chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Headache, Illness
Clinical narrative: Heart failure; Weak; She wasn't sure if she was running a fever but feels really hot right now; She also mentioned she had started walking but she felt like she couldn't breathe. She had difficulty breathing while walking; felt weird; Headache; Extremely tired; received booster or third dose of product; a little ill; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received third dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot number/ NDC number/ expiration date was not reported) via an unspecified route of administration on 13Sep2021 15:00 as dose 3, single for covid-19 immunisation. Medical history and concomitant medication were not reported. The patient previously took first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and expiration date: not reported), via an unspecified route of administration on as dose 1, single and dose 2, single both for COVID-19 immunisation. On an unspecified date, the patient experienced heart failure. On 13Sep2021 15:00, the patient received booster or third dose of product. On the same day at 17:00, patient felt weird, headache, extremely tired and at 17:30, patient felt weak, she wasn't sure if she was running a fever but feels really hot right now. On 13Sep2021, she also mentioned she had started walking but she felt like she couldn't breathe. she had difficulty breathing while walking and little il. Additional information included that the caller is calling regarding the Pfizer COVID-19 vaccine. She received her booster or her third dose yesterday and by the time she got home she felt weird and a little ill around 5:00PM. She also stated that she experienced a headache, weakness, and she felt extremely tired. She also mentioned that she is still not feeling that great right now. She stated that she did good with the 2 previous doses of the Pfizer COVID-19 vaccine and only experienced side effects with the third dose. She also stated that she wasn't sure if she was running a fever but feels really hot right now. She also mentioned she had started walking but she felt like she couldn't breathe. She had difficulty breathing while walking. She also brought up her medical condition that she had, she has heart failure and she is taking medication for that. The agent did not get name of that medication. It is not specified if the caller had the heart failure prior to receiving the Pfizer COVID-19 vaccines. Outcome of the events was unknown.  The lot number for [BNT162B2] was not provided and will be requested during follow-up.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Biopsy, Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable Consumer. A 59-years-old patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: ER8729, expiry date: unknown) via unspecified route of administration, in left arm on 12Apr2021 09:00 (age at vaccination: 59), as dose 1, single for covid-19 immunisation. Patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0172, expiry date: unknown) via unspecified route of administration, in left arm on 05May2021 09:00 (age at vaccination: 59), as dose 2, single for covid-19 immunisation. Vaccination facility type was school/student health clinic. No prior vaccinations (within 4 weeks) taken within four weeks prior to the first administration date of the suspect vaccine. Medical history included high blood pressure from an unspecified date and unknown if ongoing. Concomitant medication included ongoing Valsartan (pill), start date unknown, taken for high blood pressure. On 15Apr2021, patient experienced herpes zoster. Emergency room visit took place due to the adverse event. Treatment regimen was provided as a result of the adverse event. Patient underwent lab test which included biopsy test on 19Apr2021 with positive result (shingles). The outcome of event was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable consumer. A 7-decade-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch / Lot number and expiration date was not reported) via an unspecified route of administration on an unknown date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that one person had Bell's Palsy (medically significant) after the receiving the first vaccine and they did not get the second dose. Outcome of the event was unknown. The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.
Age: 99.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Off label use, Pain in extremity, Vaccination site pain, Vaccination site swelling
Clinical narrative: left shoulder is warm at the injection site; left shoulder is a little sore at the injection site; left arm swollen; if she picks up her left arm it's sore; received booster dose; received booster dose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 99-years-old female patient received third dose of the BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 15 Sep2021 11:00 (at the age of 99 years-old) as dose 3, single for COVID-19 immunization. Medical history included staph infection from 2005 to an unknown date. When probing medical history, she states she had never had anything serious happen to her except one time she had a staph infection that was pretty serious. She had taken a trip and 2-3 weeks after returning home she developed the staph infection. She was really sick. patient had not received any other vaccine within 4 weeks. Patient was not pregnant at time of vaccination. The patient's concomitant medications were not reported. When probing concomitant medications, she states she didn't think her medications are relevant. The patient previously received dose (first and second) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) in right arm on an unknown date in Jan2021 as single dose for COVID-19 immunization. The patient stated that first doses were given in her right arm, and she had no reaction at all from the first 2 doses. She didn't even believe she had the first 2 doses because she felt nothing. Clarified she had no reaction to the first 2 doses. She was calling about the booster shot. She just got her booster dose on Friday 10Sep2021. She reported that today is 15Sep2021, her shoulder is warm and a little sore and it had been sore but today it got very warm at the injection site. It's warm and sore, it's not terrible but she thought she should call. She states she woke up today and her left arm is warm and swollen and if she picks up her left arm it's sore. On 15Sep2021, the patient experienced left shoulder is warm at the injection site, left shoulder is a little sore at the injection site, left arm swollen, if she picks up her left arm it's sore, received booster dose. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 99.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: left shoulder is warm at the injection site; left shoulder is a little sore at the injection site; left arm swollen; if she picks up her left arm it's sore; received booster dose; received booster dose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 99-years-old female patient received third dose of the BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 15 Sep2021 11:00 (at the age of 99 years-old) as dose 3, single for COVID-19 immunization. Medical history included staph infection from 2005 to an unknown date. When probing medical history, she states she had never had anything serious happen to her except one time she had a staph infection that was pretty serious. She had taken a trip and 2-3 weeks after returning home she developed the staph infection. She was really sick. patient had not received any other vaccine within 4 weeks. Patient was not pregnant at time of vaccination. The patient's concomitant medications were not reported. When probing concomitant medications, she states she didn't think her medications are relevant. The patient previously received dose (first and second) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) in right arm on an unknown date in Jan2021 as single dose for COVID-19 immunization. The patient stated that first doses were given in her right arm, and she had no reaction at all from the first 2 doses. She didn't even believe she had the first 2 doses because she felt nothing. Clarified she had no reaction to the first 2 doses. She was calling about the booster shot. She just got her booster dose on Friday 10Sep2021. She reported that today is 15Sep2021, her shoulder is warm and a little sore and it had been sore but today it got very warm at the injection site. It's warm and sore, it's not terrible but she thought she should call. She states she woke up today and her left arm is warm and swollen and if she picks up her left arm it's sore. On 15Sep2021, the patient experienced left shoulder is warm at the injection site, left shoulder is a little sore at the injection site, left arm swollen, if she picks up her left arm it's sore, received booster dose. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Tiredness; Ache/ little aching; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received bnt162b2 (BNT162B2, formulation: solution for injection, lot number: not reported; expiration date: not reported), via an unspecified route of administration on an unspecified date in 2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced tiredness and ache/ little aching that went away the next day. Outcome of the events was reported as recovered in 2021.  The lot number for the vaccine was not provided and will be requested during follow up.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pruritus
Clinical narrative: Minor itching on cheeks; Sore arm; Headache; This is a spontaneous report from a contactable consumer or other non health professional. This consumer reported for the patient in response to consumer letter. A 82-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982, Expiration date not reported), via an unspecified route of administration on 29Jan2021 (at the age of 82 years) as dose 2, single for covid-19 immunization. The patient medical history was not reported. Concomitant medication included triamterene, verapamil, levothyroxine, and atorvastatin, all taken for an unspecified indication from an unspecified start date and ongoing. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EK9231, Expiration date not reported), via an unspecified route of administration in right arm on 08Jan2021 (at the age of 82 years) as dose 1, single for covid-19 immunization and experienced reaction in mouth broke out in tiny sores, facial flushing, sore arm, and mild headache. Before vaccination, patient took Benadryl for unspecified indication and was required to wait 40minutes. On an unknown date, the patient experienced minor itching on cheeks, sore arm and mild headache. The nurse recommended treatment with loratadine allergy medication, which patient took before bed, and another one the next evening. The treatment relieved facial itching. The outcome of all the events was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Headache, Nervousness
Clinical narrative: Had two headaches, front and back; Stomach ache; Loose stools; Hurt all over; Eyes would not stay open, very very tired; Very scary; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Sep2021 at 00:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety and high blood pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included paracetamol (TYLENOL) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received acetylsalicylic acid (ASPIRIN) and experienced drug allergy. On 15Sep2021 at 00:00, the patient felt that the reactions were a lot worse than they should be. On the same day, the patient had two headaches front and back, stomach ache, loose stools, hurt all over, her eyes would not stay open, and was very very tired. She almost went to the emergency room (ER). She would not take the second one. She was very scary. The events did not result in doctor or other healthcare professional office/clinic visit, and 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 had two headaches, front and back, stomach ache, loose stools, hurt all over, eyes would not stay open, very very tired and very scary were resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Had two headaches, front and back; Stomach ache; Loose stools; Hurt all over; Eyes would not stay open, very very tired; Very scary; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Sep2021 at 00:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety and high blood pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included paracetamol (TYLENOL) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received acetylsalicylic acid (ASPIRIN) and experienced drug allergy. On 15Sep2021 at 00:00, the patient felt that the reactions were a lot worse than they should be. On the same day, the patient had two headaches front and back, stomach ache, loose stools, hurt all over, her eyes would not stay open, and was very very tired. She almost went to the emergency room (ER). She would not take the second one. She was very scary. The events did not result in doctor or other healthcare professional office/clinic visit, and 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 had two headaches, front and back, stomach ache, loose stools, hurt all over, eyes would not stay open, very very tired and very scary were resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: could not move his fingers for 2 weeks after the first dose; This is a spontaneous report from a contactable consumer. The consumer reported for a male patient. A male patient of unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: was not reported) via an unspecified route of administration, administered anatomical location not reported on unspecified date as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. Reporter stated she received both Pfizer COVID-19 vaccines and will not get the booster dose. Reporter stated that looking at how many had reactions and how many people died, Pfizer did not do so well. Reporter reported that after patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: was not reported) via an unspecified route of administration, administered anatomical location not reported on unspecified date as dose 2, single for COVID-19 immunization patient was sick for 3 weeks. Reporter Caller stated a report that had information about the vaccines stating Pfizer and Moderna, showed that Pfizer had the highest number of reactions, lowest number of reported cases and highest numbers of deaths. Reporter stated this is a withheld report. Reporter stated there were 7000 deaths and it is not over yet. Reporter stated her husband will not get the vaccine because he thinks it is poetic garbage. Reporter stated she got the Pfizer COVID-19 vaccine because of the name and she trusted the name. On unspecified date, after the first bnt162b2 vaccine dose patient could not move his fingers for 2 weeks. The outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Headache, Palpitations
Clinical narrative: heart pain; mild headache; I do get, sometimes, like a hard beat in my heart so there is some similarity there; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 23-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 09Sep2021 (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was inquiring about additional information regarding side effects of the Pfizer COVID-19 vaccine. On an unspecified date in Sep2021, the patient experienced a mild headache and heart pain. The patient stated that he did get, sometimes, like a hard beat in his heart so there was some similarity there. The patient stated that the heart pain now was rare but it was still there. The patient asked if that was normal. This case was reported as non-serious. The outcome of the event mild headache was unknown. The outcome of the other events was not resolved.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, X-ray
Clinical narrative: The first dose was last JAN2021 and the second dose was on FEB2021. Last 11AUG2021, her husband started to get sick and got diagnosed with Covid.; The first dose was last JAN2021 and the second dose was on FEB2021. Last 11AUG2021, her husband started to get sick and got diagnosed with Covid.; The first dose was last JAN2021 and the second dose was on FEB2021. Last 11AUG2021, her husband started to get sick and got diagnosed with Covid.; This is a spontaneous report from a contactable consumer or other non hcp via a Pfizer-sponsored program. A 66-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Jan2021 as dose 1, single and second dose via an unspecified route of administration on Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Reporter said that last 11Aug2021, her husband started to get sick and got diagnosed with COVID and has been in the surgical ICU for a month and in a ventilator for 2 weeks. An x-ray showed that the virus has ravaged his lungs and at this point, the doctors said it doesn't look like there's any way he's going to bounce back from this. Reporter also asked that she wanted to know how it's possible that her husband still got sick despite being vaccinated. She also wanted to know if Pfizer can assist in getting a lung transplant. The patient underwent lab tests and procedures which included x-ray: the virus has ravaged his lungs. The outcome of the events was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Eye irritation, Pain, Pain in extremity, Pyrexia
Clinical narrative: Scratchy eyes; Achy; Sore arm; Low fever 100.2; This is a spontaneous report from a non-contactable consumer, the patient. A 66-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 15Sep2021 at 13:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa. 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 were not reported. On 16Sep2021 at 07:30, the patient experienced sore arm, low fever 100.2 (unspecified units), achy and scratchy eyes. The events did not result in doctor or other healthcare professional office/clinic visit, and 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 sore arm, low fever 100.2 (unspecified units), achy and scratchy eyes were recovering at the time of report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Skin rash; This is a spontaneous report from a contactable consumer. A non-pregnant adult female patient (patient's occupation was reported as nurse) of unknown age received 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 and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unknown date, the patient experienced skin rash. The reporter had described a skin rash which was followed up with the dermatologist and questioned about the possible relation to the vaccination. The event resulted 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, it was unknown whether the patient was tested for COVID-19. The clinical outcome of the event skin rash was not recovered 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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Menstrual cycle time shift to earlier in the month; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on an unknown date in Apr2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were 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 COVID-19 vaccine. On an unknown date in 2021, the patient's menstrual cycle time shifted to earlier in the month. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event menstrual cycle time shift to earlier in the month was unknown at the time of this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: he was diagnosed to have COVID-19; he was diagnosed to have COVID-19; This is a spontaneous report from a contactable other HCP (patient) reported for himself via medical information team. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Aug2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient was unable to get his second dose (scheduled originally on 24Aug2021) due to reasons not health related. The patient medical history and concomitant medications were not reported. In that coming weekend in Aug2021 the patient was diagnosed covid-19 and was currently roughly 17 days out.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported event Covid 19 and suspect drug BNT162B2 cannot be completely excluded.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: Moderate abdominal cramping about 30 mins following the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Aug2021 (at the age of 31-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 vaccines within four weeks prior to the COVID vaccine. Concomitant medications included levothyroxine sodium (TIROSINT), vitamin D NOS (MANUFACTURER UNKNOWN), prenatal (MANUFACTURER UNKNOWN) and biotin (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. On 24Aug2021, about 30 minutes following the vaccine, the patient experienced moderate abdominal cramping, lasting about 30 minutes where the patient had to lay day and it was bad. The moderate abdominal cramping did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event moderate abdominal cramping was resolved an unknown date in Aug2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration in the left arm on 05Sep2021 at 11:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient had no 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 other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 12Sep2021 at 13:00, the patient experienced shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with an unspecified medication. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shingles was resolving at the time of the report.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Paraesthesia
Clinical narrative: Tingly feeling in nose (like that of water up the nose); Diminished sense of smell and taste, followed by total loss of smell and taste; Diminished sense of smell and taste, followed by total loss of smell and taste; 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: UNKNOWN) via an unspecified route of administration in the left arm on 16Sep2021 at 09:15 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. 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 16Sep2021 at 17:15, 7-8 hours after injection, the patient experienced tingly feeling in nose (like that of water up the nose) followed by diminished sense of smell and taste, followed by total loss of smell and taste. The events did not result in doctor or other healthcare professional office/clinic visit, 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 tingly feeling in nose (like that of water up the nose) and diminished sense of smell and taste, followed by total loss of smell and taste was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Vaginal discharge
Clinical narrative: Strange vaginal discharge unlike any period or spotting. Dark in color and at mid cycle; This is a spontaneous report from a non-contactable consumer, the patient. A female patient of an unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 09Sep2021 at 18:30 as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. On an unknown date in Sep2021, the patient experienced strange vaginal discharge unlike any period or spotting, dark in color and at mid cycle. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event strange vaginal discharge unlike any period or spotting, dark in color and at mid cycle 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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Nauseous and throwing up; Nauseous and throwing up; Fever; Legs and arms hurt so badly couldn't lay down; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 16Sep2021 at 12:15 (at the age of 29-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 concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Sep2021 at 02:00, the patient woke up nauseous and throwing up. The patient had a fever and her legs and arms hurt so badly that she couldn't lay down. The patient felt like this for 5 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events nauseous and throwing up, fever and legs and arms hurt so badly couldn't lay down was resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: Period arrived 11 days late; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 07Sep2021 at 00:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant 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 other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. On 08Sep2021, the patient's period arrived 11 days late. 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 not been tested for COVID-19. The clinical outcome of the event period arrived 11 days late was resolved on an unknown date in Sep2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vision blurred
Clinical narrative: After both shots had issues with eyes focusing; Intermittent dizziness; This is a spontaneous report from a contactable nurse, the patient. A 45-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 13Aug2021 at 11:00 (at the age of 45-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3F83) via an unspecified route of administration in the left arm on 14Sep2021 at 11:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis (MS) and attention deficit disorder (ADD). The patient had no known allergies. 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 natalizumab (TYSABRI), methylphenidate hydrochloride (CONCERTA), vitamin d nos (VITAMIN D), levocetirizine dihydrochloride (XYZAL) and fluticasone propionate (FLONASE); all taken for unknown indications from unknown dates and unknown if ongoing.  On an unknown date in 2021, after both the shots, the patient had issues with her eyes focusing and intermittent dizziness. The events did not result in doctor or other healthcare professional office/clinic visit, and 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 after both shots had issues with eyes focusing and intermittent dizziness was not resolved at the time of the report.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives all over body; This is a spontaneous report from a contactable healthcare professional, the patient. A 26-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via intramuscular route of administration in the right arm on 13Sep2021 at 14:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient had no 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 other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 14Sep2021 at 13:00, the patient experienced hives all over body. The event resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event hives all over body was not resolved at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: little soreness in her arm at the injection site (as for the first dose); This is a spontaneous report from a contactable consumer (patient).A 78-year-old female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On unknown date, the patient experienced a little soreness in her arm at the injection site. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nausea, Pain, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer reported for herself. A 73-years-old non-pregnant female patient received BNT162B2 (BNT162B2, Pfizer-BioNTech COVID 19 vaccine, Solution for injection, Lot number EN6200) via an unspecified route of administration, administered in Arm Right on 18Feb2021 10:00AM as dose 1, single (age at vaccination 73 years) for COVID-19 immunisation (Other). Medical history included atrial fibrillation, supraventricular tachycardia (SVT), asthma, hypothyroidism, dust and pollen allergy all from an unknown date and unknown if ongoing. Patient was taking other medications in two weeks. Patient was not taken any other vaccines in four weeks. On 18Feb2021 16:00 (04:00 pm) the patient experienced extreme fatigue, some nausea, body aches, overall muscle pain, injection site very sore. Most side effects lasted 3 plus days. No therapeutic measures were taken as result of events. Patient was not having covid prior vaccination and not tested post vaccination. The outcome of the events was recovered on an unknown date in 2021.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a little bit of a sore arm; This is a spontaneous report from a contactable consumer (patient). A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiry date: unknown), dose 1 via an unspecified route of administration on 29Jan2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received second dose of Pfizer-BioNTech COVID-19 Vaccine last Thursday 18Feb2021. The patient reported that first dose was on 29Jan2021, and he had no reactions whatsoever, except for maybe a little bit of a sore arm that lasted for about a day. Patient asked this normal and wanted to know if it is normal or common to not experience side effects after completing the vaccination series. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Peripheral swelling
Clinical narrative: My arm swelled; My arm swelled and was very sore; I was very tired/felt exhausted; This is a spontaneous report from a contactable other hcp. A 23-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9262), dose 1 via an unspecified route of administration, administered in Arm Left on 27Jan2021 as SINGLE DOSE, dose 2 intramuscular, administered in Arm Left on 17Feb2021 10:00 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient was not pregnant. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive any treatment. Patient was not diagnosed with COVID, prior vaccination.  Patient did not receive other vaccine in four weeks of vaccination. Patient has not been tested for COVID, post vaccination. Patient had no known allergies. The patient experienced my arm swelled on 17Feb2021 16:30, my arm swelled and was very sore at 16:30 with outcome of recovered and i was very felt exhausted. The outcome of the events was recovered.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Nausea
Clinical narrative: dizziness; extreme fatigue; diarrhea; nausea; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on an unspecified date Feb2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. It was reported that, I had prolonged side effects since I received my second shot of the vaccine which was last week Wednesday. On an unspecified date Feb2021, one day and half after receiving the vaccine, the patient experienced diarrhea, nausea, dizziness, and extreme fatigue. Most of my symptoms had resolved except the fatigue, tired more then usual it was getting hard to focus and wanted to know if Pfizer had any recommendations. The clinical outcome of the fatigue was not resolved and rest of the events on an unspecified date Feb2021 was resolved.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Extreme Hair Loss; This is a spontaneous report from a contactable consumer (patient, self-reported). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EM9810 STEHS and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 06Feb2021 at 11:45 PM (age at vaccination: 58 years), as a single dose for COVID-19 immunization at school or student health clinic. The patient was not pregnant at the time of vaccination. The patient's medical history included high B/P, high cholesterol, and kidney donor. The patient did not have any known allergies. Concomitant medications included unspecified medications. The patient did not received any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On 22Feb2021 at 07:00 AM, the patient experienced extreme hair loss. The patient did not receive any treatment for the event. Outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Underarm swelling; This is a spontaneous report from a contactable consumer (patient). This (age: 74; Unit: Unknown) female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on Thursday, 11Feb2021 09:00 (Batch/Lot Number: EM9809; Expiration Date: 30Jun2021) as DOSE 2, SINGLE for covid-19 immunisation. There were no medical history and concomitant medications. Patient previously took first dose of bnt162b2 (Lot number: EL8982, Expiration Date: 31May2021) administered in Left arm on 21Jan2021 for covid-19 immunisation. It was reported that the patient has had both doses of the COVID Vaccine. After the second dose she started to experience under arm swelling in the arm that she received the vaccine, the left arm. She noticed this around 6PM on 14Feb2021. She confirmed she had no reaction with the first dose. The event did not require Emergency Room and Physician's Office visit. None of the additional vaccines administered on the same date of the Pfizer vaccine considered as suspect. The patient had not received any other vaccine within 4 weeks and did not have any adverse events following prior vaccinations. She questioned if this was a common side effect. Stated she did not see it listed as a common side effect. Outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Body aches; This is a spontaneous report from a non-contactable consumer. A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: SN5318) via an unspecified route of administration, administered in Arm Left on 17Feb2021 as DOSE 2, SINGLE (at the age of 39-year-old) for covid-19 immunisation. The patient received the historical vaccine of bnt162b2. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced body aches on 18Feb2021. The patient did not received any treatment for the event. The outcome of the events was recovered on unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Throwing up; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration, administered in Arm Right on 24Feb2021 15:00 (at the age of 67-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included cancer, hypertension and diabetes from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in 4 weeks prior to the COVID vaccine. Patient did not receive any other medications in 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. Patient had no known allergies. On 25Feb2021 at 12:00 AM, patient experienced throwing up. There was no treatment for the event. The clinical outcome of event was not recovered.  Follow-up attempts completed. No further information expected.