chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Paraesthesia, Pyrexia, Respiratory tract congestion, Vomiting
Clinical narrative: who was inadvertently given a 3rd dose of the COMIRNATY vaccine yesterday afternoon; who was inadvertently given a 3rd dose of the COMIRNATY vaccine yesterday afternoon; experienced having a hard time breathing further described as congested; experienced having a hard time breathing further described as congested; throws up; tingling of hands (needle like); fever; chills; felt hot; This is a spontaneous report from a contactable consumer. A 25-year-old female patient received third dose of BNT162B2 (PFIZER-BIONTEHC COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 06Sep2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historic vaccine included first and second dose of BNT162B2 (PFIZER-BIONTEHC COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. On an unspecified date in Sep2021, the patient experienced having a hard time breathing further described as congested, throws up, tingling of hands, fever, chills, felt hot, on 06Sep2021, who was inadvertently given a 3rd dose of the comirnaty vaccine yesterday afternoon. Caller called for his wife about the Pfizer Covid vaccine, She was inadvertently given a 3rd dose of the COMIRNATY vaccine yesterday afternoon (06Sep2021) by a local pharmacy even though patient did not fall into the category of being immunocompromised. Caller mentioned that the Pharmacy tech gave the 3rd dose to her wife with the premise of her mother being immunocompromised and that she could have been potentially exposed to her. Also, another information was given that the dose given to her wife was a dose supposed to be disposed because it was an extra one and thus offering it to her wife so that dose will not be put to waste. They gave her the vaccine anyway because of the patient's mother; states the patient's mother was not able to get the 3rd dose of the Pfizer Covid vaccine and that was the reason they gave the patient her 3rd dose and he wanted to know if this is what is recommended and she was also having side effects. Stated the patient was having a hard time breathing and threw up this morning and her hands are getting tingly and she had got a little bit of fever 100.2 degrees as of 20 minutes ago; states the patient was taking Ibuprofen and nothing seems to be better regarding her side effects and she had to be driven home and could not drive herself home. The patient underwent lab tests and procedures which included body temperature: 100.2 degrees. Therapeutic measures were taken as a result of adverse events. The outcome of events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site hypoaesthesia
Clinical narrative: having numbness from her shoulder, neck, cheek and left thigh; having numbness from her shoulder, neck, cheek and left thigh; having numbness from her shoulder, neck, cheek and left thigh; having numbness from her shoulder, neck, cheek and left thigh; The numbness is from the left side from the injection site.; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as a DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history included covid-19 from an unknown date and unknown if ongoing. Reporter stated that she had COVID before. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced having numbness from her shoulder, neck, cheek and left thigh and the numbness is from the left side from the injection site. Reporter stated that she has weird symptoms that is not on the sheet that was given to her from the pharmacy. Reporter stated that she is having numbness from her shoulder, neck, cheek and left thigh. Reporter wanted to know if these are commonly reported side effects. The numbness was from the left side from the injection site. Reporter also stated that she had COVID before. She reported that, she was having numbness from her shoulder to her neck to her cheek on the left side. She was interested in knowing if its common. Her doctor thought there was aluminum in the vaccine. Outcome of all the events were unknown.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Pain in extremity
Clinical narrative: just had a little arm pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable 80-years-old male consumer (patient) reported for self that patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced just had a little arm pain (pain in extremity). The patient underwent lab tests and procedures which included antibody test: less than 50 on 4 antibody tests that both showed less than 50. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I likely had COVID-19 during the week of Feb. 14, 2021. My hematologist was sure I had it, in retrospect.; This is a spontaneous report from a contactable consumer or other non hcp. This case was split to capture events after first and second dose of vaccine. This is the first of two reports, reflecting events after the 1st dose.  A 73-years-old male patient received BNT162b2 (CONMINTARY, Solution for injection, Lot No: EL9265), via an unspecified route of administration, administered in Arm Right on 12Feb2021 16:30 as 1stdose, single covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient experienced i likely had covid-19 during the week of feb. 14, 2021. my hematologist was sure i had it, in retrospect. on 14Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative   on   Nasal Swab. No patient did not have any other vaccine in four weeks, patient had other medication in two weeks, Patient had physician office visit. Treatment was not received. No, covid prior vaccination, yes it was tested Covid post vaccination, no known allergies. Upon follow -up on 09Sep2021 Follow-up attempts are completed. No further information is expected. Outcome of the event was unknown.    Follow-up (09Sep2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Menstruation irregular
Clinical narrative: noticed some spotting issues with her period, it comes on and off for about "15-20 and some days"; noticed some spotting issues with her period, it comes on and off for about "15-20 and some days"; This is a spontaneous report from a contactable consumer. This consumer reported similar event for her Daughter and Daughter particular classmate. This is daughter report.  This consumer (parent) reported that a 16-year-old female patient (daughter) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on Jul2021 at single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Jun2021 for COVID-19 immunization. Reporter wanted to know if we have additional information on menstrual irregularities as a reported adverse event after getting the Pfizer BioNTech Covid-19 Vaccine. Reporter also requesting for medical advice. Reporter stated that her daughter received the first dose of the Pfizer BioNTech Covid-19 Vaccine on 28Jun2021 and her second dose on Jul2021. Reporter's daughter noticed some spotting issues with her period, it comes on and off for about 15-20 and some days. The outcome of events was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101170062 same drug and AE, different patient
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Appetite disorder, Body temperature, Extra dose administered, Illness
Clinical narrative: After the third dose; After the third dose; pretty sick; lost 4 pounds; didn't eat for 3 days; had a fever of 100.9 for 2 days; couldn't get out of bed; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that an 80-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: SW0175, Expiry date: unknown, at the age of 80 years), dose 3 via an unspecified route of administration on 11Aug2021 as dose 3, single for COVID-19 immunisation. Medical history included chronic lymphocytic leukaemia (bone marrow cancer diagnosed about 7 years ago), Congestive heart failure from 2004 to unknown if ongoing (very weak heart, ejection fraction of less than 20). There were no concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 administered on deltoid left upper arm on 12Jan2021 (Batch/Lot Number: EL8982, at the age of 80 years) for covid-19 immunization and experienced little arm pain; and second dose of BNT162B2 on 02Feb2021 (Batch/Lot Number: EN6318, at the age of 80 years) for covid-19 immunization and experienced little arm pain. After the third dose the patient reported that he was pretty sick, lost 4 pounds, didn't eat for 3 days, had a fever of 100.9 for 2 days and couldn't get out of bed. On the 4th day he got better. He has now had 4 antibody tests that both showed less than 50. Caller reports tomorrow, 4 weeks after his third shot, he is going to get another antibody test. He had an antibody test, called spike protein tests, at (Hospital name withheld), about a month ago, then one test about two weeks ago and he is getting another test tomorrow. He got himself tested and is showing low antibodies for the virus. Outcome of events for off label use and extra dose administered was unknown and for the rest of the events it was recovering.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Off label use, Pyrexia, Weight, Weight decreased
Clinical narrative: After the third dose; After the third dose; pretty sick; lost 4 pounds; didn't eat for 3 days; had a fever of 100.9 for 2 days; couldn't get out of bed; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that an 80-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: SW0175, Expiry date: unknown, at the age of 80 years), dose 3 via an unspecified route of administration on 11Aug2021 as dose 3, single for COVID-19 immunisation. Medical history included chronic lymphocytic leukaemia (bone marrow cancer diagnosed about 7 years ago), Congestive heart failure from 2004 to unknown if ongoing (very weak heart, ejection fraction of less than 20). There were no concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 administered on deltoid left upper arm on 12Jan2021 (Batch/Lot Number: EL8982, at the age of 80 years) for covid-19 immunization and experienced little arm pain; and second dose of BNT162B2 on 02Feb2021 (Batch/Lot Number: EN6318, at the age of 80 years) for covid-19 immunization and experienced little arm pain. After the third dose the patient reported that he was pretty sick, lost 4 pounds, didn't eat for 3 days, had a fever of 100.9 for 2 days and couldn't get out of bed. On the 4th day he got better. He has now had 4 antibody tests that both showed less than 50. Caller reports tomorrow, 4 weeks after his third shot, he is going to get another antibody test. He had an antibody test, called spike protein tests, at (Hospital name withheld), about a month ago, then one test about two weeks ago and he is getting another test tomorrow. He got himself tested and is showing low antibodies for the virus. Outcome of events for off label use and extra dose administered was unknown and for the rest of the events it was recovering.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Influenza, Nausea, Psoriatic arthropathy, Trigger finger
Clinical narrative: psoriatic arthritis flare up; Right middle finger triggered; covid-19 vaccine reaction was nausea; Feeling flu symptoms with Humira; This is a solicited report based on the information received by Pfizer from a company (MFR Control No. 21K-163-4061923-00). A contactable female consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown) on 18Mar2021 as dose 2, single and on 18Feb2021 as dose 1, single, both via an intramuscular route of administration for COVID- 19 Vaccination; adalimumab (HUMIRA, Solution for injection in pre-filled pen, Lot number: not reported) via Subcutaneous from on an unknown date to 2021 at an unknown dose (citrate free) and frequency for Psoriatic arthritis. Other Relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. It was reported that on an unknown date in 2021, the patient experienced right middle finger triggered, psoriatic arthritis flare up and COVID-19 vaccine reaction was nausea and feeling flu symptoms with Humira. The outcome of the event psoriatic arthritis flare up not recovered outcome of other events was unknown.   The reporter's causality for bnt162b2 with respect to the events of right middle finger triggered and psoriatic arthritis flare up was Not Reported; covid-19 vaccine reaction was nausea and feeling flu symptoms with Humira was Not Related. The reporter's causality for co-suspect Humira with respect to the events of right middle finger triggered was not provided; psoriatic arthritis flare up was a reasonable possibility; COVID-19 vaccine reaction was nausea and feeling flu symptoms with Humira was no reasonable possibility.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information the reported events nausea and influenza may be related to suspect product BNT162B2, and events trigger finger and psoriatic arthropathy may not be related suspect product BNT162B2 but related to HUMIRA.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a solicited report based on the information received by Pfizer (Mfr. Control No.: 21K-163-4062321-00) via a contactable consumer (patient). A 43-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported, expiry date was not reported) via intramuscular route of administration on 16Mar2021 (at the age of 43-years-old) as DOSE 1, SINGLE, second dose (Batch/Lot number was not reported, expiry date was not reported) via intramuscular route of administration on 08Apr2021 as DOSE 2, SINGLE for covid-19 immunisation and adalimumab (HUMIRA, formulation: solution for injection in pre-filled pen) via subcutaneous route from Apr2021 and ongoing, at unspecified dose for an unspecified indication. The patient's medical history and the concomitant medications were not reported. On 25Aug2021, the patient experienced covid-19. The patient underwent lab tests and procedures which included sars-cov-2 test: experienced covid-19 on 25Aug2021. The outcome for the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  The reporter's assessment of the causal relationship of the events (vaccination failure & COVID-19) with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.; Sender's Comments: As there is limited information in the case provided, the causal association between the events vaccination failure, COVID-19 and the suspect drug BNT162B2 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 product and on the conduct of the study 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.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Influenza like illness
Clinical narrative: COVID-19; COVID-19; Flu like symptoms; This is a solicited report from a Non-Interventional Study based on information received by Pfizer from pharmaceutical company, manufacturer control number: 21K-163-4062611-00. A non- contactable patient reported that a 14-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 vaccine, formulation: solution for injection; Batch no/Lot Number: not reported) via intramuscularly on 13Aug2021 (at the age of 14-year-old) as dose 1, single for COVID-19 immunization; adalimumab (HUMIRA) via subcutaneously on an unknow date for an unknown indication. Medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced Covid-19 and flu like symptoms. It was unknown if the patient was enrolled in a COVID-19 vaccine trial. On an unknown date in 2021, the patient underwent lab tests which included covid-19 test: positive. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. Causality for adalimumab (HUMIRA) the reporter's causality for the events of covid/flue like symptoms onset in 2021 was no reasonable possibility. The reporter's causality for the events of covid/flue like symptoms onset in 2021 was not provided. Outcome of the event Covid-19 was recovering, and other events was unknown.The reporter's assessment of the causal relationship of the event with the suspect products was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of  LOE. The case will be reassessed once new information is available.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Psychotic disorder
Clinical narrative: she has had a full blown psychosis episode; This is a spontaneous report from a contactable consumer. This contactable consumer (Patient's mother) reported for 34-year-old female patient.  A 34-year-old female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on 04Sep2021 (at the age of 34-year-old) as dose 2, single for COVID-19 immunization. Patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in right arm on 12Aug2021 (at the age of 34-year-old) as dose 1, single for COVID-19 immunization and experienced the patient was a little bit off/different but she didn't think much of it since she had not had a psychosis episode in a long time. Patient also received pneumonia vaccine on 13Aug2021 at the age of 34 years. The patient medical history includes Psychotic disorder, Allergy, pneumonia vaccine, Penicillin allergy, Shellfish allergy, Latex allergy, Pollen allergy, and Bladder disorder, Environmental allergy, and concomitant medications were not reported. Past drug event includes MAGNESIUM induced unknown reaction, SUMATRIPTAN induced unknown reaction and IODINE induced unknown reaction. On 04Sep2021, after the vaccination, the patient experienced a full-blown psychosis episode. The psychosis started the night of 04Sep2021, and it was full blown psychosis by the next morning 05Sep2021. Caller reports that she couldn't get the patient to take any of her meds and she was going to take her to the Emergency Department. The outcome of the events was not recovered.  No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: They received the Pfizer/Biontech COVID vaccine and they are sick with COVID; They received the Pfizer/Biontech COVID vaccine and they are sick with COVID; This is a spontaneous report from a contactable consumer via Pfizer sales representative. This report was received via a sales representative.   A patient of unspecified age and gender received bnt162b2 (BNT162B2), 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's medical history and concomitant medications were not reported. It was reported that after receiving the pfizer/biontech covid vaccine the patient was sick with covid on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of all the events were unknown.  No follow up attempts are possible. Information on Lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101170074 same reporter/product/event, different patient
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Ear disorder, Ear pain, Eye pain, Face injury, Feeling abnormal
Clinical narrative: Shingles; Ear pain, ear ache; Eye pain; pain in her eye, going up from her eyebrow to her forehead; tingling sensation in her head, left side of scalp; huge lump behind her ear; pissed; rash around the left eye; pain from her eye brow, tip of nose forehead up into her scalp; pain from her eye brow, tip of nose forehead up into her scalp; This is a spontaneous report from a contactable consumer. This 44-year-old female consumer (patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0196) via an unspecified route of administration on 18Aug2021 at 09:30 on left arm (at 44-year-old), as dose 2, single for COVID-19 immunization. The patient's medical history, concomitant medications, prior vaccinations and relevant tests were reported as none. The family medical history relevant to event were not reported. She had been healthy, did not have any issues and COVID. It was mentioned that additional vaccines administered on same date of the pfizer suspect were reported as none. The patient did not require emergency room visit and she went to urgent care. The patient went to physician office. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0191) via an unspecified route of administration on 29Jul2021 (at 44-year-old) in left arm as dose 1, single for COVID-19 immunization. On an unknown date in Aug2021 she had shingles and was pissed, she started off having like ear pain and eye pain, she thought it was a pimple and it turned out not being a pimple. She had pain in her eye, going up from her eyebrow to her forehead. She had a tingling sensation in her head, it hurted. She had a huge lump behind her ear she has an ear ache. She had a rash around the left eye which she received the shot on the left side of her body, and pain from her eye brow, tip of nose forehead up into her scalp. Caller does not know what it was, but she had a tingling sensation on the left side of her scalp. She clarified the shingles outbreak was on the left side of her body, the side she received the shot in. When probed for the dose amount, the caller stated that she does not know, it was just the regular dose. The caller states she has read this has been happening to a lot of people. There should be more information about this, people need to know this can be a potential side effect of the vaccine. She states she will be reaching out to multiple news outlets about her experience. The event outcome was unknown.  Description of complaint: The caller is calling in regards to the COVID vaccine. The caller clarifies she received her second vaccine on 18Aug2021. When probed for the dose amount, the caller states she doesn't know, it was just the regular dose. The caller states she has read this has been happening to a lot of people. There should be more information about this, people need to know this can be a potential side effect of the vaccine.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Herpes zoster, Pain of skin, Paraesthesia, Rash
Clinical narrative: Shingles; Ear pain, ear ache; Eye pain; pain in her eye, going up from her eyebrow to her forehead; tingling sensation in her head, left side of scalp; huge lump behind her ear; pissed; rash around the left eye; pain from her eye brow, tip of nose forehead up into her scalp; pain from her eye brow, tip of nose forehead up into her scalp; This is a spontaneous report from a contactable consumer. This 44-year-old female consumer (patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0196) via an unspecified route of administration on 18Aug2021 at 09:30 on left arm (at 44-year-old), as dose 2, single for COVID-19 immunization. The patient's medical history, concomitant medications, prior vaccinations and relevant tests were reported as none. The family medical history relevant to event were not reported. She had been healthy, did not have any issues and COVID. It was mentioned that additional vaccines administered on same date of the pfizer suspect were reported as none. The patient did not require emergency room visit and she went to urgent care. The patient went to physician office. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0191) via an unspecified route of administration on 29Jul2021 (at 44-year-old) in left arm as dose 1, single for COVID-19 immunization. On an unknown date in Aug2021 she had shingles and was pissed, she started off having like ear pain and eye pain, she thought it was a pimple and it turned out not being a pimple. She had pain in her eye, going up from her eyebrow to her forehead. She had a tingling sensation in her head, it hurted. She had a huge lump behind her ear she has an ear ache. She had a rash around the left eye which she received the shot on the left side of her body, and pain from her eye brow, tip of nose forehead up into her scalp. Caller does not know what it was, but she had a tingling sensation on the left side of her scalp. She clarified the shingles outbreak was on the left side of her body, the side she received the shot in. When probed for the dose amount, the caller stated that she does not know, it was just the regular dose. The caller states she has read this has been happening to a lot of people. There should be more information about this, people need to know this can be a potential side effect of the vaccine. She states she will be reaching out to multiple news outlets about her experience. The event outcome was unknown.  Description of complaint: The caller is calling in regards to the COVID vaccine. The caller clarifies she received her second vaccine on 18Aug2021. When probed for the dose amount, the caller states she doesn't know, it was just the regular dose. The caller states she has read this has been happening to a lot of people. There should be more information about this, people need to know this can be a potential side effect of the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: still has issues trying to normalize the menstruation; This is Spontaneous report received from a contactable consumer (patient). This consumer reported similar events for 2 patients (mother and daughter). This is a mother case.  An unknown age female patient received BNT162B2 on Mar2021 at single dose for COVID-19 immunisation. Medical history and concomitant drug were not reported. Patient experienced menstrual irregularities as a reported adverse event after getting the Pfizer BioNtech Covid-19 Vaccine. Outcome of the event was unknown.  This lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101169504 same drug and AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: She now has something slipped up into her heart and she would've been dead if she wasnt taken in; This is a spontaneous report from a contactable consumer. This consumer reported for a 99-year-old female patient (aunt). A 99-years-old female patient 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. The reporter stated, she wants to thank you for your vaccine, it was most likely that, that got her 99-year-old aunt, she would've died in her sleep anyway at 104. No cane, no walker. Full head of hair. Probably born in . Something slipped up the heart now. They were the responsibility party. She now has something slipped up into her heart and she would've been dead if she was not taken in. The healthiest people like her aunt (patient), she took one of them vaccines and now she has something slipped up her heart (on an unspecified date). The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had covid a couple of weeks after the first vaccine for covid; had covid a couple of weeks after the first vaccine for covid; This is a solicited report based on the information received from contactable consumer, the patient by Pfizer from. (Manufacturer Control No: 21K163402660400).  A 66-years-old female patient received first dose of BNT162B2, (tozinameran) (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via intramuscular route on an unspecified date in 2021 as dose 1, single for COVID-19 vaccination, and received upadacitinib (RINVOQ, Batch/Lot number was not reported), oral from an unspecified date to an unspecified date, at unspecified dose for moderate to severe rheumatoid arthritis. Medical history and concomitant medications were not reported. On an unspecified date in 2021, after couple of weeks of the first vaccine, patient experienced COVID. It was also reported patient later received second dose of BNT162B2 (Batch/Lot number was not reported), via intramuscular route on 10Jul2021 as dose 2, single for COVID-19 vaccination. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The action taken in response to the events for upadacitinib (RINVOQ) was unknown. The outcome of the events was unknown. The reporter's causality for the suspect product BNT162B2 to event of COVID with onset 2021 was possible, and the reporter's causality for the RINVOQ to event of COVID with onset 2021 was not provided.  opinion is that there is no reasonable possibility that the event of COVID is related to RINVOQ(UPADACITINIB).  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events (Drug ineffective, Covid-19) and the administration of the vaccine cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Felt unwell after Covid Vaccine; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The report was not related to a study or programme. The reporter mentioned while reporting her son's adverse events after the Pfizer Covid 19 Vaccine she mentioned that she was feeling unwell at the time also. No investigation assessment was provided. She declined to complete a report for herself. Stated she already did her own online. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Overdose
Clinical narrative: Five days after receiving booster I developed shingles; injection for vaccine received same date; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: FC3184), via an unspecified route of administration, administered in Arm Left on 02Sep2021 at 10:00 hours, as DOSE NUMBER UNKNOWN, SINGLE, via an unspecified route of administration, administered in Arm Right on 02Sep2021 (Batch/Lot Number: EL9764) as DOSE NUMBER UNKNOWN, SINGLE, via an unspecified route of administration, administered in Arm Left on 02Sep2021 (Batch/Lot Number: EL3249) as DOSE NUMBER UNKNOWN, SINGLE (at the age of 62-years-old) for COVID-19 immunisation. The patient's medical history included menieres from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced five days after receiving booster I developed shingles on 07Sep2021 at 14:00 hours, injection for vaccine received same date on 02Sep2021. Therapeutic measures were taken as a result of the event and the patient was treated with Valacyclovir HCL 1 gram 3 times day. The event did not cause prolonged hospitalization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, did not received any other medications within 2 weeks of vaccination. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the event five days after receiving booster I developed shingles.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune haemolytic anaemia, SARS-CoV-2 test
Clinical narrative: Autoimmune hemolytic anemia; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL 6206), via an unspecified route of administration, administered in arm left on 09Mar2021 (at the age of 70-years-old) as dose 2, single for COVID-19 immunisation. Medical history included chronic lymphocytic leukaemia (CLL) and known allergies: Sulfa. There were no concomitant medications. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. The patient experienced autoimmune hemolytic anemia on 29Mar2021. The event resulted in doctor or other healthcare professional office/clinic visit, hospitalization, life threatening illness (immediate risk of death from the event). The patient was hospitalized for the event for 10 days. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 10Aug2021. Therapeutic measures were taken as a result of autoimmune hemolytic anemia which included transfusions and steroids. The outcome of the event was not recovered.    No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Nasal Swab: Positive; This is a spontaneous report received from a contactable consumer (Patient). A 50-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN5318), Solution for injection, via an unspecified route of administration, administered in Arm Left on 20Jan2021 as single dose for covid-19 immunisation. Medical history included polycythaemia vera, food allergy and environmental allergy. Concomitant medications included probiotics and multivitamins (in two weeks). The patient previously took antihistamines and experienced antihistamines allergy, steroids and experienced steroids allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. On 21Jan2021, the patient experienced nasal swab: positive. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 21Jan2021. The event resulted into doctor or other healthcare professional office/clinic visit (seeing allergist) and emergency room/department or urgent care visit. The outcome of event was not recovered/not resolved.   Follow-Up (10Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Aggression, Body temperature, Headache, Illness
Clinical narrative: Pacing; Talking gibberish; Temperature; highest 101 degrees; Being crazy; never acted like that before/Acting very different; Aggressive, pulling his hair; Body aches; Bad headache; Frequently waking up; Could never get comfortable; Very sick for 2 days; This is a spontaneous report from a contactable consumer (parent). A 13-years-old male (son) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: FC3182, patient was 13-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 22Aug2021 at 10:30 as DOSE 2, SINGLE for covid-19 immunisation. Medical history reported as no. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: FA7485, patient was 13-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 02Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. Reported that patient wake up and have the behaviors, then sleep for about 30 minutes or so, wake up and do it again for about 15 minutes. He could never get comfortable. States this only occurred for that night. Caller states the fever, body aches, and bad headache her son experienced lasted for about 2 days. No additional Vaccines Administered on Same Date of the Pfizer Suspect, no prior Vaccinations within 4 weeks, no AE(s) following prior vaccinations. On 22Aug2021, the patient experienced pacing, talking gibberish, temperature; highest 101 degrees, being crazy; never acted like that before/acting very different, aggressive, pulling his hair, body aches, bad headache, frequently waking up, could never get comfortable, very sick for 2 days. AE(s) does not require to visit emergency Room or physician Office. The patient underwent lab tests and procedures which included body temperature: 101 degrees on 22Aug2021. The outcomes of events (Temperature; highest 101 degrees, Body aches, Bad headache, very sick for 2 days) were recovered on an unspecified date in 2021 and the outcomes of events (Pacing, Talking gibberish, Being crazy; never acted like that before/Acting very different, Aggressive, pulling his hair, Frequently waking up, Could never get comfortable) were recovered on 23Aug2021.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Malaise, Pain, Pyrexia, Restlessness
Clinical narrative: Pacing; Talking gibberish; Temperature; highest 101 degrees; Being crazy; never acted like that before/Acting very different; Aggressive, pulling his hair; Body aches; Bad headache; Frequently waking up; Could never get comfortable; Very sick for 2 days; This is a spontaneous report from a contactable consumer (parent). A 13-years-old male (son) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: FC3182, patient was 13-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 22Aug2021 at 10:30 as DOSE 2, SINGLE for covid-19 immunisation. Medical history reported as no. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: FA7485, patient was 13-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 02Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. Reported that patient wake up and have the behaviors, then sleep for about 30 minutes or so, wake up and do it again for about 15 minutes. He could never get comfortable. States this only occurred for that night. Caller states the fever, body aches, and bad headache her son experienced lasted for about 2 days. No additional Vaccines Administered on Same Date of the Pfizer Suspect, no prior Vaccinations within 4 weeks, no AE(s) following prior vaccinations. On 22Aug2021, the patient experienced pacing, talking gibberish, temperature; highest 101 degrees, being crazy; never acted like that before/acting very different, aggressive, pulling his hair, body aches, bad headache, frequently waking up, could never get comfortable, very sick for 2 days. AE(s) does not require to visit emergency Room or physician Office. The patient underwent lab tests and procedures which included body temperature: 101 degrees on 22Aug2021. The outcomes of events (Temperature; highest 101 degrees, Body aches, Bad headache, very sick for 2 days) were recovered on an unspecified date in 2021 and the outcomes of events (Pacing, Talking gibberish, Being crazy; never acted like that before/Acting very different, Aggressive, pulling his hair, Frequently waking up, Could never get comfortable) were recovered on 23Aug2021.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: Pacing; Talking gibberish; Temperature; highest 101 degrees; Being crazy; never acted like that before/Acting very different; Aggressive, pulling his hair; Body aches; Bad headache; Frequently waking up; Could never get comfortable; Very sick for 2 days; This is a spontaneous report from a contactable consumer (parent). A 13-years-old male (son) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: FC3182, patient was 13-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 22Aug2021 at 10:30 as DOSE 2, SINGLE for covid-19 immunisation. Medical history reported as no. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: FA7485, patient was 13-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 02Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. Reported that patient wake up and have the behaviors, then sleep for about 30 minutes or so, wake up and do it again for about 15 minutes. He could never get comfortable. States this only occurred for that night. Caller states the fever, body aches, and bad headache her son experienced lasted for about 2 days. No additional Vaccines Administered on Same Date of the Pfizer Suspect, no prior Vaccinations within 4 weeks, no AE(s) following prior vaccinations. On 22Aug2021, the patient experienced pacing, talking gibberish, temperature; highest 101 degrees, being crazy; never acted like that before/acting very different, aggressive, pulling his hair, body aches, bad headache, frequently waking up, could never get comfortable, very sick for 2 days. AE(s) does not require to visit emergency Room or physician Office. The patient underwent lab tests and procedures which included body temperature: 101 degrees on 22Aug2021. The outcomes of events (Temperature; highest 101 degrees, Body aches, Bad headache, very sick for 2 days) were recovered on an unspecified date in 2021 and the outcomes of events (Pacing, Talking gibberish, Being crazy; never acted like that before/Acting very different, Aggressive, pulling his hair, Frequently waking up, Could never get comfortable) were recovered on 23Aug2021.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.