chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Body temperature, Fatigue, Pyrexia, Rash
Clinical narrative: she reports she just slept. Patient took 1st booster dose instead 3rd primary dose; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (she reports she just slept.) and ACCIDENTAL UNDERDOSE (Patient took 1st booster dose instead 3rd primary dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     Concurrent medical conditions included CLL (She is immunocompromised with CLL, a type of leukemia.). Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for Migraine NOS, ESTRADIOL for an unknown indication.    On 27-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced ACCIDENTAL UNDERDOSE (Patient took 1st booster dose instead 3rd primary dose). On an unknown date, the patient experienced SOMNOLENCE (she reports she just slept.). At the time of the report, SOMNOLENCE (she reports she just slept.) had resolved and ACCIDENTAL UNDERDOSE (Patient took 1st booster dose instead 3rd primary dose) outcome was unknown.            No treatment medications were reported   This case was linked to MOD-2022-550721, MOD-2022-550746, MOD-2022-550751 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chills, Erythema, Fatigue, Headache, Insomnia
Clinical narrative: she reports she just slept. Patient took 1st booster dose instead 3rd primary dose; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (she reports she just slept.) and ACCIDENTAL UNDERDOSE (Patient took 1st booster dose instead 3rd primary dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     Concurrent medical conditions included CLL (She is immunocompromised with CLL, a type of leukemia.). Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for Migraine NOS, ESTRADIOL for an unknown indication.    On 27-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced ACCIDENTAL UNDERDOSE (Patient took 1st booster dose instead 3rd primary dose). On an unknown date, the patient experienced SOMNOLENCE (she reports she just slept.). At the time of the report, SOMNOLENCE (she reports she just slept.) had resolved and ACCIDENTAL UNDERDOSE (Patient took 1st booster dose instead 3rd primary dose) outcome was unknown.            No treatment medications were reported   This case was linked to MOD-2022-550721, MOD-2022-550746, MOD-2022-550751 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pruritus, Sensitive skin, Skin reaction, Somnolence
Clinical narrative: she reports she just slept. Patient took 1st booster dose instead 3rd primary dose; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (she reports she just slept.) and ACCIDENTAL UNDERDOSE (Patient took 1st booster dose instead 3rd primary dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     Concurrent medical conditions included CLL (She is immunocompromised with CLL, a type of leukemia.). Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for Migraine NOS, ESTRADIOL for an unknown indication.    On 27-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced ACCIDENTAL UNDERDOSE (Patient took 1st booster dose instead 3rd primary dose). On an unknown date, the patient experienced SOMNOLENCE (she reports she just slept.). At the time of the report, SOMNOLENCE (she reports she just slept.) had resolved and ACCIDENTAL UNDERDOSE (Patient took 1st booster dose instead 3rd primary dose) outcome was unknown.            No treatment medications were reported   This case was linked to MOD-2022-550721, MOD-2022-550746, MOD-2022-550751 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Accidental underdose, Somnolence
Clinical narrative: she reports she just slept. Patient took 1st booster dose instead 3rd primary dose; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (she reports she just slept.) and ACCIDENTAL UNDERDOSE (Patient took 1st booster dose instead 3rd primary dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     Concurrent medical conditions included CLL (She is immunocompromised with CLL, a type of leukemia.). Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for Migraine NOS, ESTRADIOL for an unknown indication.    On 27-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced ACCIDENTAL UNDERDOSE (Patient took 1st booster dose instead 3rd primary dose). On an unknown date, the patient experienced SOMNOLENCE (she reports she just slept.). At the time of the report, SOMNOLENCE (she reports she just slept.) had resolved and ACCIDENTAL UNDERDOSE (Patient took 1st booster dose instead 3rd primary dose) outcome was unknown.            No treatment medications were reported   This case was linked to MOD-2022-550721, MOD-2022-550746, MOD-2022-550751 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered after manufacturer date of expiry; Moderna booster administered after expiry 01Apr2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna booster administered after expiry 01Apr2022) and PRODUCT STORAGE ERROR (Dose administered after manufacturer date of expiry) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 031A21A and 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 25-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 25-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna booster administered after expiry 01Apr2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna booster administered after expiry 01Apr2022) and PRODUCT STORAGE ERROR (Dose administered after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No allergies (medications, food and other products) reported and patient did not have COVID positive test or diagnosis. Date the vial was initially stored in the refrigerator 25-Apr-2022. No concomitant medication was reported. No treatment information was reported.   This case was linked to MOD-2022-550986 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: They received their Moderna booster dose 2 months after the JJ booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (They received their Moderna booster dose 2 months after the JJ booster dose) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE (booster dose) in October 2021 and JANSSEN COVID-19 VACCINE (Initial dose). Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE and JANSSEN COVID-19 VACCINE.    In December 2021, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (They received their Moderna booster dose 2 months after the JJ booster dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (They received their Moderna booster dose 2 months after the JJ booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported. HCP  told the patient is over the age of 50 years old.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First Dose administered on 22-Dec-2020 and second dose administered on 12-Jan-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose administered on 22-Dec-2020 and second dose administered on 12-Jan-2021) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose administered on 22-Dec-2020 and second dose administered on 12-Jan-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose administered on 22-Dec-2020 and second dose administered on 12-Jan-2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.   This case was linked to MOD-2022-551251 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: stayed tired all day and lounged around the house.; left arm was a little sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left arm was a little sore at the injection site) and FATIGUE (stayed tired all day and lounged around the house.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056A22A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer Vaccine (First Dose) on 05-Jan-2021, Pfizer Vaccine (Second Dose) on 26-Jan-2021 and Pfizer Vaccine (1st Booster Dose) on 03-Sep-2021. Past adverse reactions to the above products included No adverse event with Pfizer Vaccine, Pfizer Vaccine and Pfizer Vaccine.    On 23-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 23-Apr-2022, the patient experienced VACCINATION SITE PAIN (left arm was a little sore at the injection site). On 24-Apr-2022, the patient experienced FATIGUE (stayed tired all day and lounged around the house.). At the time of the report, VACCINATION SITE PAIN (left arm was a little sore at the injection site) and FATIGUE (stayed tired all day and lounged around the house.) had resolved.            No concomitant medication was provided.  No allergies were reported. It was reported that the patient was never tested or diagnosed with COVID. The AE did not cause patient to seek medical care.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2022: Follow-up received includes vaccine administration dates of historical vaccine updated.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation reaction, Pain in extremity
Clinical narrative: I was tired for a couple of days; arm hurt/arm only hurt in certain positions; side effects she experienced were not unreasonably and didn't bother her that much.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I was tired for a couple of days), PAIN IN EXTREMITY (arm hurt/arm only hurt in certain positions) and VACCINATION COMPLICATION (side effects she experienced were not unreasonably and didn't bother her that much.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced FATIGUE (I was tired for a couple of days), PAIN IN EXTREMITY (arm hurt/arm only hurt in certain positions) and VACCINATION COMPLICATION (side effects she experienced were not unreasonably and didn't bother her that much.). At the time of the report, FATIGUE (I was tired for a couple of days), PAIN IN EXTREMITY (arm hurt/arm only hurt in certain positions) and VACCINATION COMPLICATION (side effects she experienced were not unreasonably and didn't bother her that much.) outcome was unknown.            No concomitant medication were reported.  She said that the side effects she experienced were not unreasonable and didn't bother her that much.   She asked to not report the side effects as she believes in this vaccine and does not want to complain about it. She wants people to get the vaccine.   She initially stated that her husband had the same side effects but during the call she confirmed with her husband that he did not experience any side effects from his shots.   No treatment drug were reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: horrific headache; tired; This spontaneous case was reported by a medical assistant and describes the occurrence of HEADACHE (horrific headache) and FATIGUE (tired) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised, Irritable bowel syndrome, Hypertension and Asthma. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), MONTELUKAST, LINACLOTIDE (LINZESS), OMEGA-3-ACID ETHYL ESTER (LOVAZA), ATORVASTATIN, TELMISARTAN, DIGOXIN, FAMOTIDINE (PEPCID [FAMOTIDINE]), ACYCLOVIR [ACICLOVIR], LEVOCETIRIZINE DIHYDROCHLORIDE (ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]), BUTALBITAL, CAFFEINE, PARACETAMOL (ESGIC) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced HEADACHE (horrific headache) and FATIGUE (tired). At the time of the report, HEADACHE (horrific headache) and FATIGUE (tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received the vaccine in her left arm shoulder deltoid muscle. She received her second Moderna Covid-19 vaccine on 05-Feb-2021 with lot number 026L20A.  No treatment information was reported.   This case was linked to MOD-2022-549009, MOD-2022-549089 (Patient Link).
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pruritus, Scratch
Clinical narrative: he feels like wringing his hands; has scabs from scratching; itchiness/itching all over/rubs his hands together; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness/itching all over/rubs his hands together), FEELING ABNORMAL (he feels like wringing his hands) and SCRATCH (has scabs from scratching) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066K21A, 014F21A, 030B21A and 036A21A) for COVID-19 vaccination.     Patient had no concurrent conditions and did not have any diagnosis of Covid-19 pre or post vaccination.  The patient's past medical history included Feeling sick (for a week after a trip to a place where Covid-19 was pretty high but was not tested.) in February 2020. Concurrent medical conditions included Penicillin allergy.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (itchiness/itching all over/rubs his hands together). On an unknown date, the patient experienced FEELING ABNORMAL (he feels like wringing his hands) and SCRATCH (has scabs from scratching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching all over, at an unspecified dose and frequency. At the time of the report, PRURITUS (itchiness/itching all over/rubs his hands together) was resolving and FEELING ABNORMAL (he feels like wringing his hands) and SCRATCH (has scabs from scratching) outcome was unknown.            No concomitant medications were reported. Patient had flu vaccine on an unknown date in Sep-2021.   This case was linked to MOD-2022-551352 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction, Vaccination site injury
Clinical narrative: my ENT told me about an influx of patients who had an over reaction; thousands and thousands of patients have had vaccine injury; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (my ENT told me about an influx of patients who had an over reaction) and VACCINATION SITE INJURY (thousands and thousands of patients have had vaccine injury) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (my ENT told me about an influx of patients who had an over reaction) and VACCINATION SITE INJURY (thousands and thousands of patients have had vaccine injury). At the time of the report, VACCINATION COMPLICATION (my ENT told me about an influx of patients who had an over reaction) and VACCINATION SITE INJURY (thousands and thousands of patients have had vaccine injury) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Lichen planus
Clinical narrative: diagnostic with Lichen Planus; This is inconvenient; This spontaneous case was reported by a consumer and describes the occurrence of LICHEN PLANUS (diagnostic with Lichen Planus) and FEELING ABNORMAL (This is inconvenient) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A and 004F21A) for COVID-19 vaccination.     Patient never had COVID positive test. No history relating to mentioned AE and both acute and chronic illnesses at the time of vaccination. Patient did not have similar events in the past.  Concurrent medical conditions included Penicillin allergy and Allergy to antibiotic (Amoxicillin). Concomitant products included VITAMINS NOS for an unknown indication.   On 07-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LICHEN PLANUS (diagnostic with Lichen Planus) and FEELING ABNORMAL (This is inconvenient). At the time of the report, LICHEN PLANUS (diagnostic with Lichen Planus) and FEELING ABNORMAL (This is inconvenient) had not resolved.            It was reported that after getting the second dose of the Moderna covid19 vaccine a month and half later patient got red marks in her stomach, forearms, back and chest. She went to the dermatologist and was diagnosed with Lichen Planus, she also reported that lot of articles stated that is in correlation with the vaccine, the rash was going to take months to get away and she had to take steroids. It was inconvenient and was itching all the time. Patient no office visit. It had been 3 months so far and was not giving signs of getting better and it had worsened.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2022: Follow up received contains no new information.
Sex: M
Vaccine: PNC13
Symptoms: Accidental exposure to product, Burning sensation, Underdose
Clinical narrative: Resulting in some of the vaccine running down his arm; The vaccine "burned"; Estimated that "2/3" of the vaccine was administered to the patient; This is a spontaneous report received from a non-contactable reporter(s) (Consumer) from medical information team.  A 57-year-old male patient received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ACCIDENTAL EXPOSURE TO PRODUCT (non-serious), outcome "unknown", described as "Resulting in some of the vaccine running down his arm"; BURNING SENSATION (non-serious), outcome "unknown", described as "The vaccine "burned""; UNDERDOSE (non-serious), outcome "unknown", described as "Estimated that "2/3" of the vaccine was administered to the patient". It was reported that while receiving the vaccine, the patient jerked his arm and the needle came out, resulting in some of the vaccine running down his arm. He stated that the vaccine "burned" thus he moved as he did during administration. It was reported that the clinical staff member who administered the vaccine estimated that "2/3" of the vaccine was administered to the patient. They would like to know if the amount that was administered is sufficient or if they should get more.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Intermenstrual bleeding, Oligomenorrhoea, Palpitations, Peripheral swelling
Clinical narrative: Client presented at the vaccination site on 01/20/22. The client reported she received a first dose of Pfizer COVID vaccine on 03/13/21 (lot #: EP7534) and a second dose of Pfizer COVID vaccine on 04/03/21 (lot #: ER8729) both at the COVID vaccination site. Client reported with her first dose on 03/13/21, she felt tired and sleepy on the second day after vaccination which lasted only one day. Client reported with her second dose of Pfizer COVID vaccine on 04/03/21, she had tiredness and sleepiness on day two which lasted only one day, heart palpitation for less than one minute at nighttime on day two and had her menstrual cycle (spotting red blood) on day two after vaccination which lasted for three weeks. Client reported with her second dose of Pfizer COVID vaccine, she had swelling of her left hand and arm on the side of injection with facial swelling too on day six which lasted one day only. She only told her heart palpitation at her PCP visit, but she didn?t mention other symptoms she had or take any medications for the symptoms she had. She reported her PCP told her heart palpitation was normal. But client reported she didn?t ask her PCP for approval to get her booster dose of Pfizer COVID vaccine. Client reported she has no chronic illnesses, not taking any medications, nor has any known allergy. Client is requesting for the booster dose of Pfizer COVID vaccine today. PHN submitted a medical consult via text message to clinical project coordinator requesting to proceed with the booster dose of Pfizer COVID vaccine. Per the doctor, approval to proceed with the booster dose of Pfizer COVID vaccine was obtained via text message from clinical project coordinator. At 1740, she decided not to wait for the medical consult approval and left the vaccination site. But she requested a phone call from PHN to let her know the result of the approval. At 1740, the booster dose of Pfizer COVID vaccine was not administered to client because she left the vaccination site. Today, PHN called client and told her she got approved for her booster dose of Pfizer COVID vaccine and she requested to come get it when she is available without making an appointment. Client is aware of the COVID vaccination site hours of operation.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Swelling face
Clinical narrative: Client presented at the vaccination site on 01/20/22. The client reported she received a first dose of Pfizer COVID vaccine on 03/13/21 (lot #: EP7534) and a second dose of Pfizer COVID vaccine on 04/03/21 (lot #: ER8729) both at the COVID vaccination site. Client reported with her first dose on 03/13/21, she felt tired and sleepy on the second day after vaccination which lasted only one day. Client reported with her second dose of Pfizer COVID vaccine on 04/03/21, she had tiredness and sleepiness on day two which lasted only one day, heart palpitation for less than one minute at nighttime on day two and had her menstrual cycle (spotting red blood) on day two after vaccination which lasted for three weeks. Client reported with her second dose of Pfizer COVID vaccine, she had swelling of her left hand and arm on the side of injection with facial swelling too on day six which lasted one day only. She only told her heart palpitation at her PCP visit, but she didn?t mention other symptoms she had or take any medications for the symptoms she had. She reported her PCP told her heart palpitation was normal. But client reported she didn?t ask her PCP for approval to get her booster dose of Pfizer COVID vaccine. Client reported she has no chronic illnesses, not taking any medications, nor has any known allergy. Client is requesting for the booster dose of Pfizer COVID vaccine today. PHN submitted a medical consult via text message to clinical project coordinator requesting to proceed with the booster dose of Pfizer COVID vaccine. Per the doctor, approval to proceed with the booster dose of Pfizer COVID vaccine was obtained via text message from clinical project coordinator. At 1740, she decided not to wait for the medical consult approval and left the vaccination site. But she requested a phone call from PHN to let her know the result of the approval. At 1740, the booster dose of Pfizer COVID vaccine was not administered to client because she left the vaccination site. Today, PHN called client and told her she got approved for her booster dose of Pfizer COVID vaccine and she requested to come get it when she is available without making an appointment. Client is aware of the COVID vaccination site hours of operation.
Sex: U
Vaccine: COVID19
Symptoms: Chronic graft versus host disease
Clinical narrative: exacerbation of chronic graft versus host disease; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "haematopoietic stem cell transplantation (HSCT)" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19  vaccine (manufacturer unknown, Dose 1), for COVID-19 immunisation. The following information was reported: CHRONIC GRAFT VERSUS HOST DISEASE (medically significant), outcome "unknown", described as "exacerbation of chronic graft versus host disease".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event: "Chronic graft versus host disease" 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 drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200611693 Same reporter/product/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Caller verified that she is still within the 5-day period since symptom onset; Caller verified that she is still within the 5-day period since symptom onset; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SIMVASTATIN; ROSUVASTATIN [ROSUVASTATIN CALCIUM]. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "Caller verified that she is still within the 5-day period since symptom onset".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Latent autoimmune diabetes in adults, SARS-CoV-2 test
Clinical narrative: I was diagnosed with LADA latent autoimmune diabetes in adults; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Oct2021 at 10:00 as dose 3 (booster), single (Lot number: FF2593) at the age of 65 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The did not have any known allergies. There were no concomitant medications or other medications in two weeks. Vaccination history included: BNT162b2 (Dose 1, Lot number: EH9899, Location of injection: Left arm, Vaccine administration time: 19:30 pm), administration date: 16Dec2020, when the patient was 64-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Lot number: EL1284, Location of injection: Left arm, Vaccine administration time: 19:00 pm), administration date: 07Jan2021, when the patient was 64-year-old, for COVID-19 immunization. The following information was reported: LATENT AUTOIMMUNE DIABETES IN ADULTS (disability) with onset 06Jan2022 at 09:00, outcome "not recovered", described as "I was diagnosed with LADA latent autoimmune diabetes in adults". The event "i was diagnosed with lada latent autoimmune diabetes in adults" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jan2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of latent autoimmune diabetes in adults which included metformin, glipizide, humalog, lantus. On 24Mar2022, the patient was diagnosed with LADA latent autoimmune diabetes in adults. There was disability or permanent damage. The facility where the most recent COVID-19 vaccine was administered was Doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.; Sender's Comments: As there is limited information in the case provided, the causal association between the event latent autoimmune diabetes in adults  and the suspect 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 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: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Gait inability, Pain in extremity, Peripheral swelling
Clinical narrative: Within 24 hours after receiving my 2nd Pfizer booster vaccine, my right foot became swollen, red, and extremely painful.  I can't walk on it.  It has been like this for 1 day now.; Within 24 hours after receiving my 2nd Pfizer booster vaccine, my right foot became swollen, red, and extremely painful.  I can't walk on it.  It has been like this for 1 day now.; Within 24 hours after receiving my 2nd Pfizer booster vaccine, my right foot became swollen, red, and extremely painful.  I can't walk on it.  It has been like this for 1 day now.; Within 24 hours after receiving my 2nd Pfizer booster vaccine, my right foot became swollen, red, and extremely painful.  I can't walk on it.  It has been like this for 1 day now.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 21Apr2022 at 18:00 as dose 4 (booster), single (Lot number: Fp4554) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: En6208, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 16Mar2021, when the patient was 54-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: Er8733, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 06Apr2021, when the patient was 54-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 3, Batch/Lot No: 301258a, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 21Oct2021, when the patient was 55-year-old, for COVID-19 Immunization. The following information was reported: PERIPHERAL SWELLING (disability), ERYTHEMA (disability), PAIN IN EXTREMITY (disability), GAIT INABILITY (disability) all with onset 22Apr2022 at 18:00, outcome "not recovered" and all described as "Within 24 hours after receiving my 2nd Pfizer booster vaccine, my right foot became swollen, red, and extremely painful. I can't walk on it. It has been like this for 1 day now.". Therapeutic measures were not taken as a result of peripheral swelling, erythema, pain in extremity, gait inability.  Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No hospitalization Prolonged. AE resulted in Disability or permanent damage. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Reported Event: Within 24 hours after receiving his 2nd Pfizer booster vaccine, his right foot became swollen, red, and extremely painful. He couldn't walk on it. It has been like this for 1 day now.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: they had gotten COVID-19 after receiving two primary and one booster dose of Comirnaty (BionTech/Pfizer COVID-19 vaccine).; they had gotten COVID-19 after receiving two primary and one booster dose of Comirnaty (BionTech/Pfizer COVID-19 vaccine).; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "they had gotten COVID-19 after receiving two primary and one booster dose of Comirnaty (BionTech/Pfizer COVID-19 vaccine).". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: COVID-19, notes: Reporter stated they had gotten COVID-19 after receiving two primary and one booster dose of Comirnaty (BionTech/Pfizer covid-19 vaccine).Reporter acknowledged minor symptoms, no hospitalization.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Investigation, Suspected COVID-19
Clinical narrative: Rebound effect. Felt great after day 7 of infection. Then tested positive again and symptoms returned until day 18; Rebound effect. Felt great after day 7 of infection. Then tested positive again and symptoms returned until day 18; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 26Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 31 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose Number:1 , Manufacture unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacture unknown), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 28Mar2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 28Mar2022, outcome "recovered with sequelae" and all described as "Rebound effect. Felt great after day 7 of infection. Then tested positive again and symptoms returned until day 18". The patient underwent the following laboratory tests and procedures: Tested: (28Mar2022) positive. Therapeutic measures were taken as a result of suspected covid-19.  Clinical course: Drug(s) Information: Characterization of drug role: Suspect Proprietary medicinal product name: Paxlovid Indication for use in the case: Treatment of COVID-19 Date of start of drug: 23Mar2022 Date of last administration: 28Mar2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Feb2022 at 13:00 as dose 3 (single), booster (Lot number: FK9896) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hyperthyroid" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL TARTRATE, start date: 02Dec2013; METHIMAZOLE, start date: 02Dec2013; ZOLOFT, start date: 01Oct2018. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "report with Pfizer BioNTech Vaccine administered(patient also took plaxvid for covid-19 treatment)". Therapeutic measures were taken as a result of suspected covid-19.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EL3247), in right arm, on 25Mar2021 as dose 2, single (Lot number: EL3247), in right arm and on 22Oct2021 as dose 3 (booster), single (Lot number: PF2590) at the age of 54 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension, treated" (ongoing), notes: hypertension, treated; "Joint Health" (ongoing); "Multi-vitamin" (ongoing). The patient did not have any known allergies. Concomitant medication(s) and other medication the patient received in 2 weeks included: LISINOPRIL taken for hypertension, start date: Apr2007; CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN taken for multi-vitamin deficiency start date: Apr2007, stop date: Dec2019; OSTEO-BI-FLEX taken for arthropathy. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 06Apr2022 to 22Apr2022.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID test result positive; COVID test result positive; 22Apr2022 emails with reports of illness; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 46-year-old male patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL3247), on 17Feb2021 as dose 2, single (Lot number: EL3247) and on 22Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 22Apr2022, outcome "unknown", described as "22Apr2022 emails with reports of illness"; COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 22Apr2022, outcome "unknown" and all described as "COVID test result positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Apr2022) Positive, notes: COVID test type post vaccination: Unknown. It was unknown if therapeutic measures were taken as a result of covid-19, illness. Clinical course: Prior to the vaccination, the patient diagnosed with COVID-19 was unknown. Since the vaccination, the patient has been tested positive for COVID-19. It was unknown, whether the patient received any other vaccines prior to the COVID-19 vaccine.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Vaccination failure, Covid 19 cannot be completely excluded
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LITHIUM; QUETIAPINE; SYNTHROID; LINZESS. Past drug history included: Risperidone, reaction(s): "Allergy". Vaccination history included: shingrx (Dose:2, vaccine_location=Left arm), administration date: 03Mar2022; Bnt162b2 (1st Dose), for Covid-19 Immunization; Bnt162b2 (2nd Dose), for Covid-19 Immunization; Bnt162b2 (3rd Dose), for Covid-19 Immunization. The following information was reported: TINNITUS (disability) with onset 22Apr2022, outcome "not recovered". Therapeutic measures were not taken as a result of tinnitus. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient been was not been tested for COVID-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Apr2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 14Jun2021 at 15:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 30Nov2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "AOSD" (unspecified if ongoing), notes: Was taking Kineret before I caught covid but stopped as symptoms started and have not resumed. There were no concomitant medications and no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive. Therapeutic measures were taken as a result of covid-19 (Paxlovid (anti-viral) initially worked, and symptoms resolved but 5 days after the last dose, all the symptoms came back and 2 weeks later I still am sick and testing positive using an at home antigen test).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.