chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; patient was administered a lower than authorized dose volume of the Moderna COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (patient was administered a lower than authorized dose volume of the Moderna COVID-19) and NO ADVERSE EVENT (No adverse event) in an 85-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050D22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 Vaccine (Booster dose). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 Vaccine.   On 02-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 02-Nov-2022, the patient experienced UNDERDOSE (patient was administered a lower than authorized dose volume of the Moderna COVID-19). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (patient was administered a lower than authorized dose volume of the Moderna COVID-19) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (patient was administered a lower than authorized dose volume of the Moderna COVID-19).    Patient takes multiple regular medications. No treatment medication details was reported. It was reported that bivalent dose was given after receiving 2 primary series doses and a booster dose of the Pfizer COVID-19 vaccines.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Feet swelling; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Feet swelling) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis and Psoriatic arthritis.    Concurrent medical conditions included Plaque psoriasis and Psoriatic arthritis.   On 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Dec-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced PERIPHERAL SWELLING (Feet swelling). At the time of the report, PERIPHERAL SWELLING (Feet swelling) had not resolved.            No concomitant medications were reported.  The reporter's causality for the event of Feet swelling with Adalimumab Solution for Injection was no reasonable possibility.  AbbVie's opinion was that the causality for the event of Feet swelling with Adalimumab Solution for Injection was not Provided.  Primary reporter did not have the lot number information, because the information was not available in the patient's file.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  No treatment medications were reported.    Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Swelling
Clinical narrative: hurts/neck hurts/painful; on the left side of my neck / I have first it looks like it was a little swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (on the left side of my neck / I have first it looks like it was a little swollen) and NECK PAIN (hurts/neck hurts/painful) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Nov-2022, the patient experienced SWELLING (on the left side of my neck / I have first it looks like it was a little swollen). On 04-Nov-2022, the patient experienced NECK PAIN (hurts/neck hurts/painful). At the time of the report, SWELLING (on the left side of my neck / I have first it looks like it was a little swollen) and NECK PAIN (hurts/neck hurts/painful) outcome was unknown.            No concomitant medications were reported. Patient had the booster the Moderna booster on Tuesday morning. Last night on the left side of her neck, which, by the way, she got the shot on her left arm. Patient had first it looks like it was a little swollen, in this morning It did not look like it was swollen. But her next side of her neck hurts. And if you push on the area, it was somewhat painful. And patient was asking Could that be a side effect of the injection. No treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Similar symptoms/ but one that is not well known side effect; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Similar symptoms/ but one that is not well known side effect) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Similar symptoms/ but one that is not well known side effect). At the time of the report, IMMUNISATION REACTION (Similar symptoms/ but one that is not well known side effect) outcome was unknown.            No concomitant medications were reported.  The patient stated that the doctor deemed the symptoms not to be caused by the vaccine. However, after receiving 2 boosters and getting similar symptoms patient feel more confident that it was a side effect and, not only that, but one that was not well known.  Treatment information was not provided.   This case was linked to MOD-2021-158733 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Received Monovalent instead of Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received Monovalent instead of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received Monovalent instead of Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received Monovalent instead of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received Monovalent instead of Bivalent Booster).    No concomitant information was reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-669144 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669144:MOD-2022-669144(Husband case)
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: The patient experienced itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (The patient experienced itchy rash) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (The patient experienced itchy rash). At the time of the report, RASH PRURITIC (The patient experienced itchy rash) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter.  Treatment details were not reported by the reporter.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state
Clinical narrative: he had confusion after receiving Spikevax; This spontaneous case was reported by a patient and describes the occurrence of CONFUSIONAL STATE (he had confusion after receiving Spikevax) in an 81-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONFUSIONAL STATE (he had confusion after receiving Spikevax). At the time of the report, CONFUSIONAL STATE (he had confusion after receiving Spikevax) 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 medication was provided by the reporter No treatment medication was provided by the reporter.
Sex: F
Vaccine: PNC20
Symptoms: Breast swelling, Lymphadenopathy
Clinical narrative: Swollen lymph nodes end to the arm; breast swelling; The initial case was missing the following minimum criteria: Unidentifiable patient. Upon receipt of follow-up information on 02Nov2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 47-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for 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 end to the arm"; BREAST SWELLING (non-serious), outcome "unknown". Additional information: The patient isn't the reporter. Caller is a pharmacist. Pharmacist stated "So, my common, would be question is can Prevnar 20 shot cause like swollen lymph nodes end to the arm and like swelling of the breast. I don't know if any of this?" (Further clarification unknown if administered to any patient). Caller asked for the possible side effects of prevnar 20 after administration. Caller clarified that she has a patient with unknown history of pnuemococcal vaccine who experienced "swollen lymph nodes on the arm, under the arm, swelling on the breast on the right side."   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Off label use, Pain, Product use issue, Pyrexia
Clinical narrative: Fever, aches, lethargy; Fever, aches, lethargy; Fever, aches, lethargy; other vaccine same date product=GSK; other vaccine same date product=GSK; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 5 (booster), single (Lot number: GJ6739) at the age of 53 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 4, unknown manufacturer), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 01Nov2022, outcome "unknown" and all described as "other vaccine same date product=GSK"; PYREXIA (non-serious), PAIN (non-serious), LETHARGY (non-serious) all with onset 02Nov2022, outcome "recovering" and all described as "Fever, aches, lethargy". Therapeutic measures were not taken as a result of pyrexia, pain, lethargy.  Additional information: Location of injection for vaccine received same date: GSK - left arm. The patient was not diagnosed with COVID-10 prior to vaccination. The patient was not tested for COVID-19 since the vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Vaccination site pain
Clinical narrative: The issue has gone from mild to severe; When trying to get out of bus today, she tried to hold the rail and couldn't because the pain is horrible; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: FJ1614) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: EP6955, Route of Administration: Intramuscular), administration date: 09Apr2021, for Covid-19 Immunization, reaction(s): "Moderate pain/ pain was only from her shoulder to her elbow", "Moderate pain/ pain was only from her shoulder to her elbow"; BNT162b2 (DOSE 2, SINGLE, Lot Number: FR8729, Route of Administration: Intramuscular), administration date: 30Apr2021, for Covid-19 Immunization, reaction(s): "pain in her arm/severe left shoulder/arm pain", "pain in her arm/severe left shoulder/arm pain", "pain in her arm/severe left shoulder/arm pain", "she can't lift her arm because it hurts very much/ patient cannot lift her arm past her shoulder", "Frozen shoulder"; Flu (flu shot before and didn't get pain or anything with), for immunization. The following information was reported: CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "The issue has gone from mild to severe"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "When trying to get out of bus today, she tried to hold the rail and couldn't because the pain is horrible".  Additional information: When trying to get out of bus today, she tried to hold the rail and couldn't because the pain was horrible. Had appointment tomorrow with doctor and wants to mention it because it could be related. This had started since getting shot. She had been going back and forth with Pfizer. She wanted to make sure it was not related. Caller clarified that the pain was where she got the Covid shot.
Age: 68.0
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 a contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation; BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in Jan2021 as dose 2, single (Batch/Lot number: unknown), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing), notes: High BP. Concomitant medication(s) included: HCTZ, start date: Feb2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events vaccination failure and Covid-19 are related to BNT162b2 (COMIRNATY) cannot be excluded. This case will be reassessed should additional information become available.,Linked Report(s) : US-PFIZER INC-202201274826 same patient, different dose/event.;
Age: 33.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Off label use, Product use issue, Vision blurred
Clinical narrative: Blurry vision in my right eye; Influenza: 2Nov2022 / Pfizer Bivalent: 2Nov2022; Influenza: 2Nov2022 / Pfizer Bivalent: 2Nov2022; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 at 19:15 as dose 4 (booster), single (Lot number: 6H9702) at the age of 33 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA), on 02Nov2022 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Epilepsy" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing), notes: High Blood Pressure; "Known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: DAYQUIL. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 02Nov2022, outcome "unknown" and all described as "Influenza: 2Nov2022 / Pfizer Bivalent: 2Nov2022"; VISION BLURRED (non-serious) with onset 03Nov2022 at 06:45, outcome "unknown", described as "Blurry vision in my right eye". It was unknown if therapeutic measures were taken as a result of vision blurred.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech - Dose Number: 3 ... Moderna - Dose Number: 4; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 17Dec2020 at 12:00 as dose 1, single (Lot number: EJ1685), in right arm, on 04Jan2022 at 12:00 as dose 2, single (Lot number: EJ1686), in right arm and on 21Aug2022 at 12:00 as dose 3 (booster), single (Lot number: FC3181) at the age of 73 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Jan2022 at 12:00 as dose 4 (booster), single (Lot number: 0451249), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Coronary artery disease" (unspecified if ongoing); "bronchiectasis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "not recovered", described as "Pfizer / BioNTech - Dose Number: 3 ... Moderna - Dose Number: 4"; DRUG INEFFECTIVE (medically significant), 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: (unspecified date) Positive, notes: COVID 19 Treatment; (31Oct2022) Negative; (02Nov2022) Positive, notes: Started having rebound symptoms 02Nov and positive test again. Therapeutic measures were taken as a result of drug ineffective, covid-19. COVID 19 Treatment was PAXLOVID. No known allergies.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: she had rash that came up on her body on several places; This is a spontaneous report received from a contactable reporter(s) (Consumer) from medical information team. The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), as dose 1, 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: RASH (non-serious), outcome "not recovered", described as "she had rash that came up on her body on several places". Additional information: Caller is a consumer. Caller reported that after one and a half month after her first Pfizer covid-19 injection she had rash that came up on her body on several places and up until now the rashes are still there. Caller asked if there is a possibility that the rash could be caused by the vaccine. Caller clarified that she received 4 Pfizer covid vaccines including the bivalent booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Emotional distress, Fear of death, Gait inability, Loss of personal independence in daily activities
Clinical narrative: Caller states she has been suffering for 9 months; Adversities have impacted her daily life; Whether she is going to die, She does not think she will survive; everyday she cannot stand or walk; everyday she cannot stand or walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, 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: EMOTIONAL DISTRESS (non-serious), outcome "not recovered", described as "Caller states she has been suffering for 9 months"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "not recovered", described as "Adversities have impacted her daily life"; FEAR OF DEATH (non-serious), outcome "not recovered", described as "Whether she is going to die, She does not think she will survive"; DYSSTASIA (non-serious), GAIT INABILITY (non-serious), outcome "not recovered" and all described as "everyday she cannot stand or walk".  Additional information: Caller stated the patient had been suffering for 9 months. It had impacted her earnings. Adversities had impacted her daily life and she was not recovered. Stated everyday she could not stand or walk. She did not think she will survive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Erythema, Joint range of motion decreased, Joint stiffness
Clinical narrative: Extreme diarrhea; Chills; Body aches; There's stiffness in the joint, swollen, and red; There's stiffness in the joint, swollen, and red; There's stiffness in the joint, swollen, and red; With this last booster she just got, it is unbelievably painful and swelling; With this last booster she just got, it is unbelievably painful and swelling; Arm is difficult to lift; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown), for Covid-19 immunization, reaction(s): "arm was hurting and was sore". The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "Extreme diarrhea"; CHILLS (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "Body aches"; JOINT STIFFNESS (non-serious), JOINT SWELLING (non-serious), ERYTHEMA (non-serious), outcome "unknown" and all described as "There's stiffness in the joint, swollen, and red"; PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious), outcome "unknown" and all described as "With this last booster she just got, it is unbelievably painful and swelling"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "Arm is difficult to lift". Therapeutic measures were taken as a result of pain, joint stiffness, joint swelling, erythema, pain in extremity, peripheral swelling, joint range of motion decreased.  Additional information: Patient has taken all three Pfizer shots. With the second one her arm was hurting and was sore. With this last booster she just got, it was unbelievably painful and swelling. There was stiffness in the joint, swollen and red. Arm was difficult to lift. Taking Tylenol for that. Having extreme diarrhea, chills and body aches. Calling to see if that was a side effect. It was funky to have that.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201277095 Same patient, different vaccine dose and different events;
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Extreme diarrhea; Chills; Body aches; There's stiffness in the joint, swollen, and red; There's stiffness in the joint, swollen, and red; There's stiffness in the joint, swollen, and red; With this last booster she just got, it is unbelievably painful and swelling; With this last booster she just got, it is unbelievably painful and swelling; Arm is difficult to lift; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown), for Covid-19 immunization, reaction(s): "arm was hurting and was sore". The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "Extreme diarrhea"; CHILLS (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "Body aches"; JOINT STIFFNESS (non-serious), JOINT SWELLING (non-serious), ERYTHEMA (non-serious), outcome "unknown" and all described as "There's stiffness in the joint, swollen, and red"; PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious), outcome "unknown" and all described as "With this last booster she just got, it is unbelievably painful and swelling"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "Arm is difficult to lift". Therapeutic measures were taken as a result of pain, joint stiffness, joint swelling, erythema, pain in extremity, peripheral swelling, joint range of motion decreased.  Additional information: Patient has taken all three Pfizer shots. With the second one her arm was hurting and was sore. With this last booster she just got, it was unbelievably painful and swelling. There was stiffness in the joint, swollen and red. Arm was difficult to lift. Taking Tylenol for that. Having extreme diarrhea, chills and body aches. Calling to see if that was a side effect. It was funky to have that.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201277095 Same patient, different vaccine dose and different events;
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was hurting and was sore; 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), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: unknown), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was hurting and was sore".  Additional information: With the second one her arm was hurting and was sore. The patient had taken all three Pfizer shots.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 4 (booster), single (Lot number: GH9703) at the age of 46 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: ER8733), in left arm, on 22Apr2021 as dose 2, single (Lot number: EW0164), in left arm and on 04Nov2021 as dose 3 (booster), single (Lot number: FH8028), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: RITALIN [METHYLPHENIDATE HYDROCHLORIDE]. Past drug history included: Azithromycin, reaction(s): "Allergy", notes: known allergies: Azithromycin and Claritin; Claritin, reaction(s): "Allergy", notes: known allergies: Azithromycin and Claritin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of covid-19 which included Paxlovid.
Age: 46.0
Sex: F
Vaccine: COVID19, 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 contactable reporter(s) (Physician). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2020 as dose 1, single (Lot number: EK5730) and on 15Oct2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing); "Addisons disease" (unspecified if ongoing); "celiac" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: HYDROCORTISONE; NOVOLOG; LEVOTHYROXINE; FLUDROCORTISONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Oct2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Oct2022) positive; (03Nov2022) positive, notes: I tested again for Covid 19 and was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid Treatment start date: 21Oct2022, stop date: 26Oct2022. No known allergies. Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However, on conservative basis, the possible causality cannot be excluded.
Sex: F
Vaccine: COVID19-2
Symptoms: Pruritus, Rash erythematous
Clinical narrative: developed a red rash; itchiness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose number unknown, single), for COVID-19 Immunization; Covid-19 vaccine (DOSE NUMBER UNKOWN; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: RASH ERYTHEMATOUS (non-serious), outcome "unknown", described as "developed a red rash"; PRURITUS (non-serious), outcome "unknown", described as "itchiness".  Additional information: Patient was calling about the new Bivalent booster, Pfizer covid 19. Caller stated that the last time she got the Pfizer injection, she was fine, but she have developed this rash since that. Patient stated that the only sulfate contact she has had has been direct contact with the skin, never had a sulfate injection. Patient wanted to know if the new Pfizer vaccine have any sulfates.    The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Multiple sclerosis
Clinical narrative: MS; Received the Pfizer bivalent booster on the 28Oct2022 and re-boosted with Pfizer bivalent booster on 03Nov222; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 bivalent booster (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), administration date: 28Oct2022, for COVID-19 immunization; Covid-19 vaccine (Primary immunization series completed; Manufacturer unknown), for COVID-19 immunization. The following information was reported: MULTIPLE SCLEROSIS (medically significant) with onset 03Nov2022, outcome "unknown", described as "MS"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 03Nov2022, outcome "unknown", described as "Received the Pfizer bivalent booster on the 28Oct2022 and re-boosted with Pfizer bivalent booster on 03Nov222". Patient received the bivalent booster on the 28th and then another company came and re-boosted the patient. The patient had 2 boosters within a few days. Nurse asked if there was anything to monitor for. The patient has MS. The Nurse was unsure with the color of the cap as the card only says "Pfizer bivalent on 28Oct and the other one just says Pfizer on the 03".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event multiple sclerosis  and the suspect product 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.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: very dizzy; very fatigued; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "very dizzy"; FATIGUE (non-serious), outcome "unknown", described as "very fatigued".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Limb discomfort, Pyrexia
Clinical narrative: arm bothered him; chills; fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6202) at the age of 78 years for covid-19 immunisation. The patient's family history included: "Glaucoma" (ongoing), notes: Glaucoma. Concomitant medication(s) included: LATANOPROST taken for glaucoma (ongoing). Vaccination history included: Flu vaccine (Dose Number: Unknown, Manufacturer: Unknown), reaction(s): "Bad reaction", "was very achy", "would run a 102 fever". The following information was reported: LIMB DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "arm bothered him"; CHILLS (non-serious) with onset 2021, outcome "unknown"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever".  Additional information: the patient has been taking latanoprost 1 drop in each eye at night for about 25 years. On his first shot, his arm bothered him and had chills and a fever. He only took one medication for glaucoma for his eyes. He had no prior vaccination within 4 weeks. He usually gets a bad reaction from the flu shot and had not had it in years. He would run a 102 fever and was very achy and did not take it anymore.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201277505 same patient/reporter, different event/dose;US-PFIZER INC-202201277506 same patient/reporter, different event/dose;US-PFIZER INC-202201277504 same patient/reporter/events, different dose;
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Limb discomfort, Pyrexia
Clinical narrative: His arm bothered him; Chills; Fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 2, single (Lot number: ER8727) at the age of 78 years, in right arm for covid-19 immunisation. The patient's family history included: "Glaucoma" (ongoing). Concomitant medication(s) included: LATANOPROST taken for glaucoma (ongoing). Vaccination history included: BNT162b2 (Dose 1, single, Lot: EN6202, Expiry Date: Unknown, Site: Unknown, by injection), administration date: 26Feb2021, when the patient was 78-year-old, for COVID-19 immunization, reaction(s): "Arm bothered", "Chills", "Fever"; Flu vaccine (usually gets a bad reaction from the flu shot and has not had it in years), for immunisation, reaction(s): "Bad reaction", "Was very achy", "Would run a 102 fever". The following information was reported: CHILLS (non-serious) with onset 2021, outcome "unknown"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever"; LIMB DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "His arm bothered him".  Additional Information: Patient had no prior vaccination within 4 weeks. On the first shot his arm bothered him and had chills and a fever. The second shot was the same, but a little more severe.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201277494 same patient/reporter/events, different dose;
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain in extremity
Clinical narrative: arm hurt; chills; muscle aches throughout his body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old male patient received BNT162b2 (BNT162B2), on 28Sep2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 79 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). The patient's family history included: "Glaucoma" (ongoing). Concomitant medication(s) included: LATANOPROST taken for glaucoma (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6202), administration date: 26Feb2021, when the patient was 78-year-old, for COVID-19 Immunization, reaction(s): "his arm bothered him", "chills", "fever"; BNT162b2 (DOSE 2, SINGLE; Lot number: ER8727, Site: Thinks it was the right arm by injection), administration date: 19Mar2021, when the patient was 78-year-old, for COVID-19 Immunization, reaction(s): "his arm bothered him", "chills", "fever"; Flu shot, for Influenza Immunization, reaction(s): "bad reaction", "very achy", "run a 102 fever". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "arm hurt"; CHILLS (non-serious), outcome "recovered"; MYALGIA (non-serious), outcome "recovered", described as "muscle aches throughout his body".  Additional information: On the first shot his arm bothered him and had chills and a fever. The second shot was the same, but a little more severe. The first booster everything started getting worse. His arm hurt, he had chills and muscle aches throughout his body and that lasted for a day and a half. He only takes one medication for glaucoma for his eyes. Been on it for about 25 years. Usually gets a bad reaction from the flu shot and has not had it in years. He would run a 102 fever and was very achy and does not take it anymore. No further details provided. He does not think he will take another booster. A lot of other people his age had reactions, but they were not as severe as his. No other information provided. Looked at statistics and over a million people died.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201277494 same patient/reporter, different event/dose;
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Interchange of vaccine products, Yawning
Clinical narrative: yawning; the Johnson and Johnson 2 doses; tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing); "Left heart failure" (ongoing); "Mild kidney disease" (ongoing). There were no concomitant medications. Vaccination history included: janssen coviD-19 vaccine (Dose: 01, Lot number: 1805029), administration date: 26Mar2021, when the patient was 79-year-old, for COVID-19 Immunization; janssen coviD-19 vaccine (Dose: 02, Lot number: 1822811), administration date: 11Nov2021, when the patient was 80-year-old, for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 2022, outcome "not recovered", described as "tiredness"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset Sep2022, outcome "unknown", described as "the Johnson and Johnson 2 doses"; YAWNING (non-serious) with onset Oct2022, outcome "not recovered". The events "the johnson and johnson 2 doses" required physician office visit.  Additional information: The patient was at the doctor for a check-up and he got the shot sometime in Sep2022 and about a month later he noticed he was yawning. Caller states he listens to his body, and he would go lay down and then get up and take care of his responsibilities, but he was just tired and yawning and he has never had that before. Prior Vaccinations (within 4 weeks) was reported as none.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Vaccine brand: Pfizer / BioNTech; Vaccine dose number: 3/ vaccine brand: Other Moderna; Vaccine dose number: 4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 09Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 23Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 30Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "High cholesterol" (unspecified if ongoing); "Obesity" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; HYDROCHLOROTHIAZIDE; OMEPRAZOLE. Past drug history included: Tylenol, reaction(s): "Known allergies: Tylenol", notes: Known allergies: Tylenol; Ibuprofen, reaction(s): "Known allergies: Ibuprofen", notes: Known allergies: Ibuprofen; Aspirin, reaction(s): "Known allergies: Aspirin", notes: Known allergies: Aspirin. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Apr2022, outcome "unknown", described as "Vaccine brand: Pfizer / BioNTech; Vaccine dose number: 3/ vaccine brand: Other Moderna; Vaccine dose number: 4"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "recovered" (2022) and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient took Paxlovid for 5 days, starting on 20Oct2022, started feeling better after 3 days, although patient have consistently still had a bit of congestion and fatigue, but last night woke up and coughed for a couple hours, patient was more congested and have had diarrhea at the time of the report  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.