chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Enlarged uvula, Mass, Oral pain, Oropharyngeal pain, Pain
Clinical narrative: it is really hurting; It hurts to talk because my issue is in my mouth; Uvula is swollen with the sore on it; Uvula is really swollen and it's got a mass of sore on it; Fever; sore throat; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: FC3183), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes patient received first dose bnt162b2 on an unspecified date (Batch/Lot Number: FC3180) as a single dose for covid-19 immunization. On an unspecified date the patient experienced it is really hurting, it hurts to talk because my issue is in my mouth, uvula is swollen with the sore on it, uvula is really swollen and it's got a mass of sore on it, fever and sore throat. Patient was experiencing the side effect of the second dose of Pfizer. Patient had the code that the dose patient had. Patient was experiencing a side effects from the second round of Pfizer. It hurts to talk because patient's issue is in its mouth. So, patient was trying to like cut down on all the talking that patient was doing because it really hurts to talk. Patient was looking to see if it is something, someone that can help me or if there has been any other reaction, a reported reaction like this. Patient was just trying to hurry so patient can find relief. patient can call that number right now. Patient got second round of Pfizer 2 days ago. Yesterday patient experienced a fever and a sore throat in the afternoon. Mind you patient got second late afternoon, very late afternoon two days ago, so yesterday afternoon  started showing side effects fever and a sore throat. The sore throat has stays the same but it turned out that it's not a sore throat, patient looked into its mouth right now, well actually patient looked into its mouth about an hour ago and its uvula was swollen with the sore on it and patient was not feeling like that prior to its injection. Patient was actually feeling really good, really healthy but prior to its second round and then patient called pharmacy where patient received second round of Pfizer and they told patient to call this number. Events were reported as non-serious. The outcome of events was unknown.  Follow-up (20Oct2021): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: it is really hurting; It hurts to talk because my issue is in my mouth; Uvula is swollen with the sore on it; Uvula is really swollen and it's got a mass of sore on it; Fever; sore throat; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: FC3183), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes patient received first dose bnt162b2 on an unspecified date (Batch/Lot Number: FC3180) as a single dose for covid-19 immunization. On an unspecified date the patient experienced it is really hurting, it hurts to talk because my issue is in my mouth, uvula is swollen with the sore on it, uvula is really swollen and it's got a mass of sore on it, fever and sore throat. Patient was experiencing the side effect of the second dose of Pfizer. Patient had the code that the dose patient had. Patient was experiencing a side effects from the second round of Pfizer. It hurts to talk because patient's issue is in its mouth. So, patient was trying to like cut down on all the talking that patient was doing because it really hurts to talk. Patient was looking to see if it is something, someone that can help me or if there has been any other reaction, a reported reaction like this. Patient was just trying to hurry so patient can find relief. patient can call that number right now. Patient got second round of Pfizer 2 days ago. Yesterday patient experienced a fever and a sore throat in the afternoon. Mind you patient got second late afternoon, very late afternoon two days ago, so yesterday afternoon  started showing side effects fever and a sore throat. The sore throat has stays the same but it turned out that it's not a sore throat, patient looked into its mouth right now, well actually patient looked into its mouth about an hour ago and its uvula was swollen with the sore on it and patient was not feeling like that prior to its injection. Patient was actually feeling really good, really healthy but prior to its second round and then patient called pharmacy where patient received second round of Pfizer and they told patient to call this number. Events were reported as non-serious. The outcome of events was unknown.  Follow-up (20Oct2021): Follow-up attempts completed. No further information expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lump/swollen lymph node at left clavicle; This is a spontaneous report from a contactable other hcp (patient). A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: 301358a) dose 3 via an unspecified route of administration, administered in Arm Left on 08Oct2021 12:30 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation (at the age 42 years). No known allergies were reported. Medical history included covid-19 and hypertension from an unknown date and unknown if ongoing. Concomitant medication included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]). The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: ER2613) dose 2 via an unspecified route of administration, administered in Arm Left on 22Mar2021 as DOSE 2, SINGLE and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: not written on card) dose 1 via an unspecified route of administration, administered in Arm Left on 14Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient had not received any other vaccine within 4 weeks. Patient had been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient experienced lump/swollen lymph node at left clavicle on 09Oct2021. No therapeutic measures were taken as a result of event. The clinical outcome of the event was not recovered.  Follow-Up (21Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: I have had a moderate to a severe headache for 3 days.; This is a spontaneous report from a contactable consumer, the patient. A 42-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 right arm on 06Oct2021 at 06:00 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. The patient did not have medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 06Oct2021 at 18:00, the patient had a moderate to a severe headache for 3 days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event had a moderate to a severe headache for 3 days was resolved on 09Oct2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Myalgia, Pain in extremity, Rash
Clinical narrative: Leg pain; Trouble walking; Rash on arms; Joint pain; muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the left arm on 19Sep2021 at 00:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the left arm on 26Aug2021 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. On 19Sep2021, the patient experienced leg pain, trouble walking, rash on arms, joint and muscle pain. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with prednisone (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events leg pain, trouble walking, rash on arms, joint and muscle pain was resolving at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Immunisation
Clinical narrative: Booster dose; Felt tired; Patient indicated had diarrhea; This is a spontaneous report from a non-contactable consumer. A non-pregnant female patient of unknown age received third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown if patient received any other vaccines within four weeks prior to the COVID vaccine. Concomitant medication included umbralisib (UKONIQ) for unknown indication from an unknown date and was unknown if ongoing. The patient previously received first dose and and second dose covid-19 vaccine on an unknown date for COVID-19 immunisation, primary Immunization series complete but unknown manufacturer. On 08Oct2021, followed by receiving the COVID-19 booster shot, the patient had diarrhea. The patient believed the shot was the cause of the sudden onset of diarrhea, and on 11Oct2021, as of the current day (of reporting), the patient felt tired and patient believed this was also due to the covid vaccine booster shot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the events. The clinical outcome of the event the patient indicated had diarrhea and felt tired was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Menstruation irregular, Pain in extremity
Clinical narrative: Swollen lymphoid; Early unset period by 2 weeks; Fatigue; Continued pain in arm post4 days; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 30-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 on 08Oct2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, diagnosed prior to the vaccination. The patient had no known allergies. Concomitant medications were not reported. On an unknown date in Oct2021, the patient experienced continued pain in arm post 4 days, swollen lymphoid, early onset (also reported as unset) period by 2 weeks and fatigue. The events resulted in emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events continued pain in arm was resolved on an unknown date in Oct2021; while that of the events swollen lymphoid, early onset period by 2 weeks and fatigue were not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Condition aggravated, SARS-CoV-2 test
Clinical narrative: Sudden onset of significant hair loss; Rapid significant onset of hair thinning; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 23Sep2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfa drugs and she also had been experiencing normal thinning with age and was genetically predisposed to gradual hair thinning with age. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Sep2021 the patient experienced sudden onset of significant hair loss within a few days of receiving the vaccine. Handful of hair were coming out. The patient had obvious bald patches on her scalp. There was no way that was coincidental. There were no other changes. she also had been experiencing normal thinning with age and was genetically predisposed to gradual hair thinning with age, but this was different. A rapid significant onset that lasted about a week or so. The events did not result in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On 08Oct2021, the patient underwent nasal swab and the result was negative. The clinical outcome of the events sudden onset of significant hair loss and rapid significant onset of hair thinning within a few days of receiving the vaccine was resolved with lasting effects on an unknown date in Oct2021.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Immunisation, Lymphadenopathy
Clinical narrative: Booster\received dose 3 of BNT162B2; Swollen lymph nodes under the arm on the side of injection; Temp 102; This is a spontaneous report from a contactable nurse. A 32-year-old non-pregnant female patient received the third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient had received any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 11Oct2021, the patient experienced swollen lymph nodes under the arm on the side of the injection and a body temperature of 102 (units unspecified). On 11Oct2021, the patient underwent body temperature test and the result was 102 (units unspecified). The reported events resulted in emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph nodes under the arm on the side of injection and temp 102 (units unspecified) was recovering at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Inappropriate schedule of product administration, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Soreness at injection site; Diarrhea; Nausea; Low fever; Dose 1 on 03Aug2021 and Dose 2 on 08Oct2021; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8839) via an unspecified route of administration in the right arm on 08Oct2021 at 13:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included depression, stress processing disorder, central auditory processing disorder, penicillin allergy and latex allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included bupropion (MANUFACTURER UNKNOWN) and drospirenone/ethinylestradiol (DROSPIRENONE; ETHINYLESTRADIOL) for unknown indication from an unknown date and unknown if ongoing. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 03Aug2021 at 16:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. On 09Oct2021 at 08:00, the patient experienced soreness at injection site, diarrhea, nausea and low fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events soreness at injection site, diarrhea, nausea, low fever were resolved on an unknown date in Oct2021.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, SARS-CoV-2 test
Clinical narrative: Menstrual Cycle started 2 weeks early.; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8027) via an unspecified route of administration on an unknown date (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2589) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date in 2021, the patient's menstrual cycle started 2 weeks early. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On 15Oct2021, the patient underwent BinaxNOW COVID-19 test via nasal swab and the result was negative. The clinical outcome of the event menstrual cycle started 2 weeks early was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Swelling
Clinical narrative: Tiredness; Swelling in left armpit.; Booster; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Oct2021 at 11:45 (at the age of-56-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included first dose of influenza vaccine (FLU) on 11Oct2021 in the left arm and vitamins (unspecified) for unknown indications from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENS318) via an unspecified route of administration in the left arm on 02Mar2021 (at the age of-56-years-old) and second dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Mar2021 (at the age of-56-years-old); as a single dose for COVID-19 immunisation. On 16Oct2021 at 12:15, the patient experienced tiredness and swelling in left armpit. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tiredness and swelling in left armpit were resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm; This is a spontaneous report from a contactable nurse (patient's parent). A 46-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left on 21Sep2021 at 46 years (Batch/Lot number FFEE39 or FFEE79) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included ongoing overweight. The patient's concomitant medications were not reported. The patient experienced sore arm (non-serious) in 2021 with outcome of unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101384449 Same patient/drug, different dose/events
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Started experiencing slight numbness, tingling, and pins and needle sensations up and down my left arm from the shoulder to my hand within a hour after my second dose.; Tingling and pins and needle sensations up and down my left arm from the shoulder to my hand within a hour after my second dose; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the right arm on 01Oct2021 at 09:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the right arm on 10Sep2021 at 09:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. On 01Oct2021 at 10:30, within an hour after second dose of vaccination, the patient experienced slight numbness, tingling, pins and needle sensations up and down the left arm from the shoulder to hand. This had been a generally consistent sensation since then and comes and goes throughout the day and night. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events slight numbness, tingling, pins and needle sensations up and down the left arm from the shoulder to hand were not resolved at the time of this report.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Postmenopausal haemorrhage
Clinical narrative: in menopause/went to the restroom and found light diluted blood discharge; I'm the last hour, I am experiencing more painful cramping.; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER BIONTECH), dose 1 at vaccination age of 53-year-old via an unspecified route of administration in the left arm on 16Oct2021 at 15:30 (Lot Number: EW0168) as dose 1, single for covid-19 immunisation. Medical history included menopause from 14Apr2021. The patient did not have Covid prior to vaccination. The patient has no known allergies. Concomitant medications included vitamin c [ascorbic acid] (VITAMIN C); zinc; sambucus nigra fruit (ELDERBERRY); and colecalciferol (D3 VITAMIIN), all indication, start and stop date were not reported. The patient reported that she was in menopause and date of last period was 14Apr2021. On 18Oct2021 at 18:00 pm (also reported as 19:00), the patient went to the restroom and found light diluted blood discharge. Now in the last hour, she was experiencing more painful cramping. She has historically have never had cramping problems when she had her normal periods. The cramping is escalating now as she was typing this. The patient considered the report as non-serious. It was unknown if the patient received treatment. The patient has not been tested for covid-19 post vaccination. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Nausea, Night sweats
Clinical narrative: Feels like she has Covid again; terrible headache; Nausea; Fatigue; Night sweats; she does not feel very good; This is a spontaneous report from a Pfizer sponsored program  support from consumer (patient) reporting herself. A 59-year-old female patient received BNT162B2 (Pfizer Covid-19 Vaccine, Formulation: Solution for injection, Batch/Lot number, Expiry Date and  number were not reported), dose 1 via an unspecified route of administration on 15Oct2021 as dose 1, single for covid-19 immunisation. Medical history included covid-19 in Aug2021. The patient's concomitant medications were not reported. In Oct2021, the patient experienced feels like she has covid again, headache, nausea, fatigue, night sweats and she does not feel very good. It was reported that she got her first dose of the Pfizer Covid-19 Vaccine on 15Oct2021, and she feels like she has Covid again. She had Covid-19 in Aug2021. She has a terrible headache, nausea, fatigue, and night sweats. She wanted to know how long this will last. She stated that she does not feel very good. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: Feels like she has Covid again; terrible headache; Nausea; Fatigue; Night sweats; she does not feel very good; This is a spontaneous report from a Pfizer sponsored program  support from consumer (patient) reporting herself. A 59-year-old female patient received BNT162B2 (Pfizer Covid-19 Vaccine, Formulation: Solution for injection, Batch/Lot number, Expiry Date and  number were not reported), dose 1 via an unspecified route of administration on 15Oct2021 as dose 1, single for covid-19 immunisation. Medical history included covid-19 in Aug2021. The patient's concomitant medications were not reported. In Oct2021, the patient experienced feels like she has covid again, headache, nausea, fatigue, night sweats and she does not feel very good. It was reported that she got her first dose of the Pfizer Covid-19 Vaccine on 15Oct2021, and she feels like she has Covid again. She had Covid-19 in Aug2021. She has a terrible headache, nausea, fatigue, and night sweats. She wanted to know how long this will last. She stated that she does not feel very good. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Dyspnoea, Fatigue, Musculoskeletal stiffness
Clinical narrative: Upset stomach; Neck muscles stiff; Sore throat; Tingly lips and throat; Stuffy nose; Tingly lips and throat; Muscle pain more than 5 days; Shortness of breath; Nausea; Diarrhea; Fatigue; Rash; Hives; Itching skin; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30135B2) via an unspecified route of administration on 13Oct2021 at 15:15 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included complicated health profile and many unspecified allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 13Oct2021, the patient experienced upset stomach, nausea, diarrhoea, sore throat, stuffy nose, fatigue, neck muscles stiff, muscle pain more than 5 days, rash, hives, tingly lips and throat, itching skin and shortness of breath. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events upset stomach, nausea, diarrhea, sore throat, stuffy nose, fatigue, neck muscles stiff, muscle pain more than 5 days, rash, hives, tingly lips and throat, itching skin and shortness of breath was recovering at the time of this report.  Amendment: This follow-up report is being submitted to amend previously reported information: added the pregnance information and updated concomitant therapy field.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nasal congestion, Nausea, Oropharyngeal pain, Paraesthesia oral
Clinical narrative: Upset stomach; Neck muscles stiff; Sore throat; Tingly lips and throat; Stuffy nose; Tingly lips and throat; Muscle pain more than 5 days; Shortness of breath; Nausea; Diarrhea; Fatigue; Rash; Hives; Itching skin; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30135B2) via an unspecified route of administration on 13Oct2021 at 15:15 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included complicated health profile and many unspecified allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 13Oct2021, the patient experienced upset stomach, nausea, diarrhoea, sore throat, stuffy nose, fatigue, neck muscles stiff, muscle pain more than 5 days, rash, hives, tingly lips and throat, itching skin and shortness of breath. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events upset stomach, nausea, diarrhea, sore throat, stuffy nose, fatigue, neck muscles stiff, muscle pain more than 5 days, rash, hives, tingly lips and throat, itching skin and shortness of breath was recovering at the time of this report.  Amendment: This follow-up report is being submitted to amend previously reported information: added the pregnance information and updated concomitant therapy field.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal paraesthesia, Pruritus, Rash, Urticaria
Clinical narrative: Upset stomach; Neck muscles stiff; Sore throat; Tingly lips and throat; Stuffy nose; Tingly lips and throat; Muscle pain more than 5 days; Shortness of breath; Nausea; Diarrhea; Fatigue; Rash; Hives; Itching skin; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30135B2) via an unspecified route of administration on 13Oct2021 at 15:15 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included complicated health profile and many unspecified allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 13Oct2021, the patient experienced upset stomach, nausea, diarrhoea, sore throat, stuffy nose, fatigue, neck muscles stiff, muscle pain more than 5 days, rash, hives, tingly lips and throat, itching skin and shortness of breath. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events upset stomach, nausea, diarrhea, sore throat, stuffy nose, fatigue, neck muscles stiff, muscle pain more than 5 days, rash, hives, tingly lips and throat, itching skin and shortness of breath was recovering at the time of this report.  Amendment: This follow-up report is being submitted to amend previously reported information: added the pregnance information and updated concomitant therapy field.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: It is not safe and effective; positive for Covid-19; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at singe dose, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at singe dose for covid-19 immunisation. Medical history and concomitant medications were not reported. Caller added you were vaccine chasing, this vaccine was the same concept, you will never get rid of it because it was a virus, the vaccine didn't work. It was not safe and effective, I get it, but after 2 vaccines and a person tests positive for Covid-19 and I know my friend's Dad went in for an antibody test after 6 months and he had literally zero. It's the vaccinated people who are spreading the virus not the unvaccinated. The patient underwent lab tests included antibody test: negative on unspecified date, covid test: positive on unspecified date. The outcome of events was unknown.  The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Chills, Heart rate, Immunisation
Clinical narrative: Tachycardia within 3 hours of 3rd booster dose of 115 bpm for 36 hours; at 100 bpm at 48 hours-60 hours (still unresolved).; gastro discomfort; Fever; chills; joint aches; muscle aches; the third dose; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the third dose via unspecified route of administration in right arm on 16Oct2021 at 09:30 AM (lot number: Pfizer FE3590) as single dose for COVID-19 immunization. The relevant medical history included birth control from unspecified date. Concomitant medications included esomeprazole magnesium (NEXIUM) from unspecified date for unspecified indication; ethinylestradiol, norethisterone (NECON) from unspecified date for birth control. The patient previously received BNT162B2, the first dose on 09Apr2021 (Pfizer BioNTech, lot number: EW0150, administration time: 11:00 AM, dose number: 1, vaccine location: Left arm) and the second dose on 29Apr2021 (Pfizer Biontech, lot number: Pfizer ER8731, administration time: 10:00 AM, dose number: 2, vaccine location: Left arm), both at the age of 42 years old for Covid-19 Immunization. The patient experienced tachycardia within 3 hours (as reported) of 3rd booster dose of 115 bpm for 36 hours; at 100 bpm at 48 hours-60 hours (still unresolved). Fever, chills, gastro discomfort, muscle aches and joint aches 12 hours-36 hours after booster. These adverse events were started on 16Oct2021 at 09:30 PM. No treatment received for these events. No covid prior vaccination. These events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab test included heart rate showed 115 bpm for 36 hours on 16Oct2021 and 100 bpm at 48 hours-60 hours on an unspecified date in Oct2021; Covid-19 test with unknown results on an unspecified date. The outcome of the event "Tachycardia within 3 hours of 3rd booster dose of 115 bpm for 36 hours; at 100 bpm at 48 hours-60 hours (still unresolved)" was not recovered, for event "the third dose" was unknown, while the other events were recovered with sequel on an unspecified date in Oct2021.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, SARS-CoV-2 test, Tachycardia
Clinical narrative: Tachycardia within 3 hours of 3rd booster dose of 115 bpm for 36 hours; at 100 bpm at 48 hours-60 hours (still unresolved).; gastro discomfort; Fever; chills; joint aches; muscle aches; the third dose; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the third dose via unspecified route of administration in right arm on 16Oct2021 at 09:30 AM (lot number: Pfizer FE3590) as single dose for COVID-19 immunization. The relevant medical history included birth control from unspecified date. Concomitant medications included esomeprazole magnesium (NEXIUM) from unspecified date for unspecified indication; ethinylestradiol, norethisterone (NECON) from unspecified date for birth control. The patient previously received BNT162B2, the first dose on 09Apr2021 (Pfizer BioNTech, lot number: EW0150, administration time: 11:00 AM, dose number: 1, vaccine location: Left arm) and the second dose on 29Apr2021 (Pfizer Biontech, lot number: Pfizer ER8731, administration time: 10:00 AM, dose number: 2, vaccine location: Left arm), both at the age of 42 years old for Covid-19 Immunization. The patient experienced tachycardia within 3 hours (as reported) of 3rd booster dose of 115 bpm for 36 hours; at 100 bpm at 48 hours-60 hours (still unresolved). Fever, chills, gastro discomfort, muscle aches and joint aches 12 hours-36 hours after booster. These adverse events were started on 16Oct2021 at 09:30 PM. No treatment received for these events. No covid prior vaccination. These events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab test included heart rate showed 115 bpm for 36 hours on 16Oct2021 and 100 bpm at 48 hours-60 hours on an unspecified date in Oct2021; Covid-19 test with unknown results on an unspecified date. The outcome of the event "Tachycardia within 3 hours of 3rd booster dose of 115 bpm for 36 hours; at 100 bpm at 48 hours-60 hours (still unresolved)" was not recovered, for event "the third dose" was unknown, while the other events were recovered with sequel on an unspecified date in Oct2021.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Immunisation
Clinical narrative: Booster; Tightness in chest; Mild trouble breathing; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Oct2021 at 15:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 15Oct2021, the patient experienced tightness in chest and mild trouble breathing. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tightness in chest and mild trouble breathing were unknown at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Patient tested positive for COVID following completion of the 2 dose series.; Patient tested positive for COVID following completion of the 2 dose series.; The patient received BNT162B2  dose 1 on 04Mar2021 and dose 2 on 15Sep2021; This is a spontaneous report from a non-contactable consumer. A 25-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Sep2021 (Lot Number: FF2587) as DOSE 2, SINGLE, and via an unspecified route of administration on 04Mar2021 (Lot Number: EN5318) as DOSE 1, SINGLE for COVID-19 immunization at a Pharmacy, at the age of 25 years old. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID on an unspecified date following completion of the 2 dose series . The patient received BNT162B2 dose 1 on 04Mar2021 and dose 2 on 15Sep2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Asthenia, Fall, Guillain-Barre syndrome, Pain
Clinical narrative: Diagnosed with Guillian Barre Syndrome (GBS); paresthesia in all extremities; falls x3; memory loss; weakness; pain; This is a spontaneous report from a contactable Other Healthcare Professional (patient) reported for herself. A 31-year-old female patient (not pregnant) received bnt162b2 (Pfizer COVID-19 vaccine), dose 1 via an unspecified route of administration, administered in Arm Right on 08Aug2021 at 31 years old (Lot Number: FC3181) as single dose for covid-19 immunization. Medical history was none, no known drug allergy, no COVID prior to vaccination. Concomitant medication in two weeks included omeprazole taken for an unspecified indication, start and stop date were not reported. No other vaccines in four weeks. The patient experienced diagnosed with Guillian Barre Syndrome (GBS), paresthesia in all extremities, falls x3, memory loss, weakness and pain on 22Aug2021. The patient underwent lab tests and procedures which included Nasal Swab for COVID: negative on 09Oct2021. Events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 7 days, Disability or permanent damage. Treatment received for the events included PT, OT, IVIG, pain meds, lyrica, gabapentin. The outcome of the events was not recovered. The patient received the second dose of bnt162b2 (Lot number: FC3184) administered in Right arm on 02Sep2021.; Sender's Comments: Based on temporal relationship the possibility of causal association between the events Gullian Barre Syndrome, Paraesthesia, Fall, Amnesia, Asthenia, Pain and the suspect drug BNT162B2 cannot be excluded.    The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, SARS-CoV-2 test
Clinical narrative: Diagnosed with Guillian Barre Syndrome (GBS); paresthesia in all extremities; falls x3; memory loss; weakness; pain; This is a spontaneous report from a contactable Other Healthcare Professional (patient) reported for herself. A 31-year-old female patient (not pregnant) received bnt162b2 (Pfizer COVID-19 vaccine), dose 1 via an unspecified route of administration, administered in Arm Right on 08Aug2021 at 31 years old (Lot Number: FC3181) as single dose for covid-19 immunization. Medical history was none, no known drug allergy, no COVID prior to vaccination. Concomitant medication in two weeks included omeprazole taken for an unspecified indication, start and stop date were not reported. No other vaccines in four weeks. The patient experienced diagnosed with Guillian Barre Syndrome (GBS), paresthesia in all extremities, falls x3, memory loss, weakness and pain on 22Aug2021. The patient underwent lab tests and procedures which included Nasal Swab for COVID: negative on 09Oct2021. Events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 7 days, Disability or permanent damage. Treatment received for the events included PT, OT, IVIG, pain meds, lyrica, gabapentin. The outcome of the events was not recovered. The patient received the second dose of bnt162b2 (Lot number: FC3184) administered in Right arm on 02Sep2021.; Sender's Comments: Based on temporal relationship the possibility of causal association between the events Gullian Barre Syndrome, Paraesthesia, Fall, Amnesia, Asthenia, Pain and the suspect drug BNT162B2 cannot be excluded.    The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.