chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Limb discomfort, Skin lesion
Clinical narrative: difficulty breathing; left hand is sometimes heavy; red lesions on her body; This is a spontaneous report from a contactable consumer. This consumer (patient husband) reported for a female patient (reporter wife) that.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 14Sep2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced difficulty breathing, left hand is sometimes heavy, and red lesions on her body on 2021. Customer Service states she has a consumer on the line reporting an AE for bruises after receiving the Pfizer BioNTech Covid-19 Vaccine. Customer Service unable to verify in the caller had Medical Information questions. Customer Service brought the caller on the line and MI agent took over the call. Caller states his wife received the Pfizer BioNTech Covid-19 Vaccine first dose on 14Sep2021. Caller states her second dose is due 07Oct2021. Caller states, however, that his wife is having difficulty breathing and her left hand is sometimes heavy, and she has red lesions on her body. Caller asking if his wife should get the second dose of the Pfizer BioNTech Covid-19 Vaccine, and if not, how she could get a medical waiver. Caller remote disconnected from the call prior to agent being able to provide closing remarks and offer survey. Response: Spoke from FAQ-COVID-19 Vaccine-receiving second dose after side effect from first dose (v2.0). "As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision."Referred caller to HCP and informed caller that Pfizer is unable to provide medical releases or health waivers for patients. Advised caller to speak with HCP to determine safest and most appropriate course of action for his wife. The outcome of events 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.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain
Clinical narrative: lump on his armpit; had pain in the left arm pit; This is a spontaneous report from a Contactable Consumer (patient). A 25-Year-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0191 and expiry date was not reported), via an unspecified route of administration, in left arm, on 01Oct2021, (Age at vaccination: 25-Year-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history was not reported. The patients concomitant medications were none. Patient previously received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0186 and expiry date was not reported), via an unspecified route of administration in Arm left, on 07Sep2021, (Age at vaccination: 25-Year-old) as a single dose for COVID-19 immunization. On 02Oct2021, on the second day after his vaccine, the patient had pain in the left arm pit, and he could see a lump and he can still feel it now. The patient would like to know if this is a normal side effect of the vaccine, and he wants to know what the probability is of having this effect and does it get away. The patient wanting to know if his lump never goes away, will Pfizer be held liable. Patient was called to report adverse reactions to second dose of the Pfizer Covid 19 Vaccine, and he called to make sure that it gets reported and that he provided the caller with the direct Medical Information phone number, but he was not asking any questions for him. The patient stated that he has called and reported this before and there are no new events, however, he wants to make sure that it is documented. He stated that his main concern is if this is to be an ongoing issue, like with pain and the lump, is the anyone that takes responsibility. The patient called about Pfizer COVID-19 vaccine who says he got a side effect that has not gone away, and maybe it might be normal, so he wanted to double check. He says his side effect is a lump on his armpit. The patient did not receive any treatment for the events (he said that he has done no treatment for the lump). The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Feeling hot, Pain, Pain in extremity
Clinical narrative: atrial fibrillation; a little achiness the evening of her 1st dose and soreness the next day; took little warm and my arm was little ache; took little warm and my arm was little ache; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 27Aug2021 09:30 (also reported as about 9:15-9:30am) (lot number: FD8448; expiry date: unknown) at the age of 74-years-old, as dose 1, single for Covid-19 immunisation. Medical history included kidney stones, tuberculosis (TB) from 1950 to 1952 young child before age 5, pancreatic cancer from Nov2006 to Dec2006 about 15 years ago and had surgery and chemo (whipple resection), pancreatic cancer-had surgery, chemo, atrioventricular nodal reentrant tachycardia, ongoing hypothyroid, and ongoing depression. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroid from 1994 and ongoing; bupropion hydrochloride (WELLBUTRIN) taken for depression from 2002 and ongoing; cyanocobalamin (VITAMIN B 12) taken for an unspecified indication, start and stop date were not reported, and cyanocobalamin, pyridoxine, thiamine (NEUROBION) taken for an unspecified indication, start and stop date were not reported. The vaccine was administered in a pharmacy.  Patient stated that she waited a long time and researched because she has had an adverse reaction to every vaccine she has ever had, and she doesn't do the flu, shingle or pneumonia shot as she has always had very bad adverse events. Because of the newer technology with MrNA she suspected she would be fine, and she waited a long time and did a lot of research and decided Pfizer was the best one for her. She was concerned about myocarditis and pericarditis and those can happen with Moderna and Guillen Barre with the Johnson & Johnson so she picked Pfizer as it had fewer side effects she was concerned about. She hasn't had a vaccine since she was in her late 20's, she had a few injections before she went to travel but no vaccine since her late 20's. With rubella she had 3 weeks of joint pain and fever. These were certainly not life threatening but she always reports side effects from when she changes medication if it's serious. On 27Aug2021, the patient experienced little achiness in the evening of her 1st dose and soreness the next day. Patient took Tylenol as treatment for these events, then she was a little warm on unspecified date in 2021. She also had a little ache on her arm. On unspecified date, the patient experienced atrial fibrillation. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: lump under her arm; This is a spontaneous report from a contactable consumer or other non hcp.   A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Reporter said that some other lady said she had a lump under her arm also and it went down. Pfizer should have something put out saying it should be something that's known especially in women. No further details provided. The patient experienced lump under her arm on an unspecified date. The outcome of event was recovered on an unknown date.  Lot/batch number was not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Pyrexia
Clinical narrative: third shot; fatigued; low grade fever; This is a spontaneous report from a non-contactable consumer (patient) via company representative.  A 60-years-old male patient received bnt162b2 (COMIRNATY), dose 3 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation .  The patient medical history was not reported.     The patient's concomitant medications were not reported. The patient previously took first and second dose bnt162b2 (PHIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on unspecified date at single dose for covid-19 immunisation.   The patient had 12 hours of mild symptoms following his third shot of our COVID vaccine. Symptoms began about 24 hours after receiving his shot and lasted for about 12 hours. He felt fatigued and had a low grade fever. The outcome of events was recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Dysmenorrhoea, Pain
Clinical narrative: For 2 days I have been cramping hard enough to think Im going to start; bloating and the pains are soo bad I feel like my insides are going to fall out; bloating and the pains are soo bad I feel like my insides are going to fall out/dull full ache going from front to my back; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: 4989177-06755), via an unspecified route of administration, administered in Arm Right on 21Oct2021 10:15 (at the age of 53-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included ibuprofen (MOTRIN), cetirizine hydrochloride (CITIRIZINE) both taken for an unspecified indication, start and stop date were not reported. There were no known allergies. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: 4978916-06755), via an unspecified route of administration, administered in Arm Right on 30Sep2021 20:45 (at the age of 53-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Patient did not have covid prior vaccination and covid was not tested post vaccination. The patient stated that she has been in post menopause for 6 years with no spotting or bleeding or cramping in all this time. For 2 days (from 26Oct2021 06:00) she has been cramping hard enough to think she was going to start. No spotting or bleeding but bloating and the pains were so bad she felt like her insides were going to fall out. Motrin helped for a little bit, but the pain was still there, dull full ache going from front to her back. The patient did not receive any treatment for adverse events. The outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: Took Benadryl prior to 2nd shot and symptoms limited to swelling around eyes; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date of 2021 as dose 2, single for covid-19 immunization. Medical history included peg allergy from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Historically the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date of 2021 as dose 1, single for covid-19 immunisation and experienced numbness around mouth, swelling of eyes / swelling around eyes and delayed hypersensitivity reaction after first covid immunization. On an unspecified date of 2021, the patient took benadryl prior to second shot and symptoms limited to swelling around eyes. It was reported that the patient experienced delayed hypersensitivity reaction after first covid immunization. The patient had swelling of eyes, numbness mouth 40 minutes after vaccine. It was reported that the patient had appointment with allergist and peg allergy was confirmed. The patient took Benadryl prior second shot and symptoms limited to swelling around eyes. Therapeutic measures were taken as a result of took benadryl prior to second shot and symptoms limited to swelling around eyes. 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: Chills, Fatigue, Immunisation, Incorrect dose administered, Lymph node pain
Clinical narrative: 2nd booster dose; 2nd booster dose; chills; injection site redness; lymph nodes under arm sore; Fatigue; Inappropriate dose of Vaccine administered; 2nd booster dose; This is a spontaneous report from a contactable consumer or other non-health care professional reported for patient. A patient of unspecified age and gender received forth dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: not reported), dose 4 via an unspecified route of administration, unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 4 (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: not reported), via an unspecified route of administration, administered at unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single, second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: not reported), via an unspecified route of administration, administered at unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 2, single, third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: not reported), via an unspecified route of administration, administered at unspecified anatomical location administered at unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 3, single for COVID-19 immunization. On an unspecified date, the patient experienced 2nd booster dose, chills, injection site redness, lymph nodes under arm sore, fatigue. Event took place after use of product. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Medication error, Off label use, Vaccination site erythema
Clinical narrative: 2nd booster dose; 2nd booster dose; chills; injection site redness; lymph nodes under arm sore; Fatigue; Inappropriate dose of Vaccine administered; 2nd booster dose; This is a spontaneous report from a contactable consumer or other non-health care professional reported for patient. A patient of unspecified age and gender received forth dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: not reported), dose 4 via an unspecified route of administration, unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 4 (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: not reported), via an unspecified route of administration, administered at unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single, second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: not reported), via an unspecified route of administration, administered at unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 2, single, third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: not reported), via an unspecified route of administration, administered at unspecified anatomical location administered at unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 3, single for COVID-19 immunization. On an unspecified date, the patient experienced 2nd booster dose, chills, injection site redness, lymph nodes under arm sore, fatigue. Event took place after use of product. 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: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Off label use, Somnolence
Clinical narrative: Dose number: 3, date 30Aug2021; Dose number: 3, date 30Aug2021; sleepy; This is a spontaneous report from a contactable consumer (patient).    A 65-years-old male patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch number/lot number: FD8448), via an unspecified route of administration on 30Aug2021 (at the age of 65-years-old), as dose 3 (booster), single for covid-19 immunisation.  The patient medical history was not reported. The concomitant medications were reported as none. The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient did not receive any other vaccine in four weeks.  The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch number/lot number Unknown), via an unspecified route of administration on 10Feb2021, as dose 1, single for covid-19 immunisation and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch number/lot number Unknown), via an unspecified route of administration on 20Jun2021 (at the age of 65-years-old), as dose 2, single for covid-19 immunisation. On 30Oct2021, the patient reported booster dose and off label use. On an unspecified date in 2021, the patient experienced sleepy. The outcome of the event sleepy was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Blood test, Contusion, Immunisation, Mass
Clinical narrative: Where they gave me the shot is extremely bruised; I have this lump like in my armpit, like kind of by my left breast, very swollen and very tender and kind of painful; I have this lump like in my armpit, like kind of by my left breast, very swollen and very tender and kind of painful; I have this lump like in my armpit,; booster; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient).  A 48-years-old female patient received bnt162b2 (PFIZER- BIONTECH COVID-19 mRNA vaccine, solution for injection, Lot Number: FF2588), via an unspecified route of administration, administered in Arm Left (Left upper arm as reported) on 28Oct2021 (at the age of 48-Years-old) as dose 3 (booster), single for COVID-19 immunization. The patient's medical history included blood pressure high. Concomitant medication included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) 25 mg taken for blood pressure high and norethisterone (TULANA) 0.35 mg taken for birth control pill. Patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. Historical vaccine included first and second dose of bnt162b2 (PFIZER- BIONTECH COVID-19 mRNA vaccine, solution for injection) for COVID-19 immunization. Patient received third dose of Pfizer Vaccine on Thursday and today on 29Oct2021, the 'interpoint' where they gave the shot was extremely bruised and then she woke up in the middle of the night and had this lump like, in her armpit, like kind of by my left breast. It was very swollen and very tender and kind of painful, she took Ibuprofen 800 mg tablets and it kind of went down a little bit. But she called the pharmacy to ask if this was a normal reaction and she said she had never heard of it. The patient underwent lab tests and procedures which included blood work and showed normal results on an unspecified date. It was reported that she just did routine lab work, she did a bunch of different just blood work because she got her physical, several different tests. It was reported her doctor did run a test which included transvaginal ultrasound and found a fibroid. The patient did not receive any treatment for fibroid. They were still running the tests, like more tests done. Therapeutic measures were taken as a result of reported events. At the time of this report, the outcome of event was resolving.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Ultrasound scan vagina
Clinical narrative: Where they gave me the shot is extremely bruised; I have this lump like in my armpit, like kind of by my left breast, very swollen and very tender and kind of painful; I have this lump like in my armpit, like kind of by my left breast, very swollen and very tender and kind of painful; I have this lump like in my armpit,; booster; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient).  A 48-years-old female patient received bnt162b2 (PFIZER- BIONTECH COVID-19 mRNA vaccine, solution for injection, Lot Number: FF2588), via an unspecified route of administration, administered in Arm Left (Left upper arm as reported) on 28Oct2021 (at the age of 48-Years-old) as dose 3 (booster), single for COVID-19 immunization. The patient's medical history included blood pressure high. Concomitant medication included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) 25 mg taken for blood pressure high and norethisterone (TULANA) 0.35 mg taken for birth control pill. Patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. Historical vaccine included first and second dose of bnt162b2 (PFIZER- BIONTECH COVID-19 mRNA vaccine, solution for injection) for COVID-19 immunization. Patient received third dose of Pfizer Vaccine on Thursday and today on 29Oct2021, the 'interpoint' where they gave the shot was extremely bruised and then she woke up in the middle of the night and had this lump like, in her armpit, like kind of by my left breast. It was very swollen and very tender and kind of painful, she took Ibuprofen 800 mg tablets and it kind of went down a little bit. But she called the pharmacy to ask if this was a normal reaction and she said she had never heard of it. The patient underwent lab tests and procedures which included blood work and showed normal results on an unspecified date. It was reported that she just did routine lab work, she did a bunch of different just blood work because she got her physical, several different tests. It was reported her doctor did run a test which included transvaginal ultrasound and found a fibroid. The patient did not receive any treatment for fibroid. They were still running the tests, like more tests done. Therapeutic measures were taken as a result of reported events. At the time of this report, the outcome of event was resolving.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Abdominal discomfort, Abdominal distension, Arthralgia, Headache, Immunisation
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received the second dose (booster) of BNT162b2 (BNT162B2), (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration in the left arm on 14Oct2021 at 10:00 (at the age of 69-years-old) as a single dose for COVID-19 immunization. The patient also received influenza vaccine (high dose flu) in the left arm on 14Oct2021 for immunization. Medical history included multiple orthopedic surgeries and a history of hypersensitivity to medicines. The patient had unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received COVID-19 vaccine NRVV AD26 (JOHNSON and JOHNSON) an unknown date in Mar2021 (at the age of 68-years-old) for COVID-19 immunization. On 14Oct2021, after receiving the booster and within a day, the patient had sore arm, which was no problem. On 21Oct2021, the patient had upset stomach which persisted and lessened after vomiting once. On 26Oct2021 at 07:00, the patient experienced headache which was followed by nausea, intense muscle, and joint aches. The patient got tested on 02Nov2021 for COVID, which was negative. On 03Nov2021, the patient still had headache but not as bad. On an unknown date in 2021, the patient had bloated stomach and tingling of tongue which continued. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 02Nov2021, the patient underwent COVID-19 virus test via nasal swab and the result was negative. The clinical outcome of the events within a day sore arm, nausea, intense muscle and joint aches, upset stomach which persisted, lessened after vomiting were unknown at the time of this report while headache, bloated stomach and tingling of tongue were not recovered at the time of this report. The lot number for BNT162b2 was not provided and will be requested during follow-up.
Age: 69.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Interchange of vaccine products, Myalgia, Nausea, Pain in extremity, Paraesthesia oral
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received the second dose (booster) of BNT162b2 (BNT162B2), (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration in the left arm on 14Oct2021 at 10:00 (at the age of 69-years-old) as a single dose for COVID-19 immunization. The patient also received influenza vaccine (high dose flu) in the left arm on 14Oct2021 for immunization. Medical history included multiple orthopedic surgeries and a history of hypersensitivity to medicines. The patient had unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received COVID-19 vaccine NRVV AD26 (JOHNSON and JOHNSON) an unknown date in Mar2021 (at the age of 68-years-old) for COVID-19 immunization. On 14Oct2021, after receiving the booster and within a day, the patient had sore arm, which was no problem. On 21Oct2021, the patient had upset stomach which persisted and lessened after vomiting once. On 26Oct2021 at 07:00, the patient experienced headache which was followed by nausea, intense muscle, and joint aches. The patient got tested on 02Nov2021 for COVID, which was negative. On 03Nov2021, the patient still had headache but not as bad. On an unknown date in 2021, the patient had bloated stomach and tingling of tongue which continued. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 02Nov2021, the patient underwent COVID-19 virus test via nasal swab and the result was negative. The clinical outcome of the events within a day sore arm, nausea, intense muscle and joint aches, upset stomach which persisted, lessened after vomiting were unknown at the time of this report while headache, bloated stomach and tingling of tongue were not recovered at the time of this report. The lot number for BNT162b2 was not provided and will be requested during follow-up.
Age: 69.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Product use issue, SARS-CoV-2 test, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received the second dose (booster) of BNT162b2 (BNT162B2), (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration in the left arm on 14Oct2021 at 10:00 (at the age of 69-years-old) as a single dose for COVID-19 immunization. The patient also received influenza vaccine (high dose flu) in the left arm on 14Oct2021 for immunization. Medical history included multiple orthopedic surgeries and a history of hypersensitivity to medicines. The patient had unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received COVID-19 vaccine NRVV AD26 (JOHNSON and JOHNSON) an unknown date in Mar2021 (at the age of 68-years-old) for COVID-19 immunization. On 14Oct2021, after receiving the booster and within a day, the patient had sore arm, which was no problem. On 21Oct2021, the patient had upset stomach which persisted and lessened after vomiting once. On 26Oct2021 at 07:00, the patient experienced headache which was followed by nausea, intense muscle, and joint aches. The patient got tested on 02Nov2021 for COVID, which was negative. On 03Nov2021, the patient still had headache but not as bad. On an unknown date in 2021, the patient had bloated stomach and tingling of tongue which continued. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 02Nov2021, the patient underwent COVID-19 virus test via nasal swab and the result was negative. The clinical outcome of the events within a day sore arm, nausea, intense muscle and joint aches, upset stomach which persisted, lessened after vomiting were unknown at the time of this report while headache, bloated stomach and tingling of tongue were not recovered at the time of this report. The lot number for BNT162b2 was not provided and will be requested during follow-up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dysuria, Immunisation, Pollakiuria, Urinary tract infection
Clinical narrative: feels like I have a urinary tract infection; The night after receiving the booster I had urinary frequency. By the next night this increased; urinary burning; Dose Number: 3; This is a spontaneous report from a contactable other HCP (patient).   A 53-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Batch/Lot Number: FH8028) via an unspecified route of administration, administered in Arm Left on 01Nov2021 at 14:00 (age at the time of vaccination: 53 year-old) as dose 3 (booster), single for COVID-19 immunisation. Medical history included COVID-19 from Jan2021 to an unknown date. None medical history was reported. Concomitant medication included routine vitamins (unspecified) for unknown indication, start and stop dates not reported. She had no known allergies. The patient was not pregnant at the time of vaccination. She did not receive any other vaccines within 4 weeks prior to COVID vaccine. Since the vaccination, she had not been tested for COVID-19. Prior to vaccination, She was diagnosed with COVID-19. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Batch/Lot Number: EN6198) via an unspecified route of administration, administered in Arm Left on 05Mar2021 as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: ER8732) via an unspecified route of administration, administered in Arm Left on 26Mar2021 as dose 2, single for COVID-19 immunisation. On 01Nov2021 at 14:00 patient received dose 3 booster. The patient reported that the night after receiving the booster i had urinary frequency, by the next night this increased, urinary burning as well, she feels like she had a urinary tract infection on 01Nov2021 at 21:00. She did not experience this after the first two vaccines but did experience when she contracted COVID in Jan2021. She may go to urgent case later today if the symptoms remain. She did not receive any treatment for the adverse events. The seriousness of events was reported as non-serious. The outcome of events was unknown.   Follow-up attempts completed. No further information expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Diarrhoea, Dizziness, Fatigue
Clinical narrative: had difficulty driving; Severe chills; fever; body ache; diarrhea; fatigue; Felt worse than the 2nd shot and much worse than first shot.; dizziness; Booster; This is a spontaneous report from a non-contactable consumer (Patient). A 41-years-old male patient received third dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: 330268D), dose 3 via an unspecified route, administered in Arm Left on 04Nov2021 11:15 (at the age of 41 years old) as dose 3 (booster), single for covid-19 immunisation. Medical history included Known allergies: Tree fruits and nuts. There were no concomitant medications reported. Historical vaccination included first dose of BNT162B2 (solution for injection, Batch/Lot Number: CP7534) via an unspecified route, administered in Arm Left on 17Mar2021 at 18:00 and second dose of BNT162B2 (solution for injection, Batch/Lot Number: EW0153) via an unspecified route, administered in Arm Left on 07-APR-2021 at 15:00 for covid-19 immunization. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 04Nov2021 at 11:15 the patient experienced booster. On 05Nov2021 at 14:00 the patient experienced, had difficulty driving, severe chills, fever, body ache, diarrhoea, fatigue, felt worse than the 2nd shot and much worse than first shot and dizziness. The patient reported the events as Severe chills, fever, body ache, diarrhea and fatigue from 14: 00 on day 2 which was 27 hrs after the booster shot. Felt worse than the 2nd shot and much worse than first shot. Booster shot caused dizziness and had difficulty driving. Reaction was delayed and hit suddenly. No treatment received for the events. The outcome of the events had difficulty driving, severe chills, fever, body ache, diarrhea, fatigue, felt worse than the 2nd shot and much worse than first shot and dizziness was resolving. No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Impaired driving ability, Pain, Pyrexia
Clinical narrative: had difficulty driving; Severe chills; fever; body ache; diarrhea; fatigue; Felt worse than the 2nd shot and much worse than first shot.; dizziness; Booster; This is a spontaneous report from a non-contactable consumer (Patient). A 41-years-old male patient received third dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: 330268D), dose 3 via an unspecified route, administered in Arm Left on 04Nov2021 11:15 (at the age of 41 years old) as dose 3 (booster), single for covid-19 immunisation. Medical history included Known allergies: Tree fruits and nuts. There were no concomitant medications reported. Historical vaccination included first dose of BNT162B2 (solution for injection, Batch/Lot Number: CP7534) via an unspecified route, administered in Arm Left on 17Mar2021 at 18:00 and second dose of BNT162B2 (solution for injection, Batch/Lot Number: EW0153) via an unspecified route, administered in Arm Left on 07-APR-2021 at 15:00 for covid-19 immunization. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 04Nov2021 at 11:15 the patient experienced booster. On 05Nov2021 at 14:00 the patient experienced, had difficulty driving, severe chills, fever, body ache, diarrhoea, fatigue, felt worse than the 2nd shot and much worse than first shot and dizziness. The patient reported the events as Severe chills, fever, body ache, diarrhea and fatigue from 14: 00 on day 2 which was 27 hrs after the booster shot. Felt worse than the 2nd shot and much worse than first shot. Booster shot caused dizziness and had difficulty driving. Reaction was delayed and hit suddenly. No treatment received for the events. The outcome of the events had difficulty driving, severe chills, fever, body ache, diarrhea, fatigue, felt worse than the 2nd shot and much worse than first shot and dizziness was resolving. No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Bone disorder, Bone pain, Chest pain, Eye irritation
Clinical narrative: Debilitating headache; chest hurts; kidneys hurt; stuffed head (but dry stuffed head); balance issues; extreme fatigue; eyeballs BURNING; body skin warm (no temp) BUT bones freezing and aching; body skin warm (no temp) BUT bones freezing and aching; body skin warm (no temp) BUT bones freezing and aching; Dose Number : 3; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FH8028), via an unspecified route of administration, administered in Arm Left on 03Nov2021 12:00 (at the age of 65-year-old) as dose 3 (booster), single for covid-19 immunisation. Medical history included hypothyroidism, drug hypersensitivity (known allergies: I avoid sulfa drugs). Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0162), via an unspecified route of administration, administered in Arm Left on 15Apr2021 (at the age of 64-year-old) as dose 2, single and received dose 1 (Batch/Lot Number: ER8733), via an unspecified route of administration, administered in Arm Left on 25Mar2021 (at the age of 64-year-old) as dose 1, single for covid-19 immunisation. Patient did not have covid prior vaccination and covid was not tested post vaccination. On 04Nov2021 at 04:00, patient experienced debilitating headache, chest hurts, kidneys hurt, stuffed head (but dry stuffed head), balance issues, extreme fatigue, eyeballs burning, body skin warm (no temp) but bones freezing and aching. Patient did not receive any treatment for adverse events. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immunisation, Renal pain, Skin warm
Clinical narrative: Debilitating headache; chest hurts; kidneys hurt; stuffed head (but dry stuffed head); balance issues; extreme fatigue; eyeballs BURNING; body skin warm (no temp) BUT bones freezing and aching; body skin warm (no temp) BUT bones freezing and aching; body skin warm (no temp) BUT bones freezing and aching; Dose Number : 3; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FH8028), via an unspecified route of administration, administered in Arm Left on 03Nov2021 12:00 (at the age of 65-year-old) as dose 3 (booster), single for covid-19 immunisation. Medical history included hypothyroidism, drug hypersensitivity (known allergies: I avoid sulfa drugs). Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0162), via an unspecified route of administration, administered in Arm Left on 15Apr2021 (at the age of 64-year-old) as dose 2, single and received dose 1 (Batch/Lot Number: ER8733), via an unspecified route of administration, administered in Arm Left on 25Mar2021 (at the age of 64-year-old) as dose 1, single for covid-19 immunisation. Patient did not have covid prior vaccination and covid was not tested post vaccination. On 04Nov2021 at 04:00, patient experienced debilitating headache, chest hurts, kidneys hurt, stuffed head (but dry stuffed head), balance issues, extreme fatigue, eyeballs burning, body skin warm (no temp) but bones freezing and aching. Patient did not receive any treatment for adverse events. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Upper respiratory tract congestion
Clinical narrative: Debilitating headache; chest hurts; kidneys hurt; stuffed head (but dry stuffed head); balance issues; extreme fatigue; eyeballs BURNING; body skin warm (no temp) BUT bones freezing and aching; body skin warm (no temp) BUT bones freezing and aching; body skin warm (no temp) BUT bones freezing and aching; Dose Number : 3; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FH8028), via an unspecified route of administration, administered in Arm Left on 03Nov2021 12:00 (at the age of 65-year-old) as dose 3 (booster), single for covid-19 immunisation. Medical history included hypothyroidism, drug hypersensitivity (known allergies: I avoid sulfa drugs). Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0162), via an unspecified route of administration, administered in Arm Left on 15Apr2021 (at the age of 64-year-old) as dose 2, single and received dose 1 (Batch/Lot Number: ER8733), via an unspecified route of administration, administered in Arm Left on 25Mar2021 (at the age of 64-year-old) as dose 1, single for covid-19 immunisation. Patient did not have covid prior vaccination and covid was not tested post vaccination. On 04Nov2021 at 04:00, patient experienced debilitating headache, chest hurts, kidneys hurt, stuffed head (but dry stuffed head), balance issues, extreme fatigue, eyeballs burning, body skin warm (no temp) but bones freezing and aching. Patient did not receive any treatment for adverse events. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Immunisation, Pyrexia
Clinical narrative: serious pain in my joints throughout my body/I have had since then constant and severe pain in the left shoulder; I had my booster on 15Oct2021; slight fever; chills; headache; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient) reported for herself. A 72-year-old non pregnant female patient received third booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number: Unknown), via an unspecified route of administration, administered in Arm Left on 15Oct2021 at 13:00 (at the age of: 72-year-old) as dose 3 (booster), single for covid-19 immunisation. Medical history included adrenal gland cancer, hypertension and allergy to Penicillin from an unknown date and unknown if ongoing. Concomitant medications included losartan (LOSARTAN) and atenolol (ATENOLOL) received within 2 weeks of vaccination. The patient did not receive any other vaccine within 4 weeks prior to covid vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6199), via an unspecified route of administration, administered in Arm Left on an unspecified date and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN7534), via an unspecified route of administration, administered in Arm Left on an unspecified date, both as a single dose for covid-19 immunisation. She had her booster on 15Oct2021. On 15Oct2021, the night of the booster shot, patient had a normal minor side effects with slight fever, chills, headache by two days later (18Oct2021) at 12:00, she began to develop serious pain in her joints throughout her body. It was very bad for about a week, but she has had since then constant and severe pain in the left shoulder, and it has not gone away. The patient did not receive any treatment for the events. The clinical outcome of the events was not recovered/not resolved at the time of this report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.