chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: heart seemed to be racing; Rash; muscle aches; tiredness; low grade fever; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Mar2021 as dose 1, single for COVID-19 immunisation. Medical history included historical allergic reaction to Penicillin and also got itchy over 40 years ago. The patient's concomitant medications were not reported. After first dose of vaccination, patient experienced mild symptoms, including, muscle aches, tiredness, a low grade fever which was around 99 point something. He took ibuprofen and went to bed. It lasted for 12 hours. But on an unspecified date, his heart seemed to be racing for first few hours and had a rash on his body. Patient asked if that was a severe reaction and does it prevent him or contraindicate him from getting the second vaccine dose. It was also reported that that he already informed his primary care physician and physician wasn't sure and advised him to call Pfizer to speak with a medical professional. The outcome of the events his heart seemed to be racing for first few hours and had a rash on his body was unknown and of all other events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: rash/hives on my neck and arms; rash/hives on my neck and arms; This is a spontaneous report from a contactable consumer(patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on 30Mar2021 as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced rash/hives on his neck and arms on 31Mar2021. The outcome was unknown for the reported events.  No follow-up attempts are possible. Information on batch/lot number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Arthralgia, Diarrhoea, Ear pain
Clinical narrative: swollen injection site with redness; swollen injection site with redness; swollen lymph nodes in armpit and neck; earache; fever of 102; joint pain; fatigue; nausea; diarrhea; headache; loss of smell and taste; loss of smell and taste; This is a spontaneous report from a non-contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7533), via an unspecified route of administration in left arm on 30Mar2021 (at the age of 48-years-old) as dose 2, single for COVID-19 immunization. Medical history included Obesity and Penicillin allergy. Concomitant medication included ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMINS) and calcium. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204), via an unspecified route of administration on 09Mar2021 09:30 (at the age of 48-years-old) as dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks and was not pregnant. The patient experienced swollen injection site with redness, swollen lymph nodes in armpit and neck, earache, fever of 102, joint pain, fatigue, nausea, diarrhea, headache and loss of smell and taste on 30Mar2021. Since the vaccination, patient has not been tested for COVID-19. No treatment was received for the event. Outcome of events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Nausea, Pyrexia
Clinical narrative: swollen injection site with redness; swollen injection site with redness; swollen lymph nodes in armpit and neck; earache; fever of 102; joint pain; fatigue; nausea; diarrhea; headache; loss of smell and taste; loss of smell and taste; This is a spontaneous report from a non-contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7533), via an unspecified route of administration in left arm on 30Mar2021 (at the age of 48-years-old) as dose 2, single for COVID-19 immunization. Medical history included Obesity and Penicillin allergy. Concomitant medication included ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMINS) and calcium. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204), via an unspecified route of administration on 09Mar2021 09:30 (at the age of 48-years-old) as dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks and was not pregnant. The patient experienced swollen injection site with redness, swollen lymph nodes in armpit and neck, earache, fever of 102, joint pain, fatigue, nausea, diarrhea, headache and loss of smell and taste on 30Mar2021. Since the vaccination, patient has not been tested for COVID-19. No treatment was received for the event. Outcome of events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: swollen injection site with redness; swollen injection site with redness; swollen lymph nodes in armpit and neck; earache; fever of 102; joint pain; fatigue; nausea; diarrhea; headache; loss of smell and taste; loss of smell and taste; This is a spontaneous report from a non-contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7533), via an unspecified route of administration in left arm on 30Mar2021 (at the age of 48-years-old) as dose 2, single for COVID-19 immunization. Medical history included Obesity and Penicillin allergy. Concomitant medication included ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMINS) and calcium. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204), via an unspecified route of administration on 09Mar2021 09:30 (at the age of 48-years-old) as dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks and was not pregnant. The patient experienced swollen injection site with redness, swollen lymph nodes in armpit and neck, earache, fever of 102, joint pain, fatigue, nausea, diarrhea, headache and loss of smell and taste on 30Mar2021. Since the vaccination, patient has not been tested for COVID-19. No treatment was received for the event. Outcome of events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EN6205), at the age of 40, via an unspecified route of administration, left arm, on Mar 8, 2021, at 17:30, single dose, for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included obesity and COVID-19 (prior to vaccination). The patient's concomitant medications: none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took penicillin and experienced allergies. The patient experienced arm pain, swollen lymph node and fever on an unspecified date. The patient did not receive any treatment for the events. The outcome of the events: recovering. Since the vaccination, patient has not tested for COVID-19. No follow-up attempts needed. No further information expected.
Age: 37.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Hyperhidrosis, Influenza like illness, Pain
Clinical narrative: flu like symptoms; body ache; chills; sweats; joint pain; fever; This is a spontaneous report from a contactable consumer (patient). A 37-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6200), intramuscular, administered in right arm on 19Feb2021 08:00 (at the age of 37 year old) as dose 2, single for COVID-19 immunisation. Medical history included ongoing lupus from 2017. Concomitant medications included ongoing bupropion hydrochloride (WELLBUTRIN) for depression from 2017; lisinopril from 2017 and metoprolol from 2020, both for high BP.  Prior vaccination, patient did not receive any other vaccines within four weeks. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), intramuscular, administered in left arm on 29Jan2021 08:00 (at the age of 37 year old) as single dose for COVID-19 immunization and the patient experienced swelling on 05Feb2021 08:00. On 19Feb2021 23:00, the patient had fever and  joint pain and on an unspecified date, patient had Flu like symptoms, body ache, chills and sweats. No relevant tests and treatment was initiated in response to the events. The outcome of the events was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: flu like symptoms; body ache; chills; sweats; joint pain; fever; This is a spontaneous report from a contactable consumer (patient). A 37-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6200), intramuscular, administered in right arm on 19Feb2021 08:00 (at the age of 37 year old) as dose 2, single for COVID-19 immunisation. Medical history included ongoing lupus from 2017. Concomitant medications included ongoing bupropion hydrochloride (WELLBUTRIN) for depression from 2017; lisinopril from 2017 and metoprolol from 2020, both for high BP.  Prior vaccination, patient did not receive any other vaccines within four weeks. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), intramuscular, administered in left arm on 29Jan2021 08:00 (at the age of 37 year old) as single dose for COVID-19 immunization and the patient experienced swelling on 05Feb2021 08:00. On 19Feb2021 23:00, the patient had fever and  joint pain and on an unspecified date, patient had Flu like symptoms, body ache, chills and sweats. No relevant tests and treatment was initiated in response to the events. The outcome of the events was recovered.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: fatigue; Fever; This is a spontaneous report from a contactable consumer (daughter). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 26Mar2021 as dose 2, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 04Mar2021 as dose 1, single for covid-19 immunisation. The patient has experienced fatigue and fever during nighttime for 3 days now. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Feeling cold, Joint swelling, Vaccination site pain
Clinical narrative: painful wrist/ right hand was hurting very bad/joint is swollen with severe pain; joint is swollen with severe pain; felt very cold; arm hurt at the injection site; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 30Mar2021 (at the age of 66-years-old) as dose 2, single for covid-19 immunization.  Medical history included acid reflux. The patient had no concomitant medications. Patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported),  via an unspecified route of administration on 09Mar2021 (at the age of 66-years-old) as dose 1, single for covid-19 immunization. The patient had a little pain in arm where the vaccine was injected on the day of vaccination. On the second night the patient felt very cold. This morning when he woke up his right hand was hurting very bad where he had put his watch and the joint was swollen with severe pain.  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: U
Vaccine: COVID19
Symptoms: Ecchymosis, Rash
Clinical narrative: Rash on the buttocks or upper thigh, ecchymotic appearance; Rash on the buttocks or upper thigh, ecchymotic appearance; This is a spontaneous report from a contactable nurse reporting same event under the same suspect product for four patients. This is one of four reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced rash on the buttocks or upper thigh, ecchymotic appearance on an unspecified date. The rash begins with an appearance similar to shingles. After about a week the lesions are flat with an ecchymotic appearance. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021375425 same drug, event, different patient; US-PFIZER INC-2021375443 same drug, event, different patient
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Limb mass, Peripheral swelling, Poor quality product administered, Product temperature excursion issue, Vaccination site haemorrhage
Clinical narrative: lump like a golf ball on her arm; second dose was unrefrigerated; second dose was unrefrigerated; Experienced swelling of the left arm; pain on the injection site; there's blood when she took of the band aid; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: ER2613 and Expiration Date: 13Jul2021), via an unspecified route of administration, on 05Apr2021 at 11:30 (at the age of 74-year-old) as DOSE 2, SINGLE for covid-19 immunization. Medical history included stroke from Sep2020 and Kidney stones from Feb2020.  The patient had no concomitant medications. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204 and Expiration Date: 30 Jun 2021), via an unspecified route of administration, on left arm, on 08Mar2021 at 11:30 (at the age of 74-year-old) as DOSE 1, SINGLE for covid-19 immunization. The patient not had any other recent vaccinations. The patient experienced swelling of the left arm, pain on the injection site and there's blood when patient took of the band aid on 2021. The patient had a lump like golf ball on her arm, on 05Apr2021. The patient further stated that she also thought the vaccine had to be refrigerated, but the person had syringes sitting on the desk, which was different from the first time, when they pulled from fridge to give shot. The Patient noticed that the vaccines being administered in the vaccination site were not in the refrigerator. The patient would like to know if she can have pain relievers like Advil to ease the pain and also Asking if it is ok for the vaccines to stay in the room temperature. The patient would like to know what can she use, Motrin, Aspirin, or Aleve. The patient said, she would like to get the swelling down, she put some heat on the area first which didn't work so she used ice and had more relief from ice. The patient said she doesn't want to have gone thru all this and her vaccine not work because the second dose was four weeks and was unrefrigerated. The patient stated she would also like to know how long the vaccines are allowed to be unrefrigerated if they are allowed to be. Therapeutic measures were taken as a result of event swelling of the left arm included heat and ice. The outcome of the events was unknown at time of report.  No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: lump like a golf ball on her arm; second dose was unrefrigerated; second dose was unrefrigerated; Experienced swelling of the left arm; pain on the injection site; there's blood when she took of the band aid; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: ER2613 and Expiration Date: 13Jul2021), via an unspecified route of administration, on 05Apr2021 at 11:30 (at the age of 74-year-old) as DOSE 2, SINGLE for covid-19 immunization. Medical history included stroke from Sep2020 and Kidney stones from Feb2020.  The patient had no concomitant medications. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204 and Expiration Date: 30 Jun 2021), via an unspecified route of administration, on left arm, on 08Mar2021 at 11:30 (at the age of 74-year-old) as DOSE 1, SINGLE for covid-19 immunization. The patient not had any other recent vaccinations. The patient experienced swelling of the left arm, pain on the injection site and there's blood when patient took of the band aid on 2021. The patient had a lump like golf ball on her arm, on 05Apr2021. The patient further stated that she also thought the vaccine had to be refrigerated, but the person had syringes sitting on the desk, which was different from the first time, when they pulled from fridge to give shot. The Patient noticed that the vaccines being administered in the vaccination site were not in the refrigerator. The patient would like to know if she can have pain relievers like Advil to ease the pain and also Asking if it is ok for the vaccines to stay in the room temperature. The patient would like to know what can she use, Motrin, Aspirin, or Aleve. The patient said, she would like to get the swelling down, she put some heat on the area first which didn't work so she used ice and had more relief from ice. The patient said she doesn't want to have gone thru all this and her vaccine not work because the second dose was four weeks and was unrefrigerated. The patient stated she would also like to know how long the vaccines are allowed to be unrefrigerated if they are allowed to be. Therapeutic measures were taken as a result of event swelling of the left arm included heat and ice. The outcome of the events was unknown at time of report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# not reported), via an unspecified route of administration, on Mar 22, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On Mar 24, 2021, she developed a rash all over her body. It itched. She kept on scratching. On Mar 28, 2021, she went to a clinic. They prescribed her a steroid to take along with Benadryl. The physician informed her the steroid would interfere with the COVID-19 vaccine; so she took Benadryl, and put on Cortisone-10, which helped with the itching. At the time of report, she still had the rash. That day was the first day the itching was not so bad as before. She had a scheduled appointment for a second dose due on Apr 12, 2021. She asked if this would happen again or worst if she got her second dose. The patient has tested for COVID-19 several times, and results were negative. The outcome of the events: recovering. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Pain
Clinical narrative: Really tired achie; Joints ached very bad; very tired; had chills; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9266), intramuscular, administered in Left arm on 17Feb2021 10:40 as dose 2, single for COVID-19 immunisation. Medical history included Type 2 Diabetes and Cholesterol. Concomitant medications included ongoing lisinopril; choline fenofibrate (TRILIPIX); metformin, all for type 2 diabetes and cholesterol; magnesium chloride (SLOW-MAG); multivitamins and alene, all for an unspecified indication. Patient had no prior vaccinations. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982) , Intramuscular, in left arm, on 21Jan2021 10:40, as single dose for COVID-19 immunization and on 05Feb2021, the patient experienced night sweats, shortness of breath, tired more so than usual. On 17Feb2021 20:00, the patient experienced very tired and had chills and on 18Feb2021 18:00, she was really tired, achie and  joints ached very bad. Therapeutic measures were taken in response to the events included, Tylenol. It was reported that she seemed okay in the morning. The outcome of the event had chills was unknown and of other events was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face
Clinical narrative: Lip swelling; facial swelling and Cheek swelling; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on 06Apr2021, as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 06Apr2021, an hour after the vaccine,  the patient noticed her cheeks felt they were swelling. On 7Apr2021, the patient had minor swelling on her lips. The patient would like to know, if this is a common side effect after the vaccine. The outcome of the events was unknown at time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Decreased appetite, Drug interaction, Lethargy, Malaise
Clinical narrative: after the vaccine she is only getting like 2 good days out of her infusions, making the infusions not help now; after the vaccine she is only getting like 2 good days out of her infusions, making the infusions not help now; severe lethargy and malaise; severe lethargy and malaise; severe neck pain; smells things burning; no appetite; tinnitus in both ears; chest pains; lost a lot of weight; This is a spontaneous report from a contactable nurse (patient).   A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 08Mar2021 (at the age of 65-years-old) as dose 2, single for covid-19 immunization  .  Medical history included ongoing Primary immune deficiency disease diagnosed around 2017. States she has multiple drug allergies, no further information provided. Concomitant medication included immunoglobulin human normal (GAMMAPLEX) taken for an primary immune deficiency disease from 2018. Patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL9266), via an unspecified route of administration, administered in Arm Left on 15Feb2021 (at the age of 65-years-old) as dose 2, single for covid-19 immunization Patient state she was lethargic and had severe malaise, she had severe neck pain and had to ice things, states she smells things burning all the time, the house burning, toast burning, stopped checking because she knows it was just a symtom, she had no appetite, had tinnitus in both ears and now it is unbearable, can barely hear because it is so loud in both ears, has chest pains that she has never had before, and states  after the vaccine she was only getting like 2 good days out of her infusions, it had decreased the effectiveness of the infusions, used to get a good 10 days after the infusions, now she only gets 2. States she has lost a lot of weight as well since the second dose of the vaccine, used to be 175.  The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Parosmia, Therapeutic response decreased, Tinnitus, Weight decreased
Clinical narrative: after the vaccine she is only getting like 2 good days out of her infusions, making the infusions not help now; after the vaccine she is only getting like 2 good days out of her infusions, making the infusions not help now; severe lethargy and malaise; severe lethargy and malaise; severe neck pain; smells things burning; no appetite; tinnitus in both ears; chest pains; lost a lot of weight; This is a spontaneous report from a contactable nurse (patient).   A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 08Mar2021 (at the age of 65-years-old) as dose 2, single for covid-19 immunization  .  Medical history included ongoing Primary immune deficiency disease diagnosed around 2017. States she has multiple drug allergies, no further information provided. Concomitant medication included immunoglobulin human normal (GAMMAPLEX) taken for an primary immune deficiency disease from 2018. Patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL9266), via an unspecified route of administration, administered in Arm Left on 15Feb2021 (at the age of 65-years-old) as dose 2, single for covid-19 immunization Patient state she was lethargic and had severe malaise, she had severe neck pain and had to ice things, states she smells things burning all the time, the house burning, toast burning, stopped checking because she knows it was just a symtom, she had no appetite, had tinnitus in both ears and now it is unbearable, can barely hear because it is so loud in both ears, has chest pains that she has never had before, and states  after the vaccine she was only getting like 2 good days out of her infusions, it had decreased the effectiveness of the infusions, used to get a good 10 days after the infusions, now she only gets 2. States she has lost a lot of weight as well since the second dose of the vaccine, used to be 175.  The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Paraesthesia
Clinical narrative: Bad joint and muscle pain in my left leg; Bad joint and muscle pain in my left leg; poking me with the pin on my chin and my left chin also.; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: unknown and expiration date: not reported), via an unspecified route of administration, on 27Mar2021, as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 30Mar2021, 3 days after the vaccination, the patient experienced bad joint and muscle pain in left leg, patient had got like someone is poking patient with the pin on chin and left chin also. The patient would like to know if that was normal. The outcome of the events was unknown at time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Rash
Clinical narrative: Rash on my neck and upper chest within 6 hrs of vaccine; Rash on neck burns; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0162), via an unspecified route of administration, administered in Right arm on 10Apr2021 14:00 (at the age of 59 year old) as dose 2, single for COVID-19 immunisation. Medical history included allergies to Sulfa products, doxycycline and was sensitive to epinephrine. Concomitant medications included alprenolol hydrochloride (ATENENOL); duloxetine hydrochloride (CYMBALTA); levothyroxine sodium (SYNTHROID) and metformin all for an unspecified indication.  Prior to vaccination, patient  was not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8730), via an unspecified route of administration, administered in left arm on 20Mar2021 13:45 (at the age of 59 year old) as dose 1, single for COVID-19 immunisation. On 10Apr2021, within 6 hours of vaccination, at 18:00, patient had rash on neck and upper chest, where rash on neck burns. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the event rash was not recovered and of burning sensation was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: My blood pressure was high the next day 152/103. It's normally 128/88 or 130/90; This is a spontaneous report received from a contactable other-healthcare professional (patient). A 61-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 16Apr2021 11:00 (at the age of 61-years-old) as dose 1, single for COVID-19 immunisation. Medical history included blood cholesterol increased from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin calcium (LIPITOR), celecoxib (CELEBREX) taken for an unspecified indication, start and stop date were not reported. The patient previously took demerol and experienced drug hypersensitivity. Patent received vaccine facility in pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. The patient experienced my blood pressure was high the next day 152/103. it's normally 128/88 or 130/90 on 17Apr2021 06:00. No treatment was received for the events. The patient underwent lab tests and procedures which included blood pressure measurement: high 152/103 (It's normally 128/88 or 130/90) on 17Apr2021. The outcome of the events was reported as unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Today is the second day that the Gland under my right arm is very swollen.  It is the size of a Golf Ball.; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot Number: EP7533) via an unspecified route of administration in arm left on 27Mar2021 12:30 as dose 1, single and dose 2 (Lot Number: EW0161) via an unspecified route of administration in arm right on 27Mar2021 as dose 2, single (age at vaccination: 53 years) for COVID-19 immunisation. Medical history included none relevant history. Concomitant medications included sulfamethoxazole, trimethoprim (SMZ-TMP DS); ibuprofen (IBUROFEN); tadalafil (TADAFIL); phenazopyridine (PHENAZOPYRIDINE), all taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. No COVID prior vaccination and did not tested COVID post vaccination. No known allergies. On 26Apr2021 16:00 PM, the patient experienced that today is the second day that the gland under my right arm is very swollen. It is the size of a golf ball. No treatment was received. The clinical outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Myalgia, Pain in extremity
Clinical narrative: Fever up to 101 degrees fahrenheit; Muscle aches; headache; fatigue; lymph node swollen to size of golf ball under shot arm; sore arm; This is a spontaneous report from a contactable consumer (patient). A 45 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0175) via an unspecified route, administered in Left Arm on 29Apr2021 at 13:15 (45-year-old vaccination) as Dose 2, Single for Covid-19 immunization. The patient was non-pregnant. The patient's medical history included current subacute thyroiditis, endometriosis. The patient's concomitant medication(s) included ascorbic acid (VITAMIN C), VITAMIN D3, loratadine and ascorbic acid; biotin; calcium pantothenate; cyanocobalamin; folic acid; nicotinic acid; pyridoxine hydrochloride; riboflavin; thiamine hydrochloride; tocopheryl acetate (MULTIVITAMIN). The patient previously took avelox, prednisone, singulair and experienced allergies for all past drugs. The patient had not received any other vaccine within 4 weeks prior vaccination. The patient was neither tested for Covid prior vaccination nor post vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8729) via an unspecified route, administered in Left Arm on 08Apr2021 at 16:30 (45-year-old vaccination) as Dose 1, Single for Covid-19 immunization. On 30Apr2021 at 02:00 AM, the patient had experienced fever up to 101 degrees Fahrenheit, muscle aches, headache, fatigue (after 18-36 hours of vaccination) and (after 36-96 hours) lymph node swollen to size of golf ball under shot arm, sore arm. No treatment received for resulted events. The outcome of the events was recovering.   No follow-up attempts are possible. No further information was expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever up to 101 degrees fahrenheit; Muscle aches; headache; fatigue; lymph node swollen to size of golf ball under shot arm; sore arm; This is a spontaneous report from a contactable consumer (patient). A 45 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0175) via an unspecified route, administered in Left Arm on 29Apr2021 at 13:15 (45-year-old vaccination) as Dose 2, Single for Covid-19 immunization. The patient was non-pregnant. The patient's medical history included current subacute thyroiditis, endometriosis. The patient's concomitant medication(s) included ascorbic acid (VITAMIN C), VITAMIN D3, loratadine and ascorbic acid; biotin; calcium pantothenate; cyanocobalamin; folic acid; nicotinic acid; pyridoxine hydrochloride; riboflavin; thiamine hydrochloride; tocopheryl acetate (MULTIVITAMIN). The patient previously took avelox, prednisone, singulair and experienced allergies for all past drugs. The patient had not received any other vaccine within 4 weeks prior vaccination. The patient was neither tested for Covid prior vaccination nor post vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8729) via an unspecified route, administered in Left Arm on 08Apr2021 at 16:30 (45-year-old vaccination) as Dose 1, Single for Covid-19 immunization. On 30Apr2021 at 02:00 AM, the patient had experienced fever up to 101 degrees Fahrenheit, muscle aches, headache, fatigue (after 18-36 hours of vaccination) and (after 36-96 hours) lymph node swollen to size of golf ball under shot arm, sore arm. No treatment received for resulted events. The outcome of the events was recovering.   No follow-up attempts are possible. No further information was expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes, soft, tender, bean sized along collar bone. All on the left side only; This is a spontaneous report from a contactable consumer (patient). A 33 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, 33-year-old at vaccination), via an unspecified route, administered in Left Arm on 15Apr2021 at 11:00 (Lot Number: ER8729) as a Dose 1, Single and via an unspecified route, administered in Left Arm on 06May2021 at 11:00 (Lot Number: EW0168) as a Dose 2, Single, both doses for COVID-19 immunization. The patient was non-pregnant at time of vaccination. The patient's medical history included IBS (irritable bowel syndrome). No known allergies. There were no concomitant medications within two weeks of vaccination. Facility type vaccine was reported Pharmacy or Drug Store. The patient was not tested for Covid prior vaccination. The patient had not received any other vaccine within four weeks prior vaccination. On 07May2021, the patient had experienced swollen lymph nodes in armpit, soft, tender, and about golf ball sized swollen lymph nodes, soft, tender, bean sized along collar bone. All on the left side only. These adverse events did not resulted in emergency room/physician office visit. No treatment was received for resulted events. The patient was not tested for Covid post vaccination. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information was expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Lymph node pain, Lymphadenopathy
Clinical narrative: significant swelling up and down the arm that had the injection; pain in the elbow; A low fever of 100.8 F; body aches in the lower back and knee; body aches in the lower back and knee; painful lymph node swelling in the same arm as the injection is present with significant fluid (more than a golf ball size); painful lymph node swelling in the same arm as the injection is present with significant fluid (more than a golf ball size); This is a spontaneous report from a contactable consumer (patient). A 42-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0170, Expiration date: not reported), via an unspecified route of administration in arm left on 09May2021 at 10:15 AM (at the age of 42-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history included birth control. Past drug event included oxycodone hydrochloride;oxycodone terephthalate;paracetamol [PERCOCET] and experienced allergy. The patient's concomitant medications in two weeks included ethinylestradiol, norethisterone acetate (JUNEL), taken for birth control. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8731, Expiration date: not reported), via an unspecified route of administration in arm left on 18Apr2021 at 10:30 AM (at the age of 41-year-old) as a dose 1, single for COVID-19 immunization. It was reported that, the patient was not pregnant at time of vaccination. Other vaccine in four weeks was reported as no. No covid prior vaccination and no covid tested post vaccination. On 10May2021, the day after the vaccine, significant swelling up and down the arm that had the injection, with pain in the elbow. A low fever of 100.8 F and body aches in the lower back and knee occurred. 48 hrs after receiving the vaccine, painful lymph node swelling in the same arm as the injection was present with significant fluid (more than a golf ball size). This pain has persisted even with 400 mg of ibuprofen taken daily. Treatment was not received for the events. On 10May2021, the patient underwent lab tests and procedures which included fever (body temperature), resulted as 100.8 Fahrenheit, low fever of 100.8 F. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: significant swelling up and down the arm that had the injection; pain in the elbow; A low fever of 100.8 F; body aches in the lower back and knee; body aches in the lower back and knee; painful lymph node swelling in the same arm as the injection is present with significant fluid (more than a golf ball size); painful lymph node swelling in the same arm as the injection is present with significant fluid (more than a golf ball size); This is a spontaneous report from a contactable consumer (patient). A 42-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0170, Expiration date: not reported), via an unspecified route of administration in arm left on 09May2021 at 10:15 AM (at the age of 42-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history included birth control. Past drug event included oxycodone hydrochloride;oxycodone terephthalate;paracetamol [PERCOCET] and experienced allergy. The patient's concomitant medications in two weeks included ethinylestradiol, norethisterone acetate (JUNEL), taken for birth control. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8731, Expiration date: not reported), via an unspecified route of administration in arm left on 18Apr2021 at 10:30 AM (at the age of 41-year-old) as a dose 1, single for COVID-19 immunization. It was reported that, the patient was not pregnant at time of vaccination. Other vaccine in four weeks was reported as no. No covid prior vaccination and no covid tested post vaccination. On 10May2021, the day after the vaccine, significant swelling up and down the arm that had the injection, with pain in the elbow. A low fever of 100.8 F and body aches in the lower back and knee occurred. 48 hrs after receiving the vaccine, painful lymph node swelling in the same arm as the injection was present with significant fluid (more than a golf ball size). This pain has persisted even with 400 mg of ibuprofen taken daily. Treatment was not received for the events. On 10May2021, the patient underwent lab tests and procedures which included fever (body temperature), resulted as 100.8 Fahrenheit, low fever of 100.8 F. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Fatigue, Pain in extremity
Clinical narrative: Chest Pains of 7/8 over two days; Pain in my back; Pain in my left arm; Tired after biking 10-15 miles. I usually do 30-40 and not tried.; This is a spontaneous report from a contactable consumer (patient). A 72-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 04Jun2021 14:15 (at the age of 72-years-old) as dose number unknown, single for COVID-19 immunisation. Medical history included mild asthma and  known penicillin allergy. There were no concomitant medications. On 05Jun2021 18:00, the patient experienced chest pains of 7/8 over two days. Pain in my left arm and back. Tired after biking 10-15 miles. He usually does 30-40 and not tired. The patient underwent lab tests and procedures which included chest pain intensity 7/8 over two days on 05Jun2021. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and not tested for Covid-19 post vaccination. It was unknown if patient had treatment for the events. The outcome of the events was resolving.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Gait disturbance, Pain
Clinical narrative: Extreme pain in back and stomach after second dose; Extreme pain in back and stomach after second dose; couldn't barely walk day after; eased off pain still there; This is a spontaneous report from a contactable consumer (patient) or other non hcp.   A 37-years-old female patient received 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 28Jun2021 16:45 (at the age of 37-years-old) as dose 2, single for COVID-19 immunization. Medical history included contraception from an unknown date and unknown if ongoing. Concomitant medication included butalbital, caffeine, paracetamol (FIORICET) taken for contraception, start and stop date were not reported. The patient previously took macrobid [clarithromycin] and experienced drug hypersensitivity. Previously patient received 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 07Jun2021 05:45 (at the age of 37-years-old) as dose 1, single for COVID-19 immunization. No COVID prior to the vaccination. COVID not tested post vaccination. On 29Jun2021 07:00, the patient experienced extreme pain in back and stomach after second dose, couldn't barely walk day after, eased off pain still there. The outcome of the event eased off pain still there was recovering. The outcome of the events extreme pain in back and stomach after second dose, couldn't barely walk day after was unknown.  No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.