chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dyskinesia, Fatigue, Limb discomfort, Muscle contractions involuntary
Clinical narrative: arm tremors/shaking; pins and needles/tingling; burning sensations/forearm has a burning sensations intermittently; her arms flops like a fish; involuntary movements; muscle contractions; her upper arm muscles are twitching; injection site pain; still pain in the arm, but its not continuous; Very tired; This is a spontaneous report from a contactable consumer (patient mother). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was EW0158 and expiration date was not reported), dose 1 via an unspecified route of administration on 09Apr2021 at 11: 00 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had injection site pain and a myriad of other symptoms on the same arm that she received the injection. She experienced arm tremors, pins and needles, burning sensations, her arms flops like a fish, involuntary movements, muscle contractions, tingling. She developed some of the same side effects on the other arm other arm this weekend. It was reported that the symptoms started within minutes and it was still occurring. As of a few minutes ago at the time of the reporting, her upper arm muscles were twitching, her forearm had burning sensations intermittently. She went to the ER over the weekend, and the ER doctor suggested she be transferred to the hospital and been seen by the neurologist. They plan to be seen by the pediatrician and possibly see a neurologist. she has symptoms, it was tremor/pain/involuntary movements. Not seen by any HCP other than the ER, called pediatrician today and has not heard back yet No symptoms on the other side/in other arm anymore that has resolved (only occurred 1 time in ER when the patient was very tired) She was awaiting a call back from the pediatrician and know the patient should be evaluated. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Pain in extremity, Paraesthesia, Tremor, Vaccination site pain
Clinical narrative: arm tremors/shaking; pins and needles/tingling; burning sensations/forearm has a burning sensations intermittently; her arms flops like a fish; involuntary movements; muscle contractions; her upper arm muscles are twitching; injection site pain; still pain in the arm, but its not continuous; Very tired; This is a spontaneous report from a contactable consumer (patient mother). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was EW0158 and expiration date was not reported), dose 1 via an unspecified route of administration on 09Apr2021 at 11: 00 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had injection site pain and a myriad of other symptoms on the same arm that she received the injection. She experienced arm tremors, pins and needles, burning sensations, her arms flops like a fish, involuntary movements, muscle contractions, tingling. She developed some of the same side effects on the other arm other arm this weekend. It was reported that the symptoms started within minutes and it was still occurring. As of a few minutes ago at the time of the reporting, her upper arm muscles were twitching, her forearm had burning sensations intermittently. She went to the ER over the weekend, and the ER doctor suggested she be transferred to the hospital and been seen by the neurologist. They plan to be seen by the pediatrician and possibly see a neurologist. she has symptoms, it was tremor/pain/involuntary movements. Not seen by any HCP other than the ER, called pediatrician today and has not heard back yet No symptoms on the other side/in other arm anymore that has resolved (only occurred 1 time in ER when the patient was very tired) She was awaiting a call back from the pediatrician and know the patient should be evaluated. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenopathy, Pain in extremity, Peripheral swelling, Vaccination site pain
Clinical narrative: had pain and soreness in the arm which has subsided now; There's a bump which is extremely sensitive and is swollen; her hands had gotten puffy; injection site soreness in her left arm; pain in between my knuckles on both hands; This is a spontaneous report from a contactable consumer or other non-HCP. A 52-years-old female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ER8729), via intramuscular route of administration, in left arm on 10Apr2021 04:30 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had vaccination on Saturday at 4:30 and probably about 3 hours afterwards, patient noticed her hands had gotten puffy on 10Apr2021. However, patient had pain between the knuckles of both her hands on 10Apr2021. On the left hand, right where the wrist bends, there was kind of like a bump there that is very tender and up to the pointer finger, that knuckle is very tender (of her left hand). There was a bump which is extremely sensitive and is swollen on an unspecified date. On 10Apr2021(maybe 2 hours afterwards), the patient had injection site soreness in her left arm, after four hours her arm became noticeably sore. The patient woke up this morning and had pain and soreness in the arm had subsided greatly on an unspecified date, the soreness is almost gone. The pain with the bending of her wrist and the knuckle joint to her pointer finger on the left hand was staying the same. On 11 Apr 2021(yesterday), this pain came on noticed. She mentions she had not even taken her vitamins that day, she made sure she nothing prior to the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The outcome of event pain and soreness in the arm which has subsided now recovered on an unspecified date in 2021, outcome of pain in between my knuckles on both hands and her hands had gotten puffy was not recovered, outcome of there's a bump which is extremely sensitive and is swollen was unknown whereas outcome of site soreness in her left arm was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Chills, Fatigue, Hypokinesia, Insomnia
Clinical narrative: taste buds were not working; felt bloated; muscle aches' all muscles ached real bad (especially muscles in the leg); difficulty sleeping; shoulders and neck are stiff; "bad pain like I've been beaten"; shoulders and neck are stiff; "bad pain like I've been beaten"; can barely move; fatigue; "can't keep my eyes open", "no energy; chills; "cold from inside of the body"; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 02Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient received the first dose of the Pfizer-BioNTech COVID-19 Vaccine last 2APR2021, In Apr2021, patient had after leaving the vaccination site, Caller mentioned that his taste buds were not working (persistent; it has been 10 days); felt bloated; couldn't feel anymore; muscle aches' all muscles ached real bad (especially muscles in the leg); difficulty sleeping - shoulders and neck are stiff; "bad pain like I've been beaten"; can barely move; fatigue; "can't keep my eyes open", "no energy" chills; "cold from inside of the body" The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Taste disorder
Clinical narrative: taste buds were not working; felt bloated; muscle aches' all muscles ached real bad (especially muscles in the leg); difficulty sleeping; shoulders and neck are stiff; "bad pain like I've been beaten"; shoulders and neck are stiff; "bad pain like I've been beaten"; can barely move; fatigue; "can't keep my eyes open", "no energy; chills; "cold from inside of the body"; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 02Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient received the first dose of the Pfizer-BioNTech COVID-19 Vaccine last 2APR2021, In Apr2021, patient had after leaving the vaccination site, Caller mentioned that his taste buds were not working (persistent; it has been 10 days); felt bloated; couldn't feel anymore; muscle aches' all muscles ached real bad (especially muscles in the leg); difficulty sleeping - shoulders and neck are stiff; "bad pain like I've been beaten"; can barely move; fatigue; "can't keep my eyes open", "no energy" chills; "cold from inside of the body" The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: had a strong pain at the site of injection; This is a spontaneous report from a contactable consumer (patient, reported for herself). A female patient of an unspecified age, received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number: EP7533 and expiry dates was not provided), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunisation and latanoprost, form an unknown date, at 2.5 ml once a day for unknown indication. Patient's medical history and concomitant medications were not reported. Patient stated that she had a side effect after the 1st dose of the COVID 19 vaccine, she had a strong pain at the site of injection and it was resolved after 2-3 days. Action taken in response to the event for latanoprost was unknown. Outcome of the event was reported as recovered on an unknown date.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: arm pain; numbness in her hand; This is an initial spontaneous report received from a contactable consumer (Patient). A 53-Year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not provided) first dose via an unspecified route of administration in arm on03Apr2021 as single dose for COVID-19 immunization. The patient medical history was reported. The patient concomitant medication was not reported. The patient experienced that she stated she has been having issues with her arm. She reported arm pain and numbness in her hand. She asked if this is a side effect? She stated she needs to know if it is from the vaccine or if it is potentially another medical problem. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I can contact with virus vaccination; contact with the virus after two of the COVID shot; I had Covid; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (,Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as SINGLE DOSE, dose 2 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 was not reported and concomitant medications were not reported. The patient was in contact with virus vaccination; contact with the virus after two of the covid shot (drug ineffective) and had covid. Further stated that, tatient had both shot and the first one obviously will give an incredible amount of coverage and had Covid. It was stated that, LOT#: 3321 and 32421, that's all I have. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome for the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue
Clinical narrative: tiredness; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 11Apr2021 at 14:40 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. This case classified as non-serious was reported. On an unspecified date, the patient experienced tiredness and diarrhea. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cough, Delirium, Hyperhidrosis, Illness
Clinical narrative: unconscious at times; perspiring profusely; bad cough; coughing until he throws up; He was very ill; high fever" of 104; really bad pain in his arm; delirious and out of it; This is a spontaneous report from a contactable nurse (patient's wife). A 63-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm on 08Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included sick from Dec2019, down to the eye, diarrhea and fever. There were no concomitant medications.  The patient experienced high fever" of 104, had really bad pain in his arm, was delirious and out of it and he was very ill on 08Apr2021. The reporter also stated that the patient also was unconscious at times, perspiring profusely, had bad cough, was coughing until he throws up on an unspecified date. The event pyrexia was assessed as life-threatening and pain in arm was assessed as disability by the reporter. The patient underwent lab tests and procedures which included fever: 104 on 08Apr2021. Therapeutic measures were taken as a result of pyrexia included Tylenol. Outcome of the events was unknown.   Information on about lot/batch number has been requested.; Sender's Comments: The information currently provided is very limited, hence the reported events are conservatively assessed as related to the administration of the vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: unconscious at times; perspiring profusely; bad cough; coughing until he throws up; He was very ill; high fever" of 104; really bad pain in his arm; delirious and out of it; This is a spontaneous report from a contactable nurse (patient's wife). A 63-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm on 08Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included sick from Dec2019, down to the eye, diarrhea and fever. There were no concomitant medications.  The patient experienced high fever" of 104, had really bad pain in his arm, was delirious and out of it and he was very ill on 08Apr2021. The reporter also stated that the patient also was unconscious at times, perspiring profusely, had bad cough, was coughing until he throws up on an unspecified date. The event pyrexia was assessed as life-threatening and pain in arm was assessed as disability by the reporter. The patient underwent lab tests and procedures which included fever: 104 on 08Apr2021. Therapeutic measures were taken as a result of pyrexia included Tylenol. Outcome of the events was unknown.   Information on about lot/batch number has been requested.; Sender's Comments: The information currently provided is very limited, hence the reported events are conservatively assessed as related to the administration of the vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not feeling well; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable consumer (patient) reported that a female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was scheduled today (07Apr2021) for the second dose. Patient was sent home from work today (07Apr2021) since she was not feeling well. Patient wanted to know if she could still have the vaccine even if she was not feeling well. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: in the interim I had Covid; in the interim I had Covid; This is a spontaneous report from a Pfizer sponsored program. A Contactable consumer (patient) reported that a 63-year-old female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration, administered in Arm Right on 15Mar2021 at a single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient reported that today was my second dose of Pfizer vaccine but in the interim I had Covid on an unspecified date in 2021, so I spoke with my healthcare provider and they told me to wait 90 days and then I have to start it all over again. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a Pfizer- sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Apr2021 (Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Mar2021 for covid-19 immunisation. Caller (patient) had her 2nd dose of the Pfizer vaccine and she has headache (in Apr2021) and is asking if she can take Tylenol. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Circumstance or information capable of leading to medication error, Pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Medical Information Potential AE; Ten days after vaccination rash/itching occurred inner elbow right arm followed by same under the arm. Then same areas on left arm developed rash/itching.  Rash and itching continues./Followed by a rash; Ten days after vaccination rash/itching occurred inner elbow right arm followed by same under the arm. Then same areas on left arm developed rash/itching. Rash and itching continues.; She experienced pain that lasted for about 3-4 days; she was diagnosed with covid arm about 10-12 days after the vaccine; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: unknown) via an unspecified route of administration in right arm on 25Mar2021 at 11:15 AM as single dose for COVID-19 immunization. Medical history included sinusitis, Allergy to antibiotic. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient previously took ibuprofen (ADVIL) and had allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 06Apr2021 at 08:00 AM, ten days after vaccination rash/itching occurred inner elbow right arm followed by same under the arm. Then same areas on left arm developed rash/itching. Rash and itching continue. Patient was diagnosed with covid arm about 10-12 days after the vaccine. She experienced pain that lasted for about 3-4 days. Followed by a rash. New or worsened muscle pain on 06Apr2021 was reported. She had the COVID arm like is mentioned on the CDC website after the first injection. She needs advice to proceed with second one. It was a delayed response happening 10-12 days after the initial vaccine. The rash appeared on inside of elbow and creases of underarm on right side where shot was administered. No treatment received for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events rash/itching occurred inner elbow right arm followed by same under the arm was not recovered; for other events was unknown.   Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: swollen lymph node under the injection site on her arm pit/ lymph nodes were swollen under the injection site on her arm; tiredness; injection site pain; muscle ache; chills; swelling around the injection site; nausea; wasn't feeling well; Headache; Fever; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 06Apr2021 (Batch/Lot Number: EN6207) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, on unknown date for covid-19 immunisation. On an unknown date in Apr2021, the patient experienced injection site pain, tiredness, headache, muscle ache, chills, fever, swelling around the injection site, nausea, wasn't feeling well, and swollen lymph node under the injection site on her arm pit/ lymph nodes were swollen under the injection site on her arm which was still swollen today. The outcome of the event vaccination site lymphadenopathy was not recovered and other events was unknown.   No follow up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site lymphadenopathy, Vaccination site pain, Vaccination site swelling
Clinical narrative: swollen lymph node under the injection site on her arm pit/ lymph nodes were swollen under the injection site on her arm; tiredness; injection site pain; muscle ache; chills; swelling around the injection site; nausea; wasn't feeling well; Headache; Fever; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 06Apr2021 (Batch/Lot Number: EN6207) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, on unknown date for covid-19 immunisation. On an unknown date in Apr2021, the patient experienced injection site pain, tiredness, headache, muscle ache, chills, fever, swelling around the injection site, nausea, wasn't feeling well, and swollen lymph node under the injection site on her arm pit/ lymph nodes were swollen under the injection site on her arm which was still swollen today. The outcome of the event vaccination site lymphadenopathy was not recovered and other events was unknown.   No follow up attempts are needed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Illness, SARS-CoV-2 test
Clinical narrative: admitted with stroke; He had symptoms of an illness (perhaps covid like symptoms) starting on 19Mar2021 (between his 1st & 2nd dose of Pfizer BioNtech).; This is a spontaneous report from a contactable consumer. A 36-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number; Unknown), dose 1 via an unspecified route of administration on an unspecified date as SINGLE DOSE, dose 2 via an unspecified route of administration on 21Mar2021 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number; Unknown) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced he had symptoms of an illness (perhaps covid like symptoms) starting on 19mar2021 (between his 1st & 2nd dose of pfizer biontech). (illness) on 18Mar2021, admitted with stroke (cerebrovascular accident) (hospitalization) on 08Apr2021. The patient was hospitalized for admitted with stroke (cerebrovascular accident) on 08Apr2021 in ICU currently/still as of 11Apr2021, not yet recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 18Mar2021, sars-cov-2 test: negative on 08Apr2021. Therapeutic measures were taken as a result of admitted with stroke (cerebrovascular accident). A 36 year old brother in law of my friend. He had symptoms of an illness (perhaps covid like symptoms) starting on 19Mar2021 (between his 1st & 2nd dose of Pfizer BioNTech). He went ahead and got his 2nd dose on 21March2021. He then went to see his dr in the last week (week of 05Apr2021 I believe) because of not being well. That primary care dr thought the patient had perhaps been exposed to covid between the 1st & 2nd doses (due to symptoms that the dr thought seemed like body's over-reaction to covid) but a covid test was done and it was negative. Then the patient has been admitted to (Hospital name) in (city name) (state name) suffering from a stroke on 08Apr2021. He still has not tested positive for covid (again) but he is in ICU at (Hospital name) with stroke symptoms. This was all related to my by the sister-in-law (my friend (name)). I wanted to report since the 2nd dose Pfizer BioNTech was taken on 21Mar2021 & then in hospital ICU with a stroke (at 36 yrs old) on 08Apr2021. Hospitalized for 4 days in ICU currently/still as of 11Apr2021, not yet recovered, admitted with stroke on 08Apr2021. The outcome of the event for illness was unknown and for stroke was not recovered.  Information about Lot/batch number is requested.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Feeling abnormal, Hypersensitivity, SARS-CoV-2 test
Clinical narrative: I have contracted COVID-19 3 weeks after getting 1st COVID Vacc; Covid-19 positive; mild allergy; lot of weird going on/ feeling odd; This is a spontaneous report from a contactable consumer (patient) via support team. Follow-up (08Apr2021) received from a contactable consumer was processed together with initial information.   A 64-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: Unknown), dose 2 via an unspecified route of administration on 06Apr2021 as SINGLE DOSE for COVID-19 immunization. Patient received 1 Pfizer dose on an unspecified date three weeks prior to second dose as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 07Apr2021 after receiving second dose the patient contracted COVID-19. Further details are as follows: Patient was notified a few hours later that a niece he spent time with on 02Apr2021 just tested positive for COVID. Patient had been feeling odd and attributed it to allergies but after hearing news of his niece he scheduled a COVID test the next morning on 07Apr2021. He got the results that same night that he was also positive. On 06Apr2021, the patient has been feeling alright but have had feeling of allergies kind. The next day he was still feeling odd but not really, anything terrible just like mild allergy and lot of weird going on so he just assumes what it was. After testing positive the patient spoke to contact centre and he was informed that she had never heard of anybody doing that. Patient was having anecdotes individual here just one case, but it is kind of unusual. He doesn't mind testing for the variant he was having. Patient stated he is having symptoms to the onus. The symptoms of the onus he experienced, Monday 5Apr2021. Outcome of events was unknown.   Information about lot/batch number has been requested.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Malaise, SARS-CoV-2 test positive
Clinical narrative: I have contracted COVID-19 3 weeks after getting 1st COVID Vacc; Covid-19 positive; mild allergy; lot of weird going on/ feeling odd; This is a spontaneous report from a contactable consumer (patient) via support team. Follow-up (08Apr2021) received from a contactable consumer was processed together with initial information.   A 64-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: Unknown), dose 2 via an unspecified route of administration on 06Apr2021 as SINGLE DOSE for COVID-19 immunization. Patient received 1 Pfizer dose on an unspecified date three weeks prior to second dose as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 07Apr2021 after receiving second dose the patient contracted COVID-19. Further details are as follows: Patient was notified a few hours later that a niece he spent time with on 02Apr2021 just tested positive for COVID. Patient had been feeling odd and attributed it to allergies but after hearing news of his niece he scheduled a COVID test the next morning on 07Apr2021. He got the results that same night that he was also positive. On 06Apr2021, the patient has been feeling alright but have had feeling of allergies kind. The next day he was still feeling odd but not really, anything terrible just like mild allergy and lot of weird going on so he just assumes what it was. After testing positive the patient spoke to contact centre and he was informed that she had never heard of anybody doing that. Patient was having anecdotes individual here just one case, but it is kind of unusual. He doesn't mind testing for the variant he was having. Patient stated he is having symptoms to the onus. The symptoms of the onus he experienced, Monday 5Apr2021. Outcome of events was unknown.   Information about lot/batch number has been requested.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Feeling abnormal, Hypersensitivity, SARS-CoV-2 test
Clinical narrative: I had the 2nd vaccine/ I was also positive/symptoms of COVID; I was also positive/symptoms of COVID; This is a spontaneous report from a contactable consumer (patient) through the Pfizer-sponsored program . This consumer reported information for two reports. This case is the second of the two reports: The second vaccine dose. This 64-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 06Apr2021 (at the age of 64-year-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 02Apr2021, the patient was with his great grandniece who later tested positive for COVID-19. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date in Apr2021 as single dose for COVID-19 immunization, then he experienced feeling odd / lot of weird going on and like mild allergy in Apr2021. After receiving his second dose of vaccine, the patient was tested positive for COVID on 07Apr2021 and experienced symptoms of COVID in Apr2021. The clinical course was as the patient stated, " I had my first COVID vaccination, Pfizer COVID vaccination just three weeks ago (Mar2021). All over the weekend last Friday (02Apr2021), I was with the great grandniece of mine and spent few hours with her. When I come Monday, I have been feeling alright, I was feeling I have allergies that kind. The next day was my second scheduled vaccination on Tuesday (06Apr2021) and I was still feeling odd but not really, anything terrible just like mild allergy and lot of weird going on so I just assume what it was. After I got the second vaccination (06Apr2021) and 3 hours later, I got notified that niece of mine have tested positive for COVID. After that news, I scheduled a COVID test and got tested the next morning (07Apr2021). I got the result that same night that I was also positive. I am still feeling the symptoms of COVID." On 07Apr2021, patient's COVID-19 test was positive. The clinical outcome of the "I had the 2nd vaccine/ I was also positive/symptoms of COVID" was not resolved.  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-2021401059 Same patient and reporter/Different Vaccine Dose and event
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Malaise, SARS-CoV-2 test positive
Clinical narrative: I had the 2nd vaccine/ I was also positive/symptoms of COVID; I was also positive/symptoms of COVID; This is a spontaneous report from a contactable consumer (patient) through the Pfizer-sponsored program . This consumer reported information for two reports. This case is the second of the two reports: The second vaccine dose. This 64-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 06Apr2021 (at the age of 64-year-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 02Apr2021, the patient was with his great grandniece who later tested positive for COVID-19. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date in Apr2021 as single dose for COVID-19 immunization, then he experienced feeling odd / lot of weird going on and like mild allergy in Apr2021. After receiving his second dose of vaccine, the patient was tested positive for COVID on 07Apr2021 and experienced symptoms of COVID in Apr2021. The clinical course was as the patient stated, " I had my first COVID vaccination, Pfizer COVID vaccination just three weeks ago (Mar2021). All over the weekend last Friday (02Apr2021), I was with the great grandniece of mine and spent few hours with her. When I come Monday, I have been feeling alright, I was feeling I have allergies that kind. The next day was my second scheduled vaccination on Tuesday (06Apr2021) and I was still feeling odd but not really, anything terrible just like mild allergy and lot of weird going on so I just assume what it was. After I got the second vaccination (06Apr2021) and 3 hours later, I got notified that niece of mine have tested positive for COVID. After that news, I scheduled a COVID test and got tested the next morning (07Apr2021). I got the result that same night that I was also positive. I am still feeling the symptoms of COVID." On 07Apr2021, patient's COVID-19 test was positive. The clinical outcome of the "I had the 2nd vaccine/ I was also positive/symptoms of COVID" was not resolved.  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-2021401059 Same patient and reporter/Different Vaccine Dose and event
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Paranasal sinus discomfort, Rhinorrhoea, SARS-CoV-2 test, Sinusitis
Clinical narrative: I tested positive for Covid (3 rapid tests to confirm); I tested positive for Covid (3 rapid tests to confirm)/dry cough; sinus infection; Runny nose; sinus pressure; This is a spontaneous report from a contactable consumer (patient). A 27-years-old female patient (who was not pregnant at the time of vaccination), received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 04Feb2021 (Batch/Lot Number: EL1283) as SINGLE DOSE for covid-19 immunisation. The patient had received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 14Jan2021 (Batch/Lot Number: EL1238) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive Other medications in two weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has been tested for COVID-19, post vaccination. On 07Apr2021, the patient experienced sinus infection, runny nose, sinus pressure, dry cough and on 10Apr2021 COVID-19. The patient underwent lab tests and procedures which included COVID-19 test positive, on 10Apr2021 two times test was done and on 11Apr2021. Outcome of these events was recovering.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: I tested positive for Covid (3 rapid tests to confirm); I tested positive for Covid (3 rapid tests to confirm)/dry cough; sinus infection; Runny nose; sinus pressure; This is a spontaneous report from a contactable consumer (patient). A 27-years-old female patient (who was not pregnant at the time of vaccination), received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 04Feb2021 (Batch/Lot Number: EL1283) as SINGLE DOSE for covid-19 immunisation. The patient had received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 14Jan2021 (Batch/Lot Number: EL1238) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive Other medications in two weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has been tested for COVID-19, post vaccination. On 07Apr2021, the patient experienced sinus infection, runny nose, sinus pressure, dry cough and on 10Apr2021 COVID-19. The patient underwent lab tests and procedures which included COVID-19 test positive, on 10Apr2021 two times test was done and on 11Apr2021. Outcome of these events was recovering.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain, Product dose omission issue, Pruritus, Rash
Clinical narrative: Back pain; Did not take thyroid medication morning of first dose of Covid-19 vacc; she has broke out with a rash on the side of her stomach area; Itching; Prickling; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 64-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 1 via an unspecified route of administration in Arm Left on 09Apr2021 09:30 (Lot Number: EL9264; Expiration Date: 20May2021) as single dose for covid-19 immunisation. Medical history included peripheral venous disease from 2018 and ongoing, ongoing unspecified thyroid condition, ongoing Acid reflux disease, ongoing seasonal allergy, ongoing heat rash. Concomitant medications included levothyroxine (LEVOTHYROXINE) 112 mg once daily taken for thyroid disorder, gabapentin (GABAPENTIN) 100 mg three times per day taken for vein nerves from 2018 to an unspecified stop date; pantoprazole (PANTOPRAZOLE) 40 mg once daily as needed taken for acid reflux disease, tizanidine hydrochloride (TIZANIDINE ARROW) 6 mg as needed taken for hypersensitivity, loratadine, pseudoephedrine sulfate (CLARITIN-D) one tablet once daily as needed, 24-hour strength taken for hypersensitivity. Family medical history was none. No vaccinations prior to COVID-19 vaccine within 4 weeks. On 09Apr2021, the patient experienced she has broken out with a rash on the side of her stomach area, itching, prickling and did not take thyroid medication morning of first dose of covid-19 vaccine, on an unspecified date, experienced back pain. Friday, 09Apr2021, following the Covid-19 vaccine she got a rash. She reported that she thought the rash was a heat rash and the rash was on the right side of her body, on her side by her stomach on the right side. Caller inquired how long the rash will last. Patient reported that she was still experiencing the rash at time of call on 12Apr2021. Patient reported that she has been applied baby powder to the rash like she would if she had a heat rash. Caller reported that she has one section on her body where the rash has congregated. Caller reported that other parts of her body like the side of her stomach have 1 or 2 and reported that it felt like prickling on her skin when the rash was coming out on the night of Friday, 09Apr2021. Caller reported that the prickling became itching, and she can tolerate pain a lot and that she is trying not to let the itching bother her. she did not take her thyroid medication and reported that someone had mentioned that she shouldn't take any medications before she got the Covid-19 vaccine, so she avoided taking her thyroid medication. Caller reported that the back pain started Wednesday of last week, 07Apr2021. Caller reported that later in the day on 09Apr2021, she took Tylenol and the next day, 10Apr2021, she started taking her medications like she normally would. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tinnitus on an unspecified date, the next day after receiving her first dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive yesterday; This is a spontaneous report. A contactable female consumer (patient) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 24Mar2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient got symptoms last Monday, 05Apr2021, and tested positive yesterday, 07Apr2021 for Covid-19. She would like to know whether she should proceed with her second dose appointment which was why she was calling. Outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 62-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 23Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced shingles on an unspecified date. She was due for the second dose on Wednesday, 14Apr2021. It was asked that if she can receive second dose of vaccine as scheduled. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: patient tested positive for CoVid after first dose; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer (patient) reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 05Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient received first dose of vaccine on 05Apr2021 and has had covid exposure. She was inquiring if vaccine will show as positive on covid test and if positive should they get the second dose. Also inquiring if patient that tested positive after receiving first dose, if they should continue with second dose. It was further reported that on efficacy, patient tested positive for covid (Apr2021) after first dose. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Kidney infection, Product dose omission issue
Clinical narrative: Kidney infection; missed their 2nd shot of vaccine; This is a spontaneous report from a contactable consumer (patient's wife). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration on 09Mar2021 as single dose for Covid-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 on 09Mar2021 for Covid-19 immunisation. It was reported that the patient had kidney infection on an unspecified date and was hospitalized on 24Mar2021 to 26Mar2021 and she was in the hospital the whole week. It was also reported that the patient missed her 2nd shot of vaccine on 30Mar2021. Therapeutic measures were taken as a result of kidney infection. The outcome of the events was unknown.  Information on the lot/batch number has been requested.