chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Discomfort, Hepatitis, Hepatomegaly, Ultrasound scan
Clinical narrative: had an US and CT, which showed a mildly enlarged/inflamed liver; had an US and CT, which showed a mildly enlarged/inflamed liver; discomfort; This is a spontaneous report from a contactable consumer (parent). A 17-years-old male patient received BNT162B2 (COMIRNATY, solution for injection), dose 2 via an unspecified route of administration on 04Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY, solution for injection), dose 1, SINGLE on 14Mar2021 for covid-19 immunisation. On an unknown date in 2021, patient experienced discomfort, so had an ultrasound and CT, which showed a mildly enlarged/inflamed liver. Reporter said maybe there was a link. At the time of this report, the outcome of events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement
Clinical narrative: blood pressure dropped to 60/40; This is a Spontaneous report from a contactable consumer. This consumer reported for a female patient (Daughter). This is the second case out of the 2 cases A female patient of unspecified age had received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose  number unknown via an unspecified route of administration on unknown date  as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient had experienced Blood pressure dropped to 60/40 after the administration of vaccine. It was also reported that because of side -effect patient had to require an ambulance and hospitalized. On an unspecified date, the patient underwent lab test and procedures which had included blood pressure measurement and diagnosed as having 60/40 blood pressure. The outcome of the event was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Angiopathy, Contusion, Disease recurrence, Mass, Restlessness
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient).  A 40-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 13May2021 (at the age of 40-years-old) as dose 2, single for covid-19 immunisation. Medical history included food intolerance. The patient's concomitant medications were not reported.  Historical vaccine included BNT162B2 (Batch/Lot Number: Unknown) as dose 1 on 03Jun2021 (at the age of 40-years-old) for covid-19 immunisation and experienced bruise on her right foot. On 15May2021, the patient experienced "one dr said i do have something vascular going on", within like 2 days after i got my second shot i got the same bruise in the same spot, feeling of restlessness, a lump first on one leg that went away in about 4 days and then another around pelvic area also took about 4 days. Days after the patient got the first shot, she got a bruise on her right foot. Went away. Within like 2 days after she got the second shot she got the same bruise in the same spot. Since then started getting them on her arms as well, back on foot, feeling of restlessness and a lump first on one leg that went away in about 4 days and then another around pelvic area also took about 4 days. One dr said it was something vascular going on. Blood and urine test came out ok. Doctors did not rule out that it could a reaction. She got several opinions and nothing explained why. AE resulted in doctor or other healthcare professional office/clinic visit. No treatment was given for the events. The patient was not COVID prior vaccination and did not test for COVID post vaccination. Device time stamp was provided as 09Sep2021. Outcome of the events were not recovered. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101185903 same reporter/patient/product, different dose/event.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Arthropathy, Pain
Clinical narrative: I am experiencing aches and pains throughout my body; My joints are clicking; This is a spontaneous report from a contactable consumer or other non hcp (patient himself).   A 45-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: FE3181, Expiry date: Unknown, Age at vaccination: 45 years) via an unspecified route of administration, administered in Arm Left on 26Aug2021 as dose 1, singe for COVID-19 immunisation. The patient's medical history and concomitant medications were none. The patient had no known allergies. The patient was not tested positive for COVID-19 prior to vaccination and had not been tested post vaccination. Patient did not receive any other vaccines within 4 weeks prior and other medications 2 weeks prior to the COVID vaccine. On 26Aug2021, the patinet stated that, immediately after receiving the vaccine and through today, I am experiencing aches and pains throughout my body. My joints are clicking. I never had this before. It is interfering with my routine and life. I did not want to take the vaccine. I did so because of a workplace mandate. I got a call from human resources. Tylenol and Aleve don't help. I am concerned that the vaccine triggered an autoimmune reaction. No treatment taken for the events. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Nausea
Clinical narrative: Like nausea is just a day and don't feel very well; Like nausea is just a day and don't feel very well; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated, I was wondering, I got my booster (Unspecified Vaccine) on the 2nd and I did not know how long after you had booster that you could experience side effects, like nausea was just a day and you did not feel very well on an unspecified date and I did not know then the reason why I should. So, I was just wondering can you experience side effects 11 days afterwards. The clinical outcome of events was unknown.  Follow-up activities closed. Batch/lot number not available for [vaccine/BNT162B2].
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise, Pain in extremity
Clinical narrative: She had flu like symptoms; She had some arm pain; she is really sick; This is a spontaneous report from contactable consumer. This consumer (mother) reported that, a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: not reported, Expiry Date: Unknown), dose 1 via an unspecified route of administration on an unspecified date as a DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter said that, on an unspecified date she (patient) is really sick, she had flu like symptoms, and she had some arm pain. Reporter stated, "I am calling about my daughter, she had the Pfizer vaccine, and she is really sick. She has had both doses and the 1st time she had flu like symptoms. Afterwards she had some arm pain but then it seemed to go away and then she asked the pharmacist before she the 2nd one if she should get it or if that was normal. He said yeah that was normal, no problem and then she got the 2nd one and she was been so ill ever since. She had been in emergency room like 5 times. So, we need to find somebody that knows the side effects and what we supposed to do about it." Reporter stated, "Do you have the (website name) that they mentioned on the thing?" Reporter further stated, "That is not what they said on the message. It was something about the (website name)." Reporter said I already reported it, I just want to get information on what I am supposed to do to help her." Outcome of all the events were unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Neck pain, Nervousness
Clinical narrative: Bad sore neck on the left side; exact side that she had the vaccine arm, she had on the left side; she can hardly move her neck; Flu like symptoms; Chills really bad; real shaky; Chills really bad; real shaky; This is a spontaneous report from a contactable consumer (parent). A 16-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported, patient was 16-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 08Sep2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. On 09Sep2021 at 03:30, the patient experienced flu like symptoms, chills really bad; real shaky, on 10Sep2021, the patient experienced bad sore neck on the left side; exact side that she had the vaccine arm, she had on the left side; she can hardly move her neck. The outcomes of events (Flu like symptoms, Bad sore neck on the left side; exact side that she had the vaccine arm, she had on the left side; she can hardly move her neck) were unknown and the outcomes of events (Chills really bad; real shaky) were recovered on an unspecified date in Sep2021.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: her sugar always controlled but skyrocketed to 600 and will not get down; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown, expiration date: not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history included diabetic. Concomitant medications were not reported. Reporter stated that, on an unspecified date, her sugar always controlled but skyrocketed to 600 and will not get down. Reporter also stated that one diabetic patient that came in with her sugar always controlled but skyrocketed to 600 and will not get down no matter what they give her. Lab test included sugar measurement: increased; (skyrocketed to 600 and will not get down). The outcome of 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: Illness
Clinical narrative: She is been so ill ever since. She has been in emergency room like 5 times; This is a Spontaneous report from a contactable consumer. This consumer reported for a female patient (Daughter). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation and experienced flu like symptoms, arm pain, and She is really sick. Reporter stated, she was calling about her daughter, that she had the Pfizer vaccine and she is really sick. She has had both doses and the 1st time she had flu like symptoms. Afterwards she had some arm pain but then it seemed to go away and then she asked the pharmacist before she the 2nd one if she should get it or if that was normal. He said yeah that was normal, no problem and then she got the 2nd one and she is been so ill ever since. She has been in emergency room like 5 times. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: Postmenopausal bleeding; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 09Sep2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced postmenopausal bleeding on an unspecified date in Sep2021. After getting the first shot of vaccine, 15 hours later, she got postmenopausal bleeding, The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Extra dose administered, Headache
Clinical narrative: Off label use; Extra Dose administered; ill; Very painful injection site; chills; fever; cough; muscle and joint pain; muscle and joint pain; nausea; headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: FC3182), via an unspecified route of administration in left arm on 09Sep2021 at 12:00 (at the age of 65-year-old) as dose 3, single for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, arthritis from an unknown date and unknown if ongoing (arthritis encoded as ARTHRITIS PAIN), hashimoto's disease from an unknown date and unknown if ongoing, positive RA factor (rheumatoid factor positive) from an unknown date and unknown if ongoing, breast cancer from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had known allergy. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on unknown date as dose 1, single and dose 2, single for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Sep2021 at 23:00, the patient experienced very painful injection site; chills; fever (102); cough; muscle and joint pain; nausea; intense headache. After the third vaccine, the patient has been very ill for 72 hours so far. The patient did not receive any treatment for the events. The outcome of the events was reported as resolving.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Myalgia, Nausea, Off label use, Pyrexia
Clinical narrative: Off label use; Extra Dose administered; ill; Very painful injection site; chills; fever; cough; muscle and joint pain; muscle and joint pain; nausea; headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: FC3182), via an unspecified route of administration in left arm on 09Sep2021 at 12:00 (at the age of 65-year-old) as dose 3, single for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, arthritis from an unknown date and unknown if ongoing (arthritis encoded as ARTHRITIS PAIN), hashimoto's disease from an unknown date and unknown if ongoing, positive RA factor (rheumatoid factor positive) from an unknown date and unknown if ongoing, breast cancer from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had known allergy. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on unknown date as dose 1, single and dose 2, single for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Sep2021 at 23:00, the patient experienced very painful injection site; chills; fever (102); cough; muscle and joint pain; nausea; intense headache. After the third vaccine, the patient has been very ill for 72 hours so far. The patient did not receive any treatment for the events. The outcome of the events was reported as resolving.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Off label use; Extra Dose administered; ill; Very painful injection site; chills; fever; cough; muscle and joint pain; muscle and joint pain; nausea; headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: FC3182), via an unspecified route of administration in left arm on 09Sep2021 at 12:00 (at the age of 65-year-old) as dose 3, single for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, arthritis from an unknown date and unknown if ongoing (arthritis encoded as ARTHRITIS PAIN), hashimoto's disease from an unknown date and unknown if ongoing, positive RA factor (rheumatoid factor positive) from an unknown date and unknown if ongoing, breast cancer from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had known allergy. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on unknown date as dose 1, single and dose 2, single for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Sep2021 at 23:00, the patient experienced very painful injection site; chills; fever (102); cough; muscle and joint pain; nausea; intense headache. After the third vaccine, the patient has been very ill for 72 hours so far. The patient did not receive any treatment for the events. The outcome of the events was reported as resolving.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Dysphonia, Dyspnoea, Fatigue
Clinical narrative: Also developed rashes on both upper arms a day after.; IV due to low bp.; felt tired/weak.; felt tired/weak.; itchy throat; experienced shortness of breath; hoarseness; This is a spontaneous report from a contactable consumer(patient). A 46-year-old female non pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date: Not reported), via an unspecified route of administration, administered in Arm Right on 16Aug2021 (at the age of 46-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included polycystic ovaries, Known allergies. Other medications (in two weeks) included iron (IRON) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (B12 [CYANOCOBALAMIN]) taken for an unspecified indication, start and stop date were not reported; ascorbic acid (VIT C) taken for an unspecified indication, start and stop date were not reported; colecalciferol, menaquinone (D3 plus K2) taken for an unspecified indication, start and stop date were not reported; magnesium (MAGNESIUM) taken for an unspecified indication, start and stop date were not reported; glutathione (GLUTATHIONE) taken for an unspecified indication, start and stop date were not reported. Facility type vaccine was Pharmacy or Drug Store, the patient took no other vaccine in four weeks, had no COVID prior vaccination, was not COVID tested post vaccination. The patient stated that 10-15 minutes after shot on 16Aug2021, she felt tired/weak, shortness of breath and itchy throat, hoarseness and was rushed to the ER after an hour as, also developed rashes on both upper arms a day after (17Aug2021). Adverse event resulted in Emergency room/department or urgent care. Treatment was taken IV due to low bp. The patient underwent lab test and procedure which included bp: Low IV due to low bp on an unspecified date. The outcome of events IV due to low bp, felt tired/weak, also developed rashes on both upper arms a day after was unknown and of other events was not recovered. The patient stated that she was still experiencing shortness of breath, itchy throat and hoarseness.   The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Rash, Throat irritation
Clinical narrative: Also developed rashes on both upper arms a day after.; IV due to low bp.; felt tired/weak.; felt tired/weak.; itchy throat; experienced shortness of breath; hoarseness; This is a spontaneous report from a contactable consumer(patient). A 46-year-old female non pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date: Not reported), via an unspecified route of administration, administered in Arm Right on 16Aug2021 (at the age of 46-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included polycystic ovaries, Known allergies. Other medications (in two weeks) included iron (IRON) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (B12 [CYANOCOBALAMIN]) taken for an unspecified indication, start and stop date were not reported; ascorbic acid (VIT C) taken for an unspecified indication, start and stop date were not reported; colecalciferol, menaquinone (D3 plus K2) taken for an unspecified indication, start and stop date were not reported; magnesium (MAGNESIUM) taken for an unspecified indication, start and stop date were not reported; glutathione (GLUTATHIONE) taken for an unspecified indication, start and stop date were not reported. Facility type vaccine was Pharmacy or Drug Store, the patient took no other vaccine in four weeks, had no COVID prior vaccination, was not COVID tested post vaccination. The patient stated that 10-15 minutes after shot on 16Aug2021, she felt tired/weak, shortness of breath and itchy throat, hoarseness and was rushed to the ER after an hour as, also developed rashes on both upper arms a day after (17Aug2021). Adverse event resulted in Emergency room/department or urgent care. Treatment was taken IV due to low bp. The patient underwent lab test and procedure which included bp: Low IV due to low bp on an unspecified date. The outcome of events IV due to low bp, felt tired/weak, also developed rashes on both upper arms a day after was unknown and of other events was not recovered. The patient stated that she was still experiencing shortness of breath, itchy throat and hoarseness.   The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Energy increased, Therapeutic response unexpected
Clinical narrative: noticed an unusual increase in my energy level; noticed an unusual increase in my energy level; This is a spontaneous report from a contactable nurse (patient). A patient of unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 18Dec2020 as dose 1, single for COVID-19 immunisation. Medical history included chronic fatigue syndrome for 8 years, thought to be caused by Herpetic Seni. Zoster (systemic shingles virus) (both from an unknown date and unknown if ongoing). Concomitant medication(s) included valaciclovir hydrochloride (Valtrex) taken for an unspecified indication, start and stop date were not reported. On 18Dec2020, after first vaccine, patient noticed an unusual increase in his/her energy level. The outcome of both 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: Energy increased, Extra dose administered, Fatigue, Off label use, Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable nurse (patient). A patient, of unspecified age and gender, received the third dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown, expiry date: unknown), via unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. Historical vaccine included the first and second dose of BNT162B2, via unspecified route of administration on Dec 18, 2020 and Jan 15, 2021, both single dose, for COVID-19 immunisation. Patient suffered from chronic fatigue syndrome for 8 years (thought to be caused by herpetic seni zoster/systemic shingles virus). Concomitant medications not reported. After the first dose, patient noticed an unusual increase in energy level. After second dose, patient was off of the antiviral medication (Valtrex), which was taken for 9 months and was symptom free. Patient had an episode three weeks ago with a sinus infection/shingles attack (began steroids and antiviral medications). Patient still felt extremely tired but pain-free, and took booster dose of COVID-19 vaccine. In approximately 4 hours, patient felt a tingling sensation in lymph nodes in groin, breasts and neck and then felt a surge of energy (much like when steroids begin to reduce inflammation). Patient would like to know if any other CFS patients have had the same response to the vaccine. Patient would like to know more about how and why this worked for symptoms. Patient felt better than had felt in 8 years. Any feedback would be appreciated. The outcome of events unknown. The lot number for BNT162B2 not provided and will be requested during follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: This is a spontaneous report from a contactable nurse (patient). A patient, of unspecified age and gender, received the third dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown, expiry date: unknown), via unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. Historical vaccine included the first and second dose of BNT162B2, via unspecified route of administration on Dec 18, 2020 and Jan 15, 2021, both single dose, for COVID-19 immunisation. Patient suffered from chronic fatigue syndrome for 8 years (thought to be caused by herpetic seni zoster/systemic shingles virus). Concomitant medications not reported. After the first dose, patient noticed an unusual increase in energy level. After second dose, patient was off of the antiviral medication (Valtrex), which was taken for 9 months and was symptom free. Patient had an episode three weeks ago with a sinus infection/shingles attack (began steroids and antiviral medications). Patient still felt extremely tired but pain-free, and took booster dose of COVID-19 vaccine. In approximately 4 hours, patient felt a tingling sensation in lymph nodes in groin, breasts and neck and then felt a surge of energy (much like when steroids begin to reduce inflammation). Patient would like to know if any other CFS patients have had the same response to the vaccine. Patient would like to know more about how and why this worked for symptoms. Patient felt better than had felt in 8 years. Any feedback would be appreciated. The outcome of events unknown. The lot number for BNT162B2 not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Gastroenteritis viral, SARS-CoV-2 test, Vomiting
Clinical narrative: diarrhea; throwing up for 4 hours straight; he feels his stomach not quite right; he got the stomach virus; This is a spontaneous report from a contactable consumer. This consumer reported for a 30-year-old male patient.  A 30-year-old male patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, after the vaccination, the patient experienced throwing up and threw up continuously for about 4 hours and being for about next 3 days, he kept going to the bathroom. He had diarrhoea and he feel even now it is not bad but then he feels his stomach not quite right. He was tested for COVID. He does not have COVID. So, his doctor asked him, not to get the second dose and they want him fully vaccinated. His doctor said if he had COVID, then probably the vaccine did not cause the reaction. But he didn't have COVID, so unless he just by some chance at the same time back when he got the stomach virus (Further Clarification Unknown). No, he does not, he got the results yesterday, he does not have COVID (Hence, PC was not made). He had the rapid test and he had the other test. He had 'two' different tests. The patient lab data includes SARS-CoV-2 test on an unspecified date with unknown results. He was tested for COVID. He does not had COVID. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.  Follow-up (17SEP2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: tested positive; tested positive; This is a spontaneous report from a contactable consumer (patient). This 40-Year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Sep2021 as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The reporter asked how long she needed to wait before getting her second COVID vaccine dose after having COVID. She received her first COVID vaccine dose on 04Sep2021. Her son came home with COVID and she tested positive on 09Sep2021. She was scheduled to get her second vaccine dose on 25Sep2021 and asked if she still keep that appointment or if she need to change it. She has heard from her doctor to wait 30 days, then somewhere else she heard to wait 90 days and she calls now to obtain clarification. This case was reported as Non-Serious. The outcome of the event was unknown.  The lot number for [BNT162B2] was not requested and will be requested during follow up.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Groin pain, Hyperhidrosis, Pyrexia
Clinical narrative: Sweating; tired; thinks he had a fever; lost his appetite; pain in his groin; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) dose 1 via an unspecified route of administration, administered in Arm Right on 15Jul2021 (Lot Number: EW0198) (at the age of 56 years old) as dose 1, single, and dose 2 via an unspecified route of administration on 07Aug2021 (Batch/Lot number was not reported) (at the age of 56 years old) as dose 2, single for COVID-19 immunisation. Medical history reported as None. There were no concomitant medications. The patient experienced pain in his groin on 09Aug2021, sweating, tired, thinks he had a fever, lost his appetite on an unspecified date. Reported as, patient was calling about the Pfizer Covid-19 Vaccine and said that he got the vaccine about 3.5 weeks ago. He said that he got the symptoms which was normal, like sweating. He told that he got a pain in his groin that went up about 6 inches above his groin towards his stomach. It was weird the way he feels. Patient clarified the normal symptoms he experienced were sweating profusely, tired, he may have had a low grade, although he did not check his temperature. He said that the sweating was nonstop and pretty bad. He said that the first shot was not bad, but the second shot was worse, the second day after the second dose, he had lost his appetite. He thinks he had a fever because he was sweating. He said that his groin felt like a nasty pull in his groin. It's starting to slowly go away. The tinge/the pull was going away. It felt like an elastic band pulling. It was something he never had before. He got it at the same time as his other symptoms. He experienced the groin pain 2 days after he got his second dose. He woke up and thought he would breeze through and wasn't hungry that night, then he had sweats and was tired, someone mentioned lymph nodes and he does not know what was causing his groin symptoms. The pull/ tinge or yank was improved. There was just weird symptoms from it. No further details provided. Outcome of all the events were unknown.  Information on lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Limb discomfort, Vaccination site irritation
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-health care professional. A 31-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FC3182), via an intramuscular route of administration, administered in Arm Left on 30Aug2021 (at the age of 31-years-old) as dose 2, single for COVID-19 immunisation. Medical history included , asthma from an unknown date and unknown if ongoing Diagnosed as a child. The patient concomitant medications were not reported. Patient received vaccine facility in Pharmacy. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FA7485) via an unknown route of administration, administered in Arm left on 09Aug2021 (at the age of 30-years-old) as dose 1, single for COVID-19 immunisation. The patient would like to report that she got her last dose 30Aug2021, and for the past couple of days, at the injection site, after a long period, left arm feels like pressure and is irritated and tight. It feels weird like and when she just gets shot where it is irritated. It was right where she got the last dose. She wanted to know if that was normal to feel this after such a long period of time. She stated she is a biomedical technician. Patient not visited emergency room and physician office. The outcome of the event limb discomfort was reported as not recovered and while for other events was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nail discolouration, Paraesthesia
Clinical narrative: Experiencing bad chills, tingling in left arm from finger tips to the area of the shot and half of the finger tips are a purplish color; Experiencing bad chills, tingling in left arm from finger tips to the area of the shot and half of the finger tips are a purplish color; Fingertips turning purple; This is a spontaneous report received from a contactable consumer. A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: FC3184) via an unspecified route of administration, administered in Arm Left on 13Sep2021 at 13:30 as DOSE 1, SINGLE (at the age of 47-year-old) for covid-19 immunisation. There were no concomitant medications. Medical history reported as none.The NDC number of Covid Vaccine was unknown. Patient received the first dose of Pfizer covid vaccine on 13Sep2021 at 13:30 and at 15:30 and all of a sudden started experiencing bad chills, tingling in left arm from finger tips to the area of the shot and half of the finger tips were a purplish colour. Patient got up and walked outside and she still has tingling from her left hand to where the shot was. Reporter asked if these were side effects after vaccination and if she needed to worry about them. The patient did not received treatment for the events. The outcome of the events was not resolved.  No further information can be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got COVID; got COVID; This is a spontaneous report received from a contactable consumer (patient). This male patient of unspecified age received the first dose of bnt162b2 (COMIRNATY) on 18Dec2020 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer BioNtech (COMIRNATY) vaccine on 18Dec2020 and got COVID, as well as was not able to get the second dose on his schedule. Reporter wanted to know if it is safe to restart the vaccination series. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Feeling abnormal, Muscular weakness
Clinical narrative: arm was feeling kind of weak/a weakness in my arm; a weakness in my arm, not really tingling or numbness but just kind of a weak funny feeling; she has a lot of anxiety/she hates the anxiety of this; This is a spontaneous report from a contactable consumer (Patient). A 66-year-old female patient received first dose BNT162B2 (PFIZER-BIONTEHC COVID-19 VACCINE, Batch/Lot Number: FC3181), Solution for injection, via an unspecified route of administration on 23Aug2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced arm was feeling kind of weak/a weakness in my arm, a weakness in my arm, not really tingling or numbness but just kind of a weak funny feeling and she has a lot of anxiety/she hates the anxiety of this. Patient received her first dose of the Pfizer-BioNTech Covid-19 vaccine on 23Aug and she did okay but about a week after, her arm was feeling kind of weak. It felt kind of funny like when she went to sleep but not all the way. She can use her hand and lift it and it did not seem to affect her dexterity. However, it was continued, and her arm felt funny. She stated she had a lot of anxiety so that could be a contributing factor. She was supposed to get her second shot today and she was there now and talked to the pharmacist and they told her to call and discuss it with us, but they did not think it would be a problem to get the second dose. The pharmacist said it may be how it was administered that caused the side effects. She wanted to know if anything like this has been reported or if it is safe to get the second dose. She stated she hates the anxiety of this and would almost rather just go for it and not worry about it. The outcome of event anxiety was unknown and all other events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Came down with COVID; Came down with COVID; This is a spontaneous report from a contactable pharmacist. This pharmacist (patient's father) reported that a female patient (reporter's daughter) of unspecified age received bnt162b2 (COMIRNATY) first dose and second dose, both on unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. His daughter was fully vaccinated. Attended a swim team meet and greet when she arrived at college. Approximately 40 in attendance and all 40 came down with COVID. Her symptoms were very mild (congestion, loss of taste and smell). She was quarantined but then returned to school activities and sports. Event took place after use of product. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 in this patient cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: breakthrough Covid; Breakthrough Covid; This is a spontaneous report from a contactable consumer or other non-HCP (daughters friends mother). A female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN) via an unspecified route of administration on 11Sep2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced breakthrough covid on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: breakthrough covid on an unspecified date. The clinical outcome of the breakthrough Covid was unknown.  Description of Product Complaint: Caller relays his daughter (name) best friend told him, she was talking with his daughter and he heard them talking, and his daughter asked him if she could come over for a sleepover and he said sure and then found out that the friends mom had come down with Covid 3 weeks ago and he didn't ask at that time about vaccine and just said no she can't come over. Caller states he asked (name) if her mom got the vaccine and (name) said yes and he asked which one and her mom got the Pfizer Covid vaccine and that put him on the hook to report.  Caller states this was Saturday night that he got confirmation that she did have a breath through case. Caller has no further details or information to provide.  This lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Peripheral swelling
Clinical narrative: Aches in my joint/I can hardly get on my chair, cause my hands and my knees, ankles hurts so much; My hand are so swollen I can not hold a pen; I can hardly get on my chair, cause my hands and my knees, ankles hurts so much; This is a spontaneous report from a contactable consumer or other non healthcare professional. A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced aches in the joint and can hardly get on the chair, cause the hands and knees, ankles hurts so much causing arthralgia on 2021 with outcome of not recovered , the hands are so swollen that the patient can not hold a pen causing peripheral swelling on 2021 with outcome of not recovered and pain in extremity on 2021 with outcome of not recovered.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer (patient) via medical information team.   A patient of unspecified age and gender received bnt162b2 (Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date on Apr2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The reporter stated that the patient had both Pfizer vaccines on an unspecified date in Mar2021 and Apr2021. The patient had tested positive for Covid on 01Sep2021 and had been quarantined for the past 2 weeks. The patient was wondering when or if the patient could get the booster and if the patient still should get it. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 01Sep2021 (have been quarantined for the past 2 weeks). The outcome of the event was unknown.  The lot number for [BNT162B2] was not requested and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Contusion, Lymphadenopathy, Swelling, Vaccination site discolouration
Clinical narrative: Under his armpit it was swelled up and a little lumpy; Under his armpit it was swelled up and a little lumpy; He noticed that under his armpit it was swelled up and a little lumpy/ he thinks it was his lymph nodes; Some discoloration, like a bruise in his arm where the shot was administered; Some discoloration, like a bruise in his arm where the shot was administered; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 30Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated he received his first dose of the Pfizer Covid 19 vaccine on 30Aug, and he is scheduled to receive his second dose next Monday. When he received his first shot, he noticed that under his armpit it was swelled up and a little lumpy, it only lasted 48 hours. He stated he thinks it was his lymph nodes. He also noticed some discoloration, like a bruise in his arm where the shot was administered, the pharmacist told him to put an ice pack since it felt swollen. Since it was swollen, the pharmacist said to put an ice pack on it. The outcome of the events under his armpit it was swelled up and a little lumpy was recovered and outcome for other events was recovered.  This lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.