph nodes; This is a spontaneous report from a contactable other healthcare professional (patient).  A 22-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL1284, via an unspecified route of administration in Left arm from 04Jan2021 03:45 to 04Jan2021 03:45 as SINGLE DOSE COVID-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported. On 05Jan2021 04:00 AM, the injection site is very painful, chills, body aches, and swollen lymph nodes (no sore throat). The outcome of the event was unknown. No treatment was received for the events.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Joint swelling, Peripheral swelling, Swelling, Tenderness
Clinical narrative: Arm, shoulder, and neck swollen; shoulder and neck swollen; shoulder and neck swollen; Extremely sour; Tender; This is a spontaneous report from a contactable other healthcare professional (HCP, patient). A 49-year-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9232) Intramuscular at Left arm on 04Jan2021 08:00 AM at single dose for COVID-19 immunization. Medical history included known allergies to sulfa based antibiotics and a steroid. There are other medications in two weeks. the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient used took ibuprofen and had allergy. Patient experienced arm, shoulder, and neck swollen. Extremely sour and tender on 04Jan2021 11:00 AM. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination the patient has not been tested for COVID-19. The most recent COVID-19 vaccine was administered at workplace clinic. No treatment received for the events. Patient was recovering from the events. It was non serious case. Not results in death, Life threatening, caused/prolonged hospitalization, Disabling/Incapacitating nor congenital anomaly/birth defect. Patient was recovering from the events.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Headache, Inappropriate schedule of product administration, Pain
Clinical narrative: Headache; Chest pains; high fever; body aches; chills; first dose 16Dec2020/ second dose 04Jan2021; This is a spontaneous report from a contactable pharmacist (the patient). A 21-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL1284), intramuscularly in the right arm on 04Jan2021 at 12:30 PM (at the age of 21-years-old) as a single dose for COVID-19 immunization. The patient's medical history included COVID-19. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EK5730), intramuscularly in the right arm on 16Dec2020 at 11:30 AM (at the age of 21-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 05Jan2021 at 12 AM, the patient experienced chest pains, high fever, chills, body aches, and headache. No treatment was given for chest pains, high fever, chills, body aches, and headache. The clinical outcome of chest pains, high fever, chills, body aches, and headache, was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.