chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Feeling tired) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included IBUPROFEN and PARACETAMOL (ACETAMINOPHEN) for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced FATIGUE (Feeling tired). At the time of the report, FATIGUE (Feeling tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient received his first dose at left arm shoulder deltoid muscle. The patient received her second Moderna Covid-19 vaccine on 22JAN2021 lot number is unknown expiration date is not known. Patient does not remember which arm that he received the Moderna Covid-19 vaccine in. Patient received the vaccine as an Intramuscular injection. The patient had no adverse Reactions or side effects after the second Moderna Covid-19 vaccine. Treatment information was not provided
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: runny nose; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ENZALUTAMIDE for Prostate cancer.    No Medical History information was reported.   On 19-Oct-2019, the patient ENZALUTAMIDE (Oral) dosage was changed to 160 milligram once a day. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and ENZALUTAMIDE (Oral) 160 milligram once a day. On an unknown date, ENZALUTAMIDE (unknown route) dosage was changed to 160 milligram once a day and ENZALUTAMIDE (unknown route) dosage was changed to 80 milligram once a day. On an unknown date, the patient experienced RHINORRHOEA (runny nose). At the time of the report, RHINORRHOEA (runny nose) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported.  On 17-Nov-2019, the patient ran out of medication for Enzalutamide for a couple of days as the patient did not know how to proceed with getting the refill. It was previously reported that the patient was on second month of taking Enzalutamide and needed 120 capsules each month and had enough of medication, until 21-Dec-2019 and the physician advised the patient to continue taking it.  There had been no restart of medication during that time. The patient had been on Enzalutamide tablets for one year and was taking 2 tablets of Enzalutamide daily (starting dose was 4 tablets daily), reason for decrease was not provided. The patient had a runny rose for the past few months and associated it with the COVID vaccine. The patient had been without medication for 1 month.  The patient had undergone two pacemaker insertion on 03-December.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursions; Patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursions; Patient is Pregnant and received Moderna Covid-19 vaccine; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursions) and MATERNAL EXPOSURE DURING PREGNANCY (Patient is Pregnant and received Moderna Covid-19 vaccine) in a 39-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 07-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursions) and MATERNAL EXPOSURE DURING PREGNANCY (Patient is Pregnant and received Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursions). On 07-Mar-2022, MATERNAL EXPOSURE DURING PREGNANCY (Patient is Pregnant and received Moderna Covid-19 vaccine) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursions) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were provided It was not known which arm the patient received the vaccine. The Nurse reported no adverse reactions or side effects to the Moderna Covid-19 vaccine.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Urticaria, Visual impairment
Clinical narrative: Hives in her hip/Hives in her chin/Hives in her mouth/Hives in her neck/Hives in her arm; Second vaccine on 19Jul2021 and Booster on the 19Nov2021; Vision got worse since the booster shot; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Vision got worse since the booster shot), URTICARIA (Hives in her hip/Hives in her chin/Hives in her mouth/Hives in her neck/Hives in her arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccine on 19Jul2021 and Booster on the 19Nov2021) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033A21A, 030A21A and 024N20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (High blood pressure). Concomitant products included PROPRANOLOL for Heart disorder, LISINOPRIL for Hypertension, APIXABAN (ELIQUIS) for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced VISUAL IMPAIRMENT (Vision got worse since the booster shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccine on 19Jul2021 and Booster on the 19Nov2021). In December 2021, the patient experienced URTICARIA (Hives in her hip/Hives in her chin/Hives in her mouth/Hives in her neck/Hives in her arm). At the time of the report, VISUAL IMPAIRMENT (Vision got worse since the booster shot), URTICARIA (Hives in her hip/Hives in her chin/Hives in her mouth/Hives in her neck/Hives in her arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccine on 19Jul2021 and Booster on the 19Nov2021) outcome was unknown.            Concomitant medication Eliquis was indicated to use as Blood Thinner and Neuro Propranolol indicated to use as heart medicine.  It was reported that, On 30-Dec-2021, hives got very bad for a couple of days. Patient did not have any allergies, was never tested positive for COVID-19. Did not have any acute or chronic illnesses.   Treatment included allergy pills and cut down foods which might caused allergy.   This case was linked to MOD-2022-513779 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Nausea
Clinical narrative: Sickness; nauseated; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), NAUSEA (nauseated) and HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2022, the patient experienced ILLNESS (Sickness), NAUSEA (nauseated) and HEADACHE (Headache). In March 2022, ILLNESS (Sickness), NAUSEA (nauseated) and HEADACHE (Headache) had resolved.            No concomitant medication were provided.  No treatment medication were provided.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chills, Feeling abnormal, Inappropriate schedule of product administration, Influenza like illness
Clinical narrative: Out of my left eye, I saw shooting stars, like I was having a stroke, or something; laid out & shivering; Inappropriate schedule of vaccine administered; had flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (had flu-like symptoms), FEELING ABNORMAL (Out of my left eye, I saw shooting stars, like I was having a stroke, or something), CHILLS (laid out & shivering) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   In November 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (had flu-like symptoms), CHILLS (laid out & shivering) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 08-May-2021, the patient experienced FEELING ABNORMAL (Out of my left eye, I saw shooting stars, like I was having a stroke, or something). At the time of the report, INFLUENZA LIKE ILLNESS (had flu-like symptoms), FEELING ABNORMAL (Out of my left eye, I saw shooting stars, like I was having a stroke, or something), CHILLS (laid out & shivering) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: high cholesterol I've had blood work done. Everything shows up normal. It did show high cholesterol.         No Concomitant product use was reported.  The patient received second dose of Moderna Covid-19 vaccine on 06-May-2021 and on the same day the patient was laid out and shivering and had flu-like symptoms.  On approximately 08-May-2021, Out of patient's left eye, the patient saw shooting stars, like the patient was having a stroke, or something. It was also reported that the patient had seen doctors and they said there were no conditions. Reportedly, the patient had blood work done and everything showed up normal, but it did show high cholesterol.  No treatment information was provided.   This case was linked to MOD-2022-513804, MOD-2022-513827 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: first dose: was pooped; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "sepsis" (unspecified if ongoing), notes: The caller had sepsis a couple of months ago. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "first dose: was pooped".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Infection, Pain
Clinical narrative: they had a vial that was diluted and in the fridge for 72 hours and was mistakenly given to a staff member; they had a vial that was diluted and in the fridge for 72 hours and was mistakenly given to a staff member; body aches; chills; extreme fatigue; they had a vial that was diluted and in the fridge for 72 hours and was mistakenly given to a staff member; temp high to 102.9; infection; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 52 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date Oct2021 (Lot number: 30155BA, Expiration Date: 31Dec2021) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: THYROID. Vaccination history included: Bnt162b2 (1st dose of covid vaccine), for COVID-19 immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset Oct2021, outcome "unknown" and all described as "they had a vial that was diluted and in the fridge for 72 hours and was mistakenly given to a staff member"; PAIN (non-serious) with onset Oct2021, outcome "unknown", described as "body aches"; CHILLS (non-serious) with onset Oct2021, outcome "unknown", described as "chills"; FATIGUE (non-serious) with onset Oct2021, outcome "unknown", described as "extreme fatigue"; PYREXIA (non-serious) with onset Oct2021, outcome "unknown", described as "temp high to 102.9"; INFECTION (non-serious) with onset Oct2021, outcome "unknown", described as "infection". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Vaccination facility type: Doctor's office/Urgent care. Vaccine not administrated at Facility. Prior vaccination within 4Weeks. Concomitant drugs: Unknown. Patient Medical History: Unknown. Relevant tests: None. Specific relevant test: None. Proprietary medicinal product name: thyroid medication. States that they had a vial that was diluted and in the fridge for 72 hours and was mistakenly given to a staff member for their second Covid shot. Storage of vaccine outside Prescribing Information recommendations DURING and AFTER DILUTION (US) (v9.0) under Internal Data; Vial used appeared to have reconstituted date 25Oct2021 upon further review post admin it was 22Oct2021. Expiration date post reconstitution poorly written. Patient experienced temp high to 102.9 body aches chill and extreme fatigue 24hrs post infection temp low to 99.6 -100.1 27Oct however still fatigue.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported Information: Removed "At Risk" classification. Added events "High Temperature", "Infection" and "Product administration error".
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administration error, Product temperature excursion issue, Pyrexia
Clinical narrative: they had a vial that was diluted and in the fridge for 72 hours and was mistakenly given to a staff member; they had a vial that was diluted and in the fridge for 72 hours and was mistakenly given to a staff member; body aches; chills; extreme fatigue; they had a vial that was diluted and in the fridge for 72 hours and was mistakenly given to a staff member; temp high to 102.9; infection; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 52 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date Oct2021 (Lot number: 30155BA, Expiration Date: 31Dec2021) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: THYROID. Vaccination history included: Bnt162b2 (1st dose of covid vaccine), for COVID-19 immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset Oct2021, outcome "unknown" and all described as "they had a vial that was diluted and in the fridge for 72 hours and was mistakenly given to a staff member"; PAIN (non-serious) with onset Oct2021, outcome "unknown", described as "body aches"; CHILLS (non-serious) with onset Oct2021, outcome "unknown", described as "chills"; FATIGUE (non-serious) with onset Oct2021, outcome "unknown", described as "extreme fatigue"; PYREXIA (non-serious) with onset Oct2021, outcome "unknown", described as "temp high to 102.9"; INFECTION (non-serious) with onset Oct2021, outcome "unknown", described as "infection". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Vaccination facility type: Doctor's office/Urgent care. Vaccine not administrated at Facility. Prior vaccination within 4Weeks. Concomitant drugs: Unknown. Patient Medical History: Unknown. Relevant tests: None. Specific relevant test: None. Proprietary medicinal product name: thyroid medication. States that they had a vial that was diluted and in the fridge for 72 hours and was mistakenly given to a staff member for their second Covid shot. Storage of vaccine outside Prescribing Information recommendations DURING and AFTER DILUTION (US) (v9.0) under Internal Data; Vial used appeared to have reconstituted date 25Oct2021 upon further review post admin it was 22Oct2021. Expiration date post reconstitution poorly written. Patient experienced temp high to 102.9 body aches chill and extreme fatigue 24hrs post infection temp low to 99.6 -100.1 27Oct however still fatigue.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported Information: Removed "At Risk" classification. Added events "High Temperature", "Infection" and "Product administration error".
Sex: U
Vaccine: COVID19
Symptoms: Joint range of motion decreased
Clinical narrative: She could not lift or rotate her arm/person to complain about this; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (002191). This is 4 of 5 reports.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "She could not lift or rotate her arm/person to complain about this".  Additional information: This spontaneous report from a contactable consumer reporting same events under the same suspect product for 5 patients. No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. Below is the verbatim report. Reporter wanted to know if she has the correct information about getting a refund for her husband who is taking Latanaprost. The eye drops never worked, no solution came out of the bottle, relayed information from withheld and she did have the correct info. As we were talking she said when she got her 1st dose of the Pfizer Covax vaccine she could not lift or rotate her arm. It still has not gone away. When she went to get her 2nd dose the HCP told her she was the 5th person to complain about this. He told her the first dose was given in the wrong part of her arm. She is now waiting to have surgery on her arm. She said she is an RN and this has affected her job as well. Caller did not want to go to (name) so will fax on her behalf.  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 completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101619553
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: constant headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 30 year-old female patient received bnt162b2 (BNT162B2), administration date 24Oct2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "constant headaches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Morning sickness, Nausea, Pain in extremity
Clinical narrative: Sore arm; a little nausea; sick to stomach; morning sickness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 05Feb2021 (Batch/Lot number: unknown) at the age of 72 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "cholesterol" (ongoing), notes: Diagnosed with before 2007.; "Hypertension", start date: 2007 (ongoing); "Coronary artery disease", start date: 2007 (ongoing); "Interstitial lung disease" (ongoing); "10 coronary artery stems" (unspecified if ongoing); "Water pill" (ongoing). Concomitant medication(s) included: METOPROLOL SUCCINATE taken for hypertension (ongoing); ENALAPRIL taken for hypertension (ongoing); HYDROCHLOROTHIAZIDE taken for fluid retention; REPATHA taken for blood cholesterol abnormal (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Feb2021, outcome "unknown", described as "Sore arm"; NAUSEA (non-serious) with onset 05Feb2021, outcome "recovered" (Feb2021), described as "a little nausea"; ABDOMINAL DISCOMFORT (non-serious) with onset 05Feb2021, outcome "recovered" (Feb2021), described as "sick to stomach"; MORNING SICKNESS (non-serious) with onset 05Feb2021, outcome "recovered" (Feb2021), described as "morning sickness". Therapeutic measures were taken as a result of pain in extremity.  Additional information: First dose: felt kind of a little nausea, sick to stomach like had morning sickness: With the first dose Pfizer Covid Vaccine the caller felt kind of a little nausea, sick to stomach like had morning sickness. This began happening within a couple hours of receiving the first dose Pfizer Covid Vaccine and lasted maybe 30 hours or so. The caller occasionally has a sore arm: The caller clarifies the sore arm occurred after receiving the first dose Pfizer Covid Vaccine. First dose: Sore arm: After the first dose Pfizer Covid Vaccine the sore arm began maybe 5 or 6 hours after receiving and the caller iced arm and took Tylenol. With the first dose Pfizer Covid Vaccine the caller felt kind of a little nausea, sick to stomach like had morning sickness. This began happening within a couple hours of receiving the first dose Pfizer Covid Vaccine and lasted maybe 30 hours or so. The caller clarifies the sore arm occurred after receiving the first dose Pfizer Covid Vaccine. After the first dose Pfizer Covid Vaccine the sore arm began maybe 5 or 6 hours after receiving and the caller iced arm and took Tylenol.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: Stiffness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "Stiffness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: diarrhea; vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 03Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Previous dose product: COVID 19, Previous dose brand: Pfizer, Previous dose number: 1), for Covid-19 Immunization.  The following information was reported: DIARRHOEA (non-serious) with onset 04Dec2021, outcome "unknown", described as "diarrhea"; VOMITING (non-serious) with onset 04Dec2021, outcome "unknown", described as "vomiting". Therapeutic measures were not taken as a result of diarrhoea, vomiting.  Additional information: The patient had no covid prior vaccination. The patient had not been tested for covid post vaccination.  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 completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: had very very positive side effects from each vaccine / increase effective extreme concentration, decreased anxiety, increased productivity/Increased energy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right (Batch/Lot number: unknown) as dose 2, single and administered in arm right (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Sulfa allergy. There were no concomitant medications. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "had very very positive side effects from each vaccine / increase effective extreme concentration, decreased anxiety, increased productivity/Increased energy". Therapeutic measures were not taken as a result of therapeutic response unexpected.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No other medications were received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination was not tested for COVID-19.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: stated that had discomfort; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: DISCOMFORT (non-serious), outcome "recovered", described as "stated that had discomfort".  Additional information: The patient reported that the discomfort lasted a couple of days and was fine. She was about to be 50 years old. Wanted to know if this was something people had been saying about a side effect. she got the flu shot around second vaccine. Wanted to know there were anything that she should be taking it.  No follow-up attempts are possible; information about lot/batch number was not available despite the follow-up attempts made. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: some complications she experienced when she took the vaccine for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (002591). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION COMPLICATION (non-serious), outcome "unknown", described as "some complications she experienced when she took the vaccine for COVID".   Additional information: Patient indicated that she had to stop taking her Xeljanz medication due to some complications she experienced when she took the vaccine for COVID. Patient was prescribed Xeljanz XR 11mg.  Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Laboratory test abnormal, SARS-CoV-2 test
Clinical narrative: I had a spike proteins test done on 29Nov2021. The results were I had a number of 5034.4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 20Jan2021 (Batch/Lot number: unknown) as dose 1, single and administration date 10Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: LABORATORY TEST ABNORMAL (non-serious) with onset 29Nov2021, outcome "unknown", described as "I had a spike proteins test done on 29Nov2021. The results were I had a number of 5034.4". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: presented to his office 4 days later with pain in her right leg/pain in her right leg from the knee down; This is a spontaneous report received from contactable reporter(s) (Physician) from the medical information team.  A 11-year-old female patient received bnt162b2 (BNT162B2), administration date 04Dec2021 (Batch/Lot number: unknown) at the age of 11 years as dose 1, single for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered" (Dec2021), described as "presented to his office 4 days later with pain in her right leg/pain in her right leg from the knee down". Therapeutic measures were taken as a result of pain in the extremity.  Additional Information: The reported was stated that a patient, female11 y/o, who received the 1st dose of the Pfizer BTC vaccine (orange cap formula, 5-11y/o) on 04Dec2021 and presented to his office 4 days later with pain in her right leg. The pain was from the knee down, no swelling, no fever or warmth, good ROM in all joints, and no weakness in the leg. The patient took ibuprofen and 24hours later was doing better.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Therapeutic response unexpected
Clinical narrative: a decrease in swelling after taking my first dose; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "a decrease in swelling after taking my first dose"; FATIGUE (non-serious), outcome "unknown", described as "Tired".  Additional Information: The patient stated she has been taking Xeljanz for 4 years now. she love the product and states her knuckles in her hand were so swollen before, but she noticed a decrease in swelling after taking her first dose. She stated, she really didn't have any reaction to the first shot. she was real tired, so she slept.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: hand swelled; This is a spontaneous report received from a contactable reporter(s) (Other HCP). A male patient received BNT162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "not recovered", described as "hand swelled". Additional information: The patient experienced hand swelled and his hand was still swollen weeks later after an injection.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown , single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph nodes".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Left arm stiffening; Caller states she had left arm pain with her first Covid vaccine, but not as bad as now; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Dec2021 (Lot number: unknown) at the age of 36 years as dose 2, single for covid-19 immunisation. Relevant medical history reported as No. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Anatomical Location : Left arm, Lot: unknown), administration date: 29Oct2021, when the patient was 36 years old, for COVID-19 immunization. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 16Dec2021, outcome "not recovered", described as "Left arm stiffening"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "Caller states she had left arm pain with her first Covid vaccine, but not as bad as now".  Additional information: Patient did not receive any additional vaccines on same date of the Pfizer Suspect. Patient did not receive any other vaccine prior covid 19 vaccine within four weeks. Family history not provided. She stated that her arm was stiffening up, she could not hold her phone. It was the arm in which she got the vaccine. She could not hold her arm up for more than a minute, and it has a feeling like blood was rushing to her hand. She stated that it started last night and happened after her second vaccine. She stated that the feeling goes away and comes back. She had left arm pain with her first Covid vaccine, but not as bad as now. She asked is this normal and she asked who should she contact and what should she be doing about this effect? Patient did not visited emergency room or physician office. No relevant test were reported.   Follow-up activities closed. Batch/lot number not available for [Vaccine/BNT162B2],; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101823808 Same patient and drug, different event separated in time
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Caller states she had left arm pain with her first Covid vaccine, but not as bad as now; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Oct2021 (Batch/Lot number: unknown) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Caller states she had left arm pain with her first Covid vaccine, but not as bad as now". Additional Information: Caller did not have product information on her vaccine card. Patient took Covid 19 vaccine, adult because mandated for employment. Other products were not provided. No investigation assessment. Healthcare provider info was as provided by Caller. Additional vaccines were not administered on same date of the Pfizer suspect. There was no requirement of emergency room visit and physician office for AE's. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Family medical history relevant to ae(s) was not provided. No relevant tests.   Follow-up activities closed, information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101823595 Same patient and drug, different event separated in time
Sex: F
Vaccine: COVID19
Symptoms: Laziness
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 64-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation.  Medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), at the age of 63, Jan 2020, single dose, for immunization. The patient experienced laziness, with outcome of recovered. Additional information: Patient got her second dose (date unspecified) and experienced mild side effects like laziness for 1 day. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: felt achy after his first dose of the Pfizer COVID-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "felt achy after his first dose of the Pfizer COVID-19 vaccine".  Additional information: The patient also reported that he had mild side effects that were "kind of like hers (his granddaughter)" and felt achy after his first dose of the Pfizer COVID-19 vaccine but did not experience any side effects after his second dose and the booster dose. Responded per attached document and referred the reporter to granddaughter's HCP if symptoms do not improve or become worrisome.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 83 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATENOLOL taken for blood pressure measurement (ongoing); FUROSEMIDE (ongoing); AMLODIPINE (ongoing); LOSARTAN (ongoing); CLONIDINE (ongoing); HYDRALAZINE (ongoing). The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like symptoms". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient had a headache, with outcome of not recovered. Additional information: The reporter said his wife experienced some side effects after taking the vaccination. She had a headache that had been going on for 3 days now. She took the vaccine 3 days ago. This follow-up submitted to notify the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: After first one, I was little bit tried; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 10Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "After first one, I was little bit tried".  Additional information: Reporter stated, well, patient just have two questions patient just got my booster the other day on Monday and patient know that you will have side effects but is it but do they typically only last, patient guess about 1 to 3 days because with my first 2 doses, patient didn't feel too bad, but patient don't, but this time seems patient was experiencing flu like symptoms. So, patient didn't know like if they don't clear up with in like 3 days should patiently call my primary physician. Reporter confirmed the name of the product as Pfizer Covid-19 vaccine. When paraphrased the concern, consumer stated, patient read the paperwork, but it says typically, because patient felt fine today that patient had it and in past with the first two doses she didn't really have. Reporters mean the second dose patient didn't really have any issues that patient could remember, after first one, patient was little bit tried but patient didn't have any flu like symptoms or anything but this time patient having some flu like symptoms. So, patient just didn't know like will those hopefully pass at some point or patient just want to know if they last longer than three days should patient call physician. Reporter was informed about the Pfizer medical information department for the concern. Reporter other question was so my vaccination card patient was looking at so patient got my first one 10Apr and then patient got my second one 29Apr and so you supposed to get it 6months after your second booster right, after your second dose is that correct.  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 completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Frustration tolerance decreased
Clinical narrative: I just had certain side effects and problems ever since my second shot of the vaccine and I'm really frustrated with it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization. The following information was reported: FRUSTRATION TOLERANCE DECREASED (non-serious), outcome "unknown", described as "I just had certain side effects and problems ever since my second shot of the vaccine and I'm really frustrated with it".  Additional information: Patient reported that they just really wanted to talk to somebody from there about, they just had certain side effects and problems ever since my second shot of the vaccine and patient really frustrated with it. The patient did not specify which vaccine they received. Pfizer-BioNTech COVID-19 Vaccine is being reported out of an abundance of caution.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered at inappropriate site
Clinical narrative: The mother thinks was in injected too high in shoulder or in the shoulder joint; Arm pain; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A 17 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious), outcome "unknown", described as "The mother thinks was in injected too high in shoulder or in the shoulder joint"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm pain".  Additional Information: Caller was a registered nurse that was calling about the 12 plus adult dose of the Pfizer Covid-19 Vaccine and had a question. Caller reported that they had a 17 year old that had the vaccine and it may have been injected too high and into the shoulder joint. She said that she is not 100 percent sure that it did happen and declined to complete a report at this time. The patient's mom said that is what she thinks happened.  Follow-up attempts completed. No further information is expected.