chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Myalgia
Clinical narrative: headache; muscle ache on the left side of his neck; This is a spontaneous report from a contactable consumer (patient himself). A 73-years-old male patient received first dose of bnt162b2 (COMIRNATY, solution injection; Batch/Lot Number: FC3181), via an unspecified route of administration, administered in Arm Left on 28Aug2021 (at the age of 73-years-old) as single dose for covid-19 immunisation. Medical history included ongoing sinus problems, operations on his neck (9 operations, shoulder right 6-7 months ago but that was over) and he had covid in Dec2020 and it didn't hardly bother him, he had a temp of 100.4 and a little headache and was tired. There were no concomitant medications. Patient did not receive any other vaccine within 4 weeks prior to covid vaccine. Caller stated that in the evening he started getting a headache and muscle aches on the left side of his neck. Caller stated his arm didn't bother him at all. Caller stated that he still has them slightly. Caller states it just started to slow down in the last 4-5 days. Caller stated that most of the problem was at night, and he takes a pill in the morning and it goes away in a few hours, well he still felt his neck. Caller stated he was thinking of going to a clinic to see if everything was alright. Caller asked if it was normal to still have that. Caller stated it got worse and has stayed for more than 3 weeks now and he was getting his next shot on 19Sep2021. Caller stated he was questioning having that now, because he doesn't want to go through this again. Caller states he had Covid in Dec2020 and it didn't hardly bother him, he had a temp of 100.4 and a little headache and was tired. Caller states this is worse. Therapeutic measures were taken as a result of headache and muscle ache on the left side of his neck. The outcome of the event muscle ache on the left side of his neck was not recovered while the outcome of the event headache was recovering.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive with covid-19 after getting the vaccine; tested positive with covid-19 after getting the vaccine; This is a spontaneous report from a non-contactable consumer. 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 an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced tested positive with covid-19 after getting the vaccine. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Depressed mood, Pain in extremity
Clinical narrative: I was in absolute agony; Pain in my shoulder like shoulder to shoulder; kind of flaring on and off for a few weeks; Pain in arm; Pain in leg; 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), via an unspecified route of administration in Aug2021 (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that patient had a serious side effect. The patient had the Pfizer Vaccine (Unspecified Vaccine) three weeks ago (Aug2021). 36 hours after (Aug2021) the patient had the vaccine, patient woke up with 'flaring' pain in the shoulder like shoulder to shoulder. The patient was able to make it through the night with pain medication and that were (word not clear) kind of flaring on and off for a few weeks. On Saturday night which was Saturday afternoon 'three' and a half week after the patient got the vaccine, in Sep2021, it flared up again, the patient was in absolute agony 'because nothing' (Not clarified over the call) had ever been neurotically in patient life (Further clarification was unknown) and the patient had to go the hospital. The patient was given high dose IV steroid and pain medication (treatment) and now on lower dose steroid (intent: treatment) and the patient was still having the pain (Further clarification was unknown). So, just wanted to report the side effect that cause the patient had to go to the hospital and speak to someone in United States rather. The patient had concern about both shoulder, not just one, both but other symptoms as well, pain in arm, pain in leg but the really bad pain was in both shoulder (on an unspecified date in 2021). Outcome of the event shoulder pain was not recovered; other events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Condition aggravated, Fatigue, Muscle fatigue, Muscle twitching
Clinical narrative: Muscle twitches; pain in both his forearms and the back of his hands; Pain in both his forearms and the back of his hands; He was tired; Had muscular fatigue particularly in his calves; Intermittent paresthesias in his arms; Painful bulging veins around the muscles; Painful bulging veins around the muscles; Anxiety; Twitches are constantly present day and night and for made worse by exercise; This is a spontaneous report from a contactable physician. A 35-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), via an unspecified route of administration on Aug2021 as DOSE NUMBER UNKNOWN, SINGLE for Covid-19 immunization.The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient received other medications within 2 weeks of vaccination. There were no concomitant medications. The patient was not diagnosed with Covid 19 and has not been tested for Covid-19 Since the vaccination. On Aug2021 the patient experienced muscle twitches , pain in both his forearms and the back of his hands, he was tired, had muscular fatigue particularly in his calves, intermittent paresthesias in his arms, painful bulging veins around the muscles, anxiety, twitches are constantly present day and night and for made worse by exercise. Therapeutic measures were taken as a result of muscle twitches , pain in both his forearms and the back of his hands , pain in both his forearms and the back of his hands , he was tired , had muscular fatigue particularly in his calves, intermittent paresthesias in his arms , painful bulging veins around the muscles , painful bulging veins around the muscles , anxiety, twitches are constantly present day and night and for made worse by exercise treatment was received with Ativan. The outcome of event was recovering.  The lot number for [BNT162B2] was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Vascular pain, Vein disorder
Clinical narrative: Muscle twitches; pain in both his forearms and the back of his hands; Pain in both his forearms and the back of his hands; He was tired; Had muscular fatigue particularly in his calves; Intermittent paresthesias in his arms; Painful bulging veins around the muscles; Painful bulging veins around the muscles; Anxiety; Twitches are constantly present day and night and for made worse by exercise; This is a spontaneous report from a contactable physician. A 35-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), via an unspecified route of administration on Aug2021 as DOSE NUMBER UNKNOWN, SINGLE for Covid-19 immunization.The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient received other medications within 2 weeks of vaccination. There were no concomitant medications. The patient was not diagnosed with Covid 19 and has not been tested for Covid-19 Since the vaccination. On Aug2021 the patient experienced muscle twitches , pain in both his forearms and the back of his hands, he was tired, had muscular fatigue particularly in his calves, intermittent paresthesias in his arms, painful bulging veins around the muscles, anxiety, twitches are constantly present day and night and for made worse by exercise. Therapeutic measures were taken as a result of muscle twitches , pain in both his forearms and the back of his hands , pain in both his forearms and the back of his hands , he was tired , had muscular fatigue particularly in his calves, intermittent paresthesias in his arms , painful bulging veins around the muscles , painful bulging veins around the muscles , anxiety, twitches are constantly present day and night and for made worse by exercise treatment was received with Ativan. The outcome of event was recovering.  The lot number for [BNT162B2] was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Caller is asking for herself if a 4-day fever is a normal response with the vaccine; This is a spontaneous report from a contactable consumer or other non hcp.    A 44-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA 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. The patient medical history and concomitant was not reported. It was reported that, the patient experienced caller is asking for herself if a 4-day fever is a normal response with the vaccine on an unspecified date with outcome of unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Extra dose administered, Lymphadenopathy, Off label use
Clinical narrative: received her third dose of Cominarty approximately 6 and half months after primary series; received her third dose of Cominarty approximately 6 and half months after primary series; severe pain and swollen lymph nodes by her breast and under her arm pit; severe pain and swollen lymph nodes by her breast and under her arm pit; This is a spontaneous report from a contactable consumer or other non hcp. A 44-years-old female patient received third dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 3, SINGLE for covid-19 immunisation. The patient medical history and 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 received her third dose of Comirnaty approximately 6 and half months after primary series on an unspecified date, received her third dose of Comirnaty approximately 6 and half months after primary series on an unspecified date, severe pain and swollen lymph nodes by her breast and under her arm pit on an unspecified date. The outcome of the events off label use, extra dose administered, axillary pain, lymphadenopathy was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Investigation, Pain, Pain in extremity
Clinical narrative: wrists were sore/ had sores on legs/sores on crease of buttocks and back of head; Both wrists sore; Sores on legs/ a big round one on the front left leg and a big round one on the back right leg; Sores on back of head, crease of buttocks; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received second dose bnt162b2 (Solution for injection; Lot number and expiry date was not reported; manufacturer: Unspecified) via an unspecified route of administration on Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historical vaccine includes first dose bnt162b2 on Mar2021 for Covid-19 immunisation. Patient stated that he received his vaccines in March and April. After he took the vaccines, he was having problems. Both of his wrists were sore on an unknown date in 2021. A week later he got out of the shower and noticed he had sores on his legs; a big round one on the front left leg and a big round one on the back right leg on an unknown date in 2021. He got sores on the back of his head and in the crease of his buttocks on an unknown date in 2021. He stated that he had an adverse ultrasound. Patient stated that he knew it had to do with the vaccine because he had not had any problems until a week or two after the vaccine. Stated that he has called to find out what he can do to get rid of this stuff; stated it was still going on since April. Patient mentioned that he goes through the clinic for healthcare. The patient underwent lab test which includes ultrasound with unknown results on an unknown date in 2021. The outcome of all the events was unknown. Because these reactions are reported voluntarily, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.  The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: he feel like he kind of weak; he had the side effect, because he is weak; This is a spontaneous report from a contactable consumer or other non hcp. This Patient's wife reported for a 71-year-old male patient (Husband). A 71-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported; Expiry Date: Unknown), via an unspecified route of administration, administered in Arm Right on 15Sep2021 at 13:30 (at the age of 71-years-old) as dose number unknown, single for covid-19 immunisation. Medical history included diabetes mellitus and high blood pressure. Concomitant medication included metformin; diazepam (BENZOPIN); glimepiride. The patient experienced he feel like he kind of weak; he had the side effect, because he is weak on 15Sep2021. When asked about lot number it was reported that she do not have the card. They did not give her this information, she reported when the patient got the shot on yesterday but she don't see any card or anything. The reporter informed about her name and her husband's name. She said her husband received the shot on yesterday and he is not, he feel like he kind of week like 'concenter' (Further not clarified) and she was just trying to see the status check, and if the patient have to go to hospital or what, he had kid (voice not clear).  He was around 169 (Pounds). She reported that she was just trying to find that how long would he had the side effect because he is weak. She was given contact details of Pfizer Medical Information Department. Outcome of the event was unknown.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea
Clinical narrative: I personally was down and out for three days with dizziness; fatigue; extreme nausea; This is Spontaneous report from a contactable consumer. This consumer reported similar events for self and 3 patients (Three friends). This is a First (Self) of Four reports. This report included:  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration, on an unspecified date as dose number unknown, single for covid-19 immunisation. Patients medical history and concomitant medications were not reported. Patient kept hearing various communication sites that the side effects of the booster shot in 5% of the people were sore arms and swollen gland. Patient personally was down and out for three days with dizziness, fatigue and extreme nausea on an unspecified date. The outcome of events was unknown.   The lot number for BNT162B2 was not provided and will be request during follow-up. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101224287 same, reporter and drug , different patient;US-PFIZER INC-202101224288 same, reporter and drug , different patient;US-PFIZER INC-202101224286 same, reporter and drug , different patient
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea
Clinical narrative: dizziness; fatigue; extreme nausea; This is Spontaneous report from a contactable consumer received via Pfizer. This consumer reported similar events for self and 3 patients (Three friends). This is a third (Friend no 2) of four reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration, on an unspecified date as dose number unknown, single for covid-19 immunization. Patient medical history and concomitant medications were not reported. Reporter kept hearing from various sites that the side effects of the booster shot in 5% of the people were sore arms and swollen gland. Reporter personally was down and out for three days with dizziness, fatigue and extreme nausea and three of his friends had the same thing on an unspecified date. The clinical outcome of events was unknown.   The lot number for BNT162B2 was not provided and will be request during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101224267 same, reporter and drug , different patient;US-PFIZER INC-202101224288 same, reporter and drug , different patient;US-PFIZER INC-202101224286 same, reporter and drug , different patient
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea
Clinical narrative: Dizziness; Fatigue; Extreme nausea; This is a spontaneous report received from a contactable consumer or other non-health care professional. This consumer reported similar events for 4 patients. This is Fourth of four reports. A patient of unspecified age and gender received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated, I keep hearing and various communication sites that the side effects of the booster shot in 5% of the people were sore arms and swollen gland. patient personally was down and out for three days with dizziness, fatigue and extreme nausea on unknown date. Three of my friends had the same thing. The outcome of the events was reported as 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-202101224287 same, reporter and drug and event, different patient; US-PFIZER INC-202101224267 same, reporter and drug and event, different patient; US-PFIZER INC-202101224286 same, reporter and drug and event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Headache
Clinical narrative: Headache; Diarrhea; 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; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (two weeks ago) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced headache and diarrhea last night. The outcome of the events was unknown.  The lot number for the vaccine was not provided and will be requested during follow up.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Gait disturbance, Pain, Red blood cell sedimentation rate increased
Clinical narrative: extreme pain; barely able to walk; anemia; Elevated Sed Rate after receiving 2nd dose of Pfizer COVID Vaccine; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received  2nd dose of bnt162b2 (COMIRNATY,Batch/Lot Number: EW0191), via an unspecified route of administration on 10Jun2021 as Dose 2,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced extreme pain,barely able to walk,anemia,elevated sed rate after receiving 2nd dose of pfizer covid vaccine on an unspecified date.Caller also wants to know if .3ml is the same dose everyone gets or if there are different doses? Caller thinks that she definitely has received an overdose.The patient previously received her 1st dose of Pfizer covid vaccine on 11May2021,EW0183 lot number.The outcome of the event was unknown.The patient was suggested to take anti-inflammatories by the physician.  Follow up (17Sep2021): This is a follow-up spontaneous report from a contactable consumer.The treatment suggestion for extreme pain was updated.When writing down information being provided to the caller, the caller stated that what she is experiencing is not involving her hands so far. Follow-Up (24Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Erythema, Lymph node pain, Lymphadenopathy
Clinical narrative: Left arm pain; redness; swelling of lymph nodes; swelling of lymph nodes with pain; chest pain; mild trouble breathing.; This is a spontaneous report from a contactable other hcp. A 36-years-old non-pregnant female patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: FF2589) via an unspecified route of administration, administered in Arm Left on 15Sep2021 12:15 (age at vaccination:36-Years-old) as DOSE 2, SINGLE for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Patient didn't had covid-19 prior to vaccination. Patient didn't receive other vaccines within 4 weeks prior to vaccination, patient received other medications Lamotrigine, Loratadine, Ibuprofen, Tylenol within 2 weeks of vaccination. Medical history included epilepsy from an unknown date and unknown if ongoing, rheumatoid arthritis from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing, migraine from an unknown date and unknown if ongoing, rubber sensitivity from an unknown date and unknown if ongoing. Concomitant medications included lamotrigine (LAMOTRIGINE) taken for an unspecified indication, start and stop date were not reported; loratadine (LORATADINE) taken for an unspecified indication, start and stop date were not reported; ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported; paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: FC3183) via unspecified route of administration on 24Aug2021 03:30 in as DOSE 1, SINGLE for covid-19 immunisation. Patient previously took optivar and experienced drug hypersensitivity. On 16Sep2021 12:00 the patient experienced left arm pain, redness, swelling of lymph nodes, swelling of lymph nodes with pain, chest pain, mild trouble breathing. Patient had physician office visits for the events. Therapeutic measures were taken as a result of left arm pain, redness, swelling of lymph nodes, swelling of lymph nodes with pain, chest pain, mild trouble breathing was antibiotics. Patient was not tested with covid-19 to post vaccination. The outcome of the events pain in extremity, erythema, lymphadenopathy, lymph node pain, chest pain, dyspnoea was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Left arm pain; redness; swelling of lymph nodes; swelling of lymph nodes with pain; chest pain; mild trouble breathing.; This is a spontaneous report from a contactable other hcp. A 36-years-old non-pregnant female patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: FF2589) via an unspecified route of administration, administered in Arm Left on 15Sep2021 12:15 (age at vaccination:36-Years-old) as DOSE 2, SINGLE for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Patient didn't had covid-19 prior to vaccination. Patient didn't receive other vaccines within 4 weeks prior to vaccination, patient received other medications Lamotrigine, Loratadine, Ibuprofen, Tylenol within 2 weeks of vaccination. Medical history included epilepsy from an unknown date and unknown if ongoing, rheumatoid arthritis from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing, migraine from an unknown date and unknown if ongoing, rubber sensitivity from an unknown date and unknown if ongoing. Concomitant medications included lamotrigine (LAMOTRIGINE) taken for an unspecified indication, start and stop date were not reported; loratadine (LORATADINE) taken for an unspecified indication, start and stop date were not reported; ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported; paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: FC3183) via unspecified route of administration on 24Aug2021 03:30 in as DOSE 1, SINGLE for covid-19 immunisation. Patient previously took optivar and experienced drug hypersensitivity. On 16Sep2021 12:00 the patient experienced left arm pain, redness, swelling of lymph nodes, swelling of lymph nodes with pain, chest pain, mild trouble breathing. Patient had physician office visits for the events. Therapeutic measures were taken as a result of left arm pain, redness, swelling of lymph nodes, swelling of lymph nodes with pain, chest pain, mild trouble breathing was antibiotics. Patient was not tested with covid-19 to post vaccination. The outcome of the events pain in extremity, erythema, lymphadenopathy, lymph node pain, chest pain, dyspnoea was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough infection with COVID-19 /Tested positive for COVID-19 infection; Breakthrough infection with COVID-19 /Tested positive for COVID-19 infection; This is a spontaneous report from a contactable consumer (Pfizer employee). An adult male patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EP7534, Expiry date was not reported), via intramuscular route of administration on 15Mar2021 as dose 1, single for COVID-19 immunization and patient received dose 2 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8734, Expiry date was not reported), via intramuscular route of administration on 06Apr2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. It was unknown that, the patient received any other medications within 2 weeks. It was unknown that, the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 22Aug2021, the patient experienced breakthrough infection with covid-19 /tested positive for covid-19 infection. Symptoms started around 22Aug2021. Suffered watery eyes, congestion, tiredness, chills and headache. Tested positive for COVID-19 infection shortly thereafter. Started having breathing issue and nighttime cough around 28Aug2021. Slowly improving since that time. The Patient visited physician's office and patient did not received treatment. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 22Aug2021. The outcome for the events was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash erythematous, Scratch, Skin haemorrhage
Clinical narrative: Scratch after itching begin to break out red rashes and then it became dark brown, now it is becoming black on both feet; looks like blood getting out of his skin; Scratch after itching begin to break out red rashes and then it became dark brown, now it is becoming black on both feet; looks like blood getting out of his skin; Scratch after itching begin to break out red rashes and then it became dark brown, now it is becoming black on both feet; looks like blood getting out of his skin; Scratch after itching begin to break out red rashes and then it became dark brown, now it is becoming black on both feet; looks like blood getting out of his skin; Scratch after itching begin to break out red rashes and then it became dark brown, now it is becoming black on both feet; looks like blood getting out of his skin; This is a spontaneous report from a contactable consumer.   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Reporter stated that the patient had taken the Pfizer Covid-19 Vaccine and about 2 weeks after he started to scratch and after itching began to break out red rashes and then that became dark brown, now that had become black on both feet. Reporter also queried to know what to do and where to go (treatment) because the patient had visited several Doctors who had not really given other diagnosis or reason why the patient got that rash on his feet. Reporter also stated, that looked like blood got out of his skin. Reporter stated that they do not know the product details (expiration date, NDC number and UPC number, pharmacy details and treatment). The outcome of the events was not recovered on an unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Oropharyngeal pain, Rash, Swelling
Clinical narrative: He got sick; Sore throat; Swelling a little bit.; He broke out with his hands, face, chest and feet but the rash and the rash is very painful/He has faced it is painful rash on his face, Neck, Ears hand really bad and feet; This is a spontaneous report from a contactable consumer (parent). A 22-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 2 via unspecified route on Sep2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient received historical vaccine of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) dose 1 via unspecified route on an unknown date as dose 1, single for COVID-19 immunisation. The patient after 3-4 days, got sick, sore throat, he broke out with his hands, face, chest and feet's but the rash and the rash is very painful/he has faced it is painful rash on his face, neck, ears hand really bad and feet and swelling little bit on Sep2021. The outcome of the events was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Inflammation, Palpitations, Panic attack
Clinical narrative: Tired for last couple of days after the vaccine; Heart racing; Panic attack; concerning because it seems something that can cause like inflammation of my heart muscle or inflammation below outside of my heart.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: SE3592), via an unspecified route of administration on 14Sep2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (lot number: unknown) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. On an unspecified date in Sep2021, after second vaccination, the patient experienced tired for last couple of days after the vaccine, heart racing, panic attack and was concerning because it seems something that can cause like inflammation of heart muscle or inflammation below outside of heart. Clinical course included: patient had the Pfizer vaccine on Tuesday and didn't have any really side effect or anything. The patient doesn't know if the patient was having any side effect now; was not exactly sure what was going on. When probed for the side effects, it was reported that like the patient was just really tired for last couple of days and has been getting heart racing, was that means like a panic attack it just happened for about 20 minutes ago as well and the patient doesn't know if maybe like doing something or if it was the vaccine does something to heart or vaccine making it; the patient was not exactly sure what's going on, don't know if that was like the side effect or not. When paraphrased the concern, it was reported that the patient was concerning because it seems something that can cause like inflammation of heart muscle or inflammation below outside of heart. It was with the second dose of the vaccine. It was reported that the patient was ok right now. The outcome of events was resolved on an unspecified date in Sep2021.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: one of his sons experienced a break through infection; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (Reporter's son) that.  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that one of his sons experienced a breakthrough infection after being vaccinated with Comirnaty and that his other son experienced fatigue and flu-like symptoms after being vaccinated. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Herpes virus infection
Clinical narrative: Had herpes; This is a spontaneous report from Pfizer. A contactable consumer reported for a male patient of an unspecified age who received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and 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 and concomitant medications were not reported. On an unknown date, the patient had herpes. The outcome of event was unknown.  The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow up.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid test result was positive; Covid test result was positive; This is a spontaneous report from a contactable health professional (patient).   This 56-year-old male Health Professional(patient) reported for himself who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EL3247), via intramuscular route, administered in left arm on 03Feb2021 (at the age of 55-years-old), as dose 1, single for covid-19 immunization and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EL3247), via intramuscular route, administered in left arm on 02Mar2021 (at the age of 55-years-old), as dose 2, single for covid-19 immunization at workplace clinic facility. Medical history included benign prostatic hyperplasia (BHP). Known allergies were reported as no. The patient's concomitant medication was not provided. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient did not have any other medications within 2 weeks of vaccination. On 18Sep2021 at 13:00, patient experienced sneezing, running nose and aching. On 19Sep2021, patient underwent lab tests and procedures which included Binax nasal swab test which resulted in positive COVID-19. Therapeutic measures were reported as no. The outcome of the event Covid test result was positive was reported as not recovered and other event was unknown.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Vaccination Failure and Covid 19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for the COVID-19; tested positive for the COVID-19; This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer (patient himself). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Feb2021 (Batch/Lot Number: EN6200; Expiration Date: 12Jun2021) as dose 2, single and via an unspecified route of administration on 26Jan2021 (Batch/Lot Number: EL1283; Expiration Date: Apr2021) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was asking if he can get the third booster shot of the vaccine since he already received the first dose and second dose but after getting those two doses, he tested positive for COVID-19 on 03Aug2021. Outcome of events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Developed a stroke; This is a spontaneous report received from a contactable consumer.  A 74-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration on an unspecified date (30 days after received first dose) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were none. The patient previously 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 an unspecified date (maybe 6 months for the first dose) as dose 1, single for COVID-19 immunization. On an unspecified date the patient developed a stroke. The patient was fine. The patient did not function properly, was not right anymore, lots of stuff wrong with the patient that could have been avoided. The outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: The PCP had a cousin that died from the covid vaccine; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter's new PCP recommended that she not take the COVID vaccine. The PCP had a cousin that died from the COVID vaccine. They had done all of the autopsy and everything and he had just died, so the doctor had kind of advised caller not to do it. The patient died on an unspecified date. The cause of death was not reported.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: died from the covid vaccine
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: She tested positive for Covid-19 on 13Sep2021; She tested positive for Covid-19 on 13Sep2021; This is a spontaneous report received from a contactable consumer. This 55-year-old female consumer(patient) reported for herself.  A 55 years female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 14Apr2021 and 2nd dose on 06May2021 at single dose for COVID-19 immunisation. The patient medical history included "she received monoclonal antibody" and concomitant medications were not reported. On an unspecified date in sep2021, patient said she can't smell, taste, and is losing her voice. Patient said the symptoms started on Monday and has not went away and is getting worse. Patient wants to know if this is normal and is seeking guidance on what to do. However, patient tested positive for Covid-19 on 13Sep2021. She also mentioned that she received monoclonal antibody. At the time of reporting, the outcome of the events were unknown   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injected limb mobility decreased, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: I have tried ibuprofen and massages and nothing works I don?t have insurance and like I stated I never had these issues before getting the vaccine
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: I have tried ibuprofen and massages and nothing works I don?t have insurance and like I stated I never had these issues before getting the vaccine
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Lethargy, Pain
Clinical narrative: Pleurisy-type symptoms in left, upper chest; severe body aches all over; lethargic and difficulty getting a deep breath. Lasted several days. Happened after 2nd shot as well.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Heart rate increased, Pyrexia
Clinical narrative: Shortness of breath, rapid heart rate, chest pain/ tightness and high fever
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: blood pressure goes "sky high"; somebody pulled the shade down for a split second and she was also dizzy for about 4 to 5 hours; inside of her feels hot but the outside of her feels cold; diarrhea, just like water for about 3 or 4 days; couldn't get up; This is a spontaneous report from a contactable consumer (patient). A 73-Year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 10Sep2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 20Aug2021 (age at vaccination: 73 years), as a single dose for COVID-19 immunization and had 10 days after the first she like somebody pulled the shade down for a split second, she was also dizzy for about 4 to 5 hours, and her blood pressure went up to 215/88. She stated she had both vaccines and then 10 days after the first she like somebody pulled the shade down for a split second and she was also dizzy for about 4 to 5 hours and then the same thing happened 10 days after her second dose and her doctor said it might be a possible side effect of the vaccine, and on an unspecified date in Sep2021, she had diarrhea, just like water for about 3 or 4 days. But she also gets real dizzy and her blood pressure goes "sky high" had to call the paramedics because her blood pressure went up to 215/88, 10 days after the vaccine each time with both vaccines. It got scary. She stated her symptoms will occur for 3 or 4 days and then sometimes it passes. But never had the problems till she go the vaccine. Also mentioned that she couldn't get up because she was so dizzy and her legs were weak and the inside of her feels hot but the outside of her feels cold and that never happened till she got the vaccines so it could be some new effect they didn't know about. This has been happening every evening for the last 3 to 4 days and I don't know how long it's going to last and she was by herself and it's kind of scary when you have to hold on to get up if you can get up. There may be many factors to consider including your medical history and medical condition. The patient advised to consult with your doctor/healthcare provider about what you have experienced/are experiencing. Your doctor/healthcare provider is in the best position to advise you about the appropriate action to take as your doctor/healthcare provider was most familiar with your medical condition, clinical history, how your treatment has been conducted and any relevant information to your specific case. The patient underwent lab test and procedure included blood pressure with 215/88 on an unspecified date. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be re-quested during follow up.