chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding
Clinical narrative: Excessively heavy menstrual flow for 24 hours, 6 days after my second dose, excessive menstrual cramps; Excessively heavy menstrual flow for 24 hours, 6 days after my second dose, excessive menstrual cramps; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP6955), via an unspecified route of administration at the age of 41-year-old administered in arm left on 31Mar2021 12:30 PM at single dose for COVID-19 immunization. The patient medical history was not reported. There was no covid prior vaccination. Concomitant medications included sertraline hydrochloride (SERTRALINE); loratadine, pseudoephedrine sulfate (CLARITIN-D); acetylsalicylic acid (ASPIRIN ANALGESIC); colecalciferol (D3); zinc. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247) at left arm on 10Mar2021 12:30 PM for COVID-19 immunisation. There was no other vaccine in four weeks. The patient experienced excessively heavy menstrual flow for 24 hours, "6 days" after her second dose,  excessive menstrual cramps on 06Apr2021 01:30 AM. There was no covid tested post vaccination. There was no treatment. The outcome of event menstrual flow excessive was recovered on 07Apr2021 01:30 AM and other event was recovered on unspecified date. This report was reported as non-serious.  No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Constricted affect, Headache, Pain, Pyrexia
Clinical narrative: Aches/pain; Took next day off work. Had fever; Headache; whole body constricted including throat closing; whole body constricted including throat closing; This is a spontaneous report from a contactable consumer. A 68-year-old contactable consumer(patient) reported herself.  A 68-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER2613 and Expiration date was not reported), via intramuscular route, administered in Arm Left on 17Mar2021 15:50 as single dose for COVID-19 immunization. The patient's Medical history included colon cancer, sigmoidectomy, allergic to chemo from Mar2016 to Aug2016, normal blood pressure was normal is 120/80. Familial history includes father side heart disease and diabetes, mother side crohn's disease and colon cancer. Concomitant medications included ibuprofen per oral daily for arthralgia and arthritis and still ongoing. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6202 and Expiration date was not reported), via intramuscular route, administered in Arm Left on 24Feb2021 15:50, as single dose for COVID-19 immunization. At the time of 2d Pfizer the patient experienced vaccination numbness and tingling on left arm that was vaccinated, went to urgent case- blood pressure increased 153/95, patient normal blood pressure was 120/80, urgent case did not just suggested to observe and come back if needed as go to emergency room or call. whole body constricted including throat closing at time of vaccination went to urgent care blood pressure increase 153/94. On 17Mar2021, patient had fever and took next day off work. On an unknown date in Mar2021, the patient experienced aches, pain and headache. Therapeutic measures were taken as a result of adverse events and patient received treatment with Tylenol from 19Mar2021 to 21Mar2021 for Fever, aches, headache pain 2 days after second shot. The patient underwent COVID test on 15May2020 and the result was negative. The patient was scheduled for CT scan abdomen in Jun2021. The outcome of the event was reported as unknown.   No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Throat tightness
Clinical narrative: Aches/pain; Took next day off work. Had fever; Headache; whole body constricted including throat closing; whole body constricted including throat closing; This is a spontaneous report from a contactable consumer. A 68-year-old contactable consumer(patient) reported herself.  A 68-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER2613 and Expiration date was not reported), via intramuscular route, administered in Arm Left on 17Mar2021 15:50 as single dose for COVID-19 immunization. The patient's Medical history included colon cancer, sigmoidectomy, allergic to chemo from Mar2016 to Aug2016, normal blood pressure was normal is 120/80. Familial history includes father side heart disease and diabetes, mother side crohn's disease and colon cancer. Concomitant medications included ibuprofen per oral daily for arthralgia and arthritis and still ongoing. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6202 and Expiration date was not reported), via intramuscular route, administered in Arm Left on 24Feb2021 15:50, as single dose for COVID-19 immunization. At the time of 2d Pfizer the patient experienced vaccination numbness and tingling on left arm that was vaccinated, went to urgent case- blood pressure increased 153/95, patient normal blood pressure was 120/80, urgent case did not just suggested to observe and come back if needed as go to emergency room or call. whole body constricted including throat closing at time of vaccination went to urgent care blood pressure increase 153/94. On 17Mar2021, patient had fever and took next day off work. On an unknown date in Mar2021, the patient experienced aches, pain and headache. Therapeutic measures were taken as a result of adverse events and patient received treatment with Tylenol from 19Mar2021 to 21Mar2021 for Fever, aches, headache pain 2 days after second shot. The patient underwent COVID test on 15May2020 and the result was negative. The patient was scheduled for CT scan abdomen in Jun2021. The outcome of the event was reported as unknown.   No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Sudden hearing loss, Tinnitus
Clinical narrative: Left ear sudden hearing loss; increased tinnitus; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6202), via an unspecified route of administration on 01Mar2021 at 11:00 in arm left as a single dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER2613), via an unspecified route of administration on 22Mar2021 in arm left as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications in two weeks included lisinopril (LISINOPRIL), atorvastatin (ATORVASTATIN), citalopram (CITALOPRAM) and pantoprazole (PANTOPRAZOLE). It was reported that, the patient had no known allergies. No other vaccine in 4 weeks. No covid prior vaccination and no covid tested post vaccination. On 08Mar2021, the patient experienced left ear sudden hearing loss and increased tinnitus. Treatment medication included prednisone. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered with lasting effects.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Pregnancy test
Clinical narrative: Menstrual Cycle went completely away, like it disappeared/hasn't seen anymore cycles; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN5318 and expiry: 31May2021), via an unspecified route in left arm on 12Feb2021 11:30 (at the age of 30-years-old) as 2 nd dose, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was a clinic and vaccine was not administered at a (name) facility. No additional vaccines administered on same date of bnt162b2. The patient received first dose of bnt162b2 (lot:EL1284,expiry:30Apr2021) on 21Jan2021 at 11:00 (at the age of 30-years-old) for COVID-19 immunisation and experienced a small allergic reaction, left side of her lip was swollen and became numb from 21Jan2021 to 22Jan2021, recovered. The patient went home, she put ice on it and it was gone the next day. The patient had no medical history and no concomitant medications. The patient previously took a Flu Shot in Jan2021. The patient reported that her menstrual cycle went completely away, like it disappeared in Feb2021. The patient got her cycle on 19Feb2021, and it only stayed on for three to four days, when it normally stays for five to six days. After that, her period has disappeared, she hasn't seen anymore cycles. The patient clarified that she was a natural cycle person, she didn't have irregular cycles. Her periods came on regular all of the time, this was just since she got the vaccine. The bloodwork pregnancy test and pregnancy test on unspecified dates were negative. Apparently this just came up and she thinks it was from the vaccine. Clarified that she was not pregnant. Asked if what hormones were in the vaccine that may have caused the disappearance of her cycle. No treatment for the event (none for cycle). The event required Physician Office visit but no emergency room visit. The outcome of the event was not recovered.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Feeling of body temperature change, Menstruation irregular
Clinical narrative: experienced bleeding last night, when she is not even scheduled to have her menstruation yet; Vaginal bleeding; dizziness; waves of nausea; tiredness; chills; feels hot and cold a lot/hot flashes or cold a lot; had cramps similar to that of menstrual cramps; felt like she had a fever; This is a spontaneous report from a contactable consumer (Patient). A 29 years old female patient received the 1st dose of BNT162B2 (the Pfizer-BioNTech Covid-19 Vaccine, Batch/lot number: ER8729) on 09Apr2021 on left arm at single dose for covid-19 immunization. Medical history was not reported. She took a lot of medications, antidepressants and antianxiety meds, states she told the facility where she got the vaccine about these. Until now, she said she is still experiencing dizziness, waves of nausea, tiredness, and chills. She said she feels hot and cold a lot. Last night (14Apr2021), she said she had cramps similar to that of menstrual cramps. She said she has not had cramps ever since she started being on an Intrauterine Device (IUD) and birth control. Consumer also said that she experienced Vaginal bleeding last night (14Apr2021), when she is not even scheduled to have her menstruation yet. She wants to know if this is a normal reaction to the vaccine, and if it is normal that she is still having the symptoms even after almost 7 days since receiving the vaccine. Caller states she gets dizzy a lot, waves of nausea, and felt like she had a fever, hot flashes or cold a lot. Had to call out of work on the weekend. Last night was really weird for her, was having cramps, like menstrual cramps, has an IUD and takes birth control and went to the bathroom and she was bleeding, even if she was supposed to have her period it wouldn't be the time she was supposed to be having it, called her Gynocologist to let them know. Dizziness gets worse during the day, nausea comes in waves, tries to sleep through the day, the more she sleeps the better she feels. Does not know if this is an allergic reaction. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Nausea, Pyrexia, Vaginal haemorrhage
Clinical narrative: experienced bleeding last night, when she is not even scheduled to have her menstruation yet; Vaginal bleeding; dizziness; waves of nausea; tiredness; chills; feels hot and cold a lot/hot flashes or cold a lot; had cramps similar to that of menstrual cramps; felt like she had a fever; This is a spontaneous report from a contactable consumer (Patient). A 29 years old female patient received the 1st dose of BNT162B2 (the Pfizer-BioNTech Covid-19 Vaccine, Batch/lot number: ER8729) on 09Apr2021 on left arm at single dose for covid-19 immunization. Medical history was not reported. She took a lot of medications, antidepressants and antianxiety meds, states she told the facility where she got the vaccine about these. Until now, she said she is still experiencing dizziness, waves of nausea, tiredness, and chills. She said she feels hot and cold a lot. Last night (14Apr2021), she said she had cramps similar to that of menstrual cramps. She said she has not had cramps ever since she started being on an Intrauterine Device (IUD) and birth control. Consumer also said that she experienced Vaginal bleeding last night (14Apr2021), when she is not even scheduled to have her menstruation yet. She wants to know if this is a normal reaction to the vaccine, and if it is normal that she is still having the symptoms even after almost 7 days since receiving the vaccine. Caller states she gets dizzy a lot, waves of nausea, and felt like she had a fever, hot flashes or cold a lot. Had to call out of work on the weekend. Last night was really weird for her, was having cramps, like menstrual cramps, has an IUD and takes birth control and went to the bathroom and she was bleeding, even if she was supposed to have her period it wouldn't be the time she was supposed to be having it, called her Gynocologist to let them know. Dizziness gets worse during the day, nausea comes in waves, tries to sleep through the day, the more she sleeps the better she feels. Does not know if this is an allergic reaction. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Breast discomfort, Breast enlargement, Menstrual disorder, Vaginal haemorrhage
Clinical narrative: she felt like her breast were sensitive and more larger like when she got her period; she felt like her breast were sensitive and more larger like when she got her period; unexpected menstrual period; unexpected vaginal bleeding; This is a spontaneous report from a contactable consumer (patient). A 37-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 07Apr2021 4:00 pm (Batch/Lot number was not reported) as single dose for covid-19 immunisation. There are no patient history and concomitant medications. Prior vaccinations (within 4 weeks) was none. Patient is healthy. She hasn't had vaccines since she was a child. Patient experienced unexpected menstrual period from 13Apr2021 and ongoing. Caller thought she was having a side effect to the COVID vaccine. She was having unexpected vaginal bleeding. She got the Pfizer COVID vaccine, first dose. Caller declined email. She didn't have a prescribing doctor. This was the first dose. She got the first dose on 07Apr2021, and then started bleeding the 13Apr2021. She thought it was gone last night, but then this morning it is more like a menstrual period. She had her period for 6 days, and it ended 4 days ago. Her period ended. She has never had unexpected bleeding. Her period was always on time and normal. She was pretty sure it was another period. It was weird because she felt like her breast were sensitive and more larger like when she got her period. She was confused for 2 days because she didn't understand why she felt like that. Then, she started bleeding. She scheduled her second dose. She has misplaced the card with the NDC/lot/expiration. She only has her receipt. She would like to know the ingredients of the vaccine. No emergency room and physician office visit. But she was going to the doctor Friday to talk to her. No investigation assessment. No relevant tests. The event outcome for unexpected menstrual period was not recovered, for other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral
Clinical narrative: Lost hearing in left ear 36 hours after 2nd vaccination; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 22Mar2021 16:00 (Batch/Lot Number: EN6207) as 2nd dose, single for covid-19 immunisation. The patient has no medical history and concomitant medications. The patient has no known allergies. The patient had no other vaccine in four weeks and no covid prior to vaccination. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EN6148) on 01Mar2021 16:00 in the left arm for COVID-19 immunization. The patient lost hearing in left ear, 36 hours after 2nd vaccination (25Mar2021). The event resulted in doctor or other healthcare professional office/clinic visit. The event was not treated. The patient was not tested for covid post vaccination. The outcome of the event was not recovered.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Mammogram, Nodule
Clinical narrative: Left side of neck I had two small lumps, it is been a month since vaccination and I still have the lump; This is a spontaneous report from a contactable other hcp. A 30-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 16Mar2021 12:30 (Batch/Lot Number: 59267-1000-02) (at the age of 30-years-old) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other medications within 2 weeks of vaccination. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Patient did not have Allergies to medications, food, or other products . On an unspecified date patient experienced , on the neck part of the left side I got two balls, it's been 1 month of the vaccine and I still have a ball, talk to the pharmacy and they told me it was part of a mammogram, that to think that's nothing to do with what came out. The patient underwent lab tests and procedures which included mammogram of unknown results . Patient did not receive any treatment for the adverse event. Outcome of the event was Not recovered/Not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Headache, Tinnitus
Clinical narrative: Tinnitus both ears.  Ongoing headache occur w movement at times or just pressure.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Mobility decreased, Nausea
Clinical narrative: Diarrhea  Nauseous  Headache  Fever Chills Joint pain Limited mobility in arm with injection
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Diarrhea  Nauseous  Headache  Fever Chills Joint pain Limited mobility in arm with injection
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Fatigue, Feeling abnormal
Clinical narrative: Swelling at injection site, fatigue, nausea, chills, hot flashes, mental fog, upset stomach and trouble with appetite for 2-3 days.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Hot flush, Injection site swelling, Nausea
Clinical narrative: Swelling at injection site, fatigue, nausea, chills, hot flashes, mental fog, upset stomach and trouble with appetite for 2-3 days.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Throat tightness, took 50mg benadryl, problem resolved
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: They were diagnosed with COVID-19 last 01Apr; This is a spontaneous report from a Pfizer Sponsored Program  Support via a contactable consumer (patient) reported for himself. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration Date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 31Mar2021 (age at vaccination was unknown) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he and his wife had the 1st shot of the vaccine last 31Mar2021 and they were scheduled for the 2nd shot on 23Apr2021. On 01Apr2021, the patient's SARS-CoV-2 test was positive and they were diagnosed with COVID-19. On 17Apr2021, the patient's SARS-CoV-2 test was negative and now they were negative of the virus. His main concern was to know if the vaccine was safe to take after all. The outcome of the event was recovered on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-up (17Apr2021): New information received from a Pfizer-sponsored program Support via a contactable consumer (patient) included: No new information was reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Food allergy, Heart rate, Heart rate increased, Insomnia
Clinical narrative: could not sleep at all; fainted; felt worse fainted and almost felt passing out; multiple panics attacks during the day; sensitiveness to salty food; palpitations/heart palpitation 138 "bps"; heart raised really quick; felt difficulty breathing; This is a spontaneous report received via COVID-19 Vaccine Adverse Event Reporting System (COVAES). A conta sctable consumer (patient) reported a 39-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6207) via an unspecified route of administration on 26Mar2021 at 10:00 (at the age of 39-years-old) as aingle dose in the left arm  for COVID-19 immunization. Medical history included non-alcoholic steatohepatitis (NASH) and pre-diabetic. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included multivitamins. The patient did not have any allergies. On 26Mar2021, ten minutes after the vaccine (also reported as 10:15) the patient experienced heart raised really quick and felt difficulty breathing but calmed down and left the site. The next day (27Mar2021) she drank coffee like every morning but noticed palpitations, noticed sensitiveness to salty foods after ingestion felt palpitations but was not concerned as she thought it was a side effect. On 31Mar2021 she suddenly woke up at 05:00 with heart palpitations "138 bps." She thought it was going to go away but she felt worse, fainted, and almost "felt" passing out. Paramedics showed up and her heart rate was 115 but nothing serious, suspected panic attack. She never had before so she thought it was going to go away but she had multiple panic attacks during the day and night, could not sleep at all for 3 consecutive days. The patient visited a doctor as a result of the events. She was prescribed trazodone "one at night." The patient also saw a cardiologist for the palpitations and was treated with metoprolol 25 mg twice a day to control palpitations but the meds gave her intrusive thoughts and deep depression with suicidal thoughts. The outcomes of heart raised really quickly/palpitations, difficulty breathing, sensitiveness to salty foods, fainted, almost "felt" passing out, and panic attacks were recovering.    No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Panic attack, Presyncope, Syncope
Clinical narrative: could not sleep at all; fainted; felt worse fainted and almost felt passing out; multiple panics attacks during the day; sensitiveness to salty food; palpitations/heart palpitation 138 "bps"; heart raised really quick; felt difficulty breathing; This is a spontaneous report received via COVID-19 Vaccine Adverse Event Reporting System (COVAES). A conta sctable consumer (patient) reported a 39-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6207) via an unspecified route of administration on 26Mar2021 at 10:00 (at the age of 39-years-old) as aingle dose in the left arm  for COVID-19 immunization. Medical history included non-alcoholic steatohepatitis (NASH) and pre-diabetic. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included multivitamins. The patient did not have any allergies. On 26Mar2021, ten minutes after the vaccine (also reported as 10:15) the patient experienced heart raised really quick and felt difficulty breathing but calmed down and left the site. The next day (27Mar2021) she drank coffee like every morning but noticed palpitations, noticed sensitiveness to salty foods after ingestion felt palpitations but was not concerned as she thought it was a side effect. On 31Mar2021 she suddenly woke up at 05:00 with heart palpitations "138 bps." She thought it was going to go away but she felt worse, fainted, and almost "felt" passing out. Paramedics showed up and her heart rate was 115 but nothing serious, suspected panic attack. She never had before so she thought it was going to go away but she had multiple panic attacks during the day and night, could not sleep at all for 3 consecutive days. The patient visited a doctor as a result of the events. She was prescribed trazodone "one at night." The patient also saw a cardiologist for the palpitations and was treated with metoprolol 25 mg twice a day to control palpitations but the meds gave her intrusive thoughts and deep depression with suicidal thoughts. The outcomes of heart raised really quickly/palpitations, difficulty breathing, sensitiveness to salty foods, fainted, almost "felt" passing out, and panic attacks were recovering.    No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: 'seizes'/seizure; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 31Mar2021 at 13:00 (at the age of 54-years-old) as 1st dose, single (Batch/Lot Number: ER8732), via an unspecified route of administration, administered in arm left for COVID-19 immunisation. Medical history included coconut allergy from an unknown date and unknown if ongoing. Concomitant medications included topiramate and triamterene, both taken for an unspecified indication, start and stop dates were not reported. Between 31Mar2021 and 21Apr2021 (reported as Apr2021), the patient had a total of 10 'seizes'/seizure. Before, he had 2 to 4 'seizes' within a three months' time. The patient received the second dose of BNT162B2 on 21Apr2021 at 13:00 (Batch/Lot Number: EW0151), via an unspecified route of administration, administered in arm left for COVID-19 immunisation. There was no treatment received for the event. The outcome of the event was unknown.    Information about lot/ batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Hypoaesthesia
Clinical narrative: Stomach cramps; Numbness in right leg; This is a spontaneous report from a contactable consumer (patient) from COVAES. This 38-year-old non-pregnant female patient received the second dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME; lot number ER8735) via an unspecified route of administration in the left arm on 21Apr2021 at 13:00 (at the age of 38-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 and had not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received the first dose of COVID-19 vaccine on an unspecified date for COVID-19 immunisation. On 21Apr2021 at 19:00 the patient experienced stomach cramps and numbness in the right leg. No treatment was received for the events. The clinical outcomes of stomach cramps and numbness in right leg were recovering. It was also reported that since vaccination the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Euphoric mood, Fatigue, Feeling abnormal, Rash, Somnolence
Clinical narrative: very brain fogged; sensation of feeling high; exhausted; need multiple naps per day; rash on my stomach; This is a spontaneous report from a contactable consumer (patient). This 35-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0169) via an unspecified route of administration in the left arm on 21Apr2021 at 10:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety from an unknown date and unknown if ongoing. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines in the 4 weeks prior to the COVID vaccine. Concomitant medications included sertraline from an unknown date for an unknown indication, and loratadine (CLARITIN "OTC") from an unknown date for an unknown indication. The patient previously received the first dose of BNT162B2 (lot number ER8734) on 31Mar2021 (at the age of 35-years-old) for COVID-19 immunisation. The patient reported that within 2 hours after vaccination she became very brain fogged which then turned into a sensation of feeling high; further reporting she could not stop laughing for an hour and was super high for another 4 hours. She reported that also on day 3, "now," and she was still exhausted and needed multiple naps per day. She also reported she had a rash on her stomach. The events were reported as non-serious and no treatment was received. The clinical outcomes of very brain fogged and sensation of feeling high were recovering and the outcomes of exhausted, need multiple naps per day and rash on her stomach were not recovered. It was also reported that since vaccination the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Pain in extremity
Clinical narrative: Nose bleed the next day; Immediate pain through the hand and fingers on the arm; This is a spontaneous report received from a contactable consumer (patient).  A 37-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 21Apr2021 17:30 (Batch/Lot number was not reported), age at vaccination of 37-years-old, as single dose, for covid-19 immunisation. Medical history included corneal erosion from an unknown date and unknown if ongoing (Recurrent Corneal Erosion syndrome), food allergy from an unknown date and unknown if ongoing known (allergies to Dairy products), allergy to chemicals from an unknown date and unknown if ongoing known (allergies to MRI contrast dye). The patient was not pregnant and was not pregnant at the time of vaccination. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX) taken for an unspecified indication, start and stop date were not reported; hydroxyzine (HYDROXYZINE) taken for an unspecified indication, start and stop date were not reported; valeriana officinalis root, valeriana officinalis root extract (VALERIAN ROOT EXTRACT) taken for an unspecified indication, start and stop date were not reported. . The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took penicilline and experienced drug hypersensitivity, quinolones and experienced drug hypersensitivity, zoloft and experienced drug hypersensitivity. The patient experienced immediate pain through the hand and fingers on the arm it was administered on 24Apr2021 at 12.00 and  woke up with a nose bleed the next day on 23Apr2021. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Fatigue, Pain
Clinical narrative: Chills; Body aches; Fever; Cough; Fatigued; This is a spontaneous report from a contactable consumer (patient) via COVAES. This 55-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0153) via an unspecified route of administration in the left arm on 16Apr2021 at 10:30 (at the age of 55-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 and had not received any other vaccines in the 4 weeks prior to the COVID vaccine. Concomitant medications included esomeprazole magnesium and ibuprofen, both from unknown dates for unknown indications. The patient previously received the first dose of BNT162B2 (lot number unknown) on 25Mar2021 at 11:15 (at the age of 55-years-old) for COVID-19 immunisation. The patient reported that 24 hours post injection she experienced chills, body aches, fever and a cough; further reporting the fever peaked at 100.7 and her symptoms lasted about 24 hours. She also reported she was fatigued for 72 hours after that. The clinical outcomes of chills, body aches, fever and a cough were recovered on 18Apr2021 at 12:00, the outcome of fatigue was recovered in Apr2021. It was also reported the patient was not tested for COVID-19 since vaccination.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills; Body aches; Fever; Cough; Fatigued; This is a spontaneous report from a contactable consumer (patient) via COVAES. This 55-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0153) via an unspecified route of administration in the left arm on 16Apr2021 at 10:30 (at the age of 55-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 and had not received any other vaccines in the 4 weeks prior to the COVID vaccine. Concomitant medications included esomeprazole magnesium and ibuprofen, both from unknown dates for unknown indications. The patient previously received the first dose of BNT162B2 (lot number unknown) on 25Mar2021 at 11:15 (at the age of 55-years-old) for COVID-19 immunisation. The patient reported that 24 hours post injection she experienced chills, body aches, fever and a cough; further reporting the fever peaked at 100.7 and her symptoms lasted about 24 hours. She also reported she was fatigued for 72 hours after that. The clinical outcomes of chills, body aches, fever and a cough were recovered on 18Apr2021 at 12:00, the outcome of fatigue was recovered in Apr2021. It was also reported the patient was not tested for COVID-19 since vaccination.  No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: Soft walnut sized mass appeared under right armpit; This is a spontaneous report received from a contactable consumer via COVAES. A non-pregnant 74-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6205) via an unspecified route of administration in the left arm on 12Mar2021 at 13:30 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included peripheral neuropathy, allergies and chronic headaches, all from unknown dates and unknown if ongoing. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines in the 4 weeks prior to the COVID vaccine. The patient experienced a soft walnut sized mass appeared under right armpit on 12Apr2021. The event was reported as non-serious and did not require hospitalization. The event required a doctor or other healthcare professional office/clinic visit; no treatment was received for the event. The clinical outcome of soft walnut sized mass appeared under right armpit was not recovered. It was also reported that since vaccination the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received dose 1 of BNT`61B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 21Apr2021 at 14:30 (at the age of 51-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included allergies to wheat, rice, peanut, soy, and garlic. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included losartan potassium (COZAAR), acebutolol hydrochloride (SECTRAL), fexofenadine (ALLEGRA) and phentermine from unknown dates for unknown indications. On 23Apr2021 at 16:00 the patient experienced extreme tiredness exhaustion. The event was reported as non-serious. The outcome of extreme tiredness exhaustion was not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Diarrhoea
Clinical narrative: Severe diarrhea; To the point of extreme dehydration; This is a spontaneous report received from a contactable consumer (patient).  A 34-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 22Apr2021 15:00 (Batch/Lot Number: EW0161; Expiration Date: 31Jul2021), age at vaccination of 34-years-old, as single dose,for covid-19 immunisation. The patient medical history was not reported; patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 28Mar2021 17:00 (Batch/Lot Number: ER8732; Expiration Date: 31Jul2021) for covid-19 immunisation. The patient had no allergy. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced non-serious severe diarrhea and non-serious extreme dehydration, both on 23Apr2021 06:00 AM. No treatments were administered. Facility where the most recent COVID-19 vaccine was administered: Hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Feeling hot, Head discomfort, Neck pain
Clinical narrative: severely shivering; body was so sore I could barely stand up; full body was freezing cold; neck was sore in a lot of pain; face felt like it was on fire; lot of pressure to the Head; This is a spontaneous report received from a contactable consumer (patient). A 27-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 21Apr2021 at 14:30 (at the age of 27-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. The patient did not take any concomitant medications. The patient did not have any allergies. The patient previously received dose 1 of BNT162B2 on 31Mar2021 at 14:30 as a single dose in the left arm for COVID-19 immunization. On 22Apr2021, at 03:00 (also reported as 02:00) the patient woke up severely shivering for a few hours. Following that her body was so sore she could barely stand up. Her full body was freezing cold but her face felt like it was on fire. Those symptoms lasted 24 hours. After that, day 2 and 3 her neck was sore in a lot of pain and every once in a while she got a lot of pressure to the head which felt like it was going to explode. The patient did not receive any treatment for the events. The outcomes of shivering, body was so sore, full body was freezing cold, face felt like it was on fire, neck soreness and pain, and pressure to the head were recovered with lasting effects. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: severely shivering; body was so sore I could barely stand up; full body was freezing cold; neck was sore in a lot of pain; face felt like it was on fire; lot of pressure to the Head; This is a spontaneous report received from a contactable consumer (patient). A 27-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 21Apr2021 at 14:30 (at the age of 27-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. The patient did not take any concomitant medications. The patient did not have any allergies. The patient previously received dose 1 of BNT162B2 on 31Mar2021 at 14:30 as a single dose in the left arm for COVID-19 immunization. On 22Apr2021, at 03:00 (also reported as 02:00) the patient woke up severely shivering for a few hours. Following that her body was so sore she could barely stand up. Her full body was freezing cold but her face felt like it was on fire. Those symptoms lasted 24 hours. After that, day 2 and 3 her neck was sore in a lot of pain and every once in a while she got a lot of pressure to the head which felt like it was going to explode. The patient did not receive any treatment for the events. The outcomes of shivering, body was so sore, full body was freezing cold, face felt like it was on fire, neck soreness and pain, and pressure to the head were recovered with lasting effects. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis, Pain in extremity, Vision blurred
Clinical narrative: Her vision in her left eye became blurry; Started out as if she had pink eye or conjunctivitis; Arm soreness; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 01Apr2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 on an unspecified date as a single dose for COVID-19 immunization and experienced arm soreness. Nine days after the patient received dose 2 of BNT162B2 (10Apr2021) the patient experienced vision in her left eye became blurry and she couldn't see because it was completely blurry. It started out as if she had pink eye or conjunctivitis. She normally did not wear glasses except for reading but now the vision was blurry. She also had arm soreness on an unspecified date. The outcomes of arm soreness, conjunctivitis, and blurry vision were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Mass, Myalgia, Oropharyngeal pain
Clinical narrative: Muscle soreness; High fever; Coughing; Chills; Sore throat; lump and swelling...above her collarbone; lump and swelling...above her collarbone; This is spontaneous report from a contactable consumer (patient). A 59-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date (at the age of 59-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 on an unspecified date as a single dose for COVID-19. The patient received dose 2 of the vaccine on Tuesday morning. She felt fine at first but that evening she had muscle soreness. On Wednesday she had a high fever, coughing, chills, and sore throat. The fever went away that evening. "Yesterday" (23Apr2021) between 16:00-17:00 the patient noticed where the seatbelt goes a lump and swelling on the same side the vaccine was injected above her collarbone. The patient had an appointment with a dermatologist but if her symptoms resolved before the appointment she would cancel it. The outcome of fever was recovered. The outcomes of muscle soreness, coughing, chills, sore throat, lump, and swelling were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling
Clinical narrative: Muscle soreness; High fever; Coughing; Chills; Sore throat; lump and swelling...above her collarbone; lump and swelling...above her collarbone; This is spontaneous report from a contactable consumer (patient). A 59-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date (at the age of 59-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 on an unspecified date as a single dose for COVID-19. The patient received dose 2 of the vaccine on Tuesday morning. She felt fine at first but that evening she had muscle soreness. On Wednesday she had a high fever, coughing, chills, and sore throat. The fever went away that evening. "Yesterday" (23Apr2021) between 16:00-17:00 the patient noticed where the seatbelt goes a lump and swelling on the same side the vaccine was injected above her collarbone. The patient had an appointment with a dermatologist but if her symptoms resolved before the appointment she would cancel it. The outcome of fever was recovered. The outcomes of muscle soreness, coughing, chills, sore throat, lump, and swelling were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained