chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer
Clinical narrative: developed painful genital aphthous ulcers.; developed painful genital aphthous ulcers.; This is a spontaneous report from a contactable physician. A 15-year-old non-pregnant female patient received second dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: FC3183) intramuscular on 03Sep2021 (age at vaccination: 15-year-old) as dose 2, single for covid-19 immunization. In the Physician Office Visit. The patient medical history and patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE; Lot Number: 088d21a), intramuscular on 13Aug2021 as a single for COVID-19 immunization. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Patient did not received any other medications within 2 weeks of vaccination. Reportedly, patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. On 05Sep2021, patient experienced developed painful genital aphthous ulcers. Topical Lidocaine, Topical Clobetasol, antibiotics were taken as a result of developed painful genital aphthous ulcers.The outcome was recovering  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Off label use
Clinical narrative: I am kind of tired here; Received a booster shot; Received a booster shot; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 3 via an unspecified route of administration on 14Aug2021 (Lot number was not reported) as dose 3 (booster), single for COVID-19 immunization (at the age of 69-year-old). The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date in Mar2021 (Lot number: ER6213) as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on an unspecified date in Mar2021 (Lot number: EN6201) as dose 2, single for COVID-19 immunization (at the age of 69-year-old). The patient received a booster shot on 14Aug2021. On an unspecified date, the patient was a kind of tired. The clinical outcome of the event was unknown.  QR Comment: AE filed conservatively.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Immunisation
Clinical narrative: light little like headache; I got the booster shot on the 17Sep2021; This is a spontaneous report from a contactable consumer (patient). A 75-years-old patient of an unspecified gender received third dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 17Sep2021 (age at vaccination 75 years) as dose 3 (booster), single for covid-19 immunization. The patient medical history was none. There were no concomitant medications. Patient got the booster shot on friday (17Sep2021), Thursday Friday any way thursday afternoon patient got light headache and they came and went but this morning (18Sep2021) patient woke up and got this same headache it was not really severe patient still could do all regular activity so it was not something 'doing' but it was just did not go away." patient wonder was there anything should do about it or let it went or what. Therapeutic measure (Tylenol) were taken as a result of headache. The outcome of events was reported as not recovered.  This follow-up was being submitted to notify that the lot/batch number was not available despite the follow-up attempts were made.  Follow-up attempts were completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Off label use
Clinical narrative: she got her Booster shot on Saturday 25Sep2021; she got her Booster shot on Saturday 25Sep2021; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: not reported), via an unspecified route of administration on 25Sep2021 dose 3 (booster), single for covid-19 immunisation (booster dose and off label). The patient medical history and concomitant medications were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: not reported), via an unspecified route of administration on unspecified date as dose1 and dose 2 for covid-19 immunisation. Patient wants to raise her experience in getting her Booster shot, she said she got her Booster shot on Saturday 25Sep2021, and she noticed that the lot number she received on her email is different from the lot number what was written on her vaccine card. Caller said her mother who is 91-year-old also received her Booster dose at a different, and also in her case she had two different lot numbers, 1 that was handwritten and one that was on the email. In her case, they said the email was wrong, but the handwritten number was probably correct. Patient wants to know which lot number is correct.  lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Chills, Feeling of body temperature change, Head discomfort, Headache
Clinical narrative: Had itching on her hands and feet; The area turns a little pink when she itched it; Cold congestion; Chills; Headache; Has experienced congestion, stated her head felt like a marshmallow; She was hot and cold for 2-3 days; This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, lot number: FC3183), dose 2 via an unspecified route of administration, administered in Arm Left on 28Sep2021 17:50 (at the age of 58 years) as dose 2, single for covid-19 immunization. Medical history included asthma from 1990 and ongoing, chronic obstructive pulmonary disease from 2015 and ongoing, fat tumor from an unknown date and unknown if ongoing, covid-19 from Nov2019 to an unknown date patient stated she believed she had Covid before it came out, like in Nov2019 because she was in the hospital for 5 days and she couldn't breathe. There were no concomitant medications. Patient previously took BNT162B2 on 07Sep2021 as Dose 1, Lot Number: FC3183 in Left Arm. Patient had no prior vaccination within 4 weeks. On 28Sep2021, 3-4 hours after her vaccine, the patient experienced has experienced congestion, stated her head felt like a marshmallow, she was hot and cold for 2-3 days, had itching on her hands and feet, the area turns a little pink when she itched it, cold congestion, chills, headache, has experienced congestion, stated her head felt like a marshmallow. The patient underwent lab tests and procedures which included biopsy: fat tumor. Therapeutic measures were taken as a result of events. She has been doing nebulizers treatments and was really not too concerned about that. Patient had itching on her hands and feet; there are no bumps or rashes associated with it, just that the area turns a little pink when she itched it. It comes and goes sporadically. Patient had cold congestion, chills, and headache started about 3-4 hours after her vaccine on 28Sep2021. She had had a couple of cancer scares, so she got a biopsy and it was not cancer and another was a fat tumor. Treatment was Nebulizer and Inhaler, Advil; Tries to let her body recover on its own. Clinical outcome of the events had itching on her hands and feet, the area turns a little pink when she itched it was reported as not recovered; unknown for Cold congestion and recovered on 02Oct2021 for rest of the events.  Follow-Up (12Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pruritus, Skin discolouration
Clinical narrative: Had itching on her hands and feet; The area turns a little pink when she itched it; Cold congestion; Chills; Headache; Has experienced congestion, stated her head felt like a marshmallow; She was hot and cold for 2-3 days; This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, lot number: FC3183), dose 2 via an unspecified route of administration, administered in Arm Left on 28Sep2021 17:50 (at the age of 58 years) as dose 2, single for covid-19 immunization. Medical history included asthma from 1990 and ongoing, chronic obstructive pulmonary disease from 2015 and ongoing, fat tumor from an unknown date and unknown if ongoing, covid-19 from Nov2019 to an unknown date patient stated she believed she had Covid before it came out, like in Nov2019 because she was in the hospital for 5 days and she couldn't breathe. There were no concomitant medications. Patient previously took BNT162B2 on 07Sep2021 as Dose 1, Lot Number: FC3183 in Left Arm. Patient had no prior vaccination within 4 weeks. On 28Sep2021, 3-4 hours after her vaccine, the patient experienced has experienced congestion, stated her head felt like a marshmallow, she was hot and cold for 2-3 days, had itching on her hands and feet, the area turns a little pink when she itched it, cold congestion, chills, headache, has experienced congestion, stated her head felt like a marshmallow. The patient underwent lab tests and procedures which included biopsy: fat tumor. Therapeutic measures were taken as a result of events. She has been doing nebulizers treatments and was really not too concerned about that. Patient had itching on her hands and feet; there are no bumps or rashes associated with it, just that the area turns a little pink when she itched it. It comes and goes sporadically. Patient had cold congestion, chills, and headache started about 3-4 hours after her vaccine on 28Sep2021. She had had a couple of cancer scares, so she got a biopsy and it was not cancer and another was a fat tumor. Treatment was Nebulizer and Inhaler, Advil; Tries to let her body recover on its own. Clinical outcome of the events had itching on her hands and feet, the area turns a little pink when she itched it was reported as not recovered; unknown for Cold congestion and recovered on 02Oct2021 for rest of the events.  Follow-Up (12Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymph node pain, Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: sore under left arm - lymph nodes; Sore neck; stiff neck; sore arm; dose number=3; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 66-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FF8839), intramuscular, administered in Arm Left on 30Sep2021 18:30 (at the age of 66-years-old) as dose 3 (booster), single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included gastro-oesophageal reflux disease and arthritis. Concomitant medications/other medications in two weeks included pantoprazole sodium sesquihydrate (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]) taken for gastro-oesophageal reflux disease and ibuprofen (IBUPROFEN) taken for arthritis from an unspecified start date and ongoing. No known allergies. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN5318), intramuscular, administered in Arm Left on 09Feb2021 13:00 as dose 1, single for COVID-19 immunization and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: FL3302), intramuscular, administered in Arm Left on 09Mar2021 13:00 as dose 2, single for COVID-19 immunization. No other prior vaccinations (within 4 weeks). No Covid prior to the vaccination. No Covid tested post vaccination. On 30Sep2021 18:30, the patient received dose number=3 (booster). On 01Oct2021, the patient experienced sore arm. On 02Oct2021, the patient had stiff neck and sore neck. On 03Oct2021, the patient had sore under left arm - lymph nodes lasting 2-days. No treatment was given for adverse events. The events were reported as non-serious.The outcome of the event sore neck was unknown. The outcome of the events sore arm, stiff neck and sore under left arm - lymph nodes was recovered on an unknown date in 2021.  Follow-up attempts were completed. No further information was expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Herpes zoster, Pain in extremity, Urticaria, Vaccination site pain
Clinical narrative: left arm was very sore at injection site; a hive type rash appeared on left forearm; pain radiated throughout my entire arm; more hives appeared on upper arm. The hives were very tender.; diagnosed the rash as shingles as a result of the covid vaccination; This is a spontaneous report from a contactable consumer (patient).   A 57-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 24Sep2021 16:00 (Lot Number: 30135B4) as dose 2, single for COVID-19 immunization (at the age of 57-year-old). Medical history included known allergies: sulfonamides. Concomitant medications included fish oil and zinc. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 31Aug2021 16:00 (Lot Number: FE3183) as dose 1, single for COVID-19 immunization (at the age of 57-year-old). No other vaccine in four weeks and other medications in two weeks included Multi vitamin. No COVID prior vaccination and not tested for COVID post vaccination. On 25Sep2021 16:00, 24 hours after injection, the patient's left arm was very sore at injection site, a hive type rash appeared on left forearm, pain radiated throughout her entire arm, more hives appeared on upper arm. the hives were very tender and diagnosed the rash as shingles as a result of the COVID vaccination. AE resulted in doctor or other healthcare professional office/clinic visit. The patient was treated with Acyclovir 800 mg as a therapeutic measure of all the events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: she had hip pain two days after she took the first shot; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported for herself that, A 59-years-old female patient received bnt162b2 (COMIRNATY, formulation: solution for injection via an unspecified route of administration, administered in Left Arm on 25Sep2021 (Batch/Lot Number: EW0179) as Dose 1, Single (age at vaccination:59-Years-old) for Covid-19 immunisation. Relevant medical history was none. There were no concomitant medications. Historical immunisation includes administration of pneumonia vaccination and experienced swelling on her left arm in 2012-2013. Stated that she received the pneumonia shot on while hospitalized due to being sick which was all prior to the shot (with a problem for her heart). Patient has received Flu vaccination on unspecified date and experienced rash on her right arm. Stated that she had a breakout rash on her right arm from the flu shot 7-8 years ago. Stated that she was unable to take TB, flu and pneumonia shot. No further details provided. On 27Sep2021 the patient experienced she had hip pain two days after she took the first shot. Stated that she received the vaccine because she was mandated through employment. Stated that she is concerned with the hip pain and her supervisor wanted her to get X-ray and MRI, but she cannot afford it. Stated that she took her first Pfizer shot and did not have hip pain until the shot. Stated that she waited to see if would go away. Stated that she went to get the second shot and told the nurse that she was having joint and hip pain and was told that it was a side effect from the shot. Stated that she was told to follow up with her doctor to see if needed an X-ray or MRI and was told that it would go away in 24- 48 hours. Stated that she had told him that it had been a month since she had it. The patient had not received treatment for all the events. The outcome of the events was reported as not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Insomnia, Neuralgia, Off label use, Vaccination site mass
Clinical narrative: My left arm had a knot in it right below the shot; the entire top of my left arm from shoulder to elbow hurt very badly with nerve pain for about 10 days; could not sleep; Off Label; Booster; This is a spontaneous report from a contactable consumer (patient).   A 71-year-old non-pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: 301358A, Expiration Date: 01Jun2021), dose 3 via unspecified rout administered in left arm on 28Sep2021 at 03:00 PM (at age of 71-year-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient medical history included lyme disease and concomitant medications were not reported. Patient was not pregnant at time of Vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient has no known allergies. Previously patient took bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6199) dose 1 on 05Mar2021 and bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8727) dose 2 on 26Mar2021 in Arm Right for covid-19 immunization. It was reported that "On the 13th day after I got the booster, my left arm had a knot in it right below the shot. I massaged out the knot and the entire top of my left arm from shoulder to elbow hurt very badly with nerve pain for about 10 days. I had to take 2 pills of 300 mg. of gabapentin at 2 pm and 10 om daily or could not sleep since pain was so severe. Could only sleep on my back. I have fully recovered now". On 11Oct2021, the patient experienced left arm had a knot in it right below the shot, the entire top of left arm from shoulder to elbow hurt very badly with nerve pain for about 10 days and could not sleep since pain was so severe. Treatment was received for the events with two pills of 300 mg. of gabapentin twice/day. Outcome of the events was resolved on an unspecified date in Oct2021.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Epstein-Barr virus infection, Polymerase chain reaction
Clinical narrative: I came down with epstine Barr virus that left me bed ridden for 3 months; This is a spontaneous report from a contactable Consumer (Patient).  A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: not reported) via an unspecified route of administration, administered in right arm on 27May2021 at 14:00 (at the age of 38-year-old) as dose 2, single for COVID-19 immunization. Patient's medical history was none. Concomitant medications in two weeks were none. Patient had no Known allergies. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: not reported) via an unspecified route of administration, administered in right arm on 27Apr2021 at 14:00 (at the age of 38-year-old) as dose 1, single for COVID-19 immunization. Facility type vaccine administered was hospital. Reporter stated that on 01Jun2021 at 12:00 am after receiving the vaccine, he came down with epstine Barr virus that left him bed ridden for 3 months. Adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient underwent lab test and procedures which included on 07Jun2021 PCR (Nasal Swab) result was Negative. Patient did not receive any treatment for the adverse event. Outcome of the event was resolving.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Interchange of vaccine products, Off label use
Clinical narrative: feeling very tired after the 3rd dose, Exhaustion; Patient originally received Moderna's COVID vaccine; Patient originally received Moderna's COVID vaccine/ vaccine in the same arm and at the same time as her annual flu shot; This is a spontaneous report from a contactable consumer (patient). This report was received via a sales representative. A female patient of an unspecified age received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FMB020) via an unspecified route of administration, administered in Arm Left on 22Oct2021 at 15:00 as dose 3 (booster), single for COVID-19 immunisation; influenza vaccine (FLU), via an unspecified route of administration from unknown date in 2021 to unknown date in 2021 as dose number unknown, single for an unspecified indication. The patient medical history and concomitant medications were reported as none. Historical vaccine included moderna vaccine (MODERNA COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as dose 1, single and moderna vaccine (MODERNA COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as dose 2, single for an unspecified indication and was completely ill and unable to function for days after receiving those two doses. Prior vaccinations reported as none. On 23Oct2021 Patient experienced feeling very tired after the 3rd dose. The action taken in response to the event for influenza vaccine was not applicable. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. Relevant tests reported as none. Outcome of the event feeling very tired was recovered on unknown date in 2021 and other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: have "covid arm" got red and swollen few mins after the vaccine, red circle around the area; have "covid arm" got red and swollen few mins after the vaccine; a hard lump was under the area and red circle around the area and sore to touch; a hard lump was under the area and red circle around the area and sore to touch; Sore to the touch hard knot under the area and slightly itchy; This is a spontaneous report from a contactable consumer. A 33-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection Lot Number: Ff2590), via an unspecified route of administration, administered in Arm Left on 24Oct2021 10:45 (at the age of 33 years old) as dose 2, single for COVID-19 immunization. Medical history included Sulfa Allergy from an unknown date and unknown if ongoing Known allergies: Sulfa. There were no concomitant medications. Patient was not pregnant at the time of vaccination. Historical vaccine patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection Batch/Lot Number: 301258A), via an unspecified route of administration, administered in Arm Left on 03Oct2021 (at the age of 33 years old) as dose 1, single for COVID-19 immunization. The adverse event after 1st vaccine just super sore arm esp if lifiting or touching it. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not take any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Oct2021 after the 2nd vaccine had Covid arm got red and swollen few mins after the vaccine, hours later a hard lump was under the area and red circle around the area and sore to touch. Day later it was bigger and a bigger harder lump. 3 days about a half dollar size and little itchy, red swollen and hard knot under the red circle. Day 4 bigger its 3x2 inches seems to get bigger throughout the day and each day after. Sore to the touch hard knot under the area and slightly itchy. It was unknown whether the treatment was taken. There was no prolonged hospitalization. Seriousness criteria was reported as non serious. The outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Off label use, Pain in extremity, Peripheral swelling
Clinical narrative: arm stayed sore and swollen, as well as underarm and armpit; arm stayed sore and swollen, as well as underarm and armpit; arm stayed sore and swollen, as well as underarm and armpit; arm stayed sore and swollen, as well as underarm and armpit; patient received third (booster) dose of BNT162B2; patient received BNT162B2 and influenza vaccine on the same day; patient received BNT162B2 and influenza vaccine on the same day; This is a spontaneous report from a non-contactable consumer (patient). A 71-year-old female patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Fe3590), via an unspecified route of administration in the left arm, on 23Oct2021 12:00 (at the age of 71-years-old) as a single dose for COVID-19 immunization and influenza vaccine (MANUFACTURER UNKNOWN), via an unspecified route of administration in the right arm, on 23Oct2021 as a single dose for immunisation. Medical history included penicillin allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL9262), in the left arm, on 11Feb2021 (at the age of 70-years-old) for COVID-19 immunisation and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6198), in the left arm, on 05Mar2021 (at the age of 70-years-old) for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced arm stayed sore and swollen, as well as underarm and armpit on 23Oct2021 20:00. Additionally, the patient received BNT162B2 and influenza vaccine on the same day on 23Oct2021 and patient received third (booster) dose of BNT162B2 on 23Oct2021 at 12:00. The clinical course was reported as follows: Right after the booster, the patient iced the arm as she did for the first two vaccines. This time the arm stayed sore and swollen, as well as the underarm and armpit. She took paracetamol (TYLENOL EXTRA STRENGTH) 3 times a day for 3 days, then just at bedtime for 2 days. Therapeutic measures were taken as of arm stayed sore and swollen, as well as underarm and armpit as aforementioned. The clinical outcome of arm stayed sore and swollen, as well as underarm and armpit was recovered on an unspecified date and of patient received BNT162B2 and influenza vaccine on the same day and patient received third (booster) dose of BNT162B2 was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Product use issue, Swelling
Clinical narrative: arm stayed sore and swollen, as well as underarm and armpit; arm stayed sore and swollen, as well as underarm and armpit; arm stayed sore and swollen, as well as underarm and armpit; arm stayed sore and swollen, as well as underarm and armpit; patient received third (booster) dose of BNT162B2; patient received BNT162B2 and influenza vaccine on the same day; patient received BNT162B2 and influenza vaccine on the same day; This is a spontaneous report from a non-contactable consumer (patient). A 71-year-old female patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Fe3590), via an unspecified route of administration in the left arm, on 23Oct2021 12:00 (at the age of 71-years-old) as a single dose for COVID-19 immunization and influenza vaccine (MANUFACTURER UNKNOWN), via an unspecified route of administration in the right arm, on 23Oct2021 as a single dose for immunisation. Medical history included penicillin allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL9262), in the left arm, on 11Feb2021 (at the age of 70-years-old) for COVID-19 immunisation and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6198), in the left arm, on 05Mar2021 (at the age of 70-years-old) for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced arm stayed sore and swollen, as well as underarm and armpit on 23Oct2021 20:00. Additionally, the patient received BNT162B2 and influenza vaccine on the same day on 23Oct2021 and patient received third (booster) dose of BNT162B2 on 23Oct2021 at 12:00. The clinical course was reported as follows: Right after the booster, the patient iced the arm as she did for the first two vaccines. This time the arm stayed sore and swollen, as well as the underarm and armpit. She took paracetamol (TYLENOL EXTRA STRENGTH) 3 times a day for 3 days, then just at bedtime for 2 days. Therapeutic measures were taken as of arm stayed sore and swollen, as well as underarm and armpit as aforementioned. The clinical outcome of arm stayed sore and swollen, as well as underarm and armpit was recovered on an unspecified date and of patient received BNT162B2 and influenza vaccine on the same day and patient received third (booster) dose of BNT162B2 was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; tired; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unspecified date (Batch/Lot number was not reported) for COVID-19 immunization. On an unspecified date, the patient experienced: sore arm (non-serious) and tired (non-serious). The clinical course was reported as follows: the patient initially reported adverse events following her daughter's second dose of the Pfizer COVID vaccine. This report was for the reporter (patient herself). The patient stated that neither she or her daughter had any symptoms after the Pfizer COVID vaccine, they just both had a sore arm; and the caller herself was tired but they fared well with the vaccine (as reported).  The patient declined to complete a report on herself and she added that she thought that she was "good", and she expected her side effects that she had, and she was pleased that those were all that she had. The clinical outcome of the events, sore arm and tired, was recovering.  The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Immunisation
Clinical narrative: Short of breath on exertion; patient received third (booster) dose of BNT162B2; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 02Nov2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) in 2021 for COVID-19 immunization. The patient experienced short of breath on exertion on 03Nov2021 and patient received third (booster) dose of BNT162B2 on 02Nov2021. The clinical outcome of short of breath on exertion and patient received third (booster) dose of BNT162B2 was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Arthralgia, Chills, Fatigue
Clinical narrative: Debilitating fatigue; Extreme chills; Headaches; Joint pain; Loss of taste and smell; Loss of taste and smell; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE; both for COVID-19 immunisation. The patient's medical history included COVID from Dec2020 to an unknown date. Concomitant medications were not reported. On an unspecified date, the patient experienced: debilitating fatigue (non-serious), extreme chills (non-serious), headaches (non-serious), joint pain (non-serious), loss of taste and smell (non-serious). The clinical course was reported as follows: The reporter wanted to give an update from a patient who had contracted COVID last Dec2020 and experienced symptoms of debilitating fatigue, extreme chills, headaches, joint pain, loss of taste and smell for three weeks, and had experienced most of these same symptoms after being inoculated three times with the vaccine.  The clinical outcome of the events was unknown.  The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Debilitating fatigue; Extreme chills; Headaches; Joint pain; Loss of taste and smell; Loss of taste and smell; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE; both for COVID-19 immunisation. The patient's medical history included COVID from Dec2020 to an unknown date. Concomitant medications were not reported. On an unspecified date, the patient experienced: debilitating fatigue (non-serious), extreme chills (non-serious), headaches (non-serious), joint pain (non-serious), loss of taste and smell (non-serious). The clinical course was reported as follows: The reporter wanted to give an update from a patient who had contracted COVID last Dec2020 and experienced symptoms of debilitating fatigue, extreme chills, headaches, joint pain, loss of taste and smell for three weeks, and had experienced most of these same symptoms after being inoculated three times with the vaccine.  The clinical outcome of the events was unknown.  The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Feeling abnormal, Immunisation, Urinary tract infection
Clinical narrative: Dose received: 3; light headiness; foggy; weak; within 6 hours of vax I contracted a UTI.; This is a spontaneous report from a contactable consumer(patient)  A 76-years-old non-pregnant female patient received booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number, Expiry date: not reported), via an unspecified route of administration, administered in left arm on 01Nov2021 (Age at vaccination: 76 years old) as dose 3 (booster), single for covid-19 immunization. Medical history included interstitial lung disease (ILD) from an unknown date and unknown if ongoing, and known allergies with penicillin, cipro, tramadol, codeine since an unknown date. Concomitant medications included magnesium, krill oil, colecalciferol (D3) tocopherol (VITAMIN E) all taken for an unspecified indication, start and stop date were not reported for all drugs. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: el92962, Expiry date: not reported), via an unspecified route of administration, administered in left arm on 27Jan2021 at 08:30 (Age at vaccination: 75 years old) as dose 1, single for covid-19 immunization and patient previously took second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: en6200, Expiry date: not reported), via an unspecified route of administration, administered in left arm on 17Feb2021 at 08:15 (Age at vaccination: 75 years old) as dose 2, single for covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, patient was not diagnosed with COVID-19 prior to vaccination, patient has not been tested for COVID-19 since the vaccination. On 01Nov2021 patient received 3rd dose (booster dose) of covid-19 vaccine and patient experienced light headiness, foggy, weak and within 6 hours of vax patient contracted a urinary tract infection (UTI). Patient did not receive any treatment for the events. Outcome for events light headiness, foggy, weak and within 6 hours of vax patient contracted a urinary tract infection was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: International normalised ratio increased
Clinical narrative: INR increased from the therapeutic range (2-3) to 5.2; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received the 1st dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included pulmonary embolism from an unknown date and unknown if ongoing recurrent. Concomitant medication included warfarin (WARFARIN) taken for pulmonary embolism (recurrent), start and stop date were not reported.  The patient experienced INR increased from the therapeutic range (2-3) to 5.2 (medically significant) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included international normalised ratio: from the therapeutic range (2-3) to 5.2 on unknown date, platelet count: well within the normal range on unknown date. The patient reported bleeding more easily with blood draws and finger sticks than previous.   The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Limited information precludes a comprehenisve causality of event INR increased with BNT162b2 .Concomitant medication warfarin can be significant risk factor.
Sex: M
Vaccine: COVID19
Symptoms: Tooth infection
Clinical narrative: Been taking amoxicillin to treat a tooth infection after he had received the primary series of the COVID vaccine; This is a spontaneous report received from a contactable consumer (patient's wife) via a Pfizer-sponsored program.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) dose 1 via an unspecified route of administration on an unspecified date (Lot number was not reported) as DOSE 1, SINGLE, and dose 2 via an unspecified route of administration on an unspecified date (Lot number was not reported) as DOSE 2,SINGLE both for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced tooth infection after he had received the primary series of the COVID vaccine. Consumer reported that her husband has been taking amoxicillin to treat a tooth infection after he had received the primary series of the COVID vaccine, and she was wondering if her husband can take the booster dose after being on amoxicillin. Therapeutic measures were taken as a result of event. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Immunisation
Clinical narrative: getting more frequent nosebleeds from my left nostril/blood usually dripping on the floor; dose 3 (booster), single; This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in left arm on 23Oct2021 at 15:15 (Batch/Lot Number: FF2589) (at the age of 24-years-old) as dose 3 (booster), single for COVID-19 immunisation. Vaccination facility type was Pharmacy or Drug Store. The patient has no medical history that would interfere with vaccine efficacy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received nothing within 2 weeks of vaccination other than OTC cold medicine. Historical vaccine included first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on 31Mar2021 at 11:00 AM (Batch/Lot Number: ER8730) (at the age of 24-years-old) as dose 1, single; and on 21Apr2021 at 11:15 AM (Batch/Lot Number: EW0164) (at the age of 24-years-old) as dose 2, single both via an unspecified route of administration in left arm for COVID-19 immunisation. The patient also has previous allergy to unknown drug. On 25Oct2021 at 12:00 PM, the patient had noticed that he had been getting more frequent nosebleeds from his left nostril. They usually only last for 15-20 minutes maximum, but they always start rather suddenly, with blood usually dripping on the floor. The patient received no treatment. The patient was not diagnosed with COVID-19 prior to vaccination. The patient been tested for COVID-19 since the vaccination. The event was considered serious by reporter. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary oedema
Clinical narrative: having fluid on her lungs; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient states after she received 2 COVID vaccines she started having fluid on her lungs from an unspecified date and has to have it drained regularly. Also started on Entresto and Farxiga (no diabetes), and diuretic. Pulmonologist advised to have kidneys checked monthly but patient does not think she has kidney problems. The outcome of the event was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood test, Blood triglycerides, Investigation, Rash
Clinical narrative: rash got better and about 12 days ago it got worse; weight has gone down substantially; This is difficult for him to talk about or hear about therefore very stressful; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient's wife). A 72-year-old male patient received BNT162B2 (Lot ZN6200, second dose) solution for injection intramuscular in left arm on 20Mar2021 (at the age of 72-years-old) as a single dose for COVID-19 immunization. There was no medical history. Concomitant medications were not reported. Historical vaccine included BNT162B2 (first dose, lot EL3248) for COVID-19 vaccination on 20Feb2021 and experienced bullous pemphigoid, severe rash blisters from his neck all the way down to his legs, arms, back and chest, anxiety, loss of weight, mental distress, itching a little bit, dry skin, stinging, and knee and foot got swollen. In Mar2021, the patient had a rash which got better and about 12 days ago it got worse which resulted in emergency room visit and physician office visit. In 2021, the patient weight has gone down substantially and this was difficult for him to talk about or hear about therefore very stressful. Treatment for the event rash included doxycycline. Lab tests in 2021 included cholesterol and triglycerides: low, it came back that he was healthy; blood tests: unknown; lot of tests: all came back negative; urine tests: unknown. The outcome of the event rash was not recovered. The outcome of the other events was unknown.  Follow-up (09Nov2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101515942 same reporter/drug, different patient, similar AE