chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Lymph node pain
Clinical narrative: Terrible headache in lower back of head.; Extreme fatigue which has continued from first vaccine.; Terrible joint pain but feels like rheumatory arthritis after the second shot./my right hip is sore; debilitating; My lymph nodes in my right groin; my rib cage feels like it is broken; pain I am experiencing is debilitating; This is a spontaneous report from a contactable consumer (patient).  A 63-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration in Arm Left on 03Sep2021 16:00 (at the age of 63-year-old), as single for COVID-19 immunization. The patient's medical history included mastectomy from Dec2017, DBL Mastectomy No Cancer BRCA 2 Gene, hysterectomy from Dec2016 Complete Hysterectomy No Cancer BRCA 2 Gene. There were no concomitant medications. The patient's historic vaccine included first dose of bnt162b2 (BNT162B2, Solution for injection, lot no: unknown), dose1 on 02Aug202103:45pm at arm left for COVID-19 immunization and she experienced terrible headache in lower back of head and extreme fatigue. The patient was not diagnosed with COVID-19, Prior to vaccination. No known allergies and no Prior vaccine in four weeks. On 11Sep2021, The patient experienced terrible headache in lower back of head and extreme fatigue which has continued from first vaccine. She had Terrible joint pain which felt like rheumatory arthritis after the second shot. She never had any such symptoms before and the pain was debilitating. They were affecting her right side of body. Her lymph nodes in right groin, rib cage felt like it was broken, her right hip was sore. The pains came and went but her ribs and lymph glands hurt continuously. She was very active person who was always on the move and exercising, but not anymore. She regrets taking the vaccine as she goes nowhere unless necessary and use all precautions. The treatment was not provided for the events. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 25Aug2021 Nasal Swab , sars-cov-2 test: negative on 27Aug2021 Employeed family came down with Covid sowe tested to be sure did not get covid , sars-cov-2 test: negative on 30Aug2021 Employed family came down with Covid sowe tested to be sure did not get covid. The outcome of all 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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Pain, SARS-CoV-2 test
Clinical narrative: Terrible headache in lower back of head.; Extreme fatigue which has continued from first vaccine.; Terrible joint pain but feels like rheumatory arthritis after the second shot./my right hip is sore; debilitating; My lymph nodes in my right groin; my rib cage feels like it is broken; pain I am experiencing is debilitating; This is a spontaneous report from a contactable consumer (patient).  A 63-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration in Arm Left on 03Sep2021 16:00 (at the age of 63-year-old), as single for COVID-19 immunization. The patient's medical history included mastectomy from Dec2017, DBL Mastectomy No Cancer BRCA 2 Gene, hysterectomy from Dec2016 Complete Hysterectomy No Cancer BRCA 2 Gene. There were no concomitant medications. The patient's historic vaccine included first dose of bnt162b2 (BNT162B2, Solution for injection, lot no: unknown), dose1 on 02Aug202103:45pm at arm left for COVID-19 immunization and she experienced terrible headache in lower back of head and extreme fatigue. The patient was not diagnosed with COVID-19, Prior to vaccination. No known allergies and no Prior vaccine in four weeks. On 11Sep2021, The patient experienced terrible headache in lower back of head and extreme fatigue which has continued from first vaccine. She had Terrible joint pain which felt like rheumatory arthritis after the second shot. She never had any such symptoms before and the pain was debilitating. They were affecting her right side of body. Her lymph nodes in right groin, rib cage felt like it was broken, her right hip was sore. The pains came and went but her ribs and lymph glands hurt continuously. She was very active person who was always on the move and exercising, but not anymore. She regrets taking the vaccine as she goes nowhere unless necessary and use all precautions. The treatment was not provided for the events. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 25Aug2021 Nasal Swab , sars-cov-2 test: negative on 27Aug2021 Employeed family came down with Covid sowe tested to be sure did not get covid , sars-cov-2 test: negative on 30Aug2021 Employed family came down with Covid sowe tested to be sure did not get covid. The outcome of all 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: 31.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fall, Immunisation, Joint dislocation, Joint swelling, Off label use
Clinical narrative: Knee caps out of place to strengthen; Slipped on ice and made knee swell and ankles and elbow swelling; Slipped on ice and made knee swell and ankles and elbow swelling; Patient received covid-19 vaccine booster dose; Patient received covid-19 vaccine booster dose; This is a solicited report based on the information received by Pfizer from AbbVie Inc. (MFR Control No. # 21K-163-4074903-00). A contactable 31-year-old female consumer (patient) received third of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via intramuscular route of administration on an unspecified date (age at the time of vaccination 31-years-old), as a single dose for COVID-19 immunization; and Humira (solution for injection in pre-filled pen) (adalimumab), via Subcutaneous, on an unspecified date for Moderate to severe Rheumatoid Arthritis, and Psoriatic Arthritis. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 vaccine on an unspecified date, as a single dose for COVID-19 immunization, and second dose of BNT162B2 vaccine on an unspecified date, as a single dose for COVID-19 immunization. On an unspecified date, the patient experienced Knee caps out of place to strengthen, Slipped on ice and made knee swell and ankles and elbow swelling, and Patient received covid-19 vaccine booster dose. It was unknown if patient was enrolled in a covid-19 vaccine trial. The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The outcome of the events Knee caps out of place to strengthen was not recovered; and Slipped on ice and made knee swell and ankles and elbow swelling was recovered on an unspecified date; and Patient received covid-19 vaccine booster dose was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information in the narrative the causality between the suspect vaccine BNT162B2 and the events Fall, Joint dislocation and Joint swelling were considered Unrelated since these happened due to Accidental Injury. Events Off label use and Immunization were assessed as Related.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: My first period after the vaccine was abnormal for me.; There was no blood; 24 days I have had bleeding ranging from black to bright red/My cycle is normally very regular; This is a spontaneous report from a contactable Nurse (Patient). A 22-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FA6780), via an unspecified route of administration on 02Jul2021(at the age of 22-years-old) administered in Arm Left as a single dose for COVID-19 immunization at Pharmacy or Drug Store. Medical history included ehlers-danlos syndrome, covid-19 (all from an unknown date and unknown if ongoing). Concomitant medication(s) included omeprazole; montelukast; Multivitamin (all taken for an unspecified indication, start and stop date were not reported). The patient did not receive any other vaccine in four weeks. The patient had no allergy. On 20Aug2021, it was reported that the patient first period after the vaccine was abnormal. There was no blood, only lining shed. She had four days after that with nothing. And now for 24 days She have had bleeding ranging from black to bright red. Her cycle was normally very regular. No treatment was given for the events. Post vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.  Follow-Up (28Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Vaccination site pain
Clinical narrative: Vaccination site pain; COVID-19; COVID-19; This is a Solicited report based on the information received by Pfizer from  (Manufacturer Control No: 21K-163-3819448-00) from a non-contactable female consumer reporting for herself. This is the second of two report.  A 66-year-old female subject received a dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization.  Medical history was none. No known allergies. Concomitant medications included adalimumab (HUMIRA) subcutaneous, start and stop date were not reported for an unspecified indication.  The subject experienced COVID-19 in Jul2021 with outcome of recovered and vaccination site pain on an unspecified date with outcome of recovered.   The reporter's assessment of the causal relationship of the event with BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.  Amendment: This follow-up report is being submitted to amend previously reported information: BNT126B2 product wrongly coded to BLA instead of EUA, BNT162b2 coding updated.; Sender's Comments: The information provided is very limited and does not allow for a complete medical assessment. Based on available information a contributory role of BNT162B2 to the reported Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information. Based on the known drug safety profile the causal association between the suspect vaccine BNT162B2 and the reported Vaccination site pain is possible. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101241813 same patient, different event and drug
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dyspepsia, Ear pain, Headache, Neck pain
Clinical narrative: Pain right side of neck in to right ear; Pain right side of neck in to right ear; Pain right side temple; Heartburn; This is a spontaneous report received from a contactable consumer (patient). This consumer reported events for two separate vaccine doses. This is the first of two reports. This report is for the events related to the first vaccine dose.   A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration, administered in the right arm on 29Aug2021 at 10:30 (Batch/Lot Number: FC3184) as a single dose for COVID-19 immunisation at a pharmacy or drug store. Medical history included pemphigus (affects mucosa areas) and allergy to sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included glucosamine, methylsulfonylmethane (MSM WITH GLUCOSAMINE) and fish oil (OMEGA 3) and other unspecified vitamins. Past drug history included drug allergy with codeine and morphine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Aug2021 (after the first dose of the vaccine), the patient experienced pain on the right side of the neck into the right ear. Then a couple days later in Aug2021, the patient had pain that lasted for 3 days on the right side of the temple, located in that area only. Also, heartburn was pretty bad and lasted 3 days, then went away. No treatment was received for the events. That was the only issues with the first dose of the vaccine. Since the vaccination, the patient has tested negative for COVID-19 in 2021. The outcome of pain right side of the temple and heartburn was recovered on an unspecified date in 2021. The outcome of events pain right side of neck into the right ear was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101265356 Same reporter/SD, Different potential/AE
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: lightheadedness and dizziness; This is a spontaneous report from a non-contactable pharmacist. A 43-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in left arm on 21Apr2021 (Batch/Lot Number: er8733) at the age of 42 years old as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced lightheadedness and dizziness on an unspecified date. The patient was given water and symptoms resolved in 20 minutes. The patient recovered from the event on an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown, if the patient was diagnosed with COVID-19. Since the vaccination, it was unknown if the patient has been tested for COVID-19. The facility where the most recent COVID-19 vaccine was administered was in a hospital.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Throat feels tight upon breathing; This is a spontaneous report from a non-contactable pharmacist (patient). An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via intramuscular, administered in Left Arm on 09Mar2021 (Batch/Lot Number: en6199) as dose number unknown, single for covid-19 immunization. Medical history included ongoing anxiety. The patient was not pregnant at vaccination. Facility where the most recent COVID-19 vaccine administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included alprazolam (XANAX) taken for anxiety; start date and stop date was not provided. In 2021 the patient experienced throat feels tight upon breathing. The patient was not hospitalized. The outcome of the event was unknown.  No follow-up attempts are possible. No further information expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chest pain, Pain in extremity, Vaccination site pain
Clinical narrative: the pain radiated down her arm and into her chest and her underarm and it was worse than it was two days ago; the pain radiated down her arm and into her chest and her underarm and it was worse than it was two days ago; the pain radiated down her arm and into her chest and her underarm and it was worse than it was two days ago; her arm at the injection site started really hurting her; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 24Sep2021 01:00 (Batch/Lot Number: 30145B2) at the age of 72 years old as DOSE NUMBER UNKNOWN (BOOSTER), SINGLE for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medications included ibuprofen; and ibuprofen (ADVIL); both taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient had pain in her arm. She had several other of the side effects uncomfortable side effects but nothing severe. Starting yesterday (26Sep2021), her arm at the injection site started really hurting her, it hurt the whole time but now it got worse and the pain radiated down her arm and into her chest and her underarm and it was worse than it was two days ago. Outcome of the events was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Heart rate increased, Nervousness, Palpitations
Clinical narrative: rapids fluttering heart beats; fast heart beating; palpitations of my heart; nervous; This is a spontaneous report from a contactable consumer (patient). A 64 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 01Sep2021 (at age of 64 years old, Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced rapids fluttering heart beats, fast heart beating, palpitations of heart, nervous on 01Sep2021 after 5 hours received vaccine. No admission to hospital involved. The patient reported after five hours of received the pfizer vaccine she had very fast heart beating, palpitations of her heart for about six hours very fast hard beating and by nervous and finally I was able to fall asleep and then the next day she continue to have fast but not as bad as the day before, but continued rapids fluttering heart beats for most of the day. Now her heart just continues to beat heavier than what it normally was, but it's not as bad and palpitating as it was for the two days. The outcome of the event "fast heart beating" was not recovered. The outcome of other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Erythema, Eye pain, Feeling hot
Clinical narrative: heart was beating really fast; feeling hot; Her nose swelled/swollen nose; Her eyes hurt; she is sure it was her sinuses; She didn't feel good; She adds to it when she gets scared; it was hard to breathe through the nose; face swollen and red; face swollen and red/redness in face; throat tight; inside nose was swollen; headache in the eyes; difficulty swallowing; This is a spontaneous report received from a contactable consumer (Patient herself) PFIZER-BIONTECH COVID-19 VACCINE. A 68-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: er87132 and ER8732) via an unspecified route of administration, in arm left on 23Mar2021 13:30 (at the age of 68-years-old) as dose 1, single for COVID-19 immunization. Medical history included Penicillin allergy, Latex allergy and High blood pressure. Concomitant medications included propranolol (PROPANOLOL) taken for High blood pressure. The patient experienced redness in face and difficulty swallowing when she took the first dose of the Pfizer COVID19 vaccine on 23Mar2021. She did not get the second dose. It was asked that if she can take a different brand of the COVID19 vaccine after these symptoms. The patient stated that her heart was beating really fast and it was within an hour after she got it. She started feeling hot and her face was getting red. She washed her face with a rag. Her nose swelled and her face was swelling. It felt like she was at the dentist. Her eyes hurt because her nose was swollen and she was sure it was her sinuses. She didn't feel good. It was hard to breathe through the nose. It was difficult to swallow. At that point it was probably nerves too. She added to it when she gets scared. She tried to calm down and relax. Her nose was swollen for 2 days. She put ice on her face and stuff. The patient stated that the difficulty swallowing redness of face and throat tight started within 45 minutes of getting the shot. The patient also stated that she had never had a flu shot. She did had Tetanus shot. She didn't react bad but was sick from it. She had two Tetanus shots and they affect her, but she doesn't die. Caller did not have NDC, lot, and expiry to provide for Tetanus shots that she also received. She was almost 70 years old next year. She did not want to infect anyone else. The patient stated she had never had measles, mumps, or rubella or no child illness. The outcome of nose was swollen, headache in the eyes, redness in face, throat tight was recovered on an unspecified date in 2021 and was unknown for other events.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Malaise, Nasal oedema, Nervousness
Clinical narrative: heart was beating really fast; feeling hot; Her nose swelled/swollen nose; Her eyes hurt; she is sure it was her sinuses; She didn't feel good; She adds to it when she gets scared; it was hard to breathe through the nose; face swollen and red; face swollen and red/redness in face; throat tight; inside nose was swollen; headache in the eyes; difficulty swallowing; This is a spontaneous report received from a contactable consumer (Patient herself) PFIZER-BIONTECH COVID-19 VACCINE. A 68-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: er87132 and ER8732) via an unspecified route of administration, in arm left on 23Mar2021 13:30 (at the age of 68-years-old) as dose 1, single for COVID-19 immunization. Medical history included Penicillin allergy, Latex allergy and High blood pressure. Concomitant medications included propranolol (PROPANOLOL) taken for High blood pressure. The patient experienced redness in face and difficulty swallowing when she took the first dose of the Pfizer COVID19 vaccine on 23Mar2021. She did not get the second dose. It was asked that if she can take a different brand of the COVID19 vaccine after these symptoms. The patient stated that her heart was beating really fast and it was within an hour after she got it. She started feeling hot and her face was getting red. She washed her face with a rag. Her nose swelled and her face was swelling. It felt like she was at the dentist. Her eyes hurt because her nose was swollen and she was sure it was her sinuses. She didn't feel good. It was hard to breathe through the nose. It was difficult to swallow. At that point it was probably nerves too. She added to it when she gets scared. She tried to calm down and relax. Her nose was swollen for 2 days. She put ice on her face and stuff. The patient stated that the difficulty swallowing redness of face and throat tight started within 45 minutes of getting the shot. The patient also stated that she had never had a flu shot. She did had Tetanus shot. She didn't react bad but was sick from it. She had two Tetanus shots and they affect her, but she doesn't die. Caller did not have NDC, lot, and expiry to provide for Tetanus shots that she also received. She was almost 70 years old next year. She did not want to infect anyone else. The patient stated she had never had measles, mumps, or rubella or no child illness. The outcome of nose was swollen, headache in the eyes, redness in face, throat tight was recovered on an unspecified date in 2021 and was unknown for other events.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus disorder, Swelling, Swelling face, Throat tightness
Clinical narrative: heart was beating really fast; feeling hot; Her nose swelled/swollen nose; Her eyes hurt; she is sure it was her sinuses; She didn't feel good; She adds to it when she gets scared; it was hard to breathe through the nose; face swollen and red; face swollen and red/redness in face; throat tight; inside nose was swollen; headache in the eyes; difficulty swallowing; This is a spontaneous report received from a contactable consumer (Patient herself) PFIZER-BIONTECH COVID-19 VACCINE. A 68-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: er87132 and ER8732) via an unspecified route of administration, in arm left on 23Mar2021 13:30 (at the age of 68-years-old) as dose 1, single for COVID-19 immunization. Medical history included Penicillin allergy, Latex allergy and High blood pressure. Concomitant medications included propranolol (PROPANOLOL) taken for High blood pressure. The patient experienced redness in face and difficulty swallowing when she took the first dose of the Pfizer COVID19 vaccine on 23Mar2021. She did not get the second dose. It was asked that if she can take a different brand of the COVID19 vaccine after these symptoms. The patient stated that her heart was beating really fast and it was within an hour after she got it. She started feeling hot and her face was getting red. She washed her face with a rag. Her nose swelled and her face was swelling. It felt like she was at the dentist. Her eyes hurt because her nose was swollen and she was sure it was her sinuses. She didn't feel good. It was hard to breathe through the nose. It was difficult to swallow. At that point it was probably nerves too. She added to it when she gets scared. She tried to calm down and relax. Her nose was swollen for 2 days. She put ice on her face and stuff. The patient stated that the difficulty swallowing redness of face and throat tight started within 45 minutes of getting the shot. The patient also stated that she had never had a flu shot. She did had Tetanus shot. She didn't react bad but was sick from it. She had two Tetanus shots and they affect her, but she doesn't die. Caller did not have NDC, lot, and expiry to provide for Tetanus shots that she also received. She was almost 70 years old next year. She did not want to infect anyone else. The patient stated she had never had measles, mumps, or rubella or no child illness. The outcome of nose was swollen, headache in the eyes, redness in face, throat tight was recovered on an unspecified date in 2021 and was unknown for other events.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fungal infection, Hypomenorrhoea, Oral herpes
Clinical narrative: Started to get cold sores on lip two and a half weeks later; Period was lighter; Yeast infection two weeks; This is a spontaneous report from a contactable consumer (patient).   A 41-year-old non pregnant female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, batch/ lot number: FA 6780), via an unspecified route of administration, administered in left arm on 10Sep2021 01:00 (at the age of 41 years) as dose 1, single for COVID-19 immunization. The patients medical history included seasonal allergies and doxycycline allergies. There were no concomitant medications. The patient did not take other vaccine in four weeks. The patient did not take other medications in two weeks. The patient did not have COVID prior vaccination. The patient did not get COVID tested post vaccination. Patient was not pregnant at the time of vaccination. On 24Sep2021 03:00 (two and a half weeks later) the patient started to get cold sores on lip. On an unspecified date in Sep2021 patient stated period was lighter. On an unspecified date in 2021 (two weeks) the patient experienced yeast infection. She was not prone to these and had not changed her diet. Acyclovir was taken as a therapeutic measure as a result of the events. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Nausea, Off label use, Overdose, Pain in extremity
Clinical narrative: Caller has received two Covid-19 AstraZeneca vaccines as well as both Pfizer Covid-19 vaccines; Caller has received two Covid-19 AstraZeneca vaccines as well as both Pfizer Covid-19 vaccines; Caller has received two Covid-19 AstraZeneca vaccines as well as both Pfizer Covid-19 vaccines; pain in her right arm; nausea; This is a spontaneous report from a contactable consumer. This female consumer(patient) reported for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 2 via an unspecified route of administration, administered in Arm left on an unspecified date as a single dose for covid-19 immunization. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included covid-19 vaccine nrvv ad (chadox1 ncov-19) (COVID-19 VACCINE ASTRAZENECA) taken for covid-19 immunisation. The patient has received two covid-19 astrazeneca vaccines as well as both pfizer covid-19 vaccines. She had pain in her right arm, nausea on an unspecified date. Caller received her second Pfizer covid-19 vaccine in her left arm, but reports pain in her right arm. Caller is interested in clinical trials for individuals in her situation and would like to report experienced side effects. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. 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.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Reaction to excipient, Throat tightness
Clinical narrative: allergies to the pfizer covid-19 vaccine ingredients; throat closed off; lips swelled; This is a spontaneous report from a non-contactable consumer via Pfizer sponsored program (patient, reported for self). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number and expiry date were not reported), via an unspecified route of administration, on an unspecified date in year 2021, as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in year 2021, after receiving the first dose of the Pfizer covid-19 vaccine the patient had a severe allergic reaction to the ingredients in it (allergies to the Pfizer covid-19 vaccine ingredients). The patient stated that her throat closed off and lips swelled. Reportedly the patient was told not get the second dose of the Pfizer COVID-19 vaccine, but patient stated she would like to speak with Pfizer medical professionals to see their information. Outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Ear disorder
Clinical narrative: she has ear problems; This is a spontaneous report from a contactable consumer (patient) reporting herself.  A 71-years-old female patient BNT162B2 (COMIRNATY, Formulation: Solution for Injection, Lot Number: Unknown), via an unspecified route of administration on 29Sep2021, as dose 3 (booster), single (at the age of 71-years-old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient historical vaccine included BNT162B2 (COMIRNATY, Formulation: Solution for Injection, Lot Number: Unknown), via an unspecified route of administration on unspecified date, as dose 2, single for COVID-19 immunization and BNT162B2 (COMIRNATY, Formulation: Solution for Injection, Lot Number: Unknown), via an unspecified route of administration on unspecified date, as dose 1, single for COVID-19 immunization. On 29Sep2021 patient received the third dose of the COVID-19 vaccine from Pfizer. In 2021 the patient reported that she has ear problems. Patient wanted to know how to get the "global code" on her card with her vaccination certificate. The clinical outcome of the event was unknown.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.  .
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Off label use, Vaccination site haemorrhage
Clinical narrative: there was a little blood at the injection site this time; patient received booster (dose 3); patient received booster (dose 3); headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine, solution for injection, Batch/Lot number was not reported; Expiration Date: 31Jan2022) via an unspecified route of administration on 04Oct2021 as dose 3 (BOOSTER), single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single and second dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation.  On 04Oct2021, the patient experienced a little blood at the injection site and received booster (dose 3). On an unspecified date in Oct2021, the patient experienced headache. The patient wanted to know how long the vaccine could be out. The patient was concerned that it was sitting around. The patient wanted to know how old the vaccine was. The patient stated that she received her booster dose today in the same arm she got her previous doses. The patient said that there was a little blood at the injection site this time, but there wasn't any blood when she got the 1st 2 doses. The patient said she had a little headache. The patient wanted to know if injection site would more likely bleed after the booster. The outcome of the events was unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Pain, Scar
Clinical narrative: smallpox like scar on her chin; cold sore; throbbing, stinging pain; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non-pregnant female patient received the second dose of bnt162b2, via an unspecified route of administration, administered in Arm Left on 01Mar2021 16:30 (at the age of 68-year-old) (Lot Number: EN9266) as single dose for covid-19 immunisation. Medical history included Sjogrens, hypothyroidism, arthritis; known allergies: Augmentin, demerol, some sulfa drugs. Concomitant medications included Levothyroxine, simvastatin, Omeprazole, ibuprofen, vitamins B,C,D E, biotin, magnesium, zinc. The patient previously took the first dose of bnt162b2, via an unspecified route of administration, administered in Arm Left on 08Feb2021 16:30 (at the age of 68-year-old) (Lot: EN5318) as single dose for covid-19 immunisation. A few days after the second dose, she got what she thought was a cold sore starting on her chin. It got bigger each day until the 4th day, it was about 3/8" in diameter, and throbbing, stinging pain. She used Melaleuca oil on it, and it gradually subsided and went away, but left a smallpox like scar on her chin. The outcome of the event scar was not recovered, others was recovered in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstrual disorder, Thrombosis, Vaginal haemorrhage
Clinical narrative: I have mild bleeding and blood clots and cramps; I have mild bleeding and blood clots and cramps; I have mild bleeding and blood clots and cramps; I have vaginal bleeding; This is a spontaneous report from a non-contactable consumer. A 24-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 01Oct2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included birth control. Unspecified concomitant medication was reported. On 03Oct2021, the patient had vaginal bleeding, she was not due to start my cycle for another 2 weeks as she just got off 2 weeks ago. The patient had mild bleeding and blood clots and cramps. No treatment was received. 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Pyrexia
Clinical narrative: Temperature of 103 for two days; severe diarrhea; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received third dose (booster dose) of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 02Oct2021 at 03:15 PM, at 72-year-old, as single dose (Lot Number: FF8839) for covid-19 immunisation. The patient was not pregnant at the time of vaccine. Known allergies was penicillin. Other medical history was none. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 19Feb2021 at 01:00 pm, as single dose (Lot number: EL9266) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 12Mar2021 at 04:00 pm, as single dose (Lot number: EN6206) for covid-19 immunisation. The patient was 71-year-old at first and second dose. No other vaccine in four weeks. There were other medications in two weeks (as reported). Prior vaccination the patient had not got covid and the patient had not been tested covid post vaccination. The patient stated she had temperature of 103 for two days and severe diarrhea on 03Oct2021 at 07:00 AM. The patient got no treatment for events fever and diarrhea. The outcome of events temperature of 103 and severe diarrhea was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest discomfort, Dyspnoea, Heart rate, Heart rate abnormal
Clinical narrative: heart was beating a little faster; it felt like her lymph nodes and her chest were swollen; she had trouble catching her breath.; still feel that area is burning a bit; that is still hurt a lot/ hurt on both sides after firs/ chest lymph nodes started to hurt on her left side; her chest glands or lymph nodes swelled up and it felt painful; it felt like her lymph nodes and her chest were swollen; This is a spontaneous report from a contactable consumer (patient herself). A 39-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number was not reported) via an unspecified route of administration on 27Sep2021 (age at vaccination was 39 years) as dose 1, single for covid-19 immunisation. The patient's medical history was not reported. The patient received as historical vaccine as Flu shot for immunization and experienced got bad reactions with flu shots: got bad reactions with flu shots about a year ago, with a regular Flu shot given in her doctor's office. She could not provide the brand name, NDC, Lot number or expiration date of the Flu shot. The patient's concomitant medications were not reported. Other products not provided. She had a tendency to get reactions to shots. The patient stated she received the first dose of the Comirnaty vaccine on 27Sep2021 and had some reaction. On the second day after her shot, it felt like her lymph nodes and her chest were swollen and it felt painful on 28Sep2021 and said that this had been about a week or so. She wanted to know if this was normal, for how long this would last, and this had been reported. She also mentioned her heart was beating a little faster, like had trouble catching her breath but had already went away and her main concern was the feeling of lymph nodes and chest being swollen and hurt on both sides after firs. She still felt that area was burning a bit and that was still hurt a lot. Her chest lymph nodes started to hurt on her left side, and then the next day both sides hurt. She just wanted to report this because she had no idea and it had been more than week and these things still hurt every morning when she woke up. She was concerned and nervous if she should get the second dose of her Comirnaty vaccine on the scheduled time due to her side effects and that the second dose might feel worse. She also reported that these symptoms went away. She did call a nurse who told her, if the symptoms got worse to go to the emergency room. The patient underwent lab test and procedure included heart rate: heart was beating a little faster and Sonogram: unknown result. The outcome of events her chest glands or lymph nodes swelled up and it felt painful was recovered on an unspecified date of 2021 and outcome of other events was recovered on unspecified date.  The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Pain, Ultrasound scan
Clinical narrative: heart was beating a little faster; it felt like her lymph nodes and her chest were swollen; she had trouble catching her breath.; still feel that area is burning a bit; that is still hurt a lot/ hurt on both sides after firs/ chest lymph nodes started to hurt on her left side; her chest glands or lymph nodes swelled up and it felt painful; it felt like her lymph nodes and her chest were swollen; This is a spontaneous report from a contactable consumer (patient herself). A 39-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/batch number was not reported) via an unspecified route of administration on 27Sep2021 (age at vaccination was 39 years) as dose 1, single for covid-19 immunisation. The patient's medical history was not reported. The patient received as historical vaccine as Flu shot for immunization and experienced got bad reactions with flu shots: got bad reactions with flu shots about a year ago, with a regular Flu shot given in her doctor's office. She could not provide the brand name, NDC, Lot number or expiration date of the Flu shot. The patient's concomitant medications were not reported. Other products not provided. She had a tendency to get reactions to shots. The patient stated she received the first dose of the Comirnaty vaccine on 27Sep2021 and had some reaction. On the second day after her shot, it felt like her lymph nodes and her chest were swollen and it felt painful on 28Sep2021 and said that this had been about a week or so. She wanted to know if this was normal, for how long this would last, and this had been reported. She also mentioned her heart was beating a little faster, like had trouble catching her breath but had already went away and her main concern was the feeling of lymph nodes and chest being swollen and hurt on both sides after firs. She still felt that area was burning a bit and that was still hurt a lot. Her chest lymph nodes started to hurt on her left side, and then the next day both sides hurt. She just wanted to report this because she had no idea and it had been more than week and these things still hurt every morning when she woke up. She was concerned and nervous if she should get the second dose of her Comirnaty vaccine on the scheduled time due to her side effects and that the second dose might feel worse. She also reported that these symptoms went away. She did call a nurse who told her, if the symptoms got worse to go to the emergency room. The patient underwent lab test and procedure included heart rate: heart was beating a little faster and Sonogram: unknown result. The outcome of events her chest glands or lymph nodes swelled up and it felt painful was recovered on an unspecified date of 2021 and outcome of other events was recovered on unspecified date.  The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Off label use, Pyrexia, Swelling, Tenderness
Clinical narrative: adverse reaction she has experienced with her third dose of the vaccine; adverse reaction she has experienced with her third dose of the vaccine; Large swelling under one arm with tenderness; Large swelling under one arm with tenderness; had a fever after the third dose of the vaccine; This is a spontaneous report from a Contactable Physician (patient). A 62-years-old female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FE3592), via an unspecified route on 01Oct2021 at 14:30 (at the age of 62-years) as dose 3 (booster), single in the left arm for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EH9899), via an unspecified route on 15Dec2020 (at the age of 62-years) as dose 1, single and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EK9231), via an unspecified route on 05Jan2021 (at the age of 62-years) as dose 2, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient Received third dose of the Pfizer Covid 19 Vaccine on 01Oct2021. The patient experienced fever on 02Oct2021, large swelling under one arm with tenderness on 03Oct2021. Patient says that with her second dose of the vaccine she had flu like symptoms. With the third one she has a large swelling with tenderness under one arm. States she got her third dose of the vaccine on Friday, 01Oct2021, the symptoms began on Sunday and have lessened today. Patient did not visit to Emergency Room/Physician Office. The outcome of the events fever was recovered on 03Oct2021 and large swelling under one arm with tenderness was recovering.