chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Weird metal taste that I have been having in my mouth; This is a spontaneous report from a contactable consumer (patient). A 45-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown; Expiry Date: Unknown), via an unspecified route of administration, administered in Arm Left on 10Aug2021 (at the age of 45-years-old) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any Other Products. The patient experienced "weird metal taste that i have been having in my mouth" on an unspecified date. The patient reported that he was just calling, the list of side effects that they listed, one of the side effect he had experienced, he found online, it was saying it was rare and he figured out to call in and report it, it was not dangerous but it was just weird metal taste that he has been having in his mouth since yesterday when he got the vaccination. The patient reported that he does annual exams but did not specify and said June this year not that long ago. He reported that he did not get any kind of treatment since the COVID shot, no. Outcome of the event was unknown.   Information on the Lot/batch number has been requested.  Follow-up activities closed. Batch/lot number not available for [Vaccine, BNT162B2]
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: a bad rash; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced a bad rash. Reporter stated that the doctor recommended not to get the 2nd dose and restart the vaccination series, but others advised the patient to go ahead and get the 2nd dose. The outcome of the event was unknown.   Information about lot/batch number cannot be obtained. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: We only had a sore arm from the second shot; This is a spontaneous report from a contactable consumer (patient). A 70-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date for COVID-19 immunization (at the age of 70-year-old) and no adverse reaction was reported. The patient experienced we only had a sore arm from the second shot on an unspecified date. It was reported that, they could help to get more to get vaccinated. Patient only had a sore arm from the second shot and this would give data on any possible side effects so when a booster was recommended, would have this data ready for those who would be hesitant. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101042090 same reporter/drug/AE, different patients
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: We only had a sore arm from the second shot; This is a Spontaneous report from a contactable consumer. This contactable Consumer(reporter's wife) reported for a 76-year-old patient(husband) that who received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Not reported) on an unknown date via an unspecified route of administration, as SINGLE for COVID-19 immunization. The patients medical history and concomitant medications were not reported. Historical vaccine included received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Not reported) on an unknown date via an unspecified route of administration, as SINGLE for COVID-19 immunization. On an unknown date the patient reported as had a sore arm from the second shot. Outcome of the events was unknown.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101042067 same reporter/drug/AE, different patients
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Therapeutic response unexpected
Clinical narrative: I had my vaccines and suddenly after two weeks approximately felt the tick symptoms disappear/After the covid vaccine my blood test came out no disease; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included tick disease (serious tick disease for 3 years). The concomitant medications of the patient were not reported. The patient reported that after taking her second covid vaccine a strange event occurred. She has a serious tick disease for 3 years, and it reoccurs around the same months. She could feel it coming back. Then she had her vaccines and suddenly after two weeks approximately felt the tick symptoms disappeared. She had been having blood test every 3 months for 3 years to check the titers level. The disease was always present at different levels. After the covid vaccine her blood test came out no disease. The patient underwent lab tests and procedures which included blood test: blood test came out no disease on an unspecified date of 2021. The outcome of event was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: eczema; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient's medical history was not reported. Concomitant medications included dupilumab (DUPIXENT) taken for eczema, start and stop date were not reported. The patient experienced eczema on an unspecified date. It was reported that for a patient who got the COVID 19 vaccine on Monday. The patient's mom was called that the patient was on Dupixent for eczema, an injection every 14 days. She wanted to know if it was ok to get the injections tomorrow since having the vaccine on Monday. The outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot obtained. No further information is excepted.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Immune system disorder, Inflammation
Clinical narrative: extreme immune response to the vaccine; back ache; inflammation; This is a spontaneous report from a contactable other HCP via medical information team. Other HCP reported for a 5-decade-old (Age: 40's) male patient 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 an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced extreme immune response to the vaccine, back ache and inflammation on an unspecified date. The outcome of events was unknown.  Information on the lot/ batch number has been requested.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, SARS-CoV-2 test
Clinical narrative: shortness of breath; tightness of chest; mild chest pains; This is a spontaneous report from a contactable consumer (Patient). A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0167), via an unspecified route of administration, on 05Aug2021 at 14:30 (at the age of 27-year-old), as dose 1, single in left arm for COVID-19 immunisation at Pharmacy/Drug Store. The patient's medical history included pre-diabetic, alcoholism, and severe dust mite allergy. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Aug2021, after first dose of vaccine, the patient experienced shortness of breath, tightness of chest, and mild chest pains. Patient did not receive treatment for the adverse events. Adverse events resulted in Physician office visit. The patient had no COVID prior vaccination and was tested COVID post vaccination. The patient underwent lab test and procedure which included SARS-CoV-2 test (nasal swab): negative, on 13Aug2021. The clinical outcome of all events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Crying, Pain, Pruritus, Skin disorder
Clinical narrative: Met the worst case, purple bumps all over your body; dealing with it through tears and pain and itching; Met the worst case, purple bumps all over your body; dealing with it through tears and pain and itching; Met the worst case, purple bumps all over your body; dealing with it through tears and pain and itching; Met the worst case, purple bumps all over your body; dealing with it through tears and pain and itching; This is a spontaneous report received from a contactable consumer. This consumer reported for a Female patient (Daughter in Law). This is the first case out of 3 split cases.   A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included auto immune condition from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Reporter stated, My daughter in law has an auto immune condition, and after she took the shot, the vaccine (Pfizer COVID 19 Vaccine) she has met the worst case ever as I complaint this which was that where you get these purple bumps all over your body. So, I just wanted to report that, she was dealing with it through tears and pain and itching. But I really would recommend that something needs to be said prior to getting that shot. If you have an auto-immune condition that really needs to be truly discussed with their doctor because anyone with the auto-immune condition is sounds like to me they are having some trouble. It is just breaking in my heart (general sentence) So, I just wanted to report that, it is horrible. Reporter further stated, What strange was, I have met two other people that have developed the same condition So, anyway I really think a warning or just say you know kind of deal. You know, something that the person administrating the vaccine could share. But anyway, you know just like they should not take the Flu Vaccine So, it is the way that the body responding to some kind of, chemical in the vaccine (not appropriately clarified hence not captured as event). But anyway, I just wanted to report that. The outcome of the events was unknown.    The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101050810 same reporter/drug/event, different patient;US-PFIZER INC-202101051050 same report/drug/AE, different patients
Sex: U
Vaccine: COVID19
Symptoms: Crying, Pain, Pruritus, Skin disorder
Clinical narrative: Purple bumps all over your body; Dealing with it through tears and pain and itching; Dealing with it through tears and pain and itching; Dealing with it through tears and pain and itching; Dealing with it through tears and pain and itching; This is a spontaneous report from a contactable consumer. This consumer reported for an Unknown patient. This is the third case out of 3 split cases.  A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not Provided) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter stated, his daughter in law had an auto immune condition, and after she took the shot, the vaccine (Pfizer COVID 19 Vaccine) she had met the worst case ever as the reporter complaint this which was that where you get these purple bumps all over your body. So, reporter just wanted to report that, she was dealing with it through tears and pain and itching. But the reporter really would recommend that something need to be said prior to getting that shot. If patients have an auto-immune condition that really need to be truly discussed with their doctor because anyone with the auto-immune condition was sounds like to reporter, they are having some trouble. It was just breaking in the report's heart (general sentence) So, the reporter just wanted to report that, it was horrible. Reporter further stated, the strange was, the reporter have met two other people that have developed the same condition So, anyway reporter really thought a warning or just said Pfizer know kind of deal. Pfizer knew, something that the person administrating the vaccine could share. But anyway, Pfizer knew just like they should not take the Flu Vaccine So, it was the way that the body responding to some kind of, chemical in the vaccine (not appropriately clarified hence not captured as event). But anyway, reporter just wanted to report that. Only limited information was reported. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101050518 same reporter/drug/event, different patient;US-PFIZER INC-202101051050 same report/drug/AE, different patients
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; 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, Batch/Lot Number: EN6204, Expiry date, NDC number: not provided), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter reporting adverse event for Pfizer Covid 19 vaccine and states the person that administered the shot, it was the same gal. The patient said had a headache first time on an unspecified date and nothing the second time. The patient confirms she received the Pfizer Covid 19 Vaccine. Outcome of the event was unknown.  The lot number for the vaccine, was not provided and will be requested during follow up.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Eczema, Rash, SARS-CoV-2 test
Clinical narrative: Eczema like skin rash; Eczema like skin rash; This is a spontaneous report from a contactable consumer (patient). A 17-year-old male patient received bnt162b2 (PFIZER-BIONTECH covid-19 vaccine, formulation: solution for injection and batch no: not reported/lot number: Ew0181) via an unspecified route of administration, in left arm on 12Jun2021 (at the age of 17-years-old) as dose 2, single for covid-19 immunization at Pharmacy or Drug Store. Patient was allergic to penicillin. Concomitant medication within 2 weeks of vaccination included naproxen. Historical vaccine included as patient received her first dose of bnt162b2 (PFIZER-BIONTECH covid-19 vaccine, formulation: solution for injection, batch no: not reported/lot number: Ew0178) via an unspecified route of administration, in left arm on 22May2021 as dose 1, single for covid-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19 and since the vaccination. The patient experienced eczema like skin rash on 23Jul2021. Patient had no treatment for events. The patient underwent lab tests and procedures which included sars-cov-2 test and results were pending. Outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Lymphadenopathy
Clinical narrative: lymph node swollen; somewhat having trouble breathing; This is a spontaneous report from a contactable consumer (patient, self-reported). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: FC3180 and expiry date was not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on an unspecified date the patient's lymph node swollen and the patient somewhat having trouble breathing. The patient wanted to know what the patient was supposed to do. The patient did not receive any treatment for the event. Outcome of the events was unknown.  Consumer hung up the call abruptly. Hence further probing could not be done. Limited information available over the call.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen painful lymph nodes under right arm (injection side) x1-2 days; This is a spontaneous report from a contactable consumer. This contactable 41-year-old female consumer (patient) reported for herself.  A 41-years-old female patient (non-pregnant) received (BNT162B2, formulation: Solution for injection, Lot Number: EL 3249), via an unspecified route of administration, administered in Arm Right on 08Jan2021 12:00 pm (at the age of 41-years-old) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration, administered in Arm Right on 18Dec2020 01:00 PM (Batch/Lot Number: EL 0140) as DOSE 1, SINGLE for covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included blood cholesterol increased and iron deficiency anaemia from an unknown date and unknown if ongoing. The patient concomitant medication (within 2 weeks of vaccination) included nifedipine, oxymetazoline hydrochloride, ethinylestradiol, norgestimate and atorvastatin all are taken for an unspecified indication, start and stop date were not reported . Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced swollen painful lymph nodes under right arm (injection side) x1-2 days on 09Jan2021 12:00. The patient did not receive treatment for event. Device date was reported as 16Aug2021.  The clinical outcome of the event was recovered on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy
Clinical narrative: receive a corticoid steroid shot in her knees; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 2 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. Historical vaccine included BNT162B2 as 1st dose for COVID-19 immunisation. The patient experienced "receive a corticoid steroid shot in her knees". Treatment was provided for the event. The patient reported that she had received her third dose of the Pfizer COVID-19 vaccine on 14Aug2021 but on 02Aug2021 she did receive a corticoid steroid shot in her knees and she was now reading on the internet that it should not have been taken. She stated she has called the CDC, they had no information and was told to try Pfizer. She reported that before getting a corticoid steroid should wait 2 weeks and then get the booster, she got it on the 13th day not the 14th day. She wanted information about the efficacy of the booster dose after receiving that but also receiving the steroid around that time and asked if that can effect the efficacy and if so would she need another dose in 6 months because of that. She received two steroid injections in her knee on 02Aug. Then on 14Aug she received her COVID vaccine booster. She was wondering if the efficacy of the Covid booster be affected by the steroids. Relayed PMI information and transferred to (name). Faxed PSCC for AE as she needed cortisone injections after taking 1st 2 doses of Covid vaccine. Outcome of the event was unknown.  Follow-up (18Aug2021): This is a follow-up spontaneous report from a Pfizer-sponsored program . A contactable consumer reported for herself included clinical information.  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: Feeling abnormal, Herpes simplex, Infection
Clinical narrative: getting an abnormal amount of HSV outbreaks, like almost daily; breakthrough infections; I'm miserable; This is a spontaneous report from a contactable consumer (patient). A 66 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, 66-year-old at vaccination) via an unspecified route, administered in Left arm on 24Feb2021 at 11:15 (Lot Number: EL9264) as Dose 1, Single and via an unspecified route, administered in Left arm on 24Mar2021 at 15:30 (Lot Number: E6955) as Dose 2, Single, both doses for COVID-19 immunization. The patient was non-pregnant at time of vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Pharmacy or Drug Store. The patient's medical history included HSV (herpes simplex infection ailment for 40 years. No known allergies reported. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for Covid post vaccination. Since getting the Pfizer-BioNtech COVID-19 vaccine she had been getting an abnormal amount of HSV outbreaks, like almost daily.  She used to only get them about 3 times a year.  Normally she could manage it with a lot of L-Lysine.  But that doesn't even work anymore, relentless.  She had to get a prescription for acyclovir which she have to take daily.  Even with taking that, she would had breakthrough infections.  She didn't have any of these long term infections before she took the vaccine.  She had both doses; last one was in March 2021.  She have had this HSV ailment for 40 years and it had never been as active as it was now.  Ever since getting your vaccine.  It was the only new thing that she got that could be the reason for the numerous outbreaks. She was miserable. These Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received Acyclovir, 400 mg daily as treatment medication for the resulted events. These adverse events resulted doctor or other healthcare professional office/clinic visit. Device date was mentioned as 23Aug2021. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information was expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Dyspnoea, Investigation, Suspected COVID-19
Clinical narrative: She felt she had the Covid virus; She felt she had the Covid virus; she still could not breath correctly and still having a hard time breathing; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EN6198) at single dose (age at time of vaccination in 58 years) for COVID-19 immunization in the left arm via unknown route on at 28Apr202 at 15:00. The patient did not have any medical history or concomitant medication. The patient family medical history was none. The patient had taken the first dose of Covid vaccine (Lot Number: EN6201) on 07Apr2021 in the left arm after which she felt like she had the flu for 2 days and her nose was runny, fever, shaky, and sweating and then 2 days later she was fine. The patient reported that she had a very, very bad reactions to the first and second Covid vaccines and felt she had the Covid virus (feeling abnormal). Had felt a little bit better and was able to get liquids in her. Was worried she would get dehydrated. After 4 days of getting second shot the worse symptoms had passed but she still could not breath correctly and still having a hard time breathing and was still feeling tired. She was very, very fatigued and tired all the time. The patient pulmonologist had 2 tests done on her on 23Aug2021. The patient visited the cardiologist on 17Aug2021 and the pulmonologist on the 18Aug2021. Patient visited the physician office for the events. The outcome of the event felt she had the Covid virus was recovering. Outcome for the event she still could not breath correctly and still having a hard time breathing.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Hypoaesthesia, Joint injury
Clinical narrative: Exhausted; body aches; joint hurt; head ache; sweating; immediately cold tongue then felt as tho semi numbness.; immediately cold tongue then felt as tho semi numbness.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Er8731; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 23Jul2021 13:00 as DOSE NUMBER UNKNOWN, SINGLE and patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Ew0172; Expiration date: unknown) via an unspecified route of administration, administered in Arm Right on 23Jul2021 as DOSE NUMBER UNKNOWN, SINGLE both for COVID-19 immunization. Relevant medical history, concurrent conditions and concomitant medications were not reported. Patient had not known allergies. Patient had not relevant past drug history. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine nor received any other medications within 2 weeks of vaccination. Prior to vaccination, the was patient diagnosed with COVID-19. On 23Jul2021 13:00 patient experienced exhausted, body aches, joint hurt, head ache, sweating, immediately cold tongue then felt as tho semi numbness, immediately cold tongue then felt as tho semi numbness. On second shot immediately cold tongue then felt as tho semi numbness. Took full 4 weeks until patient felt woke up felt like patient had no COVID symptoms. Adverse event resulted in emergency room visit. Patient had received treatment for AEs (over the counter medicines). This report was not serious. Since the vaccination, has the patient did test for COVID-19 (Nasal swab) on 18Aug2021 which was negative. The outcome of event was recovered on an unspecified date in Jul2021.  Follow-Up (02Sep2021): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test, Tongue disorder
Clinical narrative: Exhausted; body aches; joint hurt; head ache; sweating; immediately cold tongue then felt as tho semi numbness.; immediately cold tongue then felt as tho semi numbness.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Er8731; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 23Jul2021 13:00 as DOSE NUMBER UNKNOWN, SINGLE and patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Ew0172; Expiration date: unknown) via an unspecified route of administration, administered in Arm Right on 23Jul2021 as DOSE NUMBER UNKNOWN, SINGLE both for COVID-19 immunization. Relevant medical history, concurrent conditions and concomitant medications were not reported. Patient had not known allergies. Patient had not relevant past drug history. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine nor received any other medications within 2 weeks of vaccination. Prior to vaccination, the was patient diagnosed with COVID-19. On 23Jul2021 13:00 patient experienced exhausted, body aches, joint hurt, head ache, sweating, immediately cold tongue then felt as tho semi numbness, immediately cold tongue then felt as tho semi numbness. On second shot immediately cold tongue then felt as tho semi numbness. Took full 4 weeks until patient felt woke up felt like patient had no COVID symptoms. Adverse event resulted in emergency room visit. Patient had received treatment for AEs (over the counter medicines). This report was not serious. Since the vaccination, has the patient did test for COVID-19 (Nasal swab) on 18Aug2021 which was negative. The outcome of event was recovered on an unspecified date in Jul2021.  Follow-Up (02Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes virus infection
Clinical narrative: I was diagnosed with Herpes soon after the vaccine; This is a spontaneous report from a contactable consumer (patient herself). A 22-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: FA7485, expiry date: unknown) via unspecified route of administration, in left arm on 19Jul2021 15:00 (age at vaccination: 22-years) as dose 1, single for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Patient did not take any other vaccines in four weeks and medications in two weeks. On 29Jul2021, patient was diagnosed with Herpes soon after the vaccine. AE resulted in Doctor or other healthcare professional office/clinic visit. Treatment was given due to the adverse event with acyclovir. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of event was not recovered. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: Had her 1st dose injection 05Aug2021 and in between she is taking antibiotics; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 05Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller was a consumer who had her 1st dose injection 05Aug2021 and in between she is taking antibiotics on Aug2021. She was asking if it is ok to get second dose, or should she wait. Caller stated she has not had any issues and before she schedules her 2nd injection she wanted to know if she took antibiotics it is ok to still get the 2nd dosage. Patient was received treatment for the event. The outcome of the event was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Extra dose administered, Gait disturbance, Pain in extremity, Peripheral swelling
Clinical narrative: my right leg swelled up to the point we're walking was impossible; My left Thigh was very painful and felt as if on fire; I have a prosthetic right knee and a rod in my left femur with several screws and nails.; My left Thigh was very painful and felt as if on fire; Within 24 hours my right leg swelled up to the point we're walking was impossible; other vaccine same date vaccine date: 28May2021; other vaccine same date dose number=2; This is a spontaneous report received from a contactable consumer or other non hcp.A 56-years-old male patient received 1st dose of bnt162b2 (COMIRNATY,Batch/Lot Number: Ew0187), via an unspecified route of administration,administered in Arm Left ,at the age of 56 years old,on 28May2021 12:00 as Dose 1,single and dose 2 via an unspecified route of administration on 28May2021 (Batch/Lot Number: EW0202) as Dose 2,single for covid-19 immunization. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing.There were no concomitant medications.The patient experienced my right leg swelled up to the point we're walking was impossible and his left thigh was very painful and felt as if on fire on 19Jun2021 10:00,he had a prosthetic right knee and a rod in his left femur with several screws and nails,other vaccine same date vaccine date: 28may2021;other vaccine same date dose number 2 on 28May2021,his left thigh was very painful and felt as if on fire, within 24 hours patient right leg swelled up to the point where walking was impossible on 19Jun2021 10:00.The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 20Aug2021.Therapeutic measures were taken as a result of my right leg swelled up to the point we're walking was impossible,my left thigh was very painful and felt as if on fire,i have a prosthetic right knee and a rod in my left femur with several screws and nails,my left thigh was very painful and felt as if on fire,within 24 hours my right leg swelled up to the point we're walking was impossible.Treatment received for the adverse event was ibuprofen.The patient was not diagnosed with covid19 prior to vaccination and not tested post vaccination.The patient had allergy to penicillin.The patient had not received any other medication within 2 weeks.Since the vaccination,the patient was tested for COVID-19.  Device Date : 30Aug2021. Follow-Up (08Sep2021): Follow-up attempts are completed.No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: my right leg swelled up to the point we're walking was impossible; My left Thigh was very painful and felt as if on fire; I have a prosthetic right knee and a rod in my left femur with several screws and nails.; My left Thigh was very painful and felt as if on fire; Within 24 hours my right leg swelled up to the point we're walking was impossible; other vaccine same date vaccine date: 28May2021; other vaccine same date dose number=2; This is a spontaneous report received from a contactable consumer or other non hcp.A 56-years-old male patient received 1st dose of bnt162b2 (COMIRNATY,Batch/Lot Number: Ew0187), via an unspecified route of administration,administered in Arm Left ,at the age of 56 years old,on 28May2021 12:00 as Dose 1,single and dose 2 via an unspecified route of administration on 28May2021 (Batch/Lot Number: EW0202) as Dose 2,single for covid-19 immunization. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing.There were no concomitant medications.The patient experienced my right leg swelled up to the point we're walking was impossible and his left thigh was very painful and felt as if on fire on 19Jun2021 10:00,he had a prosthetic right knee and a rod in his left femur with several screws and nails,other vaccine same date vaccine date: 28may2021;other vaccine same date dose number 2 on 28May2021,his left thigh was very painful and felt as if on fire, within 24 hours patient right leg swelled up to the point where walking was impossible on 19Jun2021 10:00.The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 20Aug2021.Therapeutic measures were taken as a result of my right leg swelled up to the point we're walking was impossible,my left thigh was very painful and felt as if on fire,i have a prosthetic right knee and a rod in my left femur with several screws and nails,my left thigh was very painful and felt as if on fire,within 24 hours my right leg swelled up to the point we're walking was impossible.Treatment received for the adverse event was ibuprofen.The patient was not diagnosed with covid19 prior to vaccination and not tested post vaccination.The patient had allergy to penicillin.The patient had not received any other medication within 2 weeks.Since the vaccination,the patient was tested for COVID-19.  Device Date : 30Aug2021. Follow-Up (08Sep2021): Follow-up attempts are completed.No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Lymphadenitis, Lymphadenopathy, Pain
Clinical narrative: swelling of abdominal lymph nodes; he was in so much pain that we took him to ER; They did CT and confirmed mesenteric lymphadenitis; This is a spontaneous report from a contactable consumer (patient). A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EP7534, Expiration Date: not reported), via an unspecified route of administration, in left arm on 26Jul2021 16:15 as dose 1, single for COVID-19 immunization (at the age of 12-year-old). Medical history included acid reflux from an unknown date and unknown if ongoing and had no known allergies. Patient had not experienced any past drug event. There were no concomitant medications. Patient did not receive any other vaccine in four weeks and other medications in two weeks. Patient had no covid prior vaccination and was not covid tested post vaccination. The patient experienced swelling of abdominal lymph nodes, he was in so much pain that they took him to ER, they did ct and confirmed mesenteric lymphadenitis on 10Aug2021 06:00. It was reported that, both times 2 weeks after each vaccine he had experienced swelling of abdominal lymph nodes. The first time he was in so much pain that they took him to ER believing it to be appendicitis. They did CT and confirmed mesenteric lymphadenitis. Pain lasted 2 weeks. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included computerised tomogram: confirmed mesenteric lymphadenitis on an unspecified date. Therapeutic measures were taken as a result of events with prescription medications. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Since receiving my series of vaccinations for Covid, I have not menstruated; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that: A non-pregnant female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Jan2021, as single dose for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient reported I received my first vaccine in Jan2021 after having had covid since receiving my series of vaccinations for Covid, I have not menstruated on an unspecified date in 2021. I had never had issues with this prior to being vaccinated. I do not take any birth control, I am not/was not pregnant, and have had no other changes besides receiving the vaccine. It was over 7 months and I had to see my women's health physician who had to give me a hormone to initiate a period. The outcome of the event was reported as unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: cough; runny nose; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A contactable female consumer reported similar events for herself and 1 patient. This report is for 1 of 2 patient. A female patient of an unspecified age 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 in Aug2021 (also reported as first dose of the Pfizer covid vaccine three and a half weeks ago) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was scheduled for the second vaccine on 02Sep2021 (today) but, on an unspecified date in 2021 she was coughing with a runny nose. The patient underwent lab tests and procedures which included sars-cov-2 test: negative. The patient family was experiencing the same symptoms. Her sister already got two doses of Pfizer and had slight symptoms. Outcome for both the events were unknown.   The lot number for [BNT162B2], was not provided and would be requested during follow up; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101151527 same product and event, different patients
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Hypertension, Off label use
Clinical narrative: developed hypertension; she took her third covid-19 vaccine dose; she took her third covid-19 vaccine dose; This is a spontaneous report from a contactable other hcp. A 50-years-old female patient received third dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 3 via an unspecified route of administration on 2021 as DOSE 3, SINGLE for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis. The patient's concomitant medications were not reported. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: not reported) via unspecified route of administration on unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Patient previously received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: not reported) via unspecified route of administration on unspecified as DOSE 2, SINGLE for covid-19 immunisation. The patient experienced developed hypertension on 2021, she took her third covid-19 vaccine dose on 2021, she took her third covid-19 vaccine dose on 2021. Therapeutic measures were taken as a result of developed hypertension. The outcome of the events hypertension, extra dose administered, off label use was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Groin pain, Kidney infection, Pain
Clinical narrative: thought it was a kidney infection no infection in urine sample but, passing blood thru my kidneys; pain in my right groin; still feel pressure; pain; This is a spontaneous report from a non-contactable consumer (patient) .  This  51-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 28Aug2021 11:15 (Batch/Lot number was not reported) as DOSE SINGLE for covid-19 immunisation  .  Medical history included Aspirin allergy, abdominal discomfort sensitive in stomach , tomatoes and oranges allergy and high acid food can't tolerate.     The patient's concomitant medications were not reported. Facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks.The clinical course was reported as follows: the patient started having some pain in my right groin. Went to my dr thought it was a kidney infection no infection in urine sample but, passing blood thru my kidneys so, will probably have to see urologist still feel pressure and pain. Not taking the second shot.Onset date of the events was on 31Aug2021.The adverse event result in Doctor or other healthcare professional office/clinic visit.The outcome of the events was not reovered.Additional information :no Covid prior vaccination. No Covid tested post vaccination. No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Extra dose administered, Fatigue, Feeling hot
Clinical narrative: hot; sweaty; feeling tired; weak all over and couldn't stand up; She got a third booster dose on 01Sep2021; She got a third booster dose on 01Sep2021; She felt like she would faint.; throwing up; fever/temperature; This is a spontaneous report from a contactable consumer received from regulatory authority.   A 74-year old female consumer (patient) reported that she received the booster third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EN6205 or ED6205),  into the right arm on 01Sep2021 between 9:45AM and 10:00AM (at the age of 74-years-old) at single dose for COVID-19 immunization. The patient had received her second dose of BNT162B2 on 06Apr2021 and the first dose on 14Mar2021 (Lot Number: EN6199). Medical history included breast cancer diagnosed in 2013 and she had chemo and radiation through the first part of 2014. Concomitant drugs included Evista on it for about a year and a half for osteopenia and calcium supplements and vitamins and minerals for her thyroid.  The patient reported that after her third dose on day 4 after vaccination (05Sep2021) she had a set back of hot, sweaty, temperature, fever all over and she couldn't stand up. This has since resolved however she is still feeling tired.  She stated that was at church and teaching at school and it was so embarrassing. She came home and laid down. Her daughter called her other daughter that is a nurse. She said to get caller off her feet and just watch her. The sweating finally went away. Caller was throwing up, but not a lot. She thinks it was because she had not eaten much that morning. She had a small piece of toast. It has all cleared up. Within 2 to 3 hours she was totally better. She got up and took a shower because she sweated so badly. It knocked her off her feet. Nothing has ever knocked her off her feet like that. That is the only reason she called. She had never had a reaction like that ever, not with the other two. It all started in the morning at 9:30AM. All of a sudden she had to grab a chair and sit down. Her knees were like jelly. She got hot. She felt like she would faint. All of this occurred within 4 days of getting booster. Tiredness has improved some and she was able to come back to work. It was like she had stomach virus and that is what she was hoping.The patient doesn't think it was associated to BNT162B2.   The lot number for the vaccine, BNT162B2 was not provided and will be requested during follow up.